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Hydralazine and Hydrochlorothiazide (Hydralazine Hydrochloride / Hydrochlorothiazide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Hypertension (see boxed WARNING).

DOSAGE AND ADMINISTRATION

Dosage should be determined by individual titration (see boxed WARNING).

The usual dosage is one hydralazine HCl and hydrochlorothiazide capsule twice daily, the strength depending upon individual requirement following titration. For maintenance, the dosage should be adjusted to the lowest effective level.

When necessary, other antihypertensive agents such as sympathetic inhibitors may be added gradually in reduced dosages, and the effects should be watched carefully.

HOW SUPPLIED

Hydralazine HCl and hydrochlorothiazide are supplied as two piece hard gelatin capsules, in three dosage strengths:

25 mg hydralazine hydrochloride and 25 mg hydrochlorothiazide capsules are white and imprinted “Par 143”, and are available in bottles of 100 (NDC #49884-143-01), 500 (NDC #49884-143-05) and 1000 (NDC #49884-143-10).

50 mg hydralazine hydrochloride and 50 mg hydrochlorothiazide capsules are white/black and imprinted “Par 144”, and are available in bottles of 100 (NDC #49884-144-01), 500 (NDC #49884-144-05) and 1000 (NDC #49884-144-10).

100 mg hydralazine hydrochloride and 50 mg hydrochlorothiazide capsules are powder blue/light blue and imprinted “Par 145”, and are available in bottles of 100 (NDC #49884-145-01), 500 (NDC #49884-145-05) and 1000 (NDC #49884-145-10).

Store at controlled room temperature 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container as defined in the USP.

Manufactured by:

PAR PHARMACEUTICAL, INC.

Spring Valley, NY 10977

Rev: 03/05OS143-01-1-15

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