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DRUGS & SUPPLEMENTS
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Isosorbide Dinitrate:
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.
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.
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.
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.
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.
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.
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.
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.
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.
Safety and effectiveness in pediatric patients have not been established.
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.
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.
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.
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.
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.
Nitrisken (Isosorbide Dinitrate) Tablets, USP (Oral) 5 mg: White, Round, Scored Tablets; Debossed "West-ward 769".
Nitrisken (Isosorbide Dinitrate) Tablets, USP (Oral) 10 mg: White, Round, Scored Tablets; Debossed "WW" on one side and "771" on the other side.
Nitrisken (Isosorbide Dinitrate) Tablets, USP (Oral) 20 mg: Green, Round, Scored Tablets; Debossed "WW" on one side and "772" on the other side.
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:
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.
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.
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 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).
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.
Nitrisken (Pindolol)® (pindolol) should be administered with caution since it may block bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Since Nitrisken (Pindolol)® (pindolol) is secreted in human milk, nursing should not be undertaken by mothers receiving the drug.
Safety and effectiveness in pediatric patients have not been established.
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.
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 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 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.
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.
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.
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.
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
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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The information was verified by Dr. Rachana Salvi, MD Pharmacology