Intafenac   IM Injection
Diclofenac Sodium BP Injection

Presentation
Intafenac   IM Injection: Each 3 ml ampoule contains sterile Diclofenac Sodium BP 75 mg.
 
Description
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 inhibits the synthesis of prostaglandins by inhibiting cycloxygenase enzyme. It also has some uricosuric effect.
 
Indications and Uses
Intafenac injection has got the following therapeutic uses:
Postoperative pain
Control of pain and inflammation in orthopaedic, dental and other minor surgery
Acute trauma and fractures
Low back pain and other acute musculoskeletal disorders such as periarthritis (e.g., frozen shoulder),tendonitis, tenosynovitis, bursitis, sprains, strains and dislocations.
Renal colic pain
Osteoarthritis
Juvenile chronic arthritis
Ankylosing spondylitis
Acute gout
Rheumatoid Arthritis
Severe migraine attacks
 
Dosage and Administration
Intafenac injection is intended for intramuscular injection.
Adults: The dosage is generally one 75 mg ampoule daily. In severe cases (e.g. colic) the daily dose can exceptionally be increased to two ampoules of 75 mg, separated by an interval of a few hours. Alternatively, one ampoule of 75 mg can be combined with other dosage forms (tablets, suppositories) up to a maximum daily dosage of 150 mg.
In migraine attacks, clinical experience is limited to initial use of 1 ampoule of 75 mg administered as soon as possible, followed by suppositories up to 100 mg on the same day if required. The total dosage should not exceed 175 mg on the first day.

Children: In juvenile chronic arthritis, 1-3 mg of Diclofenac sodium/kg body weight daily in divided doses.

Elderly patients: The lowest effective dosage is recommended, commensurate with age and physical status or as prescribed by the physician.
 
Side-effects
Side-effects of Diclofenac injection are usually mild and transient. It is generally well tolerated. At the starting of the treatment, however, patients may sometimes complain of gastrointestinal discomfort, epigastric pain, eructation, nausea and diarrhoea, headache and occasionally bleeding may occur.
 
Contraindications
It is contra-indicated for those patients who are hypersensitive to Diclofenac. In patients with active or suspected peptic ulcer or gastrointestinal bleeding, or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs possessing prostaglandin synthetase inhibitinig activity, it is also contraindicated.
 
Precautions
History of gastrointestinal ulceration, haematemesis or melaena, ulcerative colitis, Crohn's disease, bleeding diathesis or haematological abnormalities. Patients with severe hepatic, cardiac or renal insufficiency or the elderly should be kept under close surveillance. All patients who are receiving long-term treatment with NSAID agents should be monitored as a precautionary measure (e.g., renal, hepatic function and blood counts).
 
Drug interactions
Intafenac may interact with following drugs: Lithium, digoxin, diuretics, other NSAIDs, anticoagulants, antidiabetics, methotrexate, cyclosporine, quinolone antibacterials. 
 
Use in Pregnancy and Lactation
Pregnancy: It should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. These types of drugs are not recommended during the last trimester of pregnancy.
Lactation:Very small quantities of Diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.
 
Storage conditions
Store in a cool and dry place, protected from light.
 
Overdosage
There is no typical clinical picture associated with an overdosage of Diclofenac. Specific measures such as forced diuresis, dialysis or haemoperfusion are unlikely to be helpful in eliminating NSAIDs because of their high protein-binding rate and extensive metabolism.
 
Commercial Pack
Intafenac   IM Injection: Each box contains 10 ampoules of 3 ml.