Serevent

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. 

In the U.S.

• Serevent

In Canada

• Serevent Diskhaler Disk
• Serevent Diskus
• Severent
• Severent Diskhaler
• Severent Diskus

Available Dosage Forms:

• Powder
• Disk
• Aerosol Powder

Therapeutic Class: Bronchodilator

Pharmacologic Class: Salmeterol

Salmeterol is used together with other medicines (such as inhaled corticosteroids) to treat asthma and prevent bronchospasm in patients with asthma. When used regularly every day, inhaled salmeterol decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Salmeterol is also used to treat air flow blockage and prevent the worsening of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm or EIB).

Salmeterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Serevent (salmeterol xinafoate) Inhalation Aerosol 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 highly selective beta2-adrenergic bronchodilator. The chemical name of salmeterol xinafoate is 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate. Salmeterol xinafoate has the following chemical structure:

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

Serevent Inhalation Aerosol is a pressurized, metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of salmeterol xinafoate in a mixture of 2 chlorofluorocarbon propellants (trichlorofluoromethane and dichlorodifluoromethane) with soya lecithin. 36.25 mcg of salmeterol xinafoate is equivalent to 25 mcg of salmeterol base. Each actuation delivers 25 mcg of salmeterol base (as salmeterol xinafoate) from the valve and 21 mcg of salmeterol base (as salmeterol xinafoate) from the actuator. Each 6.5-g canister provides 60 inhalations and each 13-g canister provides 120 inhalations.

Serevent (salmeterol) is a bronchodilator. It works by relaxing muscles in the airways 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 may also be used for purposes not listed in this medication guide.

Applies to salmeterol: inhalation aerosol powder, inhalation disk, inhalation powder

Along with its needed effects, salmeterol (the active ingredient contained in Serevent Diskus) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking salmeterol:

• Cough producing mucus
• difficulty with breathing
• headache
• irritation of the throat
• runny nose
• shortness of breath
• sneezing
• stuffy nose
• tightness in the chest
• wheezing

• Abdominal or stomach pain
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• colds
• cough or hoarseness
• diarrhea
• difficulty breathing
• dizziness
• dry mouth
• fever
• flu-like symptoms
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort or illness
• increased hunger
• increased thirst
• increased urination
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• nervousness
• noisy breathing
• pain
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• shivering
• slow or fast heartbeat
• sore mouth or tongue
• sore throat
• sweating
• swelling
• trouble with sleeping
• troubled breathing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• white patches in the mouth or on the tongue

Get emergency help immediately if any of the following symptoms of overdose occur while taking salmeterol:

• Arm, back, or jaw pain
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fainting
• fast or irregular heartbeat
• fast, slow, pounding, or irregular heartbeat or pulse
• seizures
• shakiness in the legs, arms, hands, or feet
• sleeplessness
• trembling or shaking of the hands or feet
• unable to sleep

Some side effects of salmeterol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• anxiety
• belching
• blistering, burning, crusting, dryness, or flaking of the skin
• bone pain
• burning, dry, or itching eyes
• difficulty with moving
• discharge or excessive tearing
• eye redness, irritation, or pain
• headache, severe and throbbing
• heartburn
• hives or welts
• indigestion
• itching, scaling, severe redness, soreness, or swelling of the skin
• mouth or tooth pain
• muscle cramps and spasm
• muscle stiffness or tightness
• redness of the skin
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• skin rash
• skin rash, encrusted, scaly and oozing
• stomach discomfort, upset, or pain

Applies to salmeterol: inhalation aerosol, inhalation aerosol with adapter, inhalation powder

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (12%)
Common (1% to 10%): Arthralgia, articular rheumatism, muscle cramps and spasm, bone and skeletal pain, muscle pain, muscle stiffness, muscle tightness, muscle rigidity, musculoskeletal inflammation
Frequency not reported: Join pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 14%)
Common (1% to 10%): Dizziness, migraines, tremor
Frequency not reported: Sinus headache, paresthesia[Ref]

Cardiovascular

Common (1% to 10%): Pallor, hypertension, palpitations
Uncommon (0.1% to 1%): Tachycardia
Very rare (less than 0.01%): Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles)
Frequency not reported: Peripheral vasodilation and a compensatory small increase in heart rate[Ref]

Dermatologic

Common (1% to 10%): Skin rashes, urticaria, photodermatitis
Frequency not reported: Contact dermatitis, eczema[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal signs and symptoms, nausea, vomiting, candidiasis mouth/throat, dental discomfort and pain, dyspeptic symptoms, gastrointestinal infections, hyposalivation
Frequency not reported: Oral mucosal abnormality[Ref]

Hepatic

Common (1% to 10%): Transient elevation of hepatic enzymes[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia
Rare (less than 0.1%): Hypokalemia[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, keratitis[Ref]

Other

Common (1% to 10%): Influenza, ear signs and symptoms, edema and swelling
Frequency not reported: Localized aches and pains, pyrexia of unknown origin[Ref]

Psychiatric

Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Nervousness
Rare (less than 0.1%): Insomnia
Frequency not reported: Sleep disturbances[Ref]

Respiratory

Common (1% to 10%): Nasal/sinus congestion, rhinitis, asthma, tracheitis/bronchitis, pharyngitis, sinusitis, upper respiratory tract infection, cough, throat irritation, lower respiratory signs and symptoms
Very rare (less than 0.01%): Paradoxical bronchospasm, non specific chest pain, oropharyngeal irritation
Frequency not reported: Bronchospasm
Postmarketing reports: Upper airway symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reactions including edema and angioedema, bronchospasm and anaphylactic shock
Frequency not reported: Immediate hypersensitivity reactions
Postmarketing reports: Anaphylaxis[Ref]

Some side effects of Serevent Diskus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.