TYLENOL 350/MG SUPP FOR CHILDREN 10/SUPP

Indications

Approved Uses

Symptomatic relief of mild to moderate pain and reduction of fever (antipyretic) in children.

Dosage & Administration

Dosing by Condition

Children (pain/fever): 10-15 mg/kg per dose rectally every 4-6 hours as needed; do not exceed 60 mg/kg/day (or 4 g/day, whichever is lower) and generally no more than 4 doses in 24 hours unless specifically directed by a clinician.

Initial Dose

10-15 mg/kg per dose rectally

Maintenance Dose

10-15 mg/kg per dose every 4 to 6 hours as needed.

Maximum Dose

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

Children's Dosage

10-15 mg/kg/dose rectally every 4-6 hours; 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 the lowest effective dose, limit total daily dose, and avoid prolonged unsupervised use.

How to Take

Rectal use only: wash hands; remove suppository from blister; have the child lie on their side with the upper knee bent; gently insert the suppository into the rectum (pointed end first) until it is past the sphincter; hold buttocks together briefly and keep the child lying still for 1-2 minutes; wash hands after.

Side Effects

Common Side Effects

Rectal irritation/discomfort (e.g., burning, soreness, redness); nausea/vomiting; rash/urticaria (hypersensitivity).

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol or any excipient; severe hepatic impairment/active liver disease.

Warnings & Precautions

Do not exceed recommended dose and avoid duplicate paracetamol-containing products; use caution in hepatic impairment, chronic alcohol use, malnutrition/low glutathione states (e.g., dehydration), and renal impairment; stop and seek care if rash/skin reaction occurs; avoid prolonged unsupervised use; rectal route: avoid/use caution with rectal inflammation/bleeding.

Age Restriction

Not recommended for infants <3 months unless advised by a doctor; otherwise use weight-based pediatric dosing (this 350 mg suppository is generally for larger children based on mg/kg).

Drug Interactions

Drug Interactions

Warfarin/coumarins (clinically relevant with regular/prolonged use); alcohol and other hepatotoxic drugs; enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑ hepatotoxicity risk); cholestyramine (↓ absorption); metoclopramide/domperidone (↑ absorption rate); flucloxacillin (risk of high anion gap metabolic acidosis, especially with risk factors).

Interaction Severity

MAJOR: Other paracetamol-containing products/overdose risk; chronic heavy alcohol use (increased hepatotoxicity risk). MODERATE: Warfarin (regular repeated use may increase INR/bleeding risk), enzyme inducers (carbamazepine, phenytoin, phenobarbital, rifampin) and isoniazid (may increase hepatotoxicity risk). MINOR: Metoclopramide/domperidone (may increase absorption rate), cholestyramine (may reduce absorption if given close together).

Food Interaction

No restriction

Special Populations

Children

10-15 mg/kg/dose rectally every 4-6 hours; maximum 5 doses per 24 hours

Storage & Patient Advice

Storage Conditions

Store below 30°C. Keep in original packaging. Do not freeze.

Missed Dose

Administer as soon as remembered; skip if it is nearly time for the next dose; do not double the dose

Stopping the Medicine

No taper is required; may stop when no longer needed. Seek medical advice if used regularly for >3 days for fever or >5 days for pain, or if symptoms persist/worsen.

Overdose

Early symptoms may be mild or nonspecific (nausea, vomiting, abdominal pain, pallor) with hepatotoxicity typically developing 24-72 hours later; seek emergency care immediately; treat with N-acetylcysteine (NAC) as soon as possible (activated charcoal may be used if presentation is within ~1 hour of ingestion) plus supportive care.

Patient Counseling

Rectal use only (do not swallow); use the correct dose for the child’s weight/age and keep at least 4-6 hours between doses; do not exceed the recommended maximum daily dose (commonly no more than 4 doses/24 h unless directed); do not use with any other product containing paracetamol; seek urgent help after any suspected overdose even if the child seems well; store below 30°C; see a clinician if fever persists >2-3 days or pain persists/worsens.

Monitoring Requirements

No routine monitoring is needed for short-term OTC use at recommended doses; consider liver function monitoring (and clinical assessment) with prolonged use, high doses, or in hepatic risk factors, and monitor INR if used regularly with warfarin.

Pharmacology

Mechanism of Action

Analgesic/antipyretic via predominantly central inhibition of prostaglandin synthesis (COX pathway) and modulation of central pain/thermoregulatory pathways; reduces fever by acting on the hypothalamic heat-regulating center.

Duration of Effect

4-6 hours.

Half-Life

Approximately 2-3 hours (range ~1-4 hours; may be longer in neonates or hepatic impairment)

Metabolism

Hepatic metabolism primarily via glucuronidation and sulfation; a minor fraction via CYP (mainly CYP2E1, also CYP1A2/3A4) to NAPQI, detoxified by glutathione

Excretion

Primarily renal excretion as glucuronide and sulfate conjugates; a small fraction is excreted unchanged (about 2-5%).

Protein Binding

Low protein binding at therapeutic concentrations (~10-25%); increases in overdose (can rise to ~20-50%)

Product Information

Available Dosage Forms

For this SFDA-registered product: Suppository (rectal). (Paracetamol is also available in other markets/forms such as oral tablets/capsules/liquids and IV infusion, but those are not this specific product.)

Composition per Dose

Each suppository: 350mg paracetamol

Generic Availability

Yes

OTC Alternatives

Alternative OTC antipyretic/analgesic options include ibuprofen (age-appropriate oral suspension; suppository where available) and other paracetamol formulations (oral liquid/tablets) if the rectal route is not desired and the child can take oral medicines.

Pain Type

General

Nsaid

No

Opioid

No

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