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Drug overview for ASMANEX (mometasone furoate):
Generic name: MOMETASONE FUROATE (mow-MET-uh-sown)
Drug class: Orally Inhaled Steroids
Therapeutic class: Respiratory Therapy Agents
Mometasone furoate is a synthetic glucocorticoid.
No enhanced Uses information available for this drug.
Generic name: MOMETASONE FUROATE (mow-MET-uh-sown)
Drug class: Orally Inhaled Steroids
Therapeutic class: Respiratory Therapy Agents
Mometasone furoate is a synthetic glucocorticoid.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ASMANEX (mometasone furoate) have been approved by the FDA:
Indications:
Maintenance therapy for asthma
Professional Synonyms:
Therapy to achieve long-term asthma control
Indications:
Maintenance therapy for asthma
Professional Synonyms:
Therapy to achieve long-term asthma control
The following dosing information is available for 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.
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 enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ASMANEX TWISTHALR 220 MCG #120 | Maintenance | Adults inhale 1 puff (220 mcg) by inhalation route once daily at nighttime |
| ASMANEX TWISTHALER 220 MCG #60 | Maintenance | Adults inhale 1 puff (220 mcg) by inhalation route once daily at nighttime |
| ASMANEX TWISTHALER 220 MCG #14 | Maintenance | Adults inhale 1 puff (220 mcg) by inhalation route once daily at nighttime |
| ASMANEX TWISTHALER 220 MCG #30 | Maintenance | Adults inhale 1 puff (220 mcg) by inhalation route once daily at nighttime |
| ASMANEX TWISTHALER 110 MCG #30 | Maintenance | Adults inhale 2 puffs (220 mcg) by inhalation route once daily in the evening |
No generic dosing information available.
The following drug interaction information is available for ASMANEX (mometasone furoate):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Desmopressin/Glucocorticoids SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Glucocorticoids increase the risk of hyponatremia.(1-4) CLINICAL EFFECTS: Concurrent use of glucocorticoids may increase the risk of hyponatremia with desmopressin.(1-4) PREDISPOSING FACTORS: Predisposing factors for hyponatremia include: polydipsia, renal impairment (eGFR < 50 ml/min/1.73m2), illnesses that can cause fluid/electrolyte imbalances, age >=65, medications that cause water retention and/or increase the risk of hyponatremia (carbamazepine, chlorpromazine, lamotrigine, loop diuretics, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants). PATIENT MANAGEMENT: The concurrent use of systemic or inhaled glucocorticoids with desmopressin is contraindicated.(1-4) Desmopressin may be initiated 3 days or 5 half-lives after glucocorticoid discontinuation, whichever is longer. If concurrent use is deemed medically necessary, make sure serum sodium levels are normal before beginning therapy and consider using the desmopressin nasal 0.83 mcg dose. Consider measuring serum sodium levels more frequently than the recommended intervals of: within 7 days of concurrent therapy initiation, one month after concurrent therapy initiation and periodically during treatment. Counsel patients to report symptoms of hyponatremia, which may include: headache, nausea/vomiting, feeling restless, fatigue, drowsiness, dizziness, muscle cramps, changes in mental state (confusion, decreased awareness/alertness), seizures, coma, and trouble breathing. Counsel patients to limit the amount of fluids they drink in the evening and night-time and to stop taking desmopressin if they develop a stomach/intestinal virus with nausea/vomiting or any nose problems (blockage, stuffy/runny nose, drainage).(1) DISCUSSION: In clinical trials of desmopressin for the treatment of nocturia, 4 of 5 patients who developed severe hyponatremia (serum sodium <= 125 mmol/L) were taking systemic or inhaled glucocorticoids. Three of these patients were also taking NSAIDs and one was receiving a thiazide diuretic.(2) Drugs associated with hyponatremia may increase the risk, including loop diuretics, carbamazepine, chlorpromazine, glucocorticoids, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants.(1,3-4) |
DDAVP, DESMOPRESSIN ACETATE, NOCDURNA |
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Radioactive Iodide/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1) PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(2) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(3) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1) |
ADREVIEW, JEANATOPE, MEGATOPE, SODIUM IODIDE I-123 |
| Cosyntropin/Agents Affecting Plasma Cortisol Levels SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Agents affecting plasma cortisol levels may impact the accuracy of the cosyntropin diagnostic test.(1) CLINICAL EFFECTS: Concurrent use of agents affecting plasma cortisol levels may impact the accuracy of the cosyntropin diagnostic test.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of cosyntropin states accuracy of diagnosis using the cosyntropin diagnostic test may be complicated by concomitant medications affecting plasma cortisol levels.(1) Agents affecting plasma cortisol levels and recommendation to stop prior to cosyntropin diagnostic test include: - Glucocorticoids: May elevate plasma cortisol levels. Stop these drugs on the day of testing. Long-acting glucocorticoids may need to be stopped for a longer period before testing. - Spironolactone: May elevate plasma cortisol levels. Stop spironolactone on the day of testing. - Estrogen: May elevate plasma total cortisol levels. Discontinue estrogen containing drugs 4 to 6 weeks prior to testing to allow cortisol binding globulin levels to return to levels within the reference range. Alternatively, concomitant measurement of cortisol binding globulin at the time of testing can be done; if cortisol binding globulin levels are elevated, plasma total cortisol levels are considered inaccurate.(1) DISCUSSION: Concurrent use of agents affecting plasma cortisol levels may impact the accuracy of the cosyntropin diagnostic test.(1) |
CORTROSYN, COSYNTROPIN |
| Sodium Iodide I 131/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1,2) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1,2) PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1,2) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(3) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(4) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1,2) |
HICON, SODIUM IODIDE I-131 |
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Quinolones/Corticosteroids SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Quinolone-induced arthropathy is a class effect of the quinolones.(1) Exactly how corticosteroid use increases the risk of tendon rupture is unknown. CLINICAL EFFECTS: Concurrent use of quinolones and corticosteroids may increase the risk of tendonitis and/or tendon rupture. This affect is most common in the Achilles tendon, but has been reported in the rotator cuff (shoulder), hand, biceps, thumb, and other tendons.(2-9) PREDISPOSING FACTORS: Risk factors for tendinitis and tendon rupture include age greater than 60; a history of kidney, heart, or lung transplantation, strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. PATIENT MANAGEMENT: Quinolone use should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should be instructed to rest and refrain from exercise until the diagnosis of tendonitis tendon rupture has been excluded.(2-9) DISCUSSION: Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving ciprofloxacin,(2) gatifloxacin,(3) levofloxacin,(4) lomefloxacin,(5) moxifloxacin,(6) nalidixic acid,(7) norfloxacin,(8) and ofloxacin.(9) A retrospective review of the IMS Health database examined quinolone use use from July 1, 1992 to June 30, 1998. The adjusted relative risk of tendon disorder with concurrent quinolone use was 1.9. Relative risk increased to 3.2 in patients aged 60 or older compared to 0.9 in patients aged less than 60. In patients aged 60 or older who used corticosteroids and quinolones concurrently, relative risk increased to 6.2.(10) In contrast, another retrospective review examined patients from a health insurance claims database and found no apparent effect from concurrent quinolone and corticosteroid use.(11) In a review of the follow-up to 42 spontaneously reported case of quinolone-associated tendon disorders in the Netherlands between January, 1988 and January, 1998, risk factors for tendon disorders included age older than 60, oral corticosteroid use, and existing joint problems.(12) In a review of the Swiss Drug Monitoring system, four of seven cases of levofloxacin-associated tendon problems also involved concurrent oral or inhaled corticosteroids.(13) In a review of the Medline database from 1966-2001, 98 case reports of tendinopathy associated with quinolones were located. Thirty-two (32.7%) of the patients had received systemic or inhaled corticosteroids before and during quinolone therapy. Of the 40 patients who suffered a tendon rupture, 21 (52.5%) were receiving corticosteroids.(14) Other authors have reported cases of tendon disorders in patients receiving concurrent corticosteroids and ciprofloxacin,(15) levofloxacin, (16-20) and ofloxacin.(21) |
AVELOX IV, BAXDELA, CIPRO, CIPROFLOXACIN, CIPROFLOXACIN HCL, CIPROFLOXACIN-D5W, GATIFLOXACIN SESQUIHYDRATE, LEVOFLOXACIN, LEVOFLOXACIN HEMIHYDRATE, LEVOFLOXACIN-D5W, MOXIFLOXACIN, MOXIFLOXACIN HCL, NALIDIXIC ACID, OFLOXACIN |
| Mometasone/Selected CYP3A4 Inhibitors SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: CYP3A4 inhibitors may inhibit the metabolism of mometasone.(1-14,17) CLINICAL EFFECTS: Concurrent use of CYP3A4 inhibitors may result in increased systemic exposure to and effects from mometasone, including Cushing's syndrome and adrenal suppression.(1-14,17) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Use caution when using concurrent therapy with mometasone and CYP3A4 inhibitors. Alternative corticosteroids that are less affected by CYP3A4 inhibitors should be considered, like beclomethasone and prednisolone.(14) If concurrent therapy is warranted, patients should be closely monitored for systemic effects. The corticosteroid may need to be discontinued. DISCUSSION: In a study in 24 healthy subjects, inhaled mometasone furoate (400 mcg delivered by a dry powder inhaler twice daily for 9 days) with ketoconazole (200 mg on Days 4 to 9) increased systemic mometasone furoate concentrations from <150 pg/mL on Day 3 prior to coadministration of ketoconazole to a peak plasma concentrations of mometasone furoate >200 pg/mL on Day 9 (211-324 pg/mL).(14) There have been several case reports of Cushing's syndrome in patients treated concurrently with ritonavir and nasal fluticasone and mometasone.(15) A review of corticosteroid use patients on protease inhibitors detailed the interactions that can result in accumulation of corticosteroids, leading to adrenal suppression and Cushing's syndrome.(16) Selected CYP3A4 inhibitors linked to this monograph include: atazanavir, boceprevir, ceritinib, cobicistat, darunavir, fosamprenavir, idelalisib, indinavir, lenacapavir, lonafarnib, lopinavir, mibefradil, nelfinavir, nirmatrelvir, paritaprevir, saquinavir, telaprevir, tipranavir, and tucatinib.(17) |
APTIVUS, ATAZANAVIR SULFATE, DARUNAVIR, EVOTAZ, FOSAMPRENAVIR CALCIUM, GENVOYA, KALETRA, LOPINAVIR-RITONAVIR, PAXLOVID, PREZCOBIX, PREZISTA, REYATAZ, STRIBILD, SUNLENCA, SYMTUZA, TUKYSA, TYBOST, VIRACEPT, ZOKINVY, ZYDELIG, ZYKADIA |
The following contraindication information is available for ASMANEX (mometasone furoate):
Drug contraindication overview.
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.
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 0 contraindications.
There are 5 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Fungal infection |
| Ocular herpes simplex |
| Ocular hypertension |
| Osteoporosis |
| Parasitic infection |
There are 9 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Active tuberculosis |
| Cataracts |
| Chickenpox |
| Disease of liver |
| Glaucoma |
| Hypothalamic-pituitary insufficiency |
| Immunosuppression |
| Measles |
| Osteopenia |
The following adverse reaction information is available for ASMANEX (mometasone furoate):
Adverse reaction overview.
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.
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 12 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Asthma exacerbation Cataracts Glaucoma Hypersensitivity drug reaction Hypothalamic-pituitary insufficiency Immunosuppression Infection Ocular hypertension Osteopenia Paradoxical bronchospasm |
There are 31 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Allergic rhinitis Back pain Dysmenorrhea Dyspepsia Headache disorder Musculoskeletal pain Oral candidiasis Pharyngitis Sinusitis Upper respiratory infection |
Acute abdominal pain Myalgia Nausea Oropharyngeal candidiasis Urinary tract infection |
| Rare/Very Rare |
|---|
|
Anorexia Arthralgia Blurred vision Cough Dry throat Earache Epistaxis Fatigue Flu-like symptoms Gastroenteritis Nasal passage irritation Pain Pruritus of skin Skin rash Voice change Vomiting |
The following precautions are available for ASMANEX (mometasone furoate):
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.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
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.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
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.
The following prioritized warning is available for ASMANEX (mometasone furoate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ASMANEX (mometasone furoate)'s list of indications:
| Maintenance therapy for asthma | |
| J45 | Asthma |
| J45.2 | Mild intermittent asthma |
| J45.20 | Mild intermittent asthma, uncomplicated |
| J45.3 | Mild persistent asthma |
| J45.30 | Mild persistent asthma, uncomplicated |
| J45.4 | Moderate persistent asthma |
| J45.40 | Moderate persistent asthma, uncomplicated |
| J45.5 | Severe persistent asthma |
| J45.50 | Severe persistent asthma, uncomplicated |
| J45.9 | Other and unspecified asthma |
| J45.90 | Unspecified asthma |
| J45.909 | Unspecified asthma, uncomplicated |
Formulary Reference Tool