Each tablet contains Paracetamol 500 mg and 650 mg.
Pharmacology: Paracetamol produces anti-pyresis through action on the hypothalamic heat-regulating center and analgesia by elevation of the pain threshold. Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentration occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged Paracetamol. The elimination half life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. It is reported that the binding of paracetamol to plasma protein did not occur with plasma concentration of less than 60mcg per ml, corresponding to the usual therapeutic concentration. After toxic doses of paracetamol, up to 43% could be bound to plasma proteins.
It is indicated as an analgesic and antipyretic in diseases accompanied by discomfort and fever such as the common cold and other viral infections. It also provides analgesia in conditions involving musculoskeletal pain as well as in other painful disorders such as headaches, dysmenorrhoea, myalgia and neuralgia.
500 mg: 1-2 tablets every 4 to 6 hours as needed.
Do not take more than 8 tablets in 24 hours.
650 mg: The adult dose is 650mg (1 tablet) to 975 mg (1½ tablets), 3 or 4 times daily. Not more than 3.9g (6 tablets) in 1 day unless advised by the physician.
Symptoms following a potentially hepatotoxic overdose may include nausea, vomiting, diaphoresis and general malaise. In paracetamol overdosage, regardless of the quantity of paracetamol ingested, acetylcysteine should be administered immediately if 24 hours or less have elapsed from the reported time of ingestion. Acetylcysteine is given by intravenous infusion in an initial dose of 150mg per kg body weight over 15 minutes followed by 50mg per kg over 4 hours and then 100mg per kg over the next 16 hours. Alternatively, methionine 2.5g may be given by mouth every 4 hours to a total of 4 doses. Haemoperfusion may be worthwhile if too much time has elapsed since the poisoning to allow use of acetylcysteine or methionine.
The following additional procedures are recommended: The stomach should be emptied promptly by lavage or by induction of emesis with syrup of ipecac. A serum paracetamol assay should be obtained as early as possible, but no sooner than four hours following ingestion. Liver function studies should be obtained initially and repeated at 24 hours intervals.
It is contraindicated in patients who are hypersensitive to it and also in patients who have liver impairment.
This preparation contains PARACETAMOL. Do not take any other medicines containing PARACETAMOL at the same time.
Paracetamol should be given with care to patients with impaired kidney or liver function. Paracetamol could interfere with paper chromatographic estimations of urinary amino acids by producing drug spots, and could interfere technically with laboratory estimations for metadrenalines in the urine to produce erroneous raised results. Paracetamol might interfere with the measurement of serum uric acid concentrations when the reagent used was phosphotungstic acid.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash. These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.
As there are no adequate and well-controlled studies in pregnant women, this drug should be used only if clearly needed. The use of this drug in late pregnancy is not recommended because of the effects on the foetal cardiovascular system.
Since safety of the use of this preparation in pregnancy, during lactation, or in the childbearing age has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against its possible hazard to the mother and child.
Side-effects of paracetamol are usually mild, though haematological reactions such as agranulocytosis, thrombocytopenia and pancytopenia have been reported. Cutaneous hypersensitivity reactions including skin rashes, angioderma, Stevens Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.
500 mg: Paracetamol should also be given with care to patients taking other drugs that affect the liver.
Paracetamol hepatotoxicity has been reported to be enhanced by phenobarbitone, alcohol and doxorubicin.
650 mg: Contradictory pharmacokinetic results have been reported in patients receiving both chloramphenicol and paracetamol, ranging from increase to decrease and to no significant change in chloramphenicol half-life.
A combination of paracetamol and codeine has also enhanced warfarin anticoagulation activity.
Paracetamol has been reported to increase zidovudine's haematological toxicity.
Store at or below 30°C. Protect from light.
Shelf-Life: 500 mg: 5 years.
650 mg: 3 years.
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Tab 500 mg (oval, white, deep convex, plain) x 10 x 10 x 10's. 650 mg (oblong, convex, white, plain with single score on one side only) x 10 x 10 x 10's.