What you need to know about drugs

Endodan

Percodan(aspirin, oxycodone hcl) – Endo

OTHER BRAND NAMES

Endodan (Endo)

THERAPEUTIC CLASS

Opioid analgesic

INDICATIONS

Management of moderate to moderately severe pain.

ADULT DOSAGE

Adults: Usual: 1 tab q6h PRN for pain. Titrate: Adjust according to severity of pain and response. Max: (aspirin [ASA]) 4g/day or 12 tabs/day. Cessation of Therapy: Taper dose gradually.

HOW SUPPLIED

Tab: (ASA-Oxycodone HCl) 325mg-4.8355mg* *scored

CONTRAINDICATIONS

ASA: Hemophilia, children/teenagers with viral infections, NSAID allergy, and syndrome of asthma, rhinitis, and nasal polyps. Oxycodone: Significant respiratory depression (in unmonitored settings or absence of resuscitative equipment), acute/severe bronchial asthma or hypercarbia, and known/suspected paralytic ileus.

WARNINGS/PRECAUTIONS

Oxycodone: May be abused in a manner similar to other opioid agonists. May cause respiratory depression; extreme caution with acute asthma, chronic obstructive pulmonary disorder, cor pulmonale, or preexisting respiratory impairment. Respiratory depressant effects may be markedly exaggerated in the presence of head injury, other intracranial lesions, or preexisting increased intracranial pressure. Produces effects on pupillary response and consciousness, which may obscure neurologic signs of worsening in patients with head injuries. May cause severe hypotension; caution in circulatory shock. May produce orthostatic hypotension in ambulatory patients. Caution with CNS depression, hypothyroidism, Addison's disease, prostatic hypertrophy, urethral stricture, acute alcoholism, delirium tremens, kyphoscoliosis with respiratory depression, myxedema, toxic psychosis, severe hepatic/pulmonary/renal impairment, and in elderly/debilitated. May obscure diagnosis or clinical course of acute abdominal conditions. May induce or aggravate convulsions/seizures. Monitor for decreased bowel motility in postoperative patients. May cause spasm of the sphincter of Oddi; caution with biliary tract disease, including acute pancreatitis. Physical dependence and tolerance may occur. ASA: May inhibit platelet function. GI side effects reported; monitor for signs of ulceration and bleeding. May cause gastric mucosal irritation and bleeding; avoid with history of active peptic ulcer disease. May cause elevated hepatic enzymes, BUN, SrCr, and amylase, hyperkalemia, proteinuria, and prolonged bleeding time. May cause fetal harm; avoid use during pregnancy, especially in the 3rd trimester. Avoid with severe renal failure (GFR <10mL/min), or with severe hepatic insufficiency. May increase protein-bound iodine result. Avoid use 1 week prior to and during labor and delivery.

ADVERSE REACTIONS

Respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, shock, lightheadedness, dizziness, drowsiness, sedation, N/V.

DRUG INTERACTIONS

ASA: May increase concentrations of acetazolamide, leading to toxicity. May diminish effects of ACE inhibitors, β-blockers, and diuretics. Bleeding risk increased with anticoagulants (eg, warfarin, heparin) and chronic, heavy alcohol use. May decrease total concentration of phenytoin and increase serum valproic acid levels. May enhance serious side effects and toxicity of methotrexate and ketorolac. Avoid with NSAIDs; may increase bleeding or lead to decreased renal function. May increase serum glucose-lowering action of insulin and sulfonylureas, leading to hypoglycemia. Antagonizes uricosuric action of probenecid or sulfinpyrazone. Oxycodone: May enhance neuromuscular-blocking action of skeletal muscle relaxants and increase respiratory depression. Additive CNS depression with opioid analgesics, general anesthetics, centrally acting anti-emetics, phenothiazines, tranquilizers, sedative-hypnotics, or other CNS depressants (eg, alcohol); reduce dose of one or both agents. May cause severe hypotension with drugs that compromise vasomotor tone (eg, phenothiazines). Mixed agonist/antagonist analgesics (pentazocine, nalbuphine, naltrexone, butorphanol) may reduce analgesic effect and/or may precipitate withdrawal symptoms; administer with caution. Increased concentrations with CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Decreased concentrations with CYP450 inducers (eg, rifampin, carbamazepine, phenytoin).

PREGNANCY

Category B (oxycodone) and D (ASA), not for use in nursing.

MECHANISM OF ACTION

ASA: NSAID; inhibits prostaglandin production, including those involved in inflammation. In CNS, works on hypothalamus heat-regulating center to reduce fever. Oxycodone: Opioid analgesic; pure opioid agonist. Principal therapeutic action is analgesia. Effects are mediated by receptors (notably µ and kappa) in the CNS for endogenous opioid-like compounds (eg, endorphins, enkephalins).

PHARMACOKINETICS

Absorption: ASA: Rapid from the stomach. Oxycodone: Absolute bioavailability (87%). Distribution: Found in breast milk; crosses placenta. Oxycodone: Vd=211.9L (IV); plasma protein binding (45%). Metabolism: ASA: Liver by microsomal enzymes; hydrolysis to salicylate. Oxycodone: Extensive by CYP3A4-mediated N-demethylation to noroxycodone (major); further oxidation to noroxymorphone (active). Elimination: ASA: Urine (80-100%; 10%, unchanged salicylate); T1/2=15 min (ASA), 2-3 hrs (salicylate). Oxycodone: Urine (8-14%, unchanged); T1/2=3.51 hrs.

ASSESSMENT

Assess for degree of opioid tolerance, level of pain intensity, type of pain, patient's general condition and medical status, any other conditions where treatment is contraindicated or cautioned, renal/hepatic function, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for signs/symptoms of respiratory depression, elevations in CSF pressure, hypotension, seizures/convulsions, decreased bowel motility in postoperative patients, spasm of sphincter of Oddi, GI ulceration and/or bleeding, physical dependence, tolerance, abuse/addiction, and other adverse reactions. Monitor platelet/renal/hepatic function.

PATIENT COUNSELING

Instruct to dispose of unused tabs by flushing down the toilet. Instruct not to adjust dose without consulting physician. Advise that drug may impair mental and/or physical abilities. Instruct to avoid alcohol or other CNS depressants. Advise to consult physician if pregnant, planning to become pregnant, or nursing. Inform that if taking medication for more than a few weeks, to avoid abrupt withdrawal; advise that dosing will need to be tapered. Inform that drug has potential for abuse, to protect it from theft, and not to give to anyone. Advise that drug may cause or worsen constipation; instruct to notify physician for any past history of constipation.

ADMINISTRATION/STORAGE

Administration: Oral route. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F).


  • Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

    Endodan

    Endodan

    Generic Name: oxycodone and aspirin

    Dosage Form: tablet

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Endodan®

    (Oxycodone and Aspirin Tablets, USP)

    CII

    Rx only

    Endodan Description

    Each Endodan Tablet contains:

    Oxycodone Hydrochloride, USP     4.8355 mg1

    Aspirin, USP         325 mg

    Endodan Tablets also contain the following inactive ingredients: D&C Yellow 10, FD&C Yellow 6, microcrystalline cellulose and corn starch.

    The oxycodone hydrochloride component is Morphinan-6-one, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, hydrochloride, (5a)-., a white to off-white, hygroscopic crystals or powder, odorless, soluble in water; slightly soluble in alcohol and is represented by the following structural formula:

    The aspirin component is 2-(acetyloxy)-, Benzoic acid, a white crystal, commonly tabular or needle-like, or white, crystalline powder. Is odorless or has a faint odor. Is stable in dry air; in moist air it gradually hydrolyzes to salicylic and acetic acids. Slightly soluble in water; freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether and is represented by the following structural formula:

    1
    4.8355 mg oxycodone HCl is equivalent to 4.3346 mg of oxycodone as the free base.

    Endodan – Clinical Pharmacology

    Central Nervous System

    Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. These effects are mediated by receptors (notably μ and κ) in the central nervous system for endogenous opioid-like compounds such as endorphins and enkephalins. Oxycodone produces respiratory depression through direct activity at respiratory centers in the brain stem and depresses the cough reflex by direct effect on the center of the medulla.

    Aspirin (acetylsalicylic acid) works by inhibiting the body’s production of prostaglandins, including prostaglandins involved in inflammation. Prostaglandins cause pain sensations by stimulating muscle contractions and dilating blood vessels throughout the body. In the CNS, aspirin works on the hypothalamus heat-regulating center to reduce fever, however, other mechanisms may be involved.

    Gastrointestinal Tract and Other Smooth Muscle

    Oxycodone reduces motility by increasing smooth muscle tone in the stomach and duodenum. In the small intestine, digestion of food is delayed by decreases in propulsive contractions. Other opioid effects include contraction of biliary tract smooth muscle, spasm of the Sphincter of Oddi, increased ureteral and bladder sphincter tone, and a reduction in uterine tone.

    Aspirin can produce gastrointestinal injury (lesions, ulcers) through a mechanism that is not yet completely understood, but may involve a reduction in eicosanoid synthesis by the gastric mucosa. Decreased production of prostaglandins may compromise the defenses of the gastric mucosa and the activity of substances involved in tissue repair and ulcer healing.

    Cardiovascular System

    Oxycodone may produce a release of histamine and may be associated with orthostatic hypotension, and other symptoms, such as pruritus, flushing, red eyes, and sweating.

    Platelet Aggregation

    Aspirin affects platelet aggregation by irreversibly inhibiting prostaglandin cyclo-oxygenase. This effect lasts for the life of the platelet and prevents the formation of the platelet aggregating factor thromboxane A2. Nonacetylated salicylates do not inhibit this enzyme and have no effect on platelet aggregation. At somewhat higher doses, aspirin reversibly inhibits the formation of prostaglandin 12 (prostacyclin), which is an arterial vasodilator and inhibits platelet aggregation.

    Pharmacokinetics

    Absorption and Distribution

    The mean absolute oral bioavailability of oxycodone in cancer patients was reported to be about 87%. Oxycodone has been shown to be 45% bound to human plasma proteins in vitro. The volume of distribution after intravenous administration is 211.9 ±186.6 L.

    Aspirin is hydrolyzed primarily to salicylic acid in the gut wall and during first-pass metabolism through the liver. Salicylic acid is absorbed rapidly from the stomach, but most of the absorption occurs in the proximal small intestine. Following absorption, salicylate is distributed to most body tissues and fluids, including fetal tissues, breast milk, and the CNS. High concentrations are found in the liver and kidneys. Salicylate is variably bound to serum proteins, particularly albumin.

    Metabolism and Elimination

    A high portion of oxycodone is N-dealkylated to noroxycodone during first-pass metabolism. Oxymorphone, is formed by the O-demethylation of oxycodone. The metabolism of oxycodone to oxymorphone is catalyzed by CYP2D6. Free and conjugated noroxycodone, free and conjugated oxycodone, and oxymorphone are excreted in human urine following a single oral dose of oxycodone. Approximately 8% to 14% of the dose is excreted as free oxycodone over 24 hours after administration. Following a single, oral dose of oxycodone, the mean ± SD elimination half-life is 3.51 ± 1.43 hours.

    The biotransformation of aspirin occurs primarily in the liver by the microsomal enzyme system. With a plasma half-life of approximately 15 minutes, aspirin is rapidly hydrolyzed to salicylate. At low doses, salicylate elimination follows first-order kinetics. The plasma half-life of salicylate is approximately 2 to 3 hours.

    Approximately 10% of aspirin is excreted as unchanged salicylate in the urine. The major metabolites excreted in the urine are salicyluric acid (75%), salicyl phenolic glucuronide (10%), salicyl acyl glucuronide (5%), and gentisic and gentisuric acid (less than 1%) each. Eighty to 100% of a single dose is excreted in the urine within 24 to 72 hours.

    Indications and Usage for Endodan

    Endodan tablets are indicated for the management of moderate to moderately severe pain.

    Contraindications

    Endodan tablets are contraindicated in patients with known hypersensitivity to oxycodone or aspirin, and in any situation where opioids or aspirin are contraindicated. Aspirin is contraindicated for patients with hemophilia.

    Reye Syndrome: Aspirin should not be used in children or teenagers for viral infections, with or without fever, because of the risk of Reye syndrome with concomitant use of aspirin in certain viral illnesses.

    Allergy: Aspirin is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema, or bronchospasm (asthma).

    Oxycodone is contraindicated in patients with known hypersensitivity to oxycodone. Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus.

    Warnings

    Misuse, Abuse and Diversion of Opioids

    Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

    Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Endodan tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Concerns about misuse, addiction, and diversion should not prevent the proper management of pain.

    Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

    Administration of Endodan (Oxycodone and Aspirin Tablets, USP) tablets should be closely monitored for the following potentially serious adverse reactions and complications:

    Respiratory Depression

    Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in Endodan tablets, as with all opioid agonists. Elderly and debilitated patients are at particular risk for respiratory depression as are non-tolerant patients given large initial doses of oxycodone or when oxycodone is given in conjunction with other agents that depress respiration. Oxycodone should be used with extreme caution in patients with acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

    In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized (see OVERDOSAGE ).

    Head Injury and Increased Intracranial Pressure

    The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of worsening in patients with head injuries.

    Hypotensive Effect

    Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs which compromise vasomotor tone such as phenothiazines. Oxycodone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Oxycodone may produce orthostatic hypotension in ambulatory patients.

    Alcohol Warning

    Patients who consume three or more alcoholic drinks every day should be counseled about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.

    Coagulation Abnormalities

    Even low doses of aspirin can inhibit platelet function leading to an increase in bleeding time. This can adversely affect patients with inherited (hemophilia) or acquired (liver disease or vitamin K deficiency) bleeding disorders.

    GI Side Effects

    GI side effects include stomach pain, heartburn, nausea, vomiting, and gross GI bleeding. Although minor upper GI symptoms, such as dyspepsia, are common and can occur anytime during therapy, physicians should remain alert for signs of ulceration and bleeding, even in the absence of previous GI symptoms. Physicians should inform patients about the signs and symptoms of GI side effects and what steps to take if they occur.

    Peptic Ulcer Disease

    Patients with a history of active peptic ulcer disease should avoid using aspirin, which can cause gastric mucosal irritation and bleeding.

    Precautions

    General

    Opioid analgesics should be used with caution when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.

    Endodan tablets should be given with caution to patients with CNS depression, elderly or debilitated patients, patients with severe impairment of hepatic, pulmonary, or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, urethral stricture, acute alcoholism, delirium tremens, kyphoscoliosis with respiratory depression, myxedema, and toxic psychosis.

    Endodan tablets may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

    Following administration of Endodan tablets, anaphylactic reactions have been reported in patients with a known hypersensitivity to codeine, a compound with a structure similar to morphine and oxycodone. The frequency of this possible cross-sensitivity is unknown.

    Aspirin has been associated with elevated hepatic enzymes, blood urea nitrogen and serum creatinine, hyperkalemia, proteinuria, and prolonged bleeding time.

    Hemorrhage

    Aspirin may increase the likelihood of hemorrhage due to its effect on the gastric mucosa and platelet function (prolongation of bleeding time). Salicylates should be used with caution in the presence of peptic ulcer or coagulation abnormalities.

    Pregnancy

    Aspirin can cause fetal harm when administered to a pregnant woman. Salicylates readily cross the placenta and by inhibiting prostaglandin synthesis, may cause constriction of ductus arteriosus, resulting in pulmonary hypertension and increased fetal mortality and, possibly other untoward fetal effects. Aspirin use in pregnancy can also result in alteration in maternal and neonatal hemostasis mechanisms. Maternal aspirin use during later stages of pregnancy may cause low birth weight, increased incidence of intracranial hemorrhage in premature infants, stillbirths and neonatal death. The use of aspirin during pregnancy especially in the third trimester should be avoided. If Endodan tablets are used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

    Renal Failure

    Avoid aspirin in patients with severe renal failure (glomerular filtration rate less than 10 mL/minute).

    Hepatic Insufficiency

    Avoid aspirin in patients with severe hepatic insufficiency.

    Interactions with Other CNS Depressants

    Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with Endodan tablets may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

    Interactions with Mixed Agonist/Antagonist Opioid Analgesics

    Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.

    Ambulatory Surgery and Postoperative Use

    Oxycodone and other morphine-like opioids have been shown to decrease bowel motility. Ileus is a common postoperative complication, especially after intra-abdominal surgery with use of opioid analgesia. Caution should be taken to monitor for decreased bowel motility in postoperative patients receiving opioids. Standard supportive therapy should be implemented.

    Use in Pancreatic/Biliary Tract Disease

    Oxycodone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level.

    Tolerance and Physical Dependence

    Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.

    The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory, respiratory rate, or heart rate.

    In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION: Cessation of Therapy).

    Information for Patients/Caregivers

    The following information should be provided to patients receiving Endodan tablets by their physician, nurse, pharmacist, or caregiver:

    1. Patients should be aware that Endodan tablets contain oxycodone, which is a morphine-like substance.
    2. Patients should be instructed to keep Endodan tablets in a secure place out of the reach of children. In the case of accidental ingestions, emergency medical care should be sought immediately.
    3. When Endodan tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.
    4. Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician.
    5. Patients should be advised that Endodan tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
    6. Patients should not combine Endodan tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician. When co-administered with another CNS depressant, Endodan tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.
    7. The safe use of Endodan tablets during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking Endodan tablets.
    8. Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue Endodan tablets because of the potential for serious adverse reactions to nursing infants.
    9. Patients who are treated with Endodan tablets for more than a few weeks should be advised not to abruptly discontinue the medication. Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.
    10. Patients should be advised that Endodan tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
    11. Patients should be advised that Endodan tablets may cause or worsen constipation. They should discuss any past history of constipation with their prescribing physician so a management plan may be initiated.

    Laboratory Tests

    Although oxycodone may cross-react with some drug urine tests, no available studies were found which determined the duration of detectability of oxycodone in urine drug screens. However, based on pharmacokinetic data, the approximate duration of detectability for a single dose of oxycodone is roughly estimated to be one to two days following drug exposure.

    Urine testing for opiates may be performed to determine illicit drug use and for medical reasons such as evaluation of patients with altered states of consciousness or monitoring efficacy of drug rehabilitation efforts. The preliminary identification of opiates in urine involves the use of an immunoassay screening and thin-layer chromatography (TLC). Gas chromatography/mass spectrometry (GC/MS) may be utilized as a third-stage identification step in the medical investigational sequence for opiate testing after immunoassay and TLC. The identities of 6-keto opiates (e.g., oxycodone) can further be differentiated by the analysis of their methoxime-trimethylsilyl (MO-TMS) derivative.

    Drug/Drug Interactions with Oxycodone

    Opioid analgesics may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression.

    Patients receiving CNS depressants such as other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with Endodan tablets may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

    Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, naltrexone, and butorphanol) should be administered with caution to a patient who has received or is receiving a pure opioid agonist such as oxycodone. These agonist/antagonist analgesics may reduce the analgesic effect of oxycodone or may precipitate withdrawal symptoms.

    Drug/Drug Interactions with Aspirin

    Angiotensin Converting Enzyme (ACE) Inhibitors: The hyponatremic and hypotensive effects of ACE inhibitors may be diminished by the concomitant administration of aspirin due to its indirect effect on the renin-angiotensin conversion pathway.

    Acetazolamide: Concurrent use of aspirin and acetazolamide can lead to high serum concentrations of acetazolamide (and toxicity) due to competition at the renal tubule for secretion.

    Anticoagulant Therapy (Heparin and Warfarin): Patients on anticoagulation therapy are at increased risk for bleeding because of drug-drug interactions and the effect on platelets. Aspirin can displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Aspirin can increase the anticoagulant activity of heparin, increasing bleeding risk.

    Anticonvulsants: Salicylate can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels.

    Beta Blockers: The hypotensive effects of beta blockers may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading to decreased renal blood flow, and salt and fluid retention.

    Diuretics: The effectiveness of diuretics in patients with underlying renal or cardiovascular disease may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading to decreased renal blood flow and salt and fluid retention.

    Methotrexate: Aspirin may enhance the serious side and toxicity of methotrexate due to displacement from its plasma protein binding sites and/or reduced renal clearance.

    Nonsteroidal Anti-inflammatory Drugs (NSAID’s): The concurrent use of aspirin with other NSAID’s should be avoided because this may increase bleeding or lead to decreased renal function. Aspirin may enhance the serious side effects and toxicity of ketorolac, due to displacement from its plasma protein binding sites and/or reduced renal clearance.

    Oral Hypoglycemics Agents: Aspirin may increase the serum glucose-lowering action of insulin and sulfonylureas leading to hypoglycemia.

    Uricosuric Agents: Salicylates antagonize the uricosuric action of probenecid or sulfinpyrazone.

    Drug/Laboratory Test Interactions

    Depending on the sensitivity/specificity and the test methodology, the individual components of Endodan tablets may cross-react with assays used in the preliminary detection of cocaine (primary urinary metabolite, benzoylecgonine) or marijuana (cannabinoids) in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The preferred confirmatory method is gas chromatography/mass spectrometry (GC/MS). Moreover, clinical considerations and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

    Salicylates may increase the protein bound iodine (PBI) result by competing for the protein binding sites on pre-albumin and possibly thyroid-binding globulins.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carcinogenesis

    Animal studies to evaluate the carcinogenic potential of oxycodone and aspirin have not been performed.

    Mutagenesis

    The combination of oxycodone and aspirin has not been evaluated for mutagenicity. Oxycodone alone was negative in a bacterial reverse mutation assay (Ames), an in vitro chromosome aberration assay with human lymphocytes without metabolic activation and an in vivo mouse micronucleus assay. Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation and in the mouse lymphoma assay with or without metabolic activation. Aspirin induced chromosome aberrations in cultured human fibroblasts.

    Fertility

    Animal studies to evaluate the effects of oxycodone on fertility have not been performed. Aspirin has been shown to inhibit ovulation in rats.

    Pregnancy

    Teratogenic Effects

    Oxycodone: Pregnancy Category B

    Reproduction studies in rats and rabbits demonstrated that oral administration of oxycodone was not teratogenic or embryo-fetal toxic.

    Aspirin: Pregnancy Category D (see PRECAUTIONS)

    Salicylates readily cross the placenta and by inhibiting prostaglandin synthesis, may cause constriction of ductus arteriosus resulting in pulmonary hypertension and increased fetal mortality and, possibly other untoward fetal effects. Aspirin use in pregnancy can also result in alteration in maternal and neonatal hemostasis mechanisms. Maternal aspirin use during later stages of pregnancy may cause low birth weight, increased incidence of intracranial hemorrhage in premature infants, stillbirths and neonatal death. Use during pregnancy, especially in the third trimester, should be avoided.

    Safe use of Endodan (Oxycodone and Aspirin Tablets, USP) in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, Endodan tablets should not be used in pregnant women unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.

    Nonteratogenic Effects Opioids can cross the placental barrier and have the potential to cause neonatal respiratory depression. Opioid use during pregnancy may result in a physically drug-dependent fetus. After birth, the neonate may suffer severe withdrawal symptoms. Aspirin may produce anemia, ante- or postpartum hemorrhage, prolonged gestation and labor, and oligohydramnios.

    Labor and Delivery

    Endodan tablets are not recommended for use in women during and immediately prior to labor and delivery due to its potential effects on respiratory function in the newborn. Aspirin should be avoided one week prior to and during labor and delivery because it can result in excessive blood loss at delivery. Prolonged gestation and prolonged labor due to prostaglandin inhibition have been reported.

    Nursing Mothers

    Ordinarily, nursing should not be undertaken while a patient is receiving Endodan tablets because of the possibility of sedation and/or respiratory depression in the infant. Oxycodone is excreted in breast milk in low concentrations, and there have been rare reports of somnolence and lethargy in babies of nursing mothers taking an oxycodone/acetaminophen product. Salicylic acid has also been detected in breast milk. Adverse effects on platelet function in the nursing infant exposed to aspirin in breast milk may be a potential risk. Furthermore, the risk of Reye Syndrome caused by salicylate in breast milk is unknown. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential benefits to the woman and the possible hazards to the nursing infant.

    Pediatric Use

    Endodan tablets should not be administered to pediatric patients. Reye Syndrome is a rare but serious disease which can follow flu or chicken pox in children and teenagers. While the cause of Reye Syndrome is unknown, some reports claim aspirin (or salicylates) may increase the risk of developing this disease.

    Geriatric Use

    Special precaution should be given when determining the dosing amount and frequency of Endodan tablets for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population when compared to younger patients.

    Hepatic Impairment

    In a pharmacokinetic study of oxycodone in patients with end-stage liver disease, oxycodone plasma clearance decreased and the elimination half-life increased. Care should be exercised when oxycodone is used in patients with hepatic impairment.

    Renal Impairment

    In a study of patients with end stage renal impairment, mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Oxycodone should be used with caution in patients with renal impairment.

    Adverse Reactions

    Serious adverse reactions that may be associated with Endodan tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see OVERDOSAGE).

    The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation and pruritus.

    Aspirin may increase the likelihood of hemorrhage due to its effect on the gastric mucosa and platelet function. Furthermore, aspirin has the potential to cause anaphylaxis in hypersensitive patients as well as angioedema especially in patients with chronic urticaria. Other adverse reactions due to aspirin use include anorexia, reversible hepatotoxicity, leukopenia, thrombocytopenia, purpura, decreased plasma iron concentration, and shortened erythrocyte survival time.

    Other adverse reactions obtained from postmarketing experiences with Endodan tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:

    Body as a Whole

    allergic reaction, malaise, asthenia, headache, anaphylaxis, fever, hypothermia, thirst, increased sweating, accident, accidental overdose, non-accidental overdose.

    Cardiovascular

    tachycardia, dysrhythmias, hypotension, orthostatic hypotension, bradycardia, palpitations

    Central and Peripheral Nervous System

    stupor, paresthesia, agitation, cerebral edema, coma, confusion, dizziness, headache, subdural or intracranial hemorrhage, lethargy, seizures, anxiety, mental impairment

    Fluid and Electrolyte

    dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis

    Gastrointestinal

    hemorrhagic gastric/duodenal ulcer, gastric/peptic ulcer, dyspepsia, abdominal pain, diarrhea, eructation, dry mouth, gastrointestinal bleeding, intestinal perforation, nausea, vomiting, transient elevations of hepatic enzymes, hepatitis, Reye syndrome, pancreatitis, intestinal obstruction, ileus

    Hearing and Vestibular

    hearing loss, tinnitus. Patients with high frequency loss may have difficulty perceiving tinnitus. In these patients, tinnitus cannot be used as a clinical indicator of salicylism.

    Hematologic

    unspecified hemorrhage, purpura, reticulocytosis, prolongation of prothrombin time, disseminated intravascular coagulation, ecchymosis, thrombocytopenia.

    Hypersensitivity

    acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction

    Metabolic and Nutritional

    hypoglycemia, hyperglycemia, acidosis, alkalosis

    Musculoskeletal

    rhabdomyolysis

    Ocular

    miosis, visual disturbances, red eye.

    Psychiatric

    drug dependence, drug abuse, somnolence, depression, nervousness, hallucination

    Reproductive

    prolonged pregnancy and labor, stillbirths, lower birth weight infants, antepartum and postpartum bleeding, closure of patent ductus arteriosis

    Respiratory System

    bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema

    Skin and Appendages

    urticaria, rash, flushing

    Urogenital

    interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention

    Overdosage

    Signs and Symptoms

    Serious overdose with Endodan (Oxycodone and Aspirin Tablets, USP) is characterized by signs and symptoms of opioid and salicylate overdose. Oxycodone overdosage can be manifested by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, pupillary constriction (pupils may be dilated in the setting of hypoxia), and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. Early signs of acute aspirin (salicylate) overdose including tinnitus occur at plasma concentrations approaching 200 mcg/mL. Plasma concentrations of aspirin above 300 mcg/mL are toxic. Severe toxic effects are associated with levels above 400 mcg/mL. A single lethal dose of aspirin in adults is not known with certainty but death may be expected at 30 g. For real or suspected overdose, a Poison Control Center should be contacted immediately.

    In acute salicylate overdose, severe acid-base and electrolyte disturbances may occur and are complicated by hyperthermia and dehydration, and coma. Respiratory alkalosis occurs early while hyperventilation is present, but is quickly followed by metabolic acidosis. Serious symptoms such as depression, coma, and respiratory failure progress rapidly.

    Salicylism (chronic salicylate toxicity) may be noted by symptoms such as dizziness, tinnitus, difficulty hearing, nausea, vomiting, diarrhea, and mental confusion. More severe salicylism may result in respiratory alkalosis.

    Treatment

    Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. Supportive measures (including oxygen, intravenous fluids, and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation. Treatment of acid-base disturbances and electrolyte disorders is also important. Because of the concern over salicylate toxicity, acid-base status should be followed closely with serial blood gas and serum pH determinations.

    The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids including oxycodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered (usual initial adult dose 0.4 mg-2 mg) preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose. In patients who are physically dependent on any opioid agonist including oxycodone, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use.

    Gastric emptying and/or lavage may be useful in removing unabsorbed drug. This procedure is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. After lavage and/or emesis, administration of activated charcoal, as a slurry, is beneficial, if less than three hours have passed since ingestion. Charcoal adsorption should not be employed prior to lavage and emesis.

    In severe cases of salicylate overdose, hyperthermia and hypovolemia are the major immediate threats to life. Children should be sponged with tepid water. Replacement fluid should be administered intravenously and augmented with correction of acidosis. Plasma electrolytes and pH should be monitored to promote alkaline diuresis of salicylate if renal function is normal. Infusion of glucose may be required to control hypoglycemia. With more severe acute toxicity respiratory alkalosis may occur.

    Hemodialysis and peritoneal dialysis can be performed to reduce the body content of aspirin. In patients with renal insufficiency or in cases of life-threatening salicylate intoxication dialysis is usually required. Exchange transfusion may be indicated in infants and young children.

    In case of real or suspected overdose, a poison control center should be consulted for the treatment of salicylism.

    The toxicity of oxycodone and aspirin in combination is unknown.

    Endodan Dosage and Administration

    Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Endodan tablets are given orally.

    The usual dosage is one tablet every 6 hours as needed for pain. The maximum daily dose of aspirin should not exceed 4 grams or 12 tablets.

    Cessation of Therapy

    In patients treated with Endodan tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

    Drug Abuse and Dependence

    Endodan tablets are a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.

    Drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psychological, occupational or interpersonal difficulties resulting from such use, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common. Opioid addiction is relatively rare in patients with chronic pain but may be more common in individuals who have a past history of alcohol or substance abuse or dependence. Pseudoaddiction refers to pain relief seeking behavior of patients whose pain is poorly managed. It is considered an iatrogenic effect of ineffective pain management. The health care provider must assess continuously the psychological and clinical condition of a pain patient in order to distinguish addiction from pseudoaddiction and thus, be able to treat the pain adequately.

    Physical dependence on a prescribed medication does not signify addiction. Physical dependence involves the occurrence of a withdrawal syndrome when there is sudden reduction or cessation in drug use or if an opiate antagonist is administered. Physical dependence can be detected after a few days of opioid therapy. However, clinically significant physical dependence is only seen after several weeks of relatively high dosage therapy. In this case, abrupt discontinuation of the opioid may result in a withdrawal syndrome. If the discontinuation of opioids is therapeutically indicated, gradual tapering of the drug over a 2-week period will prevent withdrawal symptoms. The severity of the withdrawal syndrome depends primarily on the daily dosage of the opioid, the duration of therapy and medical status of the individual.

    The withdrawal syndrome of oxycodone is similar to that of morphine. This syndrome is characterized by yawning, anxiety, increased heart rate and blood pressure, restlessness, nervousness, muscle aches, tremor, irritability, chills alternating with hot flashes, salivation, anorexia, severe sneezing, lacrimation, rhinorrhea, dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps, diarrhea and insomnia, and pronounced weakness and depression.

    “Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

    Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Oxycodone, like other opioids, has been diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

    Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

    Like other opioid medications, Endodan tablets are subject to the Federal Controlled Substances Act. After chronic use, Endodan tablets should not be discontinued abruptly when it is thought that the patient has become physically dependent on oxycodone.

    Interactions with Alcohol and Drugs of Abuse

    Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

    How is Endodan Supplied

    Endodan (oxycodone and aspirin tablets, USP), supplied as a yellow round tablet, with one face scored and the other debossed with “Endo” and “610”.

    Available in:

    Bottles of 100 NDC         60951-310-70

    Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]

    Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

    DEA Order Form Required.

    Manufactured for:

    Endo Pharmaceuticals Inc.

    Chadds Ford, Pennsylvania 19317

    Endodan® is a Registered Trademark of Endo Pharmaceuticals

    © 2009 Endo Pharmaceuticals

    Printed in U.S.A.            2005701/September, 2009

    Endodan 

    oxycodone and aspirin tablets tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60951-310
    Route of Administration ORAL DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 4.8355 mg
    ASPIRIN (ASPIRIN) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    CELLULOSE, MICROCRYSTALLINE  
    STARCH, CORN  
    Product Characteristics
    Color YELLOW Score 2 pieces
    Shape ROUND Size 11mm
    Flavor Imprint Code Endo;610
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:60951-310-70 100 TABLET (TABLET) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA authorized generic NDA007337 05/20/1994
    Labeler - Endo Pharmaceuticals Inc (178074951)
    Establishment
    Name Address ID/FEI Operations
    Novartis Consumer Health 129836151 MANUFACTURE

    Revised: 09/2009   Endo Pharmaceuticals Inc

    Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

    Endodan

    Endodan

    Generic Name: oxycodone/aspirin (OX-i-KOE-done/AS-pir-in)

    Brand Name: Examples include Endodan and Percodan

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Endodan is used for:

    Treating moderate to moderately severe pain.

    Endodan is a narcotic pain reliever and salicylate combination. The narcotic works in the brain to reduce pain. The salicylate works by blocking certain chemicals in the body that cause pain and inflammation.

    Do NOT use Endodan if:

    • you are allergic to any ingredient in Endodan or to a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)
    • you have had asthma symptoms (eg, shortness of breath, wheezing), nasal swelling, or growths in the nose caused by aspirin
    • you have moderate to severe breathing problems, severe asthma, or you are having an asthma attack
    • you have a history of certain bleeding problems (eg, hemophilia, von Willebrand disease), low blood platelet levels, stomach ulcers, or you have severe bleeding
    • you have known or suspected bowel blockage (paralytic ileus) or you have severe or persistent diarrhea caused by antibiotics
    • the patient is a child with a viral infection (eg, chickenpox, flu symptoms)
    • you are taking sodium oxybate (GHB) or ketorolac

    Contact your doctor or health care provider right away if any of these apply to you.

    Video: Treatment for Depression Treatments for depression are getting better everyday and there are things you can start doing right away.

    Before using Endodan:

    Some medical conditions may interact with Endodan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you are allergic to other narcotic pain relievers (eg, morphine, codeine, hydromorphone)
    • if you have a history of constipation, lung or breathing problems (eg, asthma, emphysema, bronchitis, chronic obstructive pulmonary disease [COPD]), sleep apnea (you stop breathing when you sleep), curvature of the spine (eg, kyphoscoliosis), heart problems (eg, cor pulmonale), low blood pressure, dehydration, low blood volume, or shock caused by heart problems
    • if you have a history of recent head injury, growths in the brain (eg, tumors, lesions), an enlarged blood vessel in the brain (eg, aneurysm), increased pressure in the brain, stroke, or seizures (eg, epilepsy)
    • if you have blood problems (eg, porphyria), bleeding or clotting problems, low levels of vitamin K in the blood, chickenpox or flu symptoms, hives, Kawasaki syndrome, a rheumatic condition, or severe drowsiness
    • if you have a history of kidney or liver problems, thyroid problems, stomach or bowel problems (eg, ulcers, inflammation, recent surgery), pancreas or gallbladder problems, adrenal problems (Addison disease), an enlarged prostate, blockage of your bladder, or trouble urinating
    • if you have a history of mood or mental problems (eg, depression, hallucinations), suicidal thoughts or behavior, alcohol or other substance abuse, regular alcohol use, or if you are in alcohol withdrawal
    • if you are in poor health or will be having surgery

    Some MEDICINES MAY INTERACT with Endodan. Tell your health care provider if you are taking any other medicines, especially any of the following:

    • Anticoagulants (eg, heparin, warfarin, enoxaparin), clopidogrel, dabigatran, desirudin, NSAIDs (eg, ibuprofen, ketorolac), rivaroxaban, or selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram) because the risk of bleeding or ulcers may be increased
    • Certain antinausea medicines (eg, metoclopramide), azole antifungals (eg, ketoconazole), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin), muscle relaxants (eg, cyclobenzaprine), narcotic pain relievers (eg, codeine), nefazodone, phenothiazines (eg, chlorpromazine), sodium oxybate (GHB), or telithromycin because the risk of serious side effects, such as severe drowsiness or slow or difficult breathing, may be increased
    • Mixed narcotic agonists/antagonists (eg, buprenorphine, butorphanol, nalbuphine, pentazocine), naltrexone, or rifamycins (eg, rifampin) because they may decrease Endodan’s effectiveness
    • Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, methotrexate, oral diabetes medicines (eg, glyburide, repaglinide), phenytoin, or valproic acid because the risk of their side effects may be increased by Endodan
    • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), diuretics (eg, furosemide, hydrochlorothiazide), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Endodan

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Endodan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Endodan:

    Use Endodan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • Take Endodan by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
    • Do not change your dose or suddenly stop taking Endodan without first checking with your doctor.
    • If Endodan is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Endodan properly.
    • If you miss a dose of Endodan and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

    Ask your health care provider any questions you may have about how to use Endodan.

    Important safety information:

    • Endodan may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Endodan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
    • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Endodan; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
    • Endodan may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
    • The risk of serious breathing problems may be greater if you take Endodan in high doses. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
    • Endodan may cause stomach bleeding. Your risk may be greater if you drink alcohol while you are using Endodan.
    • Endodan may cause or worsen constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while taking Endodan, talk with your doctor or pharmacist. A stool softener or fiber laxative may be required.
    • Talk to your doctor before you take Endodan if you drink 3 or more drinks with alcohol per day.
    • Endodan may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
    • Aspirin has been linked to a serious illness called Reye syndrome. Do not give Endodan to a child or teenager who has the flu, chickenpox, or a viral infection. Do not give Endodan to a child or teenager who has recently received a flu or chickenpox vaccine. Contact your doctor with any questions or concerns.
    • Tell your doctor or dentist that you take Endodan before you receive any medical or dental care, emergency care, or surgery.
    • Endodan has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin or another salicylate in it too. If it does or if you are not sure, check with your doctor or pharmacist.
    • If you are taking aspirin prescribed by your doctor to prevent heart attack or stroke, check with your doctor to see whether you should continue to take it with Endodan
    • Diabetes patients – Endodan may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
    • Endodan may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Endodan.
    • Use Endodan with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
    • Endodan should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
    • PREGNANCY and BREAST-FEEDING: Endodan has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Endodan while you are pregnant. Avoid using Endodan during the last 3 months of pregnancy. Endodan is found in breast milk. Do not breast-feed while taking Endodan.

    When used for long periods of time or at high doses, Endodan may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Endodan stops working well. Do not take more than prescribed.

    Some people who use Endodan for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

    If you suddenly stop taking Endodan, you may have WITHDRAWAL symptoms. These may include anxiety, backache, chills, diarrhea, enlarged pupils, fast breathing, fast heartbeat, increased tearing, irritability, joint pain, loss of appetite, muscle pain, nausea, restlessness, runny nose, stomach cramps, sweating, trouble sleeping, vomiting, weakness, or yawning.

    Possible side effects of Endodan:

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Constipation; dizziness; drowsiness; heartburn; lightheadedness; nausea; stomach upset; vomiting.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or black stools; confusion; dark urine; decreased or difficult urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucination; hearing loss; mood or mental changes; muscle pain, weakness, or cramps; one-sided weakness; ringing in the ears; seizures; severe dizziness, drowsiness, headache, or lightheadedness; severe or persistent constipation, heartburn, or stomach pain; shortness of breath; slow or shallow breathing; trouble swallowing; unusual bruising or bleeding; vision or speech problems; vomit that looks like coffee grounds; wheezing; yellowing of the skin or eyes.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; cold and clammy skin; coma; confusion; dehydration; depression; enlarged or decreased pupil size; fever; loss of consciousness; ringing in the ears or trouble hearing; severe drowsiness, dizziness, lightheadedness, nausea, vomiting, or diarrhea; severe weakness; slow, shallow, or difficult breathing; slow heartbeat.

    Proper storage of Endodan: Store Endodan at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Endodan out of the reach of children and away from pets.

    General information:

    • If you have any questions about Endodan, please talk with your doctor, pharmacist, or other health care provider.
    • Endodan is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • Check with your pharmacist about how to dispose of unused medicine.

    This information should not be used to decide whether or not to take Endodan or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Endodan. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Endodan. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Endodan.

    Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

    Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

    Endodan

    Endodan

    Generic Name: oxycodone and aspirin (Oral route)

    AS-pir-in, ox-i-KOE-done hye-droe-KLOR-ide

    OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

    Commonly used brand name(s)

    In the U.S.

    • Endodan
    • Percodan

    Available Dosage Forms:

    • Tablet

    Therapeutic Class: Opioid/Salicylate, Aspirin Combination

    Pharmacologic Class: NSAID

    Chemical Class: Salicylate, Aspirin

    Uses For Endodan

    Oxycodone and aspirin combination is used to relieve moderate to moderately severe pain. Oxycodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

    Aspirin is used to relieve pain and reduce fever in patients. Aspirin belongs to the group of medicines known as salicylates and acts on the immune system to reduce inflammation. It is also known as an anti-inflammatory analgesic.

    When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

    This medicine is available only with your doctor’s prescription.

    Before Using Endodan

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of oxycodone and aspirin combination in the pediatric population. Because of aspirin’s toxicity, use in children and teenagers is not recommended.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and aspirin combination in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution and an adjustment in the dose for patients receiving oxycodone and aspirin combination.

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

    Breast Feeding

    Aspirin There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Oxycodone Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Influenza Virus Vaccine, Live
    • Ketorolac
    • Naltrexone

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abciximab
    • Acenocoumarol
    • Acetophenazine
    • Adinazolam
    • Alfentanil
    • Alprazolam
    • Alteplase, Recombinant
    • Amobarbital
    • Anagrelide
    • Anileridine
    • Anisindione
    • Aprobarbital
    • Atazanavir
    • Beta Glucan
    • Brofaromine
    • Bromazepam
    • Brotizolam
    • Buprenorphine
    • Buspirone
    • Butabarbital
    • Butalbital
    • Butorphanol
    • Carisoprodol
    • Chloral Hydrate
    • Chlordiazepoxide
    • Chlorpromazine
    • Chlorzoxazone
    • Cilostazol
    • Citalopram
    • Clarithromycin
    • Clobazam
    • Clonazepam
    • Clopidogrel Hydrogen Sulfate
    • Clorazepate
    • Clorgyline
    • Clovoxamine
    • Codeine
    • Dabigatran Etexilate
    • Dantrolene
    • Desflurane
    • Desirudin
    • Desvenlafaxine
    • Dexmedetomidine
    • Dezocine
    • Diazepam
    • Dicumarol
    • Diphenhydramine
    • Doxylamine
    • Duloxetine
    • Enflurane
    • Eptifibatide
    • Erlotinib
    • Erythromycin
    • Escitalopram
    • Estazolam
    • Eszopiclone
    • Ethchlorvynol
    • Ethopropazine
    • Femoxetine
    • Fentanyl
    • Flesinoxan
    • Flumazenil
    • Flunitrazepam
    • Fluoxetine
    • Fluphenazine
    • Flurazepam
    • Fluvoxamine
    • Fospropofol
    • Furazolidone
    • Ginkgo
    • Halazepam
    • Halothane
    • Heparin
    • Hydrocodone
    • Hydromorphone
    • Hydroxyzine
    • Indinavir
    • Iproniazid
    • Isocarboxazid
    • Isoflurane
    • Itraconazole
    • Ketamine
    • Ketazolam
    • Ketoconazole
    • Ketoprofen
    • Lazabemide
    • Levorphanol
    • Linezolid
    • Lorazepam
    • Lormetazepam
    • Medazepam
    • Meperidine
    • Mephenesin
    • Mephobarbital
    • Meprobamate
    • Mesoridazine
    • Metaxalone
    • Methdilazine
    • Methocarbamol
    • Methohexital
    • Methotrexate
    • Midazolam
    • Milnacipran
    • Moclobemide
    • Morphine
    • Morphine Sulfate Liposome
    • Nalbuphine
    • Naproxen
    • Nefazodone
    • Nelfinavir
    • Nialamide
    • Nitrazepam
    • Nitrous Oxide
    • Nordazepam
    • Opium
    • Oxazepam
    • Oxycodone
    • Oxymorphone
    • Pargyline
    • Paroxetine
    • Pentazocine
    • Pentobarbital
    • Perphenazine
    • Phenelzine
    • Phenindione
    • Phenobarbital
    • Phenprocoumon
    • Prasugrel
    • Prazepam
    • Procarbazine
    • Prochlorperazine
    • Promazine
    • Promethazine
    • Propiomazine
    • Propofol
    • Propoxyphene
    • Quazepam
    • Ramelteon
    • Rasagiline
    • Remifentanil
    • Reteplase, Recombinant
    • Ritonavir
    • Rivaroxaban
    • Saquinavir
    • Secobarbital
    • Selegiline
    • Sertraline
    • Sevoflurane
    • Sodium Oxybate
    • Sufentanil
    • Tapentadol
    • Telithromycin
    • Temazepam
    • Thiethylperazine
    • Thiopental
    • Thioridazine
    • Ticagrelor
    • Ticlopidine
    • Tirofiban
    • Toloxatone
    • Tranylcypromine
    • Treprostinil
    • Triazolam
    • Trifluoperazine
    • Triflupromazine
    • Trimeprazine
    • Varicella Virus Vaccine
    • Venlafaxine
    • Vilazodone
    • Warfarin
    • Zaleplon
    • Zimeldine
    • Zolpidem

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Anagrelide
    • Ardeparin
    • Azosemide
    • Bemetizide
    • Bendroflumethiazide
    • Benzthiazide
    • Betamethasone
    • Bumetanide
    • Buthiazide
    • Captopril
    • Celecoxib
    • Certoparin
    • Chlorothiazide
    • Chlorpropamide
    • Chlorthalidone
    • Clopamide
    • Cortisone
    • Cyclopenthiazide
    • Dalteparin
    • Danaparoid
    • Deflazacort
    • Delapril
    • Dexamethasone
    • Diltiazem
    • Enalaprilat
    • Enalapril Maleate
    • Enoxaparin
    • Ethacrynic Acid
    • Furosemide
    • Glyburide
    • Hydrochlorothiazide
    • Hydroflumethiazide
    • Ibuprofen
    • Imidapril
    • Indapamide
    • Lisinopril
    • Methyclothiazide
    • Methylprednisolone
    • Metolazone
    • Miconazole
    • Nadroparin
    • Nitroglycerin
    • Paramethasone
    • Parnaparin
    • Piretanide
    • Polythiazide
    • Prednisolone
    • Prednisone
    • Probenecid
    • Reviparin
    • Rifampin
    • Rofecoxib
    • St John’s Wort
    • Streptokinase
    • Tamarind
    • Temocapril
    • Tenecteplase
    • Tinzaparin
    • Tolbutamide
    • Torsemide
    • Triamcinolone
    • Trichlormethiazide
    • Valproic Acid
    • Verapamil
    • Voriconazole
    • Xipamide

    Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Addison’s disease (adrenal gland problem) or
    • Alcohol abuse, or history of or
    • Bleeding problems or
    • Brain tumor, history of or
    • Chronic obstructive pulmonary disease (COPD) or
    • Cor pulmonale (serious heart condition) or
    • Drug dependence, especially with narcotics, or history of or
    • Enlarged prostate (BPH, prostatic hypertrophy) or
    • Gallbladder disease or gallstones or
    • Head injuries, history of or
    • Hypothyroidism (an underactive thyroid) or
    • Hypovolemia (low blood volume) or
    • Kyphoscoliosis (curvature of the spine with breathing problems) or
    • Peptic ulcer disease, active or history of or
    • Problems with passing urine or
    • Vitamin K deficiency—Use with caution. May increase risk for more serious side effects.
    • Asthma with nasal polyps and rhinitis, history of or
    • Asthma, severe or
    • Breathing problems, severe (e.g., hypoxia) or
    • Hemophilia (a bleeding problem) or
    • Paralytic ileus (intestine stops working and may be blocked) or
    • Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.
    • Hypotension (low blood pressure) or
    • Pancreatitis (inflammation of the pancreas) or
    • Seizures, history of—Use with caution. May make these conditions worse.
    • Kidney disease or
    • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    Proper Use of oxycodone and aspirin

    This section provides information on the proper use of a number of products that contain oxycodone and aspirin. It may not be specific to Endodan. Please read with care.

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (tablets):
      • For moderate to moderately severe pain:
        • Adults—One tablet every 6 hours as needed. Your doctor may adjust your dose if needed. However, the dose is usually not more than 12 tablets per day.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Flush the unused Percodan® oral tablets down the toilet.

    Precautions While Using Endodan

    It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

    Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

    This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a higher risk of bleeding problems if you drink three or more alcoholic beverages per day while you are taking aspirin. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

    This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

    Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

    This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

    Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

    Check with your doctor right away if you have the following symptoms while using this medicine: acid or sour stomach; bloody or black, tarry stools; heartburn; nausea; vomiting; stomach pain; or vomiting of blood or material that looks like coffee grounds.

    This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

    If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

    Endodan Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Incidence not known

    • Abdominal pain, cramping, or tenderness
    • agitation
    • bleeding gums
    • bloating
    • blood in the urine or stools
    • bloody, black, or tarry stools
    • blue lips, fingernails, or skin
    • blurred vision
    • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    • change in consciousness or confusion
    • chest pain or discomfort
    • chills
    • clay-colored stools
    • constipation
    • convulsions
    • coughing or vomiting blood
    • dark-colored urine
    • decrease in urine volume or frequency
    • decreased appetite
    • depression
    • difficult, fast, noisy breathing, sometimes with wheezing
    • difficulty in passing urine (dribbling)
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • drowsiness
    • dry mouth
    • fainting
    • fast, slow, irregular, pounding, or racing heartbeat or pulse
    • feeling of hostility or irritability
    • feeling of warmth
    • feeling that something terrible will happen
    • fever
    • headache, sudden, severe
    • heartburn
    • hives or itching
    • increased menstrual flow or vaginal bleeding
    • increased sweating
    • indigestion
    • irregular, fast, slow, or shallow breathing
    • large, flat, blue or purplish patches in the skin
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • loss of consciousness
    • low body temperature
    • muscle cramping, weakness, or tremors
    • muscle pain or stiffness
    • nausea or vomiting
    • nosebleeds
    • numbness or tingling in the hands, feet, or lips
    • painful or difficult urination
    • pains in the stomach, side, or abdomen, possibly radiating to the back
    • pale skin
    • pinpoint red or purple spots on the skin
    • prolonged bleeding from cuts
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • red or black, tarry stools or dark urine
    • restlessness
    • shivering
    • shortness of breath
    • skin rash
    • sleepiness
    • sunken eyes
    • sweating
    • swelling of face, ankles, hands, feet, or lower legs
    • thirst
    • tightness in the chest
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting of material that looks like coffee grounds, severe and continuing
    • weak or feeble pulse
    • weakness or heaviness of the legs
    • weight gain
    • wheezing
    • wrinkled skin
    • yellow eyes or skin

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Continuing ringing or buzzing or other unexplained noise in the ears
    • decreased awareness or responsiveness
    • diarrhea
    • drowsiness
    • enlarged pupils
    • extremely high fever or body temperature
    • fast, weak heartbeat
    • hearing loss
    • increase in heart rate
    • restlessness
    • severe sleepiness

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Relaxed and calm feeling
    • sleepiness

    Incidence not known

    • Belching
    • bloated, full feeling
    • blurred or loss of vision
    • change in color perception
    • cold sweats
    • constricted, pinpoint, or small pupils (black part of the eye)
    • cool, pale skin
    • double vision
    • excess air or gas in the stomach
    • false or unusual sense of well-being
    • flushed, dry skin
    • fruit-like breath odor
    • halos around lights
    • increased hunger or thirst
    • increased urination
    • lack or loss of strength
    • night blindness
    • nightmares
    • overbright appearance of lights
    • red eyes
    • redness of the skin
    • seeing, hearing, or feeling things that are not there
    • shakiness
    • sleepiness or unusual drowsiness
    • slurred speech
    • trouble sleeping
    • tunnel vision
    • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
    • weight loss

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    See also: Endodan side effects (in more detail)

    Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

    Endodan

    Endodan

    Generic Name: aspirin and oxycodone (AS pir in and ox i KOE done)

    Brand Name: Endodan, Percodan, Roxiprin

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is Endodan (aspirin and oxycodone)?

    Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

    Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic.

    The combination of aspirin and oxycodone is used to relieve moderate to severe pain.

    Aspirin and oxycodone may also be used for purposes not listed in this medication guide.

    What is the most important information I should know about Endodan (aspirin and oxycodone)?

    Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye’s syndrome in children.

    You should not take aspirin and oxycodone if you have a bleeding disorder, a recent history of stomach or intestinal bleeding, if you take a blood thinner, or if you are allergic to aspirin, oxycodone, or an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

    Video: Treatment for Depression Treatments for depression are getting better everyday and there are things you can start doing right away.

    Do not use aspirin and oxycodone if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

    Oxycodone may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

    Ask a doctor or pharmacist before using any other over-the-counter cold, allergy, or pain medicine. Aspirin is contained in many combination medicines. Taking certain products together can cause you to get too much aspirin. Check the label to see if a medicine contains aspirin.

    What should I discuss with my healthcare provider before taking Endodan (aspirin and oxycodone)?

    Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye’s syndrome in children.

    You should not use this medication if you are allergic to aspirin or oxycodone, or if you have:

    • a recent history of stomach or intestinal bleeding;

    • a bleeding or blood clotting disorder such as hemophilia;
    • if you are taking a blood thinner such as warfarin (Coumadin, Jantoven); or
    • an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Celecoxib, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

    Do not use aspirin and oxycodone if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

    To make sure you can safely take aspirin and oxycodone, tell your doctor if you have any of these other conditions:

    • stomach or intestinal disorder, history of stomach ulcer or bleeding;

    • severe constipation, a blockage in your stomach or intestines;
    • liver or kidney disease;
    • allergies, nasal polyps, asthma or other breathing disorders;
    • a heart rhythm disorder, low blood pressure;
    • enlarged prostate, urination problems;
    • underactive thyroid;
    • gallbladder disease;
    • seizures, or a history of head injury or brain tumor;
    • Addison’s disease or other adrenal gland disorder;
    • curvature of the spine;
    • mental illness, a history of drug or alcohol addiction; or
    • if you have been sick with diarrhea.

    Oxycodone may be habit forming and should be used only by the person for whom it was prescribed. Never share this medication with another person, especially someone with a history of drug abuse or addiction.

    FDA pregnancy category D. This medication can cause harm to an unborn baby, and breathing problems or addiction/withdrawal symptoms in a newborn. Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Do not take aspirin and oxycodone during pregnancy unless your doctor has told you to. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

    Aspirin and oxycodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    How should I take Endodan (aspirin and oxycodone)?

    Take exactly as prescribed. Never take aspirin and oxycodone in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

    Aspirin and oxycodone may be taken with food if it upsets your stomach.

    If you need surgery, tell the surgeon ahead of time that you are using aspirin and oxycodone.

    Do not stop using aspirin and oxycodone suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using aspirin and oxycodone.

    Store at room temperature away from moisture, heat, and light. After you have stopped using this medication, flush any unused pills down the toilet.

    Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

    Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

    What happens if I miss a dose?

    Since aspirin and oxycodone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

    What happens if I overdose?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of aspirin and oxycodone can be fatal.

    Overdose symptoms may include extreme drowsiness, pinpoint pupils, nausea, vomiting, diarrhea, confusion, ringing in your ears, cold or clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing.

    What should I avoid while taking Endodan (aspirin and oxycodone)?

    This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how aspirin and oxycodone will affect you.

    Ask a doctor or pharmacist before using any other over-the-counter cold, allergy, or pain medicine. Aspirin is contained in many combination medicines. Taking certain products together can cause you to get too much aspirin. Check the label to see if a medicine contains aspirin.

    Avoid taking acetaminophen (Tylenol) or an NSAID while you are taking aspirin and oxycodone, unless your doctor tells you to. NSAIDs include ibuprofen (Advil, Motrin), ketorolac (Toradol), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

    Avoid drinking alcohol. It may increase your risk of stomach bleeding while taking aspirin.

    Endodan (aspirin and oxycodone) side effects

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

    Call your doctor at once if you have a serious side effect such as:

    • severe stomach pain or constipation, vomiting;

    • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
    • weak or shallow breathing, fast or slow heartbeats;
    • confusion, hallucinations, feeling like you might pass out;
    • easy bruising or bleeding;
    • seizures; or
    • decreased hearing, ringing in your ears.

    Less serious side effects may include:

    • headache, dizziness, drowsiness;

    • constipation, heartburn, upset stomach, bloating, gas, diarrhea; or
    • dry mouth.

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Endodan side effects (in more detail)

    What other drugs will affect Endodan (aspirin and oxycodone)?

    Ask your doctor before using an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Rapiflux, Sarafem, Selfemra, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil, Pexeva), sertraline (Zoloft), trazodone (Desyrel, Oleptro), or vilazodone (Viibryd). Taking any of these medicines with aspirin may cause you to bruise or bleed easily.

    Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy or could slow your breathing (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by aspirin and oxycodone.

    Many drugs can interact with aspirin and oxycodone. Below is just a partial list. Tell your doctor if you are using:

    • bupropion (Wellbutrin, Zyban);

    • deferasirox (Exjade);
    • leflunomide (Arava);
    • methotrexate (Rheumatrex, Trexall);
    • sirolimus (Rapamune) or tacrolimus (Prograf);
    • tenofovir (Viread, Atripla, Complera, Truvada);
    • antiviral medicines such as adefovir (Hepsera) or cidofovir (Vistide);
    • aspirin or other salicylates including Kaopectate, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others;
    • bowel cleansing preparations (Half Lytely, Fleet Prep Kit, Evac-Q-Kwik, GoLytely, Supraprep, and others);
    • glaucoma medication such as acetazolamide (Diamox) or methazolamide (Glauctabs, Neptazane); or
    • medication used to prevent blood clots, such as dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra), tinzaparin (Innohep), and others.

    This list is not complete and other drugs may interact with aspirin and oxycodone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

    Next Page → Side Effects

    More Endodan resources

    • Side Effects
    • Pregnancy Warnings
    • Drug Images
    • Drug Interactions
    • Support Group
    • 0 Reviews - Add your own review/rating

    Compare Endodan with other medications

    • Pain

    Where can I get more information?

    • Your pharmacist can provide more information about aspirin and oxycodone.

    Post a Comment

    Your email is kept private. Required fields are marked *

    You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>