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Dyrenium

Dyrenium(triamterene) – WellSpring

BOXED WARNING

Abnormal elevation of serum K+ levels (≥5.5mEq/L) can occur with all K+-sparing agents, including triamterene. Hyperkalemia is more likely to occur with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly, or severely ill. Monitor serum K+ at frequent intervals.

View FDA-Approved Full Prescribing Information for Dyrenium

THERAPEUTIC CLASS

K+-sparing diuretic

INDICATIONS

Treatment of edema associated with congestive heart failure (CHF), liver cirrhosis, and nephrotic syndrome. Treatment of steroid induced edema, idiopathic edema, and edema due to secondary hyperaldosteronism.

ADULT DOSAGE

Adults: Initial: 100mg bid pc. Max: 300mg/day. Titrate dose to the needs of the individual patient.

HOW SUPPLIED

Cap: 50mg, 100mg

CONTRAINDICATIONS

Anuria, severe or progressive kidney disease or dysfunction (except with nephrosis), severe hepatic disease, hyperkalemia, K+ supplements, K+ salts or K+ containing salt substitutes, K+-sparing agents (eg, spironolactone, amiloride hydrochloride).

WARNINGS/PRECAUTIONS

Check ECG if hyperkalemia occurs. Isolated reports of hypersensitivity reactions; monitor for possible occurrence of blood dyscrasias, liver damage, or other idiosyncratic reactions. In cirrhotics with splenomegaly, may contribute to megaloblastosis in cases where folic stores have been depleted; perform periodic blood studies and observe for exacerbation of liver disease. Monitor BUN periodically. Caution with gouty arthritis; may elevate uric acid levels. May aggravate or cause electrolyte imbalances in CHF, renal disease, or cirrhosis. Caution with history of renal stones.

ADVERSE REACTIONS

Hypersensitivity reactions, hyper- or hypokalemia, azotemia, renal stones, jaundice, thrombocytopenia, megaloblastic anemia, N/V, diarrhea, weakness, dizziness.

DRUG INTERACTIONS

See Contraindications. Increased risk of hyperkalemia with ACE inhibitors. Indomethacin may cause renal failure; caution with NSAIDs. Risk of lithium toxicity. Hyperkalemia may occur when used concomitantly with blood from blood bank, low-salt milk, or potassium containing medications (eg, parenteral penicillin G potassium). May cause hyperglycemia; adjust antidiabetic agents. Chlorpropamide may increase risk of severe hyponatremia. May potentiate nondepolarizing muscle relaxants, antihypertensives, other diuretics, preanesthetics, and anesthetics.

PREGNANCY

Category C, not for use in nursing.

MECHANISM OF ACTION

K+ sparing diuretic; inhibits reabsorption of Na+ ions in exchange for K+ and H+ ions at segment of distal tubule under control of adrenal mineralocorticoids.

PHARMACOKINETICS

Absorption: Rapid; Cmax=30ng/mL, Tmax=3 hrs. Distribution: Plasma protein binding (67%); crosses placental barrier. Metabolism: Hydroxytriamterene (metabolite). Elimination: Urine (21%).

ASSESSMENT

Assess for anuria, CHF, diabetes mellitus, gout, hyperkalemia, history of kidney stones, liver/renal impairment, pregnancy/nursing status, and for possible drug interactions.

MONITORING

Monitor for signs/symptoms of electrolyte imbalance, exacerbation of gout, hypersensitivity reactions (eg, blood dyscrasias, liver damage), and for liver/renal dysfunction. Monitor for signs/symptoms of hyperkalemia and perform ECG if suspected. Monitor BUN, serum K+ levels, and CBC periodically.

PATIENT COUNSELING

Advise to take after meals to avoid stomach upset. Inform that if single dose is prescribed, it may be preferable to take in a.m. to minimize frequency of urination during nighttime sleep. Instruct not to take more than prescribed dose at next dosing interval if dose missed. Seek medical attention if symptoms of hyperkalemia, electrolyte imbalance, or hypersensitivity reactions occur.

ADMINISTRATION/STORAGE

Administration: Oral route. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Dispense in tight, light-resistant container.


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    Dyrenium

    Dyrenium

    Generic Name: triamterene

    Dosage Form: capsule

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Dyrenium® (triamterene USP) Capsules 50 mg and 100 mg potassium-sparing diuretic

    Warnings Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including Dyrenium. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients receiving Dyrenium, when dosages are changed or with any illness that may influence renal function.

    DESCRIPTION

    Each capsule for oral use, with opaque red cap and body, contains Triamterene USP, 50 or 100 mg, and is imprinted with the product name, Dyrenium, strength (50 mg or 100 mg) and WPC 002 (for the 50-mg strength) and WPC 003 (for the 100-mg strength). Inactive ingredients consist of D&C Red No. 33, FD&C Yellow No. 6, Gelatin NF, Lactose NF, Magnesium Stearate NF, Sodium Lauryl Sulfate NF, Titanium Dioxide USP and Silicon Dioxide NF.

    Triamterene is 2,4,7-triamino-6-phenyl-pteridine:

    Its molecular weight is 253.27. At 50°C, triamterene is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide and dimethylformamide. It is sparingly soluble in methanol.

    CLINICAL PHARMACOLOGY

    Triamterene has a unique mode of action; it inhibits the reabsorption of sodium ions in exchange for potassium and hydrogen ions at that segment of the distal tubule under the control of adrenal mineralocorticoids (especially aldosterone). This activity is not directly related to aldosterone secretion or antagonism; it is a result of a direct effect on the renal tubule.

    The fraction of filtered sodium reaching this distal tubular exchange site is relatively small, and the amount which is exchanged depends on the level of mineralocorticoid activity. Thus, the degree of natriuresis and diuresis produced by inhibition of the exchange mechanism is necessarily limited. Increasing the amount of available sodium and the level of mineralocorticoid activity by the use of more proximally acting diuretics will increase the degree of diuresis and potassium conservation.

    Triamterene occasionally causes increases in serum potassium which can result in hyperkalemia. It does not produce alkalosis, because it does not cause excessive excretion of titratable acid and ammonium.

    Triamterene has been shown to cross the placental barrier and appear in the cord blood of animals.

    Pharmacokinetics

    Onset of action is 2 to 4 hours after ingestion. In normal volunteers the mean peak serum levels were 30 ng/mL at 3 hours. The average percent of drug recovered in the urine (0 to 48 hours) was 21%. Triamterene is primarily metabolized to the sulfate conjugate of hydroxytriamterene. Both the plasma and urine levels of this metabolite greatly exceed triamterene levels. Triamterene is rapidly absorbed, with somewhat less than 50% of the oral dose reaching the urine. Most patients will respond to Dyrenium (triamterene) during the first day of treatment.

    Maximum therapeutic effect, however, may not be seen for several days. Duration of diuresis depends on several factors, especially renal function, but it generally tapers off 7 to 9 hours after administration.

    INDICATIONS AND USAGE

    Dyrenium (triamterene) is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism.

    Dyrenium may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism.

    Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.

    Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy (however, see PRECAUTIONS below) when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

    CONTRAINDICATIONS

    Anuria. Severe or progressive kidney disease or dysfunction, with the possible exception of nephrosis. Severe hepatic disease. Hypersensitivity to the drug or any of its components.

    Dyrenium (triamterene) should not be used in patients with pre-existing elevated serum potassium, as is sometimes seen in patients with impaired renal function or azotemia, or in patients who develop hyperkalemia while on the drug. Patients should not be placed on dietary potassium supplements, potassium salts or potassium-containing salt substitutes in conjunction with Dyrenium.

    Dyrenium should not be given to patients receiving other potassium-sparing agents, such as spironolactone, amiloride hydrochloride, or other formulations containing triamterene. Two deaths have been reported in patients receiving concomitant spironolactone and Dyrenium or Dyazide®. Although dosage recommendations were exceeded in one case and in the other serum electrolytes were not properly monitored, these two drugs should not be given concomitantly.

    WARNINGS

    Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including Dyrenium. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients receiving Dyrenium, when dosages are changed or with any illness that may influence renal function.

    There have been isolated reports of hypersensitivity reactions; therefore, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver damage or other idiosyncratic reactions.

    Periodic BUN and serum potassium determinations should be made to check kidney function, especially in patients with suspected or confirmed renal insufficiency. It is particularly important to make serum potassium determinations in elderly or diabetic patients receiving the drug; these patients should be observed carefully for possible serum potassium increases.

    If hyperkalemia is present or suspected, an electrocardiogram should be obtained. If the ECG shows no widening of the QRS or arrhythmia in the presence of hyperkalemia, it is usually sufficient to discontinue Dyrenium (triamterene) and any potassium supplementation, and substitute a thiazide alone. Sodium polystyrene sulfonate (Kayexalate®, Sanofi Synthelabo) may be administered to enhance the excretion of excess potassium. The presence of a widened QRS complex or arrhythmia in association with hyperkalemia requires prompt additional therapy. For tachyarrhythmia, infuse 44 mEq of sodium bicarbonate or 10 mL of 10% calcium gluconate or calcium chloride over several minutes. For asystole, bradycardia or A-V block transvenous pacing is also recommended.

    The effect of calcium and sodium bicarbonate is transient and repeated administration may be required. When indicated by the clinical situation, excess K+ may be removed by dialysis or oral or rectal administration of Kayexalate®. Infusion of glucose and insulin has also been used to treat hyperkalemia.

    PRECAUTIONS

    General

    Dyrenium (triamterene) tends to conserve potassium rather than to promote the excretion as do many diuretics and, occasionally, can cause increases in serum potassium which, in some instances, can result in hyperkalemia. In rare instances, hyperkalemia has been associated with cardiac irregularities.

    Electrolyte imbalance often encountered in such diseases as congestive heart failure, renal disease or cirrhosis may be aggravated or caused independently by any effective diuretic agent includingDyrenium. The use of full doses of a diuretic when salt intake is restricted can result in a low-salt syndrome.

    Triamterene can cause mild nitrogen retention, which is reversible upon withdrawal of the drug, and is seldom observed with intermittent (every-other-day) therapy.

    Triamterene may cause a decreasing alkali reserve, with the possibility of metabolic acidosis.

    By the very nature of their illness, cirrhotics with splenomegaly sometimes have marked variations in their blood. Since triamterene is a weak folic acid antagonist, it may contribute to the appearance of megaloblastosis in cases where folic acid stores have been depleted. Therefore, periodic blood studies in these patients are recommended. They should also be observed for exacerbations of underlying liver disease.

    Triamterene has elevated uric acid, especially in persons predisposed to gouty arthritis.

    Triamterene has been reported in renal stones in association with other calculus components. Dyrenium should be used with caution in patients with histories of renal stones.

    Information for Patients

    To help avoid stomach upset, it is recommended that the drug be taken after meals.

    If a single daily dose is prescribed, it may be preferable to take it in the morning to minimize the effect of increased frequency of urination on nighttime sleep.

    If a dose is missed, the patient should not take more than the prescribed dose at the next dosing interval.

    Laboratory Tests

    Hyperkalemia will rarely occur in patients with adequate urinary output, but it is a possibility if large doses are used for considerable periods of time. If hyperkalemia is observed, Dyrenium (triamterene) should be withdrawn. The normal adult range of serum potassium is 3.5 to 5.0 mEq per liter, with 4.5 mEq often being used for a reference point. Potassium levels persistently above 6 mEq per liter require careful observation and treatment. Normal potassium levels tend to be higher in neonates (7.7 mEq per liter) than in adults. Serum potassium levels do not necessarily indicate true body potassium concentration. A rise in plasma pH may cause a decrease in plasma potassium concentration and an increase in the intracellular potassium concentration. Because Dyrenium conserves potassium, it has been theorized that in patients who have received intensive therapy or been given the drug for prolonged periods, a rebound kaliuresis could occur upon abrupt withdrawal. In such patients, withdrawal of Dyrenium should be gradual.

    Drug Interactions

    Caution should be used when lithium and diuretics are used concomitantly because diuretic-induced sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. Patients receiving such combined therapy should have serum lithium levels monitored closely and the lithium dosage adjusted if necessary.

    A possible interaction resulting in acute renal failure has been reported in a few subjects when indomethacin, a nonsteroidal anti-inflammatory agent, was given with triamterene. Caution is advised in administering nonsteroidal anti-inflammatory agents with triamterene.

    The effects of the following drugs may be potentiated when given together with triamterene: antihypertensive medication, other diuretics, preanesthetic and anesthetic agents, skeletal muscle relaxants (nondepolarizing).

    Potassium-sparing agents should be used with caution in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to an increased risk of hyperkalemia.

    The following agents, given together with triamterene, may promote serum potassium accumulation and possibly result in hyperkalemia because of the potassium-sparing nature of triamterene, especially in patients with renal insufficiency: blood from blood bank (may contain up to 30 mEq of potassium per liter of plasma or up to 65 mEq per liter of whole blood when stored for more than 10 days); low-salt milk (may contain up to 60 mEq of potassium per liter); potassium-containing medications (such as parenteral penicillin G potassium); salt substitutes (most contain substantial amounts of potassium).

    Dyrenium (triamterene) may raise blood glucose levels; for adult-onset diabetes, dosage adjustments of hypoglycemic agents may be necessary during and/or after therapy; concurrent use with chlorpropamide may increase the risk of severe hyponatremia.

    Drug/Laboratory Test Interactions

    Triamterene and quinidine have similar fluorescence spectra; thus, triamterene will interfere with the fluorescent measurement of quinidine.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carcinogenesis: In studies conducted under the auspices of the National Toxicology Program, groups of rats were fed diets containing 0, 150, 300 or 600 ppm of triamterene, and groups of mice were fed diets containing 0, 100, 200 or 400 ppm triamterene. Male and female rats exposed to the highest tested concentration received triamterene at about 25 and 30 mg/kg/day, respectively. Male and female mice exposed to the highest tested concentration received triamterene at about 45 and 60 mg/kg/day, respectively.

    There was an increased incidence of hepatocellular neoplasia (primarily adenomas) in male and female mice at the highest dosage level. These doses represent 7.5X and 10X the Maximum Recommended Human Dose (MRHD) of 300 mg/kg/day (or 6 mg/kg/day based on a 50 kg patient) for male and female mice, respectively, when based on body weight and 0.7X and 0.9X the MRHD when based on body-surface area.

    Although hepatocellular neoplasia (exclusively adenomas) in the rat study was limited to triamterene-exposed males, incidence was not dose dependent and there was no statistically significant difference from control incidence at any dose level.

    Mutagenesis: Triamterene was not mutagenic in bacteria (Salmonella typhimurium strains TA98, TA100, TA1535 or TA1537) with or without metabolic activation. It did not induce chromosomal aberrations in Chinese hamster ovary (CHO) cells in vitro with or without metabolic activation, but it did induce sister chromatid exchanges in CHO cells in vitro with and without metabolic activation.

    Impairment of Fertility: Studies of the effects of triamterene on animal reproductive function have not been conducted.

    Pregnancy: Category C

    Teratogenic Effects: Reproduction studies have been performed in rats at doses as high as 20 times the Maximum Recommended Human Dose (MRHD) on the basis of body weight, and 6 times the MRHD on the basis of body-surface area, without evidence of harm to the fetus due to triamterene. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

    Nonteratogenic Effects: Triamterene has been shown to cross the placental barrier and appear in cord blood. The use of triamterene in pregnant women requires that the anticipated benefits be weighed against possible hazards to the fetus. These possible hazards include adverse reactions which have occurred in the adult.

    Nursing Mothers:

    Triamterene has not been studied in nursing mothers. Triamterene appears in animal milk and is likely present in human milk. If use of the drug product is deemed essential, the patient should stop nursing.

    Pediatric Use:

    Safety and effectiveness in pediatric patients have not been established.

    Adverse Reactions

    Adverse effects are listed in decreasing order of frequency; however, the most serious adverse effects are listed first, regardless of frequency. All adverse effects occur rarely (that is, 1 in 1000, or less).

    Hypersensitivity: anaphylaxis, rash, photosensitivity.

    Metabolic: hyperkalemia, hypokalemia.

    Renal: azotemia, elevated BUN and creatinine, renal stones, acute interstitial nephritis (rare), acute renal failure (one case of irreversible renal failure has been reported).

    Gastrointestinal: jaundice and/or liver enzyme abnormalities, nausea and vomiting, diarrhea.

    Hematologic: thrombocytopenia, megaloblastic anemia.

    Central Nervous System: weakness, fatigue, dizziness, headache, dry mouth.

    To report SUSPECTED ADVERSE REACTIONS, contact WellSpring Pharmaceutical Corporation at 1-866-337-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

    Overdosage

    In the event of overdosage, it can be theorized that electrolyte imbalance would be the major concern, with particular attention to possible hyperkalemia. Other symptoms that might be seen would be nausea and vomiting, other G.I. disturbances and weakness. It is conceivable that some hypotension could occur. As with an overdose of any drug, immediate evacuation of the stomach should be induced through emesis and gastric lavage. Careful evaluation of the electrolyte pattern and fluid balance should be made. There is no specific antidote.

    Reversible acute renal failure following ingestion of 50 tablets of a product containing a combination of 50 mg triamterene and 25 mg hydrochlorothiazide has been reported.

    The oral LD50 in mice is 380 mg/kg. The amount of drug in a single dose ordinarily associated with symptoms of overdose or likely to be life-threatening is not known.

    Although triamterene is 67% protein bound, there may be some benefit to dialysis in cases of overdosage.

    Dyrenium Dosage and Administration

    Adult Dosage

    Dosage should be titrated to the needs of the individual patient. When used alone, the usual starting dose is 100 mg twice daily after meals. When combined with another diuretic or antihypertensive agent, the total daily dosage of each agent should usually be lowered initially and then adjusted to the patient’s needs. The total daily dosage should not exceed 300 mg. Please refer to PRECAUTIONS−General.

    When Dyrenium (triamterene) is added to other diuretic therapy or when patients are switched to Dyrenium from other diuretics, all potassium supplementation should be discontinued.

    How is Dyrenium Supplied

    Capsules: 50 mg in bottles of 100, and 100 mg in bottles of 100.

    STORAGE

    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.

    50 mg 100s: NDC 65197-002-01

    100 mg 100s: NDC 65197-003-01

    DATE OF ISSUANCE MARCH 2009

    ©WellSpring, 2009

    Manufactured for

    WellSpring Pharmaceutical Corporation

    Sarasota, FL 34243 USA

    By WellSpring Pharmaceutical Canada Corp.

    Oakville, Ontario L6H 1M5 Canada

    Rev. 03/09

    PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    NDC 65197-002-06

    Dyrenium®

    (triamterene) capsules

    50 mg

    Rx Only

    6 Capsules per bottle

    Professional Sample

    NOT FOR SALE

     

    Dyrenium 

    triamterene capsule

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65197-002
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRIAMTERENE (TRIAMTERENE) TRIAMTERENE 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33  
    FD&C YELLOW NO. 6  
    GELATIN  
    LACTOSE  
    MAGNESIUM STEARATE  
    SODIUM LAURYL SULFATE  
    TITANIUM DIOXIDE  
    SILICON DIOXIDE  
    Product Characteristics
    Color RED (opaque red) Score no score
    Shape CAPSULE Size 10mm
    Flavor Imprint Code Dyrenium;50;mg;Dyrenium;WPC;002
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:65197-002-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE
    2 NDC:65197-002-06 6 CAPSULE (6 CAPSULE) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA013174 10/01/1999
    Dyrenium 

    triamterene capsule

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65197-003
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRIAMTERENE (TRIAMTERENE) TRIAMTERENE 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33  
    FD&C YELLOW NO. 6  
    GELATIN  
    LACTOSE  
    MAGNESIUM STEARATE  
    SODIUM LAURYL SULFATE  
    TITANIUM DIOXIDE  
    SILICON DIOXIDE  
    Product Characteristics
    Color RED (opaque red) Score no score
    Shape CAPSULE Size 10mm
    Flavor Imprint Code Dyrenium;100;mg;Dyrenium;WPC;003
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:65197-003-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA013174 01/01/1999
    Labeler - WellSpring Pharmaceutical Corporation (110999054)

    Revised: 10/2012   WellSpring Pharmaceutical Corporation

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    Dyrenium

    Dyrenium

    Generic Name: triamterene (trye-AM-ter-een)

    Brand Name: Dyrenium

    Dyrenium may cause high blood potassium levels that can be fatal if not corrected. High blood potassium levels occur more commonly in patients with kidney problems, diabetes, elderly patients, those who are severely ill, or patients who are not taking an agent used to increase excretion of potassium. If you develop muscle weakness or irregular heartbeat, notify your doctor immediately.

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Dyrenium is used for:

    Treating swelling (edema) associated with conditions such as congestive heart failure, cirrhosis of the liver, and certain severe kidney problems (eg, nephrosis). It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

    Dyrenium is a potassium-sparing diuretic. It works by making the kidneys eliminate sodium (salt) and water from the body while retaining potassium.

    Do NOT use Dyrenium if:

    • you are allergic to any ingredient in Dyrenium
    • you are taking potassium supplements, another potassium-sparing diuretic (eg, amiloride), or an aldosterone blocker (eg, eplerenone)
    • you are unable to urinate or have high blood potassium levels or severely decreased liver or kidney function

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

    Before using Dyrenium:

    Some medical conditions may interact with Dyrenium. 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 have heart problems, diabetes, kidney damage caused by diabetes, liver or kidney problems, low blood sodium levels, a high acidity of body fluids, dehydration, or a history of kidney stones

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

    • Aldosterone blockers (eg, eplerenone), angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin II receptor antagonists (eg, valsartan), cyclosporine, penicillin G potassium, otherpotassium-sparing diuretics (eg, amiloride), or potassium supplements because high blood potassium levels may occur and cause listlessness, confusion, abnormal skin sensations of the arms and legs, heaviness of the limbs, slow or irregular heartbeat, or stopping of the heart
    • Insulin and oral hypoglycemics (eg, chlorpropamide) because the risk of side effects, such as severe low blood sodium and changes in blood sugar, may be increased
    • Lithium because risk of side effects and toxicity may be increased by Dyrenium
    • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin) because the effectiveness of Dyrenium may be decreased and the risk of kidney problems and high blood potassium levels may be increased

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Dyrenium 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 Dyrenium:

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

    • Take Dyrenium by mouth with or without food.
    • Dyrenium may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
    • If you miss a dose of Dyrenium, 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 Dyrenium.

    Important safety information:

    • Dyrenium may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Dyrenium 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 use a salt substitute or a product that has potassium in it.
    • Tell your doctor or dentist that you take Dyrenium before you receive any medical or dental care, emergency care, or surgery.
    • LAB TESTS, including blood electrolytes, blood cell counts, kidney and liver function tests, blood uric acid levels, and blood pressure, may be performed while you use Dyrenium. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
    • Use Dyrenium with caution in the ELDERLY; they may be more sensitive to its effects.
    • Dyrenium should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
    • PREGNANCY and BREAST-FEEDING: It is not known if Dyrenium can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dyrenium while you are pregnant. It is not known if Dyrenium is found in breast milk. Do not breast-feed while taking Dyrenium.

    Possible side effects of Dyrenium:

    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:

    Diarrhea; headache; loss of appetite; nausea; weakness.

    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); dry mouth; excessive thirst; slow or irregular heart rate; unusual muscle weakness; unusual tiredness; vomiting; 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 lightheadedness; nausea; vomiting; weakness.

    Proper storage of Dyrenium: Store Dyrenium at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dyrenium out of the reach of children and away from pets.

    General information:

    • If you have any questions about Dyrenium, please talk with your doctor, pharmacist, or other health care provider.
    • Dyrenium 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 Dyrenium 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 Dyrenium. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Dyrenium. 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 Dyrenium.

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

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    Dyrenium

    Dyrenium

    Generic Name: triamterene (Oral route)

    trye-AM-ter-een

    OverviewSide EffectsInteractionsFor ProfessionalsMore… Oral route(Capsule) May cause hyperkalemia, which if uncorrected, is potentially fatal. Hyperkalemia is more likely to occur in patients with renal impairment, diabetes mellitus (with or without recognized renal insufficiency), and in the elderly or severely ill. Monitor serum potassium levels carefully in any patient receiving triamterene .

    Commonly used brand name(s)

    In the U.S.

    • Dyrenium

    Available Dosage Forms:

    • Tablet
    • Capsule

    Therapeutic Class: Cardiovascular Agent

    Pharmacologic Class: Diuretic, Potassium Sparing

    Uses For Dyrenium

    Triamterene is used alone or in combination with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

    Triamterene is also used to treat water retention (edema) in patients with congestive heart failure, liver cirrhosis, or a kidney disorder called nephrotic syndrome .

    Triamterene is a type of diuretic (water pill) that helps prevent your body from losing too much potassium. It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure .

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

    Before Using Dyrenium

    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 triamterene in the pediatric population. Safety and efficacy have not been established .

    Geriatric

    No information is available on the relationship of age to the effects of triamterene in geriatric patients .

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

    Breast Feeding

    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.

    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.

    • Amiloride
    • Eplerenone
    • Spironolactone

    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.

    • Alacepril
    • Arginine
    • Arsenic Trioxide
    • Benazepril
    • Captopril
    • Cilazapril
    • Delapril
    • Dofetilide
    • Droperidol
    • Enalaprilat
    • Enalapril Maleate
    • Fosinopril
    • Imidapril
    • Levomethadyl
    • Lisinopril
    • Methotrexate
    • Moexipril
    • Pentopril
    • Perindopril
    • Potassium
    • Quinapril
    • Ramipril
    • Sotalol
    • Spirapril
    • Tacrolimus
    • Temocapril
    • Trandolapril
    • Zofenopril

    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.

    • Aceclofenac
    • Acemetacin
    • Alclofenac
    • Amantadine
    • Apazone
    • Benoxaprofen
    • Bromfenac
    • Bufexamac
    • Carprofen
    • Clometacin
    • Clonixin
    • Dexketoprofen
    • Diclofenac
    • Diflunisal
    • Dipyrone
    • Droxicam
    • Etodolac
    • Etofenamate
    • Felbinac
    • Fenbufen
    • Fenoprofen
    • Fentiazac
    • Floctafenine
    • Flufenamic Acid
    • Flurbiprofen
    • Gossypol
    • Ibuprofen
    • Indomethacin
    • Indoprofen
    • Isoxicam
    • Ketoprofen
    • Ketorolac
    • Licorice
    • Lornoxicam
    • Meclofenamate
    • Mefenamic Acid
    • Meloxicam
    • Nabumetone
    • Naproxen
    • Niflumic Acid
    • Nimesulide
    • Oxaprozin
    • Oxyphenbutazone
    • Phenylbutazone
    • Pirazolac
    • Piroxicam
    • Pirprofen
    • Propyphenazone
    • Proquazone
    • Sulindac
    • Suprofen
    • Tenidap
    • Tenoxicam
    • Tiaprofenic Acid
    • Tolmetin
    • Zomepirac

    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 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.

    • Potassium Containing Food

    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:

    • Anuria (not able to pass urine) or
    • Diabetes or
    • Hyperkalemia (high potassium in the blood) or
    • Kidney disease, severe or
    • Liver disease, severe—Should not be used in patients with these conditions .
    • Folic acid deficiency or
    • Gout or
    • Hyperuricemia (high uric acid in the blood) or
    • Hypokalemia (low potassium in the blood) or
    • Hyponatremia (low sodium in the blood) or
    • Kidney stones, history of—This medicine may make these conditions worse .

    Proper Use of Dyrenium

    In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

    Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

    Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

    It is best to take this medicine after a meal .

    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 (capsules):
      • For hypertension or edema:
        • Adults—100 milligrams (mg) two times a day. Your doctor may adjust your dose if needed.
        • 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.

    Precautions While Using Dyrenium

    It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects .

    Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes containing potassium .

    This medicine may increase the amount of potassium in your blood. Check with your doctor right away if you are having abdominal pain; confusion; difficulty breathing; irregular heartbeats; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs .

    Dyrenium 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 or stomach pain
    • agitation
    • black, tarry stools
    • bleeding gums
    • blood in the urine or stools
    • chills
    • clay-colored stools
    • cloudy urine
    • confusion
    • convulsions
    • cough
    • dark urine
    • decreased urine output
    • depression
    • difficulty breathing
    • difficulty swallowing
    • dizziness
    • dry mouth
    • fainting spells
    • fast or irregular heartbeats
    • fever
    • headache
    • hives
    • hostility
    • increased thirst
    • irritability
    • itching
    • joint pain
    • lethargy
    • loss of appetite
    • loss of consciousness
    • mood changes
    • muscle pain or cramps
    • muscle twitching
    • nausea or vomiting
    • nervousness
    • numbness or tingling in the hands, feet, or lips
    • pain in the groin or genitals
    • pain in the lower back or side
    • pinpoint red spots on the skin
    • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
    • rapid or unusual weight gain
    • seizures
    • sharp back pain just below the ribs
    • shortness of breath
    • skin rash
    • stupor
    • swelling of the face, ankles, feet, or hands
    • tightness in the chest
    • unpleasant breath odor
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting of blood
    • weakness or heaviness of the legs
    • wheezing
    • yellow eyes or skin

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

    Symptoms of overdose

    • Blurred vision
    • diarrhea
    • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
    • indigestion
    • pain or weakness in the hands or feet
    • passing of gas
    • stomach fullness or discomfort
    • sweating
    • trembling

    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:

    Incidence not known

    • Increased sensitivity of skin to sunlight
    • redness or other discoloration of the skin
    • severe sunburn

    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: Dyrenium side effects (in more detail)

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    Dyrenium

    Dyrenium

    Generic Name: Triamterene
    Class: Potassium-sparing Diuretics

    VA Class: CV704

    CAS Number: 396-01-0

    For ProfessionalsSide EffectsInteractionsMore…

    Warning(s)

    • Hyperkalemia (i.e., serum potassium concentrations ≥5.5 mEq/L) may occur with all potassium-sparing agents, including triamterene.b c d More likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in geriatric or severely ill patients or those receiving prolonged therapy with large doses.a b c d

    • Uncorrected hyperkalemia may be fatal; monitor serum potassium concentrations at frequent intervals especially during initial therapy, after dosage adjustment, or in patients with concurrent illness that may affect renal function.b c d

    Introduction

    Potassium-sparing diuretic; pteridine derivative.b

    Uses for Dyrenium

    Edema

    Management of edema associated with CHF, cirrhosis of the liver, or nephrotic syndrome.b

    Management of steroid-induced edema, idiopathic edema, and edema caused by secondary hyperaldosteronism.b

    May be used alone but most valuable when used in combination with other diuretics to promote diuresis and/or decrease potassium excretion caused by kaliuretic diuretics.b

    May be particularly useful in patients excreting excessive amounts of potassium (especially those who cannot tolerate potassium supplements) and for those in whom potassium loss could be detrimental, such as patients receiving digitalis glycosides or those with myasthenia gravis.a b

    Promotes increased diuresis in patients resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism.b

    May be effective in some patients unresponsive to spironolactone; unlike spironolactone, diuretic effect of triamterene is independent of aldosterone concentrations.a

    Used in fixed combination with hydrochlorothiazide for treatment of edema in patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.c d

    Used in fixed combination with hydrochlorothiazide for treatment of edema in patients who develop hypokalemia during hydrochlorothiazide monotherapy.c d

    Do not use for routine therapy in pregnant women with mild edema who are otherwise healthy.b c d

    CHF

    In the management of edema associated with CHF, generally used in conjunction with other more effective, rapidly acting diuretics (e.g., thiazides, chlorthalidone, loop diuretics).a Some patients resistant to triamterene monotherapy may respond to such combined therapy.a

    Most experts state that all patients with symptomatic CHF who have evidence or a prior history of fluid retention generally should receive diuretic therapy in conjunction with moderate sodium restriction (≤3 g of sodium daily), an ACE inhibitor, and usually a β-adrenergic blocking agent, with or without a cardiac glycoside.112 113

    Most experts state that the diuretics of choice for most patients with CHF are loop diuretics (e.g., bumetanide, ethacrynic acid, furosemide, torsemide).a

    Do not use diuretics as monotherapy in CHF even if symptoms (e.g., peripheral edema, pulmonary congestion) are well controlled; diuretics alone do not prevent progression of heart failure.

    Once fluid retention in CHF has resolved, diuretic therapy should be maintained to prevent its recurrence. Ideally, diuretic therapy should be adjusted according to changes in body weight (as an indicator of fluid retention) rather than maintained at a fixed dosage.

    Diuretics should be continued in CHF and comorbid conditions (e.g., hypertension) where ongoing therapy with the drugs is indicated.

    Hypertension

    Triamterene alone has little if any hypotensive effect; however, it may be used with another diuretic (e.g., hydrochlorothiazide) or a hypotensive agent in the management of mild to moderate hypertension.a However, JNC 7 recommends that thiazides be used as initial therapy for the treatment of uncomplicated hypertension in most patients, either alone or combined with other classes of antihypertensive drugs that have demonstrated benefit (e.g., ACE inhibitors, angiotensin II receptor antagonists, β-blockers, calcium-channel blockers).119

    Used principally in patients with diuretic-induced hypokalemia or to prevent hypokalemia in patients receiving diuretics who are at risk of this adverse effect.a

    Used in fixed combination with hydrochlorothiazide for treatment of hypertension in patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.c d

    Used in fixed combination with hydrochlorothiazide for treatment of hypertension in patients who develop hypokalemia during hydrochlorothiazide monotherapy.c d

    Used in fixed combination with hydrochlorothiazide for treatment of hypertension as an adjunct to other antihypertensive drugs (e.g., β-blockers).c d

    Dyrenium Dosage and Administration

    General

    • Monitor serum potassium concentrations following changes in dosage or with concurrent illness or drug therapy.b d (See Hyperkalemia under Cautions and also see Interactions.)

    • Avoid use of potassium-sparing diuretics, including triamterene, in patients with renal insufficiency, in those with hyperkalemia who have serum potassium concentrations >5 mEq/L while not receiving drug therapy, and in those who develop hyperkalemia during therapy.109 119 b c d
    • Do not use concurrent potassium supplementation or potassium-containing salt substitutes.b Discontinue potassium supplementation when triamterene is added to other diuretic therapy or when patients are switched to triamterene from other diuretics.b
    • Do not use fixed-combination triamterene/hydrochlorothiazide tablets or capsules for initial therapy of edema or hypertension, except in patients in whom the clinical consequences of hypokalemia represent an important risk (e.g., patients receiving cardiac glycosides or patients with cardiac arrhythmias).a c d
    • Do not use as initial monotherapy in severe CHF since bowel edema or intestinal hypoperfusion may delay absorption and subsequent therapeutic effect.a
    • Careful etiologic diagnosis should precede the use of any diuretic.a

    Administration

    Oral Administration

    Capsules: Administer orally twice daily after meals.b

    Fixed-combination triamterene/hydrochlorothiazide tablets or capsules: Administer orally once daily.c d

    Twice-daily administration of the fixed combination of triamterene and hydrochlorothiazide may increase risk of electrolyte imbalance and renal dysfunction.d

    Dosage

    Individualize dosage according to patient’s requirements and response.b

    If added to an existing antihypertensive regimen, initially reduce dosage of each antihypertensive agent and then individualize dosage according to patient’s requirements and response.b

    Abrupt discontinuance may result in rebound kaliuresis; taper dosage gradually.b

    Different commercially available fixed-combination triamterene/hydrochlorothiazide preparations may not be therapeutic equivalents.a The oral bioavailabilities of the individual drugs and the amounts and ratios of these drugs in various commercially available fixed-combination preparations may differ.a

    Pediatric Patients

    Usual Dosage†
    Oral

    Initially, 2–4 mg/kg daily or 115 mg/m2 daily, given in a single dose or 2 divided doses after meals.a e

    If necessary, increase dosage to 6 mg/kg daily.a Do not exceed 300 mg daily.b e

    Hypertension†
    Oral

    Initially, 1–2 mg/kg daily given in 2 divided doses after meals.120 Increase dosage as necessary up to 3–4 mg/kg daily given in 2 divided doses.120 Do not exceed 300 mg daily.120

    Adults

    Edema
    Monotherapy

    Oral Initially, 100 mg twice daily after meals.b After edema is controlled, usual maintenance dosage is 100 mg daily or every other day.a Do not exceed 300 mg daily.b

    Combination Therapy

    Oral When Dyazide, Maxzide or Maxzide-25 mg, or therapeutically equivalent formulations of these combinations are used, the usual dosage in terms of triamterene is 37.5–75 mg once daily.c d

    Patients receiving 25 mg of hydrochlorothiazide who become hypokalemic may be switched to Maxzide-25 mg (37.5 mg triamterene/25 mg hydrochlorothiazide).d

    Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be switched to Maxzide (75 mg triamterene/50 mg hydrochlorothiazide).d

    Hypertension
    Monotherapy

    Oral Usual dosage recommended by JNC 7 as monotherapy: 50–100 mg daily.119 Some patients may benefit from dividing the daily dosage into 2 doses.119

    Combination Therapy

    Oral Usually combined with a kaliuretic diuretic.a

    In conjunction with a kaliuretic diuretic, an initial triamterene dosage of 25 mg once daily has been recommended.109 Titrate dosage upward as needed and tolerated to a suggested maximum triamterene dosage of 100 mg daily.109 119

    Initially, administer each drug separately to adjust dosage.a

    May use in fixed combination with hydrochlorothiazide if optimum maintenance dosage corresponds to drug ratio in combination preparation.a

    Administer each drug separately whenever dosage adjustment is necessary.a

    When Dyazide, Maxzide or Maxzide-25 mg, or therapeutically equivalent formulations of these combinations are used, the usual dosage in terms of triamterene is 37.5–75 mg once daily.d

    Patients receiving 25 mg of hydrochlorothiazide who become hypokalemic may be switched to Maxzide-25 mg (37.5 mg triamterene/25 mg hydrochlorothiazide).d

    Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be switched to Maxzide (75 mg triamterene/50 mg hydrochlorothiazide).d

    If BP is not adequately controlled by use of 75 mg once daily (of triamterene in the fixed combination of triamterene/hydrochlorothiazide), another antihypertensive agent may be added.d

    Prescribing Limits

    Pediatric Patients

    Oral

    Maximum 300 mg daily.120

    Adults

    Oral

    Maximum 300 mg daily.b

    The manufacturer states there is no clinical experience to date with dosages of fixed-combination Maxzide or Maxzide-25 mg exceeding 75 mg of triamterene and 50 mg of hydrochlorothiazide daily.d

    Special Populations

    Hepatic Impairment

    No specific dosage recommendations for hepatic impairment; caution if using fixed combination with hydrochlorothiazide because of risk of precipitating hepatic coma.c d (See Contraindications under Cautions.)

    Renal Impairment

    No specific dosage recommendations for renal impairment; do not use in patients with renal impairment and elevated serum potassium; discontinue in patients who develop hyperkalemia while on the drug.b (See Contraindications under Cautions and also see Hyperkalemia under Cautions.)

    Cautions for Dyrenium

    Contraindications

    • Anuria, severe or progressive renal disease or dysfunction (except possibly nephrosis), acute or chronic renal insufficiency, substantial renal impairment.b c d

    • Preexisting hyperkalemia (≥5.5 mEq/L).b d
    • History of triamterene-induced hyperkalemia.b c d
    • Concurrent potassium supplementation, including potassium salts or potassium-containing salt substitutes.b (See Interactions.)
    • Concurrent therapy with potassium-sparing agents (e.g., spironolactone, amiloride hydrochloride, or fixed-combination formulations containing triamterene).b (See Interactions.)
    • Severe hepatic disease.b
    • Known hypersensitivity to triamterene or any ingredient in the formulation.b c d

    Warnings/Precautions

    Warnings

    Hyperkalemia

    Hyperkalemia (i.e., serum potassium concentrations ≥5.5 mEq/L) may occur with all potassium-sparing agents, including triamterene.b c d (See Boxed Warning.) Serum potassium concentrations persistently >6 mEq/L require careful observation and treatment.b

    If hyperkalemia occurs, discontinue triamterene; if using a triamterene/hydrochlorothiazide fixed combination, switch to a thiazide alone.b c d

    Evaluate BUN and serum potassium concentrations regularly, especially in patients with suspected or confirmed renal insufficiency.b Monitor serum potassium concentrations closely in geriatric and diabetic patients.b

    Warning signs of hyperkalemia include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, and shock.c d

    Hyperkalemia has been associated with cardiac irregularities.b Obtain ECG if hyperkalemia present or suspected.b If ECG does not show widening of QRS or arrhythmia in the presence of hyperkalemia, usually sufficient to discontinue triamterene and any potassium supplementation and switch to a thiazide alone.b May administer sodium polystyrene sulfonate to enhance excretion of excess potassium.b

    Presence of widened QRS complex or arrhythmia in association with hyperkalemia requires prompt additional therapy.b For tachyarrhythmia, infuse 44 mEq of sodium bicarbonate or 10 mL of 10% calcium gluconate or calcium chloride over several minutes.b For asystole, bradycardia, or AV block, transvenous pacing also is recommended.b The effect of calcium and sodium bicarbonate is transient and repeated administration may be required.b When indicated by the clinical situation, excess potassium may be removed by dialysis or oral or rectal administration of sodium polystyrene sulfonate.b Infusion of glucose and insulin has also been used to treat hyperkalemia.b

    Potassium Supplementation

    Do not use potassium supplementation (e.g., potassium salts, high potassium diet, salt substitutes) in patients receiving triamterene alone.b Discontinue potassium supplements when triamterene is added to existing diuretic therapy or when patients are switched to triamterene from other diuretics.b

    Do not use potassium supplementation with fixed-combination triamterene/hydrochlorothiazide except in severe cases of hypokalemia or if dietary intake of potassium is markedly impaired.a c Such concomitant therapy may be associated with rapid increases in serum potassium concentrations.c Monitor serum potassium concentrations frequently if potassium supplementation is used, especially in patients receiving digitalis or with a history of cardiac arrhythmias.c (See Interactions.)

    If serious hypokalemia (serum potassium <3.0 mEq/L demonstrated by repeat serum potassium determinations) occurs in a patient receiving fixed-combination triamterene/hydrochlorothiazide, discontinue fixed combination and initiate potassium supplementation.c

    If hyperkalemia occurs in a patient receiving fixed-combination triamterene/hydrochlorothiazide and supplemental potassium therapy, discontinue supplementation and substitute a thiazide diuretic alone for fixed-combination triamterene/hydrochlorothiazide until potassium concentrations return to normal.c

    Sensitivity Reactions

    Hypersensitivity Reactions

    Hypersensitivity reactions (e.g., anaphylaxis, rash, photosensitivity) reported; monitor for blood dyscrasias, liver damage or other idiosyncratic reactions.b

    General Precautions

    Use of Fixed Combinations

    When triamterene is used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.d

    Use during Pregnancy

    Routine use of diuretics, including triamterene, in otherwise healthy women exposes mother and fetus to unnecessary risk and is not generally indicated.b c d Diuretics do not prevent development of toxemia of pregnancy and do not appear to be beneficial in the treatment of toxemia.b c d

    Edema may develop during pregnancy due to comorbid pathology or the physiologic and mechanical consequences of pregnancy.b c d Diuretic therapy may be appropiate in the management of edema due to a pathologic cause manifesting during pregnancy.b c d However, dependent edema in pregnancy resulting from restriction of venous return by the gravid uterus may be treated by elevating the lower extremities and using support hose; diuretic therapy to lower intravascular volume is not appropriate in such cases.b c d

    Hypervolemia and associated edema, including generalized edema, occurs in the majority of pregnant women and is not harmful to fetus or mother.b c d Increased recumbency will generally provide relief; however, edema may cause extreme discomfort which is not relieved by rest.b c d Rarely, in such cases, a short course of diuretic therapy may be appropriate to provide relief.b c d

    Electrolyte Imbalance

    Electrolyte imbalance may worsen or develop during diuretic therapy, including triamterene.b Risk of electrolyte imbalance is increased in patients with CHF, renal disease, or cirrhosis.b Full-dose diuretic therapy in patients on restricted salt intake may cause a low-salt syndrome.b

    Monitor serum electrolytes regularly.d

    Renal Effects

    Elevations in BUN and/or Scr may occur, possibly secondary to a reversible reduction of GFR or a depletion of the intravascular fluid volume.d May occur more frequently in patients receiving twice-daily dosing with fixed combination of triamterene and hydrochlorothiazide.d

    Monitor BUN and Scr, especially in geriatric patients and those with suspected or confirmed hepatic or renal disease.d If azotemia increases, discontinue fixed-combination triamterene/hydrochlorothiazide preparation.d

    Nitrogen Retention

    May cause mild nitrogen retention, which is reversible upon drug discontinuance; seldom observed with intermittent (every-other-day) therapy.b

    Metabolic Acidosis

    May cause a decreasing alkali reserve with the possibility of metabolic acidosis.b

    Avoid use of potassium-sparing diuretics in severely ill patients in whom respiratory or metabolic acidosis may occur; acidosis may result in rapid increases in serum potassium concentrations.c d Perform frequent assessments of acid-base balance and serum electrolytes.c d

    Megaloblastosis

    Triamterene is a weak folic acid antagonist and may contribute to the appearance of megaloblastosis, especially in patients with depleted folic acid stores (e.g., pregnant women, alcoholics).a b Patients with cirrhosis and splenomegaly may have marked hematologic abnormalities; these patients should have periodic blood studies and be observed for exacerbations of underlying liver disease.b

    Hyperuricemia

    May cause elevations in serum uric acid concentrations, especially in patients predisposed to gouty arthritis.b

    Renal Calculi

    Has been reported in renal calcluli associated with usual calculus components.b c d Manufacturers state that triamterene may be used with caution in patients with histories of renal calcluli;b c d however, some clinicians recommend that the drug not be used in these patients because of the risk of triamterene nephrolithiasis.a

    If a patient passes a urinary calculus during triamterene therapy, the drug should be discontinued and the calculus analyzed for the presence of triamterene and/or its metabolites.a

    Rebound Kaliuresis

    Because triamterene conserves potassium, it has been suggested that patients who have received intensive therapy or have been given the drug for prolonged periods may develop a rebound kaliuresis if such therapy is discontinued abruptly.b Discontinue drug gradually in such patients.b

    Specific Populations

    Pregnancy

    Category C.b c d

    Lactation

    Distributed into milk in animals and is likely to distribute into human milk.b Discontinue nursing or the drug.b

    Pediatric Use

    Safety and efficacy in pediatric patients remain to be fully established for triamterene or triamterene in fixed combination with hydrochlorothiazide;b c however, some experts have suggested a triamterene dosage for hypertension based on limited clinical experience.120

    Geriatric Use

    Reduced clearance and increased risk of hyperkalemia; monitor serum potassium concentrations frequently.b c d (See Hyperkalemia under Cautions.)

    Hepatic Impairment

    Use with caution in patients with impaired hepatic function.a Do not use in patients with severe hepatic disease.a Diuretic therapy in such patients should be initiated while the patient is hospitalized, because rapid alterations in fluid and electrolyte balance may precipitate hepatic coma.a Monitor serum potassium concentrations closely in patients with hepatic cirrhosis and administer potassium supplementation if required.a (See Contraindications under Cautions.)

    Potassium loss has been reported during triamterene therapy in some patients with hepatic cirrhosis and may result in signs and symptoms of hepatic coma or precoma.a

    Patients with cirrhosis and splenomegaly may have marked hematologic abnormalities; these patients should have periodic blood studies and be observed for exacerbations of underlying liver disease.b (See Megablastosis under Cautions.)

    Renal Impairment

    Use with caution; increased risk of hyperkalemia.b Monitor serum potassium concentrations closely.b Do not use in patients with renal impairment and elevated serum potassium; discontinue in patients who develop hyperkalemia while on the drug.b (See Contraindications under Cautions and also see Hyperkalemia under Cautions.)

    Common Adverse Effects

    Hyperkalemia, azotemia, increased BUN and creatinine, renal calculi, jaundice and/or liver enzyme abnormalities, nausea and vomiting, diarrhea, thrombocytopenia, megaloblastic anemia, weakness, fatigue, dizziness, headache, dry mouth.b

    Interactions for Dyrenium

    Specific Drugs, Foods, and Laboratory Tests

    Drug, Food, or Test

    Interaction

    Comments

    ACE inhibitor

    Increased risk of hyperkalemiab c d

    Use caution with concomitant ACE inhibitor therapy; monitor serum potassium concentrations frequentlya b d

    Use potassium-sparing diuretics with great caution, if at all, in patients receiving an ACE inhibitor (e.g., enalapril) for CHFa

    Discontinue or reduce dosage of potassium-sparing diuretics as necessary in patients receiving an ACE inhibitora

    Anesthetic agents

    Possible potentiation of anesthetic effectsb

    Antidiabetic agents (e.g., insulin, oral agents)

    Possible increase in blood glucose concentrationb

    Adjust dosage of antidiabetic agent during triamterene therapy and after discontinuanceb

    Antihypertensive agents

    Possible additive antihypertensive effectsb

    Blood products

    Increased risk of hyperkalemiab

    May promote potassium accumulation; plasma from blood bank may contain up to 30 mEq/L of potassium and whole blood may contain up to 65 mEq/L if stored for >10 daysb

    Chlorpropamide

    Possible increased risk of severe hyponatremiab c

    Diuretics

    Possible potentiation of diuretic effectsb

    Diuretics, potassium-sparing (e.g. amiloride, spironolactone, other fixed-dose combination formulations containing triamterene)

    Increased risk of hyperkalemia; fatalities reportedb

    Concomitant use contraindicatedb

    Laxatives

    Possible decreased potassium-retaining effects of triamterenec

    Chronic use or overuse of laxatives may reduce serum potassium concentrations by promoting excessive potassium loss from Gl tractc

    Lithium

    Reduced renal clearance of lithium and increased risk of lithium toxicityb c

    Concomitant use generally contraindicated; if concomitant therapy is necessary, monitor serum lithium concentrations closely and adjust dosageb c

    Nondepolarizing neuromuscular blocking agents

    Potential increase in neuromuscular blockadeb

    NSAIAs (e.g., indomethacin)

    Concomitant use with indomethacin may adversely affect renal function (e.g., decreased Clcr, acute anuric renal failure)105 106

    Concomitant use with indomethacin not recommendeda

    Use caution with other concomitant NSAIAsa c

    Preanesthetic agents

    Possible potentiation of effects of preanesthetic agentb

    Potassium supplements, potassium-containing medications (e.g., parenteral penicillin G potassium) and/or foods containing potassium (e.g., salt substitutes, low-salt milk)

    Increased risk of hyperkalemia, especially in patients with renal insufficiencyb

    Concomitant use generally contraindicatedb

    Tests, fluorometric (e.g., lactic dehydrogenase activity)

    Possible interference due to pale blue fluorescence in urinea

    Tests, fluorometric assay for quinidine

    Interferes with the fluorometric assay of quinidine; the two drugs have similar fluorescence spectrab c

    Dyrenium Pharmacokinetics

    Absorption

    Bioavailability

    Triamterene and fixed combinations with hydrochlorothiazide are rapidly absorbed following oral administration;c d peak plasma concentrations achieved within 1–4 hours.a b d Interindividual variation in degree of absorption reported.a

    Oral bioavailabilities of triamterene and hydrochlorothiazide from Dyazide capsules are comparable to those of aqueous suspensions of the individual drugs, averaging 85 and 82%, respectively, for the fixed-dose formulation and 100 and 100%, respectively, for the suspensions.111 Dyazide capsules also are bioequivalent to single-entity 25-mg hydrochlorothiazide tablets and 37.5-mg triamterene capsules.110

    Oral bioavailabilities of triamterene and hydrochlorothiazide from Maxzide tablets are comparable to those of aqueous suspensions of the individual drugs.d The hydrochlorothiazide component of Maxzide tablets is bioequivalent to single-entity hydrochlorothiazide tablet formulations.d

    Onset

    Onset of diuresis following oral administration of triamterene usually occurs within 2–4 hours; maximum therapeutic effect may not occur until after several days of therapy.b

    Onset of diuresis after oral administration of Dyazide usually occurs within 1 hour and peaks at 2–3 hours.c

    Duration

    After oral administration of triamterene, diuresis diminishes in approximately 7–9 hours,a b although the total duration of action may be ≥24 hours.a

    After oral administration of Dyazide, diuresis diminishes in approximately 7–9 hours.c

    Food

    Administration of Dyazide with a high-fat meal in healthy adults increased the average bioavailabilities of triamterene, 6-p-hydroxytriamterene, and hydrochlorothiazide by about 67, 50, and 17%, respectively; increased the peak concentrations of triamterene and its p-hydroxy metabolite; and delayed absorption of the active drugs by up to 2 hours.110

    Administration with food does not affect absorption of triamterene or hydrochlorothiazide from Maxzide tablets.d

    Distribution

    Extent

    Distributed into bile.a

    Crosses the placenta and distributes into milk in animals.b

    Plasma Protein Binding

    Approximately 67%.b

    Elimination

    Metabolism

    Primarily metabolized to 6-p-hydroxytriamterene and its sulfate conjugate.b 107

    Elimination Route

    Excreted in urine, primarily as 6-p-hydroxytriamterene.b

    Half-life

    100–150 minutes.a

    Special Populations

    Renal clearances of triamterene, hydroxytriamterene sulfate, and hydrochlorothiazide may be reduced in geriatric patients receiving combined triamterene and hydrochlorothiazide therapy, principally as a result of age-related reductions in renal function.107 a

    Stability

    Storage

    Oral

    Capsules

    Tight, light resistant containers at 15–30°C.a b

    Fixed-dose Combination Formulations

    Dyazide capsules: Tight, light resistant containers at 20–25°C.c

    Maxzide tablets: Tight, light resistant containers at 15–30°C.d

    Actions

    • A pteridine derivative, potassium-sparing diuretic that is structurally related to folic acid.a b

    • Does not competitively inhibit aldosterone; activity is independent of aldosterone concentrations.b
    • Does not inhibit carbonic anhydrase.a
    • Acts directly on the distal renal tubule of the nephron to depress aldosterone-stimulated reabsorption of sodium and excretion of potassium and hydrogen at that site.b
    • Increases excretion of sodium, calcium, magnesium, and bicarbonate.a
    • Potassium excretion usually reduced; serum concentrations of potassium and chloride are usually increased.a b
    • Serum bicarbonate concentrations consistently decreased; urinary pH increased slightly.a
    • Reductions in glomerular filtration observed during daily, but not intermittent, administration; suggests a reversible effect on renal blood flow.a
    • Although effective alone, often used in combination with other diuretics that act at different sites in the nephron.a
    • Little if any hypotensive effect when used alone.a

    Advice to Patients

    • Importance of taking drug after meals to help avoid stomach upset.b

    • Importance of informing patients that if a single daily dose is prescribed, it may be preferable to take it in the morning to minimize the effect of increased frequency of urination on nighttime sleep.b
    • Importance of informing patients that if a dose is missed, the patient should take only the prescribed dose at the next dosing interval.b
    • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b c d
    • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b c d
    • Importance of informing patients of other important precautionary information. (See Cautions.)b c d

    Preparations

    Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

    Triamterene
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Oral

    Capsules

    50 mg

    Dyrenium (with benzyl alcohol and povidone)

    WellSpring

    100 mg

    Dyrenium (with benzyl alcohol and povidone)

    WellSpring

    * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

    Triamterene and Hydrochlorothiazide (Co-triamterzide)
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Oral

    Capsules

    37.5 mg Triamterene and Hydrochlorothiazide 25 mg*

    Dyazide (with benzyl alcohol and povidone)

    GlaxoSmithKline

    Triamterene and Hydrochlorothiazide Capsules

    Barr, Mylan, Sandoz, UDL

    50 mg Triamterene and Hydrochlorothiazide 25 mg*

    Triamterene and Hydrochlorothiazide Capsules

    TEVA, Sandoz

    Tablets

    37.5 mg Triamterene and Hydrochlorothiazide 25 mg*

    Maxzide-25 mg (scored)

    Mylan

    Triamterene and Hydrochlorothiazide Tablets

    Barr, Mylan, Pliva, Sandoz, Watson

    75 mg Triamterene and Hydrochlorothiazide 50 mg*

    Maxzide (scored)

    Mylan

    Triamterene and Hydrochlorothiazide Tablets

    Barr, Mylan, Pliva, Sandoz, Teva, UDL, Watson

    Comparative Pricing

    This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

    Dyazide 37.5-25MG Capsules (GLAXO SMITH KLINE): 30/$45.99 or 90/$110.97

    Dyrenium 100MG Capsules (WELLSPRING PHARMACEUTICAL CORP): 30/$75.99 or 90/$205.97

    Dyrenium 50MG Capsules (WELLSPRING PHARMACEUTICAL CORP): 30/$49.99 or 90/$126.99

    Maxzide 75-50MG Tablets (MYLAN): 30/$87.99 or 90/$241.96

    Maxzide-25 37.5-25MG Tablets (MYLAN): 30/$43.99 or 90/$109.97

    Triamterene-HCTZ 37.5-25MG Capsules (MYLAN): 100/$41.99 or 200/$68.98

    Triamterene-HCTZ 37.5-25MG Tablets (MYLAN): 100/$29.99 or 200/$45.96

    Triamterene-HCTZ 50-25MG Capsules (SANDOZ): 100/$169.99 or 300/$489.96

    Triamterene-HCTZ 75-50MG Tablets (SANDOZ): 100/$27.99 or 300/$67.98

    Disclaimer

    This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

    The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug’s actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

    AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions July 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

    † Use is not currently included in the labeling approved by the US Food and Drug Administration.

    References

    Only references cited for selected revisions after 1984 are available electronically.

    100. Upton RA, Williams RL, Lin ET et al. Absence of a significant pharmacokinetic interaction between hydrochlorothiazide and triamterene when coadministered. J Pharmacokinet Biopharm. 1984; 12:575-86. [IDIS 197834] [PubMed 6533293]

    101. Blume CD, Williams RL, Upton RA et al. Bioequivalence study of a new tablet formulation of triamterene and hydrochlorothiazide. Am J Med. 1984; 77(Suppl 5A):59-61. [IDIS 192689] [PubMed 6496560]

    102. Blume CD, Williams RL. A new antihypertensive agent: Maxzide (75 mg triamterene/50 mg hydrochlorothiazide). Am J Med. 1984; 77(Suppl 5A):52-8. [IDIS 192688] [PubMed 6388327]

    104. Houston MC. Thiazides and thiazide-like diuretics in hypertension. Ann Intern Med. 1985; 103:303. [IDIS 202760] [PubMed 4014913]

    105. Favre L, Glasson P, Vallotton MB. Reversible acute renal failure from combined triamterene and indomethacin. Ann Intern Med. 1982; 96:317-20. [IDIS 146179] [PubMed 6949485]

    106. Weinberg MS, Quigg RJ, Salant DJ et al. Anuric renal failure precipitated by indomethacin and triamterene. Nephron. 1985; 40:216-8. [PubMed 4000350]

    107. Williams RL, Thornhill MD, Upton RA et al. Absorption and disposition of two combination formulations of hydrochlorothiazide and triamterene: influence of age and renal function. Clin Pharmacol Ther. 1986; 40:226-32. [IDIS 219934] [PubMed 3731685]

    108. Lederle Laboratories. Maxzide and Maxzide-25 MG tablets prescribing information. Pearl River, NY; 1988 May.

    109. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health. (NIH publication No. 98-4080.)

    110. SmithKline Beecham. Dyazide (triamterene and hydrochlorothiazide) capsules prescribing information (DZ:L65A). In: Physicians’ desk reference. 52nd ed. Montvale, NJ; 1998:2819-20.

    111. SmithKline Beecham, Philadelphia, PA: Personal communication.

    112. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9A-38A

    113. The Captopril-Digoxin Multicenter Research Group. Comparative effects of therapy with captopril and digoxin in patients with mild to moderate heart failure. JAMA. 1988; 259:539-44. [IDIS 237362] [PubMed 2447297]

    114. Richardson A, Bayliss J, Scriven AJ et al. Double-blind comparison of captopril alone against frusemide plus amiloride in mild heart failure. Lancet. 1987; 2:709-11. [IDIS 234108] [PubMed 2888942]

    115. Sherman LG, Liang CS, Baumgardner S et al. Piretanide, a potent diuretic with potassium-sparing properties, for the treatment of congestive heart failure. Clin Pharmacol Ther. 1986; 40:587-94. [IDIS 224725] [PubMed 3533372]

    116. Patterson JH, Adams KF Jr, Applefeld MM et al. Oral torsemide in patients with chronic congestive heart failure: effects on body weight, edema, and electrolyte excretion. Pharmacotherapy. 1994; 14:514-21. [IDIS 336083] [PubMed 7997385]

    117. Wilson JR, Reichek N, Dunkman WB et al. Effect of diuresis on the performance of the failing left ventricle in man. Am J Med. 1981;70:234-9.

    118. Parker JO. The effects of oral ibopamine in patients with mild heart failure—a double blind placebo controlled comparison to furosemide. Int J Cardiol. 1993; 40:221-7. [PubMed 8225657]

    119. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (). (Also published in JAMA. 2003; 289.

    120. National High Blood Pressure Education Program Working Group on Hypertension Control in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004; 114(Suppl 2):555-76.

    a. AHFS Drug Information 2005. McEvoy GK, ed. Triamterene. American Society of Health-System Pharmacists; 2005: 2596-9.

    b. WellSpring Pharmaceutical Corporation. Dyrenium (triamterene) capsules prescribing information. Neptune, NJ; 2001 June.

    c. GlaxoSmithKline. Dyazide capsules prescribing information. Philadelphia, PA; 1999 Feb.

    d. Bertek. Maxzide and Maxzide-25 mg tablets prescribing information. Sugar Land, TX; 2002 Dec.

    e. Laboratory medicine, drug therapy, and reference tables. In: Behrman RE, Kliegman RM, Jenson HB, eds. Nelson textbook of pediatrics. 17th ed. Philadelphia: Saunders; 2004:2482.

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    Dyrenium

    Dyrenium

    Generic Name: triamterene (try AM teh reen)

    Brand Name: Dyrenium

    OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

    What is Dyrenium (triamterene)?

    Triamterene is a potassium-sparing diuretic (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

    Triamterene is used to treat fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney condition called nephrotic syndrome.

    Triamterene is also used to treat edema caused by having too much aldosterone in your body. Aldosterone is a hormone produced by the adrenal glands to help regulate the salt and water balance in your body.

    Triamterene may also be used for purposes other than those listed in this medication guide.

    What is the most important information I should know about Dyrenium (triamterene)?

    Do not use this medication if you have kidney disease, urination problems, severe liver disease, or high levels of potassium in your blood. Do not use potassium supplements or other diuretics while you are taking triamterene.

    Before using this medication, tell your doctor if you have heart or liver disease, diabetes, gout, or a history of kidney stones. Tell your doctor if you are using another diuretic.

    Avoid drinking alcohol, which can increase some of the side effects of triamterene.

    Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

    Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking triamterene.

    Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

    This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

    What should I discuss with my doctor before taking Dyrenium (triamterene)?

    Do not use this medication if you have:

    • kidney disease or are unable to urinate;

    • severe liver disease;
    • high potassium levels (hyperkalemia); or
    • if you are taking potassium supplements, or another potassium-sparing diuretic such as Dyazide, Maxzide, amiloride (Midamor, Moduretic), or spironolactone (Aldactone, Aldactazide).

    Before using triamterene, tell your doctor if you have:

    • diabetes;

    • heart disease;
    • liver disease;
    • gout;
    • a history of kidney stones; or
    • if you are using another diuretic.

    If you have any of these conditions, you may not be able to use triamterene, or you may need a dosage adjustment or special tests during treatment.

    FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

    Triamterene may pass into breast milk and could cause harm to a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    How should I take Dyrenium (triamterene)?

    Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

    Take each dose with a full glass of water.

    Take this medication after eating a meal.

    To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

    Triamterene can interfere with the results of certain medical tests. Tell any doctor who treats you that you are using triamterene.

    If you need to have any type of surgery, tell the surgeon ahead of time that you are taking triamterene. You may need to stop using the medicine for a short time.

    Store this medication at room temperature away from heat, light, and moisture.

    See also: Dyrenium dosage (in more detail)

    What happens if I miss a dose?

    Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

    What happens if I overdose?

    Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a triamterene overdose may include increased urination, nausea, vomiting, weakness, fever, warmth or flushing in your face, or muscle spasms.

    What should I avoid while taking Dyrenium (triamterene)?

    Avoid drinking alcohol, which can increase some of the side effects of triamterene.

    Avoid using other medicines that make you light-headed (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to the side effects of triamterene.

    Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking triamterene.

    Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

    This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

    Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

    Dyrenium (triamterene) 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.

    Stop using this medication and call your doctor at once if you have any of these serious side effects:

    • numbness or tingly feeling;

    • muscle pain or weakness;
    • slow, fast, or uneven heartbeat;
    • feeling drowsy, restless, or light-headed;
    • urinating less than usual or not at all;
    • shallow breathing;
    • tremors, confusion; or
    • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

    Continue using triamterene and talk with your doctor if you have any of these less serious side effects:

    • mild nausea, vomiting, or diarrhea;

    • dizziness, headache;
    • dry mouth; or
    • skin rash.

    Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Dyrenium side effects (in more detail)

    What other drugs will affect Dyrenium (triamterene)?

    Before taking this medication, tell your doctor if you are using any of the following drugs:

    • lithium;

    • insulin or diabetes medicine taken by mouth;
    • an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others; or
    • indomethacin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Motrin, Advil), diclofenac (Voltaren), naproxen (Aleve, Naprosyn), piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others.

    If you are using any of these drugs, you may not be able to use triamterene, or you may need dosage adjustments or special tests during treatment.

    There may be other drugs not listed that can affect triamterene. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

    Next Page → Side Effects

    More Dyrenium resources

    • Side Effects
    • Recommended Dosage
    • Pregnancy Warnings
    • Drug Images
    • Drug Interactions
    • Support Group
    • 0 Reviews - Add your own review/rating
    • Dyrenium Prescribing Information (FDA)
    • Dyrenium MedFacts Consumer Leaflet (Wolters Kluwer)
    • Dyrenium Monograph (AHFS DI)
    • Dyrenium Advanced Consumer (Micromedex) – Includes Dosage Information
    • Triamterene Professional Patient Advice (Wolters Kluwer)

    Compare Dyrenium with other medications

    • Ascites
    • Edema

    Where can I get more information?

    • Your pharmacist has additional information about triamterene written for health professionals that you may read.

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