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.

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.

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.

This section provides information on the proper use of a number of products that contain budesonide. It may not be specific to Pulmicort. Please read with care.

Inhaled budesonide is used to prevent asthma attacks. It is not used to stop an attack that has already started. For relief of an asthma attack that has already started, you or your child should use another medicine. If you do not have another medicine to use for an acute asthma attack or if you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor. This medicine usually begins to work in about 24 to 48 hours, but up to 2 to 6 weeks may pass before you feel the full effects.

Do not change your dose or stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

When using the Pulmicort Flexhaler™:

• This medicine comes as a powder that you breathe into the lungs with a special inhaler that is placed in the mouth. It is used by adults, teenagers, and children who are 6 years of age and older.
• The medicine comes with patient instructions. Read the instructions carefully before using this medicine. If you or your child do not understand the instructions or are not sure how to use the inhaler, check with your doctor.
• When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Before using this medicine, test or prime it.
• Hold the inhaler so that the white cover points up, then twist the cover and lift it off. Hold the inhaler upright (mouthpiece up) using the brown grip, then twist the middle of the inhaler fully in one direction as far as it will go, and then back again in the other direction. You will hear a click. Repeat this process one more time.
• You do not have to prime it again after this, even if you have not used it for a long time.
• After the inhaler is primed, twist the cover and lift it off.
• To load a dose, hold the inhaler in the upright position, then twist the grip fully in one direction as far as it will go, and then fully back again in the other direction. You will hear a click.
• Turn your head away from the inhaler and breathe out. Do not shake the inhaler.
• Place the mouthpiece between your lips and breathe in deeply and forcefully. You may not taste or feel the medicine.
• Do not chew or bite on the mouthpiece.
• Remove the inhaler from your mouth and breathe out. Do not blow or breathe into the inhaler.
• Repeat these steps if more than one dose is needed.
• When you are finished, place the cover back on the inhaler and twist shut. Rinse your mouth with water and spit out the water. Do not swallow the water. This helps prevent hoarseness, throat irritation, and infections in the mouth.
• Do not use the inhaler if it has been damaged or if the mouthpiece has become detached.
• Do not use a spacer with the Pulmicort Flexhaler™.
• Keep the inhaler clean and dry at all times. Follow the patient directions for cleaning and storing the inhaler.
• The inhaler has a dose indicator that keeps track of how many times you can use the inhaler before you need to open a new one. Check the dose indicator just below the mouthpiece. The dose indicator usually starts with either the number 60 or 120 when full.
• Discard the whole device when all doses have been used. The inhaler is empty when the number zero appears in the middle of the dose indicator window. You will be given a new inhaler each time you refill your prescription.

When using the Pulmicort Respules® liquid:

• This medicine comes as a liquid that you breathe into the lungs with a special breathing machine called a jet nebulizer. The nebulizer has a face mask or mouthpiece. It is used by children who are 12 months to 8 years of age.
• Your doctor will tell you which type of nebulizer to use with this medicine and will show you how to use the nebulizer. The medicine and nebulizer come with patient instructions. Read the instructions carefully before using the medicine or the machine. If you or your child do not understand the instructions or are not sure how to use the nebulizer, check with your doctor.
• Use this medicine at the same time each day, unless your child's doctor tells you otherwise.
• Do not mix this liquid with other medicines.
• Open the sealed aluminum foil envelope containing the medicine. Remove one container from the strip of five plastic containers with sealed caps. Write the current date on the back of the envelope when you open the foil pouch.
• Each container has one dose of medicine.
• Place the unused containers back in the foil pouch. This will protect the medicine from light.
• Shake the container in a circular motion before using it.
• Hold the container upright and open it by twisting off the cap.
• Slowly squeeze out all of the contents of the container into the nebulizer cup. Throw the empty container away.
• If your child is using a face mask, make sure that the mask fits tightly on the face to avoid getting the medicine in the eyes.
• Turn on the compressor to begin nebulizing the medication. The nebulizer turns the medicine into a fine mist that the child breathes into the lungs using the mouthpiece or mask.
• After the dose is completed, wash your child's face to prevent skin irritation.
• Rinsing your child's mouth with water after each dose may help prevent hoarseness, throat irritation, and infections in the mouth. Do not allow your child to swallow the water after rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For preventing an asthma attack:
  • For inhalation dosage form (powder inhaler):
    • Adults and children 6 years of age and older—At first, one or two puffs two times a day. Your doctor may increase your dose as needed.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For inhalation dosage form (suspension in a nebulizer):
    • Children 12 months to 8 years of age—0.5 to 1 milligram (mg) in a nebulizer once a day, or divided and given twice a day. Each container of liquid has one dose and a new container is used for each dose.
    • Infants younger than 12 months of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Pulmicort Flexhaler™ in a dry place at room temperature with the cover tightly in place.

Store the unused Pulmicort Respules® in an upright position at room temperature. Keep the medicine containers in the foil pouch until you are ready to use them. Do not freeze the containers. Once you have opened a foil pouch, the containers will only be good for 2 weeks. Throw away any unused containers if it has been longer than 2 weeks since you opened the pouch.

Inhibitors of Cytochrome P450 3A4

The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the coadministration of Pulmicort RESPULES with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.12), Clinical Pharmacology (12.3)].

Pulmicort RESPULES is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose RESPULES ampules together with patient instructions for use. There are 30 RESPULES ampules in a carton. Each single-dose RESPULES ampule contains 2 mL of sterile liquid suspension.

Pulmicort RESPULES is available in three strengths, each containing 2 mL:

Pulmicort RESPULES should be stored upright at controlled room temperature 20-25°C (68-77°F) [see USP], and protected from light. When an envelope has been opened, the shelf life of the unused RESPULES ampules is 2 weeks when protected. After opening the aluminum foil envelope, the unused RESPULES ampules should be returned to the aluminum foil envelope to protect them from light. Any opened RESPULES ampule must be used promptly. Gently shake the RESPULES ampule using a circular motion before use. Keep out of reach of children. Do not freeze.

Pulmicort contains budesonide, a corticosteroid that prevents the release of substances in the body that cause inflammation.

Pulmicort is used to prevent asthma attacks in adults and children who are at least 6 years old.

Pulmicort may also be used for purposes not listed in this medication guide.

You should not use Pulmicort if you are allergic to budesonide, or if:

• you have a severe allergy to milk proteins; or

• you are having an asthma attack.

To make sure Pulmicort is safe for you, tell your doctor if you have:

• liver disease;

• osteoporosis, or low bone mineral density;

• glaucoma, cataracts, or herpes infection of the eyes;

• any type of infection caused by bacteria, fungus, virus, or parasite;

• food or drug allergies;

• a history of tuberculosis; or

• if you are malnourished, if you smoke, or if you are going through menopause.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.

Pulmicort is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Budesonide inhalation can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Pulmicort can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Pulmicort is not approved for use by anyone younger than 6 years old.

Applies to budesonide: oral capsule delayed release, oral capsule extended release, oral tablet extended release

Other dosage forms:

• inhalation aerosol liquid, inhalation aerosol powder, inhalation powder, inhalation solution, inhalation suspension
• rectal foam, rectal kit

Along with its needed effects, budesonide (the active ingredient contained in Pulmicort Turbuhaler) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking budesonide:

• Bruising easily
• chills
• colds
• cough or hoarseness
• fever
• flu-like symptoms
• sneezing
• sore throat

• Abdominal or stomach pain
• bladder pain
• bleeding after defecation
• bloody or cloudy urine
• blurred vision
• burning while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• convulsions
• cough producing mucus
• decreased urine
• diarrhea
• difficult or labored breathing
• difficult or painful urination
• dizziness
• dry mouth
• eye pain
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• general feeling of discomfort or illness
• headache
• heartburn
• increase in body movements
• increased thirst
• increased urge to urinate during the night
• irregular heartbeat
• joint pain
• loss of appetite
• lower back or side pain
• mood changes
• muscle aches and pains
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the chest, upper stomach, or throat
• pounding in the ears
• rectal bleeding
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• severe constipation
• shakiness in the legs, arms, hands, or feet
• shivering
• slow or fast heartbeat
• stomach cramps
• sweating
• swelling of the legs and feet
• swelling or puffiness of the face
• tightness in the chest
• trouble sleeping
• uncomfortable swelling around the anus
• unusual tiredness or weakness
• upper abdominal or stomach pain
• waking to urinate at night
• weight gain
• weight loss

• Bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• difficulty with swallowing
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects of budesonide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• blemishes on the skin
• heartburn
• indigestion
• pain or tenderness around the eyes and cheekbones
• pimples
• rounded or moon face
• stomach discomfort, upset, or pain
• stuffy nose

• Accumulation of pus
• agitation
• blistering, crusting, irritation, itching, or reddening of the skin
• bloated or full feeling
• change in hearing
• changes in vision
• cracked, dry, or scaly skin
• cracks in the skin at the corners of mouth
• difficulty having a bowel movement (stool)
• difficulty with moving
• dizziness or lightheadedness
• ear drainage
• earache or pain in the ear
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• increased appetite
• increased hair growth, especially on the face
• lack or loss of strength
• loss of memory
• muscle pains or stiffness
• nervousness
• pain, swelling, or redness in the joints
• passing gas
• pinpoint red or purple spots on the skin
• pressure in the stomach
• problems with memory
• redness, swelling, or soreness of the tongue
• sensation of spinning
• skin rash
• skin rash, encrusted, scaly, and oozing
• sleepiness or unusual drowsiness
• soreness or redness around the fingernails and toenails
• swelling of the abdominal or stomach area
• swollen joints
• uterine bleeding between menstrual periods