MEPRON 750 mg/5mL

atovaquone · SUSPENSION · GlaxoSmithKline LLC

No Recall History

Plain English

MEPRON is a suspension containing atovaquone at 750 mg/5mL, taken oral. Manufactured by GlaxoSmithKline LLC.

Key Facts

Brand Name: MEPRON
Generic Name: atovaquone
NDC Code (Product): 0173-0547
Manufacturer: GlaxoSmithKline LLC
Strength: 750 mg/5mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: NDA020500
Drug Class: Antimalarial [EPC]; Antiprotozoal [EPC]
Marketing Start: 09/18/1998

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE MEPRON 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 MEPRON has not been studied. • The efficacy of MEPRON in subjects who are failing therapy with TMP-SMX has also not been studied. 1.1 Prevention of Pneumocystis jirovecii Pneumonia MEPRON 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). 1.2 Treatment of Mild-to-Moderate Pneumocystis jirovecii Pneumonia MEPRON oral suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX. 1.3 Limitations of Use Clinical experience with MEPR…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • 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 foil pouches and bottles: o Foil Pouch: For a 5-mL dose, take entire contents by mouth either by dispensing into a spoon or cup or directly into the mouth. For a 10-mL dose, take entire contents of 2 pouches. ( 2.3 ) o Bottle: Shake bottle gently before use. ( 2.3 ) 2.1 Dosage for the Prevention of P. jirovecii Pneumonia The recommended oral dosage is 1,500 mg (10 mL) once daily administered with food. 2.2 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. 2.3 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 ( 5.1 ), Clinical Pharmacology ( 12.3 )]. 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 con…

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 )

Drug Interactions

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 reductio…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in another section of the labeling: • Hepatotoxicity [see Warnings and Precautions ( 5.2 )]. • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] . • 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 GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Additionally, because many subjects who participated in clinical trials with MEPRON had complications of advanced human immunodeficiency virus (HIV) disease, it was often difficult to distinguish adver…

Frequently Asked Questions

What is MEPRON used for?

MEPRON contains atovaquone. It is a suspension taken oral. Consult your doctor for specific uses.

Is MEPRON a controlled substance?

MEPRON is not classified as a controlled substance by the DEA.

What is the generic name for MEPRON?

The generic name for MEPRON is atovaquone. There are 12 other brand versions of atovaquone.

What is the NDC code for MEPRON 750 mg/5mL?

The NDC (National Drug Code) for MEPRON 750 mg/5mL is 0173-0547, listed by GlaxoSmithKline LLC.

Product NDC

0173-0547

Package NDC

0173-0547-00

Other Atovaquone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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