hydrochlorothiazide

Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Teratogenic Effects

Nonteratogenic Effects

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Nursing Mothers

Thiazides are excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue hydrochlorothiazide, taking into account the importance of the drug to the mother.

Pediatric Use

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 hydrochlorothiazide (12.5 mg) is therefore recommended. If further titration is required, 12.5 mg increments should be utilized.

HYDROCHLOROTHIAZIDE ADVERSE REACTIONS

OVERDOSAGE

HYDROCHLOROTHIAZIDE DOSAGE AND ADMINISTRATION

For Control of Hypertension: The adult initial dose of hydrochlorothiazide capsules is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.

HOW SUPPLIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hydrochlorothiazide Hydrochlorothiazide CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:16714-383 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN lactose monohydrate SILICON DIOXIDE MAGNESIUM STEARATE D&C RED NO. 28 D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN titanium dioxide FERROSOFERRIC OXIDE Product Characteristics Color Size Imprint Code Shape BLUE (Teal Blue opaque) 15 mm A129;12;5mg CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16714-383-01 30 in 1 BOTTLE 2 NDC:16714-383-04 100 in 1 BOTTLE 3 NDC:16714-383-05 500 in 1 BOTTLE 4 NDC:16714-383-02 1000 in 1 BOTTLE 5 10 in 1 BLISTER PACK 6 NDC:16714-383-03 10 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200645 2010-12-17