CloudRx - Felbinac – Generic Drug Info

Indications

Felbinac is indicated for the relief of symptoms associated with painful inflammatory conditions of the musculo-skeletal system such as:

Soft tissue traumas (sprains, strains and contusions).
Extra-articular rheumatic or inflammatory conditions including bursitis, capsulitis, frozen shoulder, myalgia, tendonitis, tenosynovitis and tennis elbow.
For the relief of pain and stiffness of rheumatic or non-serious arthritic conditions (i.e. common arthritis).

Pharmacology

The primary mechanism of action of Felbinac revolves around its ability to inhibit the cyclooxygenase (COX) 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 inhibiting COX enzymes, Felbinac effectively reduces the production of prostaglandins. This reduction attenuates the inflammatory response and provides relief from pain.

Dosage & Administration

Important:
Do not take any medication without a doctor's prescription. Self-medication can be dangerous.

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 weeks.

Elderly: No special dosage recommendations are made for elderly patients, however, NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed.

Paediatric population: There is insufficient information regarding the safety and efficacy of this medicine in children. It is not recommended for children under 18 yrs.

Method of administration: Topical to affected area: Hands should be washed following application of Felbinac 3% Gel, unless they are the treatment sites.

Interaction

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

Contraindications

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.
Use on broken skin or denuded skin.
Use with occlusive dressings.
Use simultaneously to the same site with any other topical preparations.
Use in the presence of local infection.
Use in patients with active peptic ulceration.
Pregnancy and breast feeding.

Pregnancy & Lactation

Felbinac is suspected to cause serious birth defects when administered during pregnancy. Traxam 3% w/w Gel 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-feeding. Traxam 3% w/w Gel is contraindicated during breastfeeding.

Precautions & Warnings

Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration. Concomitant long term use of NSAIDs long term, should undergo regular medical supervision to monitor for adverse events. Avoid contact with eyes and mucus membrane.
The total dose of product should not exceed 25g daily.
If there is no improvement or the condition is aggravated, the doctor should be consulted. Although the systemic effects should be low, the drug should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulceration, inflammatory bowel disease or bleeding diathesis.
Elderly patients are particularly susceptible to the adverse effects of NSAIDs. Prolonged use of NSAIDs in the elderly is not recommended. Where prolonged therapy is required, patients should be reviewed regularly.
As NSAIDs can interfere with platelet function, they should be used with caution in patients with intracranial haemorrhage and
bleeding diathesis. It should only be used on non-diseased skin.
To avoid the possibility of photosensitivity, patients should be advised against excessive exposure to sunlight of treated areas.
This medicine contains 300 mg of alcohol (ethanol) in each 1 g. which is equivalent to 300 mg/g (30%w/w). It may cause burning sensation on damaged skin.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Felbinac