Isosorbide Dinitrate
FULL PRESCRIBING INFORMATION: CONTENTS*
- ISOSORBIDE DINITRATE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- ISOSORBIDE DINITRATE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ISOSORBIDE DINITRATE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
ISOSORBIDE DINITRATE DESCRIPTION
5 mg also contains FD & C Red #40 Aluminum Lake. The20 mg also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, and FD & C Yellow #6 Aluminum Lake.
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
GeneralInformation for Patients
Drug Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Nursing Mothers
Pediatric Use
Geriatric Use
ISOSORBIDE DINITRATE ADVERSE REACTIONS
OVERDOSAGE).
OVERDOSAGE
Hemodynamic EffectsMethemoglobinemia
DOSAGE & ADMINISTRATION
CLINICAL PHARMACOLOGY, 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.CLINICAL PHARMACOLOGY, the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.
HOW SUPPLIED
5 mg:Round, pink, scored tablets, debossed GG 259 on one side and plain on the reverse side, and supplied as:
10 mg:Round, white, scored tablets, debossed GG 26 on one side and plain on the reverse side, and supplied as:
20 mg:Round, green, scored tablets, debossed GG 227 on one side and plain on the reverse side, and supplied as:
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Isosorbide DinitrateISOSORBIDE DINITRATE TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
