ERDON Injection

Diclofenac Sodium 75 mg/3 ml

Description:

Diclofenac is a potent non-steroid anti-inflammatory drug (NASID) with analgesic and anti-pyretic properties. It has also some uricosuric effect. Diclofenac inhibits cyclooxygenase activity with a reduction of the tissue production of prostaglandin.

Composition:

Each 3 ml ampoule of aqueous injection contains Diclofenac Sodium USP 75 mg.

Indications:

Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis.

Surgery and Traumatology: Sprain, bruises, dislocations, fractures, soft-tissue injuries, surgical interventions.

Obstetrics and Gynecology: Primary dysmenorrhoea, episitomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.

Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.

Other Indications: For the prevention of pain and treatment of inflammation swelling of patients operated in the urogenital tract, renal and biliary colic.

Dosage & administration:

Erdon is intended for intramuscular injection or intravenous infusion. For intravenous infusion dilute immediately before use.

Recommended dosage:

In adults:

For post-operative case: 75 mg/3ml once daily (in severe cases twice daily) by deep intramuscular injection.

Renal colic: 75 mg/3 ml once daily by deep intramuscular injection. Further 75 mg/3 ml after 30 minutes should be given. The maximum daily dose of Diclofenac Sodium is 150 mg.

In children:

For juvenile chronic arthritis: 1-3 mg of Diclofenac Sodium/Kg body weight in divided doses.

Contraindication:

Peptic ulcer, hypersensitivity to diclofenac like other non-steroid anti-inflammatory agents. Erdon injection is also contraindicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetyl salicylic acid or by other drugs with prostaglandin synthetase inhibition.

Precautions:

In the rare instances where peptic ulceration or gastro-intestinal bleeding occurs in patients under treatment with Erdon, the injection should be discontinued. In patient with advanced age should be kept under close surveillance. Patients receiving long-term anti-steroid therapy should be monitored as a precautionary measure (renal or hepatic function and blood counts)

Use in Pregnancy and Lactation:

During pregnancy Erdon should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the last trimester of pregnancy. Very insignificant quantity of diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Side-effects:

Adverse effects of diclofenac are mild, rare and transient. It is generally well tolerated. At the starting of the treatment, however, patients may sometimes complain epigastric pain, eructation, nausea and diarrhoea, dizziness or headache. These effects are usually mild in nature. Peripheral oedema and skin reactions, such rash and eczema have also been encountered.

Storage:

§         Store in a cool and dry place, protected from light.

§         Keep out of the reach of the children.

Packing:

Box containing 4x3's ampoules in blister pack.