allopurinol tablet
INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ). Allopurinol tablets are indicated in: 1. the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). 2. the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present. 3. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
arise pharamaceuticals llc
ROUND ORANGE I 136
I 136 ROUND ORANGE
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HOW SUPPLIED 100-mg (white to off white) scored, flat cylindrical tablets with "I" and "135" on either side of the break line on one side and plain on other side, bottles of 100 (NDC 69967-008-01), 500 (NDC 69967-008-02) and 1000 (NDC 69967-008-03). Store at 20° to 25°C (USP Controlled Room Temperature) (68° to 77°F) in a dry place. 300-mg (peach) scored, flat, cylindrical tablet with "I" and "136" on either side of the break line on one side and plain on other side, bottles of 100 (NDC 69967-009-01), 500 (NDC 69967-009-02)and 1000 (NDC 69967-009-03) . Store at 20° to 25°C (USP Controlled Room Temperature) (68° to 77°F) in a dry place and protect from light. Manufactured for: Arise Pharmaceuticals LLC 12 Roszel Road, Unit B202, Princeton, NJ 08543 Customer complaint toll free number: +1-855-642-2594 Manufactured by: Indoco Remedies Ltd. L-32, 33, 34, Verna Industrial Area, Verna Goa. 403 722, India. March 2020 PURINETHOL® (mercaptopurine) is registered Trademark of Teva Biologics and Specialty Products. IMURAN® (azathioprine) is registered Trademark of Prometheus Laboratories Inc.
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