ADOL 250/MG 10/SUPP

Indications

Approved Uses

For the relief of mild to moderate pain and for the reduction of fever.

Off-Label Uses

None specific to this rectal OTC product; paracetamol in other formulations may be used in hospital settings (e.g., IV adjunct analgesia), but that is not an off-label use claim needed for this SKU.

Dosage & Administration

Dosing by Condition

Pain/Fever (rectal paracetamol): Children: 10-15 mg/kg per dose every 4-6 hours as needed (max 60 mg/kg/day or 4 doses/day, whichever is lower). Adults/adolescents: 500-1000 mg every 4-6 hours as needed (max 4 g/day; lower max in hepatic risk).

Initial Dose

250 mg rectally once; may repeat every 4-6 hours as needed.

Maximum Dose

Rectal: 20 mg/kg every 6 hours; max 75-90 mg/kg/day in children depending on age/weight; for 250 mg suppository, limit to avoid exceeding weight-based max.

Children's Dosage

10-15mg/kg per dose every 4-6 hours rectally; 250mg suppository suitable for children approximately 6-12 years or 20-40kg; do not exceed 5 doses in 24 hours

Dose Adjustment Notes

Renal impairment: if severe (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/low body weight: use the lowest effective dose and reduce maximum daily dose (often ≤2-3 g/day in adults at risk) and avoid prolonged unsupervised use.

How to Take

For rectal use only. Wash hands before and after. Remove the suppository from the blister/foil; if soft, chill briefly to firm. If possible, empty the bowels first. Place patient on their side with upper knee bent; gently insert the suppository (pointed end first) into the rectum past the sphincter. Keep lying still for a few minutes to reduce expulsion.

Side Effects

Common Side Effects

Rectal irritation/discomfort; nausea; vomiting; abdominal discomfort; rash/urticaria (rare); hypersensitivity reactions (rare).

Side Effect Frequency

Common: rectal irritation/discomfort, nausea, vomiting, abdominal discomfort. Rare: rash/urticaria, hypersensitivity reactions.

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol (or excipients); severe hepatic impairment/active liver disease.

Warnings & Precautions

Do not exceed recommended dose and avoid duplicate paracetamol-containing products; use caution/consider lower maximum daily dose in hepatic impairment, chronic alcohol use, malnutrition/low body weight, dehydration, and severe renal impairment; stop and seek care if rash or hypersensitivity occurs; avoid prolonged regular use without medical advice.

Age Restriction

No fixed minimum age; use is weight-based, but 250 mg suppository strength is generally suitable for children ~15-25 kg (about 3-7 years) and younger children should use lower-strength pediatric formulations unless medically advised.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin/coumarins (INR may increase with regular/prolonged use); alcohol and enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑ hepatotoxicity risk); cholestyramine (↓ absorption if given close together); metoclopramide/domperidone (↑ absorption rate); probenecid (↓ clearance/↑ exposure); flucloxacillin (rare risk of high anion gap metabolic acidosis with paracetamol, especially with risk factors); busulfan (↑ busulfan exposure-avoid/monitor).

Interaction Severity

MAJOR: Alcohol/chronic heavy alcohol use (increased hepatotoxicity risk with overdose or prolonged high dosing). Flucloxacillin (rare risk of high anion gap metabolic acidosis, especially with risk factors). MODERATE: Warfarin (INR increase with regular repeated dosing), enzyme inducers such as rifampicin/carbamazepine/phenytoin/phenobarbital (increase hepatotoxicity risk), isoniazid (hepatotoxicity risk), probenecid (increases paracetamol exposure), busulfan (increased busulfan concentrations-avoid/monitor). MINOR: Cholestyramine (reduces absorption if oral; not relevant to rectal), metoclopramide (increases oral absorption rate; not relevant to rectal).

Food Interaction

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

Alcohol Interaction

Dangerous

Special Populations

Breastfeeding

Safe

Children

10-15mg/kg per dose every 4-6 hours rectally; 250mg suppository suitable for children approximately 6-12 years or 20-40kg; do not exceed 5 doses in 24 hours

Elderly

No specific adjustment required; use the lowest effective dose and do not exceed the adult maximum (1,000 mg/day for this 250 mg suppository regimen).

Liver Impairment

Severe hepatic impairment/active liver disease: avoid/contraindicated; mild-moderate impairment or chronic alcohol misuse/malnutrition: use with caution and reduce total daily dose and/or extend dosing interval (commonly max 2-3 g/day in adults depending on risk).

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose.

Stopping the Medicine

May stop when no longer needed; no tapering required.

Overdose

Early (0-24 h): nausea, vomiting, pallor, diaphoresis; hepatic injury typically emerges 24-72 h (may be evident by 12-48 h) with RUQ pain, rising transaminases, jaundice, coagulopathy; urgent medical assessment is required and treatment is N-acetylcysteine (plus activated charcoal if early after ingestion) without waiting for symptoms.

Patient Counseling

Use for rectal use only and follow age/weight dosing; do not exceed recommended dose or frequency and do not use with any other paracetamol-containing products. Insert gently and keep lying briefly; if softened, chill to firm. Seek urgent medical help for suspected overdose even if well. Avoid alcohol in adolescents/adults. If fever lasts >3 days or pain >5 days (or symptoms worsen), seek medical advice; seek advice sooner for very young children or if signs of serious illness/dehydration occur.

Monitoring Requirements

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

Pharmacology

Mechanism of Action

Analgesic/antipyretic primarily via central inhibition of prostaglandin synthesis (central COX activity) and modulation of central pain pathways; antipyresis via action on the hypothalamic thermoregulatory center.

Onset of Action

Rectal onset is variable; typically about 30-60 minutes, and may be slower/unpredictable than oral depending on rectal contents and formulation.

Duration of Effect

4-6 hours

Half-Life

Elimination half-life in healthy individuals is typically ~2-3 hours (often cited range ~1-4 hours).

Bioavailability

Rectal bioavailability is variable and generally lower than oral; commonly cited around ~30-60% (can be higher with some formulations), whereas oral bioavailability is ~70-90%.

Metabolism

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

Excretion

Renal excretion predominantly as glucuronide and sulfate conjugates; <5% excreted unchanged.

Protein Binding

Low protein binding at therapeutic concentrations (~10-25%); may increase in overdose.

Product Information

Available Dosage Forms

Suppository (rectal).

Composition per Dose

Each suppository: 250mg paracetamol

Generic Availability

Yes

OTC Alternatives

Other OTC antipyretic/analgesic options include oral paracetamol products (tablets/syrup) and ibuprofen (age-appropriate oral formulations); rectal alternatives depend on local availability.

Pain Type

General

Nsaid

No

Opioid

No

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