• Formoterol Oral Inhalation

    (for moh' te rol)

    IMPORTANT WARNING:

    In a large clinical study, more patients who used an asthma medication similar to formoterol experienced severe episodes of asthma that had to be treated in a hospital or caused death than patients who did not use the medication. If you have asthma, use of formoterol may increase the chance that you will experience serious or fatal asthma problems.
    Your doctor will only prescribe formoterol if your asthma is so severe that two medications are needed to control it.You should never use formoterol alone; you must always use it along with another asthma controller medication. Children and teenagers who need to be treated with formoterol will probably be treated with a product that combines formoterol and another medication in a single inhaler to make it easier for them to use both medications as prescribed.
    Because of the risks of using formoterol, you should only use formoterol as long as it is needed to bring your asthma symptoms under control. Once your asthma is controlled, your doctor will probably tell you to stop using formoterol but continue using the other asthma medication.
    Do not use formoterol if you have asthma that is quickly getting worse. Tell your doctor if you have had many severe asthma attacks or if you have ever been hospitalized because of asthma symptoms. If you have any of the following signs of worsening asthma, call your doctor immediately:
    • your short-acting inhaler (inhaled medication such as albuterol [Proventil, Ventolin] that is used to treat sudden attacks of asthma symptoms) does not work as well as it did in the past
    • you need to use more puffs than usual of your short-acting inhaler or use it more often
    • you need to use 4 or more puffs per day of your short-acting inhaler for 2 or more days in a row
    • you use more than one canister (200 inhalations) of your short-acting inhaler during an 8-week period
    • your peak-flow meter (home device used to test breathing) shows your breathing is worsening
    • you need to go to the emergency room for asthma treatment
    • your symptoms do not improve after you use formoterol regularly for 1 week or your symptoms get worse at any time during your treatment
    Talk to your doctor about the risks of using this medication.
    Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with formoterol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

    WHY is this medicine prescribed?

    Formoterol is used to treat wheezing, shortness of breath, and breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). It also is used to prevent breathing difficulties (bronchospasm) during exercise. Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

    HOW should this medicine be used?

    Formoterol comes as a powder-filled capsule to inhale by mouth using a special inhaler. If you are using formoterol to treat asthma and COPD, you will probably inhale it twice a day in the morning and the evening. Always inhale your next dose of formoterol 12 hours after you inhaled your last dose and try to inhale formoterol at about the same times every day. If you are using formoterol to prevent breathing difficulties during exercise, you will probably inhale it at least 15 minutes before exercise, but not more often than once in 12 hours. If you are using formoterol twice a day on a regular basis, do not use an additional dose before exercising. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use formoterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
    Do not swallow formoterol capsules.
    Talk to your doctor about how you should take your other oral or inhaled medications for asthma during your treatment with formoterol. If you were taking a corticosteroid (a type of medication used to prevent airway swelling in patients with asthma), your doctor will probably tell you to continue taking it just as you did before you began using formoterol. If you were using a short-acting beta agonist inhaler such as albuterol (Proventil, Ventolin) on a regular basis, your doctor will probably tell you to stop using it regularly, but to continue to use it to treat sudden attacks of asthma symptoms. Follow these directions carefully. Do not change the way you use any of your medications without talking to your doctor.
    Formoterol helps to prevent asthma or COPD attacks but will not stop an attack that has already started. Do not use formoterol during an attack of asthma or COPD. Your doctor will prescribe a short-acting inhaler to use during attacks.
    Formoterol controls the symptoms of asthma and other lung diseases but does not cure these conditions. Do not stop using formoterol without talking to your doctor. If you suddenly stop using formoterol, your symptoms may worsen.
    Before you use the formoterol inhaler the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the inhaler while he or she watches.
    To use the inhaler, follow these steps:
    1. Before you use a new inhaler for the first time, find the sticker on the box that says ''Use by'' and has been marked with a date by your pharmacist. Remove this sticker from the box and attach it to the cover of your inhaler to remind you to stop using the inhaler by this date. If the sticker on your box is blank, fill in the expiration date that is stamped on the box or the date that is 4 months after you purchased the inhaler, whichever comes sooner.
    2. Open the foil pouch containing a blister card of formoterol and set it aside. Do not remove a capsule until you are ready to inhale your dose.
    3. Pull off the inhaler cover and twist the mouthpiece open in the direction shown by the arrow on the mouthpiece. Push the buttons on each side to be sure you can see four pins in the capsule well of the inhaler.
    4. Separate one blister from the blister card by tearing along the dotted lines. Remove the capsule from the blister by peeling back the paper backing and pushing the capsule through the foil.
    5. Place the capsule in the chamber. Do not place it directly into the mouthpiece. Twist to close.
    6. Hold the inhaler upright and press in both side buttons at the same time. Do not press the buttons more than once. You will hear a click as the capsule is punctured. Release the buttons. If the buttons do not pop out, pull the wings of the buttons to release them.
    7. Exhale (breathe out) as completely as possible but not into the mouthpiece.
    8. Turn the inhaler on its side so that the blue buttons are on the left and right (not the top and bottom) of the inhaler. Hold the inhaler so that it is level.
    9. Tilt your head back slightly, place the mouthpiece in your mouth, and close your lips. Breathe in quickly and deeply. As the medicine is released from the capsule, you'll get a sweet taste and hear a whirring noise. (If you don't, the capsule may be stuck. Tap on the side of the inhaler to loosen the capsule and repeat steps 7 to 9. Do not press the side buttons again.)
    10. Remove the inhaler from your mouth and hold your breath for as long as you comfortably can. Then exhale.
    11. Open the inhaler to see if there is any powder left in the capsule. If there is, repeat steps 7 to 10.
    12. Once the capsule is empty, remove it and throw it away. Do not leave it in the chamber. Close the mouthpiece and replace the cover.
    The inhaler is made to pierce the capsule so that the powder can be released. However, it is possible that the capsule may break into small pieces inside the inhaler. If this happens, a screen in the inhaler should stop the pieces of capsule from reaching your mouth as you inhale the medication. Very tiny pieces of the capsule may reach your mouth or throat, but this will not hurt you. The capsule is less likely to break if you are careful to store the capsules properly, to keep the capsules in the foil package until you are ready to use them, and to press the buttons on the inhaler only once.
    Formoterol capsules should only be used with the special inhaler and should not be taken by mouth. Store capsules in the package and remove them immediately before use. Avoid exposing the capsules to moisture, and handle them with dry hands.
    Do not use the dry powder inhaler with a spacer. Do not exhale into the device. Keep the inhaler dry; do not wash it. Always use the new inhaler that comes with a refill of your medication. Do not use the inhaler to inhale any other type of capsules.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before using formoterol,
    • tell your doctor and pharmacist if you are allergic to formoterol, any other medications, or milk proteins.
    • tell your doctor if you use another LABA such as fluticasone and salmeterol combination (Advair) or salmeterol (Serevent). These medications should not be used with formoterol. Your doctor will tell you which medication you should use and which medication you should stop using.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminophylline (Truphylline); amiodarone (Cordarone); antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), propranolol (Inderal), and sotalol (Betapace, Betapace AF); cisapride (Propulsid) (not available in the United States); clonidine (Catapres); diet pills; disopyramide (Norpace); diuretics ('water pills'); dofetilide (Tikosyn); dyphylline (Dilor, Lufyllin); erythromycin (E.E.S., E-Mycin, Erythrocin); guanabenz; medications for colds; monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate); midodrine (Orvaten); moxifloxacin (Avelox); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); pimozide (Orap); procainamide (Procanbid, Pronestyl); quinidine (Quinidex); sparfloxacin (Zagam); theophylline (Theo-Chron, Theolair); and thioridazine (Mellaril). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you have or have ever had an irregular heartbeat, high blood pressure, seizures, diabetes, or heart or thyroid disease.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using formoterol, call your doctor.

    What SPECIAL DIETARY instructions should I follow?

    Talk to your doctor about drinking beverages that contain caffeine while using this medicine.

    What should I do IF I FORGET to take a dose?

    Skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Formoterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • nervousness
    • headache
    • uncontrollable shaking of a part of the body
    • dry mouth
    • muscle cramps
    • back pain
    • nausea
    • heartburn
    • stomach pain
    • extreme tiredness
    • dizziness
    • difficulty falling asleep or staying asleep
    • stuffed or runny nose
    • sore throat
    Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
    • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
    • hoarseness
    • difficulty swallowing or breathing
    • hives
    • rash
    • fast, pounding, or irregular heartbeat
    • chest pain
    • lightheadedness
    • fainting
    Formoterol may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep sealed in their blister cards until you are ready to use them. Keep this medication out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed, and throw away your old inhaler each time you refill your prescription. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
    Symptoms of overdose may include:
    • chest pain
    • fainting
    • fast, pounding, or irregular heartbeat
    • nervousness
    • headache
    • uncontrollable shaking of a part of the body
    • seizures
    • muscle cramps
    • dry mouth
    • nausea
    • dizziness
    • excessive tiredness
    • difficulty falling asleep or staying asleep
    • thirst
    • dry mouth
    • trouble breathing

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Foradil®
    • Dulera® (as a combination product containing Formoterol, Mometasone)
    • Symbicort® (as a combination product containing Budesonide, Formoterol)

    Mometasone Oral Inhalation

    (moe met' a sone)

    WHY is this medicine prescribed?

    Mometasone inhalation is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Mometasone inhalation is not used to treat an asthma attack (sudden episode of shortness of breath, wheezing, and coughing) that has already started. Mometasone is in a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.

    HOW should this medicine be used?

    Mometasone inhalation comes as a powder to inhale by mouth. It is usually inhaled twice daily or once a day in the evening. Use mometasone inhalation at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use mometasone inhalation exactly as directed. Do not inhale more or less of it or inhale it more often than prescribed by your doctor.
    Talk to your doctor about how you should use your other oral and inhaled medications for asthma during your treatment with mometasone inhalation. If you were taking an oral steroid such as dexamethasone, methylprednisolone (Medrol), or prednisone, your doctor may want to gradually decrease your steroid dose starting at least 1 week after you begin to use mometasone inhalation. Special care will be needed in certain situations for several months as your body adjusts to the change in medication. Ask your doctor for more information.
    Mometasone inhalation helps to prevent asthma attacks but will not stop an asthma attack that has already started. Do not use mometasone inhalation during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during asthma attacks.
    Your doctor will probably start you on an average dose of mometasone inhalation. Your doctor may decrease your dose if your symptoms are controlled or gradually increase your dose if your symptoms have not improved after 2 weeks.
    Mometasone inhalation controls asthma but does not cure it. It may take 1 to 2 weeks or longer before you feel the full benefit of the medication. Continue to use mometasone inhalation even if you feel well. Do not stop using mometasone inhalation without talking to your doctor.
    Tell your doctor if your asthma worsens during your treatment. Call your doctor immediately if you have an asthma attack that does not stop when you use your fast-acting asthma medication, or if you need to use more of your fast-acting medication than usual.
    Before you use your mometasone oral inhaler the first time, read the written instructions that come with it. Look at the diagrams carefully and be sure that you recognize all the parts of the inhaler. Ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the inhaler while he or she watches.
    The dose counter on the base of your mometasone inhaler tells you how many doses of medication are left in your inhaler. Read the numbers on the dose counter from top to bottom. The number on the dose counter decreases every time you lift the cap to load a dose of medication and will read ''01'' just before you use your last dose of medication. Do not use the inhaler if the numbers on the dose counter do not change after you load a dose. Call your pharmacist if your inhaler is not working properly.
    Throw away the inhaler after you use the last dose or 45 days after you removed it from the package, whichever is sooner.
    To use the inhaler, follow these steps:
    1. If you are using a new inhaler for the first time, remove it from the foil pouch. Write the date that you opened the inhaler in the space provided on the cap label.
    2. Hold the inhaler straight up with the colored base on the bottom. Twist the white cap counterclockwise and remove it. This loads the correct amount of medication in the base of the inhaler, so it is important to twist the cap and not twist the base with your hand. As you lift the cap off, the dose counter on the base will count down by one to show the number of doses left after this use.
    3. Breathe out fully.
    4. Hold the inhaler on its side with the mouthpiece facing you. Be sure that you are not covering the ventilation holes on the sides of the inhaler. Place the mouthpiece of the inhaler in your mouth and close your lips firmly around it.
    5. Breathe in a fast, deep breath. You will receive your medication as a very fine powder, so you may not be able to smell, feel, or taste it as you inhale.
    6. Remove the inhaler from your mouth and hold your breath for 10 seconds or as long as you comfortably can. Do not breathe out into the inhaler.
    7. Wipe the mouthpiece dry. Put the cap back onto the inhaler so that the indented arrow is in line with the dose counter. Gently press down and turn clockwise until you hear a click.
    8. Rinse your mouth with water.
    If your inhaler needs to be cleaned, gently wipe it with a dry cloth. Do not wash the inhaler. Keep the inhaler away from water or other liquids.
    Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before using mometasone oral inhalation,
    • tell your doctor and pharmacist if you are allergic to mometasone or any other medications.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention ketoconazole (Nizoral). Also tell your doctor if you are taking corticosteroids or medications for seizures, or if you have taken these medications in the past. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become thin and weak and break easily) and if you have or have ever had tuberculosis (a type of infection) in your lungs, cataracts (clouding of the lens of the eye), glaucoma (an eye disease) or high pressure in the eye, or liver disease. Also tell your doctor if you have any type of untreated infection anywhere in your body or a herpes infection (a type of infection that causes a sore on the eyelid or eye surface) in your eye, or if you are on bedrest or unable to move around.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using mometasone inhalation, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using mometasone inhalation.
    • you should know that your body may be less able to cope with stress such as surgery, illness, severe asthma attack, or injury. Call your doctor right away if you get sick and be sure that all healthcare providers who treat you know that you are using mometasone inhalation.
    • tell your doctor if you have never had chickenpox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away. You may need treatment to protect you from these infections.
    • you should know that mometasone inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, use your fast-acting (rescue) asthma medication right away and call your doctor. Do not use mometasone inhalation again unless your doctor tells you that you should.

    What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inhale a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Mometasone inhalation may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • headache
    • bone, muscle, joint, or back pain
    • heartburn
    • loss of appetite
    • stomach pain
    • vomiting
    • nose irritation or nosebleed
    • dry throat
    • difficult, frequent, or painful urination
    • painful menstrual periods
    Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
    • hives
    • swelling of the eyes, face, tongue, throat, arms, hands, feet, ankles, or lower legs
    • hoarseness
    • difficulty breathing or swallowing
    • throat tightness
    • extreme tiredness
    • muscle weakness
    • weight gain in the upper body, neck, and face
    • thinning arms and legs
    • fragile skin that bruises easily
    • excess hair growth
    • irregular or missed menstrual periods
    • decreased sexual desire
    • irritability
    • anxiety
    • depression
    • vision changes
    • painful white patches in the mouth or throat
    Mometasone inhalation may cause slowed growth in children. Your child's doctor will monitor your child's growth carefully while he or she is using mometasone inhalation. Talk to your doctor about the risks of giving this medication to your child.
    Mometasone inhalation may cause a decrease in your bone mineral density (bone strength and thickness). Talk to your doctor about the risks of using mometasone inhalation.
    Mometasone inhalation may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away your inhaler 45 days after you open the package and throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
    Symptoms of overdose may include:
    • extreme tiredness
    • muscle weakness
    • weight gain in the upper body, neck, and face
    • thinning arms and legs
    • fragile skin that bruises easily
    • excess hair growth
    • irregular or missed menstrual periods
    • decreased sexual desire
    • irritability
    • anxiety
    • depression

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Asmanex®
    • Dulera® (as a combination product containing Formoterol, Mometasone)
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