Drug Catalog - Product Detail
HYDRALAZINE HCL USP TB 25MG 10X10 UD
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00904-6441-61 | MAJOR PHARMACEUTICALS | 100 | 25MG | TABLET |
PACKAGE FILES
Generic Name
HYDRALAZINE HYDROCHLORIDE
Substance Name
HYDRALAZINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA086242
Description
DESCRIPTION HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: 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. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. Image
How Supplied
HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP 10 mg - round, convex, pink film-coated tablet engraved with HP above 1 on one side and plain on the other side Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6440-61 25 mg - round, convex, pink film-coated tablet engraved with HP above 2 on one side and plain on the other side Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6441-61 50 mg - round, convex, pink film-coated tablet engraved with HP above 3 on one side and plain on the other side Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6442-61 100 mg - round, convex, pink film-coated tablet engraved with HP above 4 on one side and plain on the other side Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6443-61 Bottle of 1000 tablets, NDC 0904-6443-10
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 to 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 hydrochloride tablets. In a few resistant patients, up to 300 mg of hydrALAZINE hydrochloride tablets daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE hydrochloride tablets 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.