Reset 15 ml Pediatric Drops

Reset Pediatric Drops 80 mg/ml

Generic: Paracetamol (Acetaminophen) 80 mg/ml
Manufacturer: Incepta Pharmaceuticals Ltd.
Dosage Form: Pediatric Oral Drop Solution
Pack Size: 15 ml bottle

Indications

Reset Pediatric Drops are indicated for the relief of fever and mild-to-moderate pain in infants and young children, including:

• Fever (pyrexia) from any cause, including post-vaccination fever
• Common cold and influenza-associated fever
• Headache, toothache, earache, and bodyache
• Myalgia and neuralgia
• Colic pain and back pain
• Post-operative and post-vaccination pain

Pharmacology

Paracetamol (acetaminophen) exerts its analgesic action primarily in the central nervous system by raising the pain threshold through inhibition of prostaglandin synthesis via COX-1, COX-2, and the CNS-selective COX-3 enzyme variant. Unlike NSAIDs, paracetamol does not inhibit cyclooxygenase in peripheral tissues and therefore lacks significant peripheral anti-inflammatory activity.

Its antipyretic effect is mediated by direct action on the heat-regulating centre of the hypothalamus, resulting in peripheral vasodilation, sweating, and heat dissipation. Paracetamol also peripherally blocks pain impulse generation to produce supplementary analgesia.

Dosage & Administration

Pediatric Drops (80 mg/ml) — Weight-based dosing (10–15 mg/kg per dose):

Do not exceed more than 5 doses in 24 hours. Do not use for more than 5 consecutive days without medical supervision.

Contraindications

• Known hypersensitivity or allergy to paracetamol or any component of the formulation

Warnings & Precautions

• Hepatotoxicity: Overdose is the most common cause of paracetamol-induced liver damage. Do not exceed the recommended dose. Risk is higher in patients with hepatic impairment, non-cirrhotic alcoholic liver disease, malnutrition, or dehydration.
• Administer with caution in children with severe renal impairment (creatinine clearance <30 ml/min).
• Do not use concurrently with other paracetamol-containing products.
• Discontinue immediately if signs of hypersensitivity or anaphylaxis occur.
• Keep out of reach of children.

Side Effects

Paracetamol is generally well tolerated. Uncommon side effects include:

• Haematological: thrombocytopenia, leucopenia, neutropenia, agranulocytosis
• Gastrointestinal: nausea, abdominal pain, pancreatitis (rare)
• Dermatological: skin rashes and other allergic reactions

Drug Interactions

• Alcohol: Chronic alcohol use increases the risk of paracetamol-induced hepatotoxicity.
• Barbiturates, tricyclic antidepressants: May diminish the metabolism of large doses of paracetamol.
• Anticonvulsants (carbamazepine, phenytoin, phenobarbitone, rifampicin): Induce liver enzymes, increasing first-pass metabolism and reducing plasma paracetamol levels.
• Oral contraceptives: May increase paracetamol clearance.

Overdose

Liver damage may occur after ingestion of excessive doses. Early symptoms (first 24 hours) include nausea, vomiting, pallor, and abdominal pain. Hepatic injury may become apparent 12–48 hours post-ingestion. In severe cases, hepatic failure, encephalopathy, and death may result. Treat as a medical emergency. N-acetylcysteine is the antidote and is most effective within 8 hours of ingestion.

Pregnancy & Lactation

Not applicable (pediatric formulation). Paracetamol is considered safe in recommended doses during pregnancy and lactation based on epidemiological data.

Storage

Store in a dry place, away from direct light and heat. Keep out of reach of children.

Disclaimer: This product information is for reference purposes only and does not substitute professional medical advice, diagnosis, or treatment. Always consult a registered physician or qualified healthcare professional before taking any medication.