Square Pharmaceuticals Ltd.
ACE XR is indicated for Mild to moderate pain and fever
Precautions and warnings
Renal or hepatic impairment; alcohol-dependent patients; G6PD deficiency.
Nausea, allergic reactions, skin rashes, acute renal tubular necrosis.
Potentially Fatal: Very rare, blood dyscrasias (e.g. thrombocytopenia, leucopenia, neutropenia, agranulocytosis); liver damage.
May reduce serum levels w/ anticonvulsants (e.g. phenytoin, barbiturates, carbamazepine). May enhance the anticoagulant effect of warfarin and other coumarins w/ prolonged use. Accelerated absorption w/ metoclopramide and domperidone. May increase serum levels w/ probenecid. May increase serum levels of chloramphenicol. May reduce absorption w/ colestyramine w/in 1 hr of admin. May cause severe hypothermia w/ phenothiazine.
Mode of actions
Paracetamol exhibits analgesic action by peripheral blockage of pain impulse generation. It produces antipyresis by inhibiting the hypothalamic heat-regulating centre. Its weak anti-inflammatory activity is related to inhibition of prostaglandin synthesis in the CNS.
Dosage & Administration
Adult: 1 - 2 tablets every 4 to 6 hours up to a maximum of 4 g (8 tablets) daily
Children (6 - 12 years) : 1/2 to 1 tablet 3 to 4 times daily
Children: 2 months: 60 mg (1/2 measuring spoonful) for post immunization pyrexia;
Under 3 months (on doctor's advice only) : 10 mg/kg (5 mg/kg if jaundiced)
3 months - 1 year : 60 - 120 mg (1/2 - 1 measuring spoonful),
1 - 5 years : 1 - 2 measuring spoonful
6 - 12 years : 2 - 4 measuring spoonful
Children Up to 3 months: 0.5 ml (40 mg)
4 to 11 months: 1.0 ml (80 mg)
1 to 2 years: 1.5 ml (120 mg)
2 to 3 years: 2 ml (160mg)
4 to 5 years: 3 ml (240 mg)
Dose can be repeated, every 4 hours.
For Suppository: Suppository should be administered rectally.
Children: 3 months-1 year: 60-125 mg
1-5 years: 125-250 mg
5-12 years: 250-500 mg
These doses may be repeated every 4-6 hours as necessary (maximum 4 doses in 24 hours).
Adults & children over 12 years: 500 mg-1 g every 4-6 hours to a maximum of 4 g daily.
Pregnancy & Lactation
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.