Label: LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet

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

Drug Label Information

Updated December 31, 2024

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  • BOXED WARNING (What is this?)

    Boxed Warning

    WARNING: FETAL TOXICITY

    • When pregnancy is detected, discontinue lisinopril and hydrochlorothiazide 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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  • SPL Unclassified
    You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088.
  • Description
    Lisinopril and hydrochlorothiazide tablets combine an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an ...
  • Clinical Pharmacology
    Lisinopril-Hydrochlorothiazide - As a result of its diuretic effects, hydrochlorothiazide increases plasma renin activity, increases aldosterone secretion, and decreases serum potassium ...
  • Indications and Usage
    Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular ...
  • Contraindications
    Lisinopril and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous ...
  • Warnings and Precautions
    General - Lisinopril - Anaphylactoid and Possibly Related Reactions: Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including ...
  • Adverse Reactions
    Lisinopril and hydrochlorothiazide tablets have been evaluated for safety in 930 patients including 100 patients treated for 50 weeks or more. In clinical trials with lisinopril and ...
  • Overdosage
    No specific information is available on the treatment of overdosage with lisinopril and hydrochlorothiazide tablets. Treatment is symptomatic and supportive. Therapy with lisinopril and ...
  • Dosage and Administration
    Lisinopril monotherapy is an effective treatment of hypertension in once-daily doses of 10 mg to 80 mg, while hydrochlorothiazide monotherapy is effective in doses of 12.5 mg to 50 mg per day. In ...
  • How Supplied/Storage and Handling
    Lisinopril and hydrochlorothiazide 10-12.5 Tablets, USP, White to off-white, round tablets, imprinted with ‘H150’ on one side and plain on the other side. Bottles of 90 Tablets NDC ...
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