Amphotericin B (Amphotericin B)

Trade Name : Amphotericin B

X-GEN Pharmaceuticals, Inc.

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 50 mg/10mL

AMPHOTERICIN B Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amphotericin B (Amphotericin B) which is also known as Amphotericin B and Manufactured by X-GEN Pharmaceuticals, Inc.. It is available in strength of 50 mg/10mL per ml. Read more

Amphotericin B (Amphotericin B) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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This drug should be used for treatment of patients with progressive and potentially life-threatening fungal infections; it should not be used to treat noninvasive forms of fungal disease such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts.
Amphotericin B for Injection should no be given in doses greater than 1.5 mg/kg.
EXERCISE CAUTION

Amphotericin B for Injection USP contains amphotericin B, an antifungal polyene antibiotic obtained from a strain of . Amphotericin B is designated chemically as [1R- (1R*, 3S*, 5R*, 6R*, 9R*, 11R*, 15S*, 16R*, 17R*, 18S*, 19E, 21E, 23E, 25E, 27E, 29E, 31E, 33R*, 35S*, 36R*, 37S*)] -33-[(3-Amino-3, 6-dideoxy-u03b2-D-mannopyranosyl)-oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo [33.3.1] nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid. Structural formula:
Each vial contains a sterile, nonpyrogenic, lyophilized cake (which may partially reduce to powder following manufacture) providing 50 mg amphotericin B and 41 mg sodium desoxycholate buffered with 20.2 mg sodium phosphates (consisting of mono and dibasic sodium phosphate, phosphoric acid and sodium hydroxide). Crystalline amphotericin B is insoluble in water; therefore, the antibiotic is solubilized by the addition of sodium desoxycholate to form a mixture which provides a colloidal dispersion for intravenous infusion following reconstitution.
At the time of manufacture the air in the vial is replaced by nitrogen.

Microbiology
Amphotericin B shows a high order of activity against many species of fungi. , , species, , , , and n are all inhibited by concentrations of amphotericin B ranging from 0.03 to 1.0 mcg/mL . While is generally quite susceptible to amphotericin B, non- species may be less susceptible. and sp. are often resistant to amphotericin B. The antibiotic is without effect on bacteria, rickettsiae, and viruses.
Susceptibility Testing
Standardized techniques for susceptibility testing for antifungal agents have not been established and results of susceptibility studies have not been correlated with clinical outcomes.
Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus. The drug acts by binding to sterols in the cell membrane of susceptible fungi with a resultant change in membrane permeability allowing leakage of intracellular components. Mammalian cell membranes also contain sterols and it has been suggested that the damage to human cells and fungal cells may share common mechanisms.
An initial intravenous infusion of 1 to 5 mg of amphotericin B per day, gradually increased to 0.4 to 0.6 mg/kg daily, produces peak plasma concentrations ranging from approximately 0.5 to 2 mcg/mL. Following a rapid initial fall, plasma concentrations plateau at about 0.5 mcg/mL. An elimination half-life of approximately 15 days follows an initial plasma half-life of about 24 hours. Amphotericin B circulating in plasma is highly bound (>90%) to plasma proteins and is poorly dialyzable. Approximately two thirds of concurrent plasma concentrations have been detected in fluids from inflamed pleura, peritoneum, synovium, and aqueous humor. Concentrations in the cerebrospinal fluid seldom exceed 2.5% of those in the plasma. Little amphotericin B penetrates into vitreous humor or normal amniotic fluid. Complete details of tissue distribution are not known.
Amphotericin B is excreted very slowly (over weeks to months) by the kidneys with 2 to 5% of a given dose being excreted in the biologically active form. Details of possible metabolic pathways are not known. After treatment is discontinued, the drug can be detected in the urine for at least 7 weeks due to the slow disappearance of the drug. The cumulative urinary output over a 7 day period amounts to approximately 40% of the amount of drug infused.

Amphotericin B for Injection USP 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.
Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera , and , and infections due to related susceptible species of and , and sporotrichosis.
Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

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 and amenable only to amphotericin B therapy.

Amphotericin B is frequently the only effective treatment available for potentially life-threatening fungal disease. In each case, its possible life-saving benefit must be balanced against its untoward and dangerous side effects.
EXERCISE CAUTIONn- Verify the product name and dosage especially if dose exceeds 1.5 mg/kg.

No data

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.
Tolerance may be improved by treatment with aspirin, antipyretics (e.g., acetaminophen), antihistamines, or antiemetics. Meperidine (25 to 50 mg IV) has been shown in some patients to decrease the duration of shaking chills and fever that may accompany the infusion of amphotericin B.
Administration of amphotericin B on alternate days may decrease anorexia and phlebitis.
Intravenous administration of small doses of adrenal corticosteroids just prior to or during the amphotericin B infusion may help decrease febrile reactions. Dosage and duration of such corticosteroid therapy should be kept to a minimum (see ).
Addition of heparin (1000 units per infusion), and the use of a pediatric scalp-vein needle may lessen the incidence of thrombophlebitis. Extravasation may cause chemical irritation.
The adverse reactions most commonly observed are:
General (body as a whole):
Cardiopulmonary:
Gastrointestinal:
Hematologic:
Local:
Musculoskeletal:
Neurologic:
Renal:n- decreased
The following adverse reactions have also been reported:
General (body as a whole):
Allergic:
Cardiopulmonary:
Dermatologic:
Gastrointestinal:
Hematologic:
Neurologic:
Renal:
Arrayn- Altered Laboratory Findings
Serum Electrolytes:
Liver Function Tests:
Renal Function Tests:

Amphotericin B overdoses can result in potentially fatal cardiac or cardiopulmonary arrest (see and ). If an overdose is suspected, discontinue therapy and monitor the patient's clinical status (e.g., cardiorespiratory, renal, and liver function, hematologic status, serum electrolytes) and administer supportive therapy, as required. Amphotericin B is not hemodialyzable.
Prior to reinstituting therapy, the patient's condition should be stabilized (including correction of electrolyte deficiencies, etc.).

****
CAUTION: Under no circumstances should a total daily dose of 1.5 mg/kg be exceeded.
Amphotericin B overdoses can result
Amphotericin B for Injection should be administered by 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 (see ). The recommended concentration for intravenous infusion is 0.1 mg/mL (1mg/10mL).
Since patient tolerance varies greatly, the dosage of amphotericin B must be individualized and adjusted according to the patient's clinical status (e.g., site and severity of infection, etiologic agent, cardio-renal function, etc.).
A single intravenous (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 and a , therapy is usually initiated with a daily dose of 0.25 mg/kg of body weight. However, in those patients having , therapy may be initiated with a daily dose of 0.3 mg/kg of body weight. In patients with or a , therapy should be initiated with smaller daily doses (i.e., 5 to 10 mg).
Depending on the patient's cardio-renal status (see ), doses may gradually be increased by 5 to 10 mg per day to final daily dosage of 0.5 to 0.7 mg/kg.
There are insufficient data presently available to define total dosage requirements and duration of treatment necessary for eradication of specific mycoses. The optimal dose is unknown. Total daily dosage may range up to 1.0 mg/kg per day or up to 1.5 mg/kg when given on alternate days.
Sporotrichosis:
Aspergillosis:
Rhinocerebral phycomycosis:
Preparation of Solutions
Reconstitute as follows: An initial concentrate of 5 mg amphotericin B per mL is first prepared by rapidly expressing 10 mL Sterile Water for Injection USP directly into the lyophilized cake, 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 . 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)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a01.59
Monobasic sodium phosphate (anhydrous)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a00.96 g
Water for Injection USPu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0qs 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 (121u02daC).
CAUTION: Aseptic technique must be strictly observed in all handlingn- All entries into the vial or into the diluents must be made with a sterile needle. Do not reconstitute with saline solutions. The use of any diluent other than the ones recommended or the presence of a bacteriostatic agentn- in the diluent may cause precipitation of the antibiotic. Do not use the initial concentrate or the infusion solution if there is any evidence of precipitation or foreign matter in either one.
An in-line membrane filter may be used for intravenous infusion of amphotericin B; n

Amphotericin B for Injection USP
Available as single vials providing 50 mg amphotericin B as a yellow to orange lyophilized cake (which may partially reduce to powder following manufacture). NDC 39822-1055-5. Retain in carton until time of use.
Prior to reconstitution Amphotericin B for Injection USP should be stored under refrigeration, 2u02da to 8u02daC (36u02dato 46u02daF), protected against exposure to light. The concentrate (5 mg amphotericin B per mL after reconstitution with 10 mL Sterile Water for Injection USP) may be stored in the dark, at room temperature for 24 hours, or at refrigerator temperatures for one week with minimal loss of potency and clarity. Any unused material should then be discarded. Solutions prepared for intravenous infusion (0.1 mg or less amphotericin B per mL) should be used promptly after preparation and should be protected from light during administration.
Rx Only
Manufactured for X-Gen Pharmaceuticals, Inc.Big Flats, NY 14814
Revisedu00a0December 2009AM-PI-04Printed in the USA

NDCn- Amphotericin B for Injection, USPn- Arrayn- 50mg n- Arrayn- For Intravenous Infusion Onlyn- Arrayn- Rx Onlyn- Arrayn- 1 Vialn- Arrayn- X-GEN Pharmaceuticals, Inc.n- Arrayn- STOP: Verify product name & dosage if dose exceeds 1.5 mg/kg
NDC n- Amphotericin B for Injection, USPn- Arrayn- 50mg n- Arrayn- For Intravenous Infusion Onlyn- Arrayn- Rx Onlyn- Arrayn- 1 Vialn- Arrayn- X-GEN Pharmaceuticals, Inc.n- Arrayn- STOP: Verify product name & dosage if dose exceeds 1.5 mg/kgn- Array

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Amphotericin B (Amphotericin B)

Trade Name : Amphotericin B

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Amphotericin B (Amphotericin B)

Trade Name : Amphotericin B

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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