Label: FOSINOPRIL SODIUM- fosinopril tablet

  • NDC Code(s): 69097-856-05, 69097-856-15, 69097-857-05, 69097-857-15, view more
  • Packager: Cipla USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 20, 2023

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  • BOXED WARNING (What is this?)

    WARNING: FETAL TOXICITY

    • When pregnancy is detected, discontinue fosinopril sodium tablets as soon as possible.
    • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity
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  • DESCRIPTION
    Fosinopril sodium tablet, USP  is the sodium salt of fosinopril USP, the ester prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action - In animals and humans, fosinopril sodium is hydrolyzed by esterases to the pharmacologically active form, fosinoprilat, a specific competitive inhibitor of ...
  • INDICATIONS AND USAGE
    Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the ...
  • CONTRAINDICATIONS
    Fosinopril sodium tablets are contraindicated in patients who are hypersensitive to this product or to any other angiotensin converting enzyme inhibitor (e.g., a patient who has experienced ...
  • WARNINGS
    Anaphylactoid and Possibly Related Reactions - Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin ...
  • PRECAUTIONS
    General - Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients ...
  • ADVERSE REACTIONS
    Fosinopril sodium has been evaluated for safety in more than 2100 individuals in hypertension and heart failure trials, including approximately 530 patients treated for a year or more. Generally ...
  • OVERDOSAGE
    Oral doses of fosinopril at 2600 mg/kg in rats were associated with significant lethality. Human overdoses of fosinopril have not been reported, but the most common manifestation of human ...
  • DOSAGE AND ADMINISTRATION
    Hypertension - Adults - The recommended initial dose of fosinopril sodium tablets is 10 mg once a day, both as monotherapy and when the drug is added to a diuretic. Dosage should then be adjusted ...
  • HOW SUPPLIED
    Fosinopril Sodium Tablets, USP - 10 mg tablets: White, round, biconvex partially scored tablets debossed with "IG" on one side and "200" on other side. They are supplied in bottles of 90 (NDC ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 69097-856-05                            Rx Only - Fosinopril - Sodium - Tablets, USP - 10 mg - 90 Tablets - Cipla - NDC 69097-857-05                            Rx ...
  • INGREDIENTS AND APPEARANCE
    Product Information