atovaquone

REMS

Treatment of mild to moderate Pneumocystis jirovecii pneumonia (PJP) in patients who are unable to tolerate trimethoprim/sulfamethoxazole.
Prophylaxis of PJP.

Contraindicated in:

Hypersensitivity
Lactation: Breastfeeding not recommended for women with HIV.

Use Cautiously in:

↓hepatic, renal, or cardiac function (dose modification may be necessary)
GI disorders (absorption may be limited)
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
Pedi: Children <13 yr (safety and effectiveness not established).

Derm: rash.

GI: diarrhea, nausea, vomiting.

Neuro: headache, insomnia.

Resp: cough.

Misc: fever.

Drug-Drug:

Rifampin or rifabutin may ↓ levels and efficacy; concurrent use not recommended.
Tetracycline may ↓ levels and efficacy; use caution when using concurrently.
Metoclopramide may ↓ levels and efficacy; use only if no other alternative available.

Drug-Food:

Food↑ absorption.

(Generic available)

Suspension (citrus flavor): 750 mg/5 mL;
In combination with: proguanil (Malarone). See Appendix [not included in this PDA edition].

Treatment of Mild to Moderate Pneumocystis jirovecii Pneumonia

PO (Adults and Children 13 yr): 750 mg twice daily for 21 days.

Prevention of Pneumocystis jirovecii Pneumonia

PO (Adults and Children 13 yr): 1500 mg once daily.

Inhibits the action of enzymes necessary to nucleic acid and ATP synthesis.

Therapeutic Effects:

Active against P. jirovecii.

Therapeutic Classification: anti-infectives

Absorption: Absorption is poor but is increased by food, particularly fat.

Distribution: Enters CSF in very low concentrations (<1% of plasma levels).

Protein Binding: >99.9%.

Metabolism/Excretion: Undergoes enterohepatic recycling; elimination occurs in feces.

Half-life: 2.2–2.9 days.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1–8 hr; 24–96 hr†	12 hr

†Two peaks are due to enterohepatic recycling.

Instruct patient to take atovaquone as directed around the clock for full course of therapy, even if feeling better. Emphasize the importance of taking atovaquone with food, especially foods high in fat; taking without food may decrease plasma concentrations and effectiveness.
Advise patient to notify health care professional if rash occurs.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

NDC Code^*

0173- GlaxoSmithKline LLC
0173-0547- MEPRON 0173-0547-00- 42 POUCH in 1 DOSE PACK (0173-0547-00) > 5 mL in 1 POUCH

0173- GlaxoSmithKline LLC
0173-0665- MEPRON 0173-0665-18- 210 mL in 1 BOTTLE (0173-0665-18)

10702- KVK-Tech, Inc.
10702-223- Atovaquone Oral Suspension 10702-223-21- 1 BOTTLE, PLASTIC in 1 CARTON (10702-223-21) > 210 mL in 1 BOTTLE, PLASTIC

16714- Northstar Rx LLC
16714-900- atovaquone 16714-900-01- 210 mL in 1 BOTTLE (16714-900-01)

31722- Camber Pharmaceuticals, Inc.
31722-629- Atovaquone 31722-629-21- 1 BOTTLE in 1 CARTON (31722-629-21) > 210 mL in 1 BOTTLE

65162- Amneal Pharmaceuticals LLC
65162-693- ATOVAQUONE 65162-693-88- 1 BOTTLE in 1 CARTON (65162-693-88) > 210 mL in 1 BOTTLE

66689- VistaPharm, Inc.
66689-062- Atovaquone 66689-062-18- 18 POUCH in 1 CASE (66689-062-18) > 1 mL in 1 POUCH (66689-062-01)

66689- VistaPharm, Inc.
66689-062- Atovaquone 66689-062-42- 42 POUCH in 1 CASE (66689-062-42) > 1 mL in 1 POUCH (66689-062-01)

66993- Prasco Laboratories
66993-062- Atovaquone 66993-062-42- 42 POUCH in 1 CARTON (66993-062-42) > 5 mL in 1 POUCH

66993- Prasco Laboratories
66993-062- Atovaquone 66993-062-72- 1 BOTTLE in 1 CARTON (66993-062-72) > 210 mL in 1 BOTTLE

68180- Lupin Pharmaceuticals, Inc.
68180-282- Atovaquone 68180-282-01- 1 BOTTLE in 1 CARTON (68180-282-01) > 210 mL in 1 BOTTLE

68462- Glenmark Pharmaceuticals Inc., USA
68462-421- atovaquone 68462-421-21- 210 mL in 1 BOTTLE (68462-421-21)

68462- Glenmark Pharmaceuticals Inc., USA
68462-421- atovaquone 68462-421-69- 42 POUCH in 1 CARTON (68462-421-69) > 5 mL in 1 POUCH

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