A-Fenac 25 mg Tab

A-Fenac 25

DESCRIPTION

A-FENAC (Diclofenac Sodium) is a potent nonsteroidal, anti-inflammatory agentwith analgesic and antipyretic properties. By virtue of its analgesic, antipyreticand anti-inflammatory properties together with its excellent tolerability marks amajor advance in the treatment of rheumatic and or inflammatory conditions.Diclofenac inhibits cyclooxygenase activity with a reduction in the tissueproduction of prostaglandins.

Tablet A-FENAC is enteric-coated (acid-resistant coating) with the result that the active constituent is not released until it has passed through the stomach. A-FENAC SR tablet has got many advantages. Because the frequency of drug administration is reduced, patient compliance can be improved and drug administration be made more convenient as well.

COMPOSITION

Tablet : Each enteric coated A-FENAC 25 tablet contains Diclofenac Sodium BP 25 mg.

Each enteric coated A-FENAC 50 tablet contains Diclofenac Sodium BP 50 mg.

Tablet SR : Each A-FENAC SR (sustained release) tablet contains Diclofenac Sodium BP 100 mg.

Injection : Each 3 ml ampoule of A-FENAC injection contains 75 mg Diclofenac Sodium BP.

Suppository : A-Fenac 12.5 : Each suppository contains declofenac sodium BP 12.5 mg.

A-Fenac 50 : Each suppository contains diclofenac sodium BP 50 mg.

A-FENAC Gel : Each 100 g A-FENAC Gel contains Diclofenac Diethylamine BP1.16 g equivalent to Diclofenac Sodium 1 g.

INDICATIONS

A-FENAC is indicated in the following cases : Rheumatoid arthritis, osteoarthritis, low back pain, injuries and manifestations of soft tissue rheumatism, ankylosing spondylitis, acute gout, control of pain & inflammation in orthopaedic, dental & other minor surgery, juvenile rheumatoid arthritis, postoperative pain, renal colic & other musculoskeletal disorders.

DOSAGE & ADMINISTRATION

Usual dosing information : Tablet A-FENAC should be taken with water during or immediately after meals. Antacid should not be taken within 1-2 hours after

taking tablet A-FENAC.

Usual adult dose :

A-FENAC Tablet : In adults, the initial dose is 25-50 mg three times a day, depending on the severity of the condition.

A-FENAC SR Tablet : 75-150 mg once daily.

Injection : For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Suppository :

Adult : 75-150 mg daily in divided doses.

Children (1-12 years) : 1-3 mg/kg daily in divided doses

Gel :

Adult (>12 years) : A small amount (2-4 g) of A-FENAC Gel should be applied 3- 4 times daily to the affected area and rubbed lightly. Treatment is dependent on the size of the affected area. A-FENAC Gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

OR AS DIRECTED BY THE PHYSICIAN.

CONTRAINDICATION

A-FENAC is contraindicated in peptic ulcer, previous sensitivity to Diclofenac  Sodium and in asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by Aspirin or other nonsteroidal anti-inflammatory agents with prostaglandin synthesis inhibiting activity.

SIDE EFFECTS

Occasional gastrointestinal disorders, headache, dizziness or vertigo, rash, elevation of SGOT/SGPT, rare peptic ulcer, gastro-intestinal bleeding, hepatitis, hypersensitivity reactions. In isolated cases, disturbances of sensation, erythema multiforme, purpura, abnormalities of renal function, blood dyscrasias may occur.

 PRECAUTIONS

Precaution should be taken in patients with symptoms/history of gastro-intestinal disease, impaired hepatic, cardiac or renal function, pregnancy, porphyria and patients who are taking diuretics, anticoagulant, or antidiabetics. During prolonged treatment, periodical monitoring of liver function should be carried out and blood counts are recommended. Possibility of hypersensitivity reactions to sodium disulphite particularly in patients with asthma.

SUPPLY

Tablet :

A-FENAC 25 : Each box contains 10x10 enteric coated tablets in blisters.

A-FENAC 50 : Each box contains 10x10 enteric coated tablets in blisters.

A-FENAC SR : Each box contains 10x10 tablets in blisters.

Injection :

A-FENAC : Each box contains 2x5 ampoules in blisters.

Suppository :

A-FENAC 12.5 : Each box contains 2x5 suppositories in blisters.

A-FENAC 50 : Each box contains 2 x 5 suppositories in blisters.

Gel :

A-FENAC : Each tube contains 10 g gel.