Mometasone furoate And Formoterol fumarate

What is Mometasone Furoate And Formoterol Fumarate?

• Mometasone Furoate And Formoterol Fumarate (DULERA) is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) used in the long-term treatment of asthma.

Mometasone furoate

Formoterol

What are the uses of this medicine?

• Mometasone Furoate And Formoterol Fumarate (DULERA) is a prescription medicine used to control symptoms of asthma and prevent symptoms such as wheezing in people 5 years of age and older.
• DULERA combines an inhaled corticosteroid medicine (ICS), mometasone furoate, and a long-acting beta2-agonist medicine (LABA), formoterol.
• ICS medicines such as mometasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
• LABA medicines such as formoterol help the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
• DULERA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of hospitalizations and death from asthma problems. DULERA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

Limitation of Use:

• Not indicated for the relief of acute bronchospasm.

How does this medicine work?

• DULERA contains both mometasone furoate and formoterol fumarate; therefore, the mechanisms of actions described below for the individual components apply to DULERA.

Mometasone furoate:

• Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on asthma is not known.
• Corticosteroids have been shown to have a wide range of inhibitory effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation and in the asthmatic response. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Formoterol fumarate:

• Formoterol fumarate is a long-acting selective beta2-adrenergic receptor agonist (beta2-agonist).
• Inhaled formoterol fumarate acts locally in the lung as a bronchodilator.
• The pharmacologic effects of beta2-adrenoceptor agonist drugs, including formoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP).
• Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• to treat sudden severe symptoms of asthma.
• as a rescue inhaler.
• if you are allergic to any of the ingredients in DULERA.

What drug interactions can this medicine cause?

• Caution should be exercised when considering the coadministration of DULERA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) .
• 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 DULERA, may be potentiated.
• Concomitant treatment with xanthine derivatives may potentiate any hypokalemic effect of formoterol, a component of DULERA.
• Caution is advised in the coadministration of DULERA with non-potassium-sparing diuretics (such as loop or thiazide diuretics).
• DULERA should be administered with caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, macrolides, or drugs known to prolong the QTc interval.
• Use Beta-blockers with caution and only when medically necessary. May decrease effectiveness and produce severe bronchospasm.
• There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.

Is this medicine FDA approved?

• The combination was approved for medical use in the United States in 2010.
• it was the 243rd most commonly prescribed medication in the United States, with more than one million prescriptions.
• It is on the World Health Organization's List of Essential Medicines.

How should this medicine be used?

Recommended dosage: Treatment of asthma in patients ≥12 years:

• 2 inhalations twice daily of DULERA 100 mcg/5 mcg or 200 mcg/5 mcg. Starting dosage is based on disease severity.

Treatment of asthma in patients aged 5 to less than 12 years:

• 2 inhalations twice daily of DULERA 50 mcg/5 mcg.

Administration:

• For children aged 5 to less than 12 years, use DULERA 50 mcg/5 mcg.
• For adults and adolescents 12 years of age and older, use DULERA 100 mcg/5 mcg or DULERA 200 mcg/5 mcg.
• DULERA should be taken every day as 2 puffs in the morning and 2 puffs in the evening.
• If you miss a dose of DULERA, skip your missed dose and take your next dose at your regular time. Do not take DULERA more often or use more puffs than you have been prescribed.
• While you are using DULERA 2 times each day, do not use other medicines that contain a long-acting beta2-agonist (LABA) for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
• If you take more DULERA than your healthcare provider has prescribed, get medical help right away if you have any unusual symptoms, such as problems breathing, palpitations, chest pain, increased heart rate, nervousness or shakiness.
• Do not change or stop using DULERA or other asthma medicines used to control or treat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed.
• DULERA does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of DULERA. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
• Remove the cap from the mouthpiece of the actuator before using DULERA.
• Do not remove the canister from the actuator because:
• You may not receive the correct amount of medicine.
• The dose counter may not function properly.
• Reinsertion may cause the dose counter to count down by 1 and may discharge a puff.
• After each dose (2 puffs) of DULERA, rinse your mouth with water. Spit out the water. Do not swallow it. This will help to lessen the chance of getting a yeast infection (thrush) in the mouth and throat.
• Prime (sprays released into the air before use) your inhaler away from your face. Do not spray DULERA in your eyes. If you accidentally get DULERA in your eyes, rinse your eyes with water and if redness or irritation continues, call your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation aerosol containing a combination of mometasone furoate (50, 100, or 200 mcg) and formoterol fumarate dihydrate (5 mcg) per actuation.

This medicine is available in fallowing brand namesː

• DULERA

What side effects can this medication cause?

The most common side effects of this medicine include:

• inflammation of the nose and throat (nasopharyngitis)
• inflammation of the sinuses (sinusitis)
• headache
• flu
• upper respiratory infection

DULERA may cause serious side effects, including:

• Thrush in the mouth and throat
• Immune system effects and a higher chance for infections
• Adrenal insufficiency
• Increased wheezing right after taking DULERA
• Serious allergic reactions
• Lower bone mineral density
• Slowed growth in children
• Eye problems including glaucoma, cataracts, and blurred vision
• Decreases in blood potassium levels (hypokalemia)
• Increases in blood sugar levels (hyperglycemia)

What special precautions should I follow?

• Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death.
• DULERA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. Do not initiate in acutely deteriorating asthma or to treat acute symptoms.
• As with other inhaled drugs containing beta2-adrenergic agents, DULERA 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.
• In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans have occurred in patients treated with DULERA. Monitor patients periodically for signs of adverse effects on the oral cavity. After dosing, advise patients to rinse their mouth with water and spit out contents without swallowing.
• Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. 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.
• Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to DULERA.
• Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue DULERA slowly.
• Caution should be exercised when considering the coadministration of DULERA with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to mometasone furoate may occur.
• DULERA may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. Immediate hypersensitivity reactions may occur after administration of DULERA, as demonstrated by cases of urticaria, flushing, allergic dermatitis, and bronchospasm. Discontinue DULERA and institute alternative therapy if paradoxical bronchospasm occurs.
• DULERA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
• Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate, one of the components of DULERA. Monitor patients with major risk factors for decreased bone mineral content.
• Orally inhaled corticosteroids, including DULERA, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving DULERA routinely (e.g., via stadiometry).
• Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of long-term administration of inhaled corticosteroids, including mometasone furoate, a component of DULERA. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use DULERA long term.
• Use with caution in patients with aneurysm, pheochromocytoma, convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
• Hypokalemia and hyperglycemia may occur. Be alert to hypokalemia and hyperglycemia.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Mometasone Furoate overdose:

• hypercorticism

Formoterol Fumarate overdose:

• angina
• hypertension or hypotension
• tachycardia
• arrhythmias
• nervousness
• headache
• tremor
• seizures
• muscle cramps
• dry mouth
• palpitation
• nausea
• dizziness
• fatigue
• malaise
• hypokalemia
• hyperglycemia
• insomnia
• Metabolic acidosis
• Cardiac arrest

Management of overdosage:

• Treatment of overdosage consists of discontinuation of DULERA together with institution of appropriate symptomatic and/or supportive therapy.
• TheUse of 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 DULERA.
• Cardiac monitoring is recommended in cases of overdosage.

Can this medicine be used in pregnancy?

• There are no randomized clinical studies of DULERA, mometasone furoate, or formoterol fumarate in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of DULERA have been established in patients 12 years of age and older.
• The safety and effectiveness of DULERA have not been established in children younger than 5 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredients: mometasone furoate and formoterol fumarate dihydrate
• Inactive ingredients: hydrofluoroalkane (HFA-227), anhydrous alcohol and oleic acid

Who manufactures and distributes this medicine?

• Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

• Manufactured by: Kindeva Drug Delivery Limited, Loughborough, United Kingdom.

What should I know about storage and disposal of this medication?

• Store DULERA at room temperature between 68°F to 77°F (20°C to 25°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 DULERA are under pressure.
• Do not puncture.
• Do not use or store near heat or open flame.
• Storage above 120°F may cause the canister to burst.
• Do not throw container into fire or incinerator.

• Dailymed label info on Mometasone furoate And Formoterol fumarate
• FDA Mometasone furoate And Formoterol fumarate

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