PARACETAMOL 1% -PHARCO B INTERNATIONAL Solution for Infusion

What is PARACETAMOL 1% -PHARCO B INTERNATIONAL

PARACETAMOL 1% - PHARCO B INTERNATIONAL is a sterile, ready-to-use intravenous solution containing 1% paracetamol (i.e., 10 mg/mL) in a 100 ml glass vial. It is used for the short-term treatment of moderate pain, particularly following surgery, or for the treatment of fever when oral or rectal administration is not possible. This formulation allows for rapid onset of action, making it ideal in hospital settings or when patients are unable to tolerate oral medications.

• Generic Name: Paracetamol (Acetaminophen)
• Form: Solution for infusion
• Concentration: 1% (1000 mg/100 mL)
• Pack Size: 1 x 100 mL glass vial
• Route of Administration: Intravenous (IV) infusion only
• Therapeutic Class: Analgesic and antipyretic

It is commonly used in perioperative care, intensive care units (ICU), and emergency settings. Its use helps minimize the need for opioids, thus reducing opioid-related side effects.

How to use PARACETAMOL 1% -PHARCO B INTERNATIONAL

PARACETAMOL IV infusion should be administered under medical supervision in a clinical setting. The administration method is as follows:

• Preparation: The vial is ready-to-use. Do not dilute or mix with other fluids. Check the solution for clarity and the integrity of the vial before use.
• Administration Route: Intravenous infusion over 15 minutes using a dedicated line or port.
• Do Not Administer: By bolus or intramuscular injection.
• In Adults and Adolescents (>50 kg): Administer the full 100 mL vial (1000 mg) over 15 minutes.
• In Children (10–50 kg): Dose should be adjusted based on body weight. Use appropriate volume of the solution according to pediatric dosing guidelines.
• Monitor: Vital signs, pain score, and liver function in prolonged use or high doses.

Single-use only: any unused portion should be discarded after opening. Ensure compatibility with infusion sets and avoid mixing with other medications to prevent precipitation or inactivation.

Mode of Action PARACETAMOL 1% -PHARCO B INTERNATIONAL

Paracetamol’s precise mechanism of action is not fully understood, but its therapeutic effects as an analgesic and antipyretic are well documented.

• Central COX Inhibition: Paracetamol selectively inhibits cyclooxygenase (COX), especially COX-2, in the central nervous system, reducing the synthesis of prostaglandins responsible for pain and fever.
• Antipyretic Effect: Acts on the hypothalamic heat-regulating center to lower elevated body temperature in fever.
• No Anti-inflammatory Action: Unlike NSAIDs, paracetamol has minimal peripheral COX inhibition, and thus limited anti-inflammatory activity.
• Opioid-Sparing Effect: When administered perioperatively, it can reduce the need for opioids, minimizing associated adverse effects like respiratory depression and constipation.
• Rapid Onset via IV: Intravenous administration allows quick therapeutic levels, typically achieving analgesic effects within 5–10 minutes and antipyretic effects within 30 minutes.

This multi-modal action makes IV paracetamol a preferred agent for acute pain and fever management in hospitalized patients, especially when oral administration is not feasible.

PARACETAMOL 1% -PHARCO B INTERNATIONAL Interactions PARACETAMOL 1% -PHARCO B INTERNATIONAL

Paracetamol is generally well-tolerated, but caution is needed when co-administering it with certain drugs that affect liver enzymes or may potentiate its toxicity.

• Enzyme Inducers (e.g., Carbamazepine, Phenytoin, Rifampicin): May increase the risk of hepatotoxicity by enhancing the metabolism of paracetamol into toxic intermediates.
• Alcohol: Chronic alcohol consumption potentiates liver damage due to depleted glutathione stores.
• Warfarin and Other Anticoagulants: Long-term use of paracetamol may enhance anticoagulant effect and increase bleeding risk; monitor INR levels.
• Probenecid: May decrease paracetamol clearance; dosage adjustment may be needed.
• Salicylates or NSAIDs: Avoid concurrent use in high doses to prevent cumulative renal or hepatic effects.

Patients should always inform their healthcare providers about any prescription or over-the-counter medications, herbal products, or supplements they are using to avoid harmful interactions.

Dosage of PARACETAMOL 1% -PHARCO B INTERNATIONAL

Paracetamol IV dosage depends on the patient’s weight, age, and hepatic function. Dosage should not exceed the recommended limits to avoid hepatotoxicity.

• Adults and Adolescents ≥50 kg: 1000 mg (100 mL) every 6 hours, not exceeding 4 doses (4000 mg) in 24 hours.
• Children 33–50 kg: 15 mg/kg every 6 hours (max 60 mg/kg/day, not to exceed 3000 mg/day).
• Children 10–33 kg: 15 mg/kg every 6 hours (max 60 mg/kg/day, not to exceed 2000 mg/day).
• Renal Impairment: Increase dosing interval to 6–8 hours when creatinine clearance is <30 mL/min.
• Hepatic Impairment: Use with caution or avoid in severe liver disease; monitor liver function closely.

Strict adherence to maximum daily dosage is critical. Accidental overdose can lead to irreversible liver damage, requiring medical intervention such as N-acetylcysteine therapy.

Possible side effects of PARACETAMOL 1% -PHARCO B INTERNATIONAL

Paracetamol is generally well tolerated. However, like all medicines, it may cause side effects, particularly with prolonged or high-dose use.

• Common:
  • Nausea
  • Dizziness or headache
  • Injection site pain or irritation
• Uncommon:
  • Increased liver enzymes (transaminases)
  • Hypotension during rapid infusion
• Rare but Serious:
  • Hepatotoxicity, especially in overdose or patients with liver disease
  • Anaphylaxis or hypersensitivity reactions
  • Thrombocytopenia or leukopenia (blood disorders)

Immediate medical attention should be sought if signs of liver damage (e.g., yellowing of the skin or eyes), unusual bleeding, or allergic reactions occur. Monitoring of liver function is recommended during prolonged therapy.

PARACETAMOL 1% -PHARCO B INTERNATIONAL Contraindications PARACETAMOL 1% -PHARCO B INTERNATIONAL

There are specific situations where the use of IV paracetamol should be avoided due to the risk of serious complications:

• Hypersensitivity: Known allergy to paracetamol or any excipients in the formulation.
• Severe Hepatic Impairment: Patients with active liver disease or significantly impaired liver function due to the risk of worsening liver damage.
• Severe Renal Dysfunction: Use with caution and under close monitoring; accumulation may occur with prolonged use.
• Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency: May increase risk of hemolytic anemia.
• Patients Receiving Other Paracetamol Products: To prevent cumulative overdose, assess total daily paracetamol intake from all sources.

Special caution is advised in malnourished individuals, alcoholics, or the elderly who may be more vulnerable to liver toxicity.

Storage of PARACETAMOL 1% -PHARCO B INTERNATIONAL

Proper storage of the product is essential to maintain efficacy and ensure patient safety. Follow the manufacturer’s instructions for storage and handling.

• Storage Temperature: Store below 25°C. Do not freeze.
• Light Protection: Keep in the original packaging to protect from light.
• Handling: Check the vial before use. Do not use if the solution is cloudy, colored, or contains particles.
• Shelf Life: Use within the expiration date printed on the label.
• After Opening: For single-use only. Discard any unused portion after 1 use.
• Keep Out of Reach of Children: Ensure safety from accidental exposure or ingestion.

Do not dispose of unused medication via household waste. Ask your pharmacist about the proper method of disposal to help protect the environment.