Each vial contains Amphotericin B 50 mg.
AMPHOTERICIN-B is an antifungal antibiotic. It acts by binding to ergosterol in the fungal cell membrane. The membrane of the fungal cell is altered, cellular macromolecules and ions are lost,
producing irreversible damage.
AMPHOTERICIN-B is poorly absorbed from the gastrointestinal tract. The intravenous injection of 0.5 mg/kg/day of AMPHOTERICIN-B results in average blood levels of 0.5 - 2 μg/ml. It is more than 90% protein-bound and is removed to a very limited extent by hemodialysis. The injected AMPHOTERICIN-B is excreted slowly in the urine over a period of several days. The drug is widely distributed in tissue, but only 2 - 3% of the blood level is reached in cerebrospinal fluid.
AMPHOTERICIN-B is intended to treat potentially life-threatening fungal infections : Aspergillus, Blastomyces, Candida, Coccidioides, Cryptococcus, Conidiobolus, Basidiobolus, Absidia, Mucor, Histoplasma, Rhizopus and Sporothrix.
For the treatment of systemic fungal infections, AMPHOTERICIN-B is given by slow intravenous infusion over a period of 2 - 6 hours. The recommended concentration for intravenous infusion is 0.1 mg/ml (1 mg/10 ml).
The initial daily dose is 0.25 mg/kg of body weight given over 2 - 6 hours.
In patients with good cardiopulmonary function and well toleration without severe reaction, the daily dose should be initiated with 0.3 mg/kg of body weight.
In patients with impaired cardiopulmonary function or severe reaction, it should be initiated with smaller daily doses: 5-10 mg.
Depending on the patient's status, doses may gradually be increased by 5 - 10 mg per day to final dosage of 0.5 to 0.7 mg/kg of body weight per day.
1. It is contraindicated in those patients who have shown hypersensitivity to AMPHOTERICIN-B.
2. The drug is contraindicated in patients with hepatic disease.
AMPHOTERICIN-B should be administered intravenously under supervision of the doctor. Fever chills, nausea, vomiting, anorexia, headache, arthralgia and hypotension are common when AMPHOTERICIN-B
is given.
Liver function, renal function, serum electrolytes (particularly magnesium and potassium) and blood count should be monitored frequently during AMPHOTERICIN-B therapy.
Under no circumstances a total daily dose should not exceed 1.5 mg/kg. The duration of treatment may be 6 to 12 weeks or longer.
General: fever (usually occur within 15 to 20 minutes after initiation of treatment), malaise, weight loss.
Gastrointestinal tract: anorexia, nausea, vomiting, diarrhea, epigastric pain.
Hematologic: normocytic anemia, phlebitis at the injection site.
Musculoskeletal: muscle and joint pains.
Neurologic: headache.
Renal: decrease renal function and renal function abnormalities including decrease creatinine clearance, hypokalemia.
Other nephrotoxic drugs e.g., cisplatin, pentamidine, aminoglycosides and cyclosporine, may enhance the potential for renal toxicity.
Corticosteroids and corticotropin may potentiate AMPHOTERICIN-B-induced hypokalemia.
Agents whose toxicity may be increased by hypokalemia e.g. digitalis glycoside, muscle relaxants and anti-arrhythmic agents.
RECONSTITUTION: AMPHOTERICIN-B should be reconstituted to a concentration of 5 mg/ml by adding 10 ml of sterile water for injection without bacteriostatic agent. The vial should be immediately shaken until the colloidal dispersion is clear. The colloidal dispersion is further diluted, usually to a concentration of 0.1 mg/ml, with 5% dextrose injection. Although the pH of commercially available 5% dextrose injection usually exceeds 4.2, the pH of each container of 5% dextrose injection should be determined and, if the pH is low, it may be adjusted. Aseptic technique must be strictly observed in the preparation of the buffer.
Reconstituted AMPHOTERICIN-B or dilutions of the drug must not be used if precipitating or foreign matter is evident.
Do not reconstitute with saline solution. The use of any diluent other than the ones recommended or the presence of the bacteriostatic agent (e.g. benzyl alcohol) in the diluent may cause precipitation.
Store in refrigerator (2-8°C). Protect from light.
J02AA01 - amphotericin B ; Belongs to the class of antibiotics. Used in the systemic treatment of mycotic infections.
Amphotericin-B Biolab infusion 50 mg
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