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Atovaquone (Atovaquone)

Trade Name : Atovaquone

Camber Pharmaceuticals, Inc.

SUSPENSION

Strength 750 mg/5mL

ATOVAQUONE Antimalarial [EPC],Antiprotozoal [EPC]

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

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

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.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Atovaquone oral suspension is a quinone antimicrobial drug indicated for: u2022u00a0Prevention of pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).(n u2022Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMXn Limitations of Use n u2022u00a0Treatment of severe PCP (alveolar arterial oxygen diffusion gradientu00a0 [(A-a)DO] >45 mm Hg) with atovaquone oralu00a0suspension has not been studied. u2022u00a0The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied.
  • u2022u00a0Prevention of PCP: 1,500 mg (10 mL) once daily with foodn u2022u00a0Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days n u2022u00a0Supplied inu00a0Bottles:u00a0Shake bottle gently before use.n
  • Atovaquone oral suspension, USP is a yellow homogenous suspension containing 750 mg of atovaquone USPu00a0per 5 mL. Atovaquone oral suspension, USP is supplied in 210 mL bottles.
  • Oral suspension: 750 mg per 5 mLn
  • 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.
  • Known serious allergic/hypersensitivity reaction (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension. n
  • u2022u00a0Failure 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.n u2022u00a0Hepatotoxicity: Elevated liver chemistry tests and cases of hepatitis and fatal liver failure have been reported. n
  • The following adverse reactions are discussed in other sections of the labeling: u2022 Hepatotoxicity n n
  • u2022u00a0PCP Prevention: The most frequent adverse reactions (u226525% that required discontinuation) were diarrhea, rash, headache, nausea, and fever. ) u2022u00a0PCP Treatment: The most frequent adverse reactions (u226514% that required discontinuation) were rash (including maculopapular), nausea, diarrhea, headache, vomiting, and fever. n n n n
  • u2022u00a0Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with atovaquone oral suspension is not recommended. n u2022u00a0Concomitant administration of tetracycline reduces atovaquone concentrations; use caution when coadministering. Monitor patients for potential loss of efficacy of atovaquone if coadministration of tetracycline is necessary. n u2022u00a0Concomitant administration with metoclopramide reduces atovaquone concentrations; administer concomitantly only if other antiemetics are not available. n u2022u00a0Concomitant administration of indinavir reduces indinavir trough concentrations; use caution when coadministering. Monitor patients for potential loss of efficacy of indinavir if coadministration is necessary. n
  • No data
  • In one patient who 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.
  • Atovaquone oral suspension is a quinone antimicrobial drug.u00a0The chemical name of atovaquone is 1,4-Naphthalenedione, 2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-, trans. Atovaquone USP is a yellow colored powder that is freely soluble in tetrahydrofuran, soluble in chloroform and sparingly soluble in acetone. It has a molecular weight of 366.84 and the molecular formula CHClO. The compound has the following structural formula: u00a0
  • Atovaquone oral suspension, USP is a formulation of micro-fine particles of atovaquone USP. Each 5 mL of atovaquone oral suspension, USP contains 750 mg of atovaquone USP and the inactive ingredients benzyl alcohol, flavor, hypromellose, poloxamer, purified water, saccharin sodium, and xanthan gum.
  • No data
  • Carcinogenicity studies in rats were negative; 24-month studies in mice (dosed with 50, 100, 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 Ames 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.
  • No data
  • Atovaquone oral suspension, USP is a yellow homogenous suspension containing 750 mg atovaquone USPu00a0per 5 mL. u2022u00a0Bottle of 210 mL with child-resistant cap (NDC 31722-629-21). Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F). . Dispense in tight container as defined in USP.
  • Administration Instructions
  • Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854n By: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 204961 Jeedimetla, Hyderabad u2013 500 055, India. n n Revised: June 2018
  • Atovaquone Oral Suspension, USP 750 mg/5 mL Container Label
  • Atovaquone Oral Suspension, USP 750 mg/5 mL Carton Label

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