PANADOL BABY&INFANT SUSP 100ML

Indications

Approved Uses

Temporary relief of mild to moderate pain and reduction of fever in infants and children.

Dosage & Administration

Dosing by Condition

Fever or mild-moderate pain (infants/children): 10-15 mg/kg per dose orally every 4-6 hours as needed; do not exceed 4 doses in 24 hours (max 60 mg/kg/day unless otherwise directed by a clinician).

Initial Dose

10-15mg/kg per dose orally

Maintenance Dose

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

Maximum Dose

Do not exceed 4 doses in 24 hours. Maximum daily dose is 60 mg/kg/day (maximum 4,000 mg/day).

Children's Dosage

2-3 months: 2.5ml (60mg) single dose for post-immunization fever only; 3-12 months: 2.5ml (60mg) every 4-6 hours, max 4 doses/24h; 1-5 years: 5-10ml (120-240mg) every 4-6 hours, max 4 doses/24h; 6-12 years: 10-20ml (240-480mg) every 4-6 hours, max 4 doses/24h; weight-based dosing preferred: 10-15mg/kg/dose

Dose Adjustment Notes

Renal impairment: extend dosing interval in severe renal impairment (e.g., CrCl <30 mL/min use at least every 6-8 hours). Hepatic impairment/chronic alcohol use/malnutrition: use caution, avoid exceeding recommended daily dose and consider lower total daily dose; neonates/premature infants require age-specific reduced dosing regimens.

How to Take

Shake well before each use. Measure the dose accurately using the provided oral syringe/cup (do not use a household spoon). Administer by mouth; may be given with or without food.

How to Prepare

Shake well before use. Measure doses with the supplied oral syringe/spoon; do not use a household teaspoon.

Side Effects

Common Side Effects

Generally well tolerated at recommended doses; uncommon/rare: nausea, vomiting, rash/urticaria (hypersensitivity).

Side Effect Frequency

Uncommon/rare: nausea, vomiting, rash/urticaria (hypersensitivity). Serious skin reactions and blood dyscrasias are rare; clinically significant hepatotoxicity is primarily associated with overdose.

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol or any excipient, severe hepatic impairment, active liver disease

Warnings & Precautions

Do not exceed recommended dose; do not use with any other paracetamol/acetaminophen-containing products; seek medical advice for persistent fever/pain (e.g., >3 days) or if the child is very young; use with caution in hepatic disease, chronic alcohol use, malnutrition/dehydration, and renal impairment; keep out of reach and use accurate dosing device.

Age Restriction

Use in infants ≥2 months of age; for <2 months only on medical advice (and typically only after clinical assessment).

Drug Interactions

Drug Interactions

Key interactions: warfarin/coumarins (INR may increase with regular/prolonged paracetamol use), alcohol and other hepatotoxic drugs (↑ hepatotoxicity risk), enzyme inducers such as carbamazepine/phenytoin/phenobarbital (↑ toxic metabolite formation/↓ effect), isoniazid (↑ hepatotoxicity risk), cholestyramine (↓ absorption if given close together).

Interaction Severity

MAJOR: Chronic heavy alcohol use (increased hepatotoxicity risk). MODERATE: Warfarin (regular repeated dosing over several days can increase INR/bleeding risk), isoniazid, and enzyme inducers such as carbamazepine/phenytoin/phenobarbital (increased hepatotoxicity risk). MINOR: Cholestyramine (reduced absorption-separate by ≥1 hour), metoclopramide/domperidone (faster absorption/onset).

Food Interaction

No food restrictions; may be given with or without food (food can delay absorption/onset slightly).

Special Populations

Children

2-3 months: 2.5ml (60mg) single dose for post-immunization fever only; 3-12 months: 2.5ml (60mg) every 4-6 hours, max 4 doses/24h; 1-5 years: 5-10ml (120-240mg) every 4-6 hours, max 4 doses/24h; 6-12 years: 10-20ml (240-480mg) every 4-6 hours, max 4 doses/24h; weight-based dosing preferred: 10-15mg/kg/dose

Storage & Patient Advice

Preparation Instructions

Shake well before use. Measure doses with the supplied oral syringe/spoon; do not use a household teaspoon.

Missed Dose

If a dose is missed and the child still needs it, give it when remembered, ensuring at least 4 hours between doses; do not give a double dose and do not exceed 4 doses in 24 hours.

Stopping the Medicine

May be stopped when no longer needed; no taper is required.

Overdose

Early symptoms (0-24 h) may include nausea, vomiting, diaphoresis, pallor, abdominal pain; hepatotoxicity can develop 24-72 h with rising transaminases, RUQ pain, jaundice, coagulopathy, encephalopathy/acute liver failure; management: urgent medical assessment, consider activated charcoal if within ~1 hour, and give N-acetylcysteine (NAC) as soon as possible (greatest benefit within 8-10 h, but still indicated later).

Patient Counseling

Shake well before each dose and measure only with the provided device. Dose by the child’s weight; leave at least 4 hours between doses and do not give more than 4 doses in 24 hours. Do not use with any other product containing paracetamol/acetaminophen. Seek medical advice if symptoms persist (e.g., >3 days) or if the child is very young, dehydrated, or has liver disease. Store below 30°C and keep out of reach of children; in suspected overdose, seek urgent care immediately even if the child seems well.

Monitoring Requirements

No routine monitoring is needed for short-term OTC use; consider liver function monitoring with prolonged/repeated high-dose use or in patients with hepatic disease/risk factors.

Pharmacology

Mechanism of Action

Produces analgesic and antipyretic effects primarily via central inhibition of prostaglandin synthesis (central COX activity) and action on the hypothalamic thermoregulatory center; peripheral anti-inflammatory activity is minimal.

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours.

Half-Life

Typically ~2-3 hours in children/adults; prolonged in neonates/young infants (~3-5 hours).

Bioavailability

Approximately 70-90% (oral; variable due to first-pass metabolism and formulation/feeding effects).

Metabolism

Hepatic metabolism predominantly via glucuronidation and sulfation; a minor CYP pathway (mainly CYP2E1, also CYP1A2/CYP3A4) forms NAPQI, detoxified by glutathione at therapeutic doses.

Excretion

Renal; >90% excreted in urine within 24 hours mainly as glucuronide and sulfate conjugates (small amounts as cysteine/mercapturate; <5% unchanged).

Protein Binding

Low: ~10-25% at therapeutic concentrations (increases with higher concentrations/overdose).

Product Information

Available Dosage Forms

For this SFDA-registered product: oral suspension (120 mg/5 mL; 24 mg/mL). (Paracetamol as an ingredient is also available in other dosage forms such as tablets/capsules, suppositories, and IV infusion depending on market/product.)

Composition per Dose

Each 5ml: 120mg paracetamol (24mg/ml)

Generic Availability

Yes

OTC Alternatives

Ibuprofen pediatric oral suspension (if age/weight appropriate and no contraindications).

Pain Type

General

Nsaid

No

Opioid

No

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