Pulmicort Turbuhaler

PULMICORT TURBUHALER (budesonide) consists of a number of assembled plastic details, the main parts being the dosing mechanism, the storage unit for drug substance and the mouthpiece. The inhaler is protected by a white outer tubular cover screwed onto the inhaler. The body of the inhaler is white and the turning grip is brown. The following wording is printed on the grip in raised lettering, “Pulmicort™ 200 mcg”. The TURBUHALER inhaler cannot be refilled and should be discarded when empty.

PULMICORT TURBUHALER (budesonide) is available as 200 mcg/dose, 200 doses (NDC 0186-0915-42) and has a target fill weight of 104 mg.

When there are 20 doses remaining in PULMICORT TURBUHALER (budesonide) , a red mark will appear in the indicator window. If the unit is used beyond the point at which the red mark appears at the bottom of the window, the correct amount of medication may not be obtained. The unit should be discarded.

Store with the cover tightened in a dry place at controlled room temperature 20-25°C (68-77°F) [see USP]. Keep out of the reach of children.

All trademarks are the property of the AstraZeneca group of companies. ©AstraZeneca 2001, 2006. Manufactured for: AstraZeneca LP, Wilmington, DE 19850 By: AstraZeneca AB, Sodertalje, Sweden 33020-00. Rev. 10/06. FDA Rev date: 8/20/2007

Particular care is needed for patients who are transferred from systemically active corticosteroids to PULMICORT TURBUHALER (budesonide) because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although PULMICORT TURBUHALER (budesonide) may provide control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.

During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a medical identification card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack.

Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to PULMICORT TURBUHALER (budesonide) . Lung function (FEV1 or AM PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to PULMICORT TURBUHALER (budesonide) may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, eg, rhinitis, conjunctivitis, arthritis, eosinophilic conditions, and eczema (see DOSAGE AND ADMINISTRATION).

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible pediatric patients or adults on immunosuppressant doses of corticosteroids. In pediatric or adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered.

PULMICORT TURBUHALER (budesonide) is not a bronchodilator and is not indicated for rapid relief of bronchospasm or other acute episodes of asthma.

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with PULMICORT TURBUHALER (budesonide) , it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with PULMICORT TURBUHALER (budesonide) should be discontinued and alternate therapy instituted.

Patients should be instructed to contact their physician immediately when episodes of asthma not responsive to their usual doses of bronchodilators occur during treatment with PULMICORT TURBUHALER (budesonide) . During such episodes, patients may require therapy with oral corticosteroids.

The following adverse reactions were reported in patients treated with PULMICORT TURBUHALER (budesonide) .

The incidence of common adverse events is based upon double-blind, placebo-controlled US clinical trials in which 1116 adult and pediatric patients age 6-70 years (472 females and 644 males) were treated with PULMICORT TURBUHALER (budesonide) (200 to 800 mcg twice daily for 12 to 20 weeks) or placebo.

The following table shows the incidence of adverse events in patients previously receiving bronchodilators and/or inhaled corticosteroids in US controlled clinical trials. This population included 232 male and 62 female pediatric patients (age 6 to 17 years) and 332 male and 331 female adult patients (age 18 years and greater).

Adverse Events with ≥ 3% Incidence reported by Patients on PULMICORT TURBUHALER (budesonide)

The table above includes all events (whether considered drug-related or non-drug-related by the investigators) that occurred at a rate of ≥3% in any one PULMICORT TURBUHALER (budesonide) group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for PULMICORT TURBUHALER (budesonide) patients should be taken into account.

The following other adverse events occurred in these clinical trials using PULMICORT TURBUHALER (budesonide) with an incidence of 1 to 3% and were more common on PULMICORT TURBUHALER (budesonide) than on placebo.

Body As A Whole:neck pain

Cardiovascular: syncope

Digestive: abdominal pain, dry mouth, vomiting

Metabolic and Nutritional: weight gain

Musculoskeletal: fracture, myalgia

Nervous: hypertonia, migraine

Platelet, Bleeding and Clotting: ecchymosis

Psychiatric: insomnia

Resistance Mechanisms: infection

Special Senses: taste perversion

In a 20-week trial in adult asthmatics who previously required oral corticosteroids, the effects of PULMICORT TURBUHALER (budesonide) 400 mcg twice daily (N=53) and 800 mcg twice daily (N=53) were compared with placebo (N=53) on the frequency of reported adverse events. Adverse events, whether considered drug-related or non-drug-related by the investigators, reported in more than five patients in the PULMICORT TURBUHALER (budesonide) group and which occurred more frequently with PULMICORT TURBUHALER (budesonide) than placebo are shown below (% PULMICORT TURBUHALER (budesonide) and % placebo). In considering these data, the increased average duration of exposure for PULMICORT TURBUHALER (budesonide) patients (78 days for PULMICORT TURBUHALER (budesonide) vs. 41 days for placebo) should be taken into account.

Patients Receiving PULMICORT TURBUHALER (budesonide) Once Daily

The adverse event profile of once-daily administration of PULMICORT TURBUHALER (budesonide) 200 mcg and 400 mcg, and placebo, was evaluated in 309 adult asthmatic patients in an 18-week study. The study population included both patients previously treated with inhaled corticosteroids, and patients not previously receiving corticosteroid therapy. There was no clinically relevant difference in the pattern of adverse events following once-daily administration of PULMICORT TURBUHALER (budesonide) when compared with twice-daily dosing.

Pediatric Studies: In a 12-week placebo-controlled trial in 404 pediatric patients 6 to 18 years of age previously maintained on inhaled corticosteroids, the frequency of adverse events for each age category (6 to 12 years, 13 to 18 years) was comparable for PULMICORT TURBUHALER (budesonide) (at 100, 200 and 400 mcg twice daily) and placebo. There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.

Adverse Event Reports From Other Sources: Rare adverse events reported in the published literature or from worldwide marketing experience with any formulation of inhaled budesonide include: immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety and psychosis.

Read the entire FDA prescribing information for Pulmicort Turbuhaler (Budesonide)

Pulmicort Turbuhaler is part of the drug class:

• Corticosteroids acting locally

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

Common side effects reported by patients using Pulmicort Turbuhaler include:

• Respiratory infection
• Inflammation of the throat and nose
• Changes in voice
• Headache
• Flu syndrome
• Pain
• Back pain
• Fever
• Fungal infection in the mouth
• Acid indigestion
• Stomach Flu
• Nausea

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

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

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

Before using Pulmicort Turbuhaler tell your healthcare provider if you:

• are allergic to any ingredients in Pulmicort Turbuhaler
• 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 certain kinds of serious infections that have not been treated, including:
  • fungal infections
  • bacterial infections
  • viral infections
  • parasitic infections
• have recently had surgery or an injury to your nose
• herpes simplex infection of the eye (ocular herpes simplex)
• have eye problems such as increased pressure in the eye, glaucoma, or cataracts
• are planning to have surgery
• have liver problems
• have decreased bone mineral density

You are at risk for decreased bone mineral density if you:

• are inactive for a long period of time
• have a family history of osteoporosis
• are a woman going through menopause or are past menopause
• 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

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

Use Pulmicort Turbuhaler exactly as prescribed by your healthcare provider. 

• You must use Pulmicort Turbuhaler regularly for it to work.
• Be sure you know the difference between Pulmicort Turbuhaler 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 Turbuhaler, even if your symptoms get better. Your healthcare provider will change your medicines as needed.
• Do not change or stop any medicines used to control or treat your breathing problems, unless your healthcare provider tells you to.
• Rinse your mouth with water and spit the water out after each dose of Pulmicort Turbuhaler. Do not swallow the water. This will lessen the chance of getting a fungal infection (thrush) in the mouth.
• If you miss a dose, just take your next regularly scheduled dose when it is due. Do not use Pulmicort Turbuhaler more often or use more puffs than you have been prescribed.
• Make sure you always have a short-acting beta2-agonist medicine with you. Use your short acting beta2-agonist medicine if you have breathing problems between doses of Pulmicort Turbuhaler or if a sudden asthma attack happens.

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 the previous medication you were taking.

The recommended starting dose is based on previous therapy are as follows:

Adults

• Bronchodilators alone: 200-400 mcg twice daily
• Inhaled corticosteroids: 200-400 mcg twice daily 
• Oral corticosteroids: 400-800 mcg twice daily

Children

• Bronchodilators alone: 200 mcg twice daily
• Inhaled corticosteroids: 200 mcg twice daily 
• Oral corticosteroids: up to 400 mcg twice 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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Respules® in children 12 months to 8 years of age. However, safety and efficacy have not been established in children younger than 12 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Flexhaler™ in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving inhaled budesonide.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bemiparin
• Boceprevir
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Clonixin
• Cobicistat
• Conivaptan
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Idelalisib
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pixantrone
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Telaprevir
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin
• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute—Should not be used in patients with this condition.

• Bone problems (e.g., osteoporosis) or
• Cataracts or
• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox, including recent exposure or
• Measles or
• Herpes simplex virus infection of the eye or
• Infections (virus, bacteria, or fungus) or
• Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.

• Milk protein allergy, severe—Use with caution. The Pulmicort Flexhaler™ contains lactose (milk sugar with milk protein), which may cause side effects for patients with this condition.