MEPRON Oral suspension (2020)

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Συγγραφείς

GlaxoSmithKline LLC

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1. Indications and Usage

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 ...

2. Dosage and Administration

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 ...

3. Dosage Forms and Strengths

MEPRON is a bright yellow, citrus-flavored, oral suspension containing 750 mg of atovaquone per 5 mL. MEPRON is supplied in 210-mL bottles or 5-mL foil pouches.

4. Contraindications

MEPRON 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 ...

5. Warnings and Precautions

5.1 Risk of Limited Oral Absorption Absorption of orally administered MEPRON oral suspension is limited but can be significantly increased when the drug is taken with food. Failure to administer MEPRON ...

6. Adverse Reactions

The following adverse reaction is discussed in another section of the labeling: Hepatotoxicity [see Warnings and Precautions (5.2)]

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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MEPRON oral suspension. Because these reactions are reported voluntarily from a population of uncertain size, it is not ...

7. Drug Interactions

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 ...

8.1. Pregnancy

Risk Summary Available data from postmarketing experience with use of MEPRON in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal ...

8.2. Lactation

Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1–infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. There are no data on the ...

8.4. Pediatric Use

Evidence of safety and effectiveness in pediatric patients (aged 12 years and younger) has not been established. In a trial of MEPRON oral suspension administered once daily with food for 12 days to 27 ...

8.5. Geriatric Use

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

10. Overdosage

Overdoses up to 31,500 mg of atovaquone have been reported. In one such patient who also took an unspecified dose of dapsone, methemoglobinemia occurred. Rash has also been reported after overdose. There ...

11. Description

MEPRON (atovaquone oral suspension) is a quinone antimicrobial drug. The chemical name of atovaquone is trans2[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow ...

12.1. Mechanism of Action

Atovaquone is a quinone antimicrobial drug [see Microbiology (12.4)].

12.2. Pharmacodynamics

Relationship between Plasma Atovaquone Concentrations and Clinical Outcome In a comparative clinical trial, HIV/AIDS subjects received atovaquone tablets 750 mg 3 times daily or TMP‑SMX for treatment of ...

12.3. Pharmacokinetics

Plasma atovaquone concentrations do not increase proportionally with dose following ascending repeat-dose administration of MEPRON oral suspension in healthy subjects. When MEPRON oral suspension was administered ...

12.4. Microbiology

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 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies in rats were negative; 24-month studies in mice (dosed with 50, 100, or 200 mg/kg/day) showed treatment-related increases in incidence of hepatocellular adenoma and hepatocellular ...

14. Clinical Studies

14.1 Prevention of PCP The indication for prevention of PCP is based on the results of 2 clinical trials comparing MEPRON oral suspension with dapsone or aerosolized pentamidine in HIV-1–infected adolescent ...

16.1. How Supplied

MEPRON oral suspension (bright yellow, citrus-flavored) containing 750 mg atovaquone per 5 mL. Bottle of 210 mL with child-resistant cap (NDC 0173-0665-18). 5-mL child-resistant foil pouch unit dose pack ...

16.2. Storage and Handling

Bottle of 210 mL with child-resistant cap: Store at 15°C to 25°C (59°F to 77°F). Do not freeze. Dispense in tight container as defined in USP. 5-mL child-resistant foil pouch unit dose ...

17. Patient Counseling Information

Administration Instructions Instruct patients to: Ensure the prescribed dose of MEPRON oral suspension is taken as directed. Take their daily doses of MEPRON oral suspension with food, as food will significantly ...