Patient w/ chronic alcoholism, known G6PD deficiency, severe hypovolaemia, chronic malnutrition. Renal and hepatic impairment. Pregnancy and lactation. Monitoring Parameters Monitor serum paracetamol levels esp when acute overdosage is suspected and w/ long-term use.
Indication
Fever, Mild to moderate pain, osteoarthritis, rheumatoid arthritis, chronic low back pain, Renal stone pain, neuropathic pain, toothache, migraine, postoperative mild to moderate pain.
Contra Indication
Hypersensitivity.
Dose
N/A
Side Effect
Thrombocytopenia, leucopenia, pancytopenia, neutropenia, agranulocytosis, pain and burning sensation at inj site. Rarely, hypotension and tachycardia.
Potentially Fatal: Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis, acute renal tubular necrosis and hepatotoxicity.
Pregnancy Category
Name :
B
Description
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.
Mode of Action
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.
Interaction
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.
Pregnancy Category Note
Pregnancy
Drug crosses placenta and can be detected in cord blood, newborn serum, and urine immediately after delivery
Increased risk of teratogenic effects not reported following maternal use of drug during pregnancy
Use of normal doses during pregnancy not associated with increased risk of miscarriage or still birth; however, increase in fetal death or spontaneous abortion may be seen with maternal overdose if treatment delayed
Wheezing and asthma in early childhood associated with frequent maternal use of drug during pregnancy
Lactation
Drug is excreted in milk; in general, breastfeeding is generally acceptable if relative infant dose (RID) is <10%; avoid breastfeeding when RID>25%
Adult Dose
Oral
Mild to moderate pain and fever
Tablet
Adult: 1 - 2 tablets every 4 to 6 hours up to a maximum of 4 g (8 tablets) daily
Extended Release (XR) Tablet
Adults: 2 tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).
Syrup/Suspension:
Adults: 4-8 Measuring spoonful 3-4 times daily;
Rectal
Suppository
Adults: 500 mg-1 g every 4-6 hours to a maximum of 4 g daily.
Child Dose
Oral
Mild to moderate pain and fever
Tablet
Children (6 - 12 years) : 1/2 to 1 tablet 3 to 4 times daily
Extended Release (XR) Tablet
Children over 12 years: 2 tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).
Syrup
Mild to moderate pain and fever
Children:
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: 2 months: 60 mg (1/2 measuring spoonful) for post immunization pyrexia;
Paediatric Drops
Mild to moderate pain and fever
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.
Rectal
Mild to moderate pain and fever
Suppository
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).
Children over 12 years: 500 mg-1 g every 4-6 hours to a maximum of 4 g daily.
Post-immunisation pyrexia
Child: 2-3 mth 60 mg. If necessary, a 2nd dose may be given after 4-6 hr.
Renal Dose
N/A
Administration
May be taken with or without food.
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