DRUGS & SUPPLEMENTS
Active ingredient: Isosorbide Dinitrate
Isosorbide Dinitrate uses
INDICATIONS AND USAGE
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. 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 Isosorbide Dinitrate in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use 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 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 Isosorbide Dinitrate. 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 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 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 Isosorbide Dinitrate is not known.
In industrial workers who have had long-term exposure to unknown 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 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 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 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 Isosorbide Dinitrate 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 Isosorbide Dinitrate. In a modified two-litter reproduction study, there was no remarkable gross pathology and no altered fertility or gestation among rats fed 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. Isosorbide Dinitrate has been shown to cause a dose-related increase in embryotoxicity in rabbits. There are no adequate, well-controlled studies in pregnant women. Isosorbide Dinitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Isosorbide Dinitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Isosorbide Dinitrate is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of 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 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 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 Isosorbide Dinitrate 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 ; 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 Isosorbide Dinitrate and it metabolites are not widely available, and such determinations have, in any event, no established role in the management of 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 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 Isosorbide Dinitrate overdose. Because the hypotension associated with 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 Isosorbide Dinitrate overdose in these patients may be subtle and difficult, and invasive monitoring may be required.
Nitrate ions liberated during metabolism of 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 Isosorbide Dinitrate are quantitatively applied to oxidation of hemoglobin, about 1 mg/kg of 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 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 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.
DOSAGE AND ADMINISTRATION
As noted under CLINICAL PHARMACOLOGY , multiple studies with Isosorbide Dinitrate and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for 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 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 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.
Isosorbide Dinitrate Tablets, USP (Oral) 5 mg: White, Round, Scored Tablets; Debossed "West-ward 769".
Isosorbide Dinitrate Tablets, USP (Oral) 10 mg: White, Round, Scored Tablets; Debossed "WW" on one side and "771" on the other side.
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: 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.
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
Rev. November 2010
Isosorbide Dinitrate 5mg tab
Isosorbide Dinitrate Chemical Structurre
Isosorbide Dinitrate available forms, composition, doses:
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Frequently asked QuestionsCan i drive or operate heavy machine after consuming Isosorbide Dinitrate?
Depending on the reaction of the Isosorbide Dinitrate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Isosorbide Dinitrate 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 Isosorbide Dinitrate 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.
Reviewsdrugs.com conducted a study on Isosorbide Dinitrate, 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 Isosorbide Dinitrate 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. Arunabha Ray, MD Pharmacology