TYLENOL 100/MG SUPP FOR CHILDREN 10/SUPP

Indications

Approved Uses

For the temporary relief of fever and mild to moderate pain.

Dosage & Administration

Dosing by Condition

Children (fever or mild-moderate pain): 10-15 mg/kg/dose rectally every 4-6 hours as needed; do not exceed 60 mg/kg/day (or 4 g/day, whichever is lower).

Initial Dose

10-15 mg/kg per dose rectally

Maintenance Dose

10-15 mg/kg every 4-6 hours as needed

Maximum Dose

Rectal (children): 10-15 mg/kg per dose every 4-6 hours as needed; do not exceed 60 mg/kg/day (maximum 4 doses in 24 hours).

Children's Dosage

10-15 mg/kg/dose rectally every 4-6 hours; 100mg suppository is suitable for infants and children approximately 6-12 months (6-10 kg); maximum 5 doses per 24 hours

Dose Adjustment Notes

Renal impairment: if severe (e.g., CrCl <30 mL/min), extend dosing interval (e.g., at least every 6-8 hours) and avoid excessive total daily dose; hepatic impairment/chronic alcohol use/malnutrition: use lowest effective dose, avoid prolonged/high-dose use, and do not exceed recommended maximum daily dose.

How to Take

Remove suppository from blister/foil; if soft, chill briefly; moisten with water or use a water-based lubricant if needed; insert gently into the rectum (generally pointed end first) and keep the child lying on their side for a few minutes to reduce expulsion.

Side Effects

Common Side Effects

Local rectal irritation/discomfort; nausea/vomiting; hypersensitivity reactions (rash/urticaria/angioedema, bronchospasm); blood dyscrasias (e.g., thrombocytopenia, leukopenia/agranulocytosis).

Side Effect Frequency

Uncommon: nausea/vomiting; Rare: local rectal irritation/discomfort; Rare/very rare: hypersensitivity reactions (rash/urticaria/angioedema, bronchospasm) and blood dyscrasias (e.g., thrombocytopenia, leukopenia/agranulocytosis).

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol (acetaminophen) or any excipients; severe hepatic impairment/active severe liver disease.

Warnings & Precautions

Do not exceed recommended dose; avoid concurrent use with other paracetamol-containing products; use caution in hepatic impairment, chronic alcohol use, malnutrition/low body weight, and dehydration; use caution in renal impairment (extend interval); stop and seek care if rash/skin reaction occurs; seek urgent care for suspected overdose even if asymptomatic.

Age Restriction

Generally suitable from ≥3 months of age (or ≥5 kg); for infants <3 months, use only under medical supervision.

Drug Interactions

Drug Interactions

Warfarin/coumarins (increased INR with regular/prolonged paracetamol use); alcohol and other hepatotoxic drugs (additive liver injury risk); enzyme-inducing anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital) and rifampicin (increased hepatotoxicity risk); isoniazid (increased hepatotoxicity risk).

Interaction Severity

MAJOR: Warfarin (clinically significant INR increase with repeated/regular paracetamol use, especially higher doses). MODERATE: Chronic heavy alcohol use, isoniazid, and enzyme inducers (carbamazepine, phenytoin, phenobarbital, rifampicin) due to increased hepatotoxicity risk. MINOR: Cholestyramine (reduces oral absorption if given close together; not relevant to rectal route).

Food Interaction

No restriction

Special Populations

Children

10-15 mg/kg/dose rectally every 4-6 hours; 100mg suppository is suitable for infants and children approximately 6-12 months (6-10 kg); maximum 5 doses per 24 hours

Storage & Patient Advice

Missed Dose

Administer the dose as soon as remembered. If it is almost time for the next dose, skip the missed dose and continue with the regular schedule. Do not administer a double dose.

Stopping the Medicine

Can be stopped abruptly; no tapering required.

Overdose

Early symptoms may be nonspecific (nausea, vomiting, diaphoresis, pallor, abdominal pain) with delayed hepatotoxicity at 24-72 hours (elevated transaminases, jaundice, coagulopathy, hepatic failure ± renal failure); treat as a medical emergency-N-acetylcysteine (NAC) as early as possible (guided by nomogram for acute ingestions) and supportive care.

Patient Counseling

Use rectally only: remove from blister, insert gently, and keep child lying briefly to prevent expulsion; dose by weight and do not exceed maximum daily dose; avoid using with any other paracetamol-containing products; seek urgent help after any suspected overdose even if well; store below 30°C; consult a clinician if fever/pain persists (e.g., >3 days) or if signs of liver injury occur.

Monitoring Requirements

No routine monitoring for short-term OTC use; consider liver function monitoring if prolonged/repeated high-dose use or in hepatic risk (liver disease, chronic alcohol use, malnutrition) and monitor INR if used regularly with warfarin.

Pharmacology

Mechanism of Action

Inhibits prostaglandin synthesis in the central nervous system and peripherally blocks pain impulse generation; reduces fever by acting on the hypothalamic heat-regulating center to produce peripheral vasodilation and sweating

Onset of Action

Rectal onset typically ~30-60 minutes (may be delayed/variable compared with oral).

Duration of Effect

4-6 hours.

Half-Life

Approximately 2 hours in healthy children/adults (typical range ~1-3 hours).

Bioavailability

Rectal bioavailability is variable, commonly lower and erratic than oral (often cited roughly ~30-80% depending on formulation and placement).

Metabolism

Primarily hepatic metabolism via glucuronidation and sulfation; a small fraction undergoes CYP-mediated oxidation (mainly CYP2E1, also CYP1A2/3A4) to NAPQI, which is detoxified by glutathione.

Excretion

Primarily renal excretion as inactive metabolites (glucuronide and sulfate conjugates), with a small fraction unchanged.

Protein Binding

10-25%.

Product Information

Available Dosage Forms

Suppository (rectal) for this SFDA-registered product; other paracetamol products exist in oral forms (tablets/caplets, oral liquid) but are not part of this specific registered item.

Composition per Dose

Each suppository: 100mg paracetamol

Generic Availability

Yes

OTC Alternatives

Other paracetamol pediatric formulations (e.g., oral suspension) and ibuprofen (oral suspension; generally for age ≥6 months if no contraindications).

Pain Type

General

Nsaid

No

Opioid

No

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