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

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

PARACETAMOL S.A.L.F. 10 mg/ml is a sterile, ready-to-use intravenous solution containing paracetamol (acetaminophen) at a concentration of 10 mg per milliliter. Each 100 ml glass bottle delivers 1,000 mg (1 g) of paracetamol. This formulation is typically available in packs of 30 bottles, commonly used in hospitals, emergency departments, perioperative settings, and intensive care units.

• Active Ingredient: Paracetamol (acetaminophen), 10 mg/ml
• Form: Intravenous infusion solution
• Presentation: 100 ml sterile glass bottles, boxed in packs of 30
• Therapeutic Category: Non-opioid analgesic and antipyretic
• Indications: Relief of mild to moderate pain; management of fever when oral or rectal routes are inappropriate
• Target Population: Adults, adolescents, and children (with weight-based dosing), under supervised clinical care

This IV paracetamol offers a rapid onset of action, reaching peak plasma levels within 10–15 minutes, making it ideal when fast symptom control is needed or when oral intake isn’t feasible due to nausea, surgery, or unconsciousness.

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

Usage of this intravenous solution must be restricted to qualified healthcare professionals in clinical environments.

• Preparation: Inspect the bottle visually—solution must be clear and free of particles. Do not use if compromised or expired.
• Administration: Infuse via a dedicated IV line over 15 minutes. Rapid bolus is contraindicated due to risk of hypotension or flushing.
• Frequency: As prescribed—typically every 4 to 6 hours, not exceeding the maximum daily dose.
• Equipment Compatibility: Use with compatible IV infusion sets; do not mix with other medications unless compatibility is confirmed.
• Single-Use: Discard any unused portion after infusion to maintain sterility.
• Monitoring: Observe for clinical effects (pain relief, temperature reduction) and monitor liver enzymes if used for prolonged periods.

Proper administration ensures effectiveness and minimizes risk of adverse events or contamination.

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

Paracetamol’s mechanism involves central, rather than peripheral, actions:

• Central COX Inhibition: Reduces prostaglandin synthesis in the CNS by reversibly inhibiting COX enzymes—particularly COX‑2 and COX‑3—lowering pain and fever signaling.
• Hypothalamic Thermoregulation: Acts on the heat-regulating center in the hypothalamus to promote heat dissipation through vasodilation and sweating.
• Endocannabinoid & Serotonergic Pathways: May modulate descending inhibitory pain pathways involving the endocannabinoid system and serotonin, enhancing analgesia.
• No Significant Peripheral Anti-inflammatory Activity: Unlike NSAIDs, paracetamol has minimal effect on peripheral prostaglandins, preserving gastric mucosa and platelet function.

IV administration allows rapid systemic delivery, ensuring quick onset—typically within 5–10 minutes—for effective pain relief and antipyresis in acute care settings.

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

Although paracetamol has relatively few interactions, certain drugs and substances can alter its metabolism or raise toxicity risk:

• Alcohol: Chronic alcohol use depletes glutathione stores, increasing risk of hepatotoxicity even at therapeutic doses.
• Enzyme Inducers: Anticonvulsants (phenytoin, carbamazepine), rifampicin, and St. John’s Wort may upregulate CYP pathways, generating more toxic metabolites.
• Anticoagulants (warfarin): High-dose or long-term use may enhance anticoagulant effect; INR monitoring advised.
• Cholestyramine: May reduce paracetamol absorption if administered simultaneously.
• Isoniazid: Co-administration increases hepatotoxic risk.
• Probenecid: May lower paracetamol clearance, necessitating dosing review.

Inform prescribers of all current medications including over-the-counter drugs and supplements to prevent harmful interactions.

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

Dosing varies based on weight, age, and clinical needs. Adhere strictly to professional guidelines:

• Adults & Adolescents ≥50 kg: 1 g (100 ml) over 15 min every 6 hours; maximum 4 g per 24 hours.
• Children 10–50 kg: 15 mg/kg per dose every 6 hours; do not exceed 60 mg/kg/day.
• Infants <10 kg: 7.5 mg/kg per dose every 6 hours; max 30 mg/kg/day.
• Hepatic/Renal Impairment: Exercise caution—dose reduction or extended intervals may be necessary.

Infusion must be administered over at least 15 minutes. Exceeding the recommended dose can result in severe liver damage or failure.

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

Generally well tolerated, but IV paracetamol may cause adverse effects in some cases:

• Common: Mild nausea, vomiting, local infusion-site irritation, headache.
• Less Common and Transient: Transient hypotension during infusion, flushing, mild elevation of liver enzymes.
• Rare: Severe allergic reactions (rash, angioedema, anaphylaxis), jaundice or hepatotoxicity in overdose, hematologic disorders (thrombocytopenia, neutropenia).

Monitor patients for allergic responses, changes in vital signs during infusion, and liver function when used repeatedly or over multiple days. Report any concerning symptoms to clinical staff immediately.

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

Avoid use in the following conditions:

• Hypersensitivity: Known allergy to paracetamol or any formulation excipients.
• Severe Liver Disease: Advanced hepatic dysfunction or hepatic failure.
• Severe Renal Disease: Use with caution; lower doses or extended intervals may be required.
• Severe Malnutrition or Chronic Alcoholism: Heightened risk of hepatotoxicity.
• Patients Receiving Potentially Hepatotoxic Agents: Weigh risk-benefit carefully.

In neonates premature infants, or those under 30 weeks’ gestation, use only under specialized supervision due to limited safety data.

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

To maintain safety and efficacy, store under these conditions:

• Temperature: Store between 15–25 °C. Do not refrigerate or freeze.
• Light Protection: Keep bottles in original cartons until use to protect from light.
• Inspection: Before use, ensure solution is clear, colorless, and free of particulate matter. Discard if compromised.
• Once Opened: Use immediately after opening; do not reuse or store partially used bottles.
• Expiry: Check the printed shelf-life; do not use past expiration date.
• Disposal: Discard unused or expired solutions per clinical waste guidelines.
• Safety: Ensure bottles are secured and stored away from children and unauthorized personnel.