Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP: 10 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘293’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-293-01 Bottles of 500 Tablets NDC 67877-293-05 Bottles of 1000 Tablets NDC 67877-293-10 25 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘292’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-292-01 Bottles of 500 Tablets NDC 67877-292-05 Bottles of 1000 Tablets NDC 67877-292-10 50 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘291’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-291-01 Bottles of 500 Tablets NDC 67877-291-05 Bottles of 1000 Tablets NDC 67877-291-10 100 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘290’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-290-01 Bottles of 500 Tablets NDC 67877-290-05 Dispense in a tight, light-resistant container. 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. Manufactured by: ALKEM LABORATORIES LIMITED H.O.: ALKEM HOUSE, Senapati Bapat Marg, Lower Parel, Mumbai - 400 013, INDIA Distributed by: Ascend Laboratories Parsippany, NJ 07054 Revised: December,2017 PT 1368-02; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL HydrALAZINE Hydrochloride Tablets, USP 10 mg - Container Label NDC 67877-293-01 HydrALAZINE Hydrochloride Tablets, USP 10 mg Rx Only 100 Tablets HydrALAZINE Hydrochloride Tablets, USP 25 mg - Container Label NDC 67877-292-05 HydrALAZINE Hydrochloride Tablets, USP 25 mg Rx Only 500 Tablets HydrALAZINE Hydrochloride Tablets, USP 50 mg - Container Label NDC 67877-291-10 HydrALAZINE Hydrochloride Tablets, USP 50 mg Rx Only 1000 Tablets HydrALAZINE Hydrochloride Tablets, USP 100 mg - Container Label NDC 67877-290-01 HydrALAZINE Hydrochloride Tablets, USP 100 mg Rx Only 100 Tablets 100s-10mg 500s-25mg 1000s-50mg 100s-100mg
- HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP: 10 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘293’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-293-01 Bottles of 500 Tablets NDC 67877-293-05 Bottles of 1000 Tablets NDC 67877-293-10 25 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘292’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-292-01 Bottles of 500 Tablets NDC 67877-292-05 Bottles of 1000 Tablets NDC 67877-292-10 50 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘291’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-291-01 Bottles of 500 Tablets NDC 67877-291-05 Bottles of 1000 Tablets NDC 67877-291-10 100 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘290’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-290-01 Bottles of 500 Tablets NDC 67877-290-05 Dispense in a tight, light-resistant container. 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. Manufactured by: ALKEM LABORATORIES LIMITED H.O.: ALKEM HOUSE, Senapati Bapat Marg, Lower Parel, Mumbai - 400 013, INDIA Distributed by: Ascend Laboratories Parsippany, NJ 07054 Revised: December,2017 PT 1368-02
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL HydrALAZINE Hydrochloride Tablets, USP 10 mg - Container Label NDC 67877-293-01 HydrALAZINE Hydrochloride Tablets, USP 10 mg Rx Only 100 Tablets HydrALAZINE Hydrochloride Tablets, USP 25 mg - Container Label NDC 67877-292-05 HydrALAZINE Hydrochloride Tablets, USP 25 mg Rx Only 500 Tablets HydrALAZINE Hydrochloride Tablets, USP 50 mg - Container Label NDC 67877-291-10 HydrALAZINE Hydrochloride Tablets, USP 50 mg Rx Only 1000 Tablets HydrALAZINE Hydrochloride Tablets, USP 100 mg - Container Label NDC 67877-290-01 HydrALAZINE Hydrochloride Tablets, USP 100 mg Rx Only 100 Tablets 100s-10mg 500s-25mg 1000s-50mg 100s-100mg
Overview
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°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 microcrystalline cellulose, sodium starch glycolate, stearic acid, povidone K-30, colloidal silicon dioxide, mannitol and FD&C Yellow No 6. structure
Indications & Usage
INDICATIONS & USAGE Essential hypertension, alone or as an adjunct.
Dosage & 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.
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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