Drug Catalog - Product Detail
HYDRALAZINE HCL USP TB 25MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0342-01 | GLENMARK PHARMACEUTICALS | 100 | 25MG | 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 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 o C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6. MM1
How Supplied
HOW SUPPLIED Hydralazine hydrochloride tablets USP: 10 mg - Mottled orange color, circular, biconvex uncoated tablets with ‘341’ engraved on one side and ‘G’ engraved on the other side, supplied in: Bottles of 100 (NDC 68462-341-01) Bottles of 500 (NDC 68462-341-05) Bottles of 1000 (NDC 68462-341-10) 25 mg - Mottled orange color, circular, biconvex uncoated tablets with ‘342’ engraved on one side and ‘G’ engraved on the other side, supplied in: Bottles of 100 (NDC 68462-342-01) Bottles of 500 (NDC 68462-342-05) Bottles of 1000 (NDC 68462-342-10) 50 mg - Mottled orange color, circular, biconvex uncoated tablets with ‘343’ engraved on one side and ‘G’ engraved on the other side, supplied in: Bottles of 100 (NDC 68462-343-01) Bottles of 500 (NDC 68462-343-05) Bottles of 1000 (NDC 68462-343-10) 100 mg - Mottled orange, color, circular, biconvex uncoated tablets with ‘344’ engraved on one side and ‘G’ engraved on the other side, supplied in: Bottles of 100 (NDC 68462-344-01) Bottles of 500 (NDC 68462-344-05) Bottles of 1000 (NDC 68462-344-10) Dispense in a tight, light-resistant container as defined in the USP.
Indications & Usage
INDICATIONS & USAGE Essential hypertension, alone or as an adjunct.
Dosage and Administration
DOSAGE & 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. 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.