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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 ) Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. ( 1.2 ) Limitations of Use ( 1.3 ): 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 ) Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days ( 2.2 ) Supplied in Unit Dose cup: Shake bottle gently before use. ( 2.3 )

Atovaquone oral suspension USP (bright yellow, tutti frutti flavored) containing 750 mg atovaquone per 5 mL.  NDC 63739-203-01: 5 mL Unit Dose Cup. NDC 63739-203-03: Case of 18 5 mL Unit Dose Cups. NDC 63739-203-02: Case of 42, 5 mL Unit Dose Cups Store at 15°C to 25°C (59°F to 77°F).  Do not freeze.  Dispense in tight container as defined in USP.

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 any of the components of atovaquone oral solution.

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 crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C 22 H 19 ClO 3 . The compound has the following structural formula: Atovaquone oral suspension USP is a formulation of micro-fine particles of atovaquone, USP. Each 5 mL of atovaquone oral suspension USP contains 750 mg of atovaquone and the inactive ingredients benzyl alcohol, tutti frutti flavor, poloxamer 188, purified water, saccharin sodium, and xanthan gum.

Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with atovaquone 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 atovaquone 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 )

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, as food will significantly improve the absorption of the drug. Shake atovaquone oral suspension gently before use each time. Lactation Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2) ]. MANUFACTURED BY:   PAI Pharma Greenville, SC  29605 DISTRIBUTED BY: McKesson Corporation dba SKY Packaging Memphis. TN  38141 Iss.  12/2023

The following adverse reactions are discussed in other sections of the labeling: Hepatotoxicity [see Warnings and Precautions  (5.2) ] .

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. There is no known antidote for atovaquone, and it is currently unknown if atovaquone is dialyzable.

Mechanism of Action Atovaquone is a hydroxy-1,4-naphthoquinone, an analog of ubiquinone, with antipneumocystis activity. The mechanism of action against Pneumocystis jirovecii has not been fully elucidated. In Plasmodium species, the site of action appears to be the cytochrome bc 1 complex (Complex III). Several metabolic enzymes are linked to the mitochondrial electron transport chain via ubiquinone. Inhibition of electron transport by atovaquone results in indirect inhibition of these enzymes. The ultimate metabolic effects of such blockade may include inhibition of nucleic acid and adenosine triphosphate (ATP) synthesis. Antimicrobial Activity Atovaquone is active against P. jirovecii  [see Clinical Studies ( 14 )]. Resistance Phenotypic resistance to atovaquone in vitro has not been demonstrated for P. jirovecii . However, in 2 subjects who developed PCP after prophylaxis with atovaquone, DNA sequence analysis identified mutations in the predicted amino acid sequence of P. jirovecii cytochrome b (a likely target site for atovaquone). The clinical significance of this is unknown.

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).

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 one unit dose cup

Lactation: Breastfeeding is not recommended in mothers with HIV-1 infection due to the potential for HIV-1 transmission. ( 8.2 )

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

Delivers 5 mL NDC 63739-203-01 Atovaquone Oral Suspension USP 750 mg/5 mL Package Not Child-Resistant RX ONLY  

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 ) Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. ( 1.2 ) Limitations of Use ( 1.3 ): 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 ) Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days ( 2.2 ) Supplied in Unit Dose cup: Shake bottle gently before use. ( 2.3 )

Atovaquone oral suspension USP (bright yellow, tutti frutti flavored) containing 750 mg atovaquone per 5 mL.  NDC 63739-203-01: 5 mL Unit Dose Cup. NDC 63739-203-03: Case of 18 5 mL Unit Dose Cups. NDC 63739-203-02: Case of 42, 5 mL Unit Dose Cups Store at 15°C to 25°C (59°F to 77°F).  Do not freeze.  Dispense in tight container as defined in USP.

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 any of the components of atovaquone oral solution.

Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with atovaquone 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 atovaquone 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 )

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, as food will significantly improve the absorption of the drug. Shake atovaquone oral suspension gently before use each time. Lactation Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2) ]. MANUFACTURED BY:   PAI Pharma Greenville, SC  29605 DISTRIBUTED BY: McKesson Corporation dba SKY Packaging Memphis. TN  38141 Iss.  12/2023

The following adverse reactions are discussed in other sections of the labeling: Hepatotoxicity [see Warnings and Precautions  (5.2) ] .

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. There is no known antidote for atovaquone, and it is currently unknown if atovaquone is dialyzable.

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 crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C 22 H 19 ClO 3 . The compound has the following structural formula: Atovaquone oral suspension USP is a formulation of micro-fine particles of atovaquone, USP. Each 5 mL of atovaquone oral suspension USP contains 750 mg of atovaquone and the inactive ingredients benzyl alcohol, tutti frutti flavor, poloxamer 188, purified water, saccharin sodium, and xanthan gum.

Mechanism of Action Atovaquone is a hydroxy-1,4-naphthoquinone, an analog of ubiquinone, with antipneumocystis activity. The mechanism of action against Pneumocystis jirovecii has not been fully elucidated. In Plasmodium species, the site of action appears to be the cytochrome bc 1 complex (Complex III). Several metabolic enzymes are linked to the mitochondrial electron transport chain via ubiquinone. Inhibition of electron transport by atovaquone results in indirect inhibition of these enzymes. The ultimate metabolic effects of such blockade may include inhibition of nucleic acid and adenosine triphosphate (ATP) synthesis. Antimicrobial Activity Atovaquone is active against P. jirovecii  [see Clinical Studies ( 14 )]. Resistance Phenotypic resistance to atovaquone in vitro has not been demonstrated for P. jirovecii . However, in 2 subjects who developed PCP after prophylaxis with atovaquone, DNA sequence analysis identified mutations in the predicted amino acid sequence of P. jirovecii cytochrome b (a likely target site for atovaquone). The clinical significance of this is unknown.

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).

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 one unit dose cup

Lactation: Breastfeeding is not recommended in mothers with HIV-1 infection due to the potential for HIV-1 transmission. ( 8.2 )

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

Delivers 5 mL NDC 63739-203-01 Atovaquone Oral Suspension USP 750 mg/5 mL Package Not Child-Resistant RX ONLY