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Isosorbdie Dinitrate
Overview
What is Isosorrbide Dinitrate?
Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is:
Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution,has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbidedinitrate is freely soluble in organic solvents such as acetone, alcohol, and, but is only sparingly soluble in water.
Each isosorbide dinitrate tablet contains 30 mg of ISDN.
Inactive ingredients are as follows: Ammonium Phosphate Dibasic, Colloidal Silicon Dioxide, FD&C Blue No. 1 Aluminum Lake, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.
What does Isosorrbide Dinitrate look like?
What are the available doses of Isosorrbide Dinitrate?
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What should I talk to my health care provider before I take Isosorrbide Dinitrate?
Sorry No records found
How should I use Isosorrbide Dinitrate?
Isosorbide Dinitrate Tablets, USP, are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
As noted under , multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for isosorbide dinitrate tablets 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 , 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 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 minimum dose which produces the desired clinical effect. The usual starting dose of isosorbide dinitrate tablets is 5 mg to 40 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.
What interacts with Isosorrbide Dinitrate?
Allergic reactions to organic nitrates are extremely rare, but they do occur. The isosorbide dinitrate tablet is contraindicated in patients who are allergic to ISDN or any of its other ingredients
What are the warnings of Isosorrbide Dinitrate?
As a result of a 40% increase in cyclobenzaprine plasma levels and a 56% increase in plasma half-life following administration of AMRIX in elderly subjects as compared to young adults, use of AMRIX is not recommended in elderly.
The benefits of immediate-release oral ISDN in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use ISDN in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral ISDN are so difficult to terminate rapidly, this formulation is not recommended in these settings.
What are the precautions of Isosorrbide Dinitrate?
General
Severe hypotension, particularly with upright posture, may occur with even small doses of ISDN. 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 ISDN may be accompanied by paradoxical bradycardia and increased angina pectoris.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
As tolerance to ISDN 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 exercise tolerance. The importance of these observations to the routine, clinical use of immediate-release oral ISDN 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 ISDN 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 ISDN. 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 ISDN-induced headaches with no deleterious effect on ISDN"S anti-anginal efficacy.
Treatment with ISDN 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 ISDN 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 ISDN. In a modified two-litter reproduction study, there was no remarkable gross pathology and no altered fertility or gestation among rats fed ISDN at 25 or 100 mg/kg/day.
Pregnancy
At oral doses 35 and 150 times the maximum recommended human daily dose, ISDN 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.ISDN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether ISDN is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ISDN is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of ISDN 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.
What are the side effects of Isosorrbide Dinitrate?
Adverse reactions to ISDN are generally dose-related, and almost all of these reactions are the result of ISDN"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 ).
Data are not available to allow estimation of the frequency of adverse reactions during treatment of isosorbide dinitrate tablets.
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.
What should I look out for while using Isosorrbide Dinitrate?
Allergic reactions to organic nitrates are extremely rare, but they do occur. The isosorbide dinitrate tablet is 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 ISDN in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use ISDN in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral ISDN are so difficult to terminate rapidly, this formulation is not recommended in these settings.
What might happen if I take too much Isosorrbide Dinitrate?
The ill effects of ISDN overdose are generally the results of ISDN"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 ISDN and it metabolites are not widely available, and such determinations have, in any event, no established role in the management of ISDN 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 (, maneuvers to change the pH of the urine) that might accelerate elimination of ISDN 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 ISDN overdose. Because the hypotension associated with ISDN 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 ISDN overdose in these patients may be subtle and difficult, and invasive monitoring may be required.
How should I store and handle Isosorrbide Dinitrate?
Shake well before using. Store at controlled room temperature 20° to 25°C (68° to 77°F). Dispense in a well-closed container as defined in the USP.Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets;Debossed “WW 773” on Scored side.Bottles of 30 tablets.Bottles of 100 tablets.Bottles of 500 tablets.Bottles of 1000 tablets.Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Also available: 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.Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths:5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets.20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets.Manufactured by:West-ward Pharmaceutical Corp.Eatontown, NJ 07724Revised December 2010
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The principal pharmacological action of ISDN is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction, and coronary dilatation remains undefined.
Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the anti-anginal efficacy of continuously-delivered nitrates. In the large majority of these trials, active agents were no more effective than placebo after 24 hours (or less) of continuous therapy.Attempts to overcome nitrate tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed. Only after nitrates have been absent from the body for several hours has their anti-anginal efficacy been restored.
Non-Clinical Toxicology
Allergic reactions to organic nitrates are extremely rare, but they do occur. The isosorbide dinitrate tablet is contraindicated in patients who are allergic to ISDN or any of its other ingredientsAmplification 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 ISDN in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use ISDN in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral ISDN are so difficult to terminate rapidly, this formulation is not recommended in these settings.
The vasodilating effects of ISDN may be additive with those of other vasodilators.Alcohol, in particular, has been found to exhibit additive effects of this variety.
Severe hypotension, particularly with upright posture, may occur with even small doses of ISDN. 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 ISDN may be accompanied by paradoxical bradycardia and increased angina pectoris.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
As tolerance to ISDN 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 exercise tolerance. The importance of these observations to the routine, clinical use of immediate-release oral ISDN 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.
Adverse reactions to ISDN are generally dose-related, and almost all of these reactions are the result of ISDN"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 ).
Data are not available to allow estimation of the frequency of adverse reactions during treatment of isosorbide dinitrate tablets.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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