Isosorbide Dinitrate 10 mg/1
Isosorbide Dinitrate · TABLET · Sandoz Inc.
Isosorbide Dinitrate is a tablet containing isosorbide dinitrate at 10 mg/1, taken oral. Manufactured by Sandoz Inc..
Key Facts
- Brand Name
- Isosorbide Dinitrate
- Generic Name
- Isosorbide Dinitrate
- NDC Code (Product)
0781-1556- Manufacturer
- Sandoz Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA086223
- Drug Class
- Nitrate Vasodilator [EPC]
- Marketing Start
- 01/07/1988
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Sandoz Inc
Cross Contamination with Other Products
Sandoz Inc
Cross Contamination with Other Products
Aidapak Services, LLC
Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.
Aidapak Services, LLC
Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD22845_10, EXP: 5/2/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: AD32757_10, EXP: 5/14/2014.
Aidapak Services, LLC
Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.
Sandoz Inc
Cross Contamination with Other Products
Sandoz Inc
Cross Contamination with Other Products
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Isosorbide dinitrate tablets 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION As noted under " CLINICAL PHARMACOLOGY ," multiple-dose 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 must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release isosorbide dinitrate, 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 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 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 …
Warnings
WARNINGS Amplification of the vasodilatory effects of isosorbide dinitrate 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.
Contraindications
CONTRAINDICATIONS Isosorbide dinitrate is contraindicated in patients who are allergic to isosorbide dinitrate or any of its other ingredients. Do not use isosorbide dinitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use isosorbide dinitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Drug Interactions
Drug Interactions 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. Concomitant use of isosorbide dinitrate with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS ). Concomitant use of isosorbide dinitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see CONTRAINDICATIONS ).
Adverse Reactions
ADVERSE REACTIONS Adverse reactions to isosorbide dinitrate are generally dose-related, and almost 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 with isosorbide dinitrate tablets. To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com ; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Frequently Asked Questions
What is Isosorbide Dinitrate used for?
Isosorbide Dinitrate contains Isosorbide Dinitrate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Isosorbide Dinitrate a controlled substance?
Isosorbide Dinitrate is not classified as a controlled substance by the DEA.
What is the generic name for Isosorbide Dinitrate?
The generic name for Isosorbide Dinitrate is Isosorbide Dinitrate. There are 3 other brand versions of Isosorbide Dinitrate.
What is the NDC code for Isosorbide Dinitrate 10 mg/1?
The NDC (National Drug Code) for Isosorbide Dinitrate 10 mg/1 is 0781-1556, listed by Sandoz Inc..
Other Isosorbide Dinitrate Dosages
- Isosorbide Dinitrate20 mg/150268-449
- Isosorbide Dinitrate5 mg/151407-147
- Isosorbide Dinitrate20 mg/155154-7991
- Isosorbide Dinitrate30 mg/149884-009
- Isosorbide Dinitrate10 mg/149884-021
- Isosorbide Dinitrate10 mg/150268-448
- Isosorbide Dinitrate20 mg/151407-149
- Isosorbide Dinitrate10 mg/10904-6619
- Isosorbide Dinitrate5 mg/149884-020
Other Isosorbide Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)