August 27, 2015
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Asmanex

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Asmanex Twisthaler




Indications
Dosage
How Supplied

INDICATIONS

Treatment Of Asthma

ASMANEX® HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

Important Limitations of Use
  • ASMANEX HFA is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

General

ASMANEX HFA should be administered only by the orally inhaled route [see Instructions for Use in the PATIENT INFORMATION leaflet]. After each dose, the patient should be advised to rinse his/her mouth with water without swallowing.

The cap from the mouthpiece of the actuator should be removed before using ASMANEX HFA.

ASMANEX HFA should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.

The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.

Dosing

ASMANEX HFA should be administered as two inhalations twice daily every day (morning and evening) by the orally inhaled route.

Shake well prior to each inhalation.

The recommended doses for ASMANEX HFA treatment based on prior asthma therapy are provided in Table 1.

TABLE 1: Recommended Dosages for ASMANEX HFA Treatment

Previous Therapy Recommended Dose
Inhaled medium-dose corticosteroids ASMANEX HFA 100 mcg,
2 inhalations twice daily
Inhaled high-dose corticosteroids ASMANEX HFA 200 mcg,
2 inhalations twice daily
Oral corticosteroids* ASMANEX HFA 200 mcg,
2 inhalations twice daily
*For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be weaned slowly, beginning after at least 1 week of ASMANEX HFA therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see WARNINGS AND PRECAUTIONS].

If a dosage regimen of ASMANEX HFA fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of ASMANEX HFA with a higher strength, initiating an inhaled corticosteroid and long-acting beta2-agonist combination product, or initiating oral corticosteroids, should be considered.

The maximum daily recommended dose is two inhalations of ASMANEX HFA 200 mcg twice daily (maximum of 800 mcg a day). If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

The maximum benefit may not be achieved for 1 week or longer after beginning treatment. Individual patients may experience a variable time to onset and degree of symptom relief. For patients who do not respond adequately after 2 weeks of therapy, higher strength may provide additional asthma control.

After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects.

HOW SUPPLIED

Dosage Forms And Strengths

ASMANEX HFA is a pressurized metered dose inhaler that is available in 2 strengths.

ASMANEX HFA 100 mcg delivers 100 mcg of mometasone furoate per actuation.

ASMANEX HFA 200 mcg delivers 200 mcg of mometasone furoate per actuation.

ASMANEX HFA is available in two strengths and supplied in the following package size (Table 4):

Table 4

Package NDC
ASMANEX HFA 100 mcg 120 metered actuations 0085-4333-01
ASMANEX HFA 200 mcg 120 metered actuations 0085-4334-01

Each strength is supplied as a pressurized aluminum canister that has a blue plastic actuator integrated with a dose counter and a pink dust cap. Each canister has a net fill weight of 13 grams. Each inhaler is placed into a carton. Each carton contains 1 inhaler.

Initially the dose counter will display “124” actuations. After the initial priming with 4 actuations, the dose counter will read “120” and the inhaler is now ready for use.

Storage And Handling

The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.

The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of actuations has been used (the dose counter will read “0”).

Store at controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59- 86°F) [see USP Controlled Room Temperature].

For best results, the canister should be at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes.

Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.

Manufactured by: 3M Health Care Ltd., Loughborough, United Kingdom. Revised: April 2014.

Last reviewed on RxList: 7/22/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Asmanex Twisthaler - User Reviews

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