PARACETAMOL 120 mg/ 5 ml Pediatric Elixir

FORMULA:

Each 5 ml (ore spoon) contains 120 mg paracetamol, ,perfume framboise, ponceau 4 R, methyl paraben, propyl paraben, sodium cyclamate, sodium sakarin and ethyl alcohol PHARMACOLOGICAL PROPERTIES: Paracetacol shows analgesic and antipyretic effect with a similar mechanism by salicylates, increases pain treshold and effects the thermo-regulatiun center in hypotalamus Its antiinflammatory effect poor. Paracetamol is absorbed fast and full, from the gastointestinal tract after ingestion. Maximum plasma concentetion is reached in 30-90 minutes . Distributed throughout most body fluids fast. Plasma half life is 1-3 hours. Metabolized by the microzomal enzyme system in lver, excreted in urine 1-3 % as unchanged paracetamol, 80 % as inactive glucuronide or suplhate compounds. INDICATIONS: Paracetamol pediatric Elixir is indicated symptomatic relief of mild to moderate fever and pain in children. CONTRAINDICATIONS: Paracetamol is contraindicated in patients with hypersensitivity to paracetamol and liver and renal insufficiency WARNINGS/PRECAUTIONS: Paracetamol should be used in patients with impaired liver and renal function under supervision of a medical doctor It should be used in patients with caution who have heart,lung diseases and who have anemia. Paracetamol should not be given to children who have pain longer than 5 days of duration, fever more than 39.5 C or 3 days of duration or intermittant fever. Hepatic necrosis is a complication of paracetamol over dosis. Liver enzymes may be incresed in 12-48 hours, protrombin time may be prolonged.The clinical symptoms may not appear 1-6 after the ingestion of paracetamol.Toxicity symptoms may appear after ingestion of more than 10grams of paracetamol. ADVERSE REACTIONS: Urticaria, itching, maculopapular erythema are rare, Prolonged treatment with high dosis may cause thrombositopenia, leucopenia and pansitopenia. Neutropenia, hemolytic anemia thrombocytopenic,purpura and agranulocytosis are reported very rarely CONSULT YOUR PHYSICIAN IN CASE OR UNEXPECTED EFFECT INTERACTIONS: A serious hypothermia should be kept in mind in patients with concomitant treated with paracetamol, phanothiazine and antipyretic treatment. Prolonged and high dose treatment paracetamol increases the effect of anticoagulant medication. Prolonged and high dose treatment of paracetamol, may interact with coumarin indantoin derivaties, phenotiazines. Alcohol, barbiturates, tricyclic antidepresants may increse hepatotoxicity of paracetamol EFFECTS TO LABORATORY TESTS: Paracetamol may cause a faLSE positive IAA (5-Hydroxy indol acetic acid) test is urine ADMINISTRATION AND DOSAGE: Recommended paracetamol syrup dosage is: 3 moths-1 year 3-4 times spoons/day(60mg) maximum dosage 10 ml/240 mg/day 1 year -4 years 3-4 times spoon/ day(120 mg) 20ml/480 mg/day 4 years -8 years 3-4 times 1.5-2 spoons/day (180-240mg) 40 960 mg/day 8 years -12 years 3-4 times 2 spoons (240 mg) 40 960 mg/day Dosage should be adjusted on age and weight 4 hours of interval should be kept between administrations Minimum doses should be gven in prolonged treatments. If not recommended by physician, paracetamol should not be gven more than 4 times in 24 hours. OVERDOSAGE: A heath center should be consulted in suspect of overdosage.

Nausea, vomiting, abdominal pain may occur in 2-3 hours after ingestion of toxic doses. Treatment of acute paracetamol toxicity is a symptomatic and supportive Vomiting, gashic aspiration or lavage application may be applied after a short period of time after ingestion. Acetyl cystein is recommended as antidote. 150 mg /1 g after the frst 8-10 hours N Acetyl cystein is infused in 15 mnutes. Prothrombin time, BUN, blood sugar, SGOT ,SGPT, bilirubin ,kreatinin, and electrolytes must be monitored. Fluid electrolyte balance should be maintaired. Hypoglycemia if present shold be treated. Laboratory tests should be repeated until reaching normal levels. If liver and renal insulliciecy appears hemodialysis and hemoperfusion may help. Peritoneal dialysis and hemoperfusion may help. Peritoreal dialysis is not effective STORAGE: Keep at room temperature below 25 C Keep in package and out of the reach of children PACKAGING n 150 ml bottles (with a spoon 5 ml) Registration date and number: 24.4.1974-118/37 Manufacturing place: Munir Sahin Ilac San ve Tic A.S. Kartal-Istanbul Holder of Registration: Saba Ilac San.ve Tic. A.S. Halkal Merkez Mah.Basn Ekspres Cad.No:1 Kat:1 Kkekmece /stanbul Sold with prescription only