Malanil Tablet

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 oral suspension has not been studied. The efficacy of atovaquone oral suspension 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 Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days Supplied in Bottles: Shake bottle gently before use
• Dosage for the Prevention of P. jirovecii Pneumonia The recommended oral dosage is 1,500 mg (10 mL) once daily administered with food
• 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
• 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 , Clinical Pharmacology ]
• Atovaquone Oral Suspension Bottle Shake bottle gently before administering the recommended dosage

Atovaquone oral suspension, USP is a yellow homogenous suspension containing 750 mg of atovaquone USP per 5 mL. Atovaquone oral suspension, USP is supplied in 210 mL bottles. Oral suspension: 750 mg per 5 mL ( 3 )

• Evidence of safety and effectiveness
• In pediatric patients (aged 12 years and younger) has not been established
• In a trial of atovaquone oral suspension administered once daily with food for 12 days to 27 HIV-1-infected, asymptomatic
• Infants and children aged between 1 month and 13 years, the pharmacokinetics of atovaquone were age-dependent
• The average steady-state plasma atovaquone concentrations in the 24 subjects with available concentration data are shown in Table 5
• Table 5. …

Clinical trials of atovaquone did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

• 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
• Manufactured for: Lupin Pharmaceuticals, Inc
• Baltimore, Maryland 21202 United States Manufactured by: Hetero Labs Limited, Unit III Plot No. 22-110, Part-II, IDA, Jeedimetla, Hyderabad, Telangana-500055, India (IND)
• Revised: March 2021 2062413

• 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 suspension
• Known serious allergic/hypersensitivity reaction (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension

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. …

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 ) 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. …

The following adverse reactions are discussed in other sections of the labeling: Hepatotoxicity [see Warnings and Precautions ( 5.2 )] . PCP Prevention: The most frequent adverse reactions (≥25% that required discontinuation) were diarrhea, rash, headache, nausea, and fever. ( 6.1 ) PCP Treatment: The most frequent adverse reactions (≥14% that required discontinuation) were rash (including maculopapular), nausea, diarrhea, headache, vomiting, and fever. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Atovaquone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atovaquone was not teratogenic and did not cause reproductive toxicity in rats at plasma concentrations up to 2 to 3 times the estimated human exposure (dose of 1,000 mg/kg/day in rats). …

In one patient who 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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.