FEVADOL 100/MG SUPP FOR CHILDREN 10/SUPP

Indications

Approved Uses

For the relief of mild to moderate pain and to reduce fever.

Dosage & Administration

Dosing by Condition

Fever or mild-moderate pain (children, rectal): 10-15 mg/kg per dose every 4-6 hours as needed; maximum 60 mg/kg/day (or 4 doses/24 h, whichever is lower).

Initial Dose

Rectal: 10-15 mg/kg per dose (e.g., 1 suppository = 100 mg if this matches the child’s weight-based dose), every 4-6 hours as needed.

Maintenance Dose

15 mg/kg rectally every 4-6 hours as needed; maximum 4 doses/24 hours.

Maximum Dose

Rectal (children): 10-15 mg/kg per dose every 4-6 hours as needed; do not exceed 60 mg/kg/day (maximum 4 doses in 24 hours).

Children's Dosage

10-15mg/kg/dose every 4-6 hours rectally; 100mg suppository is appropriate for infants and young children approximately 6-12 months or 6-10kg body weight; do not exceed 60mg/kg/day

Dose Adjustment Notes

Use caution in hepatic impairment and chronic alcohol use; avoid exceeding total daily dose and keep appropriate dosing intervals. In severe renal impairment, extend dosing interval (e.g., longer intervals when CrCl is markedly reduced).

How to Take

Remove suppository from blister; if soft, chill briefly to firm. Wash hands before/after. Moisten with water or use a small amount of water‑based lubricant. Insert gently into the rectum (usually pointed end first) and keep the child lying on their side for a few minutes to reduce expulsion.

Side Effects

Common Side Effects

Generally well tolerated; possible rectal irritation/discomfort; occasional hypersensitivity reactions (e.g., rash).

Side Effect Frequency

At therapeutic doses: adverse effects are uncommon/rare; hypersensitivity reactions (rash/urticaria/bronchospasm) and blood dyscrasias (e.g., thrombocytopenia) are rare; rectal irritation can occur with suppositories but is not typically common

Safety & Warnings

Contraindications

Hypersensitivity to paracetamol (acetaminophen) or any excipients; severe hepatic impairment/active liver disease is commonly listed as a contraindication/avoid-use condition; avoid use in proctitis/rectal bleeding for rectal dosage forms.

Warnings & Precautions

Do not exceed recommended dose or use multiple paracetamol-containing products; use caution/seek medical advice in hepatic disease, chronic alcohol use, malnutrition/dehydration, or renal impairment; stop and seek care if rash/allergy occurs; rectal absorption may be unreliable (e.g., diarrhea) and avoid use with rectal inflammation/bleeding; seek medical advice if symptoms persist (e.g., >3 days).

Age Restriction

Can be used in infants and children; in infants <3 months use only on medical advice/supervision (age alone is not an absolute contraindication).

Drug Interactions

Drug Interactions

Warfarin/coumarins (regular use may increase INR/bleeding); alcohol and other hepatotoxic drugs (additive liver injury risk); enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (increase hepatotoxicity risk); cholestyramine (reduces absorption if given close in time); metoclopramide/domperidone (increase absorption rate).

Interaction Severity

MAJOR: Chronic heavy alcohol use or other hepatotoxic risk factors (increased hepatotoxicity risk with overdose/high doses). MODERATE: Warfarin (regular repeated paracetamol use may increase INR/bleeding risk). MODERATE: Enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (may increase hepatotoxicity risk). MINOR: Cholestyramine (reduces absorption if given close together); metoclopramide/domperidone (increase rate of absorption-primarily relevant to oral forms).

Food Interaction

No restriction

Special Populations

Children

10-15mg/kg/dose every 4-6 hours rectally; 100mg suppository is appropriate for infants and young children approximately 6-12 months or 6-10kg body weight; do not exceed 60mg/kg/day

Kidney Impairment

If severe renal impairment: extend dosing interval (e.g., CrCl 10-50 mL/min: every 6 hours; CrCl <10 mL/min: every 8 hours).

Storage & Patient Advice

Missed Dose

If a dose is missed (scheduled use), give it when remembered unless it is close to the next dose; do not double the dose. If used PRN, give only when needed and maintain minimum dosing interval.

Stopping the Medicine

May stop when no longer needed; no taper required.

Overdose

Early symptoms may include nausea, vomiting, abdominal pain, pallor; serious hepatotoxicity can be delayed (24-72 h) with hepatic failure ± renal injury; management is urgent medical assessment with N-acetylcysteine as soon as possible (and activated charcoal if a recent oral ingestion).

Patient Counseling

Do not exceed recommended dose/interval; avoid using with any other paracetamol-containing products; store below 25°C (per SFDA) and keep out of children’s reach; insert rectally as directed (moisten/lubricate, gentle insertion, remain lying briefly; chill if soft); seek medical advice if fever persists >3 days or symptoms worsen; seek urgent help after any suspected overdose even if the child appears well.

Monitoring Requirements

No routine monitoring for short-term OTC use at recommended doses; consider liver function monitoring with prolonged/repeated high-dose use or in hepatic disease/malnutrition/chronic alcohol exposure.

Pharmacology

Mechanism of Action

Analgesic/antipyretic via inhibition of prostaglandin synthesis predominantly in the CNS; antipyresis through action on the hypothalamic thermoregulatory center.

Onset of Action

Rectal onset typically ~30-60 minutes and may be slower/more variable than oral.

Duration of Effect

4-6 hours

Half-Life

Approximately 2-3 hours (range ~1-4 hours; may be longer in neonates or hepatic impairment)

Bioavailability

Rectal bioavailability is variable and generally lower than oral, commonly cited around ~30-70%.

Metabolism

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

Excretion

Primarily renal excretion as conjugated metabolites (glucuronide/sulfate); a small fraction is excreted unchanged (about 2-5%).

Protein Binding

Low protein binding: ~10-25% (often cited as <20% at therapeutic concentrations)

Product Information

Available Dosage Forms

Suppository (rectal).

Composition per Dose

Each suppository: 100mg paracetamol

Generic Availability

Yes

OTC Alternatives

Paracetamol oral suspension (e.g., Panadol Baby syrup), ibuprofen oral suspension for children over 3 months

Pain Type

General

Nsaid

No

Opioid

No

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