Full Prescribing Info
Pharmacology: Mechanism of Action: Paracetamol exhibits analgesic and antipyretic activity by inhibiting prostaglandin synthesis. It produces analgesia by elevating the pain threshold and antipyresis through action on the hypothalamic heat-regulating center.
In therapeutic doses, paracetamol's analgesic and antipyretic action is comparable to that of aspirin. Paracetamol does not adversely affect platelet function and hemostasis.
Pharmacokinetics: Paracetamol is rapidly and completely absorbed after oral administration. Peak plasma concentrations occur between 15 min to 2 hrs after ingestion. The absolute oral bioavailability of paracetamol is about 80% and is independent of dose in the range of 5-20 mg/kg.
Paracetamol is not bound to plasma proteins to any extent. The concentrations of paracetamol in saliva are similar to those in plasma. Concentrations in whole blood are up to 20% higher and in breast milk about 20% lower than the plasma concentration. Paracetamol crosses the placenta.
Paracetamol is extensively metabolized in the liver and the total body clearance is about 5 mL/kg/min. The clearance of paracetamol is reduced and the half-life is increased following a hepatotoxic overdose. Prolongation beyond 4 hrs usually indicates impending liver damage.
Two to five percent of a therapeutic dose of paracetamol is excreted unchanged in the urine. Its renal clearance is about 10 mL/min and is weakly dependent on urine flow rate but not on pH.
Relief of minor aches and pains such as headache, backache, menstrual cramps, muscular aches, minor arthritis pain, toothache and pain associated with common cold and flu.
Dosage/Direction for Use
Tab: Adults and Children >12 years: 1-2 tabs every 4-6 hrs, or as needed. Do not take >8 tabs in 24 hrs.
Susp 250 mg/5 mL: Children >12 years: 2 tsp; 7-12 years: 1-1½ tsp; 3-6 years: ½-1 tsp; 1-2 years: ½ tsp.
Susp 120 mg/5 mL: Children >12 years: 3-4 tsp; 7-12 years: 2-3 tsp; 3-6 years: 1-2 tsp; 1-2 years: 1 tsp.
All doses taken orally every 4 hrs as needed. Do not exceed 5 doses in each 24-hr period for not more than 5 days at a time unless otherwise directed by a physician.
Drops: Children 1-2 years: 1-1.2 mL; 7-11 months: 1 mL; 4-6 months: 0.6-1 mL; 0-3 months: 0.3-0.6 mL.
Shake suspensions well before using. Follow with water.
Paracetamol in massive overdosage may cause hepatic toxicity in some patients. In adults and children >12 years, hepatic toxicity may occur following ingestion of >7.5-10 g over a period of ≤8 hrs. Fatalities are infrequent (<3-4% of untreated cases) and have rarely been reported with overdoses of <15 g. In children <12 years old, acute overdosage with paracetamol <150 mg/kg body weight have not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: Nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48-72 hrs after ingestion. In adults and children >12 years, any individual presenting with an unknown amount of paracetamol ingested or with a questionable or unreliable history about the time of ingestion should have a plasma paracetamol level drawn and be treated with N-acetylcysteine. Results of assays for plasma paracetamol levels should not be awaited before initiating treatment with N-acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma paracetamol assay should be obtained as early as possible, but no sooner than 4 hrs following ingestion. Liver function studies should be obtained initially and repeated at 24-hr intervals.
Serious toxicity or fatalities have been extremely infrequent following acute paracetamol overdose in young children, possibly because of differences in the way children metabolize paracetamol. In children, the maximum potential amount ingested can be more easily estimated. If >150 mg/kg or if an unknown amount of paracetamol was ingested, obtain a plasma paracetamol level as soon as possible, but no sooner than 4 hrs following ingestion. If an assay cannot be obtained and the estimated paracetamol ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy.
Hypersensitivity to paracetamol.
Repeated administration in patients with anemia, cardiac, pulmonary, renal and hepatic damage.
Special Precautions
Taking more than the recommended dose can cause serious health problems, including liver damage.
Discontinue use and consult a doctor if: Symptoms do not improve, new symptoms occur, pain or fever persists or gets worse, or redness or swelling is present.
Do not exceed recommended dose. Keep out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately. Prompt medical attention is critical for adults as well as for children even if signs or symptoms are not noticed.
Use in pregnancy & lactation: Paracetamol crosses the placenta but the drug has been widely used as an analgesic in pregnancy and no adverse fetal effects have been recorded. However, as with any drug, a doctor is to be consulted before using Biogesic if pregnant or breastfeeding.
Adverse Reactions
Paracetamol when taken within therapeutic levels have low incidence of side effects. Skin rashes or minor gastrointestinal disturbances have been reported. Paracetamol very rarely aggravates bronchospasm in patients who are sensitive to aspirin and other nonsteroidal anti-inflammatory drugs. Although paracetamol does not normally produce methemoglobinemia or hemolysis even after overdosage or in patients with glucose-6-phosphate dehydrogenase deficiency, there have been isolated reports of these complications.
Drug Interactions
Paracetamol hepatotoxicity may be increased by drugs which induce the specific microsomal isoenzyme responsible for the metabolic activation of paracetamol. Despite anecdotal reports of such interactions involving ethanol and anticonvulsants, the metabolic activation of paracetamol is not increased in regular heavy drinkers or induced in patients taking phenobarbital or phenytoin. Chronic alcoholics seem to be at particular risk of liver damage following overdosage of paracetamol, but the mechanism is uncertain. Acute ingestion of ethanol markedly reduces metabolic activation of paracetamol.
Store at temperatures not exceeding 30°C. Protect from light.
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Tab 500 mg x 20's, 500's. Oral susp (orange & strawberry flavor) 120 mg/5 mL x 60 mL. 250 mg/5 mL x 60 mL. Oral drops (orange flavor) 100 mg/mL x 15 mL.
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