Advair Diskus

Name: Advair Diskus

Indications

Treatment Of Asthma

ADVAIR DISKUS is indicated for the treatment of asthma in patients aged 4 years and older.

LABA, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, 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 [see WARNINGS AND PRECAUTIONS]. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS 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 a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue ADVAIR DISKUS) 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 ADVAIR DISKUS for patients whose asthma is adequately controlled on low-or medium-dose inhaled corticosteroids.

Important Limitation Of Use

ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.

Maintenance Treatment Of Chronic Obstructive Pulmonary Disease

ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. ADVAIR DISKUS 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated.

Important Limitation Of Use

ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.

How supplied

Dosage Forms And Strengths

Inhalation Powder. Inhaler containing a foil blister strip of powder formulation for oral inhalation. The strip contains a combination of fluticasone propionate 100, 250, or 500 mcg and salmeterol 50 mcg per blister.

Storage And Handling

ADVAIR DISKUS 100/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0695-00). ADVAIR DISKUS 100/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0695-04).

ADVAIR DISKUS 250/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0696-00). ADVAIR DISKUS 250/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0696-04).

ADVAIR DISKUS 500/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0697-00). ADVAIR DISKUS 500/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0697-04).

Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.

ADVAIR DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard ADVAIR DISKUS 1 month after opening the foil pouch or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

GlaxoSmithKline Research Triangle Park, NC 27709. Revised: April 2016

Advair Diskus Usage

Take Advair Diskus exactly as prescribed.

Advair Diskus comes in an inhaler form and is used twice a day, in the morning and evening, about 12 hours apart.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Advair Diskus at the same time.

Advair Diskus Inhaler Instructions:

  • Write the date you opened the foil pouch in the first blank line on the label.
  • Write the "use by" date in the second blank line on the label, which is 1 month after the date you wrote on the first line.
  • The counter should read 60. If you have a sample or institutional pack, then the counter should read 14.

Follow these instructions each time you use your inhaler:

  • Open your Advair Diskus by holding it in your left hand and placing the thumb of your right hand in the thumb grip. Push the thumb grip away from you as far as it will go until the mouthpiece shows and snaps into place.
  • Slide the lever until you hear it click. Hold the inhaler in a level, flat position with the mouthpiece towards you. Slide the lever away from the mouthpiece as far as it will go until it clicks. The number on the counter will count down by 1, and it is now ready to use.
  • Do not close the inhaler, do not tilt the inhaler, and do not move the lever on the inhaler so that you do not accidentally waste a dose.
  • Before you breathe in your dose from the inhaler, breathe out (exhale) as long as you can while you hold the inhaler level and away from your mouth. Do not breathe into the mouthpiece.
  • Put the mouthpiece to your lips, and breathe in quickly and deeply through the inhaler. Do not breathe in through your nose.
  • Remove the inhaler from your mouth and hold your breathe for about 10 seconds, or for as long as is comfortable for you. Breathe out slowly as long as you can.
  • The inhaler delivers your dose of medicine as a very fine powder that you may or may not taste or feel. Do not take an extra dose from the inhaler even if you do not taste or feel the medicine.
  • Close the inhaler by placing your thumb in the thumb grip and slide it back towards you as far as it will go. Make sure the inhaler clicks shut, and you cannot see the mouthpiece.
  • Rinse your mouth with water after breathing in the medicine, and spit out the water. Do not swallow the water.
  • After you have taken 55 doses (9 doses from the sample or institutional pack), it is time to get a refill from your pharmacy.

Advair Diskus Dosage

Take this medication exactly as prescribed by your doctor.  Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

The recommended dose of Advair Diskus for the treatment of asthma in people 4 years of age and older is 1 inhalation twice a day, in the morning and evening, about 12 hours apart.

The recommended dose of Advair Diskus for the treatment of COPD in adults is 1 inhalation twice a day, in the morning and evening, about 12 hours apart.

 

 

What is Advair Diskus (fluticasone and salmeterol)inhalation?

Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation. Salmeterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Fluticasone and salmeterol inhalation is a combination medicine used to prevent asthma attacks. It is also used to prevent flare-ups or worsening of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and/or emphysema.

In people with COPD, fluticasone and salmeterol is for long-term treatment. In people with asthma, this medicine is for short-term treatment until symptoms are well controlled with with other medicines.

Advair Diskus is for use in adults and children who are at least 4 years old. Advair HFA and AirDuo Respiclick are for use in adults and children who are at least 12 years old.

Fluticasone and salmeterol may also be used for purposes not listed in this medication guide.

How should I use Advair Diskus (fluticasone and salmeterol)?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Using too much of this medicine can cause life-threatening side effects.

Fluticasone and salmeterol is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast-acting inhalation medicine for an asthma attack.

Seek medical attention if you think your medications are not working as well.

Advair Diskus is a powder form of fluticasone and salmeterol that comes with a special inhaler device pre-loaded with blister packs containing measured doses of the medicine. The device opens and loads a blister each time you use the inhaler.

Advair HFA and AirDuo Respiclick each come in a canister that is used with an actuator inhaler device.

Use only the inhaler device provided with your medication.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Shake the Advair HFA inhaler for at least 5 seconds before each spray.

Rinse your mouth with water after each use of your inhaler.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

While using fluticasone and salmeterol, your vision and your bone mineral density may need to be checked often.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

Store your medicine at room temperature away from moisture, light, and heat (especially high heat, such as open flame or in a car on a hot day).

Throw the inhaler device away 1 month after you took it out of the foil pouch, or if the dose indicator shows a zero (even if it feels like there is still medicine inside).

Once your asthma is under control, your doctor may want you to stop using this medicine. Keep all follow-up appointments and do not stop using the medicine unless your doctor tells you to.

Commonly used brand name(s)

In the U.S.

  • Advair Diskus
  • Advair Diskus 100/50
  • Advair Diskus 250/50
  • Advair Diskus 500/50
  • Advair HFA
  • Advair HFA 115/21
  • Advair HFA 230/21
  • Advair HFA 45/21
  • Airduo Respiclick

In Canada

  • Advair
  • Advair Inhalation Aerosol

Available Dosage Forms:

  • Powder
  • Aerosol Liquid
  • Disk
  • Aerosol Powder

Therapeutic Class: Antiasthma, Anti-Inflammatory/Bronchodilator Combination

Pharmacologic Class: Fluticasone

What are some things I need to know or do while I take Advair Diskus?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • It may take 1 week to see the full effect.
  • If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
  • Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
  • When changing from an oral steroid to another form of a steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your doctor right away if you have any of these signs. If you have a bad injury, have surgery, or any type of infection, you may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you may need extra steroids.
  • Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
  • Have your eye pressure checked if you are on this medicine (Advair Diskus) for a long time. Talk with your doctor.
  • This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this medicine. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
  • Do not take more of this medicine (Advair Diskus) or use it more often than you have been told. Deaths have happened when too much of this type of drug has been taken. Talk with your doctor.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Use with care in children. Talk with the doctor.
  • This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (Advair Diskus) while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

COPD:

  • The chance of getting pneumonia is higher in people with COPD. This medicine may raise the chance of getting pneumonia. Talk with the doctor.

Advair Diskus Dosage and Administration

Advair Diskus should be administered as 1 inhalation twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) of the prescribed strength of Advair Diskus is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using Advair Diskus should not use additional LABA for any reason. [See Warnings and Precautions (5.3, 5.12).]

Asthma

If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Adult and Adolescent Patients Aged 12 Years and Older

For patients aged 12 years and older, the dosage is 1 inhalation twice daily, approximately 12 hours apart.

The recommended starting dosages for Advair Diskus for patients aged 12 years and older are based upon patients’ asthma severity.

The maximum recommended dosage is Advair Diskus 500/50 twice daily.

Improvement in asthma control following inhaled administration of Advair Diskus can occur within 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of Advair Diskus with a higher strength may provide additional improvement in asthma control.

If a previously effective dosage regimen fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the current strength of Advair Diskus with a higher strength, adding additional inhaled corticosteroid, initiating oral corticosteroids) should be considered.

Pediatric Patients Aged 4 to 11 Years

For patients with asthma aged 4 to 11 years who are not controlled on an inhaled corticosteroid, the dosage is 1 inhalation of Advair Diskus 100/50 twice daily, approximately 12 hours apart.

Chronic Obstructive Pulmonary Disease

The recommended dosage for patients with COPD is 1 inhalation of Advair Diskus 250/50 twice daily, approximately 12 hours apart.

If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Drug Interactions

Advair Diskus has been used concomitantly with other drugs, including short-acting beta2-agonists, methylxanthines, and intranasal corticosteroids, commonly used in patients with asthma or COPD without adverse drug reactions [see Clinical Pharmacology (12.2)]. No formal drug interaction trials have been performed with Advair Diskus.

Inhibitors of Cytochrome P450 3A4

Fluticasone propionate and salmeterol, the individual components of Advair Diskus, are substrates of CYP3A4. The use of strong 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.

Ritonavir

Fluticasone Propionate: A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology (12.3)]. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

Ketoconazole

Fluticasone Propionate: Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

Salmeterol: In a drug interaction trial in 20 healthy subjects, coadministration of inhaled salmeterol (50 mcg twice daily) and oral ketoconazole (400 mg once daily) for 7 days resulted in greater systemic exposure to salmeterol (AUC increased 16-fold and Cmax increased 1.4-fold). Three (3) subjects were withdrawn due to beta2-agonist side effects (2 with prolonged QTc and 1 with palpitations and sinus tachycardia). Although there was no statistical effect on the mean QTc, coadministration of salmeterol and ketoconazole was associated with more frequent increases in QTc duration compared with salmeterol and placebo administration.

Monoamine Oxidase Inhibitors and Tricyclic Antidepressants

Advair Diskus should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol, a component of Advair Diskus, on the vascular system may be potentiated by these agents.

Beta-adrenergic Receptor Blocking Agents

Beta-blockers not only block the pulmonary effect of beta-agonists, such as salmeterol, a component of Advair Diskus, but may also produce severe bronchospasm in patients with asthma or COPD. Therefore, patients with asthma or COPD should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.

Non–Potassium-Sparing Diuretics

The ECG changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, such as salmeterol, a component of Advair Diskus, 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 Advair Diskus with non–potassium-sparing diuretics.

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