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|Product Name:||Diclofenac Sodium Injection||Composition:||Each Ampoule Contains 75 Mg Diclofenac Sodium|
|Indications:||Therapy For Inflammatory And Degenerative Rheumatic Diseases||Storage Instructions:||Store Below 25°C. Do Not Refrigerate|
|Expiration Date:||3 Years|
DICLOFENAC SODIUM INJECTION 75 mg/3 mL
Each 3 mL contains 75 mg diclofenac sodium with 4% v/v benzyl alcohol.
Diclofenac sodium has analgesic, anti-inflammatory, antirheumatic antipyretic activities. It is non steroidal. It is an inhibitor of cyclo-oxygenase. Diclofenac is metabolised in the liver to 4-hydroxydiclofenac and other hydroxylated forms, after glucoronidation and sulphation the metabolites are excreted in the urine (65%) and bile (35%).
To be used as initial therapy for inflammatory and degenerative rheumatic diseases, as well as for painful conditions due to inflammation of non-rheumatic origin and acute attacks of gout..
Patients with known hypersensitivity to diclofenac, or other non-steroidal anti-inflammatory medicines. Asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylicacid, or other medicines with prostaglandin synthetase inhibiting activity. Diclofenac sodium is contra-indicated in patients with a history of active gastro-intestinal bleeding or peptic ulceration, or severe hepatic or renal impairment. Patients with porphyria. Safety during pregnancy and lactation has not been established.
Serious interactions have been reported after the use of methotrexate with diclofenac.
DOSAGE AND DIRECTIONS FOR USE:
Not intended for intravenous injection. Only for deep intragluteal injection into the upper quadrant. Seventy five mg by intramuscular injection once daily or twice daily in severe cases; each injection should be given at a different site. In renal colic the intramuscular dose of 75 mg may be repeated once after 30 minutes if necessary. Diclofenac ampoules should not be given for more than a few (2) days. If necessary, treatment can be continued with oral therapy.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances; reactions range from abdominal discomfort, nausea and vomiting, and abdominal pain to serious gastro-intestinal bleeding or activation of peptic ulcer. CNS-related side-effects include headache, dizziness, nervousness, tinnitus, depression, drowsiness and insomnia. Hypersensitivity reactions may occur occasionally and include fever and rashes. Hepatotoxicity and aseptic meningitis may also be hypersensitivity reactions. It can provoke bronchospasm in patients with asthma. It may cause cystitis and haematuria. It may also cause acute renal failure, interstitial nephritis, and nephrotic syndrome.
Protect from heat and light.
Store below 25°C. Do not refrigerate.
KEEP OUT OF REACH OF CHILDREN.