Diclofenac Diethylamine, Linseed Oil BP, Methyl Salicylate, Menthol IP, Benzyl Alcohol is a combination of Non-steroidal anti-inflammatory (NSAID) drug having topical use symptomatic relief of mild to moderate pain and inflammation associated various conditions including Trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises as well as localized forms of soft tissue rheumatism.
It contains Diclofenac that inhibits the cyclooxygenase (COX) enzyme, an early component of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacyclin. Methyl salicylate is a salicyclic acid derivative and acts as a rubefacient. Menthol dilates the blood vessels causing a sensation of coldness, followed by an analgesic effect.
It is indicated for symptomatic relief of mild to moderate pain and inflammation associated with:
• Trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises.
• Localized forms of soft tissue rheumatism.
Dose and Method of Administration
It is used for external use only and not to be administered orally. It should not be applied on any mucosa, open wound, cut or diseased skin. Patient should be advised that the site of application is clean and dry before application of gel. Depending on the size of the affected site to be treated 2-4g should be applied 2 times daily. The maximum dose daily is 8g.
Hypersensitivity to the active substances, any of the excipients, acetyl salicylic acid or other non steroidal anti inflammatory drugs (NSAID). Patients with asthma or in patient when attack of asthma, uticaria or acute rhinitis is precipitated by acetylsalicylic acid or other NSAID. Children and adolescents less than 14 years.
During the last trimester of pregnancy, breast feeding mothers, patient who has undergone coronary artery bypass graft surgery in past 2 weeks.
Warning and Precautions
Contact with eyes or mucous membrane should be avoided and should not be ingested. It is not recommended for occlusive dressing. Photosensitivity reactions has been reported with topical use of diclofenac. Patients should be warned against exposure of sunlight after application of Gel. Discontinue if rash appears after application.
The concomitant use with oral NSAIDS should be cautioned as the incidence of undesirable systemic effects may increase. This gel should be used with caution in patients with history of peptic ulcer, hepatic or renal insufficiency, bleeding diathesis or inflammatory bowel disease as isolated incidence of such cases with topical diclofenac have been reported.