Salmeterol

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

Salmeterol 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

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

Salmeterol 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.

Salmeterol may be found in some form under the following brand names:

• Serevent

• Serevent Diskus

Salmeterol can cause serious side effects, including:

• See “Salmeterol 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:
• sudden breathing problems immediately after inhaling your medicine
• effects on heart
• effects on nervous system
• changes in blood (sugar, potassium)

• rash
• hives
• swelling of the face, mouth, and tongue
• breathing problems
• increased blood pressure
• a fast and irregular heartbeat
• chest pain
• tremor
• nervousness

Common side effects of salmeterol 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 salmeterol. 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. Salmeterol 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.

Salmeterol can cause serious side effects, including:

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

Get emergency treatmet if:

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

Do not take salmeterol:

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

2. Do not use salmeterol as your only asthma medicine. Salmeterol 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 salmeterol. Your healthcare provider will decide if you can stop salmeterol 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 salmeterol, 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 salmeterol may harm your unborn baby.
• are breastfeeding. It is not known if salmeterol passes into your milk and if it can harm your baby.
• are allergic to salmeterol any other medicines, or food products. See the end of this Medication Guide for a complete list of ingredients in salmeterol.

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 salmeterol passes into your milk and if it can harm your baby.

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

• Children should use salmeterol with an adult’s help, as instructed by the child’s healthcare provider.
• Use salmeterol exactly as prescribed. Do not use salmeterol more often than prescribed.
• For asthma and COPD, the usual dose is 1 inhalation 2 times each day (morning and evening). The 2 doses should be about 12 hours apart.
• For preventing exercise-induced bronchospasm, take 1 inhalation at least 30 minutes before exercise. Do not use salmeterol more often than every 12 hours. Do not use extra salmeterol before exercise if you already use it 2 times each day.
• If you miss a dose of salmeterol, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at one time.
• Do not use a spacer device with salmeterol.
• Do not breathe into salmeterol.
• While you are using salmeterol 2 times each day, do not use other medicines that contain a long-acting beta2-agonist or LABA for any reason. Ask your healthcare provider or pharmacist for a list of these medicines.
• Do not stop using salmeterol or any of your asthma medicines unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
• Salmeterol does not relieve sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have an inhaled, short-acting bronchodilator, contact your healthcare provider to have one prescribed for you.

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

• your breathing problems worsen with salmeterol
• 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 salmeterol 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. 

Instructions for Using Salmeterol:

Follow the instructions below for using your salmeterol. You will breathe in (inhale) the medicine from the Diskus. If you have any questions, ask your healthcare provider or pharmacist.

Take the salmeterol out of the box and foil pouch. Write the “Pouch opened” and “Use by” dates on the label on top of the Diskus. The “Use by” date is 6 weeks from date of opening the pouch.

• The Diskus will be in the closed position when the pouch is opened.
• The dose indicator on the top of the Diskus tells you how many doses are left. The dose indicator number will decrease each time you use the Diskus. After you have used 55 doses from the Diskus, the numbers 5 to 0 will appear in red to warn you that there are only a few doses left.

Taking a dose from the Diskus requires the following 3 simple steps: Open, Click, Inhale.

1. OPEN - Hold the Diskus in one hand and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go until the mouthpiece appears and snaps into position.

2. CLICK - Hold the Diskus in a level, flat position with the mouthpiece towards you. Slide the lever away from you as far as it will go until it clicks. The Diskus is now ready to use.

Every time the lever is pushed back, a dose is ready to be inhaled. This is shown by a decrease in numbers on the dose counter. To avoid releasing or wasting doses once the Diskus is ready:

Do not close the Diskus.

Do not tilt the Diskus.

Do not play with the lever.

Do not move the lever more than once.

3. INHALE - Before inhaling your dose from the Diskus, breathe out (exhale) fully while holding the Diskus level and away from your mouth. Remember, never breathe out into the Diskus mouthpiece.

Put the mouthpiece to your lips. Breathe in quickly and deeply through the Diskus. Do not breathe in through your nose.

Remove the Diskus from your mouth. Hold your breath for about 10 seconds, or for as long as is comfortable. Breathe out slowly.

The Diskus delivers your dose of medicine as a very fine powder. Most patients can taste or feel the powder. Do not use another dose from the Diskus if you do not feel or taste the medicine.

4. Close the Diskus when you are finished taking a dose so that the Diskus will be ready for you to take your next dose. Put your thumb on the thumbgrip and slide the thumbgrip back towards you as far as it will go. The Diskus will click shut. The lever will automatically return to its original position. The Diskus is now ready for you to take your next scheduled dose, due in about 12 hours.

Remember:

• Never breathe into the Diskus.
• Never take the Diskus apart.
• Always ready and use the Diskus in a level, flat position.
• Do not use the Diskus with a spacer device.
• Never wash the mouthpiece or any part of the Diskus. Keep it dry.
• Always keep the Diskus in a dry place.
• Never take an extra dose, even if you did not taste or feel the medicine.

Asthma:

The usual dosage for adults and children aged 4 years and older is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart).

COPD:

For maintenance treatment of bronchospasm associated with COPD, the dosage for adults is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart).

Excercise-induced bronchospasm:

 One inhalation of salmeterol at least 30 minutes before exercise has been shown to protect patients against EIB.

Additional doses of salmeterol should not be used for 12 hours after the first dose of this drug.

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.

• Store salmeterol at room temperature between 68°F to 77°F (20°C to 25°C). Keep in a dry place away from heat and sunlight.
• Safely discard salmeterol 6 weeks after you remove it from the foil pouch, or after the dose indicator reads “0”, whichever comes first.
• Keep salmeterol and all medicines out of the reach of children.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, 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 salmeterol (Serevent 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). 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 salmeterol for the treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use salmeterol 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 salmeterol) 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 salmeterol 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.