PARACETAM levels are reached in 30 to 60 minutes. patients with hepatic impairment.

It
OL Paracetamol is distributed throughout should also be given with care to
FORMULATION most body fluids and is slightly bound patients with alcohol dependence,
Paracetamol 24 g to plasma proteins. malnutrition, or dehydration
Sodium benzoate 1g Metabolism/ Excretion- Average
Propylene glycol 150 mL elimination half-life is 2 to 3 hours; PREGNANCY AND LACTATION
Saccharin 1.8 g half-life is slightly prolonged in
Purified water 200 mL neonates (2.2 to 5 hours) and in Pregancy Considerations
Strawberry flavor 2 mL cirrhotics. Animal reproduction studies have not
Colorant q.s. INDICATION/S been conducted with intravenous
Glycerin q.s. ad, 1000 mL Adults and children at least 12 years acetaminophen, therefore,
of age: For the temporary reduction of acetaminophen I.V. is classified as a
PRODUCT DESCRIPTION fever and temporary relief of minor pregnancy category C. Acetaminophen
aches and pains caused by backache, crosses the placenta and can be
PHARMACOLOGIC CATEGORY the common cold, headache, detected in cord blood, newborn
Paracetamol possesses analgesic and menstrual cramps, minor arthritis serum, and urine immediately after
antipyretic activities with few anti- pain, muscular aches, and toothache. delivery.Increased risk of teratogenic
inflammatory effects. It has the same Children: Children 2 to 11 years of effects has not been observed
effectiveness as aspirin in inhibiting age: For the temporary reduction of following material use of
brain prostaglandin synthetase but fever and temporary relief of minor acetaminophen during pregnancy.
very little activity as a peripheral aches and pains caused by the Prenatal constriction of the ductus
prostaglandin inhibitor. This difference common cold, flu, headache, sore arteriosus has been noted in case
from aspirin and other NSAIDs might throat, and toothache. reports
explain its relative lack of
effectiveness as an anti-inflammatory. DOSAGE AND ROUTE OF
antirheumatic agent. Paracetamol ADMINISTRATION
does not inhibit normal platelet action,
prothrombin activity, or adversely INTERACTIONS
affect GI mucosal health. CONTRAINDICATIONS, Drug Interaction
PRECAUTIONS, WARNINGS Drugs that may affect Paracetamol
PHARMACODYNAMICS AND include activated charcoal,
PHARMACOKINETICS Contraindications: barbiturates, ethanol, hydantoins, and
Pharmacodynamics: Hypersensitivity to paracetamol or any sulfinpyrazone.
Inhibits the synthesis of component of the formulation; severe
prostaglandins in the central nervous hepatic impairment or severe active ADVERSE DRUG REACTION
system and peripherally blocks pain liver disease Dermatologic: Skin rash
impulse generation; produces Endocrine & metabolic: Decreased
antipyresis from inhibition of Precautions and Warnings: serum bicarbonate, decreased serum
hypothalamic heat-regulating center Paracetamol should be given with care calcium, decreased serum sodium,
Pharmacokinetics: to patients with impaired kidney or hyperchloremia, hyperuricemia,
Absorption/Distribution- Absorption of liver function; the BNF recommends increased serum glucose
paracetamol is rapid and peak plasma that large doses should be avoided in
Genitourinary: Nephrotoxicity (with may result. Complications of hepatic For suspected adverse drug reaction,
chronic overdosage) failure include acidosis, cerebral report to FDA: www.fda.gov.ph
Hematologic & oncologic: Anemia, edema, hemorrhage, hypoglycemia,
leukopenia, neutropenia, pancytopenia hypotension, infection, and renal DISTRIBUTED BY:
failure. UST Laboratories
OVERDOSE AND TREATMENT ESPAA, MANILA
Acute oral overdosage with Activated charcoal may be used to
paracetamol, whether accidental or reduce gastrointestinal absorption, if it
deliberate, is relatively common and can be given within 1 hour of the
can be extremely serious because of overdose, and if more than 150 mg/kg MANUFACTURED BY:
the narrow margin between of paracetamol has been ingested.
therapeutic and toxic doses. Toxic However, if acetylcysteine or
doses of paracetamol may cause methionine is to be given orally the
severe hepatocellular necrosis and, charcoal is best cleared from the
less often, renal tubular necrosis. stomach to prevent it reducing the
Paracetamol-induced hepatotoxicity is absorption of the antidote.
a major cause of acute liver failure in Reg. No.: DR-XYZ-02
western countries. Hepatotoxicity may STORAGE CONDITION Date of Renewal of Authorization:
occur after ingestion of more than 150 Preserve in tight containers, and store 14 February 2017
mg/kg, or rarely, as little as 75 mg/kg at controlled room temperature. Date of Revision of Package Insert:
of paracetamol within a 24-hour 14 February 2017
period. The risk of severe toxicity after DOSAGE FORM AND PACKAGING
acute paracetamol overdose appears AVAILABLE
to be less in children than in adults at Caplet: 160 mg, 325 mg, 500 mg
comparable doses; however, chronic Caplet, extended: 650 mg
use of supratherapeutic doses in Capsule: 80 mg
children has resulted in unintentional Drops: 48 mg/mL (15 mL); 60 mg/0.6
overdoses and severe hepatotoxicity. mL (15 mL); 80 mg/0.8 mL (15 mL);
100 mg/mL (15 mL, 30 mL)
Early signs of overdosage (very Elixir: 80 mg/5 mL, 120 mg/ 5 mL, 160
commonly nausea and vomiting mg/5 mL, 167 mg/5 mL, 325 mg/5 mL,
although they may also include Solution: 100 mg/mL (15 mL); 120
lethargy and sweating) usually settle mg/2.5 mL
within 24 hours. Abdominal pain may Suppository, rectal: 80 mg, 120 mg,
be the first indication of liver damage, 125 mg, 300 mg, 325 mg, 650 mg
which is not usually apparent for 24 to Suspension, oral: 160 mg/ 5 mL
48 hours and sometimes may be Suspension, oral drops: 80 mg/0.8 mL
delayed for up to 4 to 6 days after Tablet: 325 mg, 500 mg, 650 mg
ingestion. Liver damage is generally at Tablet, chewable: 80 mg, 160 mg
a maximum 72 to 96 hours after
ingestion. Hepatic failure, ADR REPORTING STATEMENT
encephalopathy, coma, and death
REFERENCE: The United States Pharmacopeia 37
and The National Formulary 32 (Vol. 2). Lexi-Comp, Inc. (1998). Drug
(2013). Rockville, MD: United States information handbook for nursing
Karen (Drug Facts and Comparison) Pharmacopeial Convention. (6th ed.). Hudson, Ohio: Lexi-
Comp.
Borgsdorf, L. R. (2010). Drug facts and Alison Brayfield, ed. (2014). Martindale:
comparisons 2010: pocket version. St. The Complete Drug Reference (38th
Louis, MO.: Wolters Kluwer Health. ed.). London: Pharmaceutical Press. American Pharmacists Association.(2014).
Drug information handbook: A clinically
Anderson, P. K. (2002). Handbook of relevant resource for all healthcare
Tatro, D.S. (Ed). 2005. A to Z drug facts professionals (23th ed.). Hudson, Ohio:
(6th ed.). St. Louis, MO: Facts and Clinical Drug Data (10th ed.). (N.
Lexi-Comp.
Comparisons. P. Stephen Zollo, Ed.) Unites
States of America: McGraw-Hill
Companies.