International generic name Diclofenac.
Drug form and composition Solution for injection. One ampoule of 3 ml contains 75 mg Sodium Diclofenac (25 mg per ml). Suppositories. One suppository (for adults) contains 50 mg Sodium Diclofenac. One suppository (for children) contains 25 mg Sodium Diclofenac. Gel. 1g Gel contains 10 mg Sodium Diclofenac.
Indications Acute painful conditions, requiring an anti-inflammatory or/and analgesic therapy; rheumatoid arthritis; osteoarthritis; polyarthritis; Bechterew’s disease; Behchet’s syndrome; periarticular diseases; acute gout attack; severe traumatic injuries; acute adnexitis; severe migraine attacks; renal and biliary colic. Feloran-gel is indicated in mild clinical manifestations.
Dosage and administration Solution for injection: the solution is applied deep intramuscularly. The single dose in adults is 75 mg. If necessary the same dose may be repeated at intervals equal or longer than 12 hours. Duration of the treatment should not be longer than 2 dais. Suppositories: recommended dose in adults is 100-150 mg, given 2-3 times daily. The treatment with suppositories may be combined with parenteral, oral and local preparations of the medicine, while the 24 hours dose should not exceed the permissible doses. In children older than 6 years the medicine is administered in dose 2-3 mg per kg body weight/ 24 hours. Duration of the treatment should not exceed 1 week. Gel: depending on the area of the painful region, 2 - 4 g Feloran gel is used. The preparation is spread carefully on the affected region 3 - 4 times daily.
Contraindications Hypersensitivity to diclofenac; pregnancy and lactation. Solution for injection: active ulcer disease, severe hepatal failure; children younger than 15 years. Suppositories: active stomach and duodenal ulcer; children younger than 6 years; acute and chronic proctitis.
Special warnings and precautions Feloran-ampoules is indicated only for the treatment of severe pain in the acute phase of the disease. After the severe manifestations are relieved the treatment should continue with other pharmaceutical forms of the medicine. Feloran should be used with care in patients with history for allergy - bronchial asthma, allergy rhinitis, alimentary and drug allergy (particularly to prostaglandin synthesis inhibitors), as in such cases the risk of hypersensitivity reactions is much higher. In patients with severe liver and renal diseases Feloran should be used only after precise assessment of the indications, as a possibility of disarrangement of the biotransformation and elimination of the medicine exists; in patients with hematology diseases; ulcer disease in remission and ulcerous colitis. Feloran-suppositories should be used with care in patients with hemorrhoids, rhagades, and anal fistulas, as it exerts a local irritative effect. Due to adverse reactions, including headache and somnolence, in drivers and machinery operating persons Feloran-ampoules should be used only after precise assessment of the risk. In pregnant and nursing women Feloran-gel should be administered only after precise assessment of the indications. The gel should be applied on intact skin only.
Drug interactions Concomitant treatment with Feloran and other inhibitors of prostaglandin synthesis, corticosteroids, and alcohol increases the risk of hypersensitivity reactions, ulceration and gastrointestinal hemorrhages. Feloran elevates the plasma concentrations of the lithium; reduces digoxin and diuretic activity; in combination with potassium preparations may lead to hyperkalemia.
Adverse reactions Hypersensitivity reactions (itching, skin rash, urticaria, Layell’s and Stevens-Johnson’s syndrome, anaphylactic shock, bronchial spasm) is possibly to appear. Most frequent system effects are gastrointestinal - nausea, vomiting, gastrointestinal discomfort and pain, diarrhea, ulcer disease exacerbation, ulcerations and hemorrhages. More rare system adverse effects include headache, dizziness and somnolence.
Pharmacological mechanisms Feloran possesses a powerful anti-inflammatory effect, as well as an antipyretic and analgesic effects. It inhibits prostaglandin synthesis and platelet aggregation. Inhibition of the prostaglandin biosynthesis is considered as a basic mechanism of Feloran action, as prostaglandins play an important role in pathogenesis of inflammation, pain and fever. Feloran inhibits enzyme-stimulated conformation of the arachidonic acid to prostaglandins; influence the β-endorphyn and endogene pyrogens release; inactivates lysosomal enzymes. All this leads to a clinical result characterized by relief of pain, swelling, and rigidity.
Supplied 10 or 100 ampoules Feloran of 3 ml (75 mg). 6 Suppositories Feloran of 25 mg or 50 mg. Tubes with 60 g Feloran Sopharma gel.
Expiry Solution for injection, suppositories and gel - 2 years |