PANADREX BABY&INFANT SYRUP 100ML

Indications

Approved Uses

Mild to moderate pain relief, fever reduction in infants and children

Dosage & Administration

Dosing by Condition

Fever or mild-to-moderate pain (infants/children): 10-15 mg/kg per dose orally every 4-6 hours as needed; maximum 4 doses in 24 hours (and do not exceed age/weight-appropriate maximum daily dose).

Initial Dose

10-15mg/kg per dose orally

Maintenance Dose

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

Maximum Dose

60mg/kg/day (not to exceed 4 doses in 24 hours); do not use for more than 3 days for fever or 5 days for pain without medical advice

Children's Dosage

Infants 3-6 months: 2.5ml (60mg) per dose; 6-24 months: 5ml (120mg) per dose; 2-4 years: 7.5ml (180mg) per dose; 4-6 years: 10ml (240mg) per dose; all doses every 4-6 hours, maximum 4 doses per day. Not recommended for infants under 3 months without medical supervision.

Dose Adjustment Notes

Renal impairment: extend dosing interval in severe impairment (e.g., CrCl <30 mL/min-dose no more frequently than every 6-8 hours). Hepatic impairment: use caution, avoid exceeding recommended total daily dose, and avoid use in severe hepatic impairment/active liver disease.

How to Take

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

Side Effects

Common Side Effects

Side effects are uncommon at recommended doses. Possible: nausea, vomiting, abdominal discomfort; skin rash/urticaria (hypersensitivity). Rare: blood dyscrasias (e.g., thrombocytopenia, agranulocytosis).

Side Effect Frequency

Uncommon: nausea, vomiting, abdominal discomfort; rash/urticaria. Rare: serious hypersensitivity reactions and blood dyscrasias (e.g., thrombocytopenia, agranulocytosis).

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-containing products; use caution in hepatic impairment, chronic alcohol use, malnutrition/low glutathione states (e.g., dehydration, prolonged fasting), and renal impairment; seek medical advice for infants <3 months or if symptoms persist.

Age Restriction

Usable from birth only under medical advice; routine OTC use generally from ≥3 months (or ≥5 kg) per pediatric guidance-consult a doctor for infants <3 months.

Drug Interactions

Drug Interactions

Warfarin (INR may increase with repeated/prolonged use), alcohol and other hepatotoxic drugs (↑ liver injury risk), enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑ hepatotoxicity risk), cholestyramine (↓ absorption if given close), metoclopramide/domperidone (↑ rate of absorption), and flucloxacillin (rare risk of high anion gap metabolic acidosis/pyroglutamic acidosis especially with risk factors).

Interaction Severity

MAJOR/clinically significant: Warfarin (regular, repeated paracetamol use may increase INR/bleeding risk). MODERATE: Alcohol/chronic heavy alcohol use or other hepatotoxic drugs (increased hepatotoxicity risk), enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital) 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; can be taken with or without food (food may slightly delay onset/absorption).

Special Populations

Children

Infants 3-6 months: 2.5ml (60mg) per dose; 6-24 months: 5ml (120mg) per dose; 2-4 years: 7.5ml (180mg) per dose; 4-6 years: 10ml (240mg) per dose; all doses every 4-6 hours, maximum 4 doses per day. Not recommended for infants under 3 months without medical supervision.

Kidney Impairment

If significant renal impairment, extend dosing interval: CrCl 10-50 mL/min give no more often than every 6 hours; CrCl <10 mL/min no more often than every 8 hours.

Storage & Patient Advice

Storage Conditions

Store below 30°C and protect from light.

Missed Dose

If a dose is missed (when scheduled/regular use): give as soon as remembered unless it is close to the next dose; then skip and resume the usual schedule-do not double doses.

Stopping the Medicine

Do not stop abruptly if the medicine has been used regularly for several days or at high/frequent doses; reduce and stop under medical advice. If used only occasionally/as needed, it may be stopped when no longer required. Do not exceed the recommended dose or duration; seek medical advice if fever/pain persists or if repeated dosing is needed.

Overdose

Early symptoms: nausea, vomiting, diaphoresis/pallor, abdominal pain; hepatotoxicity may be delayed with LFT rise and liver failure typically 24-72 h after ingestion. Management: urgent medical evaluation, consider activated charcoal if within ~1-2 h, and give N-acetylcysteine as early as possible per nomogram-based protocols.

Patient Counseling

Dose by the child’s weight using the provided measuring device; shake well; give every 4-6 hours as needed and do not exceed 4 doses/24 hours; avoid any other products containing paracetamol; seek urgent help after any suspected overdose even if the child seems well; see a clinician if fever lasts >3 days, symptoms worsen, or the child is very young/has red-flag symptoms; store below 30°C and protect from light.

Monitoring Requirements

No routine monitoring for short-term OTC use at recommended doses; consider liver function monitoring with prolonged/repeated use, high-risk patients, or known hepatic disease, and monitor INR if used regularly with warfarin.

Pharmacology

Mechanism of Action

Analgesic/antipyretic via inhibition of central prostaglandin synthesis (central COX activity) and action on hypothalamic thermoregulation; peripheral anti-inflammatory activity is minimal.

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours.

Half-Life

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

Bioavailability

Oral bioavailability approximately 63-89%.

Metabolism

Hepatic metabolism primarily via glucuronidation and sulfation; a small fraction undergoes CYP-mediated oxidation (mainly CYP2E1, also CYP1A2/CYP3A4) to NAPQI, which is detoxified by glutathione.

Excretion

Renal excretion predominantly as conjugated metabolites (glucuronide and sulfate); only a small fraction is excreted unchanged (typically <5%).

Protein Binding

10-25%.

Product Information

Available Dosage Forms

Syrup (oral liquid).

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

Other OTC pediatric paracetamol products of equivalent strength/formulation; pediatric ibuprofen suspension (generally for children ≥6 months, if no contraindications).

Pain Type

General

Nsaid

No

Opioid

No

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