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Category : NSAIDS, ANTIPYRETICS, ANALGESICS
Name : ACETAMINOPHEN(Paracetamol)
Type & Dosage : ORAL DROPS ; 100 mg/ml
Package : 1
Pharmacologic Category
Analgesic; Antipyretic
Mechanism Of Action
Acetaminophen may act predominantly by inhibiting prostaglandin synthesis in the CNS and , to a lesser extent , through a peripheral action by blocking pain-impulse generation. Acetaminophen probably produces antipyresis by acting centrally on the hypothalamic heat-regulation center to produce peripheral vasodilation resulting in increased blood flow through the skin , sweating , and heat loss.
Indications
Acetaminophen is indicated to relieve mild to moderate pain and reduce fever.
Side Adverse Effects
Agranulocytosis; Anemia; Thrombocytopenia; Allergic dermatitis; Heptitis; Renal colic; Renal failure; Sterile pyuria; Increased chloride , uric acid, glucose; Decreased sodium , bicarbonate, calcium; Increased renal ammonia
Contraindications
Hypersensitivity to acetaminophen or any component of the formulation
Warnings Precautions
Use with caution in patients with renal function impairment and hepatic diseases such as active alcoholism and viral hepatitis. Patients should be instructed to contact healthcare provider if used for fever lasting >3 days or for pain lasting > 10 days in children
Pregnancy
FDA pregnancy category B.
Breast Feeding
Acetaminophen enters breast milk/compatible.
Drug Interactions
Barbiturates, primidone, carbamazepine, hydantoins, rifampin and sulfinpyrazone may decrease the analgesic effect of acetaminophen. Cholestyramine may decrease acetaminophen absorption (separate dosing by at least 1 hour). Barbiturates, carbamazepine, hydantoins, isoniazid, rifampin, sulfinpyrazone and chronic ethanol abuse increase the hepatotoxic potential of acetaminophen. Effect of warfarin may be enhanced. Prolonged concurrent use of acetaminophen and a salicylate and NSAIDs may increase the risk of adverese renal effects.
Administration And Dosage
Adult dosing:
Oral, 325-500 mg every three hours, 325-650 mg every four hours, 650-1000 mg every six hours as needed, or 1300 mg every 8 hours, while symptoms persist; Do not exceed 4 g/day for short-term therapy (up to ten days) and 2.6 g/day for long-term therapy.
Children: 1/2 - 1 teaspoonfuls per day.
Pediatric dosing:
up to 3 months of age : Oral, 40 mg every four hour
4-12 months of age: Oral, 80mg every four hours
1-2 years of age: Oral, 120mg every four hours
2-4 years of age : Oral, 160 mg every four hours
4-6 years of age: Oral, 240 mg every four hours
6-9 years of age : Oral, 320 mg every four hours
9-11 years of age: Oral, 320-400 mg every four hours
11-12 years of age: Oral, 320-480 mg every hours
How Supplied
Tablet: 325 mg, 500 mg
Oral Drop: 100mg/ml, bottles of 15ml, with dropper
Storage
Store below 30°C, protect from direct light and moisture. Oral drops should be protected from freezing.
References
USP DI, 2004
Up To Date, Vol. 13.1 (2005)
Martindale, The Complete Drug Reference, 33 rd edition 2002
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