Mezo-T

Mometasone:

• Warning: asthma-related death
• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Overdosage
• Description
• Mezo-T (Mometasone) reviews

WARNING: ASTHMA-RELATED DEATH

Long-acting beta₂-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in Mezo-T (Mometasone), increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta₂-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, Mezo-T (Mometasone) 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 Mezo-T (Mometasone)) 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 Mezo-T (Mometasone) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

WARNING: ASTHMA-RELATED DEATH

See full prescribing information for complete boxed warning.

• Long-acting beta₂-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in Mezo-T (Mometasone), increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.
• When treating patients with asthma, prescribe Mezo-T (Mometasone) only for patients with asthma 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 Mezo-T (Mometasone)) 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 Mezo-T (Mometasone) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids. (1.1, 5.1)

1 INDICATIONS AND USAGE

Mezo-T is a combination product containing a corticosteroid and a long-acting beta₂-adrenergic agonist indicated for:

• Treatment of asthma in patients 12 years of age and older. (1.1)

Important limitations:

• Not indicated for the relief of acute bronchospasm. (1.1)

1.1 Treatment of Asthma

Mezo-T (Mometasone) 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 Mezo-T (Mometasone), 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 . Therefore, when treating patients with asthma, Mezo-T (Mometasone) 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 Mezo-T (Mometasone)) 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 Mezo-T (Mometasone) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Important Limitation of Use

• Mezo-T (Mometasone) is NOT indicated for the relief of acute bronchospasm.

2 DOSAGE AND ADMINISTRATION

For oral inhalation only.

Treatment of asthma in patients ≥12 years: 2 inhalations twice daily of Mezo-T (Mometasone) 100 mcg/5 mcg or 200 mcg/5 mcg. Starting dosage is based on prior asthma therapy and disease severity. (2.2)

2.1 Administration Information

Mezo-T (Mometasone) should be administered as two inhalations twice daily every day (morning and evening) by the orally inhaled route. Shake well prior to each inhalation. 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 Mezo-T (Mometasone).

Mezo-T (Mometasone) 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 Mezo-T (Mometasone) canister should only be used with the Mezo-T (Mometasone) actuator. The Mezo-T (Mometasone) actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the Mezo-T (Mometasone) canister.

2.2 Recommended Dosage

Adults and Adolescents 12 Years of Age and Older

The dosage is either 2 inhalations twice daily of Mezo-T (Mometasone) 100 mcg/5 mcg or Mezo-T (Mometasone) 200 mcg/5 mcg. The maximum recommended dosage is two inhalations of Mezo-T (Mometasone) 200 mcg/5 mcg twice daily (maximum daily dosage 800 mcg/20 mcg).

When choosing the starting dosage strength of Mezo-T (Mometasone), consider the patients' disease severity, based on their previous asthma therapy, including the inhaled corticosteroid dosage, as well as the patients' current control of asthma symptoms and risk of future exacerbation.

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 with two inhalations of Mezo-T (Mometasone) 100 mcg/5 mcg twice daily (morning and evening), increasing the dosage to two inhalations of Mezo-T (Mometasone) 200 mcg/5 mcg twice daily (morning and evening) may provide additional asthma control.

Do not use more than two inhalations twice daily of the prescribed strength of Mezo-T (Mometasone) 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 Mezo-T (Mometasone) 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 Mezo-T (Mometasone) with a higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids, should be considered.

3 DOSAGE FORMS AND STRENGTHS

Mezo-T (Mometasone) is a pressurized metered dose inhaler that is available in 2 strengths.

Mezo-T (Mometasone) 100 mcg/5 mcg delivers 100 mcg of Mezo-T (Mometasone) furoate and 5 mcg of formoterol fumarate dihydrate per actuation.

Mezo-T (Mometasone) 200 mcg/5 mcg delivers 200 mcg of Mezo-T (Mometasone) furoate and 5 mcg of formoterol fumarate dihydrate per actuation.

Inhalation aerosol containing a combination of Mezo-T (Mometasone) furoate (100 or 200 mcg) and formoterol fumarate dihydrate (5 mcg) per actuation. (3)

4 CONTRAINDICATIONS

• Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures.
• Hypersensitivity to any of the ingredients of Mezo-T (Mometasone). (4.2)

4.1 Status Asthmaticus

Mezo-T (Mometasone) is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

4.2 Hypersensitivity

Mezo-T (Mometasone) is contraindicated in patients with known hypersensitivity to Mezo-T (Mometasone) furoate, formoterol fumarate, or any of the ingredients in Mezo-T (Mometasone) .

5 WARNINGS AND PRECAUTIONS

• Asthma-related death: Long-acting beta₂-adrenergic agonists increase the risk. Prescribe only for recommended patient populations.
• Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or to treat acute symptoms. (5.2)
• Use with additional long-acting beta₂-agonist: Do not use in combination because of risk of overdose. (5.3)
• Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth following inhalation. (5.4)
• Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Use with caution in patients with these infections because of the potential for worsening of these infections. (5.5)
• Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to Mezo-T (Mometasone). (5.6)
• Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Mezo-T (Mometasone) slowly. (5.7)
• Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid effects. Exercise caution when used with Mezo-T (Mometasone). (5.8)
• Paradoxical bronchospasm: Discontinue Mezo-T (Mometasone) and institute alternative therapy if paradoxical bronchospasm occurs. (5.9)
• Patients with cardiovascular disorders: Use with caution because of beta-adrenergic stimulation. (5.11)
• Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. (5.12)
• Effects on growth: Monitor growth of pediatric patients. (5.13)
• Glaucoma and cataracts: Monitor patients with change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely. (5.14)
• Coexisting conditions: Use with caution in patients with aneurysm, pheochromocytoma, convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. (5.15)
• Hypokalemia and hyperglycemia: Be alert to hypokalemia and hyperglycemia. (5.16)

5.1 Asthma-Related Death

Long-acting beta₂-adrenergic agonists, such as formoterol, one of the active ingredients in Mezo-T (Mometasone), increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, physicians should only prescribe Mezo-T (Mometasone) for patients with asthma 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 Mezo-T (Mometasone)) 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 Mezo-T (Mometasone) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

A 28-week, placebo-controlled US study comparing the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. 3/13,179 in patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34). This finding with salmeterol is considered a class effect of the LABAs, including formoterol, one of the active ingredients in Mezo-T (Mometasone). No study adequate to determine whether the rate of asthma-related death is increased with Mezo-T (Mometasone) has been conducted.

Clinical studies with formoterol suggested a higher incidence of serious asthma exacerbations in patients who received formoterol fumarate than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups.

5.2 Deterioration of Disease and Acute Episodes

Mezo-T should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. Mezo-T (Mometasone) has not been studied in patients with acutely deteriorating asthma. The initiation of Mezo-T (Mometasone) in this setting is not appropriate.

Increasing use of inhaled, short-acting beta₂-agonists is a marker of deteriorating asthma. In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of Mezo-T (Mometasone) with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids. Patients should not use more than 2 inhalations twice daily (morning and evening) of Mezo-T (Mometasone).

Mezo-T (Mometasone) is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta₂-agonist, not Mezo-T (Mometasone), should be used to relieve acute symptoms such as shortness of breath.

When beginning treatment with Mezo-T (Mometasone), patients who have been taking oral or inhaled, short-acting beta₂-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.

5.3 Excessive Use of Mezo-T (Mometasone) and Use with Other Long-Acting Beta₂-Agonists

As with other inhaled drugs containing beta₂-adrenergic agents, Mezo-T (Mometasone) should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing long-acting beta₂-agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using Mezo-T (Mometasone) should not use an additional long-acting beta₂-agonist (e.g., salmeterol, formoterol fumarate, arformoterol tartrate) for any reason, including prevention of exercise-induced bronchospasm (EIB) or the treatment of asthma.

5.4 Local Effects

In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans have occurred in patients treated with Mezo-T. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment with Mezo-T (Mometasone) therapy, but at times therapy with Mezo-T (Mometasone) may need to be interrupted. Advise patients to rinse the mouth after inhalation of Mezo-T (Mometasone).

5.5 Immunosuppression

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals.

Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

Mezo-T (Mometasone) should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

5.6 Transferring Patients from Systemic Corticosteroid Therapy

Particular care is needed for patients who are transferred from systemically active corticosteroids to Mezo-T because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although Mezo-T (Mometasone) may improve control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid activity necessary for coping with these emergencies.

During periods of stress or severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a medical identification card indicating that they may need supplementary systemic corticosteroids during periods of stress or severe asthma attack.

Patients requiring systemic corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Mezo-T (Mometasone). Lung function (FEV₁ or PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of systemic corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to Mezo-T (Mometasone) may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.

During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.

5.7 Hypercorticism and Adrenal Suppression

Mezo-T (Mometasone) furoate, a component of Mezo-T (Mometasone), will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since Mezo-T (Mometasone) furoate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of Mezo-T (Mometasone) in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.

Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with Mezo-T (Mometasone) should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when Mezo-T (Mometasone) furoate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of Mezo-T (Mometasone) should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.

5.8 Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors

Caution should be exercised when considering the coadministration of Mezo-T with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to Mezo-T (Mometasone) furoate may occur .

5.9 Paradoxical Bronchospasm and Upper Airway Symptoms

Mezo-T (Mometasone) may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm occurs, it should be treated immediately with an inhaled, short-acting bronchodilator. Mezo-T (Mometasone) should be discontinued immediately and alternative therapy instituted.

5.10 Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of Mezo-T, as demonstrated by cases of urticaria, flushing, allergic dermatitis, and bronchospasm.

5.11 Cardiovascular and Central Nervous System Effects

Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Therefore, Mezo-T (Mometasone) should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Formoterol fumarate, a component of Mezo-T (Mometasone), can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Mezo-T (Mometasone) at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

5.12 Reduction in Bone Mineral Density

Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids, including Mezo-T (Mometasone) furoate, one of the components of Mezo-T (Mometasone). The clinical significance of small changes in BMD with regard to long-term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care.

In a 2-year double-blind study in 103 male and female asthma patients 18 to 50 years of age previously maintained on bronchodilator therapy (Baseline FEV₁ 85%–88% predicted), treatment with Mezo-T (Mometasone) furoate dry powder inhaler 200 mcg twice daily resulted in significant reductions in lumbar spine (LS) BMD at the end of the treatment period compared to placebo. The mean change from Baseline to Endpoint in the lumbar spine BMD was -0.015 (-1.43%) for the Mezo-T (Mometasone) furoate group compared to 0.002 (0.25%) for the placebo group. In another 2-year double-blind study in 87 male and female asthma patients 18 to 50 years of age previously maintained on bronchodilator therapy (Baseline FEV₁ 82%–83% predicted), treatment with Mezo-T (Mometasone) furoate 400 mcg twice daily demonstrated no statistically significant changes in lumbar spine BMD at the end of the treatment period compared to placebo. The mean change from Baseline to Endpoint in the lumbar spine BMD was -0.018 (-1.57%) for the Mezo-T (Mometasone) furoate group compared to -0.006 (-0.43%) for the placebo group.

5.13 Effect on Growth

Orally inhaled corticosteroids, including Mezo-T (Mometasone), may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving Mezo-T (Mometasone) routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including Mezo-T (Mometasone), titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms .

5.14 Glaucoma and Cataracts

Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of long-term administration of inhaled corticosteroids, including Mezo-T furoate, a component of Mezo-T (Mometasone). Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts .

5.15 Coexisting Conditions

Mezo-T (Mometasone), like other medications containing sympathomimetic amines, should be used with caution in patients with aneurysm, pheochromocytoma, convulsive disorders, or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines. Doses of the related beta₂-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.16 Hypokalemia and Hyperglycemia

Beta₂-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. Clinically significant changes in blood glucose and/or serum potassium were seen infrequently during clinical studies with Mezo-T (Mometasone) at recommended doses.

6 ADVERSE REACTIONS

Long-acting beta₂-adrenergic agonists, such as formoterol, one of the active ingredients in Mezo-T, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Data from a large placebo-controlled US trial that compared the safety of another long-acting beta₂-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol .

Systemic and local corticosteroid use may result in the following:

• Candida albicans infection
• Immunosuppression
• Hypercorticism and adrenal suppression
• Growth effects in pediatrics
• Glaucoma and cataracts

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 practice.

Most common adverse reactions (reported in ≥3% of patients) included:

• Nasopharyngitis, sinusitis and headache. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

The safety data described below is based on 3 clinical trials which randomized 1913 patients 12 years of age and older with asthma, including 679 patients exposed to Mezo-T (Mometasone) for 12 to 26 weeks and 271 patients exposed for 1 year. Mezo-T (Mometasone) was studied in two placebo- and active-controlled trials (n=781 and n=728, respectively) and in a long-term 52-week safety trial (n=404). In the 12 to 26-week clinical trials, the population was 12 to 84 years of age, 41% male and 59% female, 73% Caucasians, 27% non-Caucasians. Patients received two inhalations twice daily of Mezo-T (Mometasone) (100 mcg/5 mcg or 200 mcg/5 mcg), Mezo-T (Mometasone) furoate MDI (100 mcg or 200 mcg), formoterol MDI (5 mcg) or placebo. In the long-term 52-week active-comparator safety trial, the population was 12 years to 75 years of age with asthma, 37% male and 63% female, 47% Caucasians, 53% non-Caucasians and received two inhalations twice daily of Mezo-T (Mometasone) 100 mcg/5 mcg or 200 mcg/5 mcg, or an active comparator.

The incidence of treatment emergent adverse reactions associated with Mezo-T (Mometasone) in Table 1 below is based upon pooled data from 2 clinical trials 12 to 26 weeks in duration in patients 12 years and older treated with two inhalations twice daily of Mezo-T (Mometasone) (100 mcg/5 mcg or 200 mcg/5 mcg), Mezo-T (Mometasone) furoate MDI (100 mcg or 200 mcg), formoterol MDI (5mcg) or placebo.

Oral candidiasis has been reported in clinical trials at an incidence of 0.7% in patients using Mezo-T (Mometasone) 100 mcg/5 mcg, 0.8% in patients using Mezo-T (Mometasone) 200 mcg/5 mcg and 0.5% in the placebo group.

Long-Term Clinical Trial Experience

In a long-term safety trial in patients 12 years and older treated for 52 weeks with Mezo-T (Mometasone) 100 mcg/5 mcg (n=141), Mezo-T (Mometasone) 200 mcg/5 mcg (n=130) or an active comparator (n=133), safety outcomes in general were similar to those observed in the shorter 12 to 26 week controlled trials. No asthma-related deaths were observed. Dysphonia was observed at a higher frequency in the longer term treatment trial at a reported incidence of 7/141 (5%) patients receiving Mezo-T (Mometasone) 100 mcg/5 mcg and 5/130 (3.8%) patients receiving Mezo-T (Mometasone) 200 mcg/5 mcg. No clinically significant changes in blood chemistry, hematology, or ECG were observed.

6.2 Postmarketing Experience

The following adverse reactions have been reported during post-approval use of Mezo-T (Mometasone) or post-approval use with inhaled Mezo-T (Mometasone) furoate or inhaled formoterol fumarate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac disorders: angina pectoris, cardiac arrhythmias, e.g., atrial fibrillation, ventricular extrasystoles, tachyarrhythmia

Immune system disorders: immediate and delayed hypersensitivity reactions including anaphylactic reaction, angioedema, severe hypotension, rash, pruritus

Investigations: electrocardiogram QT prolonged, blood pressure increased (including hypertension)

Metabolism and nutrition disorders: hypokalemia, hyperglycemia

Respiratory, thoracic and mediastinal disorders: asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm

7 DRUG INTERACTIONS

In clinical trials, concurrent administration of Mezo-T and other drugs, such as short-acting beta₂-agonist and intranasal corticosteroids have not resulted in an increased frequency of adverse drug reactions. No formal drug interaction studies have been performed with Mezo-T (Mometasone). The drug interactions of the combination are expected to reflect those of the individual components.

• Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. (7.1)
• Adrenergic agents: Use with caution. Additional adrenergic drugs may potentiate sympathetic effects. (7.2)
• Xanthine derivatives and diuretics: Use with caution. May potentiate ECG changes and/or hypokalemia. (7.3, 7.4)
• MAO inhibitors, tricyclic antidepressants, macrolides, and drugs that prolong QTc interval: Use with extreme caution. May potentiate effect on the cardiovascular system. (7.5)
• Beta-blockers: Use with caution and only when medically necessary. May decrease effectiveness and produce severe bronchospasm. (7.6)
• Halogenated hydrocarbons: There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons. (7.7)

7.1 Inhibitors of Cytochrome P450 3A4

The main route of metabolism of corticosteroids, including Mezo-T (Mometasone) furoate, a component of Mezo-T (Mometasone), is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally inhaled Mezo-T (Mometasone) furoate increased. Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, Mezo-T (Mometasone) furoate. Caution should be exercised when considering the coadministration of Mezo-T (Mometasone) with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) .

7.2 Adrenergic Agents

If additional adrenergic drugs are to be administered by any route, they should be used with caution because the pharmacologically predictable sympathetic effects of formoterol, a component of Mezo-T, may be potentiated.

7.3 Xanthine Derivatives

Concomitant treatment with xanthine derivatives may potentiate any hypokalemic effect of formoterol, a component of Mezo-T (Mometasone).

7.4 Diuretics

Concomitant treatment with diuretics may potentiate the possible hypokalemic effect of adrenergic agonists. The ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of Mezo-T (Mometasone) with non-potassium-sparing diuretics.

7.5 Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, and Drugs Known to Prolong the QTc Interval

Mezo-T (Mometasone) should be administered with caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, macrolides, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the action of formoterol, a component of Mezo-T (Mometasone), on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.

7.6 Beta-Adrenergic Receptor Antagonists

Beta-adrenergic receptor antagonists and formoterol may inhibit the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta₂-agonists, such as formoterol, a component of Mezo-T (Mometasone), but may produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

7.7 Halogenated Hydrocarbons

There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.

8 USE IN SPECIFIC POPULATIONS

• Hepatic impairment: Monitor patients for signs of increased drug exposure.

8.1 Pregnancy

Risk Summary

There are no randomized clinical studies of Mezo-T (Mometasone), Mezo-T (Mometasone) furoate, or formoterol fumarate in pregnant women. There are clinical considerations with the use of Mezo-T (Mometasone) in pregnant women . Animal reproduction studies with Mezo-T (Mometasone) are not available; however, studies are available with its individual components, Mezo-T (Mometasone) furoate and formoterol fumarate. In animal reproduction studies, subcutaneous administration of Mezo-T (Mometasone) furoate to pregnant mice, rats, or rabbits caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (MRHD) on a mcg/m² or AUC basis . However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. In animal reproduction studies, oral administration of formoterol fumarate to pregnant rats and rabbits caused increased fetal malformations (rats and rabbits), decreased fetal weight (rats), and increased neonatal mortality (rats) following administration of doses that produced exposures approximately 1200 to 49,000 times the MRHD on a mg/m² or AUC basis . These adverse effects generally occurred at large multiples of the MRHD when formoterol fumarate was administered by the oral route to achieve high systemic exposures. No effects were observed in a study with rats that received formoterol fumarate by the inhalation route at an exposure approximately 500 times the MRHD.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control.

Labor or delivery

There are no adequate and well-controlled human studies that have studied the effects of Mezo-T (Mometasone) during labor and delivery. Because of the potential for beta-agonist interference with uterine contractility, use of Mezo-T (Mometasone) during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

Data

Animal Data

Mezo-T (Mometasone) Furoate

In an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, Mezo-T (Mometasone) furoate produced cleft palate at an exposure approximately one-third of the MRHD (on a mcg/m² basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at an exposure approximately equivalent to the MRHD (on a mcg/m² basis with a maternal subcutaneous dose of 180 mcg/kg). No toxicity was observed with a dose that produced an exposure approximately one-tenth of the MRHD (on a mcg/m² basis with maternal topical dermal doses of 20 mcg/kg and above).

In an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, Mezo-T (Mometasone) furoate produced fetal umbilical hernia at exposures approximately 6 times the MRHD (on a mcg/m² basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at exposures approximately 3 times the MRHD (on a mcg/m² basis with maternal topical dermal doses of 300 mcg/kg and above).

In another reproductive toxicity study, pregnant rats were dosed with Mezo-T (Mometasone) furoate throughout pregnancy or late in gestation. Treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at an exposure that was approximately 8 times the MRHD (on an area under the curve (AUC) basis with a maternal subcutaneous dose of 15 mcg/kg). There were no findings with an exposure approximately 4 times the MRHD (on an AUC basis with a maternal subcutaneous dose of 7.5 mcg/kg).

Embryofetal development studies were conducted with pregnant rabbits dosed with Mezo-T (Mometasone) furoate by either the topical dermal route or oral route throughout the period of organogenesis. In the study using the topical dermal route, Mezo-T (Mometasone) furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at an exposure approximately 3 times the MRHD (on a mcg/m² basis with maternal topical dermal doses of 150 mcg/kg and above). In the study using the oral route, Mezo-T (Mometasone) furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at an exposure approximately 1/2 of the MRHD (on AUC basis with a maternal oral dose of 700 mcg/kg). At an exposure approximately 2 times the MRHD (on an AUC basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. No effects were observed at an exposure approximately 1/10 of the MRHD (on an AUC basis with a maternal oral dose of 140 mcg/kg).

Formoterol Fumarate

In embryofetal development studies with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate did not cause malformations in either species. However, for pregnant rats dosed throughout organogenesis, formoterol fumarate caused delayed fetal ossification at an exposure approximately 80 times the MRHD (on a mcg/m² basis with maternal oral doses of 200 mcg/kg and higher) and decreased fetal weight at an exposure approximately 2400 times the MRHD (on a mcg/m² basis with maternal oral doses of 6000 mcg/kg and above). In a pre- and post-natal development study with rats dosed during the late stage of pregnancy, formoterol fumarate caused stillbirth and neonatal mortality at an exposure approximately 2400 times the MRHD (on a mcg/m² basis with maternal oral doses of 6000 mcg/kg and above). However, no effects were observed in this study at an exposure approximately 80 times the MRHD (on a mcg/m² basis with a maternal oral dose of 200 mcg/kg).

In embryofetal development studies, conducted by another testing laboratory, with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate was teratogenic in both species. Umbilical hernia, a malformation, was observed in rat fetuses at exposures approximately 1200 times the MRHD (on a mcg/m² basis with maternal oral doses of 3000 mcg/kg/day and above). Brachygnathia, a skeletal malformation, was observed in rat fetuses at an exposure approximately 6100 times the MRHD (on a mcg/m² basis with a maternal oral dose of 15,000 mcg/kg/day). In another study with rats, no teratogenic effects were observed with exposures up to approximately 500 times the MRHD (on a mcg/m² basis with a maternal inhalation dose of 1200 mcg/kg/day). Subcapsular cysts on the liver were observed in rabbit fetuses at an exposure approximately 49,000 times the MRHD (on a mcg/m² basis with a maternal oral dose of 60,000 mcg/kg/day). No teratogenic effects were observed with exposures up to approximately 3000 times the MRHD (on a mcg/m² basis with a maternal oral dose of 3500 mcg/kg).

8.2 Lactation

Risk Summary

There are no available data on the presence of Mezo-T, Mezo-T (Mometasone) furoate, or formoterol fumarate in human milk, the effects on the breastfed child, or the effects on milk production. Other inhaled corticosteroids, similar to Mezo-T (Mometasone) furoate, are present in human milk. Formoterol fumarate is present in rat milk; however, due to species specific differences in lactation physiology, animal lactation data may not reliably predict levels in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Mezo-T (Mometasone) and any potential adverse effects on the breastfed infant from Mezo-T (Mometasone) or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of Mezo-T (Mometasone) have been established in patients 12 years of age and older in 3 clinical trials up to 52 weeks in duration. In the 3 clinical trials, 101 patients 12 to 17 years of age were treated with Mezo-T (Mometasone). Patients in this age-group demonstrated efficacy results similar to those observed in patients 18 years of age and older. There were no obvious differences in the type or frequency of adverse drug reactions reported in this age group compared to patients 18 years of age and older. Similar efficacy and safety results were observed in an additional 22 patients 12 to 17 years of age who were treated with Mezo-T (Mometasone) in another clinical trial. The safety and efficacy of Mezo-T (Mometasone) have not been established in children less than 12 years of age.

Controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. In these studies, the mean reduction in growth velocity was approximately 1 cm per year (range 0.3 to 1.8 per year) and appears to depend upon dose and duration of exposure. This effect was observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. The potential for "catch up" growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied.

The growth of children and adolescents receiving orally inhaled corticosteroids, including Mezo-T (Mometasone), should be monitored routinely (e.g., via stadiometry). If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect should be considered. The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risks associated with alternative therapies. To minimize the systemic effects of orally inhaled corticosteroids, including Mezo-T (Mometasone), each patient should be titrated to his/her lowest effective dose .

8.5 Geriatric Use

A total of 77 patients 65 years of age and older have been treated with Mezo-T (Mometasone) in 3 clinical trials up to 52 weeks in duration. Similar efficacy and safety results were observed in an additional 28 patients 65 years of age and older who were treated with Mezo-T (Mometasone) in another clinical trial. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. As with other products containing beta₂-agonists, special caution should be observed when using Mezo-T (Mometasone) in geriatric patients who have concomitant cardiovascular disease that could be adversely affected by beta₂-agonists. Based on available data for Mezo-T (Mometasone) or its active components, no adjustment of dosage of Mezo-T (Mometasone) in geriatric patients is warranted.

8.6 Hepatic Impairment

Concentrations of Mezo-T (Mometasone) furoate appear to increase with severity of hepatic impairment .

10 OVERDOSAGE

10.1 Signs and Symptoms

Mezo-T : Mezo-T (Mometasone) contains both Mezo-T (Mometasone) furoate and formoterol fumarate; therefore, the risks associated with overdosage for the individual components described below apply to Mezo-T (Mometasone).

Mezo-T (Mometasone) Furoate: Chronic overdosage may result in signs/symptoms of hypercorticism . Single oral doses up to 8000 mcg of Mezo-T (Mometasone) furoate have been studied on human volunteers with no adverse reactions reported.

Formoterol Fumarate: The expected signs and symptoms with overdosage of formoterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the following signs and symptoms: angina, hypertension or hypotension, tachycardia, with rates up to 200 beats/min., arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, and insomnia. Metabolic acidosis may also occur. Cardiac arrest and even death may be associated with an overdose of formoterol.

The minimum acute lethal inhalation dose of formoterol fumarate in rats is 156 mg/kg (approximately 63,000 times the MRHD on a mcg/m² basis). The median lethal oral doses in Chinese hamsters, rats, and mice provide even higher multiples of the MRHD.

10.2 Treatment

Mezo-T (Mometasone): Treatment of overdosage consists of discontinuation of Mezo-T (Mometasone) together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Mezo-T (Mometasone). Cardiac monitoring is recommended in cases of overdosage.

11 DESCRIPTION

Mezo-T (Mometasone) 100 mcg/5 mcg and Mezo-T (Mometasone) 200 mcg/5 mcg are combinations of Mezo-T (Mometasone) furoate and formoterol fumarate dihydrate for oral inhalation only.

One active component of Mezo-T (Mometasone) is Mezo-T (Mometasone) furoate, a corticosteroid having the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16 (alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) with the following chemical structure:

Reading the counter

• The dose counter identifies the number of inhalations (puffs) left in your inhaler.
• The counter will count down each time you release a puff of medicine (either when preparing your Mezo-T (Mometasone) inhaler for use or when taking the medicine).

When to replace your Mezo-T (Mometasone):

• It is important that you pay attention to the number of inhalations (puffs) left in your Mezo-T (Mometasone) inhaler by reading the counter.
• When the counter reads 20, you should refill your prescription or ask your healthcare provider if you need a new prescription for Mezo-T (Mometasone).
• Throw away Mezo-T (Mometasone) after the counter reaches 0, indicating that you have used the number of actuations on the product label and box. Your inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it.
• Never try to change the numbers on the counter or remove the counter from the actuator.
• Do not use the inhaler after the expiration date.

How do I store Mezo-T (Mometasone)?

• Store Mezo-T (Mometasone) at room temperature between 59°F to 86°F (15°C to 30°C).
• The 120-actuation inhaler can be stored in any position. For the 60-actuation inhaler, after priming, store the inhaler with the mouthpiece down or sideways.
• The contents of your Mezo-T (Mometasone) canister are under pressure. Do not puncture or throw the canister into a fire or incinerator. Do not use or store it near heat or open flame. Storage above 120ºF (50°C) may cause the canister to burst.
• Keep Mezo-T (Mometasone) and all medicines out of the reach of children.

How to clean your Mezo-T (Mometasone):

The mouthpiece should be cleaned using a dry wipe after every 7 days of use.

Routine cleaning instructions:

• Remove the cap off the mouthpiece. Wipe the inside and outside surfaces of the actuator mouthpiece with a clean, dry, lint-free tissue or cloth. Do not wash or put any parts of your inhaler in water. Put the cap back on the mouthpiece after cleaning.
• Do not remove the canister from the actuator.
• Do not attempt to unblock the actuator with a sharp object, such as a pin.

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.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Copyright © 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

All rights reserved.

Revised: 04/2015

usmg-mk0887a-ao-1504r018

PRINCIPAL DISPLAY PANEL - 100 mcg/5 mcg Inhaler Carton

NDC 0085-7206-01

Mezo-T (Mometasone) ^®

(mometasone furoate and

formoterol fumarate dihydrate)

Inhalation Aerosol

100 mcg/5 mcg

per actuation

For oral inhalation only

Attention Health Care Professional:

Dispense the enclosed Medication Guide to each patient.

SHAKE WELL BEFORE USING.

Mezo-T (Mometasone) canister to be used with Mezo-T (Mometasone) actuator only.

Rx only

120 Metered Actuations

Net Wt. 13g

PRINCIPAL DISPLAY PANEL - 100 mcg/5 mcg Inhaler Carton

PRINCIPAL DISPLAY PANEL - 200 mcg/5 mcg Inhaler Carton

NDC 0085-4610-01

Mezo-T (Mometasone) ^®

(mometasone furoate and

formoterol fumarate dihydrate)

Inhalation Aerosol

200 mcg/5 mcg

per actuation

For oral inhalation only

Attention Health Care Professional:

Dispense the enclosed Medication Guide to each patient.

SHAKE WELL BEFORE USING.

Mezo-T (Mometasone) canister to be used with Mezo-T (Mometasone) actuator only.

Rx only

120 Metered Actuations

Net Wt. 13g

PRINCIPAL DISPLAY PANEL - 200 mcg/5 mcg Inhaler Carton

Terbinafine Hydrochloride:

• Mezo-T information
• Mezo-T indications
• Mezo-T warnings
• Mezo-T intake guidelines
• Mezo-T dose
• Mezo-T overdose
• Mezo-T missed dose
• Mezo-T side effects
• Mezo-T drug reactions
• Mezo-T (Terbinafine Hydrochloride) reviews

Mezo-T information

Mezo-T (Terbinafine Hydrochloride) is an antifungal drug used as athlete's foot medication. Mezo-T (Terbinafine Hydrochloride) works like an antibiotic to treat fungal infections.

Mezo-T indications

This medicine is mainly indicated to treat fungal infections of the fingernails and toenails. Mezo-T (Terbinafine Hydrochloride) may also be used for purposes not mentioned here.

Mezo-T warnings

This drug is classed as a FDA pregnancy category B drug and may cause severe side effects to an unborn baby. Consult with your doctor if you are pregnant or planning to conceive during the treatment period. You should inform your doctor of your pregnancy before you buy Mezo-T (Terbinafine Hydrochloride) Sanis Health.

This product can pass into the breast milk of nursing mothers and it may affect a nursing baby. Consult your doctor before you take this medication if you are breast-feeding.

Before you take Mezo-T (Terbinafine Hydrochloride) Sanis Health, tell your doctor or pharmacist if you have any of the following conditions:

kidney disease

liver disease

blood problems

immune systems problems

history of allergic reactions

Mezo-T intake guidelines

Follow the exact directions given by your doctor. You may also ask your doctor, pharmacist, nurse or any other healthcare professional to explain the instructions if it is not clear to you.

Take each dose of Mezo-T (Terbinafine Hydrochloride) with a full glass of water or rub it into the skin completely in the case of the topical cream. Do not change your the medicine dosage without the advice of your doctor. Take the entire the medication dose given to you. It may take several months before your fungal infection is fully cured with this fungus medication.

Mezo-T dose

Obtain your dose from your doctor when you buy Mezo-T (Terbinafine Hydrochloride) online. Consult your doctor if you are unclear as to the instructions. The correct dosage of Mezo-T (Terbinafine Hydrochloride) may vary from person to person.

Mezo-T overdose

Symptoms of Mezo-T (Terbinafine Hydrochloride) overdose may include the following:

drowsiness

shortness of breath

abdominal pain

poor coordination

frequent urination

rash

headache

Consult your doctor immediately if you experience any of these symptoms. Seek immediate medical attention if you suspect an overdose or if you feel any unusual or bothersome effects caused by this fungus medicine.

Mezo-T missed dose

Take the missed dose of Mezo-T (Terbinafine Hydrochloride) as soon as you remember. It is important, however, not to double dose of the drug. Therefore, skip the missed dose if it is nearly time for your next scheduled dose.

Mezo-T side effects

As with any other drugs or medication, Mezo-T (Terbinafine Hydrochloride) can also cause some serious and less serious side effects. Consult your doctor as soon as possible if you experience any of these symptoms:

changes in vision

blood problems

allergic reactions such as swelling of face, lips, tongue, or face; hives; difficulty breathing; and closing of throat

rash

nausea, stomach upset, or heartburn

diarrhea

headache

loss of taste

severe liver damage

Other side effects not mentioned here may also occur. Notify your doctor as soon as possible if you experience any of the above-mentioned side effects of Mezo-T (Terbinafine Hydrochloride) or if you feel any unusual or bothersome side effects caused by this athlete's foot medication.

Mezo-T drug reactions

Other medications may interfere with the function of this medication. Notify your doctor immediately if you are using any of the following other medicines together with Mezo-T (Terbinafine Hydrochloride) Sanis Health:

Rifampin such as Rifadin and Rimactane

Cimetidine such as Tagamet and Tagamet HB

Cyclosporine such as Sandimmune and Neoral

There are also many other drugs not mentioned here that may interfere with the function of Mezo-T (Terbinafine Hydrochloride) Sanis Health. Consult your doctor or pharmacist before taking or buying any other prescription medicines or over-the-counter medicines.