Indications

Renova (Paracetamol/Acetaminophen) is indicated for relieving various types of pain and fever. These include fever, common cold, and influenza. It is also used for headache, toothache, earache, body ache, myalgia, neuralgia, dysmenorrhea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain, and post-vaccination pain in children. Furthermore, it is indicated for rheumatic and osteoarthritic pain and stiffness of joints.

Pharmacology

Paracetamol is an analgesic and antipyretic. It works primarily in the central nervous system (CNS) by inhibiting the synthesis of prostaglandins, which are involved in pain and fever. It does this by indirectly blocking the cyclooxygenase (COX) enzymes, particularly in the brain, leading to an increased pain threshold. It also has a direct effect on the heat-regulating center in the hypothalamus to reduce fever. Unlike NSAIDs, it has very weak anti-inflammatory effects in peripheral tissues.

Dosage & Administration

• Tablet:
  • Adults: 1-2 tablets every 4-6 hours (maximum of 8 tablets or 4 gm daily).
  • Children (6-12 years): ½ to 1 tablet 3-4 times daily (maximum 2.6 gm/day for long-term use).
• Extended-Release Tablet:
  • Adults & Children >12 years: Two tablets every 6-8 hours (maximum of 6 tablets in 24 hours). Do not crush.
• Syrup/Suspension:
  • Children <3 months: 10 mg/kg body weight 3-4 times daily.
  • 3 months to <1 year: ½ to 1 teaspoonful 3-4 times daily.
  • 1-5 years: 1-2 teaspoonfuls 3-4 times daily.
  • 6-12 years: 2-4 teaspoonfuls 3-4 times daily.
• Suppository:
  • Children 3-12 months: 60-120 mg, 4 times daily.
  • Children 1-5 years: 125-250 mg, 4 times daily.
  • Children 6-12 years: 250-500 mg, 4 times daily.
  • Adults & children >12 years: 0.5-1 gm, 4 times daily.
• Pediatric Drop:
  • Up to 3 months: 0.5 ml (40 mg).
  • 4-11 months: 1.0 ml (80 mg).
  • 7 months-2 years: 1.5 ml (120 mg).
• IV Infusion:
  • Adults & adolescents ≥50 kg: 1000 mg every 6 hours or 650 mg every 4 hours (maximum 4000 mg daily).
  • Adults & adolescents <50 kg & children >2 years: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours (maximum 75 mg/kg daily).

Interaction

• Barbiturates, tricyclic antidepressants, and alcohol can reduce the metabolism of large doses of Renova.
• Chronic use of anticonvulsants or oral contraceptives may increase the clearance of Renova, reducing its effectiveness.
• Alcohol can increase the risk of liver toxicity with an overdose.

Contraindications

Renova is contraindicated in patients with a known hypersensitivity to Paracetamol.

Side Effects

Side effects are usually mild but can include haematological reactions (e.g., thrombocytopenia, leucopenia), pancreatitis, skin rashes, and other allergic reactions.

Pregnancy & Lactation

While epidemiological studies show no ill effects from recommended doses during pregnancy, it should be used under a doctor's guidance. It is excreted in breast milk in small amounts, which are not considered clinically significant.

Precautions & Warnings

• Use with caution in patients with severe kidney or liver impairment, alcoholism, chronic malnutrition, or severe hypovolemia.
• Do not exceed the recommended dose, as overdose can cause severe liver injury and death.
• Patients should not take other products containing paracetamol at the same time.

Overdose Effects

Overdose can cause liver damage, which may become apparent 12-48 hours after ingestion. Symptoms include pallor, nausea, vomiting, and abdominal pain. In severe cases, it can lead to liver failure, encephalopathy, and death. Immediate medical treatment is essential.

Therapeutic Class

Renova is a Non-Opioid Analgesic.

Storage Conditions

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