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Dulera

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Dulera

INDICATIONS

Treatment of Asthma

DULERA is indicated for the treatment of asthma in patients 12 years of age and older.

Long-acting beta2-adrenergic agonists, such as formoterol, one of the active ingredients in DULERA, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see WARNINGS AND PRECAUTIONS]. Therefore, when treating patients with asthma, DULERA should only be used for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue DULERA) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use DULERA for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Important Limitation of Use

  • DULERA is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

General

DULERA should be administered only by the orally inhaled route (see Instructions for Using DULERA in the Medication Guide). 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 DULERA.

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

Dosing

DULERA 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 starting dosages for DULERA treatment are based on prior asthma therapy.

Table 1: Recommended Dosages for DULERA

Previous Therapy Recommended Dose Maximum Recommended Daily Dose
Inhaled medium dose corticosteroids DULERA 100 mcg/5 mcg, 2 inhalations twice daily 400 mcg/20 mcg
Inhaled high dose corticosteroids DULERA 200 mcg/5 mcg, 2 inhalations twice daily 800 mcg/20 mcg

The maximum daily recommended dose is two inhalations of DULERA 200 mcg/5 mcg twice daily. Do not use more than two inhalations twice daily of the prescribed strength of DULERA as some patients are more likely to experience adverse effects with higher doses of formoterol. If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

If a previously effective dosage regimen of DULERA 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 DULERA with a higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids, should be considered.

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 ≥ 12 years of age who do not respond adequately after 2 weeks of therapy, higher strength may provide additional asthma control.

HOW SUPPLIED

Dosage Forms And Strengths

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

DULERA 100 mcg/5 mcg delivers 100 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate per actuation.

DULERA 200 mcg/5 mcg delivers 200 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate per actuation.

DULERA is available in two strengths and supplied in the following package sizes (Table 7):

Table 7

Package NDC
DULERA 100 mcg/5 mcg 120 inhalations 0085-7206-01
DULERA 100 mcg/5 mcg 60 inhalations (institutional pack) 0085-7206-07
DULERA 200 mcg/5 mcg 120 inhalations 0085-4610-01
DULERA 200 mcg/5 mcg 60 inhalations (institutional pack) 0085-4610-05

Each strength is supplied as a pressurized aluminum canister that has a blue plastic actuator integrated with a dose counter and a blue dust cap. Each 120-inhalation canister has a net fill weight of 13 grams and each 60-inhalation canister has a net fill weight of 8.8 grams. Each canister is placed into a carton. Each carton contains 1 canister and a Medication Guide.

Initially the dose counter will display “64” or “124” actuations. After the initial priming with 4 actuations, the dose counter will read “60” or “120” and the inhaler is now ready for use.

Storage and Handling

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

The 120-inhalation inhaler does not require specific storage orientation. For the 60-inhalation inhaler, after priming, store the inhaler with the mouthpiece down or in a horizontal position.

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 for : Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: 3M Health Care Ltd., Loughborough, United Kingdom.

Last reviewed on RxList: 2/1/2013
This monograph has been modified to include the generic and brand name in many instances.

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