Fluticasone and Salmeterol

(floo TIK a sone & sal ME te role)

What key warnings do I need to know about before giving this drug to my child?

• When changing from an oral steroid to a breathed in one, there may be problems. Signs such as weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your child's doctor right away if any of these signs happen. If your child has a bad crash and is hurt, has surgery, or any infection, he/she may need extra doses of oral steroids. These extra steroids will help your child's body deal with these extra stresses. Have your child wear medical alert ID (identification).
• In patients with asthma, long-acting puffers (inhalers) raised asthma-related deaths. Talk with the doctor.
• Long-acting puffers (inhalers) may add to asthma-related hospital stays in children and teens. Talk with the doctor.
• Sometimes drugs are not safe when your child takes them with other drugs. Taking them together can cause bad side effects. This is one of those drugs. Be sure to talk to your child’s doctor about all the drugs your child takes.
• This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled.

Is it safe for my child to take this drug?

• Not if your child has an allergy to fluticasone, salmeterol, or any other part of this drug.
• Be sure to let the doctor know if your child has any allergies or side effects to drugs, foods, or dyes. Make sure to tell about the allergy and what signs your child had. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• Not if your child is having a breathing attack.
• If your child is allergic to milk, talk with the doctor.

Why does my child need this drug?

• It is used to treat asthma.
• It is used to open the airways in lung diseases where spasm may cause breathing problems.

How is this drug given?

• For breathing in only.
• Shake Advair® HFA well before use.
• If your child is using more than 1 puffer (inhaler), ask the doctor which puffer to use first.
• Prepare puffer (inhaler) before first use or when puffer has not been used for more than 4 weeks. Spray 4 test sprays into the air.
• Have your child rinse out mouth after each use.
• Check your child's puffer (inhaler) use with the doctor at each visit. Read and follow facts on how to use the puffer. Make sure your child's uses the puffer the right way.

How long does this drug take to work?

• Your child may start feeling better a few days after starting this drug.
• It may take a few weeks to see the full effect from the puffer (inhaler).

What do I do if my child misses a dose?

• Give a missed dose as soon as you think about it.
• If it is close to the time for your child's next dose, skip the missed dose and go back to your child's normal time.
• Do not give 2 doses or extra doses.
• Do not change the dose or stop your child's drug. Talk with your child's doctor.

What safety measures do I need to take when my child is using this drug?

• Have your child wear disease medical alert ID (identification).
• Do not give this drug to treat an asthma attack. Use a short-acting puffer (inhaler).
• If your child has high blood sugar (diabetes), talk with the doctor.
• If your child has a fast heartbeat, talk with your child's doctor.
• If your child has heart disease, talk with the doctor.
• If your child has high blood pressure, talk with the doctor.
• If your child has liver disease, talk with the doctor.
• If your child has an overactive thyroid, talk with the doctor.
• If your child has seizures, talk with the doctor.
• If your child is being treated for any infection, talk with the doctor.
• Check all drugs your child is taking with your child's doctor. This drug may not mix well with some other drugs.
• Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
• If your child drinks grapefruit juice or eats grapefruit often, talk with your child's doctor.
• Limit your child's use of caffeine and chocolate. Use with this drug may cause nervousness, shakiness, and a fast heartbeat.
• This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.

What are some side effects of this drug?

• Headache.
• Upset stomach or throwing up. Many small meals and good mouth care may help. Older children may suck hard, sugar-free candy.
• Cough.
• Throat irritation.

When do I need to call my child's doctor?

• If any of this news causes you to be worried, any of the unwanted side effects happen, or if your child is not better after taking this drug.
• If you think there has been an overdose, call 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room (ER) right away.http://www.aapcc.org), or emergency room (ER) right away.
• If your child shows signs of a very bad reaction, call your child's doctor or the ER right away. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; swelling of face, lips, tongue, or throat; or if your child is not acting normal.
• If your child shows any signs of infection. These include a fever of 100.5°F (38°C) or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color or sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
• If your child is feeling very tired, weak, or touchy; is trembling; has a fast heartbeat, confusion, sweating, or dizziness if a dose was missed or the drug was recently stopped.
• If your child has chest pain or pressure or a fast heartbeat.
• If your child is not able to get the breathing attack under control.
• If your child is using his/her short-acting puffer (inhaler) more.
• If your child has a peak flow measurement that is low.
• If your child has trouble breathing.
• If your child has very bad mouth irritation.
• If your child is feeling very nervous and excitable.
• If your child has been exposed to chickenpox or measles and has not had chickenpox or measles or had a chickenpox or measles vaccine.
• If your child gets a rash.
• If your child’s health problem does not get better or if you believe your child’s health problem is worse.

How do I store and/or throw out this drug?

• Store at room temperature.
• Advair® Diskus®: Throw away any part not used after 1 month or when the indicator reads zero, whichever comes first.
• Advair® HFA: Throw away when the indicator reads zero.
• Protect from heat.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.

General drug facts

• If your child has a very bad allergy, he/she needs to wear an allergy ID at all times.
• You may get this drug by drug order only. If there are refills, call your pharmacy. If your child does not have refills left, you may need to call your child's doctor.
• Get rid of this drug when your child no longer needs it or if the drug is outdated.
• If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.
• In Canada, take any unused drugs to the pharmacy. Also, visit http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/disposal-defaire-eng.php#th to learn about the right way to get rid of unused drugs.http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/disposal-defaire-eng.php#th to learn about the right way to get rid of unused drugs.
• Do not share your child's drug with others and do not give anyone else's drug to your child.
• Keep all drugs out of the reach of children and pets.
• Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
• These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
• Talk with the doctor before giving your child any new drug, including OTC, natural products, or vitamins.
• If you do not use a drug the right way, it may not be safe. Follow what your child’s doctor tells you.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only your healthcare provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your healthcare provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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