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Advair Diskus

Generic Name: fluticasone and salmeterol (Inhalation, oral/nebulization route)

floo-TIK-a-sone PROE-pee-oh-nate, sal-ME-ter-ol zye-NAF-oh-ate

Inhalation, oral/nebulization routeDisk

Long-acting beta 2-adrenergic agonists, such as salmeterol, one of the active ingredients in the fluticasone propionate/salmeterol inhalation powder, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe fluticasone propionate/salmeterol for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Data from a large placebo-controlled US study that compared the safety of salmeterol inhalation aerosol or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo) .

Long-acting beta 2-adrenergic agonists may increase the risk of asthma-related deaths. Therefore, when treating patients with asthma, fluticasone propionate/salmeterol inhalation powder should only be used for patients not adequately controlled on other asthma-controller medications or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies .

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

In Canada

  • Advair
  • Advair Inhalation Aerosol

Available Dosage Forms:

  • Aerosol Liquid
  • Disk
  • Aerosol Powder

Therapeutic Class: Antiasthma, Anti-Inflammatory/Bronchodilator Combination

Pharmacologic Class: Fluticasone

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Uses For Advair Diskus

Fluticasone and salmeterol is a combination of two medicines that are used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.

This medicine is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.

Inhaled fluticasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

Inhaled salmeterol is a long-acting bronchodilator and it belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) of the lungs. Salmeterol is different than other bronchodilators because it does not act quickly enough to relieve an asthma attack that has already started.

This medicine must be used with a short-acting medicine (e.g. albuterol) for an asthma attack or asthma symptoms that need immediate attention.

This medicine is available only with your doctor's prescription.

Before Using Advair Diskus

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluticasone and salmeterol combination in children older than 4 years of age. Safety and efficacy have not been established for children younger than 4 years old.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fluticasone and salmeterol in the elderly. However, elderly people who have cardiovascular disease may have increased chances of side effects from this medicine.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Alprenolol
  • Arotinolol
  • Atazanavir
  • Atenolol
  • Befunolol
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Brofaromine
  • Bucindolol
  • Bupranolol
  • Bupropion
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Clarithromycin
  • Clorgyline
  • Darunavir
  • Dilevalol
  • Esmolol
  • Furazolidone
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Itraconazole
  • Ketoconazole
  • Labetalol
  • Landiolol
  • Lazabemide
  • Levobetaxolol
  • Levobunolol
  • Linezolid
  • Mepindolol
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nefazodone
  • Nelfinavir
  • Nialamide
  • Nipradilol
  • Oxprenolol
  • Pargyline
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Procarbazine
  • Propranolol
  • Rasagiline
  • Ritonavir
  • Saquinavir
  • Selegiline
  • Sotalol
  • Talinolol
  • Telithromycin
  • Tertatolol
  • Timolol
  • Tipranavir
  • Toloxatone
  • Tranylcypromine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Erythromycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma attack or
  • Bronchospasm (difficulty with breathing), acute or
  • COPD flare-up or
  • Milk protein allergy, severe—Should not be used in patients with these conditions.
  • Chickenpox (including recent exposure) or
  • Measles or
  • Herpes simplex (virus) infection of the eye or
  • Infections (virus, bacteria, or fungus) or
  • Tuberculosis (active or history of)—Inhaled fluticasone can reduce the body's ability to fight off these infections.
  • Diabetes mellitus or
  • Ketoacidosis—Blood sugar levels may increase.
  • Eosinophilic conditions (Churg-Strauss syndrome) or
  • Heart or blood vessel disease or
  • High blood pressure or
  • Hyperthyroidism (overactive thyroid) or
  • Liver problems or
  • Seizures—May make these conditions worse.
  • Infection or
  • Stress or
  • Surgery or
  • Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.
  • Osteoporosis (bone disease)—Inhaled corticosteroids in high doses may make this condition worse.


Proper Use of fluticasone and salmeterol

This section provides information on the proper use of a number of products that contain fluticasone and salmeterol. It may not be specific to Advair Diskus. Please read with care.

Inhaled fluticasone and salmeterol is used to prevent asthma attacks and to treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your health care professional.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Do not stop using this medicine or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.

Inhaled fluticasone and salmeterol is used with a special inhaler that comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

To use the disposable inhaler for inhalation powder:

  • To open the inhaler, push the thumb grip away from you as far as it will go. You will hear a click and feel a snap. When open, the mouthpiece will appear.
  • Slide the mouthpiece lever away from you as far as it will go until it clicks. The inhaler is now ready to use. If you close the inhaler or push the lever again, you will lose medicine.
  • Turn your head away from the inhaler, and breathe out to the end of a normal breath. Do not breathe into the inhaler.
  • Holding the inhaler level, put the mouthpiece between your lips and teeth, and close your lips around the mouthpiece. Do not bite down on the mouthpiece. Do not block the mouthpiece with your teeth or tongue.
  • Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.
  • Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
  • Turn your head away from the inhaler, and breathe out slowly to the end of a normal breath. Do not breathe into the inhaler.
  • If your doctor has told you to inhale more than one puff of medicine at each dose, take the second puff following exactly the same steps you used for the first puff.
  • When you are finished, close the inhaler. Place your thumb on the thumb grip, and slide it back toward you as far as it will go. You will hear it click shut.
  • Keep the inhaler dry. Do not wash the mouthpiece, or any other part of the inhaler. You may use a dry cloth to wipe it clean.
  • The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 5 to 0 will show up in red to remind you to refill your prescription.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For powder for inhalation:
    • For bronchial asthma:
      • Adults and children 4 years of age and older—One inhalation twice a day, about 12 hours apart.
      • Children up to 4 years of age—Use and dose must be determined by your doctor.
    • For chronic obstructive pulmonary disease (COPD) with chronic bronchitis or emphysema:
      • Adults—One inhalation (250/50) twice a day, about 12 hours apart.
      • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Advair Diskus

Check with your doctor if your asthma symptoms do not improve or your condition worsens. Check with your doctor if you notice:

  • Your short-acting inhaler does not seem to work as well as it used to.
  • You need to use your short-acting inhaler more often.
  • You have a significant decrease in your peak flow when measured as directed by your doctor.

Do not use this medicine to treat wheezing that is getting worse. Call your doctor right away if wheezing worsens while using this medicine.

If you are using this medicine twice a day, do not use other asthma medicine or medicine for breathing problems, such as budesonide and formoterol combination (Symbicort®), formoterol (Perforomist™), or arformoterol (Brovona®).

Although this medicine decreases the number of asthma episodes, these medicines may increase the chances of a severe asthma episode when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

Patients with COPD may be more likely to have pneumonia. Call your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.

Advair Diskus Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Black, tarry stools
  • blindness
  • blurred vision
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • chills
  • cough
  • decreased vision
  • difficulty breathing or swallowing
  • eye pain
  • fast heartbeat
  • fever
  • headache
  • hives or welts
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea or vomiting
  • noisy breathing
  • painful or difficult urination
  • sensation of pins and needles
  • shortness of breath
  • skin itching, rash, or redness
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • stabbing pain in extremities
  • swelling of face, throat, or tongue
  • swollen glands
  • tearing
  • unusual bleeding or bruising
  • wheezing
Incidence not known
  • Abdominal or stomach pain
  • backache
  • bruising
  • darkening of skin
  • decrease in height
  • diarrhea
  • difficulty with moving
  • dizziness
  • facial hair growth in females
  • fainting
  • fast, slow, or irregular heartbeat
  • flushed, dry skin
  • fractures
  • fruit-like breath odor
  • full or round face, neck, or trunk
  • heavy bleeding
  • increased hunger
  • increased thirst or urination
  • irritability
  • large, flat, blue or purplish patches in the skin
  • loss of sexual desire or ability
  • mental depression
  • menstrual irregularities
  • muscle pain or stiffness
  • muscle wasting
  • pain in back, ribs, arms, or legs
  • pain in joints
  • palpitations
  • sweating
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Chest pain or tightness
  • confusion
  • convulsions (seizures)
  • decreased urine output
  • dry mouth
  • faintness, or light-headedness when getting up from a lying or sitting position suddenly
  • general feeling of discomfort or illness
  • high blood pressure
  • loss of appetite
  • mood changes
  • nervousness
  • numbness or tingling in hands, feet, or lips
  • sudden sweating
  • tremors
  • trouble with sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Body aches or pain
  • choking
  • congestion
  • dryness of throat
  • high-pitched noise when breathing
  • hoarseness
  • runny nose
  • sneezing
  • trouble in swallowing
  • voice changes
Less common
  • Cough-producing mucus
  • flu-like symptoms
  • irritation or inflammation of eye
  • muscle pain
  • pain or tenderness around eyes and cheekbones
  • sleep disorders
  • stuffy nose
  • white patches in the mouth or throat or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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