Anodyne Plus - Diclofenac Sodium BP and Lidocaine Hydrochloride USP Injection

Description:
Anodyne® Plus is a potent non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. It also has some uricosuric effect. Diclofenac inhibits cyclooxygenase activity with a reduction in the tissue production of prostaglandins.

Composition:
Anodyne® Plus injection: Each 2 ml ampoule contains Diclofenac Sodium BP 75mg and Lidocaine Hydrochloride USP 20mg.

Indications:
Anodyne® Plus injection contains diclofenac sodium and is indicated in Rheumatoid arthritis, Osteoarthritis, Low back pain and other acute musculoskeletal disorders such as periarthritis (e.g. frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations, ankylosing spondylitis, acute gout, Control of pain and inflammation in orthopaedic, dental and other minor surgery, Juvenile rheumatoid arthritis, postoperative pain, renal colic pain & other uses.

Anodyne® Plus injection also contains lidocaine which is a widely used local anesthetic. Therefore, the possibility pain at the injection site which is most likely to occur after intramuscular injection of normal diclofanac, is minimized if Anodyne® Plus injection is used in the above indications.

Dosage and administration:
Adults : By deep I.M injection into the gluteal muscle, acute exacerbations and post-operative - One ampoule once daily (twice daily in severe cases) for max. of 2 days.
Renal /ureteric colic : One ampoule once daily intramuscularly. A further ampoule may be administered after 30 minutes, if necessary. Maximum daily dose: Diclofenac 150 mg, Lidocaine 200mg.
Children : In Juvenile chronic arthritis: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
Elderly patients : In elderly or debilitated patients, the lowest effective dosage is recommended, commensurate with age and physical status, or as prescribed by the physician.

Contraindications:
o Active peptic ulcer; asthma, aspirin or any non-steroid anti-inflammatory induced allergy. 
o Previous sensitivity to diclofenac sodium
o Concomitant NSAID (intravenous use) or anticoagulant use (including lowdose heparin)
o Operations associated with a high risk of hemorrhage (intravenous use)
o Moderate or severe renal impairment (serum creatinine > 160 mmol. L-1), hypovolaemia or dehydration from any cause.

Side Effects:
Mild and infrequent gastro-intestinal discomfort, bleeding, nausea, vertigo, headache, hearing disturbances such as tinnitus; thrombocytopenia; hypersensitivity reactions.

Precaution:
History of gastrointestinal lesions; impaired renal function; pregnancy & lactation; concurrent administration of plasma protein-bound drugs, lithium, beta-blockers or frusemide.

Drug Interaction:
Potential hazardous interactions with lithium, digoxin, diuretics, methotrexate.

Storage condition
Keep in a cool and dry place protected from light.

How supplied:
Anodyne® Plus injection : 5 x 2's blistered 2 ml ampoules in a printed carton.

Manufacturer’s Source: IBN SINA