ASMANEX- mometasone furoate inhalant

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Mometasone Furoate (UNII: 04201GDN4R) (Mometasone - UNII:8HR4QJ6DW8)

MAH:

Organon LLC

administration_route:

RESPIRATORY (INHALATION)

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age. ASMANEX TWISTHALER is contraindicated: - Status Asthmaticus: in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - Hypersensitivity: in patients with known hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER [see Warnings and Precautions (5.3) and Description (11)]. Risk Summary There are no adequate and well-controlled studies of ASMANEX TWISTHALER in pregnant women. There are clinical considerations with the use of ASMANEX TWISTHALER in pregnant women [see Clinical Considerations] . In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malfo

leaflet_short:

How Supplied ASMANEX TWISTHALER 220 mcg: delivers 200 mcg mometasone furoate from the mouthpiece ASMANEX TWISTHALER 110 mcg: delivers 100 mcg mometasone furoate from the mouthpiece Each inhaler is supplied in a protective foil pouch with Patient’s Instructions for Use. Storage and Handling Store in a dry place at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Discard the inhaler 45 days after opening the foil pouch or when dose counter reads "00", whichever comes first.

authorization_status:

New Drug Application

SPC

ASMANEX- MOMETASONE FUROATE INHALANT
ORGANON LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASMANEX TWISTHALER
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASMANEX
TWISTHALER.
ASMANEX TWISTHALER (MOMETASONE FUROATE INHALATION POWDER), FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
Dosage and Administration (2)
02/2021
Warnings and Precautions (5.1, 5.2)
02/2021
INDICATIONS AND USAGE
ASMANEX TWISTHALER is a corticosteroid indicated for maintenance
treatment of asthma as prophylactic
therapy in patients 4 years of age and older. (1)
Limitations of Use: ASMANEX TWISTHALER is not indicated for the relief
of acute bronchospasm (1, 5.2) or
in children less than 4 years of age (1, 8.4).
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2)
Instruct patients to inhale rapidly and deeply and, after
administration, rinse mouth with water and spit
out contents without swallowing. (2)
RECOMMENDED DOSAGES FOR ASMANEX TWISTHALER TREATMENT
PREVIOUS THERAPY
RECOMMENDED
STARTING DOSE
HIGHEST RECOMMENDED
DAILY DOSE
, , , Please refer to section 2.1 for full dosage recommendations and
details.
Patients ≥12 years who received
bronchodilators alone
220 mcg once daily in the
evening
440 mcg
Patients ≥12 years who received inhaled
corticosteroids
220 mcg once daily in the
evening
440 mcg
Patients ≥12 years who received oral
corticosteroids
440 mcg twice daily
880 mcg
Children 4-11 years of age
110 mcg once daily in the
evening
110 mcg
DOSAGE FORMS AND STRENGTHS
Inhalation powder:
220 mcg TWISTHALER: delivers 200 mcg mometasone furoate per actuation.
(3)
110 mcg TWISTHALER: delivers 100 mcg mometasone furoate per actuation.
(3)
CONTRAINDICATIONS
Patients with status asthmaticus or other acute episodes of asthma
where intensive measures are
required. (4)
Patients with a _known_ hypersensitivity to milk proteins or any
ingredients of ASMANEX TWISTHALER. (4)
WARNINGS AND PRECAUTIONS
_Candida albicans_ infection of the m