Diclofenac Sodium Injection 75MG/3ML I.M. COMPOSITION: Each ampoule contains: Diclofenac Sodium......…75 mg Excipients: Benzyl Alcohol BP, Anhydrous sodium sulfite, Water for injections. INDICATIONS: Diclofenac Sodium is indicated in initial therapy for inflammatory and degenerative rheumatic diseases. Painful conditions due to inflammation of non-rheumatic origin and acute attacks of gout. DOSAGE AND ADMINISTRATION: 75 mg by deep intragluteal injection once daily, or two times daily, in severe or hospitalized cases. Each injection must be given at a different site. Not to be given by intravenous injection. Each injection should be separated by an interval of a few hours. Parenteral administration should not be given for more than a few days, if necessary; treatment can be continued with oral therapy. CONTRAINDICATION: Diclofenac Sodiumis contraindicated in patients with porphyria, children under the age of 2 years, patients with a history of active gastro-intestinal bleeding or peptic ulceration, severe hepatic or renal impairment, in aspirin-sensitive patients, patients sensitive to any other non-steroidal anti-inflammatory agent, and in patients hypersensitive to any of the ingredients in these products, safety during pregnancy and lactation has not been established. SIDE-EFFECTS: It includes gastro-intestinal disorders, including epigastric pain, eructation, nausea and vomiting may occur. Peptic ulceration and gastro-intestinal bleeding have been reported. Other side-effects include vertigo, headache, skin rashes, pruritis, tinnitus, depression, drowsiness, nervousness, insomnia, irritability, agitation, minor hearing disorders, oedema, palpitations, blurred vision and other ocular reactions. Sensitivity reactions, abnormalities of liver function tests, impairment of renal function, agranulocytosis and thrombocytopenia have been observed. Dizziness, eczema and haemolytic anaemia may also occur. DRUG INTERACTIONS: Lithium and digoxin:Decreased elimination of lithium and digoxin. Anticoagulants:NSAIDs may enhance the effects of anti-coagulants, such as warfarin. Antidiabetic agents:Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects which have required adjustment to the dosage of hypoglycaemic agents. Ciclosporin:Increased risk of nephrotoxicity. Methotrexate:Decreased the elimination of methotrexate. Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. Other analgesics including cyclooxygenase-2 selective inhibitors and corticosteroids:Avoid concomitant use of two or more NSAIDs (including aspirin) or corticosteroids as this may increase the risk of adverse effects. Diuretics:Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs. USE IN PREGNANCY AND LACTATION: Pregnancy: Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus. Lactation: In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding. PRESENTATION: 10 ampoules per box or 100 ampoules per box. STORAGE CONDITION: Store in cool, dry place and at a temperature not exceeding 25° C. Protect from light. Keep all medicines out of the reach of children.
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