Label: ATOVAQUONE suspension

  • NDC Code(s): 0121-0956-08
  • Packager: PAI Holdings, LLC dba PAI Pharma
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 31, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ATOVAQUONE ORAL SUSPENSION safely and effectively. See full prescribing information for ATOVAQUONE ORAL SUSPENSION ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Prevention of - Pneumocystis jirovecii Pneumonia - Atovaquone oral suspension is indicated for the prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents (aged 13 years ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage for the Prevention of - P. jirovecii Pneumonia - The recommended oral dosage is 1,500 mg (10 mL) once daily administered with food. 2.2 Dosage for the Treatment of Mild-to-Moderate ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Atovaquone oral suspension USP is a bright yellow, tutti frutti flavored, oral suspension containing 750 mg of atovaquone per 5 mL. Atovaquone is supplied in 210-mL bottles.
  • 4 CONTRAINDICATIONS
    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 ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Risk of Limited Oral Absorption - Absorption of orally administered atovaquone oral suspension is limited but can be significantly increased when the drug is taken with food. Failure to ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in other sections of the labeling: Hepatotoxicity - [see - Warnings and Precautions (5.2)] . 6.1 Clinical Trials Experience - Because ...
  • 7 DRUG INTERACTIONS
    7.1 Rifampin/Rifabutin - Concomitant administration of rifampin or rifabutin and atovaquone oral suspension is known to reduce atovaquone concentrations - [see Clinical Pharmacology (12.3)] ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data from postmarketing experience with use of atovaquone in pregnant women are insufficient to identify a drug-associated risk for major birth defects ...
  • 10 OVERDOSAGE
    Overdoses up to 31,500 mg of atovaquone have been reported. In one patient who also took an unspecified dose of dapsone, methemoglobinemia occurred. Rash has also been reported after overdose ...
  • 11 DESCRIPTION
    Atovaquone oral suspension USP is a quinone antimicrobial drug. The chemical name of atovaquone is - trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Atovaquone is a quinone antimicrobial drug [see - Microbiology (12.4)]. 12.2 Pharmacodynamics - Relationship between Plasma Atovaquone Concentrations and Clinical ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity studies in rats were negative; 24-month studies in mice (dosed with 50, 100, or 200 mg/kg/day), showed ...
  • 14 CLINICAL STUDIES
    14.1 Prevention of PCP - The indication for prevention of PCP is based on the results of 2 clinical trials comparing atovaquone oral suspension with dapsone or aerosolized pentamidine in ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Atovaquone oral suspension USP (bright yellow, tutti frutti flavored) containing 750 mg atovaquone per 5 mL. NDC 0121-0956-08: 210 mL bottle with child-resistant cap. Store at 15°C to 25°C (59°F ...
  • 17 PATIENT COUNSELING INFORMATION
    Administration Instructions - Instruct patients to: Ensure the prescribed dose of atovaquone oral suspension is taken as directed. Take their daily doses of atovaquone oral suspension with food ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 0121-0956-08 - Atovaquone Oral Suspension USP - 750 mg/5 mL
  • INGREDIENTS AND APPEARANCE
    Product Information