FEVADOL 200/MG SUPP FOR CHILDREN 10/SUPP

Indications

Approved Uses

Symptomatic treatment of fever and mild-to-moderate pain in children.

Dosage & Administration

Dosing by Condition

Children (fever or mild-moderate pain): 10-15 mg/kg per dose rectally every 4-6 hours as needed; do not exceed 60 mg/kg/day (or 4 doses/24 h, whichever is lower) unless directed by a clinician.

Initial Dose

10-15 mg/kg per dose rectally

Maintenance Dose

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

Maximum Dose

Rectal (children): 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 rectally every 4-6 hours; for a child weighing ~13-20 kg, one 200mg suppository per dose is appropriate; maximum 4 doses per 24 hours

Dose Adjustment Notes

Hepatic impairment/chronic alcohol exposure: use with caution and avoid exceeding recommended total daily dose; severe hepatic disease requires medical supervision. Renal impairment: if severe (e.g., CrCl <30 mL/min), extend dosing interval (e.g., every 6-8 hours) and keep within maximum daily dose.

How to Take

For rectal use only: wash hands, remove suppository from blister, insert gently into the rectum (usually pointed end first) while the child is lying on their side; keep the child lying for a few minutes to reduce expulsion (you may hold the buttocks together briefly if needed), then wash hands again.

Side Effects

Common Side Effects

Usually well tolerated; possible local rectal irritation (redness, soreness, discomfort) and occasional gastrointestinal upset (e.g., nausea).

Side Effect Frequency

Rectal irritation (e.g., local redness/soreness) is uncommon; hypersensitivity reactions (rash/urticaria) are rare; serious skin reactions (SJS/TEN) and blood dyscrasias are very rare; clinically significant liver injury is rare at recommended doses (risk increases with overdose or predisposing factors).

Safety & Warnings

Contraindications

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

Warnings & Precautions

Do not exceed recommended dose; avoid concurrent use with other paracetamol-containing products; use caution in hepatic disease, chronic alcohol use/malnutrition, and renal impairment; stop and seek care if rash/allergy occurs; if fever/pain persists >3 days (or worsens), consult a clinician.

Age Restriction

Pediatric use; 200 mg suppository is typically appropriate for children about 12-20 kg (≈2-6 years) using weight-based dosing (10-15 mg/kg/dose every 4-6 hours; max 60 mg/kg/day). For infants <3 months, use only on medical advice.

Drug Interactions

Drug Interactions

Warfarin (↑INR with repeated/prolonged use), enzyme inducers (carbamazepine, phenytoin, phenobarbital, rifampicin) and isoniazid (↑hepatotoxicity risk), alcohol/chronic ethanol use (↑hepatotoxicity risk), cholestyramine (↓absorption-mainly relevant to oral), metoclopramide/domperidone (↑absorption-oral only; not clinically relevant for rectal).

Interaction Severity

MAJOR/clinically significant: chronic heavy alcohol use or other hepatotoxic risk factors (increased hepatotoxicity risk). MODERATE: warfarin with regular/repeated paracetamol use (can increase INR/bleeding risk); isoniazid (hepatotoxicity risk); enzyme inducers such as carbamazepine, phenytoin, phenobarbital (hepatotoxicity risk). MINOR: cholestyramine can reduce absorption of oral paracetamol (separate dosing; not relevant to rectal route).

Food Interaction

No restriction

Special Populations

Children

10-15 mg/kg/dose rectally every 4-6 hours; for a child weighing ~13-20 kg, one 200mg suppository per dose is appropriate; maximum 4 doses per 24 hours

Storage & Patient Advice

Missed Dose

If used on a schedule, give as soon as remembered; if near the next dose, skip the missed dose and continue the regular schedule-do not double the dose. If used as needed, give the next dose when needed while respecting minimum intervals and maximum daily dose.

Stopping the Medicine

No taper required. May stop when symptoms resolve; do not exceed recommended dose/frequency and seek medical advice if fever persists >3 days or pain >5 days.

Overdose

Overdose may have minimal symptoms initially (first 24 h: nausea/vomiting/diaphoresis), followed by delayed hepatotoxicity at 24-72 h; seek urgent medical care immediately even if asymptomatic; management includes early activated charcoal (if appropriate) and N-acetylcysteine (NAC) guided by nomogram/clinical assessment.

Patient Counseling

Rectal use only; dose by the child’s weight and keep at least 4-6 hours between doses; do not exceed 4 doses in 24 hours (or the product/clinician maximum). Do not use with any other paracetamol-containing medicine. Insert gently and keep the child lying briefly to reduce expulsion. Store below 25°C. Seek medical advice if fever persists >3 days, pain persists >5 days, the child is very young or symptoms worsen; seek urgent help for suspected overdose even if the child seems well.

Monitoring Requirements

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

Pharmacology

Mechanism of Action

Analgesic/antipyretic action primarily via central inhibition of prostaglandin synthesis (COX activity) and modulation of pain pathways; antipyresis via hypothalamic heat-regulating center leading to increased heat dissipation.

Duration of Effect

4-6 hours

Half-Life

Approximately 2 hours (typical range ~1-3 hours in children with normal hepatic function).

Bioavailability

Rectal bioavailability is variable and generally lower/less predictable than oral, often cited around ~30-60% depending on formulation and placement (not reliably 63-89%).

Metabolism

Hepatic metabolism mainly via glucuronidation and sulfation; a minor pathway via CYP (notably CYP2E1) forms NAPQI, which is detoxified by glutathione at therapeutic doses.

Excretion

Primarily renal excretion (>90%) as inactive glucuronide and sulfate conjugates; a small fraction is excreted unchanged in urine.

Protein Binding

10-25%

Product Information

Available Dosage Forms

Suppository (rectal) for this specific product (FEVADOL 200 mg).

Composition per Dose

Each suppository: 200mg paracetamol

Generic Availability

Yes

OTC Alternatives

Other OTC paracetamol pediatric formulations (e.g., oral suspension) and ibuprofen oral suspension (age-appropriate, typically ≥3 months) are common alternatives; avoid duplicating paracetamol across products.

Pain Type

General

Nsaid

No

Opioid

No

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