Severent Diskhaler

Generic Name: salmeterol (Inhalation route)

sal-ME-ter-ol zye-NAF-oh-ate

Commonly used brand name(s):

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

Uses For Severent Diskhaler

Salmeterol is used to help prevent the symptoms of asthma and improve breathing. It is used when a patient's asthma has not been controlled by using other asthma medicines, or when a patient's condition is so serious that more than one medicine is needed every day. This medicine 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). This includes chronic bronchitis and emphysema. This medicine is used to prevent exercise-induced bronchospasm.

Salmeterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) of the lungs. Salmeterol does not act quickly enough to relieve an asthma attack that has already started.

This medicine must be used with a short-acting medicine (e.g. albuterol) for an asthma attack that has already started and needs attention right away.

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

Before Using Severent Diskhaler

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of salmeterol in children above 4 years of age. Safety and efficacy have not been established in children younger than 4 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of salmeterol in the elderly. However, elderly patients with heart problems may require special caution when receiving salmeterol.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Alprenolol
• Arotinolol
• Atazanavir
• Atenolol
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Brofaromine
• Bucindolol
• Bupranolol
• Carteolol
• Carvedilol
• Celiprolol
• Clarithromycin
• Clorgyline
• Dilevalol
• Esmolol
• Furazolidone
• Indinavir
• Iproniazid
• Isocarboxazid
• Itraconazole
• Ketoconazole
• Labetalol
• Landiolol
• Lazabemide
• Levobetaxolol
• Levobunolol
• Linezolid
• Mepindolol
• Metipranolol
• Metoprolol
• Moclobemide
• Nadolol
• Nebivolol
• Nefazodone
• Nelfinavir
• Nialamide
• Nipradilol
• Oxprenolol
• Pargyline
• Penbutolol
• Phenelzine
• Pindolol
• Procarbazine
• Propranolol
• Rasagiline
• Ritonavir
• Saquinavir
• Selegiline
• Sotalol
• Talinolol
• Telithromycin
• Tertatolol
• Timolol
• Toloxatone
• Tranylcypromine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute or
• COPD flare-up—Should not be used in patients with these conditions.

• Diabetes or
• Heart or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) or
• Seizures, history of—Use with caution. May make these conditions worse.

Proper Use of salmeterol

This section provides information on the proper use of a number of products that contain salmeterol. It may not be specific to Severent Diskhaler. Please read with care.

Inhaled salmeterol is used to prevent asthma attacks and to treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

This medicine comes with patient directions or a medication guide. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of having breathing problems.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

To use the inhaler:

• To open the inhaler, push the thumb grip away from you as far as it will go. You will hear a click and feel a snap. When open, the mouthpiece will appear.
• Slide the mouthpiece lever away from you as far as it will go until it clicks. The inhaler is now ready to use. If you close the inhaler or push the lever again, you will lose medicine.
• Turn your head away from the inhaler, and breathe out to the end of a normal breath. Do not breathe into the inhaler.
• Holding the inhaler level, put the mouthpiece between your lips and teeth, and close your lips around the mouthpiece. Do not bite down on the mouthpiece. Do not block the mouthpiece with your teeth or tongue.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• Turn your head away from the inhaler, and breathe out slowly to the end of a normal breath. Do not breathe into the inhaler.
• If your doctor has told you to inhale more than one puff of medicine at each dose, take the second puff using exactly the same steps you used for the first puff.
• When you are finished, close the inhaler. Place your thumb on the thumb grip, and slide it back toward you as far as it will go. You will hear it click shut.
• Keep the inhaler dry. Do not wash the mouthpiece, or any other part of the inhaler. You may use a dry cloth to wipe it clean.
• The inhaler has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the inhaler has 5 doses left, the numbers from 5 to 0 will show up in red to remind you to refill your prescription.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (powder):
  • For preventing an asthma attack:
    • Adults and children 4 years of age and above—One inhalation (50 micrograms [mcg]) two times per day (morning and evening). The doses should be taken 12 hours apart.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
  • For treatment of COPD:
    • Adults—One inhalation (50 micrograms [mcg]) two times per day (morning and evening). The doses should be taken 12 hours apart.
    • Children—Use and dose must be determined by your doctor.
  • For preventing exercise-induced bronchospasm:
    • Adults and children 4 years of age and above—One inhalation (50 micrograms [mcg]) taken 30 minutes before exercise.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Severent Diskhaler

It is very important that your doctor check your progress or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects caused by the medicine.

Although this medicine decreases the number of asthma attacks, it may increase the chance for a severe asthma attack when they do occur. Talk to your doctor about any questions or concerns you may have.

You should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.

Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with other inhalers that contain budesonide and formoterol combination (Symbicort®), fluticasone and salmeterol combination (e.g., Advair® Diskus®, Advair® HFA), formoterol (Foradil® Aerolizer®, Perforomist™), or arformoterol (Brovana™).

Talk to your doctor or get medical care right away if:

• Your symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often than normal. If you use 1 whole canister of the short-acting inhaler in 8 weeks time, or if you need to use 4 or more inhalations of the short-acting inhaler for 2 or more days in a row, call your doctor right away.
• You have a big decrease in your peak flow when measured as directed by your doctor.

Do not change your dose or stop using your medicine without asking your doctor first.

Your doctor may want you to carry a medical identification (ID) card stating that you are using this medicine. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

This medicine may cause bronchospasm, which may be life-threatening. Check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

Check with your doctor right away if you have chest pain, a fast heartbeat, nervousness, shaking of the hands or feet, noisy breathing, a feeling of choking, or tightness or irritation of the throat while using this medicine.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Severent Diskhaler Side Effects

Along with its needed effects, a medicine 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:

• 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:

• 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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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