Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydralazine Hydrochloride Tablets USP are available as: 10 mg Orange, round tablets debossed with SG on one side and 182 on other side. Available in Bottles of 100 (NDC 50228-182-01) and 1000 (NDC 50228-182-10). 25 mg Orange, round tablets debossed with SG on one side and 183 on other side. Available in Bottles of 100 (NDC 50228-183-01) and 1000 (NDC 50228-183-10). 50 mg Orange, round tablets debossed with SG on one side and 184 on other side. Available in Bottles of 100 (NDC 50228-184-01) and 1000 (NDC 50228-184-10). 100 mg Orange, round tablets debossed with SG on one side and 185 on other side. Available in Bottles of 100 (NDC 50228-185-01) and 1000 (NDC 50228-185-10). Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: ScieGen Pharnaceuticals, Inc. Hauppauge, NY 11788 USA Rev: 1/2021; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL NDC 50228- 182 -01 HydrALAZINE Hydrochloride Tablets, USP 10 mg 100 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 182 -10 HydrALAZINE Hydrochloride Tablets, USP 10 mg 1,000 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 183 -01 HydrALAZINE Hydrochloride Tablets, USP 25 mg 100 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 183 -10 HydrALAZINE Hydrochloride Tablets, USP 25 mg 1,000 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 184 -01 HydrALAZINE Hydrochloride Tablets, USP 50 mg 100 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 184 -10 HydrALAZINE Hydrochloride Tablets, USP 50 mg 1,000 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 185 -01 HydrALAZINE Hydrochloride Tablets, USP 100 mg 100 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 185 -10 HydrALAZINE Hydrochloride Tablets, USP 100 mg 1,000 Tablets Rx Only ScieGen Pharmaceuticals, Inc. hht-tabs-10-mg-100s-count hht-tabs-10-mg-1000s-count hht-tabs-25-mg-100s-count hht-tabs-25-mg-1000s-count hht-tabs-50-mg-100s-count hht-tabs-50-mg-1000s-count hht-tabs-100-mg-100s-count hht-tabs-100-mg-1000s-count
- HOW SUPPLIED Hydralazine Hydrochloride Tablets USP are available as: 10 mg Orange, round tablets debossed with SG on one side and 182 on other side. Available in Bottles of 100 (NDC 50228-182-01) and 1000 (NDC 50228-182-10). 25 mg Orange, round tablets debossed with SG on one side and 183 on other side. Available in Bottles of 100 (NDC 50228-183-01) and 1000 (NDC 50228-183-10). 50 mg Orange, round tablets debossed with SG on one side and 184 on other side. Available in Bottles of 100 (NDC 50228-184-01) and 1000 (NDC 50228-184-10). 100 mg Orange, round tablets debossed with SG on one side and 185 on other side. Available in Bottles of 100 (NDC 50228-185-01) and 1000 (NDC 50228-185-10). Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: ScieGen Pharnaceuticals, Inc. Hauppauge, NY 11788 USA Rev: 1/2021
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL NDC 50228- 182 -01 HydrALAZINE Hydrochloride Tablets, USP 10 mg 100 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 182 -10 HydrALAZINE Hydrochloride Tablets, USP 10 mg 1,000 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 183 -01 HydrALAZINE Hydrochloride Tablets, USP 25 mg 100 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 183 -10 HydrALAZINE Hydrochloride Tablets, USP 25 mg 1,000 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 184 -01 HydrALAZINE Hydrochloride Tablets, USP 50 mg 100 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 184 -10 HydrALAZINE Hydrochloride Tablets, USP 50 mg 1,000 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 185 -01 HydrALAZINE Hydrochloride Tablets, USP 100 mg 100 Tablets Rx Only ScieGen Pharmaceuticals, Inc. NDC 50228- 185 -10 HydrALAZINE Hydrochloride Tablets, USP 100 mg 1,000 Tablets Rx Only ScieGen Pharmaceuticals, Inc. hht-tabs-10-mg-100s-count hht-tabs-10-mg-1000s-count hht-tabs-25-mg-100s-count hht-tabs-25-mg-1000s-count hht-tabs-50-mg-100s-count hht-tabs-50-mg-1000s-count hht-tabs-100-mg-100s-count hht-tabs-100-mg-1000s-count
Overview
Hydralazine Hydrochloride tablets 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. 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 anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Chem structure
Indications & Usage
Essential hypertension, alone or as an adjunct.
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 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.
Warnings & Precautions
WARNINGS In a few patients hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydralazine should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS , Laboratory Tests .)
Contraindications
Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.
Adverse Reactions
Adverse reactions with hydralazine are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. Common headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. Less Frequent Digestive constipation, paralytic ileus. Cardiovascular hypotension, paradoxical pressor response, edema. Respiratory dyspnea. Neurologic peripheral neuritis, evidenced by paresthesia, numbness, and tingling, dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. Genitourinary difficulty in urination. Hematologic blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura, lymphadenopathy; splenomegaly. Hypersensitive Reactions rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. Other nasal congestion, flushing, lacrimation, conjunctivitis.
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