ARFORMOTEROL TARTRATE INHALATION solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ARFORMOTEROL TARTRATE (UNII: 5P8VJ2I235) (ARFORMOTEROL - UNII:F91H02EBWT)

זמין מ:

Slate Run Pharmaceuticals

מסלול נתינה (של תרופות):

RESPIRATORY (INHALATION)

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Arformoterol tartrate inhalation solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Arformoterol tartrate inhalation solution is for use by nebulization only. Arformoterol tartrate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see Warnings and Precautions(5.2) ]. Arformoterol tartrate inhalation solution is not indicated to treat asthma. The safety and effectiveness of arformoterol tartrate inhalation solution in asthma have not been established. Arformoterol tartrate inhalation solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. Use of a LABA, including arformoterol tartrate inhalation solution, without an inhaled cortisteroid is contraindicated in patients with asthma [se

leaflet_short:

Arformoterol Tartrate Inhalation Solution is supplied in a single strength (15 mcg of arformoterol, equivalent to 22 mcg of arformoterol tartrate) as 2 mL of a sterile solution in low-density polyethylene (LDPE) unit-dose vials overwrapped in foil. Arformoterol tartrate inhalation solution is available in a shelf-carton containing 30 or 60 unit-dose vials. NDC 70436-151-57: carton of 30 individually pouched unit-dose vials. NDC 70436-151-58: carton of 60 unit-dose vials (15×4 unit-dose vial pouches). Storage and Handling Store arformoterol tartrate inhalation solution in the protective foil pouch under refrigeration at 36° to 46°F (2° to 8°C). Protect from light and excessive heat. After opening the pouch, unused unit- dose vials should be returned to, and stored in, the pouch. An opened unit-dose vial should be used right away. Discard any unit-dose vial if the solution is not colorless. Unopened foil pouches of arformoterol tartrate inhalation solution can also be stored at room temperature 68° to 77°F(20° to 25°C) for up to 6 weeks. If stored at room temperature, discard if not used after 6 weeks or if past the expiration date, whichever is sooner.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ARFORMOTEROL TARTRATE INHALATION- ARFORMOTEROL TARTRATE
INHALATION SOLUTION
SLATE RUN PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARFORMOTEROL
TARTRATE INHALATION SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
ARFORMOTEROL TARTRATE INHALATION SOLUTION.
ARFORMOTEROL TARTRATE INHALATION SOLUTION
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Box Warning………………………………….………..Removed
05/2019
Contraindications, revised (4)………………..………..05/2019
Warnings and Precautions, revised…………………..05/2019
Serious Asthma-Related Events – Hospitalizations, Intubations, Death
(5.1)
INDICATIONS AND USAGE
Arformoterol tartrate inhalation solution is a long-acting beta
-adrenergic agonist (beta -agonist) indicated
for:
•
Important limitations of use:
•
•
DOSAGE AND ADMINISTRATION
For oral inhalation only.
•
•
•
DOSAGE FORMS AND STRENGTHS
Inhalation Solution (unit-dose vial for nebulization):15 mcg/2 mL
solution (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
2
2
Long-term, twice daily (morning and evening) administration in the
maintenance treatment of
bronchoconstriction in patients with chronic obstructive pulmonary
disease (COPD), including chronic
bronchitis and emphysema. (1.1)
Arformoterol tartrate inhalation solution is not indicated to treat
acute deteriorations of chronic
obstructive pulmonary disease. (1.2, 5.2)
Arformoterol tartrate inhalation solution is not indicated to treat
asthma. (1.2)
A total daily dose of greater than 30 mcg is not recommended. (2)
One 15 mcg/2 mL vial every 12 hours. (2)
For use with a standard jet nebulizer (with a face mask or mouthpiece)
connected to an air
compressor. (2)
Arformoterol tartrate inhalation solution is contraindicated in
patients with a history of hypersensitivity
to arformoterol, racemic formoterol or to any other components of this
product. (4)
Use of a LABA, includin