ADCO-INDOMETHACIN 25 mg
(and dosage form):
ADCO-INDOMETHACIN 25 mg
Each capsule contains indomethacin 25 mg
A.3.1 Antirheumatics (Anti-inflammatory Agents)
Indomethacin is a non-steroidal anti-inflammatory drug with anti-inflammatory and analgesic properties which are mediated through its mode of action as an inhibitor of prostaglandin synthesis.
Indomethacin is indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis, osteo-arthritis, other rheumatic disorders and acute attacks of gout.
Indomethacin is contra-indicated in persons hypersensitive to it or to aspirin, in nursing mothers, persons operating machinery, or patients with psychiatric disorders, epilepsy or Parkinsonism. It is also contra-indicated in persons with renal disease or ulcerative lesions of the stomach or intestines.
Indomethacin is also contra-indicated in patients with bleeding disorders, active peptic ulcers, gastritis, regional enteritis and ulcerative colitis, as well as in pregnant women and in children.
Serious interactions have been reported after the use of high dose methotrexate with indomethacin.
DOSAGE AND DIRECTIONS FOR USE:
The recommended dosage is 25 mg to 200 mg daily in divided doses, given with food. Adverse reactions may be reduced by initiating therapy with low doses and gradually increasing them when necessary according to the patients response and requirements.
Gastro-intestinal disturbances may be reduced by administering indomethacin with food, milk or an antacid although the bioavailability of the drug may be reduced with antacids containing aluminium hydroxide, magnesium carbonate and magnesium hydroxide.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effects with indomethacin are gastro-intestinal disturbances, headache and dizziness. Gastro-intestinal ulceration and bleeding may occur. Other adverse effects may be depression, drowsiness, tinnitus, confusion, light-headedness, insomnia, psychiatric disturbances, syncope, convulsions, coma, peripheral neuropathy, blurred vision and other ocular effects, oedema and weight gain, hypertension, haematuria, skin rashes, pruritus, urticaria, stomatitis, alopecia and hypersensitivity reactions. Prolonged therapy will require regular ophthalmological examinations. Renal failure may occur.
Leucopenia, purpura, thrombocytopenia, aplastic anaemia, haemolytic anaemia, agranulocytosis, epistaxis, hyperglycaemia, hyperkalaemia and vaginal bleeding have been reported. Hypersensitivity reactions may also occur in aspirin-sensitive patients, which may be manifested in states of respiratory distress, dyspnoea and asthma and in skin rashes. Jaundice and hepatitis have been reported in conjunction with the use of indomethacin. Elderly patients may be especially susceptible to the toxic effects of indomethacin. Indomethacin is excreted in the breast milk of breast- feeding mothers. Acute renal failure may result after concomitant use of triamterene.
Concurrent administration of oral anticoagulant agents leads to increased risk of gastro-intestinal bleeding. Indomethacin antagonises the natriuretic and antihypertensive effects of furosemide. The total plasma concentration of indomethacin plus its inactive metabolites is increased by concurrent administration of probenecid.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is supportive and symptomatic.
Opaque, yellow, hard gelatin capsules containing a white powder.
ADCO-INDOMETHACIN 25 mg capsules are supplied in bottles and securitainers of 100 and 500 capsules.
Store in a dry place, below 25°C. Protect from light. Keep out of reach of children.
ADCO-INDOMETHACIN 25 mg: U/3.1/177
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New addition to this site: April 2004
Source: Pharmaceutical Industry
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