Pulmicort

Pulmicort Flexhaler is a prescription medication used to maintain control of asthma and prevent asthma attacks. Pulmicort Flexhaler belongs to a group of drugs called corticosteroids which help to relieve asthma symptoms by decreasing inflammation.

This medication comes in a powder form that is to be inhaled through the mouth through the supplied Flexhaler device. Pulmicort Flexhaler is typically used twice daily.

Common side effects of Pulmicort Flexhaler include sore nose and throat, stuffy nose, and runny nose.

Pulmicort Flexhaler is a prescription medication used to maintain control of asthma and prevent asthma attacks.

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

• Astrazeneca

Serious side effects have been reported with Pulmicort Flexhaler. See the “Drug Precautions” section.

Common side effects reported by patients using Pulmicort Flexhaler include:

• sore nose and throat
• stuffy nose
• runny nose
• nausea
• hay fever
• viral infections of the upper respiratory tract
• viral irritation and inflammation of the stomach and intestine (gastroenteritis). Symptoms may include stomach area pain, diarrhea, nausea and vomiting, loss of appetite, headaches, and weakness.
• ear infections

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of Pulmicort Flexhaler. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using Pulmicort Flexhaler with certain other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

• a corticosteroid medicine
• anti-seizure medicine (anticonvulsants)
• medicines that suppress your immune system (immunosuppressant)
• ketoconazale (Nizoral)
• ritonavir (Norvir, Kaletra)
• atazanavir (Reyataz)
• clarithromycin (Biaxin)
• indinavir (Crixivan)
• itraconazole (Sporanox, Onmel)
• nefazodone
• nelfinavir (Viracept)
• saquinavir (Invirase)
• telithromycin (Ketek)

This is not a complete list of Pulmicort Flexhaler drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects of Pulmicort Flexhaler have been reported and include the following:

• Thrush (candida), a fungal infection in your mouth and throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
• Worsening of asthma or sudden asthma attacks.
• Allergic reactions. Tell your healthcare provider or get medical help right away if you have:
  • skin rash, redness or swelling
  • severe itching
  • swelling of the face, mouth, and tongue
  • trouble breathing or swallowing
  • chest pain
  • anxiety (feeling of doom)

• Immune system effects and a higher chance of infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using Pulmicort Flexhaler. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your healthcare provider about any signs of infection while you are using Pulmicort Flexhaler.
• Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency include: tiredness, weakness, nausea and vomiting and low blood pressure.
• Decrease in bone mineral density. Your healthcare provider should check you for this during treatment with Pulmicort Flexhaler.
• Slowed or delayed growth problems in children. A child’s growth should be checked regularly while using Pulmicort Flexhaler.
• Eye problems, including glaucoma and cataracts. You should have regular eye exams while using Pulmicort Flexhaler.
• Increased wheezing right after taking Pulmicort Flexhaler. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden wheezing. 

Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.

Pulmicort Flexhaler does not treat the symptoms of a sudden asthma attack. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms. If you do not have an inhaled, short-acting bronchodilator, call your healthcare provider to have one prescribed for you.

Do not use Pulmicort Flexhaler to treat sudden severe symptoms of asthma or if you have a severe allergy to milk proteins. Pulmicort Flexhaler contains a small amount of lactose (milk sugar). People with severe allergies to milk protein may have symptoms of an allergic reaction with Pulmicort Flexhaler including cough, wheezing, trouble breathing or feeling like your throat is closing.

Grapefruit and grapefruit juice may interact with Pulmicort Flexhaler and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before using Pulmicort Flexhaler tell your healthcare provider about all of your medical conditions and especially if you:

• are allergic to Pulmicort Flexhaler or any of its ingredients
• have or had chicken pox or measles, or have recently been near anyone with chicken pox or measles.
• Have or had tuberculosis of your respiratory tract.

• have liver problems
• have decreased bone mineral density.
• You are at risk for decreased bone mineral density if you:

• have a family history of osteoporosis
• are a woman going through menopause or are past menopause (“the change of life”)
• smoke or use tobacco
• do not eat well (poor nutrition)
• are elderly
• take bone thinning medicines (such as anticonvulsant medicines or corticosteroids) for a long time.
• have eye problems such as increased pressure in the eye, glaucoma, or cataracts
• are planning to have surgery
• are pregnant or plan to become pregnant. It is not known if Pulmicort Flexhaler may harm your unborn baby
• are breast-feeding or plan to breast-feed. Pulmicort Flexhaler can pass into breast milk. You and your healthcare provider should decide if you will use Pulmicort Flexhaler or breastfeed

• have certain kinds of serious infections that have not been treated, including:
  • fungal infections
  • bacterial infections
  • viral infections
  • parasitic infections
  • herpes simplex infection of the eye (ocular herpes simplex)

Pulmicort Flexhaler may not be right for people who have or had any of these types of infections.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using Pulmicort Flexhaler with certain other medicines may affect each other causing side effects.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Pulmicort Flexhaler will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

The active ingredient in Pulmicort Flexhaler is excreted in human breast milk. Because of the possibility for adverse reactions in nursing infants from Pulmicort Flexhaler, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Use Pulmicort Flexhaler exactly as prescribed by your healthcare provider. 

Pulmicort Flexhaler comes an inhalable dry powder to be used through the supplied Flexhaler device and is typically taken twice per day.

Rinse your mouth with water and spit the water out after each dose of Pulmicort Flexhaler. Do not swallow the water. This will lessen the chance of getting a fungal infection (thrush) in the mouth.

Do not change or stop any medicines used to control or treat your breathing problems, unless your healthcare provider tells you to. You must use Pulmicort Flexhaler regularly for it to work.

Be sure you know the difference between Pulmicort Flexhaler and any other inhaled medicines that are prescribed for you, including what you use them for (prescribed use) and what they look like.

Do not stop using Pulmicort Flexhaler, even if your symptoms get better. Your healthcare provider will change your medicines as needed.

Make sure you always have a short-acting beta 2-agonist medicine with you. Use your short-acting beta 2-agonist medicine if you have breathing problems between doses of Pulmicort Flexhaler or if a sudden asthma attack happens. Call your healthcare provider right away if:

• your short-acting rescue medicine does not work as well for relieving asthma symptoms.
• you need to use your short-acting rescue medicines more often than usual.
• your breathing problems worsen with Pulmicort Flexhaler.

If you use another inhaled medicine by mouth to treat your asthma, talk with your healthcare provider for instructions about when to use the other medicine and when to use your Pulmicort Flexhaler.

If you have used corticosteroid medicines for a long time and the dose is now being lowered or stopped, you should carry a medical alert card. The medical alert card should state that you may need increased corticosteroids during times of stress or during an asthma attack that does not get better with bronchodilator medicines.

Your healthcare provider may check your breathing, do blood tests and eye exams during treatment with Pulmicort Flexhaler.

If you miss a dose, just take your next regularly scheduled dose when it is due. Do not use Pulmicort Flexhaler more often or use more puffs than you have been prescribed.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

For patients 18 years of age and older, the recommended starting dosage is 360 mcg twice daily. In some adult patients, a starting dose of 180 mcg twice daily may be adequate. The maximum dosage should not exceed 720 mcg twice daily. 

For patients 6 to 17 years of age, the recommended starting dosage is 180 mcg twice daily. In some pediatric patients, a starting dose of 360 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Pulmicort Flexhaler at 68° to 77°F (20° to 25°C).
• Keep Pulmicort Flexhaler dry.
• Keep your Pulmicort Flexhaler with the cover tightly in place when not in use.
• Keep your Pulmicort Flexhaler and all medicines out of the reach of children.