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Pulmicort Respules

"Nov. 23, 2011 -- Daily inhaled steroids are currently recommended for preschoolers with frequent wheezing who have a high risk for developing persistent asthma or high risk for severe asthma, but the treatment may cause a small decrease in their "...

Pulmicort Respules

Pulmicort Respules

Pulmicort Respules Side Effects Center

Pharmacy Editor: Charles Patrick Davis, MD, PhD

Pulmicort respules consist of corticosteroid (budesonide) inhailer for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Pulmicort respules are available in the generic form termed budesonide. Common side effects are rhinitis, coughing, epistaxis, diarrhea and abdominal pain.

PULMICORT RESPULES (budesonide inhalation suspension) is available a sterile suspension for inhalation via jet nebulizer and is available in strengths of 0.25, 0.5, and 1 mg per 2 mL inside a respule ampule. Serious side effects include fungal infections (especially Candida spp), bacterial infections, severe allergic react ions, otitis media, endocrine disorders, growth disorders, eye disorders, depression and immune depression. This drug is not used for treatment of an acute asthma attack. Some researchers suggest the drug works no better than a placebo. Use in pregnancy should be done only if clearly needed. The drug and dosages are designed for use in the pediatric population ages 12 months to 8 years.

Our Pulmicourt Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Pulmicort Respules in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weakness, tired feeling, nausea, vomiting, feeling like you might pass out;
  • wheezing or breathing problems after using this medication;
  • worsening respiratory symptoms;
  • ear pain with fever;
  • vision problems; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Less serious side effects may include:

  • white patches or sores inside your mouth or on your lips;
  • runny or stuffy nose, sneezing;
  • sore throat, cough;
  • nausea, vomiting, diarrhea, stomach pain;
  • nosebleed; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Pulmicort Respules (Budesonide Inhalation Suspension) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Pulmicort Respules Overview - Patient Information: Side Effects

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.

Read the entire patient information overview for Pulmicort Respules (Budesonide Inhalation Suspension)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Pulmicort Respules FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Systemic and inhaled corticosteroid use may result in the following:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidence of common adverse reactions is based on three double-blind, placebo-controlled, randomized U.S. clinical trials in which 945 patients, 12 months to 8 years of age, (98 patients ≥ 12 months and < 2 years of age; 225 patients ≥ 2 and < 4 years of age; and 622 patients ≥ 4 and ≤ 8 years of age) were treated with PULMICORT RESPULES (budesonide inhalation suspension) (0.25 to 1 mg total daily dose for 12 weeks) or vehicle placebo. The incidence and nature of adverse events reported for PULMICORT RESPULES (budesonide inhalation suspension) was comparable to that reported for placebo. The following table shows the incidence of adverse events in U.S. controlled clinical trials, regardless of relationship to treatment, in patients previously receiving bronchodilators and/or inhaled corticosteroids. This population included a total of 605 male and 340 female patients and 78.4% were Caucasian, 13.8% African American, 5.5% Hispanic and 2.3% Other.

Table 1 : Adverse Reactions occurring at an incidence of ≥ 3% in at least one active treatment group where the incidence was higher with PULMICORT RESPULES (budesonide inhalation suspension) than placebo

Adverse Events Vehicle
Placebo
(n=227)
%
PULMICORT RESPULES Total Daily Dose

0.25 mg
(n=178)
%

0.5 mg
(n=223)
%

1 mg
(n=317)
%
Respiratory System Disorder
Respiratory Infection 36 34 35 38
Rhinitis 9 7 11 12
Coughing 5 5 9 8
Resistance Mechanism Disorders
Otitis Media 11 12 11 9
Viral Infection 3 4 5 3
Moniliasis 2 4 3 4
Gastrointestinal System Disorders
Gastroenteritis 4 5 5 5
Vomiting 3 2 4 4
Diarrhea 2 4 4 2
Abdominal Pain 2 3 2 3
Hearing and Vestibular Disorders
Ear Infection 4 2 4 5
Platelet, Bleeding and Clotting Disorders
Epistaxis 1 2 4 3
Vision Disorders
Conjunctivitis 2 < 1 4 2
Skin and Appendages Disorders
Rash 3 <1 4 2

The information below includes all adverse reactions by system organ class with an incidence of 1 to < 3%, in at least one PULMICORT RESPULES (budesonide inhalation suspension) treatment group where the incidence was higher with PULMICORT RESPULES (budesonide inhalation suspension) than with placebo, regardless of relationship to treatment.

Blood and lymphatic system disorders: cervical lymphadenopathy

Ear and labyrinth disorders: earache

General disorders and administration site conditions: fatigue, flu-like disorder

Immune system disorders: allergic reaction

Infections and infestations: eye infection, herpes simplex, external ear infection, infection

Injury, poisoning and procedural complication: fracture

Metabolism and nutrition disorders: anorexia

Musculoskeletal and connective tissue disorders: myalgia

Nervous system disorders: hyperkinesia

Psychiatric disorders: emotional lability

Respiratory, thoracic, and mediastinal disorders: chest pain, dysphonia, stridor

Skin and subcutaneous tissue disorders: contact dermatitis, eczema, pustular rash, pruritus, purpura

The incidence of reported adverse events was similar between the 447 PULMICORT RESPULES-treated (mean total daily dose 0.5 to 1 mg) and 223 conventional therapy-treated pediatric asthma patients followed for one year in three open-label studies.

Post-marketing Experience

The following adverse reactions have been reported during post-approval use of PULMICORT RESPULES (budesonide inhalation suspension) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Some of these adverse reactions may also have been observed in clinical studies with PULMICORT RESPULES (budesonide inhalation suspension) .

Endocrine disorders: symptoms of hypocorticism and hypercorticism [see WARNINGS AND PRECAUTIONS]

Eye disorders: cataracts, glaucoma, increased intraocular pressure [see WARNINGS AND PRECAUTIONS]

General disorders and administration site conditions: fever, pain

Immune system disorders: immediate and delayed hypersensitivity reactions including, anaphylaxis, angioedema, bronchospasm, rash, contact dermatitis, and urticaria [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]

Infection and Infestation: sinusitis, pharyngitis, bronchitis

Musculoskeletal and connective tissue disorders: avascular necrosis of the femoral head, osteoporosis, growth suppression

Nervous system disorders: headache

Psychiatric disorders: psychiatric symptoms including psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, and anxiety

Respiratory, thoracic, and mediastinal disorders: cough, dysphonia and throat irritation

Skin and subcutaneous tissue disorders: skin bruising, facial skin irritation

Cases of growth suppression have been reported for inhaled corticosteroids including post-marketing reports for PULMICORT RESPULES [see WARNINGS AND PRECAUTIONS and Use In Specific Populations, Pediatric Use].

Read the entire FDA prescribing information for Pulmicort Respules (Budesonide Inhalation Suspension) »

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Pulmicort Respules - User Reviews

Pulmicort Respules User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Pulmicort Respules sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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