A-Fenac Plus (75 mg+20 mg)/2 ml IM Injection

A-Fenac Plus (75 mg+20 mg)/2 ml IM Injection

DESCRIPTION

A-FENAC Plus injection contains Diclofenac Sodium and Lidocaine Hydrochloride. Diclofenac is a potent non-steroidal anti-inflammatory drug (NSAID) with marked analgesic and antipyretic properties. The actions of Diclofenac appear to be associated principally with the inhibition of prostaglandin synthesis. Diclofenac may inhibit the synthesis of prostaglandins by inhibiting cyclo-oxygenase, an enzyme that catalyses the formation of prostaglandin precursors (endoperoxides) from arachidonic acid. Peak plasma concentration of Diclofenac is achieved within half an hour following injection. Diclofenac is 99.7% plasma protein bound. Lidocaine is the most widely used local anaesthetic drug. It acts more rapidly and is more stable than most other local anaesthetics. It is a very useful surface anaesthetic. Like other local anaesthetics, Lidocaine impairs the generation and conduction of the nerve impulses by slowing depolarisation. The onset of anaesthesia of Lidocaine HCl is more rapid and the duration is 1-2 hours. Binding of Lidocaine to plasma proteins is variable and concentration dependent.

COMPOSITION

Injection : Each 2 ml ampoule contains Diclofenac Sodium BP 75 mg and Lidocaine Hydrochloride USP 20 mg.

INDICATIONS

A-FENAC Plus injection contains Diclofenac Sodium, which has

got the following therapeutic uses :

• Ankylosing spondylitis

• Acute gout

• Acute trauma and fractures

• Control of pain and inflammation in orthopaedic, dental and

other minor surgery

• Juvenile chronic arthritis

• Postoperative pain

• Pain of renal colic

A-FENAC Plus injection also contains Lidocaine, which acts as a local anaesthetic. Therefore, the possibility of pain at the injection site, which is most likely to occur after intramuscular injection, is minimised if A-FENAC Plus injection is used in the above indications.

DOSAGE AND ADMINISTRATION

Adults : One ampoule once (or in severe cases, twice) daily intramuscularly. Renal colic : One ampoule once daily intramuscularly. A further ampoule may be administered after 30 minutes, if necessary.

Children : In juvenile chronic arthritis, 1-3 mg of Diclofenac/kg body wt. daily in divided doses. A-FENAC Plus injection should be injected intramuscularly only. OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

Side effects to Diclofenac and Lidocaine injection are usually mild and transient. However, if serious side effects occur, the injection should be discontinued. Gastrointestinal discomfort, nausea, diarrhoea and occasionally bleeding may occur. In very rare instances, injection site disorders may occur. In isolated cases, abscesses and local necrosis may occur. The adverse effects due to Lidocaine mainly involve the CNS, are usually of short duration and dose related. The CNS reaction may be manifested by drowsiness, dizziness, disorientation, confusion etc.

CONTRAINDICATIONS

It is contraindicated to the patients who are hypersensitive to Diclofenac. It is contraindicated in active or suspected peptic ulcer or gastrointestinal bleeding. Asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by Aspirin or other nonsteroidal anti-inflammatory agents with possessing prostaglandin synthetase inhibiting activity. It is also contraindicated to the patients who are hypersensitive to local anaesthetics of the amide type, although the incidence is very rare.

PRECAUTIONS

Diclofenac Sodium should be used with caution in patients with symptoms or history of gastrointestinal disease, impaired hepatic, cardiac or renal function. It should also be used with caution in elderly patients. Lidocaine should be used with caution in patients with severe liver disease. In epilepsy, there is a possibility that the convulsion threshold may be lowered by Lidocaine. Patients with impaired cardiac conduction and bradycardia are more sensitive to the cardiac depressant action of the drug.

SUPPLY

Injection : Each box contains 2 x 5 ampoules of 2 ml in blisters.

FOR HEALTH, VIGOUR AND HAPPINESS