Atovaquone

Atovaquone oral suspension is a quinone antimicrobial drug indicated for:

• Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim­-sulfamethoxazole (TMP-SMX). (
  
  
  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 and older) who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
  )
  
• Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (
  
  
  1.2 Treatment of Mild-to-Moderate

  Pneumocystis jirovecii

  Pneumonia

  Atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX.
  )
  

Limitations of Use (

• Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO 2] >45 mm Hg) with atovaquone has not been studied.
• The efficacy of atovaquone in subjects who are failing therapy with TMP­ SMX has also not been studied.

• Prevention of PCP: 1,500 mg (10 mL) once daily with food (
  
  
  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.
  )
  
• Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days (
  
  
  2.2 Dosage for the Treatment of Mild-to-Moderate

  P. jirovecii

  Pneumonia

  The recommended oral dosage is 750 mg (5 mL) twice daily (total daily dose = 1,500 mg) administered with food for 21 days.
  )
  
• Supplied in Bottles:
  
  
  • Bottle: Shake bottle gently before use. (
    
    
    2.3 Important Administration Instructions

    Administer atovaquone oral suspension with food to avoid lower plasma atovaquone concentrations that may limit response to therapy

    [see

    Warnings and Precautions (5.1)

    ,

    Clinical Pharmacology (12.3)

    ]

    .

    Atovaquone Bottle

    Shake bottle gently before administering the recommended dosage.
    )
    
    

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.

Lactation: Breastfeeding is not recommended in mothers with HIV-1 infection due to the potential for HIV-1 transmission. (

• 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 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 administer atovaquone oral suspension with food may result in lower plasma atovaquone concentrations and may limit response to therapy.

  Consider therapy with other agents in patients who have difficulty taking atovaquone oral suspension with food or in patients who have gastrointestinal disorders that may limit absorption of oral medications

  [see

  Clinical Pharmacology (12.3)

  ].
  )
  
• Hepatotoxicity: Elevated liver chemistry tests and cases of hepatitis and fatal liver failure have been reported. (
  
  
  5.2 Hepatotoxicity

  Cases of cholestatic hepatitis, elevated liver enzymes, and fatal liver failure have been reported in patients treated with atovaquone

  [see

  Adverse Reactions (6.2)

  ].

  If treating patients with severe hepatic impairment, closely monitor patients following administration of atovaquone.
  )