ATOVAQUONE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 atovaquone 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 atovaquone has not been studied. The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied. 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. Pregnancy Category

Product summary:

Atovaquone oral suspension, USP is a yellow homogenous suspension containing 750 mg atovaquone USP per 5 mL.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATOVAQUONE - ATOVAQUONE SUSPENSION
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATOVAQUONE ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ATOVAQUONE ORAL
SUSPENSION.
ATOVAQUONE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
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 ] >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.
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 Bottles: Shake bottle gently before use. (2.3)
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 atovaquone oral
suspension. (4)
WARNINGS AND PRECAUTIONS
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)
ADVERSE REACTIONS
PCP Prevention: The most frequent adverse reactions (≥25% that
required discontinuation) were
dia