Adco-Indogel 25g

Topical Analgesic for symptomatic relief of acute painful musculo-skeletal conditions caused by trauma such as sports injuries, sprains, strains and contusions.

COMPOSITION

Each one gram of gel contains 10 mg Indomethacin.

PHARMACOLOGICAL CLASSIFICATION

• A 3.1 Antirheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION

Indomethacin has anti-inflammatory and analgesic properties.
When topically applied ADCO-INDOGEL is transcutaneously absorbed and penetrates directly to the affected musculoskeletal tissue.

INDICATIONS

ADCO-INDOGEL is indicated for symptomatic relief of acute, painful musculoskeletal conditions caused by trauma such as sports injuries, sprains, strains and contusions.

CONTRA-INDICATIONS

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.

Special Precautions

• 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.

IDENTIFICATION

Smooth, pale yellow, translucent gel.

PRESENTATION

ADCO-INDOGEL is available in 25 g and 50 g tubes.

STORAGE INSTRUCTIONS:

Store below 25°C in a well-closed containers. Keep out of reach of children.