M & H Manufacturing


B L H Trading
B L Hua
Concise Prescribing Info
Acute or long-term treatment of OA, RA, ankylosing spondylitis, juvenile RA, periarticular diseases eg, acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) & tenosynovitis, acute gouty arthritis, lumbago.
Dosage/Direction for Use
400 mg/day; administer once daily or bid. May be lowered depending on response. Max: 400 mg/day. Acute gouty arthritis 7 days therapy. Juvenile RA Childn ≥2 yr 4.5 mg/kg/day in 2 divided doses, may be increased to 6 mg/kg/day in 2 divided doses. Max dose: 6 mg/kg/day.
Should be taken with food.
Hypersensitivity. Patients w/ acute asthmatic attacks, urticaria or rhinitis precipitated by aspirin or other NSAIDs; active GI bleeding.
Special Precautions
Platelet aggregation. History of GI hemorrhage or ulcers. Discontinue if hypersensitivity occurs. May mask signs/symptoms of infection. Patients w/ existing infection. Unexplained fever & other evidence of liver hypersensitivity, discontinue therapy. Perform ophthalmological evaluations in patients who develop eye complaints. Patients w/ compromised cardiac function, HTN or other conditions predisposed to fluid retention. Closely monitor patients w/ poor liver function, delayed, elevated & prolonged circulatory levels of the sulfide & sulfone metabolites. Hepatitis, jaundice w/ or w/o fever may occur w/in the first 3 mth. Determine liver function if patient develops unexplained fever, rash or other dermatologic reactions or constitutional symptoms. Monitor renal function in patients w/ reduced renal reserve; significantly impaired renal function. Patients w/ history of renal lithiasis should be well hydrated during treatment. Pregnancy (3rd trimester) & lactation. Childn <2 yr.
Adverse Reactions
GI pain, dyspepsia, nausea w/ or w/o vomiting, diarrhea, constipation, flatulence, anorexia, GI cramps; rash, pruritus; dizziness, headache, nervousness; tinnitus; edema.
Drug Interactions
Reduced plasma levels of active sulfide metabolite & may potentially reduce efficacy w/ dimethyl sulfoxide. May decrease tubular secretion & potentiate the toxicity of methotrexate. Concomitant use w/ cyclosporine may increase cyclosporine-induced toxicity. Increased GI side effects w/ acetylsalicylic acid. Decreased plasma levels w/ acetylsalicylic acid & diflunisal. Increased possibility of GI toxicity w/ other NSAIDs.
ATC Classification
M01AB02 - sulindac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Clinoril tab 200 mg
10 × 10's
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