Hydrochlorothiazide
Hydrochlorothiazide Capsules USP
FULL PRESCRIBING INFORMATION: CONTENTS*
- HYDROCHLOROTHIAZIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- HYDROCHLOROTHIAZIDE INDICATIONS AND USAGE
- HYDROCHLOROTHIAZIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- HYDROCHLOROTHIAZIDE ADVERSE REACTIONS
- OVERDOSAGE
- HYDROCHLOROTHIAZIDE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12.5 mg (100 Capsule Bottle)
FULL PRESCRIBING INFORMATION
HYDROCHLOROTHIAZIDE DESCRIPTION
H78342
CLINICAL PHARMACOLOGY
Pharmacokinetics and Metabolism
Pharmacodynamics
Clinical Studies
HYDROCHLOROTHIAZIDE INDICATIONS AND USAGE
Usage in Pregnancy
HYDROCHLOROTHIAZIDE CONTRAINDICATIONS
Hydrochlorothiazide capsules are contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.
WARNINGS
Diabetes and Hypoglycemia:
Renal Disease:
PRECAUTIONS
Electrolyte and Fluid Balance Status:
Hyperuricemia:
Impaired Hepatic Function:
Parathyroid Disease:
Drug Interactions
Alcohol, barbiturates, or narcotics -
Antidiabetic drugs
Other antihypertensive drugs -
Cholestyramine and colestipol resins -
Corticosteroid, ACTH -
Pressor amines (e.g., norepinephrine) -
Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine)
Lithium -
Non-steroidal anti-inflammatory drugs
Drug/Laboratory Test Interactions
PRECAUTIONS , General
Carcinogenesis, Mutagenesis, Impairment Of Fertility
in vitroSalmonella typhimuriumin vivoDrosophilain vitroAspergillus nidulans
Pregnancy
Teratogenic Effects
Pregnancy Category B:
Nonteratogenic Effects
Nursing Mothers
Pediatric Use
Geriatric 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 hydrochlorothiazide (12.5 mg) is therefore recommended. If further titration is required, 12.5 mg increments should be utilized.
HYDROCHLOROTHIAZIDE ADVERSE REACTIONS
Body as a whole:
Cardiovascular:
Digestive:
Hematologic:
Hypersensitivity:
Metabolic: PRECAUTIONS
Musculoskeletal:
Nervous System/Psychiatric:
Renal: WARNINGS
Skin:
Special Senses:
Urogenital:
OVERDOSAGE
50
HYDROCHLOROTHIAZIDE DOSAGE AND ADMINISTRATION
For Control of Hypertension:
HOW SUPPLIED
Hydrochlorothiazide Capsules USP 12.5 mg
Store at
Aurobindo Pharma USA, Inc.
Aurobindo Pharma Limited
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12.5 mg (100 Capsule Bottle)
NDC 65862-113-01
Hydrochlorothiazide Capsules USP
12.5 mg
Rx only 100 Capsules
AUROBINDO
HydrochlorothiazideHydrochlorothiazide CAPSULE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
