RECCOMENDED DOSAGE INTERACTION WITH OTHER MEDICAMENTS

PARACETAMOL It is more accurate to use the body weight of the child to calculate the
correct dose in pediatrics. Calculation is based on recommended dose of
The anticoagulant effect of warfarin and other coumarins may be
enhanced by prolonged regular daily use of paracetamol with increased
10 to 15 mg/kg/dose ORALLY every 4 to 6 hours. (*Note: 1kg = 2.2lb) risk of bleeding; occasional doses have no significant effect.
PYRANAL Doses of paracetamol for pain and fever in children, given according to ADVERSE DRUG REACTIONS
120mg/ 5mL Syrup age, are: On acute overdosage(single dose equaling or exceeding 10g or 7.5-10g
Analgesic/ Antipyretic 3 months to 1 year: 60 to 120 mg daily for 1-2 days), potentially fatal necrosis and possible renal tubular
1 to 5 years: 120 to 250 mg necrosis can occur.
PRODUCT DESCRIPTION 6 to 12 years: 250 to 500 mg Toxic hepatitis also has been associated with long term ingestion of 5-8 g/
Paracetamol is a round, flat tablet. These doses may be given every 4 to 6 hours if necessary up to a day for several weeks or 3-4 g/day for a year.
Chemical name: Acetaminofeno; Acetaminophen; N-Acetyl-p- maximum of 4 doses in 24 hours. Maculopapular rash or urticarial skin reactions, methemoglobinemia,
aminophenol; Asetaminofen; Paracetamolis; Paracetamolum; neutropenia, thrombocytopenia, hypoglycemia and jaundice may also
Parasetamol; 4'-Hydroxyacetanilide; N-(4-Hydroxyphenyl) acetamide. In younger children occur.
Neonates 28 to 32 weeks postmenstrual age (gestational age at birth
plus chronological age): 20 mg/kg as a single dose then 10 to 15 mg/kg OVERDOSE AND TREATMENT
every 8 to 12 hours if necessary up to a maximum of 30 mg/kg daily. Symptoms
Neonates over 32 weeks postmenstrual age: 20 mg/kg as a single dose Toxic symptoms include vomiting, abdominal pain, hypotension and
then 10 to 15 mg/kg every 6 to 8 hours if necessary up to a maximum of sweating. The most serious adverse effect of acute overdose of
60 mg/kg daily paracetamol is a dose-dependent, potentially fatal hepatic necrosis.
Molecular formula: C8H9NO2 1 to 3 months of age: 30 to 60 mg every 8 hours if necessary Clinical and laboratory evidence of hepatotoxicity may be delayed for up
Description: White or almost white, crystalline powder. Sparingly soluble to one week. Major manifestations of liver failure such as jaundice,
in water; freely soluble in alcohol; very slightly soluble in Children with more severe symptoms hypoglycemia and metabolic acidosis may take at least 3 days to
dichloromethane. 1 to 3 months: 20 to 30 mg/kg as a single dose followed by 15 to 20 mg/ develop.
kg every 6 to 8 hours if necessary up to a maximum of 60 mg/kg daily
FORMULATION Older children: 20 to 30 mg/kg as a single dose followed by 15 to 20 mg/ Treatment
Each teaspoon (5mL) contains 120mg of Paracetamol kg every 6 to 8 hours if necessary to a maximum of 90 mg/kg daily. In cases of overdose, methods of reducing the absorption of ingested
drug are important. Gastric lavage is essential even if several hours have
PHARMACOLOGY For post-immunization pyrexia, an oral dose of 60 mg has been elapsed. Prompt administration of 50g activated charcoal and 500ml iced
Pharmacodynamics recommended for children 2 to 3 months of age. If necessary a second mannitol 20% by mouth, may reduce absorption. If the history suggests
Paracetamol is a centrally acting analgesic and antipyretic with minimal dose may be given after six hours; if the pyrexia persists after that dose, that 15g Paracetamol or more has been ingested, administer one of the
anti-inflammatory medical advice should be sought. following antidotes:
properties.
Analgesic: Paracetamol may act predominantly by inhibiting MODE OF ADMINISTRATION Acetylcysteine 20% I.V.: Administer intravenously, 20% acetylcysteine
prostaglandin synthesis in the central nervous system (specifically Oral (Parvolex, Glaxo) immediately without waiting for positive urine test or
cyclooxygenase (COX)-2) and, to a lesser extent, through a peripheral plasma level results: initial dose of 150mg/kg over 15 minutes, followed
action by blocking pain impulse generation. The peripheral action may CONTRAINDICATIONS by continuous infusion of 50mg/kg in 500ml 5% glucose/dextrose over 4
also be due to inhibition of prostaglandin synthesis or to inhibition of the Hypersensitivity to paracetamol or any of the other ingredients/ hours and 100mg/kg in 1L 5% glucose/dextrose over 16 hours; or
synthesis or actions of other substances that sensitize pain receptors to components of the product.Paracetamol is also contraindicated to patient Oral Methionine: 2.5g immediately followed by three further doses of 2.5g
mechanical or chemical stimulation. with G6PD(phenylketonuria) deficiency. at four hourly intervals. For a 3 year old child, 1g methionine every four
Antipyretic: Paracetamol act centrally on the hypothalamic heat- hours for four doses has been used; or
regulating center to produce peripheral vasodilatation resulting in WARNINGS Oral Acetylcysteine 5%: 140mg/kg as a loading dose, then 70mg/kg
increase blood flow through the skin, sweating and heat loss. Do not exceed recommended dosage.Hepatotoxicity and severe hepatic every 4 hours for a total of 17 maintenance doses. If more than ten hours
Paracetamol reduces fever by inhibiting the formulation and release of failure occurred in chronic alcoholics following therapeutic doses. Chronic have elapsed since the overdosage was taken, the antidote may be in
prostaglandins in the CNS and by inhibiting endogenous pyrogens at the alcoholics should limit paracetamol intake to <2g/day. If a sensitivity ineffective
hypothalamic thermoregulator center. reaction occurs, discontinue use.
STORAGE CONDITIONS
Pharmacokinetics PRECAUTIONS Protect from light, moisture and heat.
Absorption: Absorption of paracetamol is rapid and almost complete from Severe or recurrent pain or high or continued fever may indicate serious
the GI tract. Preserve in an airtight container at temperatures not exceeding 30C.
illness. If pain persists for > 5 days or if redness or swelling is present, Keep out of reach of children.
Peak plasma concentrations occur within 0.5 to 2 hours, with slightly consult a physician.
faster absorption of liquid preparations. With overdosage, absorption is Paracetamol should be given with care to patients with impaired kidney or
complete in 4 hours. AVAILABILITY
liver function. It should also be given with care to patients with alcohol Paracetamol is available in 120/5mL, 160mg/5mL, 250mg/5mL syrup and
Distribution: Serum protein binding varies from 20% to 50% at toxic dependence.
concentrations. suspension, and 500mg tablet.
Care must also be taken into consideration on patients in their late
Metabolism/ Excretion: The half-life in plasma is 2 hours. Paracetamol is pregnancy because the frequent use of paracetamol may be associated
relatively uniformly distributed throughout most body fluids. Binding of the MANUFACTURED AND DISTRIBUTED BY:
with an increase risk of persistent wheezing in the infant which may
drug to plasma proteins is variable; only 20% to 50% may be bound at persist into childhood.
the concentrations encountered during acute intoxication. Ninety percent It must also be used with caution in chronic alcoholics(not to exceed 2g/
to 100% of the drug is recovered in the urine within the first day, primarily day).
after hepatic conjugation with glucoronic acid(~60%), sulfuric acid(~35%)
or cysteine(~3%);small amounts of hydroxylated and deacylated Effects on Ability to Drive and Use Machines
metabolites also have been detected. 143 Lopez- Jaena Street, Tacloban City, Leyte, Philippines
It is unlikely to impair a patients ability to drive or use machinery.
Paracetamol is extensively metabolized and excreted in the urine
primarily as inactive glucuronate and sulfate conjugates (94%). About 4% DATE OF FIRST AUTHORIZATION AND RENEWAL
STATEMENT ON USAGE DURING PREGNANCY AND LACTATION 01JAN2017
is metabolized via cytochrome P450 oxidase to a toxic metabolite Pregnancy Category B. Paracetamol crosses the placenta. It is routinely
normally detoxified by preferential conjugation with cellular glutathione used during all stages of pregnancy; when used in therapeutic doses, it
and excreted in urine as conjugates of cysteine and mercapturic acid. DATE OF REVISION OF PACKAGE INSERT
appears safe for short-term use. Continuous high daily dosage caused 14FEB2017
When paracetamol is used chronically or taken acutely in large doses, severe anemia in a mother, and the neonate had fatal kidney disease.
glutathione stores are depleted and hepatic necrosis may occur; 2% is
excreted unchanged. Half-life is slightly prolonged in neonates and in For suspected adverse drug reactions, report to FDA: www.fda-gov.ph
Use in lactation:
cirrhotics. Excreted in breast milk. DR no.: FPH-002
Maternal ingestion of paracetamol in normal therapeutic doses does not
INDICATION appear to present a risk to the nursing infant.
Paracetamol is useful for the relief of minor aches and due to headache If a sensitivity reaction occurs, discontinue use.
and pain associated with earache, teething, tonsillectomy; toothache;
diseases accompanied by discomfort and fever such as the common cold
and flu.