Amphotericin B for injection

This product is a polyene antifungal drug. Fungi sensitive to this product include Cryptococcus neoformans, Blastomyces dermatitidis, Histoplasma, Coccidioides, Sporothrix, Candida, etc. Some Aspergillus species are resistant to this product; most skin and trichophyton are resistant; this product has no antibacterial activity against bacteria, rickettsia, viruses, etc. The drug concentration achieved by the commonly used therapeutic dose only has an antibacterial effect on fungi. The mechanism of action is that this product combines with the sterols on the cell membrane of sensitive fungi, damages the permeability of the cell membrane, causes the leakage of important substances in the cell such as potassium ions, nucleotides and amino acids, destroys the normal metabolism of the cell and inhibits its growth.

Amphotericin B molecular formula: C47H73NO17 molecular weight: 924.09

This product is yellow or orange-yellow powder.

This product is suitable for patients with deep fungal infections caused by sensitive fungi and with progressive disease, such as sepsis, endocarditis, meningitis (cryptococcus and other fungi), abdominal infections (including those related to dialysis), lung infections, urinary tract infections and endophthalmitis.

Intravenous medication: When starting intravenous drip, first try to administer 1-5 mg or 0.02-0.1 mg/kg per body weight. Then increase by 5 mg every day or every other day according to the patient's tolerance. When it increases to 0.6-0.7 mg/kg once, you can stop increasing the dose. This is the general therapeutic dose. The maximum daily dose for adults does not exceed 1 mg/kg. It is administered once a day or every 1-2 days, with a cumulative total of 1.5-3.0 g. The course of treatment is 1-3 months, and can be as long as 6 months, depending on the condition and type of disease. For sensitive fungal infections, a smaller dose should be used, that is, 20-30 mg for adults at a time, and the course of treatment should still be long. Intrathecal administration: 0.05-0.1 mg for the first time, and then gradually increase to 0.5 mg each time. The maximum amount does not exceed 1 mg at a time, and it is administered 2-3 times a week.

1 Chills, high fever, severe headache, loss of appetite, nausea, vomiting may occur during or after intravenous infusion, and sometimes blood pressure may drop, dizziness, etc. 2 Almost all patients may experience varying degrees of renal impairment during the course of treatment. Red blood cells, white blood cells, protein and casts may appear in the urine, blood urea nitrogen and creatinine may increase, creatinine clearance rate may decrease, and renal tubular acidosis may also occur. 3 Hypokalemia, caused by the excretion of a large amount of potassium ions in the urine. 4 Toxic reactions of the blood system include normal red blood cell anemia, and occasionally leukopenia or thrombocytopenia. 5 Hepatotoxicity, which is less common, can cause liver cell necrosis, and acute liver failure may also occur. 6 Cardiovascular system reactions such as excessive intravenous infusion can cause ventricular fibrillation or cardiac arrest. In addition, electrolyte disorders caused by this product can also lead to the occurrence of arrhythmias. Thrombophlebitis is prone to occur during intravenous infusion of this product. 7. Nervous system toxicity: Intrathecal injection of this product may cause severe headache, fever, vomiting, stiff neck, lower limb pain and urinary retention, etc. In severe cases, lower limb paraplegia may occur. 8. Allergic reactions such as anaphylactic shock and rash may occur occasionally.

It is contraindicated for patients who are allergic to this product or have severe liver disease.

Precautions for children: The intravenous and intrathecal dosages are calculated by body weight in the same way as for adults, and the minimum effective dose should be used. Precautions for pregnancy and lactation: This product is used to treat pregnant women with systemic fungal infections and has no significant effect on the fetus. However, there is a lack of well-controlled studies on the use of this drug in pregnant women. Pregnant women should use it with caution only if there is a clear indication for its use. Lactating women should avoid using this product or temporarily stop breastfeeding when taking the drug. Precautions for the elderly: Elderly patients have physiological renal function decline, and it is advisable to reduce the dosage according to the degree of renal function decline.

1. Adrenal cortical hormones. This type of drug can be used together to control the adverse drug reactions of amphotericin B, but it is generally not recommended to use both at the same time because it can aggravate hypokalemia induced by amphotericin B. If it is necessary to use them together, adrenal cortical hormones should be used at the minimum dose and shortest course of treatment, and the patient's blood potassium concentration and cardiac function should be monitored. 2. Digitalis glycosides. The hypokalemia caused by this product can enhance the potential toxicity of digitalis. When the two are used together, the blood potassium concentration and cardiac function should be closely monitored. 3. Flucytosine and amphotericin B have synergistic effects, but this product can increase the cell uptake of the former and impair its renal excretion, thereby enhancing the toxic reaction of flucytosine. 4. This product has an antagonistic effect with azole antifungal drugs such as ketoconazole, fluconazole, itraconazole, etc. in vitro. 5. Aminoglycosides, antitumor drugs, capreomycin, polymyxins, vancomycin and other nephrotoxic drugs can enhance their nephrotoxicity when used together with this product. 6 Bone marrow suppressants, radiotherapy, etc. can aggravate anemia in patients. When used in combination with amphotericin B, the dose should be reduced. 7 The hypokalemia induced by this product can enhance the effect of neuromuscular blocking drugs. When the two are used together, the blood potassium concentration should be monitored. 8 The use of urine alkalinizing drugs can enhance the excretion of this product and prevent or reduce the possibility of renal tubular acidosis.

Keep in dark, airtight, cool place.

25 mg (25,000 units)

18 months

Shanghai SPH New ASIA Pharmaceutical Co., Ltd.

• Founded in:

  1993-08-11

• Address:

  No. 978 Chuansha Road, Pudong New Area, Shanghai

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  91310115133738906M

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