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Amphotericin b manufacturers

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Country of origin : Thailand

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amphotericin b

Vials, injection 50 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Thailand
GMP approvals
PICS
Manufacturer #14397
A pharmaceutical manufacturer based in Asia that has been active in Asia and the Middle East for 40+ years. The company's production lines are EU GMP-compliant. Key production lines are Rx, OTC, and nutraceuticals. The main therapeutic area includes the cardiovascular system, CNS, and anti-infec'tives.

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Amphotericin B Manufacturers

Amphotericin B is an antifungal polyene antibiotic that belongs to a class of medications called antifungals. Amphotericin B is a broad spectrum, antifungal agent and is indicated to treat serious fungal infections which are potentially life-threatening fungal infections, caused by Histoplasma capsulatum, Coccidioides immitis, Cryptococcus neoformans , and Mucor mucedo spp. It is also used to treat invasive fungal infections that are generally seen in patients who are immunocompromised. These include invasive candidiasis, invasive aspergillosis, and emerging fungal infections. Amphotericin B is advised as a prescription product, generic prescription product as well as mixture product. Manufacturers market Amphotericin B under the Brand name Abelcet, Amphotec, Fungizone, and Amphicin. Amphotericin B is available in the dosage form of Liposome Injections - powder (for suspension and solution) which are administered intravenously. Before using this medication, the risk of taking the drug must be weighed against the benefits it provides. It is always recommended to consult a physician before taking Amphotericin B as this medication may interact with other drugs and health problems. Amphotericin B is available in dosage strength of 5 mg, 50 mg, and 100 mg/mL. These injections are available as a single dose unpreserved sterile lyophile, in a pack of ten individual vial cartons, which are for single use only and any unused solution should be discarded. Only clear solutions without particles should be used and the injection of amphotericin b should commence within 6 hours of dilution with 5% dextrose injection. A test dose for over 20-30 minutes is administered before the first dose to check for drug tolerance. The duration of the treatment depends on the type of infection, patient health, and how the patient tolerates the medication. The recommended initial dose of Amphotericin B in adults and pediatric patients for systemic fungal infections like Aspergillus, Candida, Cryptococcus is 3-5 mg/kg/day and the dose for cryptococcal meningitis in HIV infected patients is 6 mg/kg/day. This drug should be administered by intravenous infusion, using a controlled infusion device over approximately two hours once daily. Amphotericin B vials are to be stored at temperature up to 25° C (77° F) and the reconstituted product may be stored for a day at 2° C to 8° C (36° F - 46° F). It should not be freeze and the container must be tightly closed. This medication should only be used to treat patients with progressing and potentially fatal fungal infections; it should not be used to treat noninvasive fungal diseases like oral thrush, vaginal candidiasis, or esophageal candidiasis in people with normal neutrophil counts. The dose of Amphotericin B injection should not exceed 1.5 mg/kg. To avoid unintended overdosing, which might result in potentially catastrophic cardiac or cardiopulmonary arrest. Diarrhea; stomach ache; loss of appetite; joint or muscular discomfort; a headache and ringing in the ears; pain, bruising, or swelling at the injection site; weight reduction; and flushing. Amphotericin B is unlikely to cause harm to an unborn child. If you are pregnant or plan to become pregnant during treatment, tell your doctor. It's unclear whether it travels into breast milk or if it can affect a nursing baby. It is not recommended that you breastfeed while using this medication.

Wholesale Price of Amphotericin B

In the U.S at local pharmacies, the wholesale price for 50 mg Amphotericin B intravenous powder for injection costs around $ 42.75 for 1 powder for injection depending upon the pharmacy one visits.

Amphotericin B - Mechanism of Action

Amphotericin B is an antifungal agent which works by slowing the growth of fungi that cause infection. In susceptible fungi, the drug mainly acts by binding to ergosterols in the cell membrane leading to alterations in cell permeability and cell death. Amphotericin B, a polyene binds to ergosterol resulting in disruption of membrane integrity and finally leading to cell death.

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