Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP are supplied as: 10 mg 100 tablets in a HDPE bottle NDC: 64380-733-06 Orange colored, circular, biconvex tablets, debossed "10" on one side and plain on other side. 500 tablets in a HDPE bottle NDC: 64380-733-07 1000 tablets in a HDPE bottle NDC: 64380-733-08 100 tablets in a HDPE bottle NDC: 64380-734-06 25 mg 500 tablets in a HDPE bottle NDC: 64380-734-07 Orange colored circular, flat bevel edged tablets debossed "25" on one side & plain on other side 1000 tablets in a HDPE bottle NDC: 64380-734-08 100 tablets in a HDPE bottle NDC: 64380-735-06 50 mg 500 tablets in a HDPE bottle NDC: 64380-735-07 Orange colored circular, flat bevel edged tablets debossed "50" on one side & plain on other side 1000 tablets in a HDPE bottle NDC: 64380-735-08 100 tablets in a HDPE bottle NDC: 64380-736-06 100 mg 500 tablets in a HDPE bottle NDC: 64380-736-07 Orange colored circular, flat bevel edged tablets debossed "100" on one side & plain on other side 1000 tablets in a HDPE bottle NDC: 64380-736-08 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) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 07/2019; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Front Panel Strides Pharma Inc Rx Only NDC 64380-733-06 HydrALAZINE Hydrochloride Tablets, USP 10 mg 100 Tablets Front Panel Strides Pharma Inc Rx Only NDC 64380-733-08 HydrALAZINE Hydrochloride Tablets, USP 10 mg 1000 Tablets Front Panel Strides Pharma Inc Rx Only NDC 64380-734-06 HydrALAZINE Hydrochloride Tablets, USP 25 mg 100 Tablets 25mg-100scount-container-label Front Panel Strides Pharma Inc Rx Only NDC 64380-735-06 HydrALAZINE Hydrochloride Tablets, USP 50 mg 100 Tablets 50mg-100scount-container-label Front Panel Strides Pharma Inc Rx Only NDC 64380-736-06 HydrALAZINE Hydrochloride Tablets, USP 100 mg 100 Tablets 100mg-100s-count-container-label Front Panel Strides Pharma Inc Rx Only NDC 64380-734-08 HydrALAZINE Hydrochloride Tablets, USP 25 mg 1000 Tablets 25mg-1000s-count-container-label Front Panel Strides Pharma Inc Rx Only NDC 64380-735-08 HydrALAZINE Hydrochloride Tablets, USP 50 mg 1000 Tablets 50mg-1000s-count-container-label 10mg-10s 10 mg-1000s 25mg-100scount-container-label 50mg-100scount-container-label 100mg-100s-count-container-label 25mg-1000s-count-container-label 50mg-1000s-count-container-label
- HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP are supplied as: 10 mg 100 tablets in a HDPE bottle NDC: 64380-733-06 Orange colored, circular, biconvex tablets, debossed "10" on one side and plain on other side. 500 tablets in a HDPE bottle NDC: 64380-733-07 1000 tablets in a HDPE bottle NDC: 64380-733-08 100 tablets in a HDPE bottle NDC: 64380-734-06 25 mg 500 tablets in a HDPE bottle NDC: 64380-734-07 Orange colored circular, flat bevel edged tablets debossed "25" on one side & plain on other side 1000 tablets in a HDPE bottle NDC: 64380-734-08 100 tablets in a HDPE bottle NDC: 64380-735-06 50 mg 500 tablets in a HDPE bottle NDC: 64380-735-07 Orange colored circular, flat bevel edged tablets debossed "50" on one side & plain on other side 1000 tablets in a HDPE bottle NDC: 64380-735-08 100 tablets in a HDPE bottle NDC: 64380-736-06 100 mg 500 tablets in a HDPE bottle NDC: 64380-736-07 Orange colored circular, flat bevel edged tablets debossed "100" on one side & plain on other side 1000 tablets in a HDPE bottle NDC: 64380-736-08 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) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 07/2019
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Front Panel Strides Pharma Inc Rx Only NDC 64380-733-06 HydrALAZINE Hydrochloride Tablets, USP 10 mg 100 Tablets Front Panel Strides Pharma Inc Rx Only NDC 64380-733-08 HydrALAZINE Hydrochloride Tablets, USP 10 mg 1000 Tablets Front Panel Strides Pharma Inc Rx Only NDC 64380-734-06 HydrALAZINE Hydrochloride Tablets, USP 25 mg 100 Tablets 25mg-100scount-container-label Front Panel Strides Pharma Inc Rx Only NDC 64380-735-06 HydrALAZINE Hydrochloride Tablets, USP 50 mg 100 Tablets 50mg-100scount-container-label Front Panel Strides Pharma Inc Rx Only NDC 64380-736-06 HydrALAZINE Hydrochloride Tablets, USP 100 mg 100 Tablets 100mg-100s-count-container-label Front Panel Strides Pharma Inc Rx Only NDC 64380-734-08 HydrALAZINE Hydrochloride Tablets, USP 25 mg 1000 Tablets 25mg-1000s-count-container-label Front Panel Strides Pharma Inc Rx Only NDC 64380-735-08 HydrALAZINE Hydrochloride Tablets, USP 50 mg 1000 Tablets 50mg-1000s-count-container-label 10mg-10s 10 mg-1000s 25mg-100scount-container-label 50mg-100scount-container-label 100mg-100s-count-container-label 25mg-1000s-count-container-label 50mg-1000s-count-container-label
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 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. 25 mg, 50 mg or 100 mg tablets also contain Anhydrous Lactose, Microcrystalline Cellulose, Sodium Starch Glycolate, Stearic Acid and Sunset Yellow Lake and 10 mg tablets contain Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Sodium Starch Glycolate, and Sunset Yellow Lake. 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, USP. In a few resistant patients, up to 300 mg of hydrALAZINE hydrochloride tablets, USP daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE hydrochloride tablets, USP 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. Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com
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