Serevent

Serevent is a prescription medication used to treat asthma, exercised-induced bronchospasm and chronic obstructive pulmonary disorder (COPD).

Serevent belongs to a group of drugs called beta agonists. It works by relaxing the muscles that surround the airways.

This medication comes in powder form and is inhaled via the mouth usually twice daily (morning and evening).

Common side effects of Serevent include rash, headache, nasal congestion and throat irritation.

Serevent is a prescription medication used to treat asthma, exercised-induced bronchospasm and chronic obstructive pulmonary disorder (COPD).

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

• Glaxo SmithKline Pharmaceuticals

Serevent can cause serious side effects, including:

• See “Serevent Precautions”
• serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling of the face, mouth, and tongue
  • breathing problems

• sudden breathing problems immediately after inhaling your medicine
• effects on heart
  • increased blood pressure
  • a fast or irregular heartbeat
  • chest pain

• effects on nervous system
  • tremor
  • nervousness

• changes in blood (sugar, potassium)

Common side effects of Serevent include:

Asthma in adults and children:

• headache
• nasal congestion
• bronchitis
• throat irritation
• runny nose
• flu

Chronic obstructive pulmonary disease:

• headache
• musculoskeletal pain
• throat irritation
• cough
• respiratory infection

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with Serevent. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Serevent and certain other medicines, especially those used to treat infections, may interact with each other. This may cause serious side effects.

Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.

Serevent can cause serious side effects, including:

1. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as Serevent have an increased risk of death from asthma problems. Call your healthcare provider if breathing problems worsen over time while using Serevent. You may need a different treatment.

Get emergency treatment

• breathing problems worsen quickly
• you use your rescue inhaler medicine, but it does not relieve your breathing problems

Do not take Serevent:

• to treat your asthma without an asthma medicine known as an inhaled corticosteroid
• if you are allergic to Serevent or any of the ingredients in Serevent 
• breathing problems worsen quickly, and you use your rescue inhaler medicine, but it does not relieve your breathing problems

2. Do not use Serevent as your only asthma medicine. Serevent must only be used with a long-term asthma-control medicine, such as an inhaled corticosteroid.

3. When your asthma is well controlled, your healthcare provider may tell you to stop taking Serevent. Your healthcare provider will decide if you can stop Serevent without loss of asthma control. You will continue taking your long-term asthma-control medicine, such as an inhaled corticosteroid.

4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Serevent, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your healthcare provider about all of your health conditions, including if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• are pregnant or planning to become pregnant. It is not known if Serevent may harm your unborn baby.
• are breastfeeding. It is not known if Serevent passes into your milk and if it can harm your baby.
• are allergic to Serevent any other medicines, or food products. 

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your healthcare provider if you are breastfeeding. It is not known if Serevent passes into your milk and if it can harm your baby.

See the step-by-step instructions for using the Serevent in the leaflet that comes with this medication. Do not use Serevent unless your healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions.

1. Shake well before using.
2. The action of Serevent Inhalation Aerosol may last up to 12 hours or longer. The recommended dosage (2 inhalations twice daily, morning and evening) should not be exceeded.
3. Serevent Inhalation Aerosol is not meant to relieve acute asthma or COPD symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist such as albuterol (the physician should provide the patient with such medication and instruct the patient in how it should be used).
4. Patients should not stop Serevent therapy for asthma or COPD without physician/provider guidance since symptoms may recur after discontinuation.
5. The physician should be notified immediately if any of the following situations occur, which may be a sign of seriously worsening asthma.
   • Decreasing effectiveness of inhaled, short-acting beta2-agonists
   • Need for more inhalations than usual of inhaled, short-acting beta2-agonists
   • Use of 4 or more inhalations per day of a short-acting beta2-agonist for 2 or more days consecutively
   • Use of more than one 200-inhalation canister of an inhaled, short-acting beta2-agonist (e.g., albuterol) in an 8-week period
6. Serevent Inhalation Aerosol should not be used as a substitute for oral or inhaled corticosteroids. The dosage of these medications should not be changed and they should not be stopped without consulting the physician, even if the patient feels better after initiating treatment with Serevent Inhalation Aerosol.
7. Patients should be cautioned regarding common adverse cardiovascular effects, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.
8. In patients receiving Serevent Inhalation Aerosol, other inhaled medications should be used only as directed by the physician.
9. When using Serevent Inhalation Aerosol to prevent exercise-induced bronchospasm, patients should take the dose at least 30 to 60 minutes before exercise.
10. Patients who are pregnant or nursing should contact the physician about the use of Serevent Inhalation Aerosol.
11. Effective and safe use of Serevent Inhalation Aerosol includes an understanding of the way that it should be administered.

Call your healthcare provider or get medical care right away if:

• your breathing problems worsen with Serevent 
• you need to use your rescue inhaler medicine more often than usual
• your rescue inhaler medicine does not work as well for you at relieving symptoms
• you need to use 4 or more inhalations of your rescue inhaler medicine for 2 or more days in a row
• you use 1 whole canister of your rescue inhaler medicine in 8 weeks’ time
• your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
• you have asthma and your symptoms do not improve after using Serevent regularly for 1 week.
• after a change in your asthma medicines you have any worsening of your asthma symptoms or an increase in the need for your rescue inhaler medicine. 

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as Serevent, the active ingredient in Serevent Diskus, increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of Serevent (Serevent Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving Serevent (13 deaths out of 13,176 patients treated for 28 weeks on Serevent versus 3 deaths out of 13,179 patients 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.

Because of this risk, use Serevent for the treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use Serevent only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Serevent) 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 Serevent for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

Pediatric and Adolescent Patients: Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA is recommended.