Trade Name: Atovaquone

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: VistaPharm, Inc.

Presentation: SUSPENSION, HUMAN PRESCRIPTION DRUG

Strength: 750 mg/5mL

Storage and handling

ATOVAQUONE Antimalarial [EPC],Antiprotozoal [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • Atovaquone oral suspension is a quinone antimicrobial drug indicated for:u2022Prevention of pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). ()u2022Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. ()n
  • 2
  • u2022 Prevention of PCP: 1,500 mg (10 mL) once daily with food ()u2022 Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days ()
  • u2022 Sachet: Shake sachet gently before use. ()n
  • Atovaquone oral suspension, USP is a bright yellow, citrus-flavored, oral suspension containing 750 mg of atovaquone, USP in 5 mL. Atovaquone oral suspension, USP is supplied in 5 mL sachets.n
  • Oral suspension: 750 mg per 5 mL. ()n
  • Atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension.n
  • Known serious allergic/hypersensitivity reaction (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension. ()n
  • u2022 Failure to administer atovaquone oral suspension with food may result in lower plasma atovaquone concentrations and may limit response to therapy. Patients with gastrointestinal disorders may have limited absorption resulting in suboptimal atovaquone concentrations. ()u2022 Hepatotoxicity: Elevated liver chemistry tests and cases of hepatitis and fatal liver failure have been reported. (n n
  • The following adverse reaction is discussed in another sections of the labeling:
  • u2022 PCP Prevention: The most frequent adverse reactions (u226525% that required discontinuation) were diarrhea, rash, headache, nausea, and fever. ()
  • u2022 PCP Treatment: The most frequent adverse reactions (u226514% that required discontinuation) were rash (including maculopapular), nausea, diarrhea, headache, vomiting, and fever. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc. atu00a01-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • u2022 Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with atovaquone oral suspension is not recommended. ()u2022 Concomitant administration of tetracycline reduces atovaquone concentrations; use caution when co-administering. Monitor patients for potential loss of efficacy of atovaquone if co-administration of tetracycline is necessary. ()u2022 Concomitant administration with metoclopramide reduces atovaquone concentrations; administer concomitantly only if other antiemetics are not available. ()u2022 Concomitant administration of indinavir reduces indinavir trough concentrations; use caution when co-administering. Monitor patients for potential loss of efficacy of indinavir if co-administration is necessary. ()
  • Lactation: Breastfeeding is not recommended in mothers with HIV-1 infection due to the potential for HIV-1 transmission. ()n
  • Overdoses up to 31,500 mg of atovaquone have been reported. In one such patient who also took an unspecified dose of dapsone, methemoglobinemia occurred. Rash has also been reported after overdose. There is no known antidote for atovaquone, and it is currently unknown if atovaquone is dialyzable.u00a0n
  • Atovaquone is a quinone antimicrobial drug for oral administration. The chemical name of atovaquone is trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone, USP is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula CHClO. The compound has the following structural formula:
  • The atovaquone particles, reduced in size to facilitate absorption, are significantly smaller than those in the previously marketed tablet formulation. Atovaquone oral suspension, USP is for oral administration and is bright yellow with a citrus flavor. Each teaspoonful (5 mL) contains 750 mg of atovaquone, USP and the inactive ingredients benzyl alcohol, flavor (ethanol, propylene glycol, triacetin), poloxamer 188, purified water, saccharin sodium and xanthan gum.n
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  • Carcinogenicity studies in rats were negative; 24-month studies in mice (dosed with 50 mg/kg/day, 100 mg/kg/day, or 200 mg/kg/day), showed treatment-related increases in incidence of hepatocellular adenoma and hepatocellular carcinoma at all doses tested, which correlated with 1.4 to 3.6 times the average steady-state plasma concentrations in humans during acute treatment of PCP. Atovaquone was negative with or without metabolic activation in the mutagenicity assay, the mouse lymphoma mutagenesis assay, and the cultured human lymphocyte cytogenetic assay. No evidence of genotoxicity was observed in the mouse micronucleus assay.
  • Impairment of Fertilityu00a0
  • No data
  • Atovaquone oral suspension, USP (bright yellow, citrus-flavored) containing 750 mg atovaquone, USP in each teaspoonful (5 mL).
  • u2022 NDC 66689-062-01: 5 mL sachet (unit-dose)u2022 NDC 66689-062-018: Case contains 18 unit-dose sachets of 5 mL (NDC 66689-062-01).u2022 NDC 66689-062-042: Case contains 42 unit-dose sachets of 5 mL (NDC 66689-062-01).n
  • Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F). . Dispense in tight container as defined in USP.n
  • Administration Instructions
  • Lactationn- see n
  • Distributed by:VistaPharm, Inc.Largo, FL, USA
  • VP2186R209/2019
  • Atovaquone Oral Suspension, USPu00a0u00a0u00a0u00a0u00a0
  • 750 mg/5 mL
  • Shake gently. Do Not Freeze.
  • Delivers 5 mL
  • Store at 15u00b0-25u00b0C [59u00b0-77u00b0F].
  • Largo, FL 33771 USA
  • NDC 66689-062-01
  • VP2188R1
  • 06/18

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Atovaquone (Atovaquone) which is also known as Atovaquone and Manufactured by VistaPharm, Inc.. It is available in strength of 750 mg/5mL.

Atovaquone (Atovaquone) 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.

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