Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Hydralazine Hydrochloride Tablets USP are available as: 10 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 398” on one side and plain on the other side. They are available as follows: NDC 51079-074-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 25 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 327” on one side and plain on the other side. They are available as follows: NDC 51079-075-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 50 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 328” on one side and plain on the other side. They are available as follows: NDC 51079-076-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in Czech Republic by: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Manufactured for: TEVA PHARMACEUTICALS USA, Inc. North Wales, PA 19454 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-11344 R3 4/20; PRINCIPLE DISPLAY PANEL – 10 MG NDC 51079-074-20 HydrALAZINE Hydrochloride Tablets USP 10 mg 100 Tablets (10 x 10) Each tablet contains 10 mg hydralazine hydrochloride, USP. Usual Dosage: See accompanying prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rx only S-11541 R2 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Hydralazine Hydrochloride 10 mg Tablets Unit Carton Label Serialized Unit Carton; PRINCIPLE DISPLAY PANEL – 25 mg NDC 51079-075-20 HydrALAZINE Hydrochloride Tablets USP 25 mg 100 Tablets (10 x 10) Each tablet contains 25 mg hydralazine hydrochloride, USP. Usual Dosage: See accompanying prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rx only S-11627 R2 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Hydralazine Hydrochloride 25 mg Tablets Unit Carton Label Serialized Unit Carton; PRINCIPLE DISPLAY PANEL – 50 mg NDC 51079-076-20 HydrALAZINE Hydrochloride Tablets USP 50 mg 100 Tablets (10 x 10) Each tablet contains 50 mg hydralazine hydrochloride, USP. Usual Dosage: See accompanying prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rx only S-11749 R1 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Hydralazine Hydrochloride 50 mg Tablets Unit Carton Label Serialized Unit Carton
- HOW SUPPLIED: Hydralazine Hydrochloride Tablets USP are available as: 10 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 398” on one side and plain on the other side. They are available as follows: NDC 51079-074-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 25 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 327” on one side and plain on the other side. They are available as follows: NDC 51079-075-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 50 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 328” on one side and plain on the other side. They are available as follows: NDC 51079-076-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in Czech Republic by: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Manufactured for: TEVA PHARMACEUTICALS USA, Inc. North Wales, PA 19454 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-11344 R3 4/20
- PRINCIPLE DISPLAY PANEL – 10 MG NDC 51079-074-20 HydrALAZINE Hydrochloride Tablets USP 10 mg 100 Tablets (10 x 10) Each tablet contains 10 mg hydralazine hydrochloride, USP. Usual Dosage: See accompanying prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rx only S-11541 R2 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Hydralazine Hydrochloride 10 mg Tablets Unit Carton Label Serialized Unit Carton
- PRINCIPLE DISPLAY PANEL – 25 mg NDC 51079-075-20 HydrALAZINE Hydrochloride Tablets USP 25 mg 100 Tablets (10 x 10) Each tablet contains 25 mg hydralazine hydrochloride, USP. Usual Dosage: See accompanying prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rx only S-11627 R2 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Hydralazine Hydrochloride 25 mg Tablets Unit Carton Label Serialized Unit Carton
- PRINCIPLE DISPLAY PANEL – 50 mg NDC 51079-076-20 HydrALAZINE Hydrochloride Tablets USP 50 mg 100 Tablets (10 x 10) Each tablet contains 50 mg hydralazine hydrochloride, USP. Usual Dosage: See accompanying prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rx only S-11749 R1 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Hydralazine Hydrochloride 50 mg Tablets Unit Carton Label Serialized Unit Carton
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, 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 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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