Isosorbide Dinitrate description, usages, side effects, indications, overdosage, supplying and lots more!

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Isosorbide Dinitrate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ISOSORBIDE DINITRATE DESCRIPTION


Isosorbide Dinitrate





CLINICAL PHARMACOLOGY




Pharmacokinetics






Clinical Trials




INDICATIONS & USAGE



ISOSORBIDE DINITRATE CONTRAINDICATIONS



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.


PRECAUTIONS

General






INFORMATION FOR PATIENTS




DRUG INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

Category C


NURSING MOTHERS



PEDIATRIC USE



ISOSORBIDE DINITRATE ADVERSE REACTIONS


OVERDOSAGE


OVERDOSAGE

Hemodynamic Effects








Methemoglobinemia





DOSAGE & ADMINISTRATION

CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY



HOW SUPPLIED
















STORAGE AND HANDLING



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Isosorbide Dinitrate

Isosorbide Dinitrate

Isosorbide Dinitrate

Isosorbide Dinitrate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-793(NDC:0781-1556)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
isosorbide dinitrate ISOSORBIDE DINITRATE 10 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
lactose monohydrate
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
white 8 mm GG;26 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-793-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086223 2011-10-19


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