Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP are available as: 10 mg – Round, peach core tablet, debossed EP on one side and 101 on the reverse side. Unit dose packages of 100 (10 x 10) NDC 60687-811-01 25 mg – Round, peach, core tablet, debossed EP over 102 on one side and plain on the reverse side. Unit dose packages of 100 (10 x 10) NDC 60687-822-01 50 mg – Round, peach, core tablet, debossed EP over 103 on one side and plain on the reverse side. Unit dose packages of 100 (10 x 10) NDC 60687-833-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. FOR YOUR PROTECTION: Do not use if blister is torn or broken.; Package/Label Display Panel – Carton – 10 mg NDC 60687- 811 -01 HydrALAZINE Hydrochloride Tablets, USP 10 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydralazine Hydrochloride, USP.................................10 mg Usual Dosage: See full prescribing information. 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 23155-832, Avet Pharmaceuticals Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 781101 0481101/0724 10 mg Hydralazine HCl Tablets Carton; Package/Label Display Panel – Blister – 10 mg HydrALAZINE Hydrochloride Tablet, USP 10 mg 10 mg Hydralazine HCl Tablet Blister; Package/Label Display Panel – Carton – 25 mg NDC 60687- 822 -01 HydrALAZINE Hydrochloride Tablets, USP 25 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydralazine Hydrochloride, USP.............................................. 25 mg Usual Dosage: See full prescribing information. 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 23155-833, Avet Pharmaceuticals Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 782201 0482201/0124 25 mg Hydralazine HCl Tablets Carton; Package/Label Display Panel – Blister – 25 mg HydrALAZINE Hydrochloride Tablet, USP 25 mg 25 mg Hydralazine HCl Tablet Blister; Package/Label Display Panel – Carton – 50 mg NDC 60687- 833 -01 HydrALAZINE Hydrochloride Tablets, USP 50 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydralazine Hydrochloride, USP.............................................. 50 mg Usual Dosage: See full prescribing information. 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 23155-834, Avet Pharmaceuticals Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 783301 0483301/0124 50 mg Hydralazine HCl Tablets Carton; Package/Label Display Panel – Blister – 50 mg HydrALAZINE Hydrochloride Tablet, USP 50 mg 50 mg Hydralazine HCl Tablet Blister
- HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP are available as: 10 mg – Round, peach core tablet, debossed EP on one side and 101 on the reverse side. Unit dose packages of 100 (10 x 10) NDC 60687-811-01 25 mg – Round, peach, core tablet, debossed EP over 102 on one side and plain on the reverse side. Unit dose packages of 100 (10 x 10) NDC 60687-822-01 50 mg – Round, peach, core tablet, debossed EP over 103 on one side and plain on the reverse side. Unit dose packages of 100 (10 x 10) NDC 60687-833-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
- Package/Label Display Panel – Carton – 10 mg NDC 60687- 811 -01 HydrALAZINE Hydrochloride Tablets, USP 10 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydralazine Hydrochloride, USP.................................10 mg Usual Dosage: See full prescribing information. 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 23155-832, Avet Pharmaceuticals Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 781101 0481101/0724 10 mg Hydralazine HCl Tablets Carton
- Package/Label Display Panel – Blister – 10 mg HydrALAZINE Hydrochloride Tablet, USP 10 mg 10 mg Hydralazine HCl Tablet Blister
- Package/Label Display Panel – Carton – 25 mg NDC 60687- 822 -01 HydrALAZINE Hydrochloride Tablets, USP 25 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydralazine Hydrochloride, USP.............................................. 25 mg Usual Dosage: See full prescribing information. 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 23155-833, Avet Pharmaceuticals Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 782201 0482201/0124 25 mg Hydralazine HCl Tablets Carton
- Package/Label Display Panel – Blister – 25 mg HydrALAZINE Hydrochloride Tablet, USP 25 mg 25 mg Hydralazine HCl Tablet Blister
- Package/Label Display Panel – Carton – 50 mg NDC 60687- 833 -01 HydrALAZINE Hydrochloride Tablets, USP 50 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Hydralazine Hydrochloride, USP.............................................. 50 mg Usual Dosage: See full prescribing information. 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 23155-834, Avet Pharmaceuticals Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 783301 0483301/0124 50 mg Hydralazine HCl Tablets Carton
- Package/Label Display Panel – Blister – 50 mg HydrALAZINE Hydrochloride Tablet, USP 50 mg 50 mg Hydralazine HCl Tablet Blister
Overview
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 magnesium stearate, microcrystalline cellulose, orange lake blend, silicon dioxide, and sodium starch glycolate. The orange lake blend consists of FD&C yellow #6. Structural Formula
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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.