Fluticasone + Salmeterol

CAUTION:
A large clinical study found a small increase in deaths from asthma in patients who used salmeterol. Do not use fluticasone and salmeterol if you have asthma that is quickly getting worse. If you have any of the following signs of worsening asthma, call your doctor without delay: short-acting inhaler (e.g., albuterol) does not work as well as it used toneed to use more puffs than usual of short-acting inhaler or use it more oftenpeak-flow meter shows breathing is worseningneed to go to the emergency room for asthma treatment.

General Information and Indications:

The combination of fluticasone and salmeterol is used to prevent wheezing, shortness of breath, and breathing difficulties caused by asthma. Fluticasone is in a class of medications called steroids. It works by reducing swelling in the airways. Salmeterol is in a class of medications called long-acting beta-agonists. It works by relaxing and opening air passages in the lungs, making it easier to breathe.

Information For Users:

The combination of fluticasone and salmeterol comes as a powder to inhale by mouth using a special inhaler device. It usually is used twice a day, in the morning and evening, about 12 hours apart. To help you remember to use fluticasone and salmeterol, use it around the same time every day. Follow the directions on your prescription label, ask your doctor or pharmacist If you have any questions. Use fluticasone and salmeterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not use fluticasone and salmeterol during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during attacks.

Fluticasone and salmeterol inhalation controls asthma but does not cure it. It may take a week or longer before you feel the full benefit of fluticasone and salmeterol. Inform your doctor if your symptoms do not improve after 2 weeks. Continue to use fluticasone and salmeterol even if you feel well. Do not stop using fluticasone and salmeterol without informing your doctor. If you stop taking fluticasone and salmeterol, your symptoms may return.

Before you use fluticasone and salmeterol inhalation for the first time, read the written instructions that come with it. Ask your doctor, pharmacist, or respiratory therapist to show you how to use the inhaler. Practice using your inhaler while he or she watches.

To use the inhaler, follow these steps:

o Hold the inhalation device in one hand, and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go until the mouthpiece appears and snaps into position.
o Hold the inhalation device in a horizontal position with the mouthpiece toward you. Slide the lever away from you as far as it will go until it clicks.
o Every time the lever is pushed back, a dose is ready to inhale. You will see the number in the dose counter go down. Do not waste doses by closing the device, playing with the lever, or advancing the lever more than once.
o Hold the inhalation device level and away from your mouth, and breathe out as far as you comfortably can.
o Put the mouthpiece to your lips. Breathe in quickly and deeply though the inhalation device, not through your nose.
o Remove the inhalation device from your mouth, and hold your breath for 10 seconds or as long as you comfortably can. Breathe out slowly.
o Put your thumb on the thumbgrip and slide it back toward you as far as it will go. The device will click shut.
o Rinse your mouth with water, but do not swallow.

Never exhale into the inhalation device, take the device apart, or wash the mouthpiece or any part of the device. Keep the device dry. Do not use the device with a spacer.
Other uses for this medicine

special precautions:

o Inform your doctor or pharmacist if you have allergy to fluticasone (Flonase, Flovent), salmeterol (Serevent), any other medications, or milk protein.
o do not use formoterol (Foradil) or salmeterol (Serevent) while using fluticasone and salmeterol.
o Inform your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); diuretics ('water pills'); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir); isoniazid (INH, Nydrazid); metronidazole (Flagyl); nefazodone (Serzone); oral contraceptives (birth control pills); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Also Inform your doctor and pharmacist if you are taking the following medications or have stopped taking them during the past 2 weeks: antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); and monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
o inform your doctor if you are breast-feeding high blood pressure, irregular heartbeat, seizures, hyperthyroidism (overactive thyroid), diabetes, tuberculosis, glaucoma, or liver or heart disease, and if you have a herpes eye infection or a fungal, viral, or bacterial infection (except an infection of the skin).
o Inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using fluticasone and salmeterol, call your doctor.
o if you are having surgery, including dental surgery, Inform your doctor or dentist that you are using fluticasone and salmeterol.
o if you have been using a short-acting beta-agonist inhaler such as albuterol (Proventil, Ventolin) on a regular basis (for example, four times a day), your doctor will probably tell you to stop using it regularly when you start using fluticasone and salmeterol. Keep your other inhaler to use during an asthma attack.
o avoid exposure to chickenpox or measles. If you are exposed to these diseases or if you develop symptoms of these diseases, call your doctor without delay. You may need to get a vaccine to protect you from these infections.

Talk to your doctor about drinking grapefruit juice while taking this medicine.

Possible Adverse Effects:

Fluticasone and salmeterol may cause adverse effects. Inform your doctor if any of the following symptoms are severe or do not go away:

o runny nose
o sneezing
o sore throat
o hoarseness
o sinus pain
o cough
o headache
o upset stomach
o vomiting
o diarrhea
o stomach pain
o musculoskeletal pain
o throat irritation

Some adverse effects could be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor without delay:

o hand tremor, shaking hands
o hives (Urticaria)
o skin rash
o swelling of the face, throat, tongue, lips, hands, feet, ankles, or lower legs
o choking or difficulty swallowing
o increased difficulty breathing
o noisy, high-pitched breathing
o pounding or fast heartbeat
o chest pain
o nervousness
o blurred vision (Impaired vision)
o white patches in the mouth
o fever, chills, and other signs of infection

Fluticasone and salmeterol may cause children to grow more slowly. If your child is using fluticasone and salmeterol and does not seem to be growing properly, talk to your child's doctor.

Possible Symptoms of Overdose:

o seizures
o chest pain
o dizziness
o fainting
o blurred vision (Impaired vision)
o fast, pounding, or irregular heartbeat
o nervousness
o headache
o hand tremor, shaking hands
o muscle cramps or weakness
o dry mouth
o upset stomach
o dizziness
o extreme tiredness (fatigue)
o lack of energy
o difficulty falling asleep or staying asleep
o thirst
o flushing
o dry skin
o frequent urination
o loss of appetite (anorexia)
o problem with breathing
 

Brand Name(s):

o Advair Diskus®