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.

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.

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.

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.

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.

Pulmicort oral inhalation is not intended for rapid relief of asthma attacks.

Albuterol, or a similar bronchodilator used for rapid relief of breathing difficulties, may be used several minutes before Pulmicort oral inhalation to help get Pulmicort into the deeper parts of your lungs.

Pulmicort and other inhaled steroids can cause glaucoma or cataracts. 

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