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profiting from Clanza CR Generic Name: aceclofenac Dosage Form: tablet, film coated DESCRIPTION White, oblong, film-coated tablet, engraved with "UT" on one side and "CL CR" on the other side. INDICATIONS Clanza CR is indicated for Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism. Dosage and Administration Adults: The recommended dose is 200 mg daily, taken as one dose (every 24 hours). However, the dose and dose frequency of Clanza CR can be modified under the supervison of physician or pharmacist. CONTRAINDICATIONS Patients with allergy to these drugs or other analogues (diclofenac). Patients with asthma. Like NSAIDS, acetylsalicylic acid and other drugs which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria. Patients with active peptic ulcer. CAUTIONS Patients with symptoms indicative of gastro-intestinal disorders, with a history of gastroulceration. Patients with severe hepatic impairment or cardiac or renal impairment. Patients under the medication of diuretics. Patients in recovery after surgical treatment. ADVERSE REACTIONS The majority of side effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness. To report suspected adverse reactions, call 1-800-FDA-1088. GENERAL PRECAUTIONS Patients suffering from dizziness, vertigo, or other central nervous system disorders while taking NSAIDS should refrain from driving or handling dangerous machinery. DRUG INTERACTIONS There has been no drug interactions reported, but close monitoring of patients on combination with lithium and digoxin, oral antidiabetic agents, anticoagulants, diuretics, and other analgesics. USE IN PREGNANCY AND NURSING MOTHERS Since there is no information on the safe use of Clanza CR during pregnancy and lactation, the use of Clanza CR should therefore be avoided in pregnancy and lactation. USE IN CHILDREN The dosage and indication is not established yet for children with less than 6 years old. OVERDOSAGE There are no human data available on the consequences of Clanza CR overdosage. If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as hypotension, gastro-intestinal irritation, respiratory depression, and convulsions. STORAGE Preserve in tight containers. Store at room temperature not exceeding 30 o C. SHELF LIFE Three (3) years from manufacturing date. Do not exceed the expiry date for use printed on the box . PACKAGE 10 Blister Packs with 10 Tablets in each Blister Pack Enter section text here label test CLANZA CR aceclofenac tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65697-450 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aceclofenac (Aceclofenac) Aceclofenac 200 mg Inactive Ingredients Ingredient Name Strength Lactose Monohydrate Cellulose, Microcrystalline Sodium Carbonate Colloidal Silicon Dioxide Crospovidone Poloxamer 407 Magnesium Stearate Alcohol Hypromellose 2208 (15000 MPA.S) Carbomer 941 Hypromellose 2910 (6 MPA.S) Alcohol Methylene Chloride Hypromellose 2910 (5 MPA.S) Titanium Dioxide Ethylcelluloses Diethyl Phthalate Product Characteristics Color white Score no score Shape OVAL (Film-coated white oblong tablet) Size 15mm Flavor Imprint Code UT;CR;CT Contains Packaging # Item Code Package Description 1 NDC:65697-450-20 1 TABLET, FILM COATED (TABLET) in 1 PACKET 2 NDC:65697-450-22 10 BLISTER PACK (BLISTER PACK) in 1 CARTON 2 NDC:65697-450-21 10 TABLET, FILM COATED (PACKET) in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 05/12/2011 Labeler - United Douglas Pharm., Inc. (001444350) Registrant - United Douglas Pharm., Inc. (001444350) Establishment Name Address ID/FEI Operations United Douglas Pharm., Inc. 001444350 pack, label Establishment Name Address ID/FEI Operations Korea United Pharm Inc. 688016534 manufacture Revised: 11/2011 United Douglas Pharm., Inc. Print this page FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More weak point


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