1% w/v PARACETAMOL Infusion/Solution for

• Formulation: Each ml contains 10 mg of paracetamol; thus, the 50 ml plastic bag provides 500 mg total.
• Therapeutic Class: Analgesic (pain reliever) and Antipyretic (fever reducer).
• Route of Administration: Intravenous (IV) infusion, allowing rapid onset of action.
• Prescription Status: Prescription-only medication, used under medical supervision.
• Indications: Pain and/or fever associated with surgery, infections, trauma, and other medical conditions.

Paracetamol injection offers a safer alternative to NSAIDs for pain relief, especially in patients with peptic ulcer disease, bleeding disorders, or renal impairment. It is also suitable for pediatric and geriatric use with adjusted dosing.

How to use 1% w/v PARACETAMOL

1% w/v Paracetamol Injection should be administered by a healthcare professional via intravenous infusion over a period of 15 minutes. Correct dosing, dilution, and infusion technique are critical to ensure efficacy and prevent adverse effects.

• Administration Route: IV infusion only. Do not administer intramuscularly or subcutaneously.
• Infusion Time: Minimum of 15 minutes to avoid side effects like hypotension or injection site pain.
• Dosage Volume: The entire 50 ml bag should be administered per prescribed dose.
• Compatibility: Do not mix with other medications or solutions in the same IV line.

Important Instructions:

• Inspect the solution for particulates or discoloration before use.
• Ensure aseptic technique during administration.
• Monitor patient for signs of allergic reaction or liver dysfunction post-administration.

Incorrect administration or dosage can lead to serious complications, including hepatotoxicity. Therefore, always follow institutional protocols and manufacturer's instructions.

Mode of Action 1% w/v PARACETAMOL

Paracetamol exerts its analgesic and antipyretic effects primarily through central mechanisms. Unlike NSAIDs, it lacks significant anti-inflammatory action and does not inhibit peripheral cyclooxygenase (COX) enzymes significantly.

• COX Inhibition: Paracetamol selectively inhibits prostaglandin synthesis in the central nervous system by acting on COX-3 (a CNS variant of COX-1).
• Antipyretic Action: Acts on the hypothalamic heat-regulating center to reduce fever by promoting peripheral vasodilation and heat dissipation.
• Analgesic Effect: Modulates descending serotonergic pathways involved in pain perception, enhancing endogenous pain control.

Due to its central action and lack of significant peripheral prostaglandin inhibition, paracetamol does not cause gastric irritation, platelet dysfunction, or renal toxicity commonly seen with NSAIDs.

Its rapid onset (within 15–30 minutes of infusion) and duration of 4–6 hours make it highly suitable for acute pain and fever management, especially in perioperative settings or critically ill patients.

1% w/v PARACETAMOL Interactions 1% w/v PARACETAMOL

Paracetamol has a relatively safe drug interaction profile, but certain combinations may increase the risk of liver toxicity or reduce therapeutic efficacy.

• Hepatotoxic Agents: Caution with isoniazid, rifampin, carbamazepine, and chronic alcohol consumption as these induce liver enzymes and increase hepatotoxic risk.
• Anticoagulants: High doses of paracetamol may enhance the anticoagulant effect of warfarin, leading to bleeding risk. Monitor INR closely.
• Anticonvulsants: Medications like phenytoin and phenobarbital may reduce paracetamol efficacy and increase hepatic enzyme activity.
• Probenecid: May reduce paracetamol clearance, requiring dose adjustment.
• Cholestyramine: Delays absorption and reduces efficacy if administered within 1 hour of paracetamol.

Always inform your healthcare provider of all medications, supplements, or herbal remedies being taken to avoid unintended interactions. Routine liver function monitoring is advised for patients on long-term therapy or with pre-existing liver disease.

Dosage of 1% w/v PARACETAMOL

The dosage of 1% w/v Paracetamol Injection should be tailored based on the patient’s weight, age, liver function, and clinical condition. It is typically administered as an infusion over 15 minutes.

• Adults and Adolescents ≥50 kg: 1 g (100 ml) every 6 hours; maximum 4 g/day.
• Adults <50 kg: 15 mg/kg per dose; maximum 60 mg/kg/day (not exceeding 3 g/day).
• Children 10–50 kg: 15 mg/kg per dose every 6 hours; do not exceed 60 mg/kg/day or 3 g/day.
• Children <10 kg: Not recommended due to limited data with 1% w/v formulation.

Dosing Considerations:

• Adjust dosage in patients with liver impairment or chronic alcohol use.
• Do not exceed the total daily limit to avoid liver toxicity.
• Use a separate IV line if other drugs are being administered.

Frequent reassessment of pain and liver function is necessary, especially in critically ill or elderly patients. Accurate weight-based dosing in children is essential to avoid overdose.

Possible side effects of 1% w/v PARACETAMOL

While generally well-tolerated, 1% w/v Paracetamol Injection may cause adverse effects in some individuals. Most side effects are mild and transient, but rare serious reactions can occur, particularly with overdose or liver disease.

• Common Side Effects:
  • Nausea
  • Vomiting
  • Headache
  • Injection site pain or burning sensation
• Less Common Side Effects:
  • Hypotension during rapid infusion
  • Increased liver enzymes (transaminases)
• Rare but Serious Side Effects:
  • Severe liver damage or hepatotoxicity (especially with overdose)
  • Allergic reactions: rash, pruritus, angioedema
  • Anaphylaxis (rare)
  • Thrombocytopenia (low platelet count)

Prompt medical attention is necessary in the case of jaundice, severe fatigue, bleeding, or hypersensitivity reactions. Regular monitoring of liver function is advised in high-risk patients.

1% w/v PARACETAMOL Contraindications 1% w/v PARACETAMOL

The use of 1% w/v Paracetamol Injection is contraindicated in certain medical conditions where the risk of harm outweighs the benefit.

• Hypersensitivity: Contraindicated in patients with known allergy to paracetamol or any excipient in the formulation.
• Severe Hepatic Impairment: Avoid in patients with severe active liver disease or hepatic failure due to the risk of hepatotoxicity.
• Severe Renal Impairment: Use with caution; adjust dosing if creatinine clearance is <30 mL/min.
• Alcoholism: Chronic alcoholics are at increased risk for liver damage even at therapeutic doses.
• Neonates and infants: Not recommended in children under 10 kg for this concentration.

Appropriate risk assessment, liver enzyme monitoring, and medical history review are necessary prior to administration. Avoid co-administration with other paracetamol-containing drugs to prevent cumulative overdose.

Storage of 1% w/v PARACETAMOL

Proper storage of 1% w/v Paracetamol Injection ensures safety, stability, and efficacy. It is essential to follow manufacturer recommendations and institutional storage guidelines.

• Temperature: Store below 25°C (77°F); do not freeze.
• Light Sensitivity: Protect from light. Keep in original outer packaging until use.
• Container: The solution is supplied in a 50ml plastic bag and is for single-use only.
• Shelf Life: Typically 24–36 months unopened. Once opened, use immediately; do not reuse or store.
• Disposal: Discard any unused portion. Do not flush or pour down drains. Follow local hazardous waste protocols.

Inspection Before Use: Always check the solution for particulate matter, cloudiness, or discoloration. Do not use if the solution is not clear or the seal is damaged.

Keep out of reach of children and unauthorized personnel. Securely store in controlled-access areas in hospital pharmacies or clinical settings.