Fluticasone and Salmeterol (Inhalation-Local)

Brand name(s): isk

Before Using This Medicine

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

Allergies-Tell your doctor if you have ever had any unusual or allergic reaction to fluticasone or salmeterol.

Pregnancy-The combination of fluticasone and salmeterol has not been studied in pregnant women. However, studies in animals have shown that the fluticasone and salmeterol causes problems. Before taking this medicine, make sure your doctor knows if you are pregnant or plan to become pregnant.

Breast-feeding-It is not known whether the combination of fluticasone and salmeterol passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children-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.

Older adults-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.

Other medicines-Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fluticasone and salmeterol, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Pamelor], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) or
• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])-Taking fluticasone and salmeterol while you are taking or within 2 weeks of taking MAO inhibitors may increase side effects

• Beta-adrenergic receptor blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], carvedilol [e.g., Coreg], celiprolol [e.g., Cardem], esmolol [e.g., Brevibloc], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Betapace], timolol [e.g., Blocadren])-Use of these medicines can block the beneficial effect of salmeterol

• Beta₂-adrenergic agonist, long lasting (e.g., Bitolterol mesylate)-You should not use additional salmeterol or other inhaled long-lasting beta₂-agonist

• Ritonavir (e.g. Norvir)-Use may increase your risk of fluticasone side effects

Other medical problems-The presence of other medical problems may affect the use of fluticasone and salmeterol combination. 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.

Last Revised: 02/14/2005