Diclofenac Sodium & 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 inhibits the synthesis of prostaglandins by inhibiting cycloxygenase enzyme. It also has some uricosuric effect.

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 anaesthetic, Lidocaine impairs the generation and conduction of the nerve impulses by slowing depolarization.

Dikotil IM Injection: Each 2 ml ampoule contains sterile Diclofenac Sodium BP 75 mg and Lidocaine Hydrochloride BP 20 mg
Indications and Uses Dikotil injection has got the following therapeutic uses: • Rheumatoid Arthritis • Osteoarthritis • Ankylosing spondylitis • Acute gout • Juvenile chronic arthritis • Low back pain and other acute musculoskeletal disorders such as periarthritis (e.g. frozen shoulder, tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations) • Acute trauma and fractures • Control of pain and inflammation in orthopedic, dental and other minor surgery • Postoperative pain • Pain of renal colic and in other uses Dikotil injection also contains Lidocaine, which act as a local anaesthetic. Therefore, the possibilty of pain at the injection site, which is most likely to occur after intermuscular injection of normal diclofenac, is minimized if Dikotil injection is used in the above mentioned indications.
Dikotil injection is intended for intramuscular injection.   Adults: One ampoule once daily (or in severe cases; twice daily) by intramuscular injection. The recommended maximum daily dose of diclofenac and lidocaine is 150 mg and 200 mg respectively, by any route.   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  
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. Because of the presence of Lidocaine, it is also contraindicated for those patients who are hypersensitive to local anaesthetics of the amide type, although the incidence is very rare.
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).
Side-effects of Diclofenac and Lidocaine 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. The adverse effects due to Lidocaine mainly involve the CNS, are usually of short duration, and are dose related. The CNS reaction may be manifested by drowsiness, dizziness, disorientation, confusion, lightheadness, etc.
Dikotil may interact with following drugs: Lithium, digoxin, diuretics, other NSAIDs, anticoagulants, antidiabetics, methotrexate, cyclosporine, quinolone antibacterials.
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.
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.
Dikotil IM Injection: Each box contains 5 ampoules of 2 ml in blister pack.