ACETALGAN 1 GM/100ML SOL. FOR I.V. VIAL

Important Disclaimer: This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product’s internal leaflet or consult a healthcare professional before use.

Drug Name: ACETALGAN 1 GM/100ML SOL. FOR I.V. VIAL

Manufacturer:

ACETALGAN 1 GM/100ML SOL. FOR I.V. VIAL is manufactured by Delta Grand Pharma and marketed/distributed by Al Ansar for Marketing in Egypt. [1, 2]

Introduction:

ACETALGAN 1 gm/100 mL I.V. Solution contains Paracetamol (Acetaminophen), a widely used analgesic (pain reliever) and antipyretic (fever reducer). In its intravenous formulation, it provides rapid relief of fever and moderate pain in hospitalized patients, especially when oral or rectal administration is not possible or practical. It is commonly used in post-operative pain management and acute care settings. [3, 4]

Indications and Usage:

ACETALGAN I.V. is indicated for the short-term treatment of: [3, 4, 5]

• Moderate pain, especially post-operative pain.
• Fever reduction in patients unable to take oral medication, or when rapid onset of action is required.
• May be used as an adjunct to opioids to reduce required opioid doses.

Characteristics:

Paracetamol (Acetaminophen) is a non-opioid analgesic and antipyretic. Its exact mechanism of action is not fully understood but is believed to involve inhibition of prostaglandin synthesis, primarily in the central nervous system. Unlike NSAIDs, it has minimal anti-inflammatory activity and does not inhibit platelet aggregation or cause gastric irritation at therapeutic doses. The intravenous formulation allows for rapid and complete bioavailability. [3, 4, 6]

• Active Ingredient: Paracetamol 10 mg/mL (1 gram in 100 mL).
• Form: Sterile solution for intravenous infusion.
• Container: Vial.
• Drug Class: Analgesic, Antipyretic.
• Mechanism of Action: Acts centrally to inhibit prostaglandin synthesis and regulate hypothalamic temperature control, thereby reducing pain and fever without significant anti-inflammatory action. [3, 4]

Dosage and Administration:

ACETALGAN I.V. is administered as a 15-minute intravenous infusion. The dosage is based on the patient's weight and clinical condition. [3, 4, 5]

• Adults and adolescents weighing ≥50 kg: 1 gram (100 ml) per administration. Maximum daily dose: 4 grams.
• Adults and adolescents weighing <50 kg:="" strong=""> 15 mg/kg per administration. Maximum daily dose: 60 mg/kg (not exceeding 3 grams).
• Children (2–12 years): 15 mg/kg per administration, every 6 hours.
• Infants and children weighing >10 kg to ≤33 kg: 15 mg/kg per administration. Maximum daily dose: 60 mg/kg (not exceeding 2 grams).
• Infants and children weighing ≤10 kg: 7.5 mg/kg per administration. Maximum daily dose: 30 mg/kg.
• Frequency: The minimum interval between administrations should be 4 hours. In patients with renal insufficiency, the interval should be extended to 6 hours.
• Administration Method: Administer by intravenous infusion over 15 minutes. Do not administer as a rapid bolus injection.
• Administration Notes:
  • Use only as IV infusion.
  • Do not mix with other medications in the same line unless compatibility is confirmed.
  • Monitor total daily paracetamol intake from all sources (oral, rectal, IV) to avoid accidental overdose.

Contraindications:

ACETALGAN I.V. is contraindicated in: [3, 4, 5]

• Hypersensitivity to paracetamol or propacetamol (a prodrug of paracetamol) or to any of the excipients.
• Severe hepatocellular insufficiency or acute hepatic failure.
• Severe renal impairment (adjust dose accordingly).
• Chronic alcohol abuse.
• Not recommended in neonates or infants under 2 months without medical supervision.

Warnings and Precautions:

• Liver Toxicity: High doses or prolonged use may cause severe and potentially fatal liver damage (hepatotoxicity). Do not exceed the recommended dose. Caution is advised in patients with hepatic impairment, chronic alcoholism, severe renal impairment, or chronic malnutrition. Monitor liver function in high-risk patients. [3, 4, 5]
• Renal Impairment: Use with caution in patients with severe renal insufficiency. The interval between doses should be extended. [3, 4]
• Dehydration/Malnutrition: Caution in patients with dehydration or chronic malnutrition. [3, 4]
• Hypovolemia: Caution in patients with hypovolemia. [3, 4]
• Allergic Reactions: Severe allergic reactions (e.g., anaphylaxis, skin rashes, angioedema) can occur. Discontinue immediately if symptoms appear. [3, 4]
• Administration Rate: Administer slowly over 15 minutes. Rapid infusion can lead to transient hypotension. [3, 4]
• Cumulative Dosing: Be aware of total paracetamol dose from all sources (oral, rectal, IV) to avoid accidental overdose. [3, 4]
• Use in Pregnancy/Lactation: Paracetamol is generally considered safe for use during pregnancy and lactation at recommended doses, but always consult a healthcare professional. [3, 4]

Pharmacokinetics:

• Absorption: Intravenous administration ensures 100% bioavailability. Peak plasma concentrations are typically reached at the end of the 15-minute infusion. [3, 4]
• Distribution: Paracetamol is widely distributed throughout body tissues. The volume of distribution is approximately 1 L/kg. It crosses the placenta and is excreted in breast milk. [3, 4]
• Metabolism: Primarily metabolized in the liver via glucuronidation and sulfation pathways. A small portion is metabolized by cytochrome P450 (CYP2E1) to a toxic intermediate (NAPQI), which is normally detoxified by glutathione. [3, 4]
• Elimination: Excreted mainly in the urine as glucuronide and sulfate conjugates. The plasma elimination half-life is approximately 1 to 3 hours. [3, 4]

Side Effects:

Side effects associated with intravenous paracetamol are generally rare and mild at therapeutic doses: [3, 4]

• Common: Injection site reactions (pain, redness), malaise.
• Less Common: Hypotension (low blood pressure), increased liver transaminases (liver enzymes).
• Rare: Hypersensitivity reactions (rash, urticaria, anaphylactic shock), thrombocytopenia (low platelet count), leukopenia (low white blood cell count), neutropenia (low neutrophil count).
• Overdose: Can lead to severe liver damage (hepatic necrosis), renal tubular necrosis, and coma.

Drug Interactions:

Paracetamol can interact with several medications: [3, 4]

• Oral Anticoagulants (e.g., Warfarin): May enhance the anticoagulant effect, increasing the risk of bleeding. Regular monitoring of INR is recommended.
• Enzyme Inducers (e.g., Phenobarbital, Phenytoin, Carbamazepine, Rifampicin): May increase the risk of paracetamol toxicity due to increased formation of the toxic metabolite.
• Probenecid: Reduces paracetamol clearance, requiring a dose reduction.
• Salicylamide: May prolong the half-life of paracetamol.
• Chloramphenicol: Paracetamol may increase chloramphenicol plasma concentrations.
• Zidovudine (AZT): Increased risk of neutropenia.

Patient Counseling:

• ACETALGAN I.V. is administered by healthcare professionals in a clinical setting.
• Inform your doctor about all medications you are taking, especially other paracetamol-containing products, to avoid overdose.
• Report any history of liver or kidney disease, alcoholism, or severe malnutrition to your healthcare provider.
• Report any unusual symptoms during or after infusion, such as rash, difficulty breathing, or dizziness.
• Do not self-administer this medication.

Sources:

• Delta Grand Pharma Official Website (or product page for Acetalgan, if available): https://deltagrandpharma.com/ [1]
• Al Ansar for Marketing Official Website (or product page for Acetalgan, if available): https://alansar.com.eg/ [2]
• Paracetamol (Acetaminophen) IV - Summary of Product Characteristics (SmPC) - Medicines.org.uk: https://www.medicines.org.uk/emc/product/1000/smpc [3]
• Paracetamol - DrugBank Online: https://go.drugbank.com/drugs/DB00316 [4]
• Acetalgan 1gm/100ml Sol. For I.V. Vial - Egyptian Drug Directories (e.g., Dawaa.org, Med.tn): https://dw2.org/drug/acetalgan-1-gm-100ml-sol-for-iv-vial [5]