Indications

Fast XR (Paracetamol/Acetaminophen) is indicated for the treatment of:

• Fever: Due to various causes.
• Pain: Headache, common cold and influenza symptoms, toothache, earache, body ache, myalgia, neuralgia, dysmenorrhea, sprains, colic pain, back pain, post-operative pain, and postpartum pain.
• Inflammatory Conditions: Rheumatic and osteoarthritic pain and joint stiffness.

Pharmacology

Paracetamol is a non-opioid analgesic and antipyretic. It works primarily in the central nervous system (CNS) by inhibiting prostaglandin synthesis, which increases the pain threshold and affects the hypothalamic heat-regulating center to reduce fever. Its anti-inflammatory effect is weak and limited to the CNS. Unlike NSAIDs, it does not inhibit cyclooxygenase (COX) in peripheral tissues.

Dosage & Administration

The dosage varies by formulation and patient age.

• Tablet:
  • Adults: 1-2 tablets every 4-6 hours (maximum 4 gm daily).
  • Children (6-12 years): ½ to 1 tablet 3-4 times daily.
• Extended Release Tablet:
  • Adults & Children >12 years: Two tablets every 6-8 hours (maximum 6 tablets in 24 hours). Do not crush.
• Syrup/Suspension:
  • Children 3-12 months: 10 mg/kg body weight 3-4 times daily.
  • 1-5 years: 1-2 teaspoonfuls 3-4 times daily.
• Suppository:
  • Children 3-12 months: 60-120 mg 4 times daily.
  • Adults & children >12 years: 0.5-1 gm 4 times daily.
• IV Infusion:
  • Adults >50 kg: 1000 mg every 6 hours or 650 mg every 4 hours. Maximum 4000 mg/day.
  • Children >2 to 12 years: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours. Maximum 75 mg/kg/day.

Interaction

• Alcohol: Can increase the risk of liver damage from overdose.
• Certain medications: Barbiturates, tricyclic antidepressants, and anticonvulsants may diminish the metabolism of Paracetamol, while chronic use of anticonvulsants or oral steroid contraceptives can increase its clearance.

Contraindications

Fast XR is contraindicated in patients with known hypersensitivity to Paracetamol.

Side Effects

Side effects are usually mild. Rare but serious reactions include blood disorders (thrombocytopenia, agranulocytosis), pancreatitis, and allergic reactions such as skin rashes.

Pregnancy & Lactation

Epidemiological studies have shown no ill effects from using Paracetamol at recommended dosages during pregnancy. It is excreted in breast milk in small, clinically insignificant amounts, and is not contraindicated for breastfeeding. However, a doctor's advice should always be followed.

Precautions & Warnings

• Use with caution in patients with severe renal or hepatic impairment, alcoholism, chronic malnutrition, or severe dehydration.
• Do not exceed the maximum recommended daily dose to avoid the risk of severe liver damage.
• Patients should not take other Paracetamol-containing products concurrently.
• Discontinue immediately if symptoms of allergy or hypersensitivity occur.

Overdose Effects

Overdose can cause severe liver damage, which may progress to encephalopathy, hemorrhage, and death. Symptoms in the first 24 hours include pallor, nausea, vomiting, and abdominal pain.

• Treatment: Immediate treatment is crucial. Activated charcoal can be used within 1 hour of ingestion. N-acetylcysteine is a specific antidote and is most effective if administered within 8 hours of ingestion.

Therapeutic Class

Fast XR is classified as a Non-Opioid Analgesic.

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.