Pulmicort Respules

Pulmicort Respules is a prescription medication used in maintaining asthma control and preventing asthma attacks in children 12 months to 8 years of age. Pulmicort Respules belongs to a group of drugs called corticosteroids which relieve symptoms by decreasing inflammation.

This medication comes as a solution to be inhaled by mouth using a jet nebulizer machine. The oral (by mouth) inhalation form is typically used once or twice a day depending on what medication was used before. 

Common side effects of Pulmicort Respules include respiratory infections, runny nose, and cough. 

Pulmicort Respules is a prescription medication used in maintaining asthma control and preventing asthma attacks in children ages 12 months to 8 years. 

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 Respules. See the “Drug Precautions” section.

Common side effects reported by patients using Pulmicort Respules include:

• sore nose and throat
• stuffy nose
• runny nose
• cough
• viral infections 
• 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
• nosebleed
• pink eye
• rash

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 Respules. 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 Respules 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 Respules drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects of Pulmicort Respules 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. Rinse your child’s mouth with water and have him or her spit the water out after each Pulmicort Respules treatment. Do not swallow the water. This will lessen the chance of getting a fungal infection (thrush) in the mouth.
• 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 Respules. 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 Respules.
• 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 Respules.
• Slowed or delayed growth problems in children. A child’s growth should be checked regularly while using Pulmicort Respules.
• Eye problems, including glaucoma and cataracts. You should have regular eye exams while using Pulmicort Respules.
• Increased wheezing right after taking Pulmicort Respules. 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 Respules does not treat the sudden symptoms (wheezing, cough, shortness of breath, and chest pain or tightness) of an asthma attack. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms. If your child does not have an inhaled, short-acting bronchodilator, ask your healthcare provider to have one prescribed for your child.

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

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

Before your child uses Pulmicort Respules, tell your healthcare provider about all of your child's medical conditiona and especially if your child:

• has an allergy to Pulmicort Respules or any of its ingredients. 
• has or recently had chicken pox or measles, or has recently been near anyone with chicken pox or measles.
• has or had tuberculosis of the respiratory tract.

• has decreased bone mineral density (bone strength). Your child is at risk for decreased bone mineral density if he or she:

• has an eye problem such as increased pressure in the eye, glaucoma or cataracts.
• has liver problems
• is planning to have surgery.
• has any other medical conditions.
• is pregnant or plans to become pregnant. It is not known if Pulmicort Respules will harm your unborn baby.
• is breast-feeding or plans to breast-feed. Pulmicort Respules can pass into breast milk. You and your healthcare provider should decide if you will use Pulmicort Respules or breast-feed.

• is inactive for a long period of time
• has a family history of osteoporosis
• does not eat well (poor nutrition)
• takes bone thinning medicines (such as anticonvulsant medicines or corticosteroids) for a long time.

• has certain kinds of 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 Respules may not be right for children who have had any of these types of infections.

Tell your healthcare provider about all the medicine your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements.

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 Respules will harm your unborn baby.

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

The active ingredient in Pulmicort Respules is excreted in human breast milk. Because of the possibility for adverse reactions in nursing infants from Pulmicort Respules, 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 Respules exactly as prescribed by your healthcare provider. 

Pulmicort Respules is a liquid that is turned into a mist by a nebulizer and inhaled into the lungs and is typically taken once or twice daily. Rinse your child’s mouth with water and have him or her spit the water out after each Pulmicort Respules treatment. Do not swallow the water. This will lessen the chance of getting a fungal infection (thrush) in the mouth.

Pulmicort Respules is for inhaled use only. Use Pulmicort Respules with a jet nebulizer connected to an air compressor set up with a mouthpiece or face mask. Do not use an ultrasonic nebulizer to give Pulmicort Respules.

Do not stop using Pulmicort Respules, and do not change your child’s dose of Pulmicort Respules without talking to your healthcare provider. Your child must use Pulmicort Respules regularly for it to work

Improvement in the control of asthma symptoms with Pulmicort Respules can occur within 2-8 days. It may take up to 4-6 weeks before maximum improvement is seen.

Your healthcare provider may check your child’s blood, breathing and do eye exams while using Pulmicort Respules.

If your child has used long-term corticosteroids and the dose is now being lowered or stopped, a warning card should be carried stating that your child may need corticosteroids during times of stress or during an asthma attack that does not get better with bronchodilator medicines.

Make sure your child always has a short-acting beta 2-agonist medicine with him or her. Your child should use the short-acting beta 2-agonist medicine for breathing problems between doses of Pulmicort Respules or if a sudden asthma attack happens. Call your healthcare provider right away if:

• the short-acting rescue medicine does not work as well for relieving asthma symptoms.
• your child needs to use the short-acting rescue medicines more often than usual.
• your child’s breathing problems worsen with Pulmicort Respules

If your child misses a dose, just give the next regularly scheduled dose when it is due. Do not use Pulmicort Respules more often than has been prescribed.

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

The dose your doctor recommends may be based on what medication your child was taking before starting Pulmicort Respules.

Dosing recommendations based on previous therapy are as follows:

• Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily
• Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily
• Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily

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

• Store Pulmicort Respules in an upright position between 68°F to 77°F (20°C to 25°C).
• Keep Pulmicort Respules in the aluminium foil envelope to protect from light until ready to use.
• After a Pulmicort Respules ampule is opened it should be used right away.
• Pulmicort Respules ampules can be stored for 2 weeks after opening the protective aluminium foil envelope.
• Throw away Pulmicort Respules ampules if not used within 2 weeks of opening the protective aluminium foil envelope.
• Do not refrigerate or freeze.
• Keep Pulmicort Respules and all medicines out of the reach of children.