Asmanex (Mometasone Furoate Inhalation) - Indications and Dosage

INDICATIONS AND USAGE

Treatment of Asthma

ASMANEX^® TWISTHALER^® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.

Important 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.

DOSAGE AND ADMINISTRATION

Administer ASMANEX TWISTHALER by the orally inhaled route only. Instruct patients to inhale rapidly and deeply. Advise patients to rinse the mouth after inhalation. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after initiation of treatment. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients ≥12 years of age who do not respond adequately to the starting dose after 2 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ASMANEX TWISTHALER when administered in excess of recommended doses have not been established.

Recommended Dosages in Patients 4 Years of Age and Older

The recommended starting doses and highest recommended daily dose for ASMANEX TWISTHALER treatment based on prior asthma therapy are provided in Table 1.

TABLE 1: Recommended Dosages for ASMANEX TWISTHALER Treatment

Previous Therapy	Recommended Starting Dose	Highest Recommended Daily Dose
Patients ≥12 years who received bronchodilators alone	220 mcg once daily in the evening 1	440 mcg 2
Patients ≥12 years who received inhaled corticosteroids	220 mcg once daily in the evening	440 mcg
Patients ≥12 years who received oral corticosteroids 3	440 mcg twice daily	880 mcg
Children 4 – 11 years of age 4	110 mcg once daily in the evening	110 mcg

DOSAGE FORMS AND STRENGTHS

ASMANEX TWISTHALER is a dry powder for inhalation that is available in two strengths.

ASMANEX TWISTHALER 220 mcg delivers 200 mcg mometasone furoate per actuation from the mouthpiece.

ASMANEX TWISTHALER 110 mcg delivers 100 mcg mometasone furoate per actuation from the mouthpiece.

HOW SUPPLIED/STORAGE AND HANDLING

The ASMANEX TWISTHALER 220 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg for the 14 and 30 inhalation units and 240 mg for the 60 and 120 inhalation units), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is pink with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").

The ASMANEX TWISTHALER product is available as:

ASMANEX TWISTHALER 220 mcg, which delivers 200 mcg mometasone furoate from the mouthpiece:
14 inhalation units (Institutional Use Only; NDC# 54868-5547-2);
30 inhalation units (NDC# 54868-5547-1);
60 inhalation units (For more than 1 inhalation daily; NDC# 54868-5547-0).

Each inhaler is supplied in a protective foil pouch with Patient's Instructions for Use.

Store in a dry place at 25°C (77°F); excursions permitted to 15°–30°C (59°–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.