Indications

Felbo is indicated for the relief of symptoms associated with painful inflammatory conditions of the musculo-skeletal system. Soft tissue traumas include sprains, strains and contusions. Extra-articular rheumatic or inflammatory conditions include bursitis, capsulitis, frozen shoulder, myalgia, tendonitis, tenosynovitis and tennis elbow. It is also used for the relief of pain and stiffness of rheumatic or non-serious arthritic conditions such as common arthritis. Always use medicine according to the advice of a registered physician.

Pharmacology

The primary mechanism of action of Felbinac revolves around its ability to inhibit the cyclooxygenase enzymes, specifically COX-1 and COX-2. These enzymes play a pivotal role in the biosynthesis of prostaglandins, which are lipid compounds that have several crucial functions in the body, including mediating inflammation, pain, and fever. By inhib iting COX enzymes, Felbinac effectively reduces the production of prostaglandins. This reduction attenuates the inflammatory response and provides re lief from pa in.

Dosage and Administration

Rub 1 gm gel lightly into the affected area 2 to 4 times a day. If symptoms do not resolve, the patient should be reviewed to assess whether continued treatment is appropriate. The total dose should not exceed 25 g a day, regardless of the number of affected areas. Treatment should not be extended beyond 6 w eeks. Elderly patients require no special dosage recommendations, however, NSAIDs should be used with particular caution as they are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. Paediatric population information regarding safety and efficacy in children is insufficient, and it is not recommended for children under 18 years. Method of administration is topical to the affected area, and hands should be washed following application unless they are the treatment sites. Always use medicine according to the advice of a registered physician.

Interaction

Felbo is highly protein bound, however serum levels following topical application are extremely low, therefore clinical drug interactions are unlikely.

Contraindications

Contraindications include hypersensitivity to the active substance or to any of the excipients. Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents should avoid it. Do not use on broken skin or denuded skin, with occlusive dressings, simultaneously to the same site with any other topical preparations, or in the presence of local infection. It is also contraindicated in patients with active peptic ulceration, and during pregnancy and breast feeding.

Pregnancy and Lactation

Felbinac is suspected to cause serious birth defects when administered during pregnancy and is contraindicated in pregnancy. As with other non-steroidal anti-inflammatory agents which inhibit prostaglandin synthesis, dystocia and delayed parturition were observed when felbinac was administered subcutaneously in animal studies. Traxam 3% w/w Gel should not be used during breast-feedin g and is contraindicated during breastfeeding.

Precautions and Warnings

Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration. Concomitant long term use of NSAIDs should undergo regular medical supervision to monitor for adverse events. Avoid contact with eyes and mucus membranes. The total dose of product should not exceed 25g daily. If there is no improvement or the condition is aggravated, consult a doctor. Use with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulceration, inflammatory bowel disease or bleeding diathesis. Prolonged use in the elderly is not recommended. Use with caution in patients with intracranial haemorrhage and bleeding diathesis. Only use on non-diseased skin. Advise patients against excessive exposure to sunlight on treated areas to avoid photosensitivity. This medicine contains 300 mg of alcohol in each 1 g and may cause burning sensation on damaged skin.

Therapeutic Class

Topical anti-inflammatory preparations

Storage Conditions

Keep below 30 degrees Celsius temperature, away from light and moisture. Keep out of the reach of children.