Asmanex (Mometasone Furoate Inhalation) - Indications and Dosage

INDICATIONS AND USAGE

ASMANEX TWISTHALER inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older. The ASMANEX TWISTHALER inhaler is also indicated for asthma patients who require oral corticosteroid therapy, where adding ASMANEX TWISTHALER therapy may reduce or eliminate the need for oral corticosteroids.

ASMANEX TWISTHALER is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

The ASMANEX TWISTHALER product should be administered by the orally inhaled route in patients 12 years of age and older. 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. The safety and efficacy of ASMANEX TWISTHALER when administered in excess of recommended doses have not been established.

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

RECOMMENDED DOSAGES FOR ASMANEX TWISTHALER TREATMENT

Previous Therapy	Recommended Starting Dose	Highest Recommended Daily Dose
NOTE: In all patients, it is desirable to titrate to the lowest effective dose once asthma stability is achieved.
Bronchodilators alone	220 mcg QD PMWhen administered once daily ASMANEX TWISTHALER should only be taken in the PM.	440 mcgThe 440 mcg daily dose may be administered in divided doses of 220 mcg twice daily or as 440 mcg once daily.
Inhaled corticosteroids	220 mcg QD PM	440 mcg
Oral corticosteroids For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of ASMANEX TWISTHALER therapy. Patients should be carefully monitored for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency (see WARNINGS). Once prednisone reduction is complete, the dosage of mometasone furoate should be reduced to the lowest effective dosage.	440 mcg BID	880 mcg

Patients should be instructed to inhale rapidly and deeply (see enclosed patient instructions). Rinsing the mouth after inhalation is advised.

HOW SUPPLIED

The ASMANEX TWISTHALER product is comprised of an assembled plastic cap-activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (240 mg), and mouthpiece, covered by a white screw cap which 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 # 0085-1341-04); 30 inhalation units (NDC # 0085-1341-03); 60 inhalation units (For more than one inhalation daily; NDC # 0085-1341-02); or 120 inhalation units (For more than 2 inhalations daily; NDC # 0085-1341-01).

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.

Schering Corporation
Kenilworth, NJ 07033 USA

Copyright © 2005, Schering Corporation.
All rights reserved.

Rev. 7/05
B-26796024