ATOVAQUONE suspension

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Major Pharmaceuticals

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)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

Bidhaa muhtasari:

Atovaquone oral suspension, USP is a yellow homogenous suspension containing 750 mg atovaquone USP per 5 mL. 18 cups x 5 mL (750 mg/ 5mL), NDC 0904-7064-25 42 cups x 5 mL (750 mg/ 5mL), NDC 0904-7064-53 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
MAJOR PHARMACEUTICALS
----------
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
REQUIR