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ParaSelix™-IV

Paracetamol Infusion IP (1.0% w/v)

PACKING SIZE / TYPE

100 ml

Summary

Paracetamol Infusion IP (1.0% w/v) is a sterile intravenous formulation of Paracetamol (1.0% w/v) designed for the rapid management of fever and mild to moderate pain when oral administration is not feasible. It ensures quick onset of action, making it ideal for hospital and clinical settings.

Side Effects

Paracetamol Infusion IP (1.0% w/v) is generally well tolerated. However, some patients may experience:

  • Nausea or vomiting
  • Headache
  • Hypotension (rare during infusion)
  • Allergic reactions (rash, itching)
  • Elevated liver enzymes (with prolonged use)

Usage

Paracetamol Infusion IP (1.0% w/v) is indicated for:

  • Management of mild to moderate pain
  • Treatment of fever
  • Post-operative pain relief
  • Pain management in critically ill patients
  • Situations where oral or rectal administration is not possible

Concerns

  • Risk of hepatotoxicity in overdose or prolonged high-dose use
  • Careful calculation of total daily paracetamol intake is essential
  • Must be administered under medical supervision

When not to use?

  • Known hypersensitivity to Paracetamol or any excipient
  • Severe hepatic impairment or active liver disease
  • Patients with paracetamol overdose history

Warnings

  • Use with caution in patients with liver impairment
  • Avoid exceeding the recommended dose
  • Monitor liver function in long-term use
  • Caution in chronic alcohol users
  • Ensure proper dosing to avoid overdose toxicity

Dosage

  • Administered intravenously (IV infusion) under medical supervision
  • Dosage depends on age, body weight, and clinical condition

Interactions

  • Alcohol: Increases risk of liver toxicity
  • Anticoagulants (e.g., Warfarin): May enhance anticoagulant effect with prolonged use
  • Enzyme-inducing drugs (e.g., Phenytoin, Carbamazepine): May increase hepatotoxicity risk
  • Other Paracetamol-containing products: Risk of overdose

General Instructions

  • Use only under the supervision of a healthcare professional
  • Do not mix with other drugs in the same infusion
  • Check solution for clarity before administration
  • Store in a cool, dry place away from light
  • Keep out of reach of children

Other Details

  • Dosage Form: Intravenous Infusion
  • Strength: 1.0% w/v
  • Pack Size: As per availability
  • Route: Intravenous (IV)

References

  • WHO Model Formulary
  • British National Formulary (BNF)
  • Goodman & Gilman’s The Pharmacological Basis of Therapeutics
  • Clinical Guidelines on Paracetamol Use in IV Therapy
  • FDA Drug Safety Communications on Paracetamol
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