Finished product reference

Diclofenac Diethylammonium

Gel · Topical · 1 % · 60 g

List code
426
Pharmacologic class
Topical non-steroidal anti-inflammatory drug (NSAID)

What it is and how it works

Diclofenac inhibits cyclo-oxygenase (COX-1 and COX-2), reducing prostaglandin synthesis in inflamed tissue. The diethylammonium salt in a gel base penetrates the skin to provide local analgesic and anti-inflammatory effects with low systemic exposure.

Indications

Local symptomatic relief of pain and inflammation in soft-tissue injuries such as sprains, strains and contusions, localised forms of soft-tissue rheumatism, and osteoarthritis of superficial joints such as the knees and fingers.

Dosage and administration (summary)

Adults: apply a thin layer to the affected area and rub in gently, usually 3–4 times daily (for 12-hourly formulations, twice daily); duration of self-treatment is generally limited to 1–2 weeks.

Contraindications

Hypersensitivity to diclofenac, or a history of asthma, urticaria or rhinitis precipitated by aspirin or other NSAIDs; the last trimester of pregnancy.

Warnings and precautions

Apply only to intact skin; avoid eyes, mucous membranes and open wounds, and do not use with occlusive dressings. Avoid exposure of treated areas to strong sunlight. Systemic NSAID adverse effects are unlikely but possible with use over large areas or for long periods.

Pregnancy

Avoid in the first two trimesters unless clearly needed, and contraindicated in the third trimester.

Storage and supply

Store below 30 °C.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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