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Indomethacin 75 MG Extended Release Oral Capsule

INDICATIONS & USAGE Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Indomethacin extended-release capsules have been found effective in active stages of the following: 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). Indomethacin extended-release capsules, USP are not recommended for the treatment of acute gouty arthritis. Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects. The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See PRECAUTIONS,Drug Interactions ).

camber pharmaceuticals, inc.


4 years ago CAPSULE YELLOW H 105 Indomethacin 75 MG Extended Release Oral Capsule

CAPSULE YELLOW H 105

HOW SUPPLIED

INDOMETHACIN Extended-release capsules USP 75 mg are size '2’ hard gelatin capsules, with dark yellow cap imprinted with 'H' and clear transparent body imprinted with '105' containing cream spherical pellets. They are supplied as Bottles of 30 capsules NDC 31722-565-30 Bottles of 60 capsules NDC 31722-565-60 Bottles of 100 capsules NDC 31722-565-01 Bottles of 500 capsules NDC 31722-565-05 Bottles of 1000 capsules NDC 31722-565-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: HETEROTM Hetero Labs Limited Jeedimetla, Hyderabad – 500 055, India. Revised: August 2015 IndomethacinERaddress1


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