DICLOFENAC WITH PARACETAMOL

DRUG INFORMATION

Strength and packing:Tablets containing 0,050 grams of diclofenac and 0,300 grams of paracetamol.
Drug Class:M01A B55. Nonsteroidal antiinflammatory and antirheumatic drug, a derivative of acetic acid. Diclofenac, a combination.
Action:Diclofenac has potent antininflammatory analgesic and antipyretic actions and antiaggregatory activity. The mechanism of these actions is inhibition of the enzyme, cyclo-oxygenase in the pathway of prostaglandin (PG) synthesis, suppression of leukotriene synthesis, antibradykinin activity, lysosomal membranes' stabilization, neutrophil activity lowering.
Paracetamol has the same direction of pharmacological effects, but they are performed mainly in central nervous system.
Pharmacokinetics:After oral administration it is rapidly and completely absorbed, diclofenac mainly in bowels. Food can slow down the absorption speed without influence on its fullness. Diclofenac and paracetamol penetrate in tissue very well. Diclofenac concentration grows more slowly in synovial fluid then in plasma, reaching higher value and longer half-period. Binding degree with proteins: diclofenac - more than 99%, paracetamol - 25%. Diclofenac and paracetamol are metabolized in liver. Diclofenac is excreted as inactive metabolites by kidneys (65%) and with stool (about 35%). Less than 1% is excreted invariable. Paracetamol is excreted by kidneys mainly as a conjugation product. Less than 5% is excreted invariable.
Indication: Pain syndrome of medium and high intensity at rheumatoid arthritis (including acute condition of disease), ankylosing spondylitis, acute podagric inflectional, psoriatic and traumatic arthritis, osteoarthritis, bursitis, tendovaginitis, radiculitis, thrombophlebitis, primary dysmenorrheal, neuralgia, myalgia and other diseases following inflammation, pain syndrome and fever.
Dosing:1 tablet 2-3 times a day. Should be taken with food, without chewing and with a small amount of water. The course of medical treatment depends on effectiveness and tolerance for it. It shouldn't be longer 21 days.
Adverse effect:Nausea, eructation, epigastric discomfort, diarrhea, headache, vertigo, thrombocytopenia, leucopenia, granulo(cyto)penia, hemolytic anemia, agranulocytosis, pancytopenia.
Contraindication:Erosive-ulcerous involvement of gastrointestinal tract, apparent derangements of kidney and liver function, lack of glucose 6-phosphate dehydrogenase enzyme, blood disease, bronchial asthma, pregnancy, lactation period, hypersensitization to the drug components.
Interactions:The drug raises the toxicity of methotrexate, cyclosporine, gastrotoxicity NSAIDs and glucocorticoids, heightens the risk of hyperkalemia against the background of potassium-sparing diuretics, and reduces the effect of diuretics. The risk of hepatotoxic action is greatly raised at the simultaneous intake of Diclofenac with barbiturates, tricyclic antidepressants and alcohol. A long-term ingestion of anticonvulsants may lower the efficacy of the drug. Diclofenac with paracetamol enhances the concentration of lithium, digoxin, indirect anticoagulants, quinolone derivatives, oral antidiabetic agents in blood (hyperglycemia as well as hypoglycemia is possible).
Overdose:In case of overdose liver necrosis, headache, psychomotor agitation, irritation, dizziness and convulsions are possible.
Features:The medication should be prescribed carefully to people with liver and kidney disease, gastrointestinal disturbance in past history, arterial hypertension, impaired cardial function and anemia.
Storage:Store at sunlight-proof place and protect from moisture. Shelf life is 2 years.
Distribution conditions:Prescription is needed.
Manufacturer:SC "Concern Stirol" Gorlovskoy divizii str. 10, Gorlovka, Donetsk reg., Ukraine, 84610.
Adress in Internet: http://pharm.stirol.net
E-mail:support