Nitrisken

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Nitrisken uses

Nitrisken consists of Isosorbide Dinitrate, Pindolol.

Isosorbide Dinitrate:


INDICATIONS AND USAGE

Nitrisken (Isosorbide Dinitrate) Tablets, USP (Oral) are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral ISDN is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

CONTRAINDICATIONS

Allergic reactions to organic nitrates are extremely rare, but they do occur. Nitrisken (Isosorbide Dinitrate) Tablets, USP (oral) are contraindicated in patients who are allergic to ISDN or any of its other ingredients.

WARNINGS

Amplification of the vasodilatory effects of ISDN by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.

The benefits of immediate-release oral Nitrisken (Isosorbide Dinitrate) in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use Nitrisken (Isosorbide Dinitrate) in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral Nitrisken (Isosorbide Dinitrate) are so difficult to terminate rapidly, this formulation is not recommended in these settings.

PRECAUTIONS

General:

Severe hypotension, particularly with upright posture, may occur with even small doses of Nitrisken. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by Nitrisken (Isosorbide Dinitrate) may be accompanied by paradoxical bradycardia and increased angina pectoris.

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

As tolerance to Nitrisken (Isosorbide Dinitrate) develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted.

Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the daily dose-free interval in some of these trials, anginal attacks have been more easily provoked than before treatment, and patients have demonstrated hemodynamic rebound and decreased exercise tolerance. The importance of these observations to the routine, clinical use of sublingual and immediate-release oral Nitrisken (Isosorbide Dinitrate) is not known.

In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.

Information for Patients:

Patients should be told that the anti-anginal efficacy of Nitrisken (Isosorbide Dinitrate) is strongly related to its dosing regimen, so the prescribed schedule of dosing should be followed carefully. In particular, daily headaches sometimes accompany treatment with Nitrisken (Isosorbide Dinitrate). In patients who get these headaches, the headaches are a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with ISDN, since loss of headache may be associated with simultaneous loss of anti-anginal efficacy. Aspirin and/or acetaminophen, on the other hand, often successfully relieve isosorbide dinitrate-induced headaches with no deleterious effect on isosorbide dinitrate's anti-anginal efficacy.

Treatment with Nitrisken (Isosorbide Dinitrate) may be associated with lightheadedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.

Drug Interactions:

The vasodilating effects of Nitrisken may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Carcinogenesis. Mutagenesis. Impairment of Fertility:

No long-term studies in animals have been performed to evaluate the carcinogenic potential of Nitrisken (Isosorbide Dinitrate). In a modified two-litter reproduction study, there was no remarkable gross pathology and no altered fertility or gestation among rats fed Nitrisken (Isosorbide Dinitrate) at 25 or 100 mg/kg/day.

Pregnancy Category C:

At oral doses 35 and 150 times the maximum recommended human daily dose. Nitrisken has been shown to cause a dose-related increase in embryotoxicity (increase in mummified pups) in rabbits. There are no adequate, well-controlled studies in pregnant women. Nitrisken (Isosorbide Dinitrate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether Nitrisken (Isosorbide Dinitrate) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nitrisken (Isosorbide Dinitrate) is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

Clinical studies of Nitrisken (Isosorbide Dinitrate) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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ADVERSE REACTIONS

Adverse reactions to Nitrisken (Isosorbide Dinitrate) are generally dose-related, and most all of these reactions are the result of isosorbide dinitrate's activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.

Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred (see OVERDOSAGE ).

Data are not available to allow estimation of the frequency of adverse reactions during treatment of Nitrisken (Isosorbide Dinitrate) tablets (oral).

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Hemodynamic Effects:

The ill effects of Nitrisken overdose are generally the results of isosorbide dinitrate's capacity to induce vasodilatation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations: visual disturbances: nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.

Laboratory determinations of serum levels of Nitrisken (Isosorbide Dinitrate) and it metabolites are not widely available, and such determinations have, in any event, no established role in the management of Nitrisken (Isosorbide Dinitrate) overdose.

There are no data suggesting what dose of ISDN is likely to be life-threatening in humans. In rats, the median acute lethal dose (LD50) was found to be 1100 mg/kg.

No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of Nitrisken (Isosorbide Dinitrate) and its active metabolites. Similarly, it is not known which - if any - of these substances can usefully be removed from the body by hemodialysis.

No specific antagonist to the vasodilator effects of ISDN is known, and no intervention has been subject to controlled studies as a therapy for Nitrisken (Isosorbide Dinitrate) overdose. Because the hypotension associated with Nitrisken (Isosorbide Dinitrate) overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward increase in central fluid volume. Passive elevation of the patient's legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary.

The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good.

In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard. Treatment of Nitrisken (Isosorbide Dinitrate) overdose in these patients may be subtle and difficult, and invasive monitoring may be required.

Methemoglobinemia:

Nitrate ions liberated during metabolism of Nitrisken (Isosorbide Dinitrate) can oxidize hemoglobin into methemoglobin. Even in patients totally without cytochrome b5 reductase activity, however and even assuming that the nitrate moieties of Nitrisken (Isosorbide Dinitrate) are quantitatively applied to oxidation of hemoglobin, about 1 mg/kg of Nitrisken (Isosorbide Dinitrate) should be required before any of these patients manifests clinically significant (≥10%) methemoglobinemia. In patients with normal reductase function, significant production of methemoglobin should require even larger doses of Nitrisken (Isosorbide Dinitrate). In one study in which 36 patients received 2 to 4 weeks of continuous nitroglycerin therapy at 3.1 to 4.4 mg/hr (equivalent, in total administered dose of nitrate ions, to 4.8 to 6.9 mg of bioavailable Nitrisken (Isosorbide Dinitrate) per hour), the average methemoglobin level measured was 0.2%; this was comparable to that observed in parallel patients who received placebo.

Notwithstanding these observations, there are case reports of significant methemoglobinemia in association with moderate overdoses of organic nitrates. None of the affected patients had been thought to be unusually susceptible.

Methemoglobin levels are available from most clinical laboratories. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO2. Classically, methemoglobinemic blood is described as chocolate brown, without color change on exposure to air.

When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, 1 to 2 mg/kg intravenously.

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DOSAGE AND ADMINISTRATION

As noted under CLINICAL PHARMACOLOGY , multiple studies with Nitrisken (Isosorbide Dinitrate) and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for Nitrisken (Isosorbide Dinitrate) tablets (oral) must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long.

As also noted under CLINICAL PHARMACOLOGY , the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.

Large controlled studies with other nitrates suggest that no dosing regimen with Nitrisken (Isosorbide Dinitrate) oral tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.

As with all titratable drugs, it is important to administer the minimum dose which produces the desired clinical effect. The usual starting dose of Nitrisken (Isosorbide Dinitrate) tablets (oral) is 5 mg to 20 mg, two or three times daily. For maintenance therapy, 10 mg to 40 mg, two or three times daily is recommended. Some patients may require higher doses. A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen.

HOW SUPPLIED

Nitrisken (Isosorbide Dinitrate) Tablets, USP (Oral) 5 mg: White, Round, Scored Tablets; Debossed "West-ward 769".

  • Bottles of 30 tablets.
  • Bottles of 90 tablets.
  • Bottles of 100 tablets.
  • Bottles of 500 tablets.
  • Bottles of 1000 tablets.
  • Unit Dose Boxes of 100 tablets.

Nitrisken (Isosorbide Dinitrate) Tablets, USP (Oral) 10 mg: White, Round, Scored Tablets; Debossed "WW" on one side and "771" on the other side.

  • Bottles of 30 tablets.
  • Bottles of 90 tablets.
  • Bottles of 100 tablets.
  • Bottles of 500 tablets.
  • Bottles of 1000 tablets.
  • Unit Dose Boxes of 100 tablets.

Nitrisken (Isosorbide Dinitrate) Tablets, USP (Oral) 20 mg: Green, Round, Scored Tablets; Debossed "WW" on one side and "772" on the other side.

  • Bottles of 30 tablets.
  • Bottles of 90 tablets.
  • Bottles of 100 tablets.
  • Bottles of 1000 tablets.
  • Unit Dose Boxes of 100 tablets.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Store at 20-25°C (68-77°F). Protect from light and moisture.

Also available: Nitrisken (Isosorbide Dinitrate) Sublingual Tablets in the following dosage strengths:

2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.

5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets.

Manufactured by:

West-ward Pharmaceutical Corp.

Eatontown, NJ 07724

Rev. November 2010

Nitrisken (Isosorbide Dinitrate) 5mg tab

Nitrisken (Isosorbide Dinitrate) Chemical Structurre

Pindolol:


INDICATIONS AND USAGE

Nitrisken (Pindolol)® (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

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


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, Nitrisken ® (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, Nitrisken (Pindolol)® (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 Nitrisken ® (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, Nitrisken (Pindolol)® (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 Nitrisken (Pindolol)® (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

Nitrisken (Pindolol)® (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 Nitrisken ® (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.

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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 Nitrisken ® (pindolol) clearance, but poor hepatic function may cause blood levels of Nitrisken (Pindolol)® (pindolol) to increase substantially.

Information for Patients

Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of Nitrisken (Pindolol)® (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 may have an additive effect when given with beta-blocking agents. Patients receiving Nitrisken (Pindolol)® (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.

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

Nitrisken (Pindolol)® (pindolol) has been shown to increase serum thioridazine levels when both drugs are co-administered. Nitrisken (Pindolol)® (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 in mice, rats, and dogs, Nitrisken (Pindolol)® (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, Nitrisken (Pindolol)® (pindolol) did not produce any neoplastic, preneoplastic, or nonneoplastic pathologic lesions. In fertility and general reproductive performance studies in rats, Nitrisken (Pindolol)® (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 Nitrisken (Pindolol)® (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 Nitrisken (Pindolol)® (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, Nitrisken ® (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 Nitrisken (Pindolol)® (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.

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CLINICAL LABORATORY

Minor persistent elevations in serum transaminases (SGOT, SGPT) have been noted in 7% of patients during Nitrisken (Pindolol)® (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 Nitrisken (Pindolol)® (pindolol) as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for Nitrisken (Pindolol)® (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% Nitrisken (Pindolol)® (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 Nitrisken (Pindolol)® (pindolol) patients and other selected important reactions.

Body System/

Adverse Reactions

Nitrisken (Pindolol)® 

(pindolol)

(N=322)

%

Active

Controls*

(N=188)

%

Placebo

(N=78)

%





Central Nervous System



   Bizarre or Many Dreams506
   Dizziness9111
   Fatigue844
   Hallucinations<100
   Insomnia10310
   Nervousness735
   Weakness421
Autonomic Nervous System



   Paresthesia316
Cardiovascular



   Dyspnea546
   Edema631
   Heart Failure<1<10
   Palpitations<110
Musculoskeletal



   Chest Pain313
   Joint Pain744
   Muscle Cramps310
   Muscle Pain1098
Gastrointestinal



   Abdominal Discomfort445
   Nausea521
Skin



   Pruritus1<10
   Rash<1<11

*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 Nitrisken (Pindolol)® (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 Nitrisken (Pindolol)® (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.

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 Nitrisken (Pindolol)® (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 Nitrisken (Pindolol)® (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 Nitrisken (Pindolol)® (pindolol) by a hypertensive patient. Blood pressure increased and heart rate was ≥80 beats/min. Recovery was uneventful. In another case, 250 mg of Nitrisken (Pindolol)® (pindolol) was taken with 150 mg diazepam and 50 mg nitrazepam, producing coma and hypotension. The patient recovered in 24 hours.

DOSAGE AND ADMINISTRATION

The dosage of Nitrisken (Pindolol)® (pindolol) should be individualized. The recommended initial dose of Nitrisken (Pindolol)® (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 SUPPLIED

Nitrisken ® (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 CorporationEast Hanover, New Jersey 07936

REV: NOVEMBER 1998                         T1999-39890037012162-25-99A

©1998 Novartis

Nitrisken pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Nitrisken available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Nitrisken destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Nitrisken Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Nitrisken pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."VISKEN (PINDOLOL) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."PINDOLOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Nitrisken?

Depending on the reaction of the Nitrisken after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Nitrisken not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Nitrisken addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Nitrisken, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Nitrisken consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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