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Canadian Brand Names

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Description

Fluticasone and salmeterol is a combination of two medicines that are used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines or when a patient's condition is so severe that more than one maintenance medicine is needed . However, this medicine will not relieve an asthma attack that has already started.

Inhaled fluticasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

Inhaled salmeterol is a long-acting bronchodilator and it belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) of the lungs. Salmeterol is different than other bronchodilators because it does not act quickly enough to relieve an asthma attack that has already started.

This medicine must be used with a short-acting beta-2 agonist (e.g. albuterol) for the treatment of an asthma attack or asthma symptoms that need immediate attention.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in the product labeling, fluticasone and salmeterol combination is used in certain patients with the following medical conditions:

• Emphysema

This product is available in the following dosage forms:

• Aerosol Liquid
• Disk
• Aerosol Powder

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Before Using

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

Corticosteroids taken by mouth or injection have been shown to slow or stop growth in children and cause reduced adrenal gland function. If enough fluticasone is absorbed following inhalation, it is possible it also could cause these effects. Your doctor will want you to use the lowest possible dose of fluticasone that controls asthma. This will lessen the chance of an effect on growth or adrenal gland function. It is also important that children taking fluticasone visit their doctors regularly so that their growth rates may be monitored. Children who are taking this medicine may be more susceptible to infections, such as chickenpox or measles. Care should be taken to avoid exposure to chickenpox or measles. If the child is exposed or the disease develops, the doctor should be contacted and his or her directions should be followed carefully. Before this medicine is given to a child, you and your child's doctor should talk about the good this medicine will do as well as the risks of using it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of fluticasone and salmeterol in the elderly with other age groups, this medicine has been used in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults. Elderly people who have cardiovascular disease may have increased chances of side effects from this medicine.

Pregnancy

Breastfeeding

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.

Drug Interactions

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
• Atenolol
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Bupranolol
• Bupropion
• Carteolol
• Carvedilol
• Celiprolol
• Clorgyline
• Darunavir
• Dilevalol
• Esmolol
• Iproniazid
• Isocarboxazid
• Labetalol
• Landiolol
• Levobetaxolol
• Levobunolol
• Mepindolol
• Metipranolol
• Metoprolol
• Moclobemide
• Nadolol
• Nebivolol
• Nialamide
• Nipradilol
• Oxprenolol
• Pargyline
• Penbutolol
• Phenelzine
• Pindolol
• Procarbazine
• Propranolol
• Ritonavir
• Selegiline
• Sotalol
• Talinolol
• Tertatolol
• Timolol
• Tipranavir
• Toloxatone
• Tranylcypromine

Other Interactions

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, severe or
• Infection or
• Stress or
• Surgery or
• Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.

• Chickenpox (including recent exposure) or
• Measles or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, or fungus) or
• Tuberculosis (active or history of)—Inhaled fluticasone can reduce the body's ability to fight off these infections.

• Diabetes mellitus or
• Ketoacidosis—Blood sugar levels may increase.

• Heart or blood vessel disease or
• High blood pressure or
• Overactive thyroid or
• Seizures—This medicine may worsen these conditions.

• Eosinophilic conditions—Fluticasone may make these conditions worse.

• Osteoporosis (bone disease)—Inhaled corticosteroids in high doses may make this condition worse.

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Proper Use

Inhaled fluticasone and salmeterol is used to prevent asthma attacks. 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 health care professional.

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 side effects.

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.

Do not stop using this medicine or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor .

Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.

Inhaled fluticasone and salmeterol is used with a special inhaler that comes with patient directions. 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 health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

To use the disposable inhaler for inhalation powder:

• To open the inhaler, push the thumbgrip 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 following exactly the same steps you used for the first puff.
• When you are finished, close the inhaler. Place your thumb on the thumbgrip, 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 remaining. This tells you when you are getting low on medicine. The doses counting down 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 powder for inhalation:
  • For bronchial asthma:
    • Adults and children 4 years of age and older—One inhalation twice a day, about 12 hours apart.
    • Children up to 4 years of age—Use and dose must be determined by your doctor.
  • For chronic obstructive pulmonary disease (COPD) with chronic bronchitis:
    • Adults—One inhalation (250/50) twice a day, about 12 hours apart.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

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Precautions

Check with your doctor if your asthma symptoms do not improve or your condition worsens. Check with your doctor if you notice:

• Your short-acting inhaler does not seem to work as well as it used to
• You need to use your short-acting inhaler more often
• You have a significant decrease in your peak flow when measured as directed by your doctor

Do not use this medicine to treat wheezing that is getting worse. Call your doctor right away if wheezing worsens while using this medicine .

Although this medicine decreases the number of asthma episodes, these medicines may increase the chances of a severe asthma episode when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have .

Patients with COPD may be more likely to have pneumonia. Call your doctor if you start having increased sputum production, change in sputum color, fever, chills, increased cough, or increased breathing problems .

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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 as soon as possible if any of the following side effects occur:

• Black, tarry stools
• Blindness
• Blurred vision
• Burning, tingling, numbness or pain in the hands, arms, feet, or legs
• Chills
• Cough
• Decreased vision
• Difficulty breathing or swallowing
• Eye pain
• Fast heartbeat
• Fever
• Headache
• Hives or welts
• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Nausea or vomiting
• Noisy breathing
• Painful or difficult urination
• Sensation of pins and needles
• Shortness of breath
• Skin itching, rash, or redness
• Sore throat
• Sores, ulcers, or white spots on lips or in mouth
• Stabbing pain in extremities
• Swelling of face, throat, or tongue
• Swollen glands
• Tearing
• Unusual bleeding or bruising
• Wheezing

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

• Blurred vision
• Chest pain or tightness
• Confusion
• Convulsions (seizures)
• Darkening of skin
• Decreased urine output
• Diarrhea
• Dizziness
• Dry mouth
• Fainting
• Faintness, or light-headedness when getting up from a lying or sitting position
• Fast, pounding, or irregular heartbeat or pulse
• Fatigue
• Flushed, dry skin
• Fruit-like breath odor
• General feeling of discomfort or illness
• Headache
• High blood pressure
• Increased hunger
• Increased thirst
• Loss of appetite
• Mental depression
• Mood changes
• Muscle pain or cramps
• Nausea
• Nervousness
• Numbness or tingling in hands, feet, or lips
• Palpitations
• Shortness of breath
• Skin rash
• Sudden sweating
• Tremors
• Trouble in sleeping
• Unusual tiredness or weakness
• Vomiting

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:

• Body aches or pain
• Choking
• Congestion
• Dryness of throat
• High-pitched noise when breathing
• Hoarseness
• Runny nose
• Sneezing
• Trouble in swallowing
• Voice changes

• Abdominal or stomach pain
• Cough-producing mucus
• Flu-like symptoms
• Irritation or inflammation of eye
• Muscle pain
• Pain or tenderness around eyes and cheekbones
• Sleep disorders
• Stuffy nose
• Tremors
• White patches in the mouth or throat or on the tongue

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

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