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Atovaquone (Atovaquone Oral Suspension)

Trade Name : Atovaquone Oral Suspension

KVK-Tech, Inc.

SUSPENSION

Strength 750 mg/5mL

ATOVAQUONE Antimalarial [EPC],Antiprotozoal [EPC]

Delivery Process

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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 Oral Suspension) which is also known as Atovaquone Oral Suspension and Manufactured by KVK-Tech, Inc.. It is available in strength of 750 mg/5mL per ml. Read more

Atovaquone (Atovaquone Oral Suspension) 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.

Read more
  • No data
  • Atovaquone oral suspension is a quinone antimicrobial drug indicated for:
  • Limitations of Use (1.3):
  • u00a0 u00a0 u00a0u00ba Bottle: Shake bottle gently before use. (2.3)
  • Prevention of PCP: 1,500 mg (10 mL) once daily with food. (2.1)
  • Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days. (2.2)
  • Supplied in Bottles:
  • Atovaquone oral suspension, USP is a bright yellow, citrus-flavored, oral suspension containing 750 mg of atovaquone per 5 mL. Atovaquone oral suspension, USP is supplied in 210-mL bottles.
  • Oral suspension: 750 mg per 5 mL. (3)
  • 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. (4)
  • No data
  • 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. (5.1)
  • Hepatotoxicity: Elevated liver chemistry tests and cases of hepatitis and fatal liver failure have been reported. (5.2)
  • The following adverse reaction is discussed in another section of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact KVK-Tech, Inc. at 1-215-579-1842 or FDA at 1-800-FDA-1088 or .
  • PCP Prevention: The most frequent adverse reactions (u226525% that required discontinuation) were diarrhea, rash, headache, nausea, and fever. (6.1)
  • PCP Treatment: The most frequent adverse reactions (u226514% that required discontinuation) were rash (including maculopapular), nausea, diarrhea, headache, vomiting, and fever. (6.1)
  • No data
  • Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with atovaquone oral suspension is not recommended. (7.1)
  • Concomitant 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. (7.2)
  • Concomitant administration with metoclopramide reduces atovaquone concentrations; administer concomitantly only if other antiemetics are not available. (7.3)
  • Concomitant administration of indinavir reduces indinavir trough concentrations; use caution when coadministering. Monitor patients for potential loss of efficacy of indinavir if coadministration is necessary. (7.4)
  • Lactation: Breastfeeding is not recommended in mothers with HIV-1 infection due to the potential for HIV-1 transmission. (8.2)
  • 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 is -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:
  • 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 and the inactive ingredients benzyl alcohol, flavor natural citrus, poloxamer 188, 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 Salmonella 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 1,000 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 (bright yellow, citrus-flavored) containing 750 mg atovaquone per 5 mL.
  • Administration Instructions
  • Instruct patients to:
  • Lactation
  • Arrayn- [see Use in Specific Populations (8.2)]
  • Manufactured by:KVK-Tech, Inc.110 Terry DriveNewtown, PA 18940
  • Manufactureru2019s code: 10702Item ID #: 6306/02u00a0 u00a0 Rev.: 03/2019
  • NDC 10702--21
  • Atovaquone Oral Suspension, USP
  • 750 mg/5 mL
  • Each 5 mL (1 teaspoonful) contains 750 mg atovaquone.
  • Contains no more than 0.34% of alcohol.
  • Contains no ingredients made from a gluten containing grain (wheat, barley, or rye).
  • Sugar Free
  • Rx only u00a0 u00a0210 mL
  • KVK-Tech, Inc.
  • NDC 10702--21n n
  • Atovaquone Oral Suspension, USPn- Array
  • 750 mg/5 mLn- Array
  • Each 5 mL (1 teaspoonful) contains 750 mg atovaquone.n- Array
  • Contains no more than 0.34% of alcohol.n- Array
  • Contains no ingredients made from a gluten containing grain (wheat, barley, or rye).n- Array
  • Sugar Freen- Array
  • Rx only
  • Net Content: 210 mLn- Array
  • KVK-Tech, Inc.

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