What is the most important information I should know about Serevent?

• Data from a large study of people using Serevent has shown a small but significant increased risk of asthma-related deaths. Discuss with your doctor the risks and benefits of using Serevent before starting treatment.
• Do not use Serevent more often than is prescribed by your doctor. Doing so could seriously affect the heart and could even lead to death. Generally, Serevent should not be used more often than every 12 hours.
• Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.
• Serevent is a long-acting medication used to treat chronic asthma. It does not treat acute asthma attacks.
• Do not substitute Serevent for any of your other asthma medications, especially if you are having an acute asthma attack.
• It is very important to use the Serevent inhaler properly, so that the medicine gets into the lungs. Your doctor may want you to use a spacer with the inhaler. (A spacer should not be used with the Serevent Diskus inhaler.) Talk to your doctor about proper inhaler use.

What is Serevent?

• Serevent is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.
• Serevent is used to treat asthma. It is used only to prevent asthma attacks, not to treat an attack already in progress. It will not work fast enough to give relief during an attack. Serevent is also used in the treatment of chronic obstructive pulmonary disease (COPD) including emphysema and chronic bronchitis.
• Serevent may also be used for conditions other than those listed in this medication guide.

What should I discuss with my healthcare provider before using Serevent?

• Data from a large study of people using Serevent has shown a small but significant increased risk of asthma-related deaths. Discuss with your doctor the risks and benefits of using Serevent before starting treatment.
• Before using this medication, tell your doctor if you have
  • heart disease or high blood pressure;
  • irregular heartbeats;
  • epilepsy or another seizure disorder;
  • diabetes;
  • an overactive thyroid (hyperthyroidism);
  • liver disease; or
  • kidney disease.
• You may require a dosage adjustment or special monitoring during therapy if you have any of the conditions listed above.
• Serevent is in the FDA pregnancy category C. This means that it is not known whether Serevent will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• It is not known whether Serevent passes into breast milk. Do not use Serevent without first talking to your doctor if you are breast-feeding a baby.
• Serevent inhalation aerosol is approved for use by children 12 years of age and older. Serevent Diskus is approved for use by children 4 years of age and older.

How should I use Serevent?

• Use Serevent exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• If you are using Serevent to prevent exercise-induced asthma, take a dose 30 to 60 minutes before exercising, or as directed by your doctor. Another dose should not be taken for at least 12 hours.
• To use the inhaler:
  • Shake the inhaler several times and uncap the mouthpiece. Breathe out fully. For best results, hold the inhaler 1 to 2 inches in front of your open mouth or attach a spacer to the inhaler and place the spacer in your mouth, above your tongue and past your teeth. Take a deep, slow breath as you push down on the canister. Hold your breath for 10 seconds, then exhale slowly. If you place your inhaler directly into your mouth, you may not receive the correct amount of medicine because it will be propelled onto the back of your tongue and/ or throat. If you do use your inhaler directly in your mouth, be sure that it is above your tongue and past your teeth.
  • If your doses consist of more than one puff each, wait for at least 1 full minute after each puff, then repeat the procedure.
  • Keep your inhaler clean and dry. Keep the mouthpiece capped to avoid getting dirt inside it. Clean your inhaler once a day by removing the canister and immersing the mouthpiece in warm water. Allow the parts to dry, then reassemble the inhaler.
• To use the Serevent Diskus inhaler:
  • Snap the mouthpiece into position. Hold the Diskus level and away from your mouth, breathe out fully away from the mouthpiece. (Do not breathe out into the Diskus mouthpiece.) Put the mouthpiece to your lips. Take a steady, deep breath in through your mouth. Remove the mouthpiece from your mouth. Hold your breath for about 10 seconds. Breathe out slowly away from the mouthpiece. Close the Diskus. The Diskus is now ready for your next scheduled dose.
  • Never wash the mouthpiece or any part of the Diskus device. Keep it dry at all times.
• It is very important to use the Serevent inhaler properly, so that the medicine gets into the lungs. Your doctor may want you to use a spacer with the inhaler. (A spacer should not be used with the Serevent Diskus inhaler.) Talk to your doctor about proper inhaler use.
• In most cases, you should be able to taste or feel a dose of Serevent being delivered. If the delivery of a dose is not detected, do not use another dose. Contact your healthcare provider if you have questions.
• Do not use Serevent more often than is prescribed by your doctor. Doing so could seriously affect the heart and could even lead to death. Generally, Serevent should not be used more often than every 12 hours.
• Do not use Serevent to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Have another, faster-acting inhalation — such as albuterol (Ventolin, Proventil) — on hand to relieve asthma attacks.
• Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.
• Serevent is not a substitute for steroid medications taken orally or by inhalation. Do not stop taking a steroid medication without first talking to your doctor.
• It is important to use Serevent regularly to get the most benefit. Do not stop using Serevent without first talking to your doctor.
• Your doctor may want you to have lung function tests or other medical evaluations during treatment with Serevent to monitor progress and side effects.
• Store Serevent at room temperature. Refill the medication before you run out and before going on vacation.

What happens if I miss a dose?

• If it is almost time for the next regularly scheduled dose, skip the missed dose and use the next one as directed. Alternatively, you can use the missed dose as soon as you remember, then wait at least 12 hours before using another dose of Serevent. Do not use a double dose of this medication.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of a Serevent overdose include angina or chest pain, irregular heartbeats or a fluttering heart, seizures, tremor, weakness, headache, nausea, and vomiting.

What should I avoid while using Serevent?

• Avoid situations that may trigger an asthma attack such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet hair.

What are the possible side effects of Serevent?

• Stop using Serevent and seek emergency medical attention if you experience any of the following serious side effects:
  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • increased difficulty breathing; or
  • chest pain or irregular heartbeats.
• Other, less serious side effects may be more likely to occur. Continue to use Serevent and talk to your doctor if you experience
  • headache, dizziness, lightheadedness, or insomnia;
  • tremor or nervousness;
  • sweating;
  • nausea, vomiting, or diarrhea; or
  • dry mouth.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Serevent?

• Before using this medication, tell your doctor if you are taking any of the following medicines:
  • a beta-blocker such as atenolol (Tenormin), metoprolol (Lopressor), propranolol (Inderal), acebutolol (Sectral), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), labetalol (Normodyne, Trandate), nadolol (Corgard), or pindolol (Visken);
  • a tricyclic antidepressant such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), or protriptyline (Vivactil);
  • a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate); or
  • caffeine, a diet medicine, or a decongestant.
• You may not be able to use Serevent, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Serevent, or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.