Brand name: Mepron
Drug class:
- Antiprotozoal Agents
Chemical name: trans2-[4-(4-Chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione
Molecular formula: C₂₂H₁₉ClO₃
CAS number: 95233-18-4

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Introduction

Antiprotozoal; hydroxynaphthoquinone derivative.

Uses for Atovaquone

Pneumocystis jirovecii Pneumonia

Alternative for treatment and prevention of Pneumocystis jirovecii (formerly Pneumocystis carinii) pneumonia (PCP) in adults, adolescents, or children^{† [off-label]} who cannot tolerate co-trimoxazole. Designated an orphan drug by FDA for treatment of PCP associated with acquired immunodeficiency syndrome (AIDS) and prevention of PCP in high-risk HIV-infected patients (i.e., history of ≥1 episode of PCP and/or CD4⁺ T-cell counts ≤200/mm²).

Co-trimoxazole is drug of choice for treatment of mild, moderate, or severe PCP in adults, adolescents, and children, including HIV-infected individuals.

Atovaquone used alone is one of several alternatives recommended by CDC, NIH, and IDSA for treatment of mild to moderate PCP in HIV-infected adults and adolescents when co-trimoxazole cannot be used. Although efficacy and safety not established in pediatric patients and data limited regarding use in children, CDC, NIH, IDSA, and AAP state atovaquone also can be considered an alternative for treatment of mild to moderate PCP in HIV-infected children^{† [off-label]} when co-trimoxazole cannot be used. Not systematically studied for treatment of severe PCP; not included in recommendations for treatment of severe PCP.

Recommended by CDC, NIH, and IDSA as alternative for prevention of initial episode of PCP (primary prophylaxis) in HIV-infected adults and adolescents who cannot tolerate drug of choice (co-trimoxazole); used alone or in conjunction with pyrimethamine (and leucovorin) for primary PCP prophylaxis in HIV-infected adults and adolescents.

Recommended by CDC, NIH, and IDSA as alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP in HIV-infected adults and adolescents who cannot tolerate drug of choice (co-trimoxazole); used alone or in conjunction with pyrimethamine (and leucovorin) for secondary PCP prophylaxis in HIV-infected adults and adolescents.

Recommended by CDC, NIH, IDSA, and AAP as alternative for primary and secondary PCP prophylaxis in HIV-infected children and infants ≥1 month of age^{† [off-label]} who cannot tolerate drug of choice (co-trimoxazole); used alone for primary and secondary PCP prophylaxis in HIV-infected pediatric patients.

Toxoplasmosis

Alternative for treatment or prevention of toxoplasmosis^{† [off-label]} caused by Toxoplasma gondii. Designated an orphan drug by FDA for primary prophylaxis in HIV-infected individuals at high risk for developing T. gondii encephalitis and for treatment and suppression of T. gondii encephalitis.

Pyrimethamine (and leucovorin) in conjunction with sulfadiazine is regimen of choice for treatment of toxoplasmosis, including toxoplasmosis in HIV-infected adults, adolescents, and children; pyrimethamine (and leucovorin) in conjunction with clindamycin is preferred alternative in those who cannot tolerate or do not respond to regimen of choice.

Atovaquone in conjunction with pyrimethamine (and leucovorin), atovaquone in conjunction with sulfadiazine, or atovaquone alone are alternative regimens for treatment of toxoplasmosis^{† [off-label]} in HIV-infected adults and adolescents when regimen of choice and preferred alternative cannot be used. Atovaquone regimens not adequately studied for treatment of toxoplasmosis in children^†.

Recommended by CDC, NIH, and IDSA as alternative for prevention of initial episode of T. gondii encephalitis (primary prophylaxis)^† in HIV-infected adults and adolescents when regimen of choice (co-trimoxazole) and preferred alternative (dapsone in conjunction with pyrimethamine [and leucovorin]) cannot be used; used alone or in conjunction with pyrimethamine (and leucovorin) for primary toxoplasmosis prophylaxis in HIV-infected adults and adolescents.

Recommended by CDC, NIH, and IDSA as alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent relapse of toxoplasmosis^† in HIV-infected adults and adolescents when regimen of choice (pyrimethamine [and leucovorin] in conjunction with sulfadiazine) cannot be used; used in conjunction with pyrimethamine (and leucovorin), in conjunction with sulfadiazine, or alone for secondary toxoplasmosis prophylaxis in HIV-infected adults and adolescents.

Recommended by CDC, NIH, IDSA, and AAP as alternative for primary toxoplasmosis prophylaxis in HIV-infected infants and children ≥1 month of age^† when regimen of choice (co-trimoxazole) and preferred alternative (dapsone in conjunction with pyrimethamine [and leucovorin]) cannot be used; used alone for primary toxoplasmosis prophylaxis in those ≥1 month of age, but can be used alone or in conjunction with pyrimethamine (and leucovorin) for primary toxoplasmosis prophylaxis in those 4–24 months of age.

Recommended by CDC, NIH, IDSA, and AAP as alternative for secondary toxoplasmosis prophylaxis in HIV-infected infants and children ≥1 month of age^† when regimen of choice (sulfadiazine in conjunction with pyrimethamine [and leucovorin]) and recommended alternative (pyrimethamine [and leucovorin] in conjunction with clindamycin) cannot be used; used alone for secondary toxoplasmosis prophylaxis in those ≥1 month of age, but can be used alone or in conjunction with pyrimethamine (and leucovorin) for secondary toxoplasmosis prophylaxis in those 4–24 months of age.

Babesiosis

Treatment of babesiosis^† caused by Babesia microti.

When anti-infectives indicated, regimens of choice for treatment of babesiosis are clindamycin in conjunction with quinine or atovaquone in conjunction with azithromycin; the clindamycin and quinine regimen may be preferred for severe babesiosis. Exchange transfusions have been used as an adjunct in severely ill patients with high levels of parasitemia (>10%), significant hemolysis, or compromised renal, hepatic, or pulmonary function.

Related/similar drugs

doxycycline, azithromycin, clindamycin, hydroxychloroquine, sulfamethoxazole / trimethoprim, Bactrim, Plaquenil

Atovaquone Dosage and Administration

Administration

Administer orally.

Must be taken with food to optimize GI absorption. Consider alternative in patients who have difficulty taking atovaquone with food.

If using multiple-dose bottle containing oral suspension, shake gently before removing a dose.

If using single-dose foil pouch containing oral suspension, open pouch by removing perforated tab and ingest entire contents; dose can be discharged from pouch into a dosing spoon or cup or directly into mouth.

Dosage

Pediatric Patients

Pneumocystis jirovecii Pneumonia (PCP)

Treatment of Mild to Moderate PCP

Oral

Infants 1–3 months of age^†: 30–40 mg/kg once daily for 21 days. Alternatively, 15–20 mg/kg twice daily for 21 days.

Infants and children 4–24 months of age^†: 45 mg/kg once daily for 21 days. Alternatively, 22.5 mg/kg twice daily for 21 days.

Children >24 months to 12 years of age^†: 30–40 mg/kg once daily for 21 days.

Adolescents ≥13 years of age: 750 mg twice daily for 21 days.

Prevention of Initial Episode (Primary Prophylaxis) of PCP

Oral

Infants 1–3 months of age^†: 30–40 mg/kg once daily.

Infants and children 4–24 months of age^†: 45 mg/kg once daily.

Children >24 months to 12 years of age^†: 30–40 mg/kg once daily.

Adolescents ≥13 years of age: 1.5 g once daily. Alternatively, 1.5 g once daily in conjunction with oral pyrimethamine (25 mg once daily) and oral leucovorin (10 mg once daily).

Infants born to HIV-infected mothers: Initiate primary PCP prophylaxis at 4–6 weeks of age and continue until infant found to be non-HIV-infected or presumptively non-HIV-infected.

HIV-infected infants <1 year of age: Initiate primary PCP prophylaxis regardless of CD4⁺ T-cell count or CD4⁺ percentage; at minimum, continue throughout first year of life.

HIV-infected children 1 to <6 years of age: Initiate primary PCP prophylaxis if CD4⁺ T-cell count <500/mm³ or CD4⁺ percentage <15%.

HIV-infected children 6–12 years of age: Initiate primary PCP prophylaxis if CD4⁺ T-cell count <200/mm³ or CD4⁺ percentage <15%.

Consider discontinuing primary PCP prophylaxis in HIV-infected children 1 to <6 years of age who have received ≥6 months of antiretroviral therapy and have CD4⁺ T-cell counts that have remained ≥500/mm³ or CD4⁺ percentages that have remained ≥15% for >3 months. Assess CD4⁺ T-cell count and CD4⁺ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.

Consider discontinuing primary PCP prophylaxis in HIV-infected children 6–12 years of age who have received ≥6 months of antiretroviral therapy and have CD4⁺ T-cell counts that have remained ≥200/mm³ or CD4⁺ percentages that have remained ≥15% for >3 months. Assess CD4⁺ T-cell count and CD4⁺ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.

Criteria for initiating or discontinuing primary PCP prophylaxis in HIV-infected adolescents are the same as those recommended for adults. (See Adult Dosage under Dosage and Administration.)

Prevention of Recurrence (Secondary Prophylaxis) of PCP

Oral

Infants 1–3 months of age^†: 30–40 mg/kg once daily.

Infants and children 4–24 months of age^†: 45 mg/kg once daily.

Children >24 months to 12 years of age^†: 30–40 mg/kg once daily.

Adolescents ≥13 years of age: 1.5 g once daily. Alternatively, 1.5 g once daily in conjunction with oral pyrimethamine (25 mg once daily) and oral leucovorin (10 mg once daily).

Initiate secondary PCP prophylaxis in all HIV-infected infants and children with a history of PCP.

Consider discontinuing secondary PCP prophylaxis in HIV-infected children 1 to <6 years of age who have received ≥6 months of antiretroviral therapy and have CD4⁺ T-cell counts that have remained ≥500/mm³ or CD4⁺ percentages that have remained ≥15% for >3 months. Assess CD4⁺ T-cell count and CD4⁺ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.

Consider discontinuing secondary PCP prophylaxis in HIV-infected children 6–12 years of age who have received ≥6 months of antiretroviral therapy and have CD4⁺ T-cell counts that have remained ≥200/mm³ or CD4⁺ percentages that have remained ≥15% for >3 months. Assess CD4⁺ T-cell count and CD4⁺ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.

Criteria for initiating or discontinuing secondary PCP prophylaxis in HIV-infected adolescents are the same as those recommended for adults. (See Adult Dosage under Dosage and Administration.)

Toxoplasmosis†

Treatment of Toxoplasmosis†

Oral

Adolescents: 1.5 g twice daily in conjunction with oral pyrimethamine (200-mg loading dose, then 50 mg once daily in those weighing <60 kg or 75 mg once daily in those weighing ≥60 kg) and oral leucovorin (10–25 mg once daily, may be increased to 50 mg once or twice daily).

Alternatively, 1.5 g twice daily in conjunction with oral sulfadiazine (1 g every 6 hours in those weighing <60 kg or 1.5 g every 6 hours in those weighing ≥60 kg).

Alternatively, 1.5 g twice daily alone.

Treatment duration at least 6 weeks; longer duration may be appropriate if clinical or radiologic disease is extensive or response incomplete at 6 weeks.

Prevention of Initial Episode (Primary Prophylaxis) of Toxoplasmosis†

Oral

Infants 1–3 months of age^†: 30 mg/kg once daily.

Infants and children 4–24 months of age^†: 45 mg/kg once daily. Alternatively, 45 mg/kg once daily in conjunction with oral pyrimethamine (1 mg/kg or 15 mg/m² [up to 25 mg] once daily) and oral leucovorin (5 mg once every 3 days).

Children >24 months of age^†: 30 mg/kg once daily.

Adolescents: 1.5 g once daily. Alternatively, 1.5 g once daily in conjunction with pyrimethamine (25 mg once daily) and oral leucovorin (10 mg once daily).

HIV-infected children seropositive for T. gondii: Initiate primary toxoplasmosis prophylaxis in those <6 years of age if CD4⁺ T-cell percentage <15% and in those ≥6 years of age if CD4⁺ T-cell count <100/mm³.

Consider discontinuing primary toxoplasmosis prophylaxis in HIV-infected children 1 to <6 years of age who have received ≥6 months of antiretroviral therapy and have CD4⁺ T-cell percentages that have remained ≥15% for >3 months. Reinitiate if CD4⁺ T-cell percentage decreases to <15%.

Consider discontinuing primary toxoplasmosis prophylaxis in HIV-infected children ≥6 years of age who have received ≥6 months of antiretroviral therapy and have CD4⁺ T-cell counts that have remained >200/mm³ for >3 months. Reinitiate if CD4⁺ T-cell count decreases to <100–200/mm³.

Criteria for initiating or discontinuing primary toxoplasmosis prophylaxis in HIV-infected adolescents are the same as those recommended for adults. (See Adult Dosage under Dosage and Administration.)

Prevention of Recurrence (Secondary Prophylaxis) of Toxoplasmosis†

Oral

Infants 1–3 months of age^†: 30 mg/kg once daily.

Infants and children 4–24 months of age^†: 45 mg/kg once daily. Alternatively, 45 mg/kg once daily in conjunction with oral pyrimethamine (1 mg/kg or 15 mg/m² [up to 25 mg] once daily) and oral leucovorin (5 mg once every 3 days).

Children >24 months of age^†: 30 mg/kg once daily.

Adolescents: 750–1500 mg twice daily in conjunction with oral pyrimethamine (25 mg once daily) and oral leucovorin (10 mg once daily). Alternatively, 750–1500 mg twice daily in conjunction with oral sulfadiazine (2–4 g daily in 2–4 divided doses). Alternatively, 750–1500 mg twice daily used alone.

Initiate secondary toxoplasmosis prophylaxis in all HIV-infected infants and children who have been treated for T. gondii encephalitis.

Consider discontinuing secondary toxoplasmosis prophylaxis in HIV-infected children 1 to <6 years of age who completed toxoplasmosis treatment, are asymptomatic with respect to toxoplasmic encephalitis, have received ≥6 months of antiretroviral therapy, and have CD4⁺ T-cell percentages that have remained ≥15% for >6 consecutive months. Reinitiate if CD4⁺ T-cell percentage decreases to <15%.

Consider discontinuing secondary toxoplasmosis prophylaxis in HIV-infected children ≥6 years of age who completed toxoplasmosis treatment, are asymptomatic with respect to toxoplasmic encephalitis, have received ≥6 months of antiretroviral therapy, and have CD4⁺ T-cell counts that have remained >200/mm³ for >6 consecutive months. Reinitiate if CD4⁺ T-cell count decreases to <200/mm³.

Criteria for initiating or discontinuing secondary toxoplasmosis prophylaxis in HIV-infected adolescents are the same as those recommended for adults. (See Adult Dosage under Dosage and Administration.)

Babesiosis†

Oral

20 mg/kg (up to 750 mg) twice daily for 7–10 days recommended by IDSA and others; used in conjunction with oral azithromycin (10 mg/kg [up to 500 mg] once on day 1, then 5 mg/kg [up to 250 mg] once daily for total of 7–10 days).

Adults

Pneumocystis jirovecii Pneumonia

Treatment of Mild to Moderate PCP

Oral

750 mg twice daily for 21 days.

Prevention of Initial Episode (Primary Prophylaxis) of PCP

Oral

1.5 g once daily. Alternatively, 1.5 g once daily in conjunction with oral pyrimethamine (25 mg once daily) and oral leucovorin (10 mg once daily).

Initiate primary PCP prophylaxis in HIV-infected adults with CD4⁺ T-cell counts <200/mm³ or a history of oropharyngeal candidiasis. Also consider primary PCP prophylaxis if CD4⁺ T-cell percentage <14% or there is a history of an AIDS-defining illness. Also consider in those with CD4⁺ T-cell counts >200/mm³ but <250/mm³ if frequent monitoring (e.g., every 3 months) not possible.

Discontinue primary PCP prophylaxis in HIV-infected adults responding to antiretroviral therapy who have CD4⁺ T-cell counts that have remained >200/mm³ for >3 months.

Reinitiate primary PCP prophylaxis if CD4⁺ T-cell count decreases to <200/mm³.

Prevention of Recurrence (Secondary Prophylaxis) of PCP

Oral

1.5 g once daily. Alternatively, 1.5 g once daily in conjunction with oral pyrimethamine (25 mg once daily) and oral leucovorin (10 mg once daily).

Initiate secondary PCP prophylaxis in all HIV-infected adults with a history of PCP.

Consider discontinuing secondary PCP prophylaxis in HIV-infected adults who have responded to antiretroviral therapy and have CD4⁺ T-cell counts that have remained >200/mm³ for >3 months. Reinitiate if CD4⁺ T-cell count decreases to <200/mm³ or PCP recurs when CD4⁺ T-cell count >200/mm³.

Consider continuing secondary PCP prophylaxis for life (regardless of CD4⁺ T-cell count) if PCP occurred or recurred when CD4⁺ T-cell count >200/mm³.

Toxoplasmosis†

Treatment of Toxoplasmosis†

Oral

1.5 g twice daily in conjunction with oral pyrimethamine (200-mg loading dose, then 50 mg once daily in those weighing <60 kg or 75 mg once daily in those weighing ≥60 kg) and oral leucovorin (10–25 mg once daily, may be increased to 50 mg once or twice daily).

Alternatively, 1.5 g twice daily in conjunction with oral sulfadiazine (1 g every 6 hours in those weighing <60 kg or 1.5 g every 6 hours in those weighing ≥60 kg).

Alternatively, 1.5 g twice daily alone.

Treatment duration at least 6 weeks; longer duration may be appropriate if clinical or radiologic disease is extensive or response incomplete at 6 weeks.

Prevention of Initial Episode (Primary Prophylaxis) of Toxoplasmosis†

Oral

1.5 g once daily. Alternatively, 1.5 g once daily in conjunction with pyrimethamine (25 mg once daily) and oral leucovorin (10 mg once daily).

Initiate primary toxoplasmosis prophylaxis in all HIV-infected adults seropositive for Toxoplasma IgG antibody who have CD4⁺ T-cell counts <100/mm³.

Discontinue primary toxoplasmosis prophylaxis in HIV-infected adults responding to antiretroviral therapy who have CD4⁺ T-cell counts that have remained >200/mm³ for >3 months.

Reinitiate primary toxoplasmosis prophylaxis if CD4⁺ T-cell count decreases to <100–200/mm³.

Prevention of Recurrence (Secondary Prophylaxis) of Toxoplasmosis†

Oral

750–1500 mg twice daily in conjunction with oral pyrimethamine (25 mg once daily) and oral leucovorin (10 mg once daily).

Alternatively, 750–1500 mg twice daily in conjunction with oral sulfadiazine (2–4 g daily in 2–4 divided doses).

Alternatively, 750–1500 mg twice daily alone.

Initiate secondary toxoplasmosis prophylaxis in all HIV-infected adults who have been treated for T. gondii encephalitis.

Consider discontinuing secondary toxoplasmosis prophylaxis in adults who completed toxoplasmosis treatment, are asymptomatic with respect to toxoplasmic encephalitis,and have responded to antiretroviral therapy with CD4⁺ T-cell counts that have remained >200/mm³ for >6 months.

Reinitiate secondary toxoplasmosis prophylaxis if CD4⁺ T-cell count decreases to <200/mm³.

Babesiosis†

Oral

750 mg twice daily for 7–10 days recommended by IDSA and others; used in conjunction with oral azithromycin (0.5–1 g on day 1, then 250 mg once daily for total of 7–10 days; 0.6–1 g daily in immunocompromised patients).

Prescribing Limits

Pediatric Patients

Babesiosis†

Oral

Maximum 750 mg twice daily.

Special Populations

No special population dosage recommendation at this time.

Cautions for Atovaquone

Contraindications

• Hypersensitivity to atovaquone or any ingredient in the formulation.

Warnings/Precautions

Warnings

Precautions Related to PCP

Clinical experience with atovaquone for treatment of PCP limited to patients with mild to moderate infections. Treatment of more severe episodes and efficacy following failure of co-trimoxazole treatment not systematically studied.

Not effective therapy for concurrent pulmonary conditions such as bacterial, viral, or fungal pneumonia or mycobacterial diseases. Clinical deterioration during atovaquone treatment could represent secondary infection with nonsusceptible pathogen and/or progression of PCP. Evaluate all patients with acute PCP for other possible causes of pulmonary disease and treat with additional agents as appropriate.

General Precautions

Administration Precautions

Must be administered with food to enhance GI absorption of the drug and provide adequate plasma concentrations. Plasma atovaquone concentrations correlate with treatment response and survival.

Consider alternative in patients unable to take atovaquone with food.

Use with caution in patients with GI disorders that may impair absorption (e.g., chronic diarrhea, malabsorption syndrome).

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk in rats; not known whether distributed into human milk. Caution advised.

Pediatric Use

Safety and efficacy not established in children.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine if they respond differently than younger adults; clinical experience has not identified differences.

Select dosage with caution because of possible age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Hepatic Impairment

Use caution and close monitoring in patients with severe hepatic impairment.

Common Adverse Effects

Rash, diarrhea, nausea, headache, vomiting, fever, asthenia.

Drug Interactions

Protein-bound Drugs

Highly bound to plasma proteins; use with caution in patients receiving highly protein-bound drugs with narrow therapeutic indices since competition for binding sites may occur.

Specific Drugs

Atovaquone Pharmacokinetics

Absorption

Bioavailability

Following oral administration, bioavailability highly dependent on formulation and diet.

Bioavailability of oral suspension in fasting or fed state is about twice that of previously available tablet formulation.

In HIV-infected adults, absolute bioavailability is approximately 47% when 750-mg dose given as the oral suspension under fed conditions compared with approximately 23% when dose given as previously available tablets.

Food

Food increases absorption approximately twofold; should be taken with food to ensure adequate plasma concentrations.

In HIV-infected adults receiving 500 mg as the oral suspension, peak plasma concentrations were 15.1 mcg/mL when administered with food (400 kcal, 23 g fat) compared with 8.8. mcg/mL when given in fasting state.

Special Populations

Absorption may be limited in patients with GI disorders.

Distribution

Plasma Protein Binding

Extensively bound to plasma proteins (99.9%).

Crosses placenta in animals.

Distributed into milk in rats in concentrations approximately 30% of concurrent maternal plasma concentrations. Not known whether distributed into human milk.

Elimination

Metabolism

Minimally metabolized; no metabolite identified.

Elimination Route

Enterohepatic recirculation and eventual elimination in feces; >94% of dose excreted unchanged in feces over 21 days. Minimal excretion in urine (<0.6%).

Half-life

67–78 hours.

Special Populations

Hepatic impairment: Studies using atovaquone/proguanil indicate no marked differences in rate or extent of systemic exposure to atovaquone in patients with mild to moderate hepatic impairment, but atovaquone elimination half-life prolonged in those with moderate hepatic impairment.

Renal impairment: Studies using atovaquone/proguanil indicate atovaquone clearance in patients with mild to moderate renal impairment similar to that in those with normal renal function, but atovaquone plasma concentrations and AUC decreased in those with severe renal impairment (Cl_cr <30 mL/minute).

Stability

Storage

Oral

Suspension

15–25°C. Do not freeze.

Actions and Spectrum

• Synthetic hydroxynaphthoquinone-derivative antiprotozoal agent.

• Selectively inhibits mitochondrial electron transport with consequent inhibition of de novo pyrimidine synthesis.

• Active in vitro and/or in vivo against a variety of protozoa, including Toxoplasma gondii and Plasmodium.

• Also active against the fungus Pneumocystis jirovecii (formerly Pneumocystis carinii); mechanism of action against P. jirovecii not fully elucidated.

• Although clinical importance unknown, P. jirovecii with amino acid substitutions in cytochrome b (a likely target for atovaquone) have been obtained from several patients who developed PCP after receiving atovaquone prophylaxis.

Advice to Patients

• Importance of taking atovaquone concomitantly with food.

• Advise patients using the multiple-dose bottle of oral suspension to shake it gently before removing a dose. Advise those using single-dose foil pouch of oral suspension to ingest entire contents by mouth by discharging the dose into a dosing spoon or cup or directly into the mouth.

• Importance of completing full course of therapy, even if feeling better after a few days.

• Importance of recognizing pulmonary manifestations of possibly concurrent bacterial, viral, fungal, or mycobacterial infections associated with HIV infection and/or progression of the underlying PCP and contacting a clinician if pulmonary symptomatology develops or worsens during atovaquone therapy.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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