Acemetacin

Should be taken with food. Take w/ or immediately after meals.

Hypersensitivity to acemetacin or indometacin, previous hypersensitivity reactions (e.g. asthma, urticaria) to aspirin or other NSAIDs (e.g. ibuprofen). Severe heart failure, haematologic disorder of uncertain aetiology, history of gastrointestinal bleeding or perforation related to previous NSAID use, nasal polyps associated with angioneurotic oedema, existing or history of recurrent (≥2 episodes) peptic ulcer or haemorrhage. Severe renal and hepatic impairment. Children and adolescents. Pregnancy (3rd trimester).

Patient with existing or history of bronchial asthma; rhinitis, swollen nasal mucosae, chronic respiratory disease, uncontrolled hypertension, oedema, CHF, established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, risk factors for CV disease (e.g. hyperlipidaemia, diabetes mellitus, smoking), increased haemorrhagic tendency, history of gastrointestinal ulcers, ulcerative colitis, Crohn's disease, SLE, mixed connective tissue disorders, hypovolaemia, dehydration, epilepsy, Parkinson's disease or parkinsonism, inducible porphyria, psychiatric disorders, varicella zoster viral infection (e.g. chickenpox, herpes zoster). Patient undergoing surgeries. Avoid concomitant use with other NSAIDs. Consider discontinuation in females who have difficulties conceiving or those undergoing infertility investigation. Extended release cap is not recommended for initial relief of acute pain. Mild to moderate renal and hepatic impairment. Elderly or debilitated patient. Pregnancy (1st-2nd trimester) and lactation. Concomitant use with oral corticosteroids, anticoagulants, SSRI, antiplatelet agents. Patient Counselling This drug may cause drowsiness, dizziness, or blurred vision, if affected, do not drive or operate machinery. Monitoring Parameters Monitor blood pressure; CBC with differential (during prolonged use); renal function (BUN, serum creatinine, urine output), liver function. Observe for gastrointestinal effects (e.g. abdominal pain, bleeding, dyspepsia) and bleeding. Perform ophthalmologic exams periodically during prolonged use.

Significant: Hypersensitivity or anaphylactoid reactions, bronchospasm (in patients with bronchial asthma), renal papillary necrosis (prolonged use), decreased prostaglandin synthesis (dose-related), Na and fluid retention, oedema, decreased platelet aggregation and adhesion, prolonged bleeding time, anaemia, elevated transaminases, may mask signs and symptoms of infection, vision disturbances (e.g. retinal changes, corneal opacification), impaired female fertility; aggravation of psychiatric disorders, epilepsy or parkinsonism; CNS effects (e.g. drowsiness, dizziness). Rarely, severe blood dyscrasias (e.g. agranulocytosis, aplastic anaemia, leucopenia, thrombocytopenia), severe hepatic reactions (e.g. fulminant hepatitis, hepatic failure, hepatic necrosis). Cardiac disorders: Cardiac failure. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain or cramps, dyspepsia, flatulence. General disorders and administration site conditions: Malaise, fatigue. Metabolism and nutrition disorders: Loss of appetite. Nervous system disorders: Headache. Psychiatric disorders: Agitation. Skin and subcutaneous tissue disorders: Urticaria, alopecia. Vascular disorders: Hypertension.
Potentially Fatal: Gastrointestinal bleeding, ulceration or perforation, CV thrombotic events (e.g. MI, stroke). Rarely, serious skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis).

May increase the risk of adverse effects with other NSAIDs. Increased risk of ulceration or bleeding with oral corticosteroids, anticoagulants (e.g. warfarin), SSRI, or antiplatelet drugs (e.g. aspirin). May diminish the effect of diuretics (e.g. loop), hypertensive agents (e.g. ACE inhibitors), and mifepristone (avoid acemetacin for 8-12 days after mifepristone use). Increased excretion with furosemide. Plasma levels of cardiac glycosides (e.g. digoxin) may be increased when used concomitantly with acemetacin. Reduced elimination of phenytoin, lithium, and methotrexate. May delay penicillin elimination. Increased risk of nephrotoxicity with ciclosporin or tacrolimus. Risk of haematological toxicity is increased when used concomitantly with zidovudine. Reduced elimination with probenecid or sulfinpyrazone. Enhanced drowsiness with haloperidol. May reduce resorption rate with antacids.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AB11 - acemetacin ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.