A-Fenac K Tablet

Short-term treatment in the following acute conditions:

• Post-traumatic pain, inflammation and swelling,e.g.due to sprains
• Post-operative pain, inflammation and swelling,e.g.following dental or orthopaedic surgery
• Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis
• Migraine attacks
• Painful syndromes of the vertebral column
• Non-articular rheumatism
• As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis, otitis.

The mechanism of action of Diclofenac Potassium, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Adults: Following an initial loading dose of 50 mg, 25-50 mg is to be taken every eight hours if necessary.

Migraine: An initial loading dose of 50 mg, then if necessary a further 25-50 mg after 2 hours. The maximum daily dose is 150 mg. The tablets should be swallowed whole with liquid, preferably before meals.

Children: Children over 14 years of age: upto 75 mg daily in divided doses.

Diclofenac may have the following drug interactions:

• Lithium and Digoxin: Diclofenac may increase plasma concentrations of Lithium and Digoxin.
• Anticoagulant:There are isolated reports of and increased risk of haemorrhage with the combined use of Diclofenac and anticoagulant therapy.
• Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving Cyclosporin and Diclofenac concomitantly.
• Methotrexate: Cases of serious toxicity have been reported when Methotrexate and NSAIDs are given within 24 hours of each other.
• Diuretics: Like other NSAIDs, Diclofenac may inhibit the activity of diuretics.
• Other NSAIDs and steroids; Co-administration of Diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects.

Diclofenac Potassium tablets are contraindicated in patients with known hypersensitivity to Diclofenac. Diclofenac should not be given to patients who have experienced asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Side-effects of Diclofenac are usually mild and transient. However, if serious side-effects occur. Diclofenac should be discontinued. Occasional: epigastric pain, other gastro-intestinal disorders (e.g., nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia,flatulence,anorexia). Rare: gastro-intestinal bleeding, peptic ulcer (with or without bleeding or perforation), bloody diarrhoea.

Diclofenac should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. This type of drugs are not recommended during the last trimester of pregnancy. Very small quantities of diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

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