Tylenol

Tylenol

paracetamol

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Full Prescribing Info
Contents
Paracetamol.
Action
Analgesic and antipyretic.
Pharmacokinetics: Paracetamol is rapidly absorbed from the gastrointestinal tract, primarily in the small intestine. This absorption process occurs by passive transport. Paracetamol is metabolized primarily by 1st-order kinetics. Mean maximal plasma levels occur within 20-90 min following ingestion. Paracetamol is metabolized in the liver.
In adults, the majority of paracetamol is conjugated with glucuronic acid and to a lesser extent with sulfuric acid. These conjugated metabolites lack biological activity. In premature, newborn and young infants, the sulfate conjugate predominates. Paracetamol appears to be widely distributed throughout most body fluids except fat and cerebrospinal fluid. Paracetamol binds minimally (<10%) to plasma proteins and binding is only increased slightly in plasma concentrations associated with overdose. The sulfate and glucuronide conjugates do not bind to plasma proteins even at relatively high concentrations.
The biological half-life of paracetamol in normal adults is about 2-3 hrs in the usual dosage range. It is shorter in children and longer in neonates and cirrhotic patients.
Indications/Uses
Temporary relief of fever and minor pains associated with cold, headache, toothache and immunization.
Dosage/Direction for Use
Children 11 years (32-43.9 kg): 3 tsp, 9-10 years (27-31.9 kg): 2½ tsp, 6-8 years (22-26.9 kg): 2 tsp, 4-5 years (16-21.9 kg): 1½ tsp, 2-3 years (11-15.9 kg): 1 tsp.
If needed, repeat dose every 4 hrs but not more than 5 times daily.
Shake well before using. Use only enclosed measuring cup.
Overdosage
Symptoms: 12-24 hrs after ingestion of potentially toxic overdose, the patient may manifest signs of gastrointestinal irritability, nausea, vomiting, anorexia, diaphoresis and pallor.
Treatment: The stomach should be emptied promptly by gastric lavage or by inducing emesis with syrup of ipecacuanha in a dose of 15 mL for children and 30 mL for adults accompanied by drinking copious quantities of water. The dose should be repeated if emesis does not occur in 20 min.
In the case of a mixed drug overdose, activated charcoal may be indicated. However, if activated charcoal has been administered, the stomach should be emptied by lavage before administering acetylcysteine treatment. Activated charcoal adsorbs acetylcysteine in vitro and may do so in patients, thereby reducing its effectiveness.
Adults and adolescents, regardless of the quantity of paracetamol reported to have been ingested, administer acetylcysteine immediately if ≤24 hrs have elapsed from the reported time of ingestion of an overdose of paracetamol.
Special Precautions
Give with care to patients with impaired renal or hepatic function.
Tylenol is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful. In case of accidental overdosage, contact a physician or Poisons Information Centre immediately. Prompt medical attention is critical even if signs and symptoms are not noticed.
Do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems.
Do not use with any other products containing paracetamol.
Use In Pregnancy & Lactation
Use in pregnancy: Pregnancy Category A: This area has not been extensively studied, although passage of unconjugated paracetamol via placental transfer has been demonstrated by analysis of urine samples.
Use in lactation: Amounts of paracetamol in milk range from 0.04-0.23% of the maternal dose. Maternal paracetamol ingestion in recommended analgesic doses does not appear to present a risk to the breastfed infant.
Adverse Reactions
Laboratory and clinical data have established that paracetamol in recommended doses is not nephrotoxic and hepatotoxic.
Dyspepsia, nausea or allergic reactions have been rarely reported.
Drug Interactions
Chronic heavy alcohol abusers may be at increased risk of hepatic toxicity from chronic paracetamol use, although reports of this event are rare.
Several reports suggest that paracetamol may produce a slight hypoprothrombinaemia when administered with coumarin derivatives. Periodic evaluation of prothrombin time should be performed when these agents are administered concurrently.
Storage
Store below 25°C.
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Presentation/Packing
Susp 160 mg/5 mL (rich, cherry-flavored liqd, alcohol- and aspirin-free) x 60 mL.
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