Label: LISINOPRIL tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 8, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)
    WARNING: FETAL TOXICITY - When pregnancy is detected, discontinue lisinopril as soon as possible - [see WARNINGS AND PRECAUTIONS ( 5.1)] . Drugs that act directly ...

    WARNING: FETAL TOXICITY

    • When pregnancy is detected, discontinue lisinopril as soon as possible [see WARNINGS AND PRECAUTIONS ( 5.1)] .
    • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see WARNINGS AND PRECAUTIONS ( 5.1)] .
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  • 1 INDICATIONS AND USAGE
    1.1 Hypertension - Lisinopril tablet USP is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Hypertension - Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20mg to ...
  • 3 DOSAGE FORMS AND STRENGTHS
    2.5 mg tablet is a white to off-white, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "2.5" on other side. 5 mg tablet is a pink coloured, round, biconvex, uncoated ...
  • 4 CONTRAINDICATIONS
    Lisinopril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lisinopril tablet USP within 36 hours of switching to or from ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Fetal Toxicity - Lisinopril can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Diuretics - Initiation of lisinopril in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with lisinopril can be minimized by ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Lisinopril can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters ...
  • 10 OVERDOSAGE
    Following a single oral dose of 20 g/kg no lethality occurred in rats, and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be ...
  • 11 DESCRIPTION
    Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Lisinopril inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - There was no evidence of a tumorigenic effect when lisinopril was administered for 105 weeks to male and female rats at doses up to 90 ...
  • 14 CLINICAL STUDIES
    14.1 Hypertension - Two dose-response studies utilizing a once-daily regimen were conducted in 438 mild to moderate hypertensive patients not on a diuretic. Blood pressure was measured 24 hours ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Lisinopril tablets USP are available as uncoated biconvex tablets in bottles of below mentioned pack ...
  • 17 PATIENT COUNSELING INFORMATION
    NOTE: This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Pregnancy - Advise pregnant women ...
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