Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydralazine hydrochloride Tablets USP, 10 mg Orange mottled, round, biconvex, uncoated tablets debossed with ''T82'' on one side and plain on other side Bottles of 100 NDC 33342-374-11 Bottles of 1000 NDC 33342-374-44 Carton of 100 (10 x 10 unit-dose) NDC 33342-374-12 Hydralazine hydrochloride Tablets USP, 25 mg Orange mottled, round, biconvex, uncoated tablets debossed with ''T83'' on one side and plain on other side Bottles of 100 NDC 33342-375-11 Bottles of 1000 NDC 33342-375-44 Carton of 100 (10 x 10 unit-dose) NDC 33342-375-12 Hydralazine hydrochloride Tablets USP, 50 mg Orange mottled, round, biconvex, uncoated tablets debossed with ''T84'' on one side and plain on other side Bottles of 100 NDC 33342-376-11 Bottles of 1000 NDC 33342-376-44 Carton of 140 (10 x 14 unit-dose) NDC 33342-376-56 Hydralazine hydrochloride Tablets USP, 100 mg Orange mottled, round, biconvex, uncoated tablets debossed with ''T85'' on one side and plain on other side Bottles of 100 NDC 33342-377-11 Bottles of 1000 NDC 33342-377-44 Carton of 100 (10 x 10 unit-dose) NDC 33342-377-12 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by : Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA Revised: September 2024; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Hydralazine Hydrochloride Tablets USP, 10 mg 100's Container Label NDC: 33342-374-11 Hydralazine Hydrochloride Tablets USP, 10 mg 1000's Container Label NDC: 33342-374-44 Hydralazine Hydrochloride Tablets USP, 25 mg 100's Container Label NDC: 33342-375-11 Hydralazine Hydrochloride Tablets USP, 25 mg 1000's Container Label NDC: 33342-375-44 Hydralazine Hydrochloride Tablets USP, 50 mg 100's Container Label NDC: 33342-376-11 Hydralazine Hydrochloride Tablets USP, 50 mg 1000's Container Label NDC: 33342-376-44 Hydralazine Hydrochloride Tablets USP, 100 mg 100's Container Label NDC: 33342-377-11 Hydralazine Hydrochloride Tablets USP, 100 mg 1000's Container Label NDC: 33342-377-44 Hydralazine Hydrochloride Tablets USP, 10 mg 100's Carton Label NDC: 33342-374-12 Hydralazine Hydrochloride Tablets USP, 25 mg 100's Carton Label NDC: 33342-375-12 Hydralazine Hydrochloride Tablets USP, 50 mg 140's Carton Label NDC: 33342-376-56 Hydralazine Hydrochloride Tablets USP, 100 mg 100's Carton Label NDC: 33342-377-12 111 152 122 147 169 159 169 123 138 157 139 196
- HOW SUPPLIED Hydralazine hydrochloride Tablets USP, 10 mg Orange mottled, round, biconvex, uncoated tablets debossed with ''T82'' on one side and plain on other side Bottles of 100 NDC 33342-374-11 Bottles of 1000 NDC 33342-374-44 Carton of 100 (10 x 10 unit-dose) NDC 33342-374-12 Hydralazine hydrochloride Tablets USP, 25 mg Orange mottled, round, biconvex, uncoated tablets debossed with ''T83'' on one side and plain on other side Bottles of 100 NDC 33342-375-11 Bottles of 1000 NDC 33342-375-44 Carton of 100 (10 x 10 unit-dose) NDC 33342-375-12 Hydralazine hydrochloride Tablets USP, 50 mg Orange mottled, round, biconvex, uncoated tablets debossed with ''T84'' on one side and plain on other side Bottles of 100 NDC 33342-376-11 Bottles of 1000 NDC 33342-376-44 Carton of 140 (10 x 14 unit-dose) NDC 33342-376-56 Hydralazine hydrochloride Tablets USP, 100 mg Orange mottled, round, biconvex, uncoated tablets debossed with ''T85'' on one side and plain on other side Bottles of 100 NDC 33342-377-11 Bottles of 1000 NDC 33342-377-44 Carton of 100 (10 x 10 unit-dose) NDC 33342-377-12 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by : Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA Revised: September 2024
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Hydralazine Hydrochloride Tablets USP, 10 mg 100's Container Label NDC: 33342-374-11 Hydralazine Hydrochloride Tablets USP, 10 mg 1000's Container Label NDC: 33342-374-44 Hydralazine Hydrochloride Tablets USP, 25 mg 100's Container Label NDC: 33342-375-11 Hydralazine Hydrochloride Tablets USP, 25 mg 1000's Container Label NDC: 33342-375-44 Hydralazine Hydrochloride Tablets USP, 50 mg 100's Container Label NDC: 33342-376-11 Hydralazine Hydrochloride Tablets USP, 50 mg 1000's Container Label NDC: 33342-376-44 Hydralazine Hydrochloride Tablets USP, 100 mg 100's Container Label NDC: 33342-377-11 Hydralazine Hydrochloride Tablets USP, 100 mg 1000's Container Label NDC: 33342-377-44 Hydralazine Hydrochloride Tablets USP, 10 mg 100's Carton Label NDC: 33342-374-12 Hydralazine Hydrochloride Tablets USP, 25 mg 100's Carton Label NDC: 33342-375-12 Hydralazine Hydrochloride Tablets USP, 50 mg 140's Carton Label NDC: 33342-376-56 Hydralazine Hydrochloride Tablets USP, 100 mg 100's Carton Label NDC: 33342-377-12 111 152 122 147 169 159 169 123 138 157 139 196
Overview
Hydralazine hydrochloride USP, is an antihypertensive, available as 10-, 25-, 50-, and 100-mg tablets 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, and has a molecular weight of 196.64. Inactive Ingredients. FD&C Yellow No. 6 Aluminium Lake, Lactose Monohydrate, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate and Stearic Acid 136
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 2-4 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-torisk 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 hydrochloride 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.
Drug Interactions
Drug/Drug Interactions MAO inhibitors should be used with caution in patients receiving hydralazine. When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydralazine, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydralazine hydrochloride tablets are used concomitantly.
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