Asmanex (mometasone furoate)

Dosage of mometasone furoate is expressed in terms of the salt.

Mometasone/formoterol is a fixed combination of mometasone furoate and formoterol fumarate dihydrate; dosage of the mometasone component is expressed in terms of the salt and dosage of the formoterol component is expressed in terms of the hydrated salt.

The strength and dosage of mometasone furoate administered as an oral inhalation powder (Asmanex(R) Twisthaler(R)) is expressed as the nominal (labeled) dose contained in the Twisthaler(R) device. The actual amount of drug delivered to the lungs depends on factors such as the patient's inspiratory flow. Based on standardized in vitro testing at a flow rate of 30 and 60 L/minute at a constant volume of 2 L, each actuation of the Twisthaler(R) inhaler labeled as containing 220 or 110 mcg of mometasone furoate delivers 200 or 100 mcg of mometasone furoate, respectively, from the mouthpiece. In adults and adolescents 12 years of age or older with asthma of varying severity, mean peak inspiratory flow through the Twisthaler(R) device was 69 L/minute. Mean peak inspiratory flow through the Twisthaler(R) device in pediatric patients 5-8 or 9-12 years of age exceeded 50 or 60 L/minute, respectively.

Each actuation of the mometasone furoate oral aerosol metered-dose inhaler (Asmanex(R) HFA) delivers 115 or 225 mcg of mometasone furoate from the valve and 100 or 200 mcg of mometasone furoate from the actuator, depending on the preparation used. The strength and dosage of these mometasone preparations are expressed in terms of drug delivered from the mouthpiece of the actuator. The actual amount of drug delivered to the lungs may depend on factors such as the patient's coordination between actuation of the device and inspiration through the delivery system. Commercially available Asmanex(R) HFA aerosol inhaler delivers 120 actuations per 13-g canister.

Each actuation of the oral aerosol inhaler containing the fixed combination of mometasone furoate and formoterol fumarate (Dulera(R)) delivers 115 or 225 mcg of mometasone furoate and 5.5 mcg of formoterol fumarate dihydrate from the valve and delivers 100 or 200 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate from the actuator per metered spray, depending on the preparation used. The strength and dosage of mometasone/formoterol preparations are expressed in terms of drug delivered from the mouthpiece of the actuator. The actual amount of drug delivered to the lungs may depend on factors such as the patient's coordination between actuation of the device and inspiration through the delivery system. Commercially available mometasone/formoterol aerosol inhaler delivers 60 or 120 metered sprays per 8.8- or 13-g canister, respectively.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

The following information addresses potential interactions with mometasone furoate. When mometasone furoate is used in fixed combination with formoterol fumarate (mometasone/formoterol), interactions associated with formoterol also should be considered. No formal drug interaction studies have been performed to date with the mometasone/formoterol fixed combination.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Mometasone furoate and the fixed combination containing mometasone furoate and formoterol fumarate (mometasone/formoterol) are contraindicated for primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids ) are required.

Mometasone furoate is contraindicated in patients hypersensitive to the drug or any ingredient (e.g., milk proteins) in the formulation. Mometasone oral inhalation powder contains small amounts of lactose, which has trace amounts of milk proteins. Anaphylactic reactions in patients with milk protein allergy have been reported; therefore, patients with known milk protein allergy should not receive mometasone oral inhalation powder.

Mometasone/formoterol fixed combination is contraindicated in patients hypersensitive to mometasone, formoterol, or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring in 5% or more of patients receiving mometasone furoate oral inhalation powder for the treatment of asthma include headache, allergic rhinitis, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, and dyspepsia.

Adverse effects occurring in 3% or more of patients receiving mometasone furoate oral inhalation aerosol for the treatment of asthma include nasopharyngitis, headache, sinusitis, bronchitis, and influenza.

Adverse effects occurring in 3% or more of patients receiving the mometasone/formoterol fixed combination for the treatment of asthma and more frequently than in those receiving placebo include nasopharyngitis, sinusitis, and headache.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of mometasone furoate oral inhalation powder have not been established in children younger than 4 years of age.

Safety and efficacy of mometasone furoate oral inhalation aerosol have not been established in children younger than 12 years of age.

Safety and efficacy of the mometasone/formoterol fixed combination have not been established in children younger than 12 years of age.

Use of corticosteroids may lead to suppression of growth in children and adolescents. Therefore, pediatric patients receiving prolonged therapy with orally inhaled mometasone should be monitored periodically (e.g., via stadiometry) for possible adverse effects on growth and development. The benefits of corticosteroid therapy should be weighed against the possibility of growth suppression and the availability of safe and effective alternative therapies. Pediatric patients should be maintained on the lowest possible dosage of mometasone that controls asthma symptoms.

Category C.

There are no adequate and well-controlled studies with mometasone furoate in pregnant women. The drug should be used during pregnancy only if potential benefits justify potential risks to the fetus.

There is an increased risk of adverse perinatal outcomes (e.g., preeclampsia, premature birth, low birth weight, neonates small for gestational age) in women with poorly or moderately controlled asthma. Pregnant women with asthma should be closely monitored and therapy adjusted as necessary to maintain optimal asthma control.

The effects of mometasone furoate in fixed combination with formoterol fumarate during labor and delivery are not known. Because of the potential for beta-agonist interference with uterine contractility, use of the mometasone/formoterol fixed combination during labor should be restricted to those patients in whom the benefits clearly outweigh the risks.

Hypoadrenalism may occur in infants of women who have received substantial oral corticosteroid dosages during pregnancy. These infants should be carefully monitored.

It is not known whether mometasone furoate is distributed into milk; however, other corticosteroids are distributed into milk. Data are not available on the effects of the drug on the breast-fed child or milk production. The benefits of breast-feeding and the importance of mometasone to the woman should be considered along with any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition. The manufacturer of mometasone oral inhalation powder (Asmanex(R) Twisthaler(R)) states that caution is advised if mometasone furoate is administered in nursing women.

The manufacturer of the mometasone/formoterol fixed combination states that a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Although no overall differences in safety and efficacy of orally inhaled mometasone furoate were observed in geriatric patients relative to younger adults, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.