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Atovaquone (Mepron)

Trade Name : MEPRON

GlaxoSmithKline LLC

SUSPENSION

Strength 750 mg/5mL

ATOVAQUONE Antimalarial [EPC],Antiprotozoal [EPC]

Delivery Process

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Product information is meant for

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Disclaimer

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 (Mepron) which is also known as MEPRON and Manufactured by GlaxoSmithKline LLC. It is available in strength of 750 mg/5mL per ml. Read more

Atovaquone (Mepron) 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
  • MEPRON oral suspension is a quinone antimicrobial drug indicated for:
  • 1.3
  • No data
  • MEPRON is a bright yellow, citrus-flavored, oral suspension containing 750u00a0mg of atovaquone per 5u00a0mL. MEPRON is supplied in 210-mL bottles or 5-mL foil pouches.
  • Oral suspension: 750u00a0mg per 5u00a0mL ()
  • MEPRON 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 MEPRON.
  • Known serious allergic/hypersensitivity reaction (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of MEPRON. ()
  • No data
  • The following adverse reaction is discussed in another section of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .
  • No data
  • Lactation: Breastfeeding is not recommended in mothers with HIV-1 infection due to the potential for HIV-1 transmission. ()
  • 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.
  • MEPRON (atovaquone oral suspension) is a quinone antimicrobial drug. The chemical name of atovaquone is -2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone 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:
  • MEPRON oral suspension is a formulation of micro-fine particles of atovaquone.
  • Each 5u00a0mL of MEPRON oral suspension contains 750u00a0mg of atovaquone and the inactive ingredients benzyl alcohol, flavor, poloxameru00a0188, 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 200u00a0mg/kg/day) showed treatment-related increases in incidence of hepatocellular adenoma and hepatocellular carcinoma at all doses tested, which correlated with 1.4 to 3.6u00a0times 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 in vivo mouse micronucleus assay.
  • Impairment of Fertility
  • Atovaquone administered by oral gavage in doses of 100, 300, or 1,000 mg/kg/day to adult male rats from 73 days prior to mating until 20 days after mating and to adult female rats from 14 days prior to mating until LD20 did not impair male or female fertility or early embryonic development at doses up to 1,000u00a0mg/kg/day corresponding to plasma exposures of approximately 3 times the estimated human exposure based on steady-state plasma concentrations.
  • No data
  • MEPRON oral suspension (bright yellow, citrus-flavored) containing 750u00a0mg atovaquone per 5u00a0mL.
  • Administration Instructions
  • Instruct patients to:
  • Lactation
  • Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk .
  • Trademarks are owned or licensed to the GSK group of companies.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92019 GSK group of companies or its licensor.
  • MPR:9PI
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0665-18
  • MEPRON
  • Arrayn- (atovaquone oral suspension)
  • Arrayn- 750mg/5mL
  • Each 5 mL (1 teaspoonful) contains 750 mg atovaquone.
  • R only
  • Arrayn- 210 mL
  • See accompanying prescribing information for Dosage and Administration.
  • Store at 15 to 25C (59 to 77F).
  • DO NOT FREEZE. Dispense in a tight container as defined in USP.
  • SHAKE GENTLY BEFORE USING.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in Canada
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0547-00
  • MEPRON
  • Arrayn- (atovaquone oral suspension)
  • Arrayn- 750 mg/ 5mL
  • Each 5 mL sachet (1 teaspoonful) contains 750 mg atovaquone.
  • Store at 15 to 25C (59 to 77F). n
  • See accompanying prescribing information for Dosage and Administration.
  • 5 mL
  • R only
  • Contains 42 sachets of 5 mL each
  • u00a92018 the GSK group of companies or its licensor.

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