Drug Catalog - Product Detail
HYDRALAZINE HCL USP TB 100MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0121-01 | PAR PHARMACEUTICAL | 100 | 100MG | TABLET |
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Description
DESCRIPTION Hydralazine hydrochloride USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: C 8 H 8 N 4 • HCl M.W. 196.64 Hydralazine hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Hydralazine HCl Tablets are available in 10, 25, 50 and 100 mg strengths. Each tablet contains the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 10 mg tablet contains FD&C Red #40. The 25 mg, 50 mg and 100 mg tablets contain FD&C Yellow #6. this is the structure
How Supplied
HOW SUPPLIED 10 mg - round, light pink colored, unscored tablets, debossed “Par 029” on one side are available in bottles of 100 (NDC #49884-029-01) and 1000 (NDC #49884-029-10). 25 mg - round, peach colored, unscored tablets, debossed “Par 027” on one side are available in bottles of 100 (NDC #49884-027-01) and 1000 (NDC #49884-027-10). 50 mg - round, peach colored, unscored tablets, debossed “Par 028” on one side are available in bottles of 100 (NDC #49884-028-01) and 1000 (NDC #49884-028-10). 100 mg - round, peach colored, unscored tablets, debossed “Par 121” on one side are available in bottles of 100 (NDC #49884-121-01) and 1000 (NDC #49884-121-10). Store at controlled room temperature 15°-30°C (59°-86°F) [see USP]. Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India by: Par Formulations Private Limited 1/58, Pudupakkam Kelambakkam-603 103 Mfg. No.: TN00002121 Revised: 11/2014
Indications & Usage
INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.
Dosage and Administration
DOSAGE AND ADMINISTRATION Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2-4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels. The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydralazine. In a few resistant patients, up to 300 mg of hydralazine daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydralazine combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.