Advair HFA

Name: Advair HFA

Uses of Advair HFA

 

Advair HFA is a prescription medication used to treat asthma, a disease involving inflammation and swelling of the airways.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

 

Advair HFA FDA Warning

 

Black Box Warning: Asthma-related death

Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in Advair HFA, increase the risk of asthma-related death. A US trial showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 out of 13,179 subjects on placebo). 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, only prescribe Advair HFA 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 HFA) 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 HFAfor patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

 

What is Advair HFA (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 HFA (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.

What other drugs will affect Advair HFA (fluticasone and salmeterol)?

Many drugs can interact with this medicine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antidepressant, heart or blood pressure medicine, a diuretic or "water pill";

  • antifungal medicine such as ketoconazole; or

  • ritonavir (Norvir) or lopinavir/ritonavir (Kaletra).

This list is not complete and many other drugs can interact with fluticasone and salmeterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

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 HFA. 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 doctor.

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

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using 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.

When you use the Advair® HFA inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine four times into the air away from the face, and shaking it well for 5 seconds before each spray. Avoid spraying it in your eyes.

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.

To use the Diskus®:

  • Open the foil pouch containing the Diskus®.
  • To open the Diskus®, 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 Diskus® is now ready to use. If you close the Diskus® or push the lever again, you will lose medicine.
  • Turn your head away from the Diskus®, and breathe out to the end of a normal breath. Do not breathe into the Diskus®.
  • Holding the Diskus® 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 Diskus®, and breathe out slowly to the end of a normal breath. Do not breathe into the Diskus®.
  • 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 Diskus®. 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 Diskus® dry. Do not wash the mouthpiece, or any other part of the Diskus®. You may use a dry cloth to wipe it clean.
  • The Diskus® has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the Diskus® has 5 doses left, the numbers from 5 to 0 will show up in red to remind you to refill your prescription.

To use the Advair® HFA inhaler:

  • Take the inhaler out of the pouch before you use it for the first time.
  • Do not use the inhaler for this medicine with any other medicine.
  • Remove the cap and look at the mouthpiece to make sure it is clean.
  • Prime the inhaler before use by shaking the inhaler well and then releasing 4 test sprays.
  • To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
  • While pressing down firmly and fully on the purple top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
  • Wait for 30 seconds and repeat these steps for the next puff, starting with shaking the inhaler.
  • Gargle and rinse your mouth with water after each dose; this will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.
  • Replace the mouthpiece cover after using the medicine.
  • 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 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the count is 000. You may not receive the right amount of medicine.

To use the Airduo™ Respiclick®:

  • Take the inhaler out of the pouch before you use it for the first time.
  • Do not use the inhaler for this medicine with any other medicine.
  • This medicine does not require priming. Do not use it with a spacer or volume holding chamber.
  • Hold the inhaler upright and open the yellow cap all the way until it clicks. Do not open the yellow cap until you are ready to take a dose of this medicine.
  • To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue. Do not block the vent above the mouthpiece with your lips or fingers.
  • Breathe in through your mouth quickly and deeply as you can until you have taken a full deep breath. Hold your breath for about 10 seconds.
  • Close the yellow cap after each inhalation. Rinse your mouth with water without swallowing after each inhalation.
  • Keep the inhaler dry and clean at all times. Gently wipe the mouthpiece with a dry cloth or tissue as needed.
  • 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 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the dose counter displays 0, 30 days after opening the pouch.

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 inhalation dosage form (aerosol liquid):
    • For preventing an asthma attack:
      • Adults and children 12 years of age and older—2 puffs in the morning and another 2 puffs in the evening. The doses should be at least 12 hours apart.
      • Children younger than 12 years of age—Use and dose must be determined by your child's doctor.
  • For inhalation dosage form (aerosol powder):
    • Advair® Diskus®:
      • For preventing an asthma attack:
        • Adults and children 4 years of age and older—1 inhalation 2 times per day (morning and evening). The doses should be at least 12 hours apart.
        • Children younger than 4 years of age—Use and dose must be determined by your doctor.
      • For maintenance treatment of COPD:
        • Adults—1 inhalation (250/50) 2 times per day (morning and evening). The doses should be at least 12 hours apart.
        • Children—Use and dose must be determined by your doctor.
    • Airduo™ Respiclick®:
      • For treatment of asthma:
        • Adults and children 12 years of age and older—1 inhalation 2 times per day (morning and evening). The doses should be at least 12 hours apart. Do not use it more than 2 times every 24 hours.
        • Children younger than 12 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of Airduo™ Respiclick®, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

What should i avoid while using fluticasone and salmeterol (advair diskus, advair hfa)?

Do not use a second form of salmeterol (such as Serevent) or use a similar inhaled bronchodilator such as formoterol (Foradil) unless your doctor has told you to.

Fluticasone and salmeterol can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicines.

  • Allergy Drugs: Prescription and OTC
  • Asthma in Children

For Healthcare Professionals

Applies to fluticasone / salmeterol: inhalation aerosol, inhalation powder

General

The most common events that occurred more frequently were nasopharyngitis, upper respiratory tract infection, nasal congestion, back pain, sinusitis, dizziness, nausea, pneumonia, candidiasis, and dysphonia.[Ref]

Nervous system

Very common (10% or more): Headache (up to 21%)
Common (1% to 10%): Migraine
Uncommon (0.1% to 1%): Tremor
Postmarketing reports: Paraesthesia, restlessness, compressed nerve syndrome, aphonia[Ref]

Respiratory

The incidence of pneumonia was higher in adult subjects with COPD older than 65 years compared with younger subjects with COPD (18% versus 14%).[Ref]

Very common (10% or more): Upper respiratory tract infections (up to 27%), pharyngitis (up to 13%), nasopharyngitis
Common (1% to 10%): Pneumonia, bronchitis, throat irritation, hoarseness, dysphonia, sinusitis, upper respiratory inflammation, viral respiratory infections, cough, rhinorrhea/postnasal drip, epistaxis, nasal congestion/blockage, laryngitis, unspecified oropharyngeal plaques, dryness of nose, lower respiratory signs and symptoms, lower respiratory infections, lower respiratory hemorrhage, congestion
Uncommon (0.1% to 1%): Dyspnea
Rare (less than 0.1%): Oropharyngeal angioedema, bronchospasm, paradoxical bronchospasm
Frequency not reported: Nose, and throat infections, laryngitis, nasal sinus disorders, nasal sinus disorders
Postmarketing reports: Paranasal sinus pain, rhinitis, throat soreness, tonsillitis, asthma, asthma exacerbation, chest congestion, chest tightness, tracheitis, wheezing, report of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or chocking[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, tachycardia, arrhythmias, myocardial infarction, postoperative complications
Uncommon (0.1% to 1%): Atrial fibrillation, angina pectoris
Rare (less than 0.1%): Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles)
Frequency not reported: Hematomas
Postmarketing reports: Ventricular tachycardia, pallor[Ref]

Dermatologic

Common (1% to 10%): Contusions, wounds, eczema, dermatitis, dermatosis
Frequency not reported: Skin flakiness and acquired ichthyosis, disorders of sweat and sebum
Postmarketing reports: Ecchymoses, photodermatitis[Ref]

Gastrointestinal

Common (1% to 10%): Oral and throat candidiasis, nausea and vomiting, gastrointestinal discomfort and pain, dental discomfort and pain, hyposalivation, gastrointestinal infections, disorders of hard tissue of teeth, abdominal discomfort and pain, oral abnormalities, gastrointestinal discomfort and pain, viral gastrointestinal infections, diarrhea
Rare (less than 0.1%): Esophageal candidiasis
Frequency not reported: Oral lesions
Postmarketing reports: Oral ulcerations, dyspepsia, xerostomia[Ref]

Immunologic

Common (1% to 10%): Allergies and allergic reactions[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, weight gain
Uncommon (0.1% to 1%): Hyperglycemia
Frequency not reported: Fluid retention[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramps, traumatic fractures, arthralgia, myalgia, arthralgia, articular rheumatism, muscle spasms, musculoskeletal inflammation, bone and skeletal pain, muscle injuries, soft tissue injuries
Postmarketing reports: Muscle stiffness, tightness and rigidity, bone and cartilage disorders, myositis, osteoporosis, fractures[Ref]

Ocular

Common (1% to 10%): Allergic eye disorders, eye edema and swelling
Uncommon (0.1% to 1%): Cataract
Rare (less than 0.1%): Glaucoma
Frequency not reported: Dry eyes, eye infections, keratitis, conjunctivitis[Ref]

Other

Common (1% to 10%): Candidiasis unspecified site, ear signs and symptoms, viral infections, bacterial infections, inflammation, bacterial reproductive infections
Rare (less than 0.1%): Angioedema, facial angioedema
Frequency not reported: Syncope, edema and swelling, dysmenorrhea, pain, unusual taste, lacerations
Postmarketing reports: Ear ache, fever[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Cutaneous hypersensitivity reactions
Rare (less than 0.1%): Anaphylactic reactions including anaphylactic shock[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, sleep disorders
Rare (less than 0.1%): Behavioral changes, including psychomotor hyperactivity and irritability (predominately in children)
Frequency not reported: Depression, aggression (predominantly in children)
Postmarketing reports: Agitation[Ref]

Endocrine

Rare (less than 0.1%): Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease bone mineral density
Frequency not reported: Hypothyroidism
Postmarketing reports: Hypercorticism[Ref]

Hepatic

Frequency not reported: Abnormal liver function tests[Ref]

Some side effects of Advair HFA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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