ATOVAQUONE suspension

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

AvPAK

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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)DO 2 ] ≤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 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). Atovaquone caused maternal toxicity in rabbits at plasma concentrations that were approximately one-half the estimated human exposure. Mean fetal body lengths and weights were decreased and there were higher numbers of early resorption and post-implantation loss per dam (dose of 1,200 mg/kg/day in rabbits). It is not clear whether these effects were caused by atovaquone directly or were secondary to maternal toxicity. Concentrations of atovaquone in rabbit fetuses averaged 30% of the concurrent maternal plasma concentrations. In a separate study in rats given a single 14 C-radiolabelled dose (1,000 mg/kg), concentrations of radiocarbon in rat fetuses were 18% (middle gestation) and 60% (late gestation) of concurrent maternal plasma concentrations. It is not known whether atovaquone is excreted into human milk. Because many drugs are excreted into human milk, caution should be exercised when atovaquone is administered to a nursing woman. In a rat study (with doses of 10 and 250 mg/kg), atovaquone concentrations in the milk were 30% of the concurrent atovaquone concentrations in the maternal plasma at both doses. 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. Average Steady-state Plasma Atovaquone Concentrations in Pediatric Subjects C ss = Concentration at steady state. 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.

Bidhaa muhtasari:

Atovaquone oral suspension, USP is a yellow homogenous suspension containing 750 mg atovaquone USP per 5 mL. • NDC 50268-086-12 (5mL unit dose cups 750mg /5mL, 20 cups carton). Store at 15° to 25°C (59° to 77°F). Do not freeze . Dispense in tight container as defined in USP.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

ATOVAQUONE- ATOVAQUONE SUSPENSION
AVPAK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
ATOVAQUONE ORAL SUSPENSION, USP
RX ONLY
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.
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
requ