ARFORMOTEROL TARTRATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lifestar Pharma LLC

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Arformoterol tartrate inhalation solution is supplied as clear, colorless solution 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 70756-612-70: carton of 30 individually pouched unit-dose vials. NDC 70756-612-60: carton of 60 unit-dose vials (15 x4 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 store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ARFORMOTEROL TARTRATE - ARFORMOTEROL TARTRATE SOLUTION
LIFESTAR PHARMA LLC
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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
INDICATIONS AND USAGE
Arformoterol tartrate inhalation solution is a long-acting beta
-adrenergic agonist (beta -agonist) indicated
for:
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).
Important limitations of use:
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)
DOSAGE AND ADMINISTRATION
For oral inhalation only.
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)
DOSAGE FORMS AND STRENGTHS
Inhalation Solution (unit-dose vial for nebulization): 15 mcg/2 mL
solution (3)
CONTRAINDICATIONS
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, including arformoterol tartrate inhalation solution,
without an inhaled corticosteroid is
contraindicated in patients with asthma. (4)
WARNINGS AND PRECAUTIONS
LABA as monotherapy (without an inhaled corticosteroid) for asthma
increases the risk of serious
asthma-related events. (5.1)
Do not initiate arformoterol tartrate inhalation solution in acutely
deteriorating patients. (5.2)
Do not use for relief of acute symptoms. C