Pacipar IV Infusion

WARNING: Risk of Medication Errors and Hepatotoxicity

Careful attention is required when prescribing, preparing, and administering paracetamol infusion to avoid dosing errors that could lead to accidental overdose and potentially fatal outcomes. Ensure that:

• Doses in milligrams (mg) and milliliters (mL) are not confused to prevent overdose.
• Infusion pumps are correctly programmed.
• The total daily dose of paracetamol from all sources does not exceed the maximum recommended limits.

Paracetamol has been linked to acute liver failure, occasionally necessitating liver transplants or resulting in death. Most liver injuries occur with doses exceeding the maximum daily limits, often involving multiple paracetamol-containing products.

Composition

Qualitative and Quantitative Composition: Each 100mL vial contains: Paracetamol BP: 1g
Pharmaceutical Form: Solution for I.V. Infusion

Clinical Particulars

Therapeutic Indications:

Pacipar is indicated for the short-term treatment of moderate pain, especially post-surgery, and for the short-term treatment of fever when intravenous administration is necessary due to the urgency of pain or hyperthermia management and when other routes are not feasible.

Posology and Method of Administration:

• Route: Intravenous (IV) use.
• Patient Group: Restricted to adults, adolescents, and children weighing more than 33 kg.

Dosage

Dosing Based on Patient Weight:

*Patients weighing less will require smaller volumes.

**The maximum daily dose should be adjusted if the patient is receiving other paracetamol-containing products.

• Administration Interval: Minimum interval of 4 hours between doses. No more than 4 doses in 24 hours.
• Severe Renal Insufficiency: Increase the interval to at least 6 hours.
• Hepatocellular Insufficiency, Chronic Alcoholism, Chronic Malnutrition, and Dehydration: Maximum daily dose must not exceed 3 g.

Method of Administration:

• Administer the infusion over 15 minutes.
• Use a 0.8 mm needle (21-gauge) to remove the solution from vials.
• Close monitoring is essential, particularly at the end of the infusion to avoid air embolism.

Dosage

Dosing Based on Patient Weight:

– 33 kg to ≤ 50 kg:

  – Dose: 15 mg/kg

  – Volume: 1.5 mL/kg

  – Maximum Volume: 75 mL

  – Maximum Daily Dose: 60 mg/kg (not exceeding 3 g)

– > 50 kg with additional risk factors for hepatotoxicity:

  – Dose: 1 g

  – Volume: 100 mL

  – Maximum Volume: 100 mL

  – Maximum Daily Dose: 3 g

– > 50 kg with no additional risk factors:

  – Dose: 1 g

  – Volume: 100 mL

  – Maximum Volume: 100 mL

  – Maximum Daily Dose: 4 g

*Patients weighing less will require smaller volumes.

**The maximum daily dose should be adjusted if the patient is receiving other paracetamol-containing products.

• Administration Interval: Minimum interval of 4 hours between doses. No more than 4 doses in 24 hours.
• Severe Renal Insufficiency: Increase the interval to at least 6 hours.
• Hepatocellular Insufficiency, Chronic Alcoholism, Chronic Malnutrition, and Dehydration: Maximum daily dose must not exceed 3 g.

Method of Administration:

• Administer the infusion over 15 minutes.
• Use a 0.8 mm needle (21-gauge) to remove the solution from vials.
• Close monitoring is essential, particularly at the end of the infusion to avoid air embolism.

Contraindications

• Hypersensitivity to paracetamol.
• Severe hepatocellular insufficiency.

Special Warnings and Precautions for Use

• Avoid dosing errors by ensuring proper administration and monitoring.
• Patients should be checked for the presence of other paracetamol-containing medications.
• Doses higher than recommended can result in severe liver damage.
• Immediate treatment with an antidote should be provided in case of overdose.

Interactions with Other Medications

• Probenecid: Reduces paracetamol clearance; dose adjustment may be needed.
• Salicylamide: May prolong paracetamol elimination.
• Enzyme-Inducing Substances: Caution required.
• Oral Anticoagulants: Monitor INR values during and after concomitant use.

Use in Pregnancy and Lactation

• Pregnancy: Use only after careful risk assessment.
• Lactation: Paracetamol is excreted in small amounts in breast milk, with no reported adverse effects on nursing infants.

Undesirable Effects

Rare or Very Rare Adverse Reactions:

• Blood and Lymphatic System Disorders: Thrombocytopenia, leucopenia, neutropenia.
• Cardiovascular: Hypotension.
• Liver: Increased hepatic transaminases.
• General Disorders: Malaise.
• Hypersensitivity Reactions: Ranging from rash to anaphylactic shock.

Overdose

• Risk of severe liver injury, particularly in vulnerable populations.
• Immediate hospitalization and treatment with N-acetylcysteine (NAC) are required.

Pharmacological Properties

• Pharmacodynamics: Rapid onset of pain relief within 5-10 minutes; peak effect at 1 hour; duration 4-6 hours. Fever reduction begins within 30 minutes and lasts at least 6 hours.
• Pharmacokinetics: Linear up to 2g with rapid absorption, distribution, and metabolism primarily in the liver.

Pharmaceutical Particulars

• Incompatibilities: Do not mix with other products.
• Storage: Protect from heat and sunlight. Store below 25°C. Do not refrigerate or freeze.
• Shelf Life: 2 years.

Caution

Keep out of reach of children. To be sold by prescription only.