Amphomul — Amphotericin B Emulsion 50 mg/10 ml

Amphomul is supplied as a sterile emulsion for intravenous administration. Each package contains 1 vial and 1 syringe filter:

• Active Ingredient: Amphotericin B — 50 mg in a 10 ml vial.
• Excipients: Soya bean oil, purified egg phospholipids, glycerol, sodium hydroxide/hydrochloric acid (for pH adjustment), water for injections.
• Package Contents: One 10 ml vial + One 5µ syringe filter.

Pharmacodynamics: Amphotericin B is a polyene antifungal antibiotic. It works by binding to ergosterol, a essential sterol in the cell membrane of susceptible fungi. This binding creates pores, causing leakage of intracellular ions (such as potassium) and leading to fungal cell death (fungicidal action). The emulsion formulation facilitates uptake by macrophages and targeted release at infection sites.

Pharmacokinetics: Following intravenous infusion of the emulsion, amphotericin B distributes rapidly into tissues (liver, spleen, lungs). Protein binding is greater than 90%. The drug exhibits slow elimination with a terminal elimination half-life (T1/2) of up to 15 days. It is excreted mainly through the kidneys and biliary tract.

Amphomul is indicated for the treatment of severe systemic fungal infections:

• 🔹 Invasive aspergillosis and severe systemic candidiasis.
• 🔹 Cryptococcal meningitis in immunocompromised patients (e.g., HIV-infected).
• 🔹 Mucormycosis (zygomycosis) and disseminated histoplasmosis.
• 🔹 Empirical therapy for suspected fungal infections in febrile neutropenic patients.
• 🔹 Visceral leishmaniasis.

Amphomul is intended **strictly for intravenous infusion only** (For I.V. Infusion Only):

• 💊 Recommended Dosage: Dosage is individualized based on patient body weight (typically ranging from 1 mg/kg/day to 3–5 mg/kg/day depending on clinical indication).
• 💉 Preparation & Dilution: Dilute the emulsion exclusively with 5% Dextrose Injection. Do not use 0.9% Sodium Chloride Solution! Use the provided 5µ syringe filter during withdrawal and preparation.
• ⏱️ Infusion Rate: Administer via slow IV infusion over a period of 1 to 2 hours. A test dose prior to initial full infusion is recommended.

Amphomul is contraindicated in:

• ❌ Known hypersensitivity or severe allergic reaction to Amphotericin B, soy, peanut, egg products, or any excipients.
• ❌ History of severe anaphylactic reaction to polyene antifungal agents.

Co-administration of Amphomul requires clinical monitoring with:

• ⚠️ Nephrotoxic Agents: Concomitant use with cyclosporine, aminoglycosides, tacrolimus, or cisplatin increases the risk of renal damage.
• ⚠️ Corticosteroids & Diuretics: May exacerbate hypokalemia (low potassium levels).
• ⚠️ Digitalis Glycosides (Digoxin): Amphotericin B-induced hypokalemia may increase digoxin toxicity.
• ⚠️ Skeletal Muscle Relaxants: Hypokalemia may potentiate the neuromuscular blocking effects.

Use during pregnancy and breastfeeding should be carefully weighed:

• 🤰 Pregnancy: Amphotericin B crosses the placenta. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• 🤱 Lactation: It is unknown whether the drug is excreted in human milk. Breastfeeding is not recommended during therapy.

Possible adverse reactions during Amphomul administration include:

• 🩸 Laboratory Alterations: Hypokalemia, hypomagnesemia, elevated serum creatinine and blood urea nitrogen.
• 🔥 Infusion-related Reactions: Fever, chills, rigors, dyspnea, hypotension during or shortly after infusion.
• 🤢 Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain.
• 🫀 Renal & Cardiovascular: Impaired renal function (nephrotoxicity), arrhythmias.
• 💆 General: Headache, malaise, myalgia, arthralgia, phlebitis at injection site.

Overdose Symptoms: Potential cardiorespiratory arrest, severe nephrotoxicity, and life-threatening electrolyte imbalance (severe hypokalemia).

Management: No specific antidote exists. Discontinue infusion immediately upon suspicion of overdose. Provide supportive care, monitor renal and cardiac function, and correct electrolyte levels.

Storage guidelines for Amphomul 50 mg / 10 ml:

• ❄️ Temperature: Store between 2 °C and 8 °C (in a refrigerator). Do not freeze.
• 💧 Light Protection: Keep the vial in the outer carton to protect from light.
• 👶 Safety: Keep out of reach of children.
• ⏳ Reconstituted Solution: Infuse immediately after dilution.

Bharat Serums and Vaccines Limited (BSV) implements key packaging security measures:

• 🛡️ BSV Brand Logo: The box front displays the official BSV floral/spherical logo printed in distinct blue and green colors.
• 🔍 Box Contents: Ensure the pack contains 1 vial (10 ml) along with 1 sterile 5µ syringe filter.
• 📦 Panel Details: Check the side panel for laser-printed Batch Number, Manufacturing Date, Expiry Date, Manufacturing License Number, and Maximum Retail Price (M.R.P.).