Drug Catalog - Product Detail
ATOVAQUONE ORAL SUSPENSION 750MG/5ML SUSP 210ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0421-21 | GLENMARK PHARMACEUTICALS | 210 | 750MG/5ML | SUSPENSION |
PACKAGE FILES
Generic Name
ATOVAQUONE
Substance Name
ATOVAQUONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA209685
Description
11 DESCRIPTION Atovaquone Oral Suspension, USP is a quinone antimicrobial drug. The chemical name of atovaquone USP is trans -2-[4-(4-chlorophenyl) cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone USP is a yellow crystalline powder that is freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran; soluble in chloroform; sparingly soluble in acetone and dimethyl sulfoxide; slightly soluble in octanol, ethyl acetate and polyethylene glycol 200; very slightly soluble in 0.1N sodium hydroxide; insoluble in water. It has a molecular weight of 366.84 g/mol and the molecular formula C 22 H 19 ClO 3 . The compound has the following structural formula: Atovaquone Oral Suspension, USP is a formulation of micro-fine particles of atovaquone USP. Each 5 mL of Atovaquone Oral Suspension, USP contains 750 mg of atovaquone USP and the inactive ingredients benzyl alcohol, citric acid monohydrate, hypromellose, poloxamer 188, purified water, saccharin sodium, trisodium citrate dihydrate, tutti frutti flavor and xanthan gum. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Atovaquone Oral Suspension, USP is a bright yellow, tutti frutti flavored, oral suspension containing 750 mg of atovaquone USP in 5 mL. It is supplied as follows: NDC 68462-421-21 Bottle of 210 mL with child-resistant cap NDC 68462-421-69 Carton of 42 sachets (5 mL unit-dose) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.
Indications & Usage
1 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 2 ] >45 mm Hg) with atovaquone has not been studied. • The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied. 1.1 Prevention of Pneumocystis jirovecii Pneumonia 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). 1.2 Treatment of Mild-to-Moderate Pneumocystis jirovecii Pneumonia 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. 1.3 Limitations of Use Clinical experience with atovaquone oral suspension 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 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
2 DOSAGE AND ADMINISTRATION • Prevention of PCP: 1,500 mg (10 mL) once daily with food ( Error! Hyperlink reference not valid. ) • Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days ( Error! Hyperlink reference not valid. ) • 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 two pouches. ( Error! Hyperlink reference not valid. ) • Bottle: Shake bottle gently before use. ( Error! Hyperlink reference not valid. ) 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 P.jirovecii Pneumonia The recommended oral dosage is 750 mg (5 mL) twice daily (total daily dose = 1,500 mg) administered with food for 21 days. 2.3 Important Administration Instructions Administer atovaquone oral suspension with food to avoid low plasma atovaquone concentrations that may limit response to therapy [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )]. Atovaquone Oral Suspension Foil Pouch • Open each 5 mL pouch by removing tab at perforation and tear at notch. • For a 5 mL dose, take entire contents either by placing directly into the mouth or by dispensing into a dosing spoon (5 mL) or cup prior to administration by mouth. • For a 10 mL dose, take the entire contents of two pouches. Atovaquone Oral Suspension Bottle Shake bottle gently before administering the recommended dosage.