(and dosage form)
Each one gram of gel contains 10 mg Indomethacin.
A 3.1 Antirheumatics (anti-inflammatory agents).
Indomethacin has anti-inflammatory and analgesic properties.
When topically applied ADCO-INDOGEL is transcutaneously absorbed and penetrates directly to the affected musculoskeletal tissue.
ADCO-INDOGEL is indicated for symptomatic relief of acute, painful musculoskeletal conditions caused by trauma such as sports injuries, sprains, strains and contusions.
Patients with known sensivity to any ingredients in the preparation.
Use in Pregnancy:-
ADCO-INDOGEL is not recommended for use in pregnancy or lactation.
DOSAGE AND DIRECTIONS FOR USE:
Apply gently three or four times a day to the affected area. ADCO-INDOGEL can also be used as adjunctive therapy with other Adco-Indomethacin oral formulations.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Pruritis, redness and rash may occur. Local dryness of the skin has been reported.
Systemic side-effects of indomethacin include the following:-
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 mass gain, hypertension, haematuria, skin rashes, pruritus, urticaria, stomatitis, alopecia and sensitivity 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. Sensitivity reactions may also occur in aspirin-sensitive patients, which may manifest in 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.
Do not use with occlusive dressing;
Do not apply to the eyes, mucosa or broken skin;
Do not ingest.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Treatment is symptomatic and supportive.
Smooth, pale yellow, translucent gel.
ADCO-INDOGEL is available in 25 g and 50 g tubes.
Store below 25°C in a well-closed containers. Keep out of reach of children.
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:
14 November 1995
New addition to this site: April 2004
Source: Pharmaceutical Industry
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