inbrija levodopa capsule

1 INDICATIONS AND USAGE INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa. INBRIJA is an aromatic amino acid indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa ( 1 )

acorda therapeutics, inc.

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] drug ineffective` `[3] completed suicide` `[4] drug abuse` `[5] nausea` `[6] dyspnoea` `[7] off label use` `[8] fatigue` `[9] cough` `[10] death`

4 years ago

CAPSULE WHITE A42

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied INBRIJA 42 mg contains foil blister strips of INBRIJA (

LEVODOPA inhalation powder) white capsules with two black bands on the body and "A42" in black on the cap, and one INBRIJA inhaler. Carton containing 4 INBRIJA capsules (1 blister card containing 4 capsules) and 1 INBRIJA inhaler: NDC 10144-342-04 Carton containing 12 INBRIJA capsules (3 blister cards containing 4 capsules each) and 1 INBRIJA inhaler: NDC 10144-342-12 Carton containing 60 INBRIJA capsules (15 blister cards containing 4 capsules each) and 1 INBRIJA inhaler: NDC 10144-342-60 Carton containing 92 INBRIJA capsules (23 blister cards containing 4 capsules each) and 1 INBRIJA inhaler: NDC 10144-342-92 INBRIJA inhaler consists of a blue cap, blue handle with "INBRIJA" imprinted on it, and white mouthpiece covering the capsule chamber. 16.2 Storage and Handling Store in a dry place between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). INBRIJA capsules should always be stored in the blister packaging and only removed immediately before use. INBRIJA capsules should not be stored inside the INBRIJA inhaler. INBRIJA capsules should be used only with the INBRIJA inhaler. The INBRIJA inhaler should not be used to administer any other medicines.

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