Serevent Diskus

Serevent is a long-acting beta2-adrenoceptor agonist (LABA) bronchodilator. It works by helping the muscles around the airways in your lungs stay relaxed to improve breathing.

Serevent Diskus is used to prevent asthma attacks or exercise-induced bronchospasm. It is also used to treat chronic obstructive pulmonary disease (COPD) including emphysema and chronic bronchitis.

Serevent Diskus is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

Do not use Serevent Diskus to treat an asthma attack that has already begun.

Serevent Diskus may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using this medicine.

If you use Serevent Diskus for asthma, you must use it together with an inhaled steroid medicine for long-term asthma control. Seek medical attention if you think any of your asthma medications are not working as well as usual.

Do not use a second form of salmeterol (such as Advair) or use a similar inhaled bronchodilator such as formoterol or arformoterol (Foradil, Perforomist, Symbicort, or Brovana) unless your doctor has told you to.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

You should not use Serevent Diskus if you are allergic to salmeterol or to milk proteins.

To make sure Serevent Diskus is safe for you, tell your doctor if you have ever had:

• a food or drug allergy;
• heart disease or high blood pressure;
• epilepsy or other seizure disorder;
• diabetes;
• a thyroid disorder; or
• liver disease.

It is not known whether salmeterol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Serevent Diskus can increase the risk of asthma-related hospitalization in children and teenagers. It is very important that children using this medicine for asthma use it together with another long-term asthma control medication.

Do not give Serevent Diskus to a child younger than 4 years old.

Get emergency medical help if you have signs of an allergic reaction to Serevent: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening asthma symptoms, or other breathing problems after using Serevent;
• severe headache, blurred vision, pounding in your neck or ears;
• chest pain, fast or irregular heartbeats;
• tremors, nervousness;
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or
• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Serevent side effects may include:

• headache;
• flu symptoms;
• joint or muscle pain;
• throat irritation, cough; or
• stuffy or runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use Serevent Diskus exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Serevent may increase the risk of asthma-related death.

Serevent Diskus is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Serevent Diskus is a powder form of salmeterol inhalation that comes with a special inhaler device preloaded with blister packs containing measured doses of the medicine. The device opens and loads a blister each time you use the inhaler. This device is not to be used with a spacer.

Use Serevent Diskus regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you use Serevent Diskus for asthma, you must use it together with an inhaled steroid medicine for long-term asthma control. Use all asthma medications as directed. Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your dose or dosing schedule without your doctor's advice.

Call your doctor if your symptoms do not improve after 7 days.

Do not stop using Serevent Diskus without first talking to your doctor. Your asthma symptoms may get worse after you stop using the medication.

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

Do not try to clean or take apart the Diskus device. Throw it away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first. Each Diskus device contains 60 doses.

Store at room temperature away from moisture, heat, and sunlight.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not exhale or blow into the Diskus device. Do not take the device apart or allow it to get wet.

Do not use a second form of salmeterol (such as Advair) or similar inhaled bronchodilator unless your doctor tells you to. This includes formoterol (Perforomist, Symbicort, Bevespi, Dulera), arformoterol (Brovana), indacaterol (Arcapta), olodaterol (Striverdi, Stiolto Respimat), or vilanterol (Anoro Ellipta, Breo Ellipta, Trelegy Ellipta).

Tell your doctor about all your current medicines. Many drugs can interact with salmeterol, especially:

• nefazodone;
• an antibiotic - clarithromycin, telithromycin;
• antifungal medicine - itraconazole, ketoconazole;
• antiviral medicine to treat HIV/AIDS - indinavir, nelfinavir, ritonavir, saquinavir;
• heart or blood pressure medicine - such as a diuretic ("water pill"), or a beta-blocker (atenolol, carvedilol, labetalol, metoprolol, propranolol, sotalol, timolol, and others); or
• a MAO inhibitor - isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

This list is not complete and many other drugs may interact with salmeterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.