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Atovaquone (Atovaquone)

Trade Name : atovaquone

Northstar Rx LLC

SUSPENSION

Strength 750 mg/5mL

ATOVAQUONE Antimalarial [EPC],Antiprotozoal [EPC]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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 (Atovaquone) which is also known as atovaquone and Manufactured by Northstar Rx LLC. 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:
  • Pneumocystis jirovecii
  • Limitations of Use
  • No data
  • Arrayn- Array
  • Atovaquone Oral Suspension, USP is a bright yellow, tutti frutti flavored, oral suspension containing 750 mg of atovaquone USP in 5 mL. Atovaquone Oral Suspension, USP is supplied in 210 mL bottles.
  • Oral suspension: 750 mg per 5 mL. ()
  • 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.
  • u00a0
  • 4
  • No data
  • The following adverse reaction is discussed in another section of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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.
  • Atovaquone Oral Suspension, USP is a quinone antimicrobial drug. The chemical name of atovaquone USP is -2-[4-(4-chlorophenyl) cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone USP is a yellow crystalline powder that is freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran; soluble in chloroform; sparingly soluble in acetone and dimethyl sulfoxide; slightly soluble in octanol, ethyl acetate and polyethylene glycol 200; very slightly soluble in 0.1N sodium hydroxide; insoluble in water. It has a molecular weight of 366.84 g/mol and the molecular formula CHClO. The compound has the following structural formula:
  • 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, citric acid monohydrate, hypromellose, poloxamer 188, purified water, saccharin sodium, trisodium citrate dihydrate, tutti frutti flavor and xanthan gum.
  • No data
  • Carcinogenicity studies in rats were negative; 24u2011month studies in mice (dosed with 50, 100, or 200 mg/kg/day) showed treatmentu2011related increases in incidence of hepatocellular adenoma and hepatocellular carcinoma at all doses tested, which correlated with 1.4 to 3.6u00a0times the average steadyu2011state 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.
  • 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 1,000 mg/kg/day corresponding to plasma exposures of approximately 3 times the estimated human exposure based on steady-state plasma concentrations.
  • No data
  • Atovaquone Oral Suspension, USP is a bright yellow, tutti frutti flavored, oral suspension containing 750 mg of atovaquone USP per 5 mL. It is supplied as follows:
  • Administration Instructions
  • Instruct patients to:
  • Lactation
  • Manufactured for:
  • Northstar Rx LLC
  • Memphis, TN 38141.
  • Manufactured by: n n
  • Village: Kishanpura, Baddi Nalagarh Road,
  • Dist. Solan, Himachal Pradesh -173205, India
  • September 2019
  • NDC 16714-900-01
  • Atovaquone Oral Suspension, USP
  • 750 mg/5 ml
  • Carton Label

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