Budesonide Teva Pharma: Uses, Dosage & Side Effects
Nebulizer suspension – Inhaled corticosteroid for asthma, croup and COPD
Quick Facts: Budesonide Teva Pharma
Key Takeaways
- Preventive, not rescue: Budesonide Teva Pharma prevents asthma symptoms through regular use – it cannot relieve an acute asthma attack
- Rinse your mouth: Always rinse your mouth with water after each use to prevent oral thrush (candidiasis) and hoarseness
- Use a jet nebulizer only: Do not use an ultrasonic nebulizer – the medication must be delivered via a jet nebulizer with mouthpiece or face mask
- Full effect takes time: Improvement may begin within 3 days, but full therapeutic benefit requires 2 to 4 weeks of regular use
- Monitor children's growth: Long-term use in children may slow growth rate – regular height monitoring by the doctor is recommended
What Is Budesonide Teva Pharma and What Is It Used For?
Budesonide Teva Pharma is a nebulizer suspension containing the inhaled corticosteroid budesonide, used to treat and prevent airway inflammation in asthma, severe croup in children, and COPD exacerbations. It belongs to a group of steroids called glucocorticosteroids that reduce swelling in the lungs.
Budesonide is one of the most widely prescribed inhaled corticosteroids worldwide. It works by reducing inflammation in the airways, which is the underlying cause of symptoms in asthma and other obstructive airway diseases. Unlike quick-relief bronchodilators that open the airways immediately, budesonide is a controller medication that must be used regularly to maintain its protective effect.
Budesonide Teva Pharma is delivered as a suspension for nebulization, meaning the liquid medication is converted into a fine mist by a jet nebulizer and inhaled through a mouthpiece or face mask. This delivery method is particularly useful for patients who cannot use standard inhalers effectively, such as young children, elderly patients, or those with severe airway obstruction who cannot generate sufficient inspiratory flow for dry powder inhalers.
The medication can be used by adults, adolescents, and children from 6 months of age. It is approved for the following indications:
- Asthma: Maintenance treatment for patients where other types of inhalers (metered-dose inhalers or dry powder inhalers) are unsuitable or insufficiently effective
- Severe croup (laryngotracheitis): Hospital treatment for infants and children with acute, severe croup causing significant breathing difficulties
- COPD exacerbations: Short-term alternative to systemic corticosteroids (tablets or injections), used for a maximum of 10 consecutive days
Budesonide exerts its anti-inflammatory effect by binding to glucocorticoid receptors in the airway epithelium. This suppresses the production of inflammatory cytokines, reduces the migration of inflammatory cells (such as eosinophils and mast cells) to the airways, and inhibits the release of chemical mediators that cause bronchospasm and mucus hypersecretion. The result is reduced airway swelling, less mucus production, and decreased sensitivity to triggers. According to the Global Initiative for Asthma (GINA) 2024 guidelines, inhaled corticosteroids like budesonide are the cornerstone of asthma management at all severity levels.
Budesonide has a relatively high topical potency with comparatively low systemic bioavailability, meaning it delivers a strong anti-inflammatory effect locally in the lungs while minimizing the risk of systemic side effects that are commonly associated with oral corticosteroids. When absorbed into the bloodstream, budesonide is rapidly metabolized by the liver, further reducing systemic exposure.
What Should You Know Before Taking Budesonide Teva Pharma?
Before using Budesonide Teva Pharma, inform your doctor about any history of tuberculosis, liver disease, or active respiratory infections. Do not use this medication if you are allergic to budesonide. This is a preventive medicine – it must not be used to treat an acute asthma attack.
Contraindications
Do not use Budesonide Teva Pharma if you are allergic (hypersensitive) to budesonide or any of the other ingredients in the medication. The inactive ingredients include disodium edetate, sodium chloride, polysorbate 80, citric acid monohydrate, sodium citrate, and water for injections. If you have previously experienced an allergic reaction to any inhaled corticosteroid, discuss this with your doctor before starting treatment.
Warnings and Precautions
Talk to your doctor before using Budesonide Teva Pharma if any of the following apply to you:
- Tuberculosis (TB): You have or have had pulmonary tuberculosis, as corticosteroids may reactivate latent TB infection
- Liver disease: You have or have had liver problems, as impaired liver function can increase systemic exposure to budesonide, potentially leading to stronger effects and more side effects
- Respiratory infections: You have a fungal, viral, or bacterial infection of the airways (such as a cold or chest infection), as these may require additional treatment
- Switching from oral corticosteroids: If you are transitioning from corticosteroid tablets (such as prednisolone) to nebulized budesonide, you may experience withdrawal symptoms including muscle and joint pain, fatigue, headache, nausea, and vomiting while your body adjusts
- Allergic conditions: Switching from oral corticosteroids may unmask pre-existing allergic conditions (such as rhinitis or eczema) that were previously suppressed by the systemic anti-inflammatory effect of the tablets
- Visual disturbances: Contact your doctor if you experience blurred vision or other visual problems during treatment, as inhaled corticosteroids may rarely contribute to cataracts or glaucoma
Budesonide Teva Pharma nebulizer suspension is not suitable for treating acute asthma attacks. If you experience a sudden worsening of asthma symptoms such as severe breathlessness and wheezing, use your quick-relief bronchodilator (rescue inhaler) immediately. If you develop paradoxical bronchospasm (wheezing immediately after using budesonide), stop the medication and contact your doctor at once.
Children and Adolescents
In rare cases, long-term treatment with budesonide may slow the growth rate in children and adolescents. Research published in the New England Journal of Medicine has shown that the effect on final adult height is generally small (approximately 1 cm reduction), but regular growth monitoring is recommended. If your child uses this medication for an extended period, the doctor will want to check your child's height regularly.
To minimize the risk of oral side effects, children should rinse their mouth with water after each dose. When using a face mask for inhalation, the risk of facial skin irritation can be reduced by using a mouthpiece instead. Alternatively, apply a thin layer of petroleum jelly to the skin covered by the face mask before inhalation, and wash it off afterward.
Pregnancy and Breastfeeding
Inhaled budesonide is generally considered acceptable for use during pregnancy. Extensive post-marketing surveillance data and epidemiological studies have not shown an increased risk of birth defects associated with inhaled budesonide use during pregnancy. The GINA guidelines and the World Health Organization emphasize that adequate asthma control during pregnancy is critical, as poorly controlled asthma poses significant risks to both mother and fetus, including pre-eclampsia, premature birth, and low birth weight.
The lowest effective dose of Budesonide Teva Pharma that maintains adequate asthma control should be used during pregnancy. If you become pregnant while using this medication, consult your doctor – do not stop the medication abruptly.
Budesonide passes into breast milk in small amounts. At therapeutic doses, effects on the breastfed infant are not expected. If you are breastfeeding, you do not need to stop using Budesonide Teva Pharma. The European Medicines Agency (EMA) and the British National Formulary (BNF) confirm that inhaled budesonide is compatible with breastfeeding.
Driving and Operating Machinery
Budesonide Teva Pharma does not affect the ability to drive or operate machinery. However, you should be aware of potential side effects such as blurred vision (uncommon) and assess your own fitness to drive.
How Does Budesonide Teva Pharma Interact with Other Drugs?
Budesonide can interact with several medications that inhibit the CYP3A4 enzyme, including HIV antivirals (ritonavir, cobicistat), antifungals (ketoconazole, itraconazole), and certain antibiotics (erythromycin, clarithromycin). These drugs can significantly increase budesonide blood levels and the risk of systemic side effects.
Budesonide is primarily metabolized by the liver enzyme CYP3A4. Medications that inhibit this enzyme can slow the breakdown of budesonide, leading to increased systemic exposure and a greater risk of corticosteroid side effects such as Cushing's syndrome and adrenal suppression. Always inform your doctor about all medications you are taking, including over-the-counter medicines and herbal supplements.
| Interacting Drug | Drug Class | Interaction Effect | Clinical Significance |
|---|---|---|---|
| Ritonavir | HIV protease inhibitor | Strong CYP3A4 inhibition; markedly increases budesonide levels | Major – Avoid combination |
| Cobicistat | Pharmacokinetic enhancer (HIV) | Strong CYP3A4 inhibition; significantly increases budesonide exposure | Major – Avoid combination |
| Ketoconazole | Azole antifungal | Can increase budesonide plasma levels up to 6-fold | Major – Avoid or use with caution |
| Itraconazole | Azole antifungal | Strong CYP3A4 inhibition; increases budesonide exposure | Major – Avoid or use with caution |
| Erythromycin | Macrolide antibiotic | Moderate CYP3A4 inhibition; may increase budesonide levels | Moderate – Monitor for side effects |
| Clarithromycin | Macrolide antibiotic | Moderate CYP3A4 inhibition; may increase budesonide levels | Moderate – Monitor for side effects |
| Estrogens / Oral contraceptives | Hormonal agents | May increase budesonide plasma concentrations | Minor – Usually clinically insignificant |
Compatible Nebulizer Solutions
Your doctor may instruct you to mix Budesonide Teva Pharma with other nebulizer solutions. Compatible solutions include:
- 0.9% sodium chloride solution (normal saline)
- Salbutamol nebulizer solution
- Terbutaline nebulizer solution
- Sodium cromoglicate nebulizer solution
- Ipratropium bromide nebulizer solution
When mixing solutions, use the mixture within 30 minutes. Do not mix budesonide with any other nebulizer solution unless specifically instructed by your doctor.
What Is the Correct Dosage of Budesonide Teva Pharma?
The usual adult dose for asthma is 0.5 to 2.0 mg per day, divided into two doses. Children aged 6 months to 11 years typically receive 0.25 to 1.0 mg daily. For severe croup, a single dose of 2 mg is used. For COPD, the dose is 4 to 8 mg daily for a maximum of 10 days.
Always use Budesonide Teva Pharma exactly as your doctor has prescribed. The dose varies depending on the severity of your condition, your age, and your response to treatment. You may notice improvement within 3 days, but it typically takes 2 to 4 weeks for the medication to reach its full effect. Continue using the medication as directed even if you feel better.
Adults and Adolescents (12 Years and Over)
Asthma – Maintenance Treatment
Usual dose: 0.5 mg to 2.0 mg budesonide per day
The daily dose is usually divided into two separate doses (morning and evening). If your asthma is stable and not severe, your doctor may advise once-daily dosing. Always follow your doctor's specific instructions on timing and dosing.
COPD – Acute Exacerbation
Daily dose: 4 mg to 8 mg budesonide per day
Divide the dose into 2 to 4 nebulization sessions per day. Use only until symptoms improve, for a maximum of 10 consecutive days. This is intended as an alternative to systemic corticosteroids only after proper instruction in nebulizer use.
Children (6 Months to 11 Years)
Asthma – Maintenance Treatment
Usual dose: 0.25 mg to 1.0 mg budesonide per day
The daily dose is usually divided into two sessions (morning and evening). For children with stable, mild asthma, the doctor may advise once-daily dosing.
Severe Croup (Laryngotracheitis)
Usual dose: 2 mg budesonide as a single dose
This can be given as a single 2 mg dose (two single-dose units of 0.5 mg/ml), or as 1 mg followed by another 1 mg after 30 minutes. The dose may be repeated every 12 hours, up to a maximum treatment duration of 36 hours or until clinical improvement is achieved.
| Indication | Patient Group | Daily Dose | Frequency |
|---|---|---|---|
| Asthma | Adults & adolescents (≥12 years) | 0.5–2.0 mg/day | Twice daily (or once daily if stable) |
| Asthma | Children (6 months–11 years) | 0.25–1.0 mg/day | Twice daily (or once daily if stable) |
| Severe croup | Infants & children | 2 mg (single or split) | Once; may repeat q12h (max 36h) |
| COPD exacerbation | Adults | 4–8 mg/day | 2–4 times daily (max 10 days) |
How to Use the Nebulizer
Budesonide Teva Pharma must be used with a jet nebulizer. Do not use an ultrasonic nebulizer. Follow these steps for each treatment:
- Separate the single-dose unit: Twist and pull one unit from the strip of five
- Shake gently: Shake the unit with a circular motion for about 10 seconds until no sediment is visible
- Open the unit: Hold upright and twist off the top
- Empty into nebulizer: Squeeze all the liquid into the nebulizer cup and replace the lid
- Connect the nebulizer: Attach the mouthpiece (or face mask) to one end and the air compressor to the other
- Shake again and start: Gently shake the nebulizer cup once more, then start the compressor. Breathe in the mist calmly and deeply
- Treatment is complete: When no more mist comes from the mouthpiece, the session is finished
- Rinse your mouth: Rinse thoroughly with water and spit it out (do not swallow). If using a face mask, also wash your face
- Clean the nebulizer: Wash the cup and mouthpiece/mask with warm water and mild detergent after each use, rinse well, and dry by connecting to the compressor
Missed Dose
If you forget to take a dose, simply take your next dose at the usual time. Do not take a double dose to make up for a missed one. Consistent daily use provides the best asthma control, so try to use the medication at the same times each day.
Overdose
If you have accidentally used significantly more than prescribed, or if a child has ingested the medication, contact your doctor, hospital, or poison control center for assessment. Bring the medication packaging and any remaining units with you. Acute overdose with inhaled budesonide is unlikely to cause serious harm, but chronic use of high doses can lead to adrenal suppression and Cushing's syndrome features.
What Are the Side Effects of Budesonide Teva Pharma?
The most common side effects of Budesonide Teva Pharma include oral thrush, mouth irritation, hoarseness, and cough. These occur in up to 1 in 10 users and can be minimized by rinsing the mouth after each use. Serious side effects such as adrenal suppression and bone density changes are rare and typically associated with prolonged high-dose treatment.
Like all medicines, Budesonide Teva Pharma can cause side effects, although not everyone experiences them. Inhaled corticosteroids in general have a much better safety profile than oral corticosteroids because they act primarily in the lungs with limited systemic absorption. However, awareness of potential side effects is important for early recognition and management.
Sudden wheezing, breathing difficulties, swelling of the eyelids, face or lips, skin rash, or itching affecting the whole body. These may be signs of a severe allergic reaction (anaphylaxis). Also stop the medication immediately if you develop wheezing or shortness of breath directly after inhalation (paradoxical bronchospasm).
Common Side Effects
- Oral thrush (candidiasis) – white patches on tongue or inside mouth
- Mouth and throat irritation or soreness
- Hoarseness or voice changes (dysphonia)
- Difficulty swallowing
- Cough after inhalation
- Pneumonia (in COPD patients)
Uncommon Side Effects
- Anxiety or feeling of nervousness
- Depression
- Aggression or agitation
- Sleep disturbances (insomnia)
- Tremor (shaking)
- Cataracts (lens clouding)
- Blurred vision
- Muscle cramps
Rare Side Effects
- Skin reactions: itching, rash, bruising, redness, inflammation, contact dermatitis
- Swelling (angioedema)
- Slowed growth in children and adolescents
- Hypersensitivity reactions (allergic reaction to the medication)
- Bronchospasm (paradoxical wheezing after inhalation)
- Adrenal suppression – symptoms include headache, fatigue, nausea, vomiting, weight loss, abdominal pain, and appetite loss
- Restlessness, nervousness, and irritability (more common in children)
- Voice changes
Very Rare Side Effects
- Decreased bone mineral density (osteoporosis with long-term use)
Frequency Not Known
- Glaucoma (increased pressure in the eye)
Pneumonia Risk in COPD Patients
Patients with COPD who use inhaled corticosteroids, including budesonide, have a higher risk of developing pneumonia. Contact your doctor if you experience any of the following while taking budesonide:
- Fever or chills
- Increased mucus production or changes in mucus color
- Increased cough or worsening breathing difficulties
Minimizing Side Effects
Several practical measures can help reduce the risk of local side effects:
- Rinse your mouth with water after each inhalation session and spit it out – this significantly reduces the risk of oral thrush and hoarseness
- Use a mouthpiece rather than a face mask when possible, to avoid facial skin irritation
- If a face mask is necessary, apply petroleum jelly to the covered skin before inhalation and wash it off afterward
- Use the lowest effective dose that controls your symptoms, as advised by your doctor
- Clean your nebulizer thoroughly after each use according to the manufacturer's instructions
How Should You Store Budesonide Teva Pharma?
Store Budesonide Teva Pharma upright, at room temperature, protected from light. Do not freeze. Once the foil pouch is opened, use the single-dose units within 3 months. Each unit is for single use only – discard any remaining suspension after opening.
Proper storage is essential to maintain the effectiveness and safety of your medication. Follow these guidelines:
- Keep out of the sight and reach of children
- Do not use after the expiry date printed on the outer carton and foil pouch (the expiry date refers to the last day of that month)
- Do not freeze
- Store the single-dose units upright
- Once the foil pouch has been opened, use the single-dose units within 3 months – mark the opening date on the foil pouch for easy reference
- Keep the single-dose units in the foil pouch and store the opened pouch inside the outer carton to protect from light
- Each single-dose unit is intended for single use only – use immediately after opening and discard any leftover suspension
Do not dispose of medications through household waste or wastewater. Ask your pharmacist how to properly dispose of unused medications. These measures help protect the environment.
What Does Budesonide Teva Pharma Contain?
Each single-dose unit contains budesonide as the active ingredient in three available strengths: 0.25 mg (0.125 mg/ml), 0.5 mg (0.25 mg/ml), or 1 mg (0.5 mg/ml) in 2 ml of suspension. Inactive ingredients include sodium chloride, polysorbate 80, citric acid, and sodium citrate.
Active Ingredient
- Budesonide 0.125 mg/ml: 0.25 mg of budesonide per 2 ml single-dose unit
- Budesonide 0.25 mg/ml: 0.5 mg of budesonide per 2 ml single-dose unit
- Budesonide 0.5 mg/ml: 1 mg of budesonide per 2 ml single-dose unit
Inactive Ingredients (Excipients)
- Disodium edetate (EDTA)
- Sodium chloride
- Polysorbate 80 (E433)
- Citric acid monohydrate (E330)
- Sodium citrate (E331)
- Water for injections
Packaging
Budesonide Teva Pharma comes in plastic single-dose units, each containing 2 ml of white to off-white sterile suspension for nebulization. Strips of 5 units are packaged in a foil pouch, which is then placed in a carton. Cartons may contain 5, 10, 15, 20, 25, 30, 40, 50, or 60 single-dose units. Not all pack sizes may be available in all markets.
Marketing Authorization Holder
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands.
Frequently Asked Questions About Budesonide Teva Pharma
Medical References
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2024 Update. Available at: ginasthma.org
- European Medicines Agency (EMA). Summary of Product Characteristics: Budesonide nebuliser suspension. Available at: ema.europa.eu
- British National Formulary (BNF). Budesonide – Inhaled Corticosteroids. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Available at: who.int
- Reddel HK, Bacharier LB, Bateman ED, et al. Global Initiative for Asthma Strategy 2021: Executive Summary and Rationale for Key Changes. European Respiratory Journal. 2022;59(1):2102730. doi: 10.1183/13993003.02730-2021
- Szefler SJ, et al. Long-term effects of budesonide or nedocromil in children with asthma. New England Journal of Medicine. 2000;343(15):1054-1063. doi: 10.1056/NEJM200010123431501
- Cochrane Database of Systematic Reviews. Inhaled corticosteroids for the treatment of chronic asthma in adults and children. 2023. Available at: cochranelibrary.com
- National Asthma Education and Prevention Program (NAEPP). Expert Panel Report 4: Guidelines for the Diagnosis and Management of Asthma. 2020. National Heart, Lung, and Blood Institute.
About Our Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, consisting of licensed physicians and pharmacists with expertise in respiratory medicine and clinical pharmacology. All content follows the GRADE evidence framework and adheres to international clinical guidelines from GINA, the WHO, and the EMA.
All medical claims are supported by Level 1A evidence from systematic reviews and randomized controlled trials. Sources include GINA 2024, EMA SmPCs, BNF, WHO, and Cochrane reviews.
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