Atovaquone
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From MedlinePlus, U.S. National Library of Medicine
Antimalarial, Antiprotozoal
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Important Administration Instructions Administer MEPRON oral suspension with food to avoid low plasma atovaquone concentrations that may limit response to therapy [see Warnings and Precautions, Clinical Pharmacology]. MEPRON Foil Pouch
Open each 5-mL pouch by folding along the dotted line and tearing open at horizontal slit as directed by arrow on pouch.
For a 5-mL dose, take entire contents either by placing directly into the mouth or by dispensing into a dosing spoon (5 mL) or cup prior to administration by mouth.
For a 10-mL dose, take the entire contents of 2 pouches. MEPRON Bottle Shake bottle gently before administering the recommended dosage.
Drug interactions
Check atovaquone against a medication listLabel text (6 paragraphs)
7 DRUG INTERACTIONS • Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with MEPRON 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 MEPRON 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 )
7.1 Rifampin/Rifabutin Concomitant administration of rifampin or rifabutin and MEPRON oral suspension is known to reduce atovaquone concentrations [see Clinical Pharmacology ( 12.3 )] . Concomitant administration of MEPRON oral suspension and rifampin or rifabutin is not recommended.
7.2 Tetracycline Concomitant administration of tetracycline and MEPRON oral suspension has been associated with a reduction in plasma concentrations of atovaquone [see Clinical Pharmacology ( 12.3 )]. Caution should be used when prescribing tetracycline concomitantly with MEPRON oral suspension. Monitor patients for potential loss of efficacy of MEPRON if coadministration is necessary.
7.3 Metoclopramide Metoclopramide may reduce the bioavailability of atovaquone and should be used only if other antiemetics are not available [see Clinical Pharmacology ( 12.3 )].
7.4 Indinavir Concomitant administration of atovaquone and indinavir did not result in any change in the steady-state AUC and C max of indinavir but resulted in a decrease in the C trough of indinavir [see Clinical Pharmacology ( 12.3 )]. Caution should be exercised when prescribing MEPRON oral suspension with indinavir due to the decrease in trough concentrations of indinavir. Monitor patients for potential loss of efficacy of indinavir if coadministration with MEPRON oral suspension is necessary.
Contraindications
4 CONTRAINDICATIONS MEPRON oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions to atovaquone or any of the components of MEPRON [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.2 )] . Known serious allergic/hypersensitivity reaction to atovaquone or any of the components of MEPRON. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
DLikelihood score D: Possible rare cause of clinically apparent liver injury.
Atovaquone is a naphthoquinone used for the prevention and treatment of Pneumocystis jevorici (formerly carinii) pneumonia and, in combination with proguanil, prevention and treatment of P. falciparum malaria. Atovaquone therapy is associated with low rates of serum enzyme elevations and has been linked to only rare cases of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data from postmarketing experience with use of MEPRON in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant women with HIV who are infected with PCP are at increased risk of adverse pregnancy outcomes (see Clinical Considerations) . Atovaquone given orally by gavage to pregnant rats and rabbits during organogenesis did not cause fetal malformations at plasma concentrations up to 3 times and 0.5 times, respectively, the estimated human exposure based on steady-state plasma concentrations (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Pregnant women with HIV who are infected with PCP are at increased risk of severe illness and maternal death associated with PCP compared with non-pregnant women.
Data Animal Data: Atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day to pregnant rats during organogenesis (Gestation Day [GD] 6 to GD15) did not cause maternal or embryo-fetal toxicity at doses up to 1,000 mg/kg/day corresponding to maternal plasma concentrations approximately 3 times the estimated human exposure during the treatment of PCP based on steady-state plasma concentrations.
In pregnant rabbits, atovaquone administered in oral doses of 300, 600, and 1,200 mg/kg/day during organogenesis (GD6 to GD18) caused decreased fetal body length at a maternally toxic dose of 1,200 mg/kg/day corresponding to a plasma concentration that is approximately 0.5 times the estimated human exposure based on steady-state plasma concentrations.
In a pre- and post-natal study in rats, atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day from GD15 until Lactation Day (LD) 20 did not impair the growth or developmental effects in first generation offspring at doses up to 1,000 mg/kg/day corresponding to approximately 3 times the estimated human exposure based on steady-state plasma concentrations during the treatment of PCP. Atovaquone crossed the placenta and was present in fetal rat and rabbit tissue.
Breastfeeding (LactMed)
No information is available on the use of atovaquone during breastfeeding. However, the quantity of drug in breast milk is assumed too low to provide adequate protection against malaria for the breastfed infant. A dosage has been established for infants weighing as little as 5 kg, so it is unlikely to adversely affect breastfed infants weighing 5 kg or more.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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