Diclotol

Diclotol

aceclofenac

Manufacturer:

Kusum Healthcare

Distributor:

Kusum Healthcare
Concise Prescribing Info
Contents
Aceclofenac
Indications/Uses
Relief of pain & inflammation in OA, RA & ankylosing spondylitis.
Dosage/Direction for Use
Adult 200 mg daily in 2 divided doses (1 tab in the morning & 1 tab in the evening). Hepatic impairment 100 mg.
Administration
Should be taken with food: Take preferably w/ or after meals. Swallow whole w/ sufficient quantity of liqd.
Contraindications
Hypersensitivity. Active or history of recurrent peptic ulcer/hemorrhage (≥2 distinct episodes of proven ulceration or bleeding); history of GI bleeding or perforation, related to NSAID therapy; active bleeding or bleeding disorders. Established CHF (NYHA II-IV), ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Previously shown hypersensitivity reactions (eg, asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other NSAIDs. Hepatic & renal failure. Pregnancy (3rd trimester).
Special Precautions
Avoid concomitant use w/ NSAIDs including COX-2 selective inhibitors. Bronchial asthma; renal function & cardiac impairment, liver dysfunction, those taking diuretics; mild to moderate renal impairment. Discontinue if abnormal liver function tests persist or worsen; mild to moderate hepatic function impairment; prodromal symptoms may occur; hepatic porphyria; history of HTN &/or mild to moderate CHF; CHF (NYHA-I) & patients w/ significant risk factors for CV events (eg, HTN, hyperlipidemia, DM, smoking); history of cerebrovascular bleeding. GI bleeding, ulceration or perforation; patients w/ symptoms indicative of GI disorders, history suggestive of GI ulceration, ulcerative colitis or Crohn's disease, bleeding diathesis or hematological abnormalities; history of ulcer particularly if complicated w/ hemorrhage or perforation; history of GI toxicity; concomitant w/ medications which could increase the risk of ulceration or bleeding eg, oral corticosteroids, anticoagulants (warfarin), SSRIs or antiplatelet agents (aspirin). SLE, mixed connective tissue disorders. Serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Discontinue at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Avoid use in case of varicella. Allergic reactions including anaphylactic/anaphylactoid reactions. May reversibly inhibit platelet aggregation. Monitor precautionary measure eg, renal, hepatic function & blood counts on long-term treatment. May impair ability to drive or operate machinery. Women attempting to conceive, 1st & 2nd trimester pregnancy, lactation. Childn <18 yr. Elderly.
Adverse Reactions
Dizziness; dyspepsia, abdominal pain, nausea, diarrhea; increased hepatic enzyme.
Drug Interactions
Increased risk of other adverse effects including GI bleeding w/ other analgesics including COX-2 selective inhibitors. May reduce the effect of antihypertensives (eg, ACE inhibitors). May inhibit the activity of diuretics. May exacerbate cardiac failure, reduce GFR & increase plasma levels w/ cardiac glycosides (eg, digoxin). Increased serum conc of lithium. Increased toxicity of methotrexate. Reduced effect of mifepristone effects. Increased risk of GI ulceration or bleeding w/ corticosteroids. Increased risk of developing convulsions w/ quinolones. May enhance the effects of anticoagulants eg, warfarin. Increased risk of GI bleeding w/ antiplatelet & SSRIs. Increased risk of nephrotoxicity w/ ciclosporin & tacrolimus. Increased risk of hematological toxicity w/ zidovudine. Hypo- & hyperglycaemic effects w/ antidiabetic agents.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB16 - aceclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Diclotol FC tab 100 mg
Packing/Price
50's
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