MEPRON- atovaquone suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ATOVAQUONE (UNII: Y883P1Z2LT) (ATOVAQUONE - UNII:Y883P1Z2LT)

Διαθέσιμο από:

GlaxoSmithKline LLC

INN (Διεθνής Όνομα):

ATOVAQUONE

Σύνθεση:

ATOVAQUONE 750 mg in 5 mL

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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). 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. Clinical experience with MEPRON for the treatment of PCP has been limited to subjects with mild-to-moderate PCP (alveolar-arterial oxygen diffusion gradient [(A-a)DO2 ] ≤45 mm Hg). Treatment of more severe episodes of PCP with MEPRON has not been studied. The efficacy of MEPRON in subjects who are failing therapy with TMP-SMX has also not been studied. 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 components of MEPRON. Risk Summary Available data from postmarketing experience with

Περίληψη προϊόντος:

MEPRON oral suspension (bright yellow, citrus-flavored) containing 750 mg atovaquone per 5 mL.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

MEPRON- ATOVAQUONE SUSPENSION
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEPRON ORAL SUSPENSION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEPRON
ORAL SUSPENSION.
MEPRON (ATOVAQUONE ORAL SUSPENSION)
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
MEPRON oral suspension is a quinone antimicrobial drug indicated for:
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Limitations of Use (1.3):
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Oral suspension: 750 mg per 5 mL (3)
CONTRAINDICATIONS
Known serious allergic/hypersensitivity reaction (e.g., angioedema,
bronchospasm, throat tightness,
urticaria) to atovaquone or any of the components of MEPRON. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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)
Treatment of severe PCP (alveolar arterial oxygen diffusion gradient
[(A-a)DO ] >45 mm Hg) with
MEPRON has not been studied.
2
The efficacy of MEPRON 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 foil pouches and bottles:
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)
Bottle: Shake bottle gently before use. (2.3)
Failure to administer MEPRON oral suspension with food may result in
lower plasma atovaquone
concentrations and may limit response to therapy. Pa