What you need to know about drugs

Visken

Pindolol(pindolol) – Various

THERAPEUTIC CLASS

Nonselective beta-blocker

INDICATIONS

Management of HTN.

ADULT DOSAGE

Adults: Initial: 5mg bid. Titrate: May increase by 10mg/day after 3-4 weeks. Max: 60mg/day.

HOW SUPPLIED

Tab: 5mg, 10mg

CONTRAINDICATIONS

Bronchial asthma, overt cardiac failure, cardiogenic shock, second- and third-degree heart block, severe bradycardia.

WARNINGS/PRECAUTIONS

Caution with well-compensated heart failure, nonallergic bronchospasm, renal or hepatic impairment. Can cause cardiac failure. Avoid abrupt withdrawal. Withdrawal before surgery is controversial. May mask hypoglycemia or hyperthyroidism symptoms.

ADVERSE REACTIONS

Dizziness, fatigue, insomnia, nervousness, dyspnea, edema, joint pain, muscle cramps/pain.

DRUG INTERACTIONS

Additive hypotension and/or bradycardia with catecholamine-depleting drugs. Both thioridazine and pindolol levels may increase when used concomitantly.

PREGNANCY

Category B, not for use in nursing.

MECHANISM OF ACTION

Nonselective β-blocker; inhibits β-adrenergic receptor with intrinsic sympathomimetic activity.

PHARMACOKINETICS

Absorption: Rapid; Tmax=1 hr. Distribution: Vd=2L/kg; plasma protein binding (40%). Metabolism: Metabolized to hydroxy-metabolites, which are excreted as glucoronides and ethereal sulfates. Elimination: Urine (35-40%), feces (6-9%); T1/2=approximately 3-4 hrs, T1/2=8 hrs (metabolites).

ASSESSMENT

Assess for history of anaphylactic reaction, bronchial asthma, overt cardiac failure, cardiogenic shock, second- or third-degree heart block, severe bradycardia, bronchospastic disease, DM, thyrotoxicosis, LFTs, renal function, pregnancy/nursing status, and possible drug interactions. D/C drug well before any surgeries.

MONITORING

Monitor for anaphylactic reactions, LFTs, dizziness, fatigue, edema, dyspnea, muscle pain, heart block, hypotension, claudication, visual disturbances, impotence, CBC with differential and platelet count, Peyronie's disease, CHF, bronchospasm.

PATIENT COUNSELING

Instruct not to interrupt or d/c therapy without consulting physician. Counsel about signs/symptoms of CHF, bronchospasm, and other adverse effects; seek prompt medical assistance if any develop.

ADMINISTRATION/STORAGE

Administration: Oral route. Storage: Below 30°C (86°F); tight, light-resistant container.


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    Visken

    Visken

    Generic Name: pindolol

    Dosage Form: Tablets

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Visken®

    T1999-39

    89003701

       Visken®

       (pindolol)

       tablets, USP

       Rx only

    Visken Description

    Visken® (pindolol), a synthetic beta-adrenergic receptor blocking agent with intrinsic sympathomimetic activity is 1-(Indol-4-yloxy)-3-(isopropylamino)-2-propanol.

    Its structural formula is:

    Pindolol is a white to off-white odorless powder soluble in organic solvents and aqueous acids. Visken® (pindolol) is intended for oral administration.

    5 mg and 10 mg Tablets

    Active Ingredient: pindolol

    Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.

    Visken – Clinical Pharmacology

    Visken® (pindolol) is a non-selective beta-adrenergic antagonist (beta-blocker) which possesses intrinsic sympathomimetic activity (ISA) in therapeutic dosage ranges but does not possess quinidine-like membrane stabilizing activity.

    PHARMACODYNAMICS

    In standard pharmacologic tests in man and animals, Visken® (pindolol) attenuates increases in heart rate, systolic blood pressure, and cardiac output resulting from exercise and isoproterenol administration, thus confirming its beta-blocking properties. The ISA or partial agonist activity of Visken® (pindolol) is mediated directly at the adrenergic receptor sites and may be blocked by other beta-blockers. In catecholamine-depleted animal experiments, ISA is manifested as an increase in the inotropic and chronotropic activity of the myocardium. In man, ISA is manifested by a smaller reduction in the resting heart rate (4-8 beats/min) than is seen with drugs lacking ISA. There is also a smaller reduction in resting cardiac output. The clinical significance of this observation has not been evaluated and there is no evidence, or reason to believe, that exercise cardiac output is less affected by Visken® (pindolol).

    Visken® (pindolol) has been shown in controlled, double-blind clinical studies to be an effective antihypertensive agent when used as monotherapy, or when added to therapy with thiazide-type diuretics. Divided dosages in the range of 10-60 mg daily have been shown to be effective. As monotherapy, Visken® (pindolol) is as effective as propranolol, α-methyldopa, hydrochlorothiazide, and chlorthalidone in reducing systolic and diastolic blood pressure. The effect on blood pressure is not orthostatic, i.e. Visken® (pindolol) was equally effective in reducing the supine and standing blood pressure.

    In open, long-term studies up to 4 years, no evidence of diminution of the blood pressure-lowering response was observed.

    An average 3-pound increase in body weight has been noted in patients treated with Visken® (pindolol) alone, a larger increase than was observed with propranolol or placebo. The weight gain appeared unrelated to blood pressure response and was not associated with an increased risk of heart failure, although edema was more common than in control patients. Visken® (pindolol) does not have a consistent effect on plasma renin activity.

    The mechanism of the antihypertensive effects of beta-blocking agents has not been established, but several mechanisms have been postulated: 1) an effect on the central nervous system resulting in a reduced sympathetic outflow to the periphery, 2) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic receptor sites, leading to decreased cardiac output, 3) an inhibition of renin release. These mechanisms appear less likely for pindolol than other beta-blockers in view of the modest effect on resting cardiac output and renin.

    Beta-blockade therapy is useful when it is necessary to suppress the effects of beta-adrenergic agonists in order to achieve therapeutic goals. However, in certain clinical situations, (e.g., cardiac failure, heart block, bronchospasm), the preservation of an adequate sympathetic tone may be necessary to maintain vital functions. Although a beta-antagonist with ISA such as Visken® (pindolol) does not eliminate sympathetic tone entirely, there is no controlled evidence that it is safer than other beta-blockers in such conditions as heart failure, heart block, or bronchospasm or is less likely to cause those conditions. In single dose studies of the effects of beta-blockers on FEV1, Visken® (pindolol) was indistinguishable from other non-cardioselective agents in its reduction of FEV1, and its reduction in the effectiveness of an exogenous beta agonist.

    Exacerbation of angina and, in some cases, myocardial infarction and ventricular dysrhythmias have been reported after abrupt discontinuation of therapy with beta-adrenergic blocking agents in patients with coronary artery disease. Abrupt withdrawal of these agents in patients without coronary artery disease has resulted in transient symptoms, including tremulousness, sweating, palpitation, headache, and malaise. Several mechanisms have been proposed to explain these phenomena, among them increased sensitivity to catecholamines because of increased numbers of beta receptors.

    PHARMACOKINETICS AND METABOLISM

    Visken® (pindolol) is rapidly and reproducibly absorbed (greater than 95%), achieving peak plasma concentrations within 1 hour of drug administration. Visken® (pindolol) has no significant first-pass effect. The blood concentrations are proportional in a linear manner to the administered dose in the range of 5-20 mg. Upon repeated administration to the same subject, variation is minimal. After a single dose, intersubject variation for peak plasma concentrations was about 4fold (e.g., 45-167 ng/mL for a 20 mg dose). Upon multiple dosing, intersubject variation decreased to 2-2.5 fold. Visken® (pindolol) is only 40% bound to plasma proteins and is evenly distributed between plasma and red cells. The volume of distribution in healthy subjects is about 2 L/kg.

    Visken® (pindolol) undergoes extensive metabolism in animals and man. In man, 35%-40% is excreted unchanged in the urine and 60%-65% is metabolized primarily to hydroxy-metabolites which are excreted as glucuronides and ethereal sulfates. The polar metabolites are excreted with a half-life of approximately 8 hours and thus multiple dosing therapy (q.8H) results in a less than 50% accumulation in plasma. About 6%-9% of an administered intravenous dose is excreted by the bile into the feces.

    The disposition of Visken® (pindolol) after oral administration is monophasic with a half-life in healthy subjects or hypertensive patients with normal renal function of approximately 3-4 hours. Following t.i.d. administration (q.8H), no significant accumulation of Visken® (pindolol) is observed.

    In elderly hypertensive patients with normal renal function, the half-life of Visken® (pindolol) is more variable, averaging about 7 hours, but with values as high as 15 hours.

    In hypertensive patients with renal diseases, the half-life is within the range expected for healthy subjects. However, a significant decrease (50%) in volume of distribution (VD) is observed in uremic patients and VD appears to be directly correlated to creatinine clearance. Therefore, renal drug clearance is significantly reduced in uremic patients, resulting in a significant decrease in urinary excretion of unchanged drug. Uremic patients with a creatinine clearance of less than 20 mL/min generally excreted less than 15% of the administered dose unchanged in the urine.

    In patients with histologically diagnosed cirrhosis of the liver, the elimination of Visken® (pindolol) was more variable in rate and generally significantly slower than in healthy subjects. The total body clearance of Visken® (pindolol) in cirrhotic patients ranged from about 50-300 mL/min and was directly correlated to antipyrine clearance. The half-life ranges from 2.5 hours to greater than 30 hours. These findings strongly suggest that caution should be exercised in dosage adjustments of Visken® (pindolol) in such patients.

    The bioavailability of Visken® (pindolol) is not significantly affected by co-administration of food, hydralazine, hydrochlorothiazide or aspirin. Visken® (pindolol) has no effect on warfarin activity or the clinical effectiveness of digoxin, although small transient decreases in plasma digoxin concentrations were noted.

    Indications and Usage for Visken

    Visken® (pindolol) is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.

    Contraindications

    Visken® (pindolol) is contraindicated in: 1) bronchial asthma; 2) overt cardiac failure; 3) cardiogenic shock; 4) second and third degree heart block; 5) severe bradycardia.

    (See WARNINGS)

    Warnings

    Cardiac Failure

    Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta-blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, if necessary, Visken® (pindolol) can be used with caution in patients with a history of failure who are well-compensated, usually with digitalis and diuretics. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle.

    In Patients Without History of Cardiac Failure

    In patients with latent cardiac insufficiency, continued depression of the myocardium with beta-blocking agents over a period of time can in some cases lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or be given a diuretic, and the response observed closely. If cardiac failure continues, despite adequate digitalization and diuretic, Visken® (pindolol) therapy should be withdrawn (gradually if possible).

    Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal

    Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing chronically administered Visken® (pindolol), particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1-2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, Visken® (pindolol) administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue Visken® (pindolol) therapy abruptly even in patients treated only for hypertension.

    Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema) – Patients with Bronchospastic Diseases Should in General Not Receive Beta-Blockers

    Visken® (pindolol) should be administered with caution since it may block bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors.

    Major Surgery

    Because beta blockade impairs the ability of the heart to respond to reflex stimuli and may increase the risks of general anesthesia and surgical procedures, resulting in protracted hypotension or low cardiac output, it has generally been suggested that such therapy should be gradually withdrawn several days prior to surgery. Recognition of the increased sensitivity to catecholamines of patients recently withdrawn from beta-blocker therapy, however, has made this recommendation controversial. If possible, beta-blockers should be withdrawn well before surgery takes place. In the event of emergency surgery, the anesthesiologist should be informed that the patient is on beta-blocker therapy.

    The effects of Visken® (pindolol) can be reversed by administration of beta-receptor agonists such as isoproterenol, dopamine, dobutamine, or levarterenol. Difficulty in restarting and maintaining the heart beat has also been reported with beta-adrenergic receptor blocking agents.

    Diabetes and Hypoglycemia

    Beta-adrenergic blockade may prevent the appearance of premonitory signs and symptoms (e.g., tachycardia and blood pressure changes) of acute hypoglycemia. This is especially important with labile diabetics. Beta-blockade also reduces the release of insulin in response to hyperglycemia; therefore, it may be necessary to adjust the dose of antidiabetic drugs.

    Thyrotoxicosis

    Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade which might precipitate a thyroid crisis.

    Precautions

    Impaired Renal or Hepatic Function

    Beta-blocking agents should be used with caution in patients with impaired hepatic or renal function. Poor renal function has only minor effects on Visken® (pindolol) clearance, but poor hepatic function may cause blood levels of Visken® (pindolol) to increase substantially.

    Information for Patients

    Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of Visken® (pindolol) therapy without the physician’s advice. Although cardiac failure rarely occurs in properly selected patients, patients being treated with beta-adrenergic blocking agents should be advised to consult the physician at the first sign or symptom of impending failure.

    Drug Interactions

    Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients receiving Visken® (pindolol) plus a catecholamine-depleting agent should, therefore, be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension.

    Visken® (pindolol) has been used with a variety of antihypertensive agents, including hydrochlorothiazide, hydralazine, and guanethidine without unexpected adverse interactions.

    Visken® (pindolol) has been shown to increase serum thioridazine levels when both drugs are co-administered. Visken® (pindolol) levels may also be increased with this combination.

    Risk of Anaphylactic Reaction: While taking beta blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    In chronic oral toxicologic studies (1-2 years) in mice, rats, and dogs, Visken® (pindolol) did not produce any significant toxic effects. In 2-year oral carcinogenicity studies in rats and mice in doses as high as 59 mg/kg/day and 124 mg/kg/day (50 and 100 times the maximum recommended human dose), respectively, Visken® (pindolol) did not produce any neoplastic, preneoplastic, or nonneoplastic pathologic lesions. In fertility and general reproductive performance studies in rats, Visken® (pindolol) caused no adverse effects at a dose of 10 mg/kg.

    In the male fertility and general reproductive performance test in rats, definite toxicity characterized by mortality and decreased weight gain was observed in the group given 100 mg/kg/day. At 30 mg/kg/day, decreased mating was associated with testicular atrophy and/or decreased spermatogenesis. This response is not clearly drug related, however, as there was no dose response relationship within this experiment and no similar effect on testes of rats administered Visken® (pindolol) as a dietary admixture for 104 weeks. There appeared to be an increase in prenatal mortality in males given 100 mg/kg but development of offspring was not impaired.

    In females administered Visken® (pindolol) prior to mating through day 21 of lactation, mating behavior was decreased at 100 mg/kg and 30 mg/kg. At these dosages there also was increased mortality of offspring. Prenatal mortality was increased at 10 mg/kg but there was not a clear dose response relationship in this experiment. There was an increased resorption rate at 100 mg/kg observed in females necropsied on the 15th day of gestation.

    Pregnancy

    Category B: Studies in rats and rabbits exceeding 100 times the maximum recommended human doses, revealed no embryotoxicity or teratogenicity. Since there are no adequate and well-controlled studies in pregnant women, and since animal reproduction studies are not always predictive of human response, Visken® (pindolol), as with any drug, should be employed during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mothers

    Since Visken® (pindolol) is secreted in human milk, nursing should not be undertaken by mothers receiving the drug.

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    CLINICAL LABORATORY

    Minor persistent elevations in serum transaminases (SGOT, SGPT) have been noted in 7% of patients during Visken® (pindolol) administration, but progressive elevations were not observed. These elevations were not associated with any other abnormalities that would suggest hepatic impairment, such as decreased serum albumin and total proteins. During more than a decade of worldwide marketing, there have been no reports in the medical literature of overt hepatic injury. Alkaline phosphatase, lactic acid dehydrogenase (LDH), and uric acid are also elevated on rare occasions. The significance of these findings is unknown.

    Adverse Reactions

    Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given Visken® (pindolol) as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for Visken® (pindolol) and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with 1 exception. When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials [16% Visken® (pindolol) vs. 9% positive control] than in placebo controlled trials [6%Visken® (pindolol) vs. 3% placebo]. The table includes adverse reactions either volunteered or elicited, and at least possibly drug related, which were reported in greater than 2% of Visken® (pindolol) patients and other selected important reactions.

    Adverse Reactions Which Were Volunteered or Elicited(and at least possibly drug related)
    Body System/

    Adverse Reactions

    Visken® 

    (pindolol)

    (N=322)

    %

    Active

    Controls*

    (N=188)

    %

    Placebo

    (N=78)

    %

    Central Nervous System
       Bizarre or Many Dreams 5 0 6
       Dizziness 9 11 1
       Fatigue 8 4 4
       Hallucinations <1 0 0
       Insomnia 10 3 10
       Nervousness 7 3 5
       Weakness 4 2 1
    Autonomic Nervous System
       Paresthesia 3 1 6
    Cardiovascular
       Dyspnea 5 4 6
       Edema 6 3 1
       Heart Failure <1 <1 0
       Palpitations <1 1 0
    Musculoskeletal
       Chest Pain 3 1 3
       Joint Pain 7 4 4
       Muscle Cramps 3 1 0
       Muscle Pain 10 9 8
    Gastrointestinal
       Abdominal Discomfort 4 4 5
       Nausea 5 2 1
    Skin
       Pruritus 1 <1 0
       Rash <1 <1 1

    *Active Controls: Patients received either propranolol, α-methyldopa or a diuretic (hydrochlorothiazide or chlorthalidone).

    The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to Visken® (pindolol) is uncertain. CENTRAL NERVOUS SYSTEM: anxiety, lethargy; AUTONOMIC NERVOUS SYSTEM: visual disturbances, hyperhidrosis; CARDIOVASCULAR: bradycardia, claudication, cold extremities, heart block, hypotension, syncope, tachycardia, weight gain; GASTROINTESTINAL: diarrhea, vomiting; RESPIRATORY: wheezing; UROGENITAL: impotence, pollakiuria; MISCELLANEOUS: eye discomfort or burning eyes.

    POTENTIAL ADVERSE EFFECTS

    In addition, other adverse effects not aforementioned have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of Visken® (pindolol).

    Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.

    Cardiovascular: Intensification of AV block. (See CONTRAINDICATIONS)

    Allergic: Erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress.

    Hematologic: Agranulocytosis; thrombocytopenic and nonthrombocytopenic purpura.

    Gastrointestinal: Mesenteric arterial thrombosis; ischemic colitis.

    Miscellaneous: Reversible alopecia; Peyronie’s disease.

    The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Visken® (pindolol) during investigational use and extensive foreign experience amounting to over 4 million patient-years.

    Overdosage

    No specific information on emergency treatment of overdosage is available. Therefore, on the basis of the pharmacologic actions of Visken® (pindolol), the following general measures should be employed as appropriate in addition to gastric lavage:

    Excessive Bradycardia: administer atropine; if there is no response to vagal blockade, administer isoproterenol cautiously.

    Cardiac Failure: digitalize the patient and/or administer diuretic. It has been reported that glucagon may be useful in this situation.

    Hypotension: administer vasopressors, e.g., epinephrine or levarterenol, with serial monitoring of blood pressure. (There is evidence that epinephrine may be the drug of choice.)

    Bronchospasm: administer a beta2 stimulating agent such as isoproterenol and/or a theophylline derivative.

    A case of an acute overdosage has been reported with an intake of 500 mg of Visken® (pindolol) by a hypertensive patient. Blood pressure increased and heart rate was ≥80 beats/min. Recovery was uneventful. In another case, 250 mg of Visken® (pindolol) was taken with 150 mg diazepam and 50 mg nitrazepam, producing coma and hypotension. The patient recovered in 24 hours.

    Visken Dosage and Administration

    The dosage of Visken® (pindolol) should be individualized. The recommended initial dose of Visken® (pindolol) is 5 mg b.i.d. alone or in combination with other antihypertensive agents. An antihypertensive response usually occurs within the first week of treatment. Maximal response, however, may take as long as or occasionally longer than 2 weeks. If a satisfactory reduction in blood pressure does not occur within 3-4 weeks, the dose may be adjusted in increments of 10 mg/day at these intervals up to a maximum of 60 mg/day.

    How is Visken Supplied

    Visken® (pindolol) tablets, USP

    White, uncoated, heart-shaped tablets; 5 mg and 10 mg, packages of 100. 5 mg tablets engraved “Visken 5’’ on one side, and embossed “V’’ on other side (NDC 0078-0111-05). 10 mg tablets engraved “Visken 10’’ on one side, and embossed “V’’ on other side (NDC 0078-0073-05).

    Store and Dispense

    Below 86°F (30°C); tight, light-resistant container.

    Manufactured by:

    Novartis Pharmaceuticals Canada Inc.

    Dorval (Quebec) Canada H9R 4P5

    Distributed by:

    Novartis Pharmaceuticals Corporation

    East Hanover, New Jersey 07936

    REV: NOVEMBER 1998                         T1999-39

    89003701

    2162-25-99A

    ©1998 Novartis

    Visken 

    pindolol tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0111
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    pindolol (pindolol) pindolol 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    colloidal silicon dioxide  
    magnesium stearate  
    microcrystalline cellulose  
    pregelatinized starch  
    Product Characteristics
    Color WHITE Score no score
    Shape FREEFORM Size 7mm
    Flavor Imprint Code Visken;5;V
    Contains         
    Coating false Symbol false
    Packaging
    # Item Code Package Description
    1 NDC:0078-0111-05 100 TABLET (100 TABLET) in 1 PACKAGE
    Visken 

    pindolol tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0073
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    pindolol (pindolol) pindolol 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    colloidal silicon dioxide  
    magnesium stearate  
    microcrystalline cellulose  
    pregelatinized starch  
    Product Characteristics
    Color WHITE Score no score
    Shape FREEFORM Size 8mm
    Flavor Imprint Code Visken;10;V
    Contains         
    Coating false Symbol false
    Packaging
    # Item Code Package Description
    1 NDC:0078-0073-05 100 TABLET (100 TABLET) in 1 PACKAGE
    Labeler - Novartis Pharmaceuticals Corporation

    Revised: 10/2006   Novartis Pharmaceuticals Corporation

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    Visken

    Visken

    Generic Name: pindolol (Oral route)

    PIN-doe-lol

    OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

    Commonly used brand name(s)

    In the U.S.

    • Visken

    In Canada

    • Alti-Pindolol

    Available Dosage Forms:

    • Tablet

    Therapeutic Class: Cardiovascular Agent

    Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

    Uses For Visken

    Pindolol is used alone or together with other medicines (such as hydrochlorothiazide) 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 .

    This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

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

    Before Using Visken

    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 pindolol 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 pindolol in geriatric patients .

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

    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.

    • Thioridazine

    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.

    • Albuterol
    • Amiodarone
    • Arformoterol
    • Bambuterol
    • Bitolterol
    • Broxaterol
    • Clenbuterol
    • Clonidine
    • Colterol
    • Diltiazem
    • Dronedarone
    • Epinephrine
    • Fenoldopam
    • Fenoterol
    • Fingolimod
    • Formoterol
    • Hexoprenaline
    • Indacaterol
    • Isoetharine
    • Levalbuterol
    • Metaproterenol
    • Pirbuterol
    • Procaterol
    • Reproterol
    • Rimiterol
    • Ritodrine
    • Salmeterol
    • Terbutaline
    • Tretoquinol
    • Tulobuterol
    • Verapamil

    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.

    • Acarbose
    • Aceclofenac
    • Acemetacin
    • Acetohexamide
    • Alclofenac
    • Alfuzosin
    • Amlodipine
    • Apazone
    • Arbutamine
    • Benfluorex
    • Benoxaprofen
    • Bromfenac
    • Bufexamac
    • Bunazosin
    • Carprofen
    • Chlorpropamide
    • Clometacin
    • Clonixin
    • Dexketoprofen
    • Diclofenac
    • Diflunisal
    • Digoxin
    • Dipyrone
    • Doxazosin
    • Droxicam
    • Etodolac
    • Etofenamate
    • Felbinac
    • Felodipine
    • Fenbufen
    • Fenoprofen
    • Fentiazac
    • Floctafenine
    • Flufenamic Acid
    • Flurbiprofen
    • Gliclazide
    • Glimepiride
    • Glipizide
    • Gliquidone
    • Glyburide
    • Guar Gum
    • Ibuprofen
    • Indomethacin
    • Indoprofen
    • Insulin
    • Insulin Aspart, Recombinant
    • Insulin Glulisine
    • Insulin Lispro, Recombinant
    • Isoxicam
    • Ketoprofen
    • Ketorolac
    • Lacidipine
    • Lercanidipine
    • Lornoxicam
    • Manidipine
    • Meclofenamate
    • Mefenamic Acid
    • Meloxicam
    • Metformin
    • Mibefradil
    • Miglitol
    • Moxisylyte
    • Nabumetone
    • Naproxen
    • Nicardipine
    • Nifedipine
    • Niflumic Acid
    • Nilvadipine
    • Nimesulide
    • Nimodipine
    • Nisoldipine
    • Nitrendipine
    • Oxaprozin
    • Oxyphenbutazone
    • Phenoxybenzamine
    • Phentolamine
    • Phenylbutazone
    • Pirazolac
    • Piroxicam
    • Pirprofen
    • Pranidipine
    • Prazosin
    • Propyphenazone
    • Proquazone
    • Repaglinide
    • St John’s Wort
    • Sulindac
    • Suprofen
    • Tamsulosin
    • Tenidap
    • Tenoxicam
    • Terazosin
    • Tiaprofenic Acid
    • Tolazamide
    • Tolbutamide
    • Tolmetin
    • Trimazosin
    • Troglitazone
    • Urapidil
    • 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    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:

    • Angina (severe chest pain)—May provoke chest pain if stopped too quickly .
    • Asthma or
    • Bradycardia (slow heartbeat) or
    • Heart block or
    • Heart failure—Should not use in patients with these conditions .
    • Diabetes or
    • Hyperthyroidism (overactive thyroid) or
    • Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .
    • Kidney disease or
    • Liver disease—Use with caution. The effects may be increased because of slower removal from the body .
    • Lung disease (e.g., bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition .

    Proper Use of pindolol

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

    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 .

    Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous .

    Dosing

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

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

    • For oral dosage form (tablets):
      • For high blood pressure:
        • Adults—At first, 5 milligrams (mg) two times a day. Your doctor may adjust your dose as 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 Visken

    It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

    Pindolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

    This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

    Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .

    Visken 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:

    More common

    • Swelling of the face, fingers, feet, or lower legs

    Less common

    • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    • chest pain
    • difficult or labored breathing
    • shortness of breath
    • tightness in chest
    • wheezing

    Rare

    • Decreased urine output
    • dilated neck veins
    • extreme fatigue
    • fast, irregular, pounding, or racing heartbeat or pulse
    • irregular breathing
    • seeing, hearing, or feeling things that are not there
    • troubled breathing
    • weight gain

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

    Symptoms of overdose

    • Blurred vision
    • dizziness
    • headache
    • nervousness
    • pounding in the ears
    • slow heartbeat

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

    More common

    • Joint pain
    • muscle pain
    • sleeplessness
    • trouble sleeping
    • unable to sleep
    • unusual tiredness or weakness

    Less common

    • Itching skin
    • muscle cramps
    • nausea
    • stomach soreness or discomfort
    • unusual dreams
    • weakness

    Rare

    • Rash

    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: Visken side effects (in more detail)

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    Visken

    Visken

    Generic Name: Pindolol
    Class: beta-Adrenergic Blocking Agents

    VA Class: CV100

    Chemical Name: 1-(Indol-4-yloxy)-3-(isopropylamino)-2-propanol

    Molecular Formula: C14H20N2O2

    CAS Number: 13523-86-9

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Introduction

    A nonselective β-adrenergic blocking agent.1 2 3 4

    Uses for Visken

    Hypertension

    Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 32 37 38 52

    One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, ischemic heart disease, and/or diabetes mellitus.84

    Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferrred by JNC 7.84

    Angina

    Management of chronic stable angina pectoris†.2 5 15 22

    Visken Dosage and Administration

    General

    • Individualize dosage according to patient response and tolerance.1

    • If long-term therapy is discontinued, reduce dosage gradually over a period of about 1–2 weeks.1 (See Abrupt Withdrawal of Therapy under Cautions.)

    Administration

    Oral Administration

    Administer orally, usually twice daily;1 bioavailability does not appear to be affected by food.1 (See Absorption under Pharmacokinetics.)

    For management of hypertension, once-daily dosing may be possible in some patients.2

    Dosage

    Adults

    Hypertension
    Oral

    Initially, 5 mg twice daily.1 38 52 84 Increase dosage gradually by 10 mg daily at 3- to 4-week intervals as necessary up to 60 mg daily.1 38 52 84 The usual maintenance dosage range is 10–40 mg daily, given in 2 divided doses.2 11 15

    Angina†
    Oral

    15–40 mg daily, given in 3 or 4 divided doses.2 5 22

    Prescribing Limits

    Adults

    Hypertension
    Oral

    Maximum 60 mg daily.1 38 52 84

    Special Populations

    Hepatic Impairment

    Dosage must be modified in response to the degree of hepatic impairment.1

    Cautions for Visken

    Contraindications

    • Bronchial asthma, heart block greater than first degree, cardiogenic shock, overt cardiac failure, or severe bradycardia.1

    Warnings/Precautions

    Warnings

    Cardiac Failure

    Possible precipitation of CHF.1 2

    Avoid use in patients with decompensated CHF, may use cautiously in patients with well-compensated heart failure (e.g., those controlled with ACE inhibitors, cardiac glycosides, and/or diuretics).1

    Adequate treatment (e.g., with a cardiac glycoside and/or diuretic) and close observation recommended if signs or symptoms of impending cardiac failure occur; if cardiac failure continues, discontinue therapy, gradually if possible.1

    Abrupt Withdrawal of Therapy

    Abrupt discontinuance of therapy is not recommended as it may exacerbate angina symptoms or precipitate MI in patients with CAD.1 Abrupt discontinuance of therapy is not recommended.1 Gradually decrease dosage over a period of about 1–2 weeks.1 Monitor patients carefully and advise to temporarily limit their physical activity.1 If exacerbation of angina occurs, reinstitute therapy promptly, and initiate appropriate measures for the management of unstable angina pectoris.1

    Bronchospastic Disease

    Possible inhibition of bronchodilation produced by endogenous catecholamines.1

    Generally should not be used in patients with bronchospastic disease, but may be used with caution in patients with nonallergic bronchospasm (e.g., chronic bronchitis, emphysema).1 (See Contraindications under Cautions.)

    Major Surgery

    Possible risks associated with general anesthesia (e.g., severe hypotension, difficulty maintenaning heart beat) due to decreased ability of the heart to respond to reflex β-adrenergic stimuli.1 Use with caution in patients undergoing major surgery involving general anesthesia.1

    Diabetes and Hypoglycemia

    Possible decreased signs and symptoms of hypoglycemia (e.g., tachycardia, palpitation, BP changes, tremor, feelings of anxiety, but not sweating or dizziness).1 68

    Use with caution in patients with diabetes mellitus receiving hypoglycemic drugs.1

    Thyrotoxicosis

    Signs of hyperthyroidism (e.g., tachycardia) may be masked.1 Possible thyroid storm if therapy is abruptly withdrawn;1 carefully monitor patients having or suspected of developing thyrotoxicosis.1

    Sensitivity Reactions

    Anaphylactic Reactions

    Possible increased reactivity to repeated, accidental, diagnostic, or therapeutic challenges with a variety of allergens while taking β-blocking agents in patients with a history of anaphylactic reactions to a variety of allergens.1 Such patients may be unresponsive to usual doses of epinephrine.1

    Specific Populations

    Pregnancy

    Category B.1

    Lactation

    Distributed into milk.1 Use not recommended.1

    Pediatric Use

    Safety and efficacy not established.1

    Hepatic Impairment

    Hepatic elimination; use with caution.1

    Common Adverse Effects

    Insomnia, dizziness, fatigue, nervousness, bizzare dreams or increased dreaming, weakness, paresthesia, edema, dyspnea, muscle pain, joint pain, chest pain, muscle cramps, nausea, abdominal discomfort, pruritus.1

    Interactions for Visken

    Specific Drugs

    Drug

    Interaction

    Comments

    Aspirin

    Pharmacokinetic interaction unlikely1

    Digoxin

    Possible decreases in serum digoxin concentrations 1

    Not considered clinically important1 18

    Reserpine

    Additive effects1

    Monitor for signs of hypotension and bradycardia (e.g., vertigo, syncope, postural hypotension)1

    Hypotensive agents (hydralazine, hydrochlorothiazide)

    Possible increased hypotensive effects1

    Adjust dosage carefully1

    Thioridazine

    Increased serum concentrations of thioridazine1 and metabolites; higher than expected serum concentrations of pindolol1 73 1

    Increased thioridazine concentrations may cause prolongation of the QTc interval and a possible increase in the risk of serious, potentially fatal cardiac arrhythmia (e.g., torsades de pointes)73 1

    Concomitant use is contraindicated73

    Warfarin

    Pharmacokinetic interaction unlikely1

    Visken Pharmacokinetics

    Absorption

    Bioavailability

    Rapidly absorbed from the GI tract with peak plasma concentrations reached within 1–2 hours.1 2

    Bioavailability 502 –95%.1 2

    Onset

    Effect on heart rate is seen within 3 hours.2

    Hypotensive effect is usually seen within 1 week, but maximum therapeutic response may not be observed until 2 weeks or longer.1

    Duration

    Acute hemodynamic effects persist for 24 hours after administration.2

    Food

    Food may increase the rate,2 but not the extent of absorption.1

    Special Populations

    Bioavailability may be at the lower end of the range in uremic patients;2 extent of absorption may be decreased in patients with impaired renal function.19

    Distribution

    Extent

    Distributed into milk.1

    Plasma Protein Binding

    Approximately 40–60%.1 2

    Elimination

    Metabolism

    Extensively metabolized in the liver (approximately 60–65%) to metabolites.1 2

    Elimination Route

    Excreted in urine (35–50%) unchanged.1 2 18

    Half-life

    3–4 hours.1 2

    Special Populations

    In patients with creatinine clearances <20 mL/minute, <15% is excreted in urine unchanged.1 18 20

    In patients with renal failure, plasma half-life is 3–11.5 hours.2 20

    In geriatric patients, plasma half-life is 7–15 hours.1

    In patients with hepatic cirrhosis, half-life is 2.5–30 hours.1

    Stability

    Storage

    Oral

    Tablets

    Tight, light-resistant containers at 15–30°C.1 31

    Actions

    • Inhibits response to adrenergic stimuli by competitively blocking β-adrenergic receptors within the myocardium (β1-receptors) and within bronchial and vascular smooth muscle (β2-receptors).2 4 5

    • In addition, causes slight activation of the β-receptors, making the drug a partial β-agonist.2 4 5
    • At higher than therapeutically obtained plasma concentrations, the drug has membrane-stabilizing activity or a quinidine-like effect.4
    • Decreases stress- and exercise-stimulated heart rate.1 2 4 5 Has a lesser effect on resting heart rate (usually decreasing resting heart rate only by about 4–8 bpm or not at all),1 2 4 5 15 22 slowing of conduction in the AV node,4 and cardiac output,2 4 13 22 than do β-adrenergic blocking agents that do not possess intrinsic sympathomimetic activity (ISA).1 2 4 5 15 22
    • The precise mechanism of hypotensive effect has not been determined;1 the drug does not consistently affect cardiac output or renin release, and other mechanisms (e.g., decreased peripheral resistance) probably contribute to its hypotensive effect.1 15 16
    • May increase airway resistance,1 2 4 depending on the patient’s pretreatment sympathetic tone; patients with high pretreatment tone show a decrease in forced expiratory volume in 1 second (FEV1), whereas those with low pretreatment tone may show little, if any, change in FEV1.17

    Advice to Patients

    • Importance of taking pindolol exactly as prescribed.1

    • Importance of not interrupting or discontinuing therapy without consulting clinician.1
    • Importance of immediately informing clinician at the first sign or symptom of impending cardiac failure (e.g., weight gain, increased shortness of breath) or if any difficulty in breathing occurs.1
    • In patients with heart failure, importance of informing clinician of signs or symptoms of exacerbation (e.g., weight gain, difficulty in breathing).1
    • Importance of patients informing anesthesiologist or dentist that they are receiving pindolol therapy prior to undergoing major surgery.1
    • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
    • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
    • Importance of informing patients of other important precautionary information.1 (See Cautions.)

    Preparations

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

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

    Pindolol
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Oral

    Tablets

    5 mg*

    Pindolol Tablets

    Genpharm, Mutual, Mylan, Sandoz, Teva, Watson

    10 mg*

    Pindolol Tablets

    Genpharm, Mutual, Mylan, Sandoz, Teva, 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.

    Pindolol 10MG Tablets (MYLAN): 60/$70.99 or 180/$194.97

    Pindolol 5MG Tablets (MYLAN): 60/$55.99 or 120/$105.98

    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 March 1, 2007. 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

    1. Zenith Goldline. Pindolol tablets prescribing information. Miami, FL; 1999 Jan.

    2. Golightly LK. Pindolol: a review of its pharmacology, pharmacokinetics, clinical uses and adverse effects. Pharmacotherapy. 1982; 2:134-47. [IDIS 153215] [PubMed 6133267]

    3. Weber MA. Beta blockers in the initial therapy of hypertension. Drug Ther. 1980; 10(11):77-80.

    4. Frishman WH. β-Adrenoceptor antagonists: new drugs and new indications. N Engl J Med. 1981; 305:500-5. [IDIS 136600] [PubMed 6114433]

    5. Opie LH. Drugs and the heart. Lancet. 1980; 1:693-8. [IDIS 111317] [PubMed 6103100]

    6. Talbert RL. Use of β-adrenergic blocking agents after myocardial infarction. Clin Pharm. 1983; 2:68-74. [IDIS 163582] [PubMed 6136362]

    7. Weber MA, Drayer JIM. Renal effects of beta-adrenoceptor blockade. Kidney Int. 1980; 13:686-99.

    8. Waal-Manning HJ. Hypertension: which beta-blocker? Drugs. 1976; 12:412-41.

    9. Leonard RG, Talbert RL. Calcium-channel blocking agents. Clin Pharm. 1982; 1:17-33. [IDIS 142428] [PubMed 6764159]

    10. Gonasun LM. Antihypertensive effects of pindolol. Am Heart J. 1982; 104:374-87. [IDIS 157068] [PubMed 7048877]

    11. Frishman W, Jacob H, Eisenberg E et al. Clinical pharmacology of the new beta-adrenergic blocking drugs. Part 8. Self-poisoning with beta-adrenoceptor blocking agents: recognition and management. Am Heart J. 1979; 98:798-811. [IDIS 107182] [PubMed 40429]

    12. Thadani U, Davidson C, Char B et al. Comparison of the immediate effects of five β-adrenoreceptor-blocking drugs with different ancillary properties in angina pectoris. N Engl J Med. 1979; 300:750-5. [PubMed 581782]

    13. Taylor SH, Solke G, Lee PS. Intravenous β-blockade in coronary heart disease. Is cardioselectivity or intrinsic sympathomimetic activity hemodynamically useful? N Engl J Med. 1982; 306:631-5.

    14. The United States pharmacopeia, 21st rev, and The national formulary, 16th ed. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1987(Suppl 5):2486.

    15. Frishman WH. Pindolol: a new β-adrenoceptor antagonist with partial agonist activity. N Engl J Med. 1983; 308:940-4. [IDIS 169257] [PubMed 6339926]

    16. Man in’t Veld AJ, Schalekamp ADH. Effects of 10 different β-adrenoreceptor antagonists on hemodynamics, plasma renin activity, and plasma norepinephrine in hypertension: the key role of peripheral vascular resistance changes in relation to partial agonist activity. J Cardiovasc Pharmacol. 1983; 5:S30-S45.

    17. Plotnick GD, Fisher ML, Hamilton JH et al. Intrinsic sympathetic activity of pindolol: evidence for interaction with pretreatment sympathetic tone. Am J Med. 1983; 74:625-9. [IDIS 169158] [PubMed 6340489]

    18. Sandoz Pharmaceuticals: Personal communication; 1983 Aug 1.

    19. Chau NP, Weiss YA, Safar ME et al. Pindolol availability in hypertensive patients with normal and impaired renal function. Clin Pharmacol Ther. 1977; 22:505-10. [PubMed 913016]

    20. Ohnhaus EE, Heidemann H, Meier J et al. Metabolism of pindolol in patients with renal failure. Eur J Clin Pharmacol. 1982; 423-8.

    21. Anon. Diuretic or beta-blocker as first-line treatment of mild hypertension. Lancet. 1982; 2:1316-7. [PubMed 6128605]

    22. Kostis JB, Frishman W, Hosler MH et al. Treatment of angina pectoris with pindolol: the significance of intrinsic sympathomimetic activity of beta blockers. Am Heart J. 1982; 104:496-504. [IDIS 157087] [PubMed 7102536]

    23. Rangno RE, Langlois S. Comparison of withdrawal phenomena after propranolol, metoprolol, and pindolol. Am Heart J. 1982; 104:473-8. [IDIS 157082] [PubMed 7102534]

    24. Walden RJ, Hernandez J, Yu Y et al. Withdrawal of beta-blocking drugs. Am Heart J. 1982; 104:515-20. [IDIS 157090] [PubMed 6125098]

    25. Gonasun LM, Langrall H. Adverse reactions to pindolol administration. Am Heart J. 1982; 104:482-6. [IDIS 157084] [PubMed 7048882]

    26. Krupp P, Fanchamps A. Pindolol: experience gained in 10 years of safety monitoring. Am Heart J. 1982; 104:486-90. [IDIS 157085] [PubMed 7048883]

    27. Gold DD. Propranolol-associated hyperglycemia: a case report. Hosp Formul. 1982; 17:92-101.

    28. Koda-Kimble MA, Rotblatt MD. Diabetes mellitus. In: Katcher BS, Young LY, Koda-Kimble MA, eds. Applied therapeutics: the clinical use of drugs. San Francisco: Applied Therapeutics; 1983:1396-7.

    29. Heel RC, Brogden RN, Speight TM et al. Atenolol: a review of its pharmacological properties and therapeutic efficacy in hypertension. Drugs. 1979; 17:425-60. [IDIS 104425] [PubMed 38096]

    30. Opie LH. Drugs and the heart. Lancet. 1980; 1:693-8. [IDIS 111317] [PubMed 6103100]

    31. The United States Pharmacopeial Convention, Inc. Pindolol tablets. Pharmacopeial Forum. 1984; 10:4411.

    32. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 report of the Joint National Committee on Detection, Evalution, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]

    33. Weinstein RS. Recognition and management of poisoning with beta-adrenergic blocking agents. Ann Emerg Med. 1984; 13:1123-31. [PubMed 6150667]

    34. Koller W, Orebaugh C, Lawson L et al. Pindolol-induced tremor. Clin Neuropharmacol. 1987; 10:449-52. [PubMed 3332615]

    35. Hod H, Har-Zahav J, Kaplinsky N et al. Pindolol-induced tremor. Postgrad Med J. 1980; 56:346-7. [PubMed 7443595]

    36. Teravainen H, Larsen A, Fogelholm R. comparison between the effects of pindolol and propranolol on essential tremor. Neurology. 1977; 27:439-42. [PubMed 558548]

    37. 1988 Joint National Committee. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

    38. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

    39. Weber MA, Laragh JH. Hypertension: steps forward and steps backward: the Joint National Committee fifth report. Arch Intern Med. 1993; 153:149-52. [PubMed 8422205]

    40. Collins R, Peto R, MacMahon S et al. Blood pressure, stroke, and coronary heart disease. Part 2, short-term reductions in blood pressure: an overview of randomized drug trials in their epidemiological context. Lancet. 1990; 335:827-38. [IDIS 264836] [PubMed 1969567]

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    Visken

    Visken

    Generic Name: pindolol (PIN doe lol)

    Brand Name: Visken

    OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

    What is Visken (pindolol)?

    Pindolol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

    Pindolol is used to treat hypertension (high blood pressure).

    Pindolol may also be used for other purposes not listed in this medication guide.

    What is the most important information I should know about Visken (pindolol)?

    You should not use this medication if you are allergic to pindolol, or if you have asthma, certain heart conditions (especially second or third degree heart block), heart failure, or severe slow heart rate.

    Before taking pindolol, tell your doctor if you have bronchitis, emphysema, diabetes, heart disease, congestive heart failure, slow heart rate, coronary artery disease, low blood pressure, liver or kidney disease, depression, or a thyroid disorder.

    Do not skip doses or stop taking pindolol without first talking to your doctor. Stopping suddenly may make your condition worse, and it can cause serious or life-threatening side effects. You will need to stop using pindolol gradually. Follow your doctor’s instructions.

    Pindolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

    Hypertension often has no symptoms, so you may not even feel that you have high blood pressure. Continue using this medicine as directed, even if you feel well. You may need to use blood pressure medication for the rest of your life.

    What should I discuss with my healthcare provider before taking Visken (pindolol)?

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

    • asthma;

    • certain heart conditions, especially second or third degree heart block;
    • heart failure; or
    • severe slow heart rate.

    Before taking pindolol, tell your doctor if you have:

    • bronchitis or emphysema;

    • diabetes (taking pindolol can make it harder for you to tell when you have low blood sugar);
    • a heart problem such as heart block, sick sinus syndrome, slow heart rate, or congestive heart failure;
    • coronary artery disease;
    • low blood pressure;
    • liver or kidney disease;
    • depression; or
    • a thyroid disorder.

    If you have any of these conditions, you may need a dose adjustment or special tests to safely take pindolol.

    FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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

    How should I take Visken (pindolol)?

    Take pindolol exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

    Do not skip doses or stop taking pindolol without first talking to your doctor. Stopping suddenly may make your condition worse, and it can cause serious or life-threatening side effects. You will need to stop using pindolol gradually. Follow your doctor’s instructions.

    To be sure this medication is helping your condition, your blood pressure will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

    If you need to have any type of surgery, tell the surgeon ahead of time that you are using pindolol. You may need to stop using the medicine for a short time. Follow your doctor’s instructions about gradually reducing your pindolol dose before a surgery.

    Pindolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

    Hypertension often has no symptoms, so you may not even feel that you have high blood pressure. Continue using this medicine as directed, even if you feel well. You may need to use blood pressure medication for the rest of your life.

    Store pindolol at room temperature away from moisture and heat.

    See also: Visken dosage (in more detail)

    What happens if I miss a dose?

    Take the missed dose as soon as you remember. If your next dose is less than 4 hours away, 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.

    Overdose symptoms may include uneven heartbeats, shortness of breath, bluish-colored fingernails, dizziness, weakness, fainting, or seizure (convulsions).

    What should I avoid while taking Visken (pindolol)?

    Pindolol 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.

    Visken (pindolol) side effects

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

    Call your doctor at once if you have any of these serious side effects:

    • slow or uneven heartbeats;

    • feeling light-headed, fainting;
    • feeling short of breath, even with mild exertion;
    • swelling of your ankles or feet;
    • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
    • depression; or
    • cold feeling in your hands and feet.

    Less serious side effects may include:

    • decreased sex drive, impotence, or difficulty having an orgasm;

    • sleep problems (insomnia);
    • tired feeling; or
    • anxiety, nervousness.

    This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Visken side effects (in more detail)

    What other drugs will affect Visken (pindolol)?

    Before taking pindolol, tell your doctor if you are using:

    • digoxin (digitalis, Lanoxin);

    • insulin or diabetes medication you take by mouth;
    • thioridazine (Mellaril);
    • a heart medication such as reserpine (Serpasil);
    • cold medicines, stimulant medicines, or diet pills; or
    • medicine for asthma or other breathing disorders, such as albuterol (Ventolin, Proventil), bitolterol (Tornalate), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), theophylline (Theo-Dur, Theolair), and others.

    This list is not complete and there may be other drugs that can interact with pindolol. 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 Visken resources

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

    Compare Visken with other medications

    • High Blood Pressure

    Where can I get more information?

    • Your pharmacist can provide more information about pindolol.

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