(and dosage form):
Each capsule contains 25 mg indomethacin.
A 3.1. Antirheumatics (anti-inflammatory agents)
Indomethacin has analgesic, anti-inflammatory and antipyretic properties and inhibits the biosynthesis of prostaglandins:
This action may be the basis of its anti-inflammatory and anti-pyretic properties (and certain of its other effects). It inhibits motility of polymorphonuclear leucocytes and in supratherapeutic concentrations uncouples oxidative phosphorylation in cartilaginous and hepatic mitochondria.
Indomethacin is used to relieve the painful symptoms of ankylosing spondylitits and osteoarthritis, and to relieve the pain and swelling in gout, rheumatoid arthritis, and acute musculoskeletal disorders.
Indomethacin should not be used in pregnant women, children, or patients with psychiatric disorders, epilepsy, or Parkinsonism. It also contra-indicated in individuals with renal disease or ulcerative lesions of the stomach or intestines.
Contra-indicated in persons hypersensitive to indomethacin, other non-steroidal anti-inflammatory agents, or aspirin, nursing mothers and in patients with bleeding disorders, active peptic ulcer, gastritis, regional enteritis and ulcerative colitis. ACUFLEX may cause dizziness, therefore, patients should be cautioned about engaging in activities requiring mental alertness and motor co-ordination, such as driving a car and operating machinery.
Serious interactions have been reported after the use of high doses of methotrexate with indomethacin. The combined use of indomethacin and diflunisal has been associated with fatal gastro-intestinal haemorrhage. Therefore indomethacin and diflunisal should not be used concomitantly.
DOSAGE AND DIRECTIONS FOR USE:
IT IS RECOMMENDED THAT INDOMETHACIN CAPSULES BE TAKEN WITH FOOD, MILK OR ANTACIDS.
In rheumatic disorders the usual initial dosage is 25 mg twice or thrice daily, increased, if required, up to 150 mg in divided dosis. In acute peri-articular disorders and in low back pain 50 mg may be given twice or thrice daily for about 10 days. In acute gout 50 mg may be given three or four times a day. Total daily dose should not generally exceed 200 mg.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most frequent central nervous system effect is severe frontal headache. Dizziness, vertigo, lightheadedness, and mental confusion are frequent. Severe psychosis, hallucinations, and suicide have been reported. Corneal opacities, visual-field changes, and pallor of the optic disk have also occurred. Anorexia, nausea and vomiting, dyspepsia, and diarrhoea may occur. Peptic ulceration, possibly with gastro-intestinal haemorrhage may also occur and is not always preceded by dyspepsia; there may be oesophageal ulceration.
Other effects include tinnitus, insomnia, syncope, convulsions, coma, peripheral neuropathy, stomatitis, alopecia, leucopenia, purpura, haemolytic anaemia, agranulocytosis, episiasis, hyperglycaemia, hyperkalaemia, vaginal bleeding and renal failure.
Haematopoietic reactions consist of neutropenia, thrombocytopenia, and aplastic anaemia. Other reported toxic effects are oedema, hypertension and angioneurotic oedema. Hypersensitivity reactions are manifested as rashes, itching, urticaria, and more seriously, acute attacks of asthma. Patients allergic to salicylates may exhibit cross-reactions to indomethacin. Elderly patients may be specially susceptible to the toxic effects of indomethacin. Concurrent administration of indomethacin with probenecid increases the risk of gastro-intestinal bleeding; probenecid inhibits the tubular secretion of indomethacin and thereby increases the plasma level and risk of systemic toxicity. Concurrent administration of oral anticoagulant agents leads to increased risk of gastro-intestinal bleeding. In some patients the administration of ACUFLEX may reduce the diuretic, natriuretic and antihypertensive effects of loop, potassium sparing, and thiazide diuretics. A decrease in the anti-hypertensive effects of beta-adrenergic receptor blocking agents by indomethacin has been reported. If ACUFLEX fails to provide benefit in 2 to 3 weeks, alternative therapy must be considered. Prolonged therapy will require regular ophthalmological examination.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Central nervous system symptoms include headache and vertigo. Gastro-intestinal irritation resulting in anorexia, nausea, vomiting, dyspepsia, peptic ulceration often with bleeding and acute pancreatitis may be precipitated. Treatment is symptomatic and supportive.
Opaque-yellow hard gelatin capsules.
100 Capsules, Securitainers or Amber PVC jars.
500 Capsules, Securitainers.
10 000 Capsules, Plastic bag inside plastic bucket.
Store in a dry place below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ACUPHARM (Pty) Ltd.
43 Richards Drive
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
||94H 0894 ACI 029|
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