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Product
Anti-fungal Products (Photericin)
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Anti-fungal Products (Photericin)
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Photericin B
Amphotericin B
For injection USP
COMPOSITION
Each Vial Contains
Amphotericin B USP.....50mg
As sterile,freeze-dried powder for reconstitution
• Photericin B is an antifungal polyene antibiotic obtained from a strain of
Streptomyces nodosus.
• It is a polyene antibiotic that acts by binding to sterols in cell membranes of
sensitive fungi, with subsequent leakage of intracellular contents and cell death to
change in membrane permeability
Indication
• should be administered primarily to patients with progressive, potentially life-
threatening fungal infections
• This potent drug should not be used to treat noninvasive fungal infections, such as
oral thrush, vaginal candidiasis, and esophageal candidiasis in patients with
normal neutrophil counts.
• Cryptococcal meningitis is a common opportunistic infection in HIV patients with
CD4 count <100 cells /ul |
• Fungus cryptococcal neoformans can cause a severe form of meningitis which is fatal without treatment
• Treatment is with iv amphotericin B infusion 0.7mg/kg for two weeks
• Secondary prophylaxis with fluconazole is needed after amphotericin or recurrence rate of cryptococcal meningitis is very high
• specifically intended to treat potentially life-threatening fungal infections:
• aspergillosis
• cryptococcosis
• blastomycosis
• systemic candidiasis
• histoplasmosis
• zygomycosis including mucormycosis
• infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis.
DOSAGE AND ADMINISTRATION
• CAUTION: Under no circumstances should a total daily dose of 1.5 mg/kg be exceeded.
• Amphotericin B overdoses can result in potentially fatal cardiac or cardiorespiratory arrest
• should be administered by slow intravenous infusion.
• Intravenous infusion should be given over a period of approximately 2 to 6 hours (depending on the dose) observing the usual precautions for intravenous
therapy
• The recommended concentration for intravenous infusion is 0.1 mg/mL (1 mg/10 mL)
• A single intravenous test dose (1 mg in 20 mL of 5% dextrose solution) administered over 20 to 30 minutes may be preferred.
• The patient's temperature, pulse, respiration, and blood pressure should be recorded every 30 minutes for 2 to 4 hours.
• In patients with good cardio-renal function and a well tolerated test dose, therapy is usually initiated with a daily dose of 0.25 mg/ kg of body weight.
• However, in those patients having severe and rapidly progressive fungal infection, therapy may be initiated with a daily dose of 0.3 mg/kg of body weight.
• In patients with impaired cardio-renal function or a severe reaction to the test dose, therapy should be initiated with smaller daily doses (i.e., 5 to 10 mg).
• Depending on the patient's cardio-renal status ,doses may gradually be increased by 5 to 10 mg per day to final daily dosage of 0.5 to 0.7 mg/kg.
• Sporotrichosis
• Therapy with intravenous amphotericin B for sporotrichosis has ranged up to 9 months with a total dose up to 2.5 g.
• Aspergillosis
• Aspergillosis has been treated with amphotericin B intravenously for a period up to 11 months with a total dose up to 3.6 g.
Preparation of Solutions
• Reconstitute as follows:
• An initial concentrate of 5 mg /mL is first prepared by rapidly expressing 10 mL Sterile Water for Injection, using a sterile needle (minimum diameter: 20 gauge)
and syringe.
• Shake the vial immediately until the colloidal solution is clear.
• The infusion solution, providing 0.1 mg amphotericin B per mL, is then obtained by further dilution (1:50) with 5% Dextrose Injection, USP of pH above 4.2.
• The pH of each container of Dextrose Injection should be ascertained before use.
• Commercial Dextrose Injection usually has a pH above 4.2; however, if it is below 4.2, then 1 or 2 mL of buffer should be added to the Dextrose Injection before
it is used to dilute the concentrated solution of amphotericin B.
• The recommended buffer has the following composition:
• Dibasic sodium phosphate (anhydrous) 1.59 g
• Monobasic sodium phosphate (anhydrous) 0.96 g
• Water for Injection, USP qs 100.0 Ml
• The buffer should be sterilized before it is added to the Dextrose Injection, either by filtration through a bacterial retentive stone, mat, or membrane, or by
autoclaving for 30 minutes at 15 lb pressure (121° C).
CONTRAINDICATIONS
• This product is contraindicated in those patients who have shown hypersensitivity to amphotericin B or any other component in the formulation
• unless, in the opinion of the physician, the condition requiring treatment is life-threatening
Warning and precautions
• Pregnancy
• adequate and well-controlled studies have not been conducted in pregnant women, this drug should be used during pregnancy only if clearly indicated.
• Nursing Mothers
• It is not known whether amphotericin B is excreted in human milk. advise a nursing mother to discontinue nursing.
• Pediatric Use
• Safety and effectiveness in pediatric patients have not been established through adequate and well-controlled studies.
SIDE EFFECTS
• Although some patients may tolerate full intravenous doses of amphotericin B without difficulty, most will exhibit some intolerance, often at less than the full
therapeutic dose.
• The adverse reactions most commonly observed are:
• General (body as a whole): fever (sometimes accompanied by shaking chills usually occurring within 15 to 20 minutes after initiation of treatment); malaise;
weight loss.
• Cardiopulmonary: hypotension; tachypnea.
• Gastrointestinal: anorexia; nausea; vomiting; diarrhea; dyspepsia; cramping epigastric pain.
• Hematologic: normochromic, normocytic anemia.
• Local: pain at the injection site with or without phlebitis or thrombophlebitis.
• Musculoskeletal: generalized pain, including muscle and joint pains.
• Neurologic:headache.
• Renal: decreased renal function and renal function abnormalities
OVERDOSE
• Amphotericin B overdoses can result in potentially fatal cardiac or cardiorespiratory arrest
Storage
• Store the powder for reconstitution under refrigeration (2-8)’C
• Protect from light
Presentation
• Photericin B........................vial of 15 ml
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