Serevent Diskus

DRUG DESCRIPTION

SEREVENT DISKUS contains salmeterol xinafoate as the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The active component of the formulation is salmeterol base, a selective beta2-adrenergic bronchodilator. The chemical name of salmeterol xinafoate is 4-hydroxy-?1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-l,3-benzenedimethanol, l-hydroxy-2-naphthalenecarboxylate. Salmeterol xinafoate has the following chemical structure:

SEREVENT DISKUS
  (salmeterol xinafoate) Structural Formula Illustration

Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4•C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water.

SEREVENT DISKUS (salmeterol xinafoate) is a specially designed plastic device containing a double-foil blister strip of a powder formulation of salmeterol xinafoate intended for oral inhalation only. Each blister on the double-foil strip within the device contains 50 mcg of salmeterol administered as the salmeterol xinafoate salt in 12.5 mg of formulation containing lactose (which contains milk proteins). After a blister containing medication is opened by activating the device, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece.

Under standardized in vitro test conditions, SEREVENT DISKUS (salmeterol xinafoate) delivers 47 mcg when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS® inhalation device was 82.4 L/min (range: 46.1 to 115.3 L/min).

The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.

What are the possible side effects of salmeterol inhalation (Serevent Diskus)?

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

Call your doctor at once if you have any of these serious side effects:

  • chest pain, fast or pounding heartbeats, tremors, shaking, or restless feeling;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • wheezing, choking, or other breathing problems after using this medication; or
  • worsening asthma...

Read All Potential Side Effects and See Pictures of Serevent Diskus »

What are the precautions when taking salmeterol xinafoate (Serevent Diskus)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this drug, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., angina, irregular heartbeat), high blood pressure, diabetes, liver problems, seizures, thyroid problems (e.g., overactive thyroid).

Salmeterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention....

Read All Potential Precautions of Serevent Diskus »


Serevent Diskus Consumer (continued)

SIDE EFFECTS: Hoarseness, throat irritation, headache, rapid heartbeat, nervousness, cough, dry mouth/throat, or upset stomach may occur.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fast/slow/irregular heartbeat, severe dizziness, fainting, seizures.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you have trouble breathing or experience sudden wheezing, use your quick-relief inhaler and seek immediate medical attention.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this drug, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., angina, irregular heartbeat), high blood pressure, diabetes, liver problems, seizures, thyroid problems (e.g., overactive thyroid).

Salmeterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using salmeterol, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using salmeterol safely.

This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.


Serevent Diskus Patient Information Including Side Effects

Brand Names: Serevent Diskus

Generic Name: salmeterol (inhalation) (Pronunciation: sal MEE ter all)

  • What is salmeterol inhalation (Serevent Diskus)?
  • What are the possible side effects of salmeterol inhalation (Serevent Diskus)?
  • What is the most important information I should know about salmeterol inhalation (Serevent Diskus)?
  • What should I discuss with my healthcare provider before using salmeterol inhalation (Serevent Diskus)?
  • How should I use salmeterol inhalation (Serevent Diskus)?
  • What happens if I miss a dose (Serevent Diskus)?
  • What happens if I overdose (Serevent Diskus)?
  • What should I avoid while using salmeterol inhalation (Serevent Diskus)?
  • What other drugs will affect salmeterol inhalation (Serevent Diskus)?
  • Where can I get more information?

What is salmeterol inhalation (Serevent Diskus)?

Salmeterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Salmeterol inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun. Salmeterol inhalation is also used to treat chronic obstructive pulmonary disease (COPD) including emphysema and chronic bronchitis.

Salmeterol inhalation may also be used for other purposes not listed in this medication guide.

What are the possible side effects of salmeterol inhalation (Serevent Diskus)?

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

Call your doctor at once if you have any of these serious side effects:

  • chest pain, fast or pounding heartbeats, tremors, shaking, or restless feeling;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • wheezing, choking, or other breathing problems after using this medication; or
  • worsening asthma symptoms.

Less serious side effects may include:

  • headache, dizziness, lightheadedness, or insomnia;
  • sweating;
  • nausea, vomiting, or diarrhea; or
  • dry mouth or throat irritation.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about salmeterol inhalation (Serevent Diskus)?

Do not use salmeterol inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

Salmeterol inhalation is has been shown to increase the risk of asthma-related death. It is critical that you use only the prescribed dose of this medicine and follow all patient instructions for safe use of the medication. Talk with your doctor about your individual risks and benefits in using salmeterol inhalation.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

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.

It is important to use salmeterol inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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

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