Fluticasone/salmeterol

What is Fluticasone/salmeterol?

• Fluticasone/salmeterol (Advair Diskus; Advair HFA ; AirDuo Respiclick) is a combination product containing a corticosteroid and a LABA used in the management of asthma and chronic obstructive pulmonary disease (COPD).

Fluticasone propionate

Salmeterol

What are the uses of this medicine?

Fluticasone/salmeterol (Advair Diskus; Advair HFA ; AirDuo Respiclick) is used for:

• Treatment of asthma in patients aged 4 years and older.
• Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

Limitations of use:

• Not indicated for the relief of acute bronchospasm.

How does this medicine work?

• Advair Diskus combines an inhaled corticosteroid medicine, fluticasone propionate (the same medicine found in FLOVENT®), and a LABA medicine, salmeterol (the same medicine found in SEREVENT®).
• Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms.
• LABA medicines are used in people with asthma and chronic obstructive pulmonary disease (COPD). LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. In severe cases, wheezing can stop your breathing and cause death if not treated right away.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• to treat sudden, severe symptoms of asthma or COPD and
• if you have a severe allergy to milk proteins.

What drug interactions can this medicine cause?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be sure to mention if you are taking any of the following: certain antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole beta-blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal) clarithromycin (Biaxin, in Prevpac) diuretics ('water pills') HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase) other medications for asthma or COPD medications for seizures metronidazole (Flagyl) nefazodone telithromycin (Ketek; no longer available in U.S.)

Also tell your doctor and pharmacist if you are taking the following medications or have stopped taking them during the past 2 weeks:

• antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).

Is this medicine FDA approved?

• The combination was approved for medical use in the United States in 2000. A generic version was approved in the United States in 2019.

How should this medicine be used?

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

• 1 inhalation of Advair Diskus 100/50, 250/50, or 500/50 twice daily.
• Starting dosage is based on asthma severity.

Treatment of asthma in patients aged 4 to 11 years:

• 1 inhalation of Advair Diskus 100/50 twice daily.

Maintenance treatment of COPD:

• 1 inhalation of Advair Diskus 250/50 twice daily.

Administration:

• The combination of fluticasone and salmeterol comes as a powder and as an inhalation solution to inhale by mouth using a specially designed inhaler.
• It is usually used twice a day, in the morning and evening, about 12 hours apart.
• Use fluticasone and salmeterol at around the same times every day.
• While you are using Advair Diskus 2 times each day, do not use other medicines that contain a LABA for any reason
• Advair Diskus does not relieve sudden symptoms.
• Always have a rescue inhaler medicine with you to treat sudden symptoms.
• If you do not have an inhaled, short-acting bronchodilator, call your healthcare provider to have one prescribed for you.

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

This medicine is available in fallowing doasage form:

• As DISKUS device containing a combination of fluticasone propionate (100, 250, or 500 mcg) and salmeterol (50 mcg) as an oral inhalation powder.

This medicine is available in fallowing brand namesː

• Advair Diskus; Advair HFA ; AirDuo Respiclick

What side effects can this medication cause?

The most common side effects of this medicine include: In Asthma:

• upper respiratory tract infection
• throat irritation
• hoarseness and voice changes
• thrush in the mouth and throat
• bronchitis
• cough
• headache
• nausea and vomiting
• In children with asthma, infections in the ear, nose, and throat are common.

In COPD:

• thrush in the mouth and throat
• throat irritation
• hoarseness and voice changes
• viral respiratory infections
• headache
• muscle and bone pain

Advair Diskus can cause serious side effects, including:

• serious allergic reactions
• sudden breathing problems immediately after inhaling your medicine
• effects on heart
• effects on nervous system
• reduced adrenal function
• changes in blood
• weakened immune system and a higher chance of infections
• lower bone mineral density
• eye problems including glaucoma and cataracts
• slowed growth in children
• pneumonia

What special precautions should I follow?

• LABAs, such as salmeterol, one of the active ingredients in Advair Diskus, increase the risk of asthma-related death. Prescribe only for recommended patient populations.
• Advair Diskus should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Do not initiate in acutely deteriorating asthma or to treat acute symptoms.
• As with other inhaled drugs containing beta2-adrenergic agents, Advair Diskus should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABAs, as an overdose may result.
• The development of localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with Advair Diskus. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth following inhalation.
• Development of pneumonia in patients with COPD may occur. Monitor patients for signs and symptoms of pneumonia.
• Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
• Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids. Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to Advair Diskus.
• Fluticasone propionate, a component of Advair Diskus, will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone.
• The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Advair Diskus is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur
• Advair Diskus can produce paradoxical bronchospasm, which may be life threatening. Discontinue Advair Diskus and institute alternative therapy if paradoxical bronchospasm occurs.
• Immediate hypersensitivity reactions may occur after administration of Advair Diskus. Therefore, patients with severe milk protein allergy should not take Advair Diskus.
• 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. Use with caution because of beta-adrenergic stimulation.
• Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. Assess bone mineral density initially and periodically thereafter.
• Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor growth of pediatric patients.
• Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD. Close monitoring is warranted.
• In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions. Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia.
• Advair Diskus, like all medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
• Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.

What to do in case of emergency/overdose?

Symptoms of overdose may include: Fluticasone Propionate overdose: hypercorticism

Salmeterol overdose:

• seizures, angina, hypertension or hypotension, prolongation of the QTc interval, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.
• cardiac arrest and even death may be associated with abuse of salmeterol.

Management of overdosage: In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies with Advair Diskus in pregnant women.
• Advair Diskus should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Use of Advair Diskus 100/50 in patients aged 4 to 11 years have been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• fluticasone propionate, salmeterol xinafoate

Inactive ingredient:

• lactose (contains milk proteins)

Who manufactures and distributes this medicine?

• ADVAIR, Advair Diskus, DISKHALER, DISKUS, FLONASE, FLOVENT, ROTADISK, SEREVENT, and VENTOLIN are registered trademarks of GlaxoSmithKline.
• GlaxoSmithKline
• Research Triangle Park, NC

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

• Store Advair Diskus at room temperature between 68° to 77° F (20° to 25° C). Keep in a dry place away from heat and sunlight.
• Safely discard Advair Diskus 1 month after you remove it from the foil pouch, or after the dose indicator reads “0”, whichever comes first.

• Dailymed label info on Fluticasone/salmeterol
• FDA Fluticasone/salmeterol

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