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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, as 2 separate 100 mg doses (1 tab in the morning & 1 tab in the evening). Hepatic impairment Initial daily dose of 100 mg may be used.
Administration
Should be taken with food: Take preferably w/ or after meals. Swallow whole w/ sufficient quantity of liqd.
Contraindications
Hypersensitivity. Patients who have previously shown hypersensitivity reactions (eg, asthma, rhinitis, angioedema or urticaria) to ibuprofen, aspirin, or other NSAIDs. Active or history of recurrent peptic ulcer/haemorrhage (≥2 distinct episodes of proven ulceration or bleeding); history of GI bleeding or perforation, related to previous NSAIDs therapy; active bleeding or bleeding disorders. Patients w/ established CHF (NYHA II-IV), ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Hepatic & renal failure. Not to be prescribed during pregnancy, especially during last trimester.
Special Precautions
Allergic reactions, including anaphylactic/anaphylactoid reactions. Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; if abnormal LFTs persist or worsen, clinical signs or symptoms consistent w/ liver disease develop or other manifestations occur. W/draw treatment if GI bleeding or ulceration occurs. Avoid use in case of varicella infection. May trigger an attack in patients w/ hepatic porphyria. May increase risk of aseptic meningitis in patients w/ SLE & mixed connective tissue disorders. May reversibly inhibit platelet aggregation. Patients suffering from or w/ previous history of bronchial asthma; CHF (NYHA I) & w/ significant risk factors for CV events eg, HTN, hyperlipidaemia, DM, smoking; history of cerebrovascular bleeding. Monitor renal function in patients at greatest risk of prostaglandin formation & precipitation of renal failure eg, those w/ renal & cardiac impairment, liver dysfunction, those taking diuretics & the elderly. Closely surveil patients w/ symptoms indicative of GI disorders, w/ history suggestive of GI ulceration, w/ ulcerative colitis or w/ Crohn's disease, bleeding diathesis or haematological abnormalities. Monitor renal & hepatic function & blood counts during long-term treatment. Avoid concomitant use w/ NSAIDs including COX-2 selective inhibitors. Concomitant use w/ medications which could increase risk of ulceration or bleeding eg, oral corticosteroids, anticoagulants (eg, warfarin), SSRIs or antiplatelets (eg, aspirin). Do not drive or operate machinery if dizziness, drowsiness, fatigue & visual disturbances occur. Mild to moderate renal & hepatic impairment. May impair female fertility & is not recommended in women attempting to conceive. Not to be given during 1st & 2nd trimesters of pregnancy. Avoid use during lactation. Not recommended in childn. Elderly.
Adverse Reactions
Dizziness; dyspepsia, abdominal pain, nausea, diarrhea; increased hepatic enzyme.
Drug Interactions
May increase risk of adverse effects including GI bleeding w/ other analgesics including COX-2 selective inhibitors & aspirin. May reduce effect of antihypertensives. May inhibit activity of diuretics. Risk of nephrotoxicity can be increased w/ diuretics. May exacerbate cardiac failure, reduce GFR & inhibit renal clearance resulting in increased plasma levels of cardiac glycosides eg, digoxin. Inhibited renal clearance resulting in increased serum conc of lithium. May increase plasma levels resulting in increased toxicity of MTX. Reduced effect of mifepristone. Increased risk of GI ulceration or bleeding w/ corticosteroids. May enhance effects of anticoagulants eg, warfarin. May increase risk of developing convulsions w/ quinolones. Increased risk of GI bleeding w/ antiplatelets & SSRIs. Increased risk of nephrotoxicity w/ ciclosporin or tacrolimus. Increased risk of haematological toxicity w/ zidovudine. Hypo- & hyperglycaemic effects w/ antidiabetics.
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 (P1,150/box)
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