Dolo IV Infusion (Paracetamol)

• Composition :
  Each 100 ml contains: Paracetamol, IP 1,000 mg, Water for Injection, IP q.s.
• Indications :
  For short term treatment of moderate pain, especially following surgery and for the short term treatment of fever, when administration by I.V route is clinically justified.
• Pharmacodynamics :
  Paracetamol is an analgesic and antipyretic. Its mechanism of action is believed to inhibit prostaglandin synthesis, primarily within the central nervous system.
• Dosage and administration :
  Adults and adolescents weighing 50 kg and over: the recommended dosage of Dolo IV is 1,000 mg every 6 hours, up to a maximum daily dose of paracetamol of 4,000 mg per day. Adults and Adolescents Weighing Under 50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval should be 4 hours. Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg patients older than 2 years is supported by evidence from adequate and every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing well-controlled studies in adults with additional safety and interval of 4 hours. Acetaminophen injection should be administered only as a 15 minutes intravenous infusion
• Contraindications :
  Hypersensitivity to paracetamol or any of the other ingredients/components of the product and in severe and active hepatic impairment.
• Precautions and warnings :
  Do not use if allergic to paracetamol. Paracetamol should be given with care to patients with impaired renal or hepatic function. Large doses should be avoided in patients with hepatic impairment as overdose may harm the liver. Maximum recommended daily dose of paracetamol should not be exceeded. Paracetamol is administered in caution when administering acetaminophen in patients with hepatotoxicity following conditions: hepatic impairment or active hepatic disease, in cases of alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance ≤ 30 mL/min).
• Use in pregnancy, lactation & pediatrics :
  Pregnancy: Category C. There are no studies of intravenous acetaminophen in pregnant women. Use only if clearly needed. Nursing Mothers: Caution should be exercised when administered to nursing woman. Pediatric Use: The effectiveness of acetaminophen for acute pain and fever has not been studied in pediatric patients less than 2 years of age.
• Drug interactions :
  The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant.
• Adverse reactions :
  The most common adverse reactions in patients treated with acetaminophen are nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in paediatric patients.
• Therapy Area :
  Analgesics & Antipyretics