Acemetacin Stada 60 mg Hard Gelatin Capsules

COMPOSITION

Each hard gelatin capsule contains: Acemetacin 60 mg.

PHARMACEUTICAL FORM

Hard gelatin capsule.

PHARMACOLOGICAL ACTION

Acemetacin is a glycolic acid ester of indomethacin and the pharmacological activity resulting from acemetacin administration in man is derived from the presence of both acemetacin and indomethacin.

The precise pharmacological mode of action of acemetacin is
not known. However, unlike other NSAIDs, acemetacin is only a relatively weak inhibitor of prostaglandin synthetase. Prostaglandins are known to have an antisecretory and cytoprotective effect on the gastric mucosa.

Acemetacin shows activity in many of the established in vitro tests of anti-inflammatory activity, including inhibition of the release of a number of mediators of inflammation.

PHARMACOKINETIC ACTION

Acemetacin is well absorbed after oral administration. Its major metabolite is indomethacin which, after repeated administration, is present at levels higher than of those of acemetacin, Acemetacin is bound to plasma protein to a slightly lesser extent than indomethacin and has a relatively short plasma elimination half-life.

It is eliminated by both hepatic and renal mechanisms. The pharmacokinetics appears to be linear at recommended therapeutic doses, unaffected by moderate renal or hepatic impairment, and unchanged in the elderly.

INDICATIONS

Rheumatoid arthritis, osteoarthritis, low back pain, and post-operative pain and inflammation.

DOSAGE

  • The recommended starting dose is 120 mg/day in divided doses, increasing to 180 mg/day in divided doses, depending on patient response.
  • For the treatment of elderly patients, adjustment of dosage is not normally required. However, non-steroidal anti-inflammatory drugs should be used with particular care in older patients who may be more prone to adverse reactions.
  • Acemetacin Stada should be taken with food, milk or an antacid to reduce the possibility of gastro-intestinal disturbance.

SIDE EFFECTS

The following side effects have been either reported with acemetacin or could possibly occur as they are common to a number of NSAIDs:

Gastro-intestinal: Gastro-intestinal discomfort/pain, anorexia, nausea, vomiting, indigestion, diarrhea and constipation, peptic ulceration, gastrointestinal perforation and hemorrhage.

Central Nervous System: Symptoms most frequently encountered are headache, dizziness, vertigo and insomnia. Rarely,
confusion, depressed mood, irritability.

Hepatic: Occasional elevation of liver function test parameters without overt clinical symptomatology. Very rarely, symptoms of cholestasis.

Cardiovascular/renal: Rarely, edema, chest pain, palpitations, blood urea elevation. NSAIDs have been reported to cause nephrotoxicity in various forms and their use can lead to interstitial nephritis, nephrotic syndrome and renal failure.

Dermatological/hypersensitivity: Pruritus, urticaria, erythema, skin rash, alopecia, and excessive sweating have been reported.

Hematological: Rarely, thrombocytopenia, leucopenia and reduced hemoglobin levels. Very rarely, reversible agranulocytosis, bone marrow depression.

Ocular/auditory: Infrequently, tinnitus, blurred vision and rarely, eye pain.

WARNING & PRECAUTIONS

As rare instances of peptic ulceration have been reported, administration should be closely supervised in patients with a history of upper gastrointestinal disease. Treatment should be discontinued if peptic ulceration or gastrointestinal bleeding occurs.

Inhibition of platelet aggregation may occur.

Aggravation of psychiatric disorders, epilepsy or Parkinsonism may occur.

Signs and symptoms of infection may be masked.

Acemetacin should be used with caution in patients with reduced renal blood flow where renal perfusion may be maintained by prostaglandins. In patients at particular risk renal or hepatic dysfunction, congestive heart failure, electrolyte or fluid imbalance, sepsis, concomitant use of nephrotoxic drugs, the dose should be kept as low as possible and renal function should be monitored.

Patients receiving long-term treatment should be periodically screened for renal and hepatic function and blood counts. Borderline elevation of renal and hepatic function test parameters may occur. If this persists or worsens, treatment should be stopped.

Eye changes may occur in chronic rheumatoid disease and patients should receive periodic ophthalmological examinations and therapy discontinued if changes occur.

Hyperkalemia has been reported with use of indomethacin and this should be considered when administration with potassium sparing diuretics is proposed.

Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. NSAIDs is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

PREGNANCY AND LACTATION

It should not be used in pregnancy or lactation in women of childbearing age unless they are taking adequate contraceptive precautions.

CONTRAINDICATIONS

Active peptic ulcer, history of recurrent ulceration; known hypersensitivity to acemetacin or indomethacin.

Patients who have experienced asthma attacks, urticaria or acute rhinitis resulting from treatment with aspirin or non-steroidal anti-inflammatory drugs.

PACKAGE & STORAGE

  • Carton box contains 1, 2, or 3 strips Alu/P.V.C each of 10 Capsules + inserted leaflet.
  • Store at temperature not exceeding 30° C.
  • Keep All Medicines Out of Reach of Children.

Acemetacin Stada – Information Leaflet

Storage

  • Store at temperature not exceeding 30°C.
  • Keep in dry place, protect from light.
  • Keep out of reach of children.
  • Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
  • Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sales the medicament.
  • The doctor and the pharmacist are experts in medicine. It’s benefits and risks.
  • Do not by yourself interrupt the period of treatment prescribed for you.
  • Do not repeat the same prescription without consulting your doctor.
  • Keep medicament out of children reach.

Council of Arab Health Ministers and Union of Arab Pharmacists

*ATC CODE: M01AB11 


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