ADOL 125MG SUPP

Indications

Approved Uses

Symptomatic treatment of mild to moderate pain and fever (antipyretic and analgesic), including in pediatric patients where rectal administration is appropriate.

Dosage & Administration

Dosing by Condition

Fever or mild-moderate pain (children): dose by weight-typically 10-15 mg/kg per dose every 4-6 hours as needed (rectal route acceptable), with a maximum of 4 doses in 24 hours (and do not exceed usual pediatric daily maximums per local guidance). A 125 mg suppository approximates a 10-15 mg/kg dose for a child ~8-12.5 kg.

Initial Dose

125mg rectally (single dose for children approximately 3 months to 1 year or as weight-based dosing: 10-15 mg/kg/dose)

Maintenance Dose

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

Maximum Dose

Rectal (paracetamol): 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 every 4-6 hours rectally; 125mg suppository suitable for children approximately 3 months to 2 years (5-12 kg); do not exceed 60 mg/kg/day

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 use without medical supervision.

Side Effects

Common Side Effects

Usually well tolerated; possible adverse effects include local rectal irritation/discomfort (with suppositories) and rare hypersensitivity reactions (e.g., rash); gastrointestinal effects such as nausea are uncommon at therapeutic doses.

Side Effect Frequency

Uncommon: local rectal irritation/discomfort; Rare: hypersensitivity reactions (e.g., rash/urticaria/angioedema) and blood dyscrasias (e.g., thrombocytopenia); Very rare: severe cutaneous adverse reactions (SJS/TEN/AGEP). Hepatic/renal injury is primarily associated with overdose (or prolonged high-dose use).

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol or any excipients; avoid use in severe hepatic impairment/active liver disease; avoid rectal use if there is rectal/anal inflammation, bleeding, or recent anorectal surgery (product-specific).

Warnings & Precautions

Do not exceed recommended dose or use multiple paracetamol-containing products; seek urgent advice after any suspected overdose even if well; use caution in hepatic disease, chronic alcohol use, malnutrition/dehydration, and renal impairment; stop and seek care if rash/skin reaction occurs; avoid rectal use with rectal/anal pathology (inflammation/bleeding).

Age Restriction

May be used in infants and children when weight-based dosing is followed; in infants <3 months use only with medical advice/supervision.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin (INR may increase with repeated/prolonged paracetamol use); alcohol and enzyme inducers (e.g., carbamazepine, phenytoin, rifampicin) and isoniazid (increased hepatotoxicity risk); cholestyramine (reduced absorption if given close together); metoclopramide/domperidone (faster absorption-mainly relevant to oral forms).

Interaction Severity

MAJOR/clinically significant: chronic heavy alcohol use or other hepatotoxic risk factors (increased hepatotoxicity risk with overdose/high doses); MODERATE: warfarin (regular scheduled paracetamol for several days can increase INR), enzyme inducers such as carbamazepine/phenytoin/phenobarbital/rifampicin and isoniazid (increase hepatotoxicity risk), cholestyramine (reduces absorption-separate dosing); MINOR: metoclopramide/domperidone (may increase absorption rate-less relevant for rectal).

Food Interaction

No restriction

Alcohol Interaction

Dangerous

Special Populations

Breastfeeding

Safe

Children

10-15 mg/kg/dose every 4-6 hours rectally; 125mg suppository suitable for children approximately 3 months to 2 years (5-12 kg); do not exceed 60 mg/kg/day

Elderly

Rectal: Use the lowest effective dose; typical maximum 3,000 mg/day in frail elderly or low body weight (do not exceed 4,000 mg/day).

Liver Impairment

Use with caution in hepatic impairment; in severe hepatic impairment/active liver disease avoid or use only under specialist/medical supervision with reduced total daily dose and/or extended interval.

Storage & Patient Advice

Missed Dose

If a dose is missed, give it when remembered if still needed; if it is close to the next dose, skip the missed dose-do not double; keep at least 4-6 hours between doses and do not exceed 4 doses in 24 hours.

Stopping the Medicine

May be stopped at any time when no longer needed; no tapering required.

Overdose

May be initially asymptomatic or cause nausea/vomiting/abdominal pain; serious hepatotoxicity can develop over 24-72 hours-seek urgent medical care; treatment is time-critical N-acetylcysteine (NAC) and supportive management (activated charcoal may be used early after ingestion).

Patient Counseling

For rectal use only; do not exceed 4 doses in 24 hours and keep at least 4-6 hours between doses; avoid using any other paracetamol-containing products concurrently; seek medical advice if symptoms persist (e.g., fever >3 days or pain persists) or if the child is very young/appears unwell; in overdose, seek urgent care immediately even if well; store below 30°C and protect from light (per SFDA data).

Monitoring Requirements

No routine monitoring is needed for short-term OTC use at recommended doses; consider liver function monitoring/clinical review with prolonged or 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

Analgesic/antipyretic effect primarily via central inhibition of prostaglandin synthesis (COX activity in the CNS) and action on hypothalamic thermoregulation; additional pathways (e.g., serotonergic descending modulation) may contribute.

Onset of Action

Rectal paracetamol has a variable onset, commonly about 30-60 minutes (may be slower than oral depending on formulation and rectal conditions).

Duration of Effect

4-6 hours

Half-Life

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

Bioavailability

Rectal bioavailability is lower and highly variable compared with oral; reported ranges vary widely (often roughly ~30-80% depending on formulation and placement), so it should be considered unpredictable rather than a single fixed value.

Metabolism

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

Excretion

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

Protein Binding

Low protein binding at therapeutic concentrations (about 10-25%; often cited as <20%).

Product Information

Available Dosage Forms

Paracetamol is available (market-dependent) as tablets/caplets, capsules, oral liquid (solution/suspension), suppositories, and intravenous infusion/injection.

Composition per Dose

Each suppository: 125mg paracetamol

Generic Availability

Yes

OTC Alternatives

Paracetamol oral suspension (e.g., Adol syrup, Panadol syrup), paracetamol tablets for older children and adults, ibuprofen oral suspension for children over 3 months

Pain Type

General

Nsaid

No

Opioid

No

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