ADOL 500/MG 10/SUPP

Indications

Approved Uses

Temporary relief of mild-to-moderate pain and reduction of fever.

Dosage & Administration

Dosing by Condition

Pain/fever: Adults and adolescents ≥50 kg: 500-1,000 mg rectally every 4-6 hours as needed (max 4,000 mg/day). Adults <50 kg or hepatic risk factors: use lower total daily maximum (often ≤3,000 mg/day) and/or longer intervals. Children: dose by weight 10-15 mg/kg per dose every 4-6 hours as needed (max 60 mg/kg/day; do not exceed 4 doses/24 h).

Initial Dose

500-1000 mg rectally

Maintenance Dose

500-1000 mg every 4-6 hours as needed

Maximum Dose

Rectal (suppository): Adults and adolescents ≥50 kg: 500-1000 mg per dose every 4-6 hours as needed; maximum 4000 mg in 24 hours. Children: 10-15 mg/kg per dose every 4-6 hours as needed; maximum 60 mg/kg/day (do not exceed 4000 mg/day).

Children's Dosage

Children 6-12 years: 250-500 mg every 4-6 hours rectally (max 4 doses/day). Children 1-5 years: 125-250 mg every 4-6 hours rectally. Neonates/infants: use weight-based dosing (10-15 mg/kg/dose every 4-6 hours) under medical supervision

Dose Adjustment Notes

Hepatic impairment/chronic alcohol use/malnutrition/low body weight: use the lowest effective dose and consider a reduced maximum daily dose (often ≤3,000 mg/day) and/or longer intervals; severe renal impairment (CrCl <30 mL/min): extend dosing interval (e.g., every 6-8 hours).

How to Take

For rectal use only: wash hands before and after; remove from blister/wrapper; insert the suppository (pointed end first) gently into the rectum while lying on your side; remain lying for a few minutes to reduce expulsion. If too soft, chill briefly to firm before insertion.

Side Effects

Common Side Effects

Uncommon: nausea, vomiting. Uncommon: rectal irritation/discomfort (suppository). Rare: hypersensitivity reactions (rash/urticaria). Very rare/serious: severe skin reactions (SJS/TEN), blood dyscrasias (e.g., thrombocytopenia/agranulocytosis), liver injury (especially with overdose).

Side Effect Frequency

Uncommon: nausea, vomiting; rectal irritation/discomfort. Rare: hypersensitivity reactions (rash/urticaria). Very rare/serious: severe skin reactions (SJS/TEN), blood dyscrasias (e.g., thrombocytopenia/agranulocytosis), liver injury (especially with overdose).

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol (or excipients); severe hepatic impairment/active severe liver disease (and generally avoid in severe hepatic failure).

Warnings & Precautions

Do not exceed recommended dose or use multiple paracetamol-containing products concurrently; maximum adult daily dose is 4 g/day (lower-often ~2 g/day-in severe liver disease/chronic alcoholism/malnutrition); use caution in hepatic or renal impairment and chronic alcohol use; discontinue and seek care if rash or hypersensitivity occurs; rectal use: avoid/use caution with significant rectal inflammation/lesions.

Age Restriction

No absolute minimum age per se for paracetamol, but ADOL 500 mg suppository is generally intended for older children/adolescents/adults; in infants <3 months use only on medical advice, and dosing must be weight-based (typical pediatric dose 10-15 mg/kg per dose).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin/coumarins (INR may increase with regular/prolonged paracetamol use); chronic alcohol use and enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑ hepatotoxicity risk); cholestyramine can reduce absorption of oral paracetamol (less relevant for rectal use).

Interaction Severity

MAJOR: Chronic heavy alcohol use (increased hepatotoxicity risk, especially with supratherapeutic dosing). MODERATE: Warfarin (regular use for several days may increase INR-monitor); enzyme inducers (rifampicin, carbamazepine, phenytoin, phenobarbital) and isoniazid (increased hepatotoxicity risk). MINOR/route-dependent: cholestyramine (reduces oral absorption) and metoclopramide (increases oral absorption rate) - largely not relevant for rectal use.

Food Interaction

No clinically relevant food interaction (not applicable for rectal administration).

Alcohol Interaction

Dangerous

Special Populations

Breastfeeding

Safe

Children

Children 6-12 years: 250-500 mg every 4-6 hours rectally (max 4 doses/day). Children 1-5 years: 125-250 mg every 4-6 hours rectally. Neonates/infants: use weight-based dosing (10-15 mg/kg/dose every 4-6 hours) under medical supervision

Elderly

Standard adult dosing is generally appropriate, but consider a lower maximum daily dose (e.g., 2-3g) in frail or malnourished elderly patients.

Liver Impairment

Use with caution in hepatic impairment; in severe hepatic impairment/cirrhosis or chronic alcoholism, reduce maximum total daily dose to about 2 g/day and/or extend dosing interval; avoid unsupervised use in severe liver disease.

Storage & Patient Advice

Missed Dose

If used regularly, take as soon as remembered unless it is close to the next dose; otherwise skip and continue the schedule-do not double doses. If used as needed, take the next dose when needed within maximum daily limits.

Stopping the Medicine

No taper is required; may stop when no longer needed. Do not exceed the maximum daily dose, and seek medical advice if symptoms persist or if high/frequent dosing has been used for several days.

Overdose

Early symptoms: nausea, vomiting, diaphoresis, abdominal pain; hepatotoxicity may develop over 24-72 hours with jaundice, coagulopathy, encephalopathy; management is urgent medical assessment with prompt N-acetylcysteine (NAC) and supportive care (activated charcoal only if a recent oral ingestion is suspected).

Patient Counseling

Do not exceed the recommended dose or maximum daily dose (adults usually max 4,000 mg/day; consider ≤3,000 mg/day in hepatic risk factors/low body weight). Do not use with other products containing paracetamol. Avoid alcohol. Use rectally as directed; if too soft, chill briefly before insertion. Seek urgent care after any suspected overdose even if well. If fever persists >3 days or pain persists >5 days (or symptoms worsen), consult a clinician; avoid use with significant rectal inflammation/bleeding unless advised.

Monitoring Requirements

No routine monitoring for short-term use. Liver function tests may be required for long-term use or in patients with risk factors.

Pharmacology

Mechanism of Action

Analgesic/antipyretic via central inhibition of prostaglandin synthesis (COX activity in the CNS) and action on the hypothalamic thermoregulatory center; minimal peripheral anti-inflammatory effect.

Onset of Action

Approximately 30-60 minutes; rectal absorption can be slower and more variable than oral.

Duration of Effect

4-6 hours

Bioavailability

Rectal bioavailability is variable, typically ~30-80% (often cited ~50-60%), generally lower and more variable than oral.

Metabolism

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

Product Information

Available Dosage Forms

Suppository (rectal).

Composition per Dose

Each suppository: 500 mg paracetamol

OTC Alternatives

Other OTC paracetamol products (including other paracetamol suppositories) and, when appropriate, ibuprofen (age/contraindication dependent). Avoid aspirin for children/adolescents; in adults it may be an option if no contraindications.

Pain Type

General

Nsaid

No

Opioid

No

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