Bofalgan 1 g Ingredients and Usage

The active ingredient is Paracetamol. The 1 g/100 mL solution is administered via a 15-minute intravenous (IV) infusion.

Bofalgan is clinically indicated for the short-term treatment of:

• Postoperative Pain: Used as part of a multimodal analgesia regimen to manage moderate pain, often immediately after surgery.
• Fever (Hyperthermia): Used for rapid and effective reduction of high-grade fever.
• When Oral Route Fails: For patients who are nil-by-mouth, severely nauseated/vomiting, or unconscious.

How Does Bofalgan Work?

Paracetamol is a non-opioid, non-salicylate analgesic. Its precise mechanism is still debated, but it primarily acts within the Central Nervous System (CNS):

1. Analgesia: It is thought to inhibit the synthesis of prostaglandins (PGs) in the CNS by acting as a preferential inhibitor of COX-3 (cyclooxygenase-3) or by acting on serotonergic pathways, effectively blocking pain impulse generation.
2. Antipyresis (Fever Reduction): It acts on the hypothalamic heat-regulating center in the brain, leading to peripheral vasodilation and sweating, which helps to dissipate heat and lower body temperature.

Bofalgan 1 g Side Effects and Warnings

While often considered safe at therapeutic doses, IV paracetamol requires careful attention to dosing to avoid severe liver damage.

Black Box Warnings and Critical Precautions:

1. Hepatotoxicity and Medication Errors: Fatal liver failure can result from Paracetamol overdose. Extreme care must be taken to ensure the total daily dose of paracetamol from all sources (oral, IV, IM) DOES NOT EXCEED the maximum daily limit (typically 4 g for adults). Confusion between mg and mL has resulted in fatal overdoses.
2. Hypersensitivity: Rare, but severe, potentially fatal hypersensitivity reactions (anaphylaxis) can occur.
3. Skin Reactions: Rarely, severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), can occur and may be fatal.
4. Use with Caution: Reduced maximum daily doses are required in patients with severe hepatic insufficiency, chronic alcoholism, severe renal impairment (CrCl ≤ 30 mL/min), chronic malnutrition, and dehydration.

Bofalgan 1 g/100 mL Storage Conditions

Bofalgan IV Infusion is typically supplied in ready-to-use vials:

• Store the unopened vials at controlled room temperature, typically between 20°C and 25°C (68°F and 77°F). Protect from light.
• Administration: The 100 mL solution is administered as a slow IV infusion over 15 minutes. It should not be administered rapidly as a bolus.
• Discard any partially used vial, as it is preservative-free.