PARACETAMOL S.A.L.F. 10mg/ml Infusion/Solution for

What is PARACETAMOL S.A.L.F. 10mg/ml

PARACETAMOL S.A.L.F. 10mg/ml is a sterile solution for intravenous infusion containing the active ingredient paracetamol, a widely used non-opioid analgesic and antipyretic agent. It is presented in a 100ml plastic bag, designed for hospital and clinical use, particularly when oral administration is not feasible.

• Each milliliter contains 10mg of paracetamol, totaling 1000mg (1g) per 100ml infusion bag.
• Used to relieve mild to moderate pain such as headache, musculoskeletal pain, or postoperative discomfort.
• Commonly administered to reduce fever in acute settings.
• Indicated for use in adults, adolescents, and children over a certain weight threshold (typically >10 kg), under professional supervision.

It is particularly suitable for patients who are fasting, vomiting, or unconscious, where oral or rectal routes are impractical.

How to use PARACETAMOL S.A.L.F. 10mg/ml

PARACETAMOL S.A.L.F. 10mg/ml is administered intravenously and should only be given by healthcare professionals in a controlled setting such as a hospital.

• Route: Intravenous infusion only.
• Duration: Administer over 15 minutes to reduce the risk of local venous irritation or hypotension.
• Frequency: As prescribed, usually every 4 to 6 hours, not exceeding the maximum daily dose.
• Equipment: Use a dedicated IV line, ensuring compatibility with other intravenous fluids.

Ensure the solution is clear and free from particles before administration. Discard any unused portion of the opened container. Dosage depends on age, weight, and clinical condition of the patient.

Mode of Action PARACETAMOL S.A.L.F. 10mg/ml

Paracetamol primarily works by inhibiting prostaglandin synthesis in the central nervous system. It exerts its effects through several mechanisms:

• Analgesic Action: Paracetamol inhibits cyclooxygenase (COX) enzymes, particularly COX-2, in the brain and spinal cord, reducing the perception of pain.
• Antipyretic Action: It acts on the hypothalamic heat-regulating center to reduce fever by promoting peripheral vasodilation and sweating.
• No Anti-inflammatory Activity: Unlike NSAIDs, paracetamol has minimal effect on peripheral inflammation.
• Safe on GI Mucosa: It does not affect gastric mucosal prostaglandins, making it safer than NSAIDs for patients with ulcers or bleeding risks.

Its rapid onset via IV route makes it highly effective in acute pain and fever management scenarios.

PARACETAMOL S.A.L.F. 10mg/ml Interactions PARACETAMOL S.A.L.F. 10mg/ml

Paracetamol generally has a favorable interaction profile, but caution should be exercised when used with the following:

• Hepatotoxic drugs: Concomitant use with isoniazid, rifampin, or alcohol increases the risk of liver damage.
• Enzyme inducers: Medications like carbamazepine and phenytoin may increase the metabolism of paracetamol, potentially reducing efficacy and increasing toxic metabolite formation.
• Warfarin and other anticoagulants: Prolonged use may enhance anticoagulant effect and risk of bleeding.
• Chloramphenicol: Paracetamol can slow the metabolism of chloramphenicol, increasing the risk of toxicity.
• Probenecid: May reduce paracetamol clearance by affecting hepatic metabolism.

Always inform the healthcare provider of all current medications before starting therapy to avoid harmful interactions.

Dosage of PARACETAMOL S.A.L.F. 10mg/ml

Dosage depends on age, weight, and clinical condition of the patient. The following are general guidelines for IV paracetamol:

• Adults and adolescents ≥50 kg: 1g (100 ml) every 6 hours, not to exceed 4g per 24 hours.
• Adolescents and children 10–50 kg: 15 mg/kg per dose every 6 hours. Do not exceed 60 mg/kg/day or 3g/day.
• Children 1–10 kg: 7.5 mg/kg per dose every 6 hours. Max 30 mg/kg/day.
• Renal/hepatic impairment: Dose adjustments are required. Consult specialist guidelines.

Infusion should be administered over 15 minutes. Avoid exceeding the recommended dose to prevent hepatotoxicity.

Possible side effects of PARACETAMOL S.A.L.F. 10mg/ml

Although paracetamol is generally well-tolerated, especially when used appropriately, intravenous administration may be associated with some side effects:

• Common:
  • Nausea
  • Vomiting
  • Injection site pain or irritation
  • Headache
• Less common:
  • Low blood pressure during infusion
  • Flushing
  • Increased liver enzymes (with prolonged or high doses)
• Rare but serious:
  • Severe allergic reactions (anaphylaxis)
  • Liver damage/hepatotoxicity in overdose
  • Thrombocytopenia or other blood dyscrasias (very rare)

Report any signs of hypersensitivity, jaundice, or unusual fatigue promptly to a healthcare provider.

PARACETAMOL S.A.L.F. 10mg/ml Contraindications PARACETAMOL S.A.L.F. 10mg/ml

This medicine should not be used in the following situations:

• Hypersensitivity: Known allergy to paracetamol or any excipients in the formulation.
• Severe hepatic impairment: Patients with acute liver failure or decompensated chronic liver disease.
• Severe renal impairment: Use with caution and at adjusted doses in moderate renal impairment.
• Children under 33 weeks gestational age: Not recommended due to limited data on safety.
• Concurrent use of hepatotoxic drugs: Avoid simultaneous use unless benefits outweigh the risk.

A full clinical assessment is necessary before initiating IV paracetamol in critically ill patients.

Storage of PARACETAMOL S.A.L.F. 10mg/ml

Proper storage ensures the safety and effectiveness of the medication:

• Temperature: Store below 25°C. Do not freeze.
• Light Protection: Keep the infusion bag in its original overwrap to protect from light until ready to use.
• Shelf-life: Check the expiration date on the outer packaging. Do not use if expired.
• Opened bag: Should be used immediately. Discard any unused portion to prevent contamination.
• Handling: Inspect solution visually. Do not use if cloudy or if particulate matter is present.

Keep out of reach of children. Only trained healthcare professionals should handle and administer the infusion.