Mometasone Furoate

Nasonex

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of ELOCON Cream was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of ELOCON Cream have also been received. In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of ELOCON Cream was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis.

The following adverse reactions were reported to be possibly or probably related to treatment with ELOCON Cream during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 subjects treated with ELOCON Cream in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1.

The following additional local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Mometasone nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using mometasone nasal.

Your pharmacist can provide more information about mometasone nasal.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Synthetic nonfluorinated glucocorticoid.1 2 4

General

• Adjust dosage carefully according to individual requirements and response.1

• After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response.1 Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth. (See Pediatric Use under Cautions.)1

• Base initial and maximum dosages in adults and children ≥12 years of age on previous asthma therapy.1

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

• When switching from systemic corticosteroids to orally inhaled mometasone furoate, asthma should be reasonably stable before initiating treatment with oral inhalation.13 14

• Initially, administer oral inhalation concurrently with the maintenance dosage of the systemic corticosteroid.1 After at least 1 week, gradually withdraw the systemic corticosteroid.1

• Decrements usually should not exceed 2.5 mg daily of prednisone (or its equivalent) each week in patients receiving the oral inhalation.1 Once oral corticosteroids are discontinued and symptoms of asthma have been controlled, titrate the dosage to the lowest effective level.1

• Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.1 (See Withdrawal of Systemic Corticosteroid Therapy under Cautions.)

Administration

Oral Inhalation

Administer by oral inhalation using the Twisthaler breath-actuated dry powder inhalation device.1 2 8

When administered once daily, use at the same time each day, preferably in the evening for optimal efficacy.1 2 5

Removal of the cap of the device (by twisting in a counterclockwise direction) releases a single 220-mcg dose of drug from the drug storage unit into the inhalation channel, making the dose available for administration via inhalation through the mouthpiece.1 8 A dose counter will decrement by 1 each time the cap is removed.8

Remove the cap with the inhaler in an upright position.1 Before inhaling the dose, exhale as completely as possible, but not into the Twisthaler device.1 8 Place the mouthpiece of the inhaler between the lips and inhale quickly and deeply through the inhaler.8 Do not cover the ventilation holes on either side of the inhaler while inhaling the dose.8 Remove the inhaler from the mouth, hold breath for about 10 seconds, then exhale slowly.8 Do not take extra doses despite not being able to taste, smell, or feel the released powder, unless otherwise instructed by a clinician.8

After inhalation, rinse mouth to minimize potential systemic or local adverse effects.1 8 Wipe the mouthpiece dry with a dry cloth or tissue.1 8 Close and reload the Twisthaler device for the next dose by twisting the cap in a clockwise direction until a click is heard.1 8

Do not wash the inhaler; store in a dry place.8 Discard the inhaler when every inhalation has been used (when the dose indicator reads “00”) or 45 days after removal from its foil overwrap pouch, whichever comes first.1 8

Dosage

Available as mometasone furoate; dosage expressed in terms of the salt.1

Dose of mometasone furoate administered as an oral inhalation powder is expressed as the nominal (labeled) dose contained in the Twisthaler device.1 The amount of drug delivered to the lungs depends on factors such as the patient’s inspiratory flow.1

Each actuation of the Twisthaler inhaler contains 110 or 220 mcg of mometasone furoate inhalation powder and delivers approximately 100 or 200 mcg of mometasone furoate, respectively, per activation from the mouthpiece.1

Pediatric Patients

Children 4–11 years of age: Initial and maximum dosage is 110 mcg once daily in the evening, regardless of prior therapy.1

Children ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Initially, 220 mcg once daily in the evening.1 If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, a higher dosage may provide additional asthma control.1 If required, dosage may be increased to a maximum 440 mcg daily, given once daily or in 2 divided doses.1

Children ≥12 years of age previously receiving oral corticosteroids: Initial and maximum dosage is 880 mcg daily, given in 2 divided doses.1

Adults

Previously receiving bronchodilators alone or inhaled corticosteroids: Initially, 220 mcg once daily in the evening.1 If control of asthma is inadequate after 2 weeks of therapy at the initial dosage, a higher dosage may provide additional asthma control.1 If required, dosage may be increased to a maximum 440 mcg daily, given once daily or in 2 divided doses.1

Previously receiving oral corticosteroids: Initial and maximum dosage is 880 mcg daily, given in 2 divided doses.1

Prescribing Limits

Pediatric Patients

Children 4–11 years of age: Maximum 110 mcg daily.1

Children ≥12 years of age previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg daily.1

Children ≥12 years of age previously receiving oral corticosteroids: Maximum 880 mcg daily.1

Adults

Previously receiving bronchodilators alone or inhaled corticosteroids: Maximum 440 mcg daily.1

Previously receiving oral corticosteroids: Maximum 880 mcg daily.1

Special Populations

No special population dosage recommendations at this time.1