PARACETAMOL KABI 10mg/ml Infusion/Solution for

What is PARACETAMOL KABI 10mg/ml

PARACETAMOL KABI 10 mg/ml is a sterile intravenous solution containing paracetamol (acetaminophen) at a concentration of 10 mg/mL. Each 100 mL glass vial contains 1,000 mg (1 g) of paracetamol. Packaged in sets of 10 vials, this formulation is intended for use in hospitals, emergency departments, perioperative situations, and critical care units.

• Active Ingredient: Paracetamol, 10 mg/mL (1 g/100 mL)
• Form: Intravenous infusion solution
• Packaging: 100 mL glass vials × 10 per carton
• Therapeutic Class: Non-opioid analgesic and antipyretic
• Indications: Management of mild to moderate pain and fever, especially when oral/rectal dosing is not feasible
• Target Population: Adults, adolescents, and pediatric patients (based on weight), under clinician supervision

This IV paracetamol ensures rapid absorption, with peak blood levels reached within 10–15 minutes, making it effective for quick symptom relief in acute clinical settings.

How to use PARACETAMOL KABI 10mg/ml

This medication must only be administered by trained medical staff in a clinical environment.

• Inspect Vial: Ensure the solution is clear and free from particulates; check the vial’s seal and expiration date.
• Administration Route: Intravenous infusion via a dedicated IV line; avoid bolus injection to reduce risk of hypotension.
• Infusion Time: Administer over a minimum of 15 minutes to ensure safety and tolerability.
• Dosing Schedule: Typically every 4–6 hours, as ordered by the physician.
• Compatibility: Do not mix with other drugs unless compatibility is confirmed; use a dedicated infusion set.
• Single-Use Only: Discard any unused solution after each use to maintain sterility.
• Monitoring: Monitor vital signs during infusion and observe for pain relief and temperature reduction.

Adhering to institutional protocols and medical guidance ensures effective and safe administration.

Mode of Action PARACETAMOL KABI 10mg/ml

Paracetamol acts primarily within the central nervous system, with negligible peripheral anti-inflammatory effects:

• Central COX Inhibition: Reversibly inhibits COX‑2 and possibly COX‑3 in the CNS, reducing prostaglandin synthesis involved in pain and fever.
• Thermoregulatory Effect: Influences the hypothalamic temperature regulation center, promoting vasodilation and sweating.
• Analgesic Modulation: May activate descending serotonergic and endocannabinoid pathways, enhancing pain inhibition.
• Peripheral Safety: Minimal peripheral COX inhibition helps preserve gastric lining and platelet function.

IV delivery ensures rapid systemic availability, with clinical effects typically observable within 5–15 minutes—essential in acute care and postoperative pain management.

PARACETAMOL KABI 10mg/ml Interactions PARACETAMOL KABI 10mg/ml

Although paracetamol is safe and well-tolerated, certain interactions merit caution:

• Alcohol: Chronic use depletes glutathione and increases risk of liver toxicity, even at therapeutic doses.
• Enzyme Inducers: Drugs like phenytoin, carbamazepine, and rifampicin accelerate metabolism and increase risk from toxic metabolites.
• Warfarin/Anticoagulants: Long-term use may potentiate bleeding risk—regular INR monitoring is recommended.
• Isoniazid: May elevate hepatotoxic risk when used concurrently.
• Cholestyramine: Reduces paracetamol absorption if used close together; separate administration times.
• Probenecid: Slows liver clearance—watch for accumulation and adjust dose if necessary.

Inform healthcare providers of all medications, supplements, and alcohol intake to avoid these risks.

Dosage of PARACETAMOL KABI 10mg/ml

Dosage is determined by patient weight, age, and clinical condition:

• Adults & Adolescents ≥50 kg: 1 g (100 mL vial) over 15 minutes, every 4–6 hours. Maximum 4 g/day.
• Children 10–50 kg: 15 mg/kg per dose, every 4–6 hours. Maximum 60 mg/kg/day (max 3 g/day).
• Infants & Smaller Children (<10 kg): 7.5 mg/kg per dose, every 4–6 hours. Max 30 mg/kg/day.
• Impaired Renal/Hepatic Function: Use lower doses or extend dosing intervals under specialist advice.

Administer infusion over at least 15 minutes. Overdosing poses risk of serious hepatic injury—stay within recommended limits.

Possible side effects of PARACETAMOL KABI 10mg/ml

IV paracetamol is generally well tolerated; however, some side effects may occur:

• Common: Nausea, vomiting, headache, infusion-site discomfort.
• Less Common: Transient hypotension, flushing, mild increased liver enzyme levels.
• Rare/Serious: Anaphylaxis, bronchospasm, serious skin reactions, liver injury (in overdose), blood disorders (e.g., thrombocytopenia, neutropenia).

Monitor patients during and after infusion, focusing on signs of hypersensitivity, blood pressure changes, and liver function. Promptly report any adverse findings to clinical staff.

PARACETAMOL KABI 10mg/ml Contraindications PARACETAMOL KABI 10mg/ml

This product should not be used in patients with:

• Known Hypersensitivity: Reaction to paracetamol or any component of the formulation.
• Severe Hepatic Impairment: Advanced liver disease or liver failure.
• Severe Renal Insufficiency: Use with caution; dose reduction or extended dosing intervals may be required.
• Severe Malnutrition/Chronic Alcoholism: These conditions increase hepatotoxic risk due to glutathione depletion.
• Concurrent Hepatotoxic Agents: Avoid combined use unless the therapeutic benefit outweighs risks.
• Neonates/Premature Infants: Should only be administered under specialist supervision.

A thorough medical assessment is recommended before initiating treatment, especially for vulnerable patient groups.

Storage of PARACETAMOL KABI 10mg/ml

Store under the following conditions to maintain stability:

• Temperature: Keep between 15–25 °C. Do not freeze; avoid high heat.
• Light Protection: Store vials in original carton to preserve from direct light exposure.
• Inspection: Check solution clarity and absence of particles before use; discard compromised vials.
• Single-Use Only: Discard any unused content after opening to maintain sterility.
• Expiry: Do not use beyond the printed expiration date.
• Disposal: Dispose of unused or expired vials per clinical waste protocols.
• Security: Store in restricted areas away from children and unauthorized personnel.