Label: HYDROCHLOROTHIAZIDE capsule, gelatin coated

  • NDC Code(s): 59746-382-05, 59746-382-06, 59746-382-10
  • Packager: JUBILANT CADISTA PHARMACEUTICALS INC.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 5, 2021

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  • DESCRIPTION
    Hydrochlorothiazide capsules, USP 12.5 mg is the 3,4-dihydro derivative of chloro­thiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its ...
  • CLINICAL PHARMACOLOGY
    Hydrochlorothiazide blocks the reabsorption of sodium and chloride ions, and it thereby increases the quantity of sodium traversing the distal tubule and the volume of water excreted. A portion of ...
  • INDICATIONS AND USAGE
    Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing ...
  • CONTRAINDICATIONS
    Hydrochlorothiazide is contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.
  • WARNINGS
    Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma ...
  • PRECAUTIONS
    Electrolyte and Fluid Balance Status: In published studies, clinically significant hypokalemia has been consistently less common in patients who received 12.5 mg of hydrochlorothiazide than in ...
  • Drug Interactions:
    When given concurrently the following drugs may interact with thiazide diuretics: Alcohol, barbiturates, or narcotics: potentiation of orthostatic hypotension may occur. Antidiabetic drugs ...
  • Pregnancy:
    Teratogenic Effects: Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3,000 and 1,000 ...
  • Pediatric Use:
    Safety and effectiveness in pediatric patients have not been established.
  • Elderly Use:
    A greater blood pressure reduction and an increase in side effects may be observed in the elderly (i.e., > 65 years) with hydrochlorothiazide. Starting treatment with the lowest available dose of ...
  • ADVERSE REACTIONS
    The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide ...
  • OVERDOSAGE
    The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has ...
  • DOSAGE AND ADMINISTRATION
    For Control of Hypertension: The adult initial dose of hydrochlorothiazide is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses ...
  • HOW SUPPLIED
    Hydrochlorothiazide capsules USP, 12.5 mg are Size 4 capsules, light blue opaque cap and white opaque body with - "TL 382" axially printed in black ink on cap and body. Bottles of 30 with ...
  • PACKAGE LABEL
    NDC 59746-382-06 - Hydrochlorothiazide Capsules, USP - 12.5 mg - CADISTA™ 100 Capsules - Rx Only - Each capsule contains: Hydrochlorothiazide USP...12.5 mg - Dispense in a tight ...
  • INGREDIENTS AND APPEARANCE
    Product Information