"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
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.
Hydralazine HCI 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 #49884-1 43-01) 500 (NDC #49884-1 43-05) and 1000 (NDC X49884-1 43-10).
50 mg hydralazine hydrochloride and 50 mg hydrochlorothiazide capsules are white/black and imprinted "Par 144", and are available in bottles of 100 (NDC X49884-144-01), 500 (NDC X49884-144-05) 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 #49884-1 45-01), 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.
CAUTION: Federal law prohibits dispensing without prescription.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Apresazide Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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