Pulmicort Flexhaler

Budesonide, the active component of PULMICORT FLEXHALER (budesonide inhalation powder) , is a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20dione cyclic 16,17-acetal with butyraldehyde. Budesonide is Viprofil provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C₂₅H₃₄O₆ and its molecular weight is 430.5. Its structural formula is:

Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 10³.

PULMICORT FLEXHALER (budesonide inhalation powder) is an inhalation-driven multi-dose dry powder inhaler containing a formulation of 1 mg per actuation of micronized budesonide and micronized lactose monohydrate which contains trace levels of milk proteins [see CONTRAINDICATIONS and Post-marketing Experience]. Each actuation of PULMICORT FLEXHALER (budesonide inhalation powder) 180 mcg delivers 160 mcg budesonide from the mouthpiece and each actuation of PULMICORT FLEXHALER 90 mcg delivers 80 mcg budesonide from the mouthpiece (based on in vitro testing at 60 L/min for 2 sec). Each PULMICORT FLEXHALER (budesonide inhalation powder) 180 mcg contains 120 actuations and each PULMICORT FLEXHALER (budesonide inhalation powder) 90 mcg contains 60 actuations.

In vitro testing has shown that the dose delivery for PULMICORT FLEXHALER (budesonide inhalation powder) is dependent on airflow through the device, as evidenced by a decrease in the fine particle dose at a flow rate of 30 L/min to a value that is approximately 40 - 50% of that produced at 60 L/min. At a flow rate of 40 L/min, the fine particle dose is approximately 70% of that produced at 60 L/min. Patient factors such as inspiratory flow rates will also affect the dose delivered to the lungs of patients in actual use [see PATIENT INFORMATION and Instructions for Use]. In asthmatic children age 6 to 17 (N=516, FEV₁ 2.29 [0.97– 4.28]) peak inspiratory flow (PIF) through PULMICORT FLEXHALER (budesonide inhalation powder) was 72.5 [19.1 – 103.6] L/min). Inspiratory flows were not measured in the adult pivotal study. Patients should be carefully instructed on the use of this drug product to assure optimal dose delivery.

SIDE EFFECTS:See also Precautions section.

Dry/irritated throat, hoarseness, voice changes, bad taste in the mouth, runny nose, or nosebleeds may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and seek immediate medical attention.

Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as ear pain, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush (yeast infection). Contact your doctor if you notice white patches in your mouth or on your tongue.

Tell your doctor immediately if any of these rare but serious side effects occur: unusual tiredness, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, increased thirst/urination.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:Before using budesonide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as lactose, milk proteins found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), high blood pressure, liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Budesonide may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

Tell your doctor if you are pregnant before using this medication. Infants born to mothers who have used corticosteroids for a long time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness.

This drug passes into breast milk and may have undesirable effects in a nursing infant. Consult your doctor before breast-feeding.

Pulmicort (budesonide)

How does it work?

Pulmicort CFC-free inhalers, respules and turbohalers all contains the active ingredient budesonide, which is a type of medicine known as a corticosteroid.

Corticosteroids are hormones that are produced naturally by the adrenal glands. They have many important functions, including control of inflammatory responses. Budesonide is a synthetic (man-made) corticosteroid and is used to decrease inflammation in the lungs Vistagra. (NB. Corticosteroids are often simply called steroids, but it should be noted that they are very different from another group of steroids, called anabolic steroids, which have gained notoriety because of their abuse by some athletes and body builders.)

When budesonide is inhaled it is absorbed into the cells of the lungs and airways. Here it works by preventing the release of certain chemicals from the cells. These chemicals are important in the immune system and are normally involved in producing immune and allergic responses that result in inflammation. By decreasing the release of these chemicals in the lungs and airways, inflammation is reduced.

Budesonide is taken using an inhaler device to treat asthma. Inhaling the budesonide allows it to act directly in the lungs where it is needed. It also reduces the potential for side effects in other parts of the body, as the amount absorbed into the blood through the lungs is lower than if the medicines are taken by mouth.

Pulmicort respules are inhaled into the lungs using a nebuliser device. A nebuliser is a machine that converts the liquid medicine inside the respules into particles that can be inhaled. This is helpful for people who cannot use inhalers or turbohalers.

In asthma, and in chronic obstructive airways disease (COPD) such as chronic bronchitis, the airways tighten due to inflammation and can also be blocked by mucus. This can make it difficult for air to get into and out of the lungs.

Budesonide is used in asthma, to prevent the inflammation and excess mucus formation, and therefore help prevent asthma attacks and shortness of breath.

What is it used for?

• Asthma

Warning!

• March 2011: Pulmicort CFC-free inhalers have been discontinued by AstraZeneca. This is due to problems with the manufacture of the inhalers and is not due to any safety issues. You can keep using any inhalers you have, but when they have run out your doctor will need to change you to a different inhaler.
• Inhaling corticosteroids can sometimes cause a fungal infection in the mouth called oral thrush. To minimise the risk of this, you should rinse your mouth with water after you use this inhaler. Consult your doctor if you develop white patches in your mouth or throat, as these are symptoms of thrush and it may need to be treated.
• Inhaled corticosteroids have considerably fewer side effects than steroids taken by mouth. However, when taken for long periods of time at high doses, inhaled steroids do have the potential to cause side effects such as glaucoma,cataracts, thinning of the bones (osteoporosis), slowed growth in children and adolescents, and to suppress the functioning of the adrenal glands (glands that produce natural steroid hormones). For this reason your doctor will prescribe the lowest effective dose to control your symptoms, and monitor for these side effects. Do not exceed the dose that your doctor has prescribed. It is recommended that children receiving long-term treatment with corticosteroids have their growth monitored. If a child's growth appears to be slowed your doctor may refer them to a paediatrician. For further information talk to your doctor or pharmacist.
• This medicine may cause an unexpected increase in wheezing (paradoxical bronchospasm) immediately after use. If this happens, stop using it immediately and consult your doctor. The medicine should be stopped and an alternative treatment found.
• This medicine should be used regularly to prevent asthma attacks. Unless your doctor tells you otherwise, you should not suddenly stop using this medicine, even if your asthma seems better. The medicine helps keep your asthma under control and stopping it may make your asthma worse again. If you have been prescribed a separate reliever inhaler you should make sure you carry that with you at all times to relieve shortness of breath if needed.

Use with caution in

• People suffering from cold or chest infection.
• Bacterial, fungal or viral infections of the airways.
• Tuberculosis affecting the lungs.
• People with liver problems.

Not to be used in

• Children under two years of age.

This medicine should not be used if you are allergic to one of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine should be used with caution during pregnancy. However, it is important that asthma is well controlled in pregnant women. Wherever possible, asthma medications should be taken by inhaler, as this minimises the amount of medicine that enters the bloodstream and crosses the placenta to the baby. Seek medical advice from your doctor.
• In general, the amount of corticosteroid that passes into the breast milk after using an inhaler is negligable and probably too small to be harmful to the baby. However, you should seek medical advice from your doctor before breastfeeding while using this medicine.

Label warnings

• Do not stop taking this medication except on your doctor's advice.
• Follow the printed instructions you have been given with this medication.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Fungal infection of the mouth or throat (oral thrush).
• Cough and hoarseness.
• Throat irritation.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Nervousness.
• Restlessness.
• Depression.
• Behavioural disturbances.
• Bruising of the skin.
• Hypersensitivity reactions such as swelling of the lips, throat and tongue (angioedema), itchy blistering rash or anaphylactic shock.

After prolonged use at high doses

• Thinning of the bones (osteoporosis) and increased risk of breaking a bone.
• Effects on the eyes, such as raised pressure inside the eye (glaucoma), cataracts.
• Decrease in the production of natural steroids by the adrenal glands (adrenal suppression).
• Slowed growth in children and adolescents.
• Cushing's syndrome, characterised by a moon-shaped face.
• Increased susceptibility to infections and increased severity of infections.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you have treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines after having treatment with this one, to make sure that the combination is safe.

Budesonide can potentially cause a serious decrease in the levels of potassium in the blood (hypokalaemia), which may result in adverse effects. This effect can be increased by the following medicines, which can also lower potassium in the blood:

• xanthine derivates, such as theophylline or aminophylline
• corticosteroids, such as beclometasone and prednisolone
• other beta 2 agonists, such as salmeterol
• diuretics, such as bendroflumethiazide and furosemide.

This is why people with severe asthma or COPD, who may be taking several of these medicines, should have their blood potassium levels monitored regularly.

The following medicines may reduce the removal of budesonide from the body and so may increase its effects or side effects:

• ciclosporin
• itraconazole
• ketoconazole
• protease inhibitors, eg ritonavir.

Other medicines containing the same active ingredient