SYMBICORT 160/4.5/MCG TURBUHALER 120/DOSES

Indications

Approved Uses

Asthma: maintenance treatment in adults and adolescents (≥12 years); may be used as maintenance-and-reliever therapy (MART/SMART) where locally approved. COPD: maintenance treatment in adults to reduce exacerbations and improve symptoms (where approved).

Dosage & Administration

Dosing by Condition

Asthma (≥12 years): typically 1-2 inhalations twice daily of an appropriate strength; if using MART/SMART (where approved), additional inhalations may be used as reliever within a defined maximum daily dose per local label. COPD (adults, where approved): typically 2 inhalations twice daily of an approved COPD strength per local label (often higher budesonide dose than 80/4.5).

Initial Dose

Asthma (Adults & Adolescents ≥12 years): 2 inhalations of 80/4.5 mcg or 160/4.5 mcg twice daily, depending on asthma severity.

Maintenance Dose

Asthma (Adults & Adolescents ≥12 years): 2 inhalations of 80/4.5 mcg twice daily. COPD (Adults): 2 inhalations of 160/4.5 mcg twice daily.

Maximum Dose

Maximum recommended dosage is 2 inhalations of 80/4.5 mcg twice daily (4 inhalations per day total) for asthma.

Children's Dosage

Children 6-11 years: Budesonide/Formoterol 80/4.5 mcg, 1-2 inhalations twice daily (lower strength only). Not approved for children under 6 years.

How to Take

Turbuhaler technique: Unscrew/remove cap; hold inhaler upright (mouthpiece up). Load a dose by turning the grip fully one way then back until a click is heard. Breathe out gently away from the device (do not exhale into it). Seal lips around mouthpiece and inhale forcefully and deeply. Remove inhaler and hold breath ~10 seconds, then breathe out. Replace cap. Rinse mouth with water and spit out after each maintenance dose to reduce oral candidiasis risk.

Side Effects

Common Side Effects

Common: oral candidiasis (thrush), dysphonia/hoarseness, throat irritation, cough, headache, nasopharyngitis/upper respiratory tract infection; LABA-related effects can include tremor and palpitations.

Side Effect Frequency

Common (≥1% to <10%): oral candidiasis, dysphonia/hoarseness, headache, tremor, palpitations, throat irritation, cough. Uncommon/rare: tachycardia/arrhythmias, hypokalemia, hyperglycemia, paradoxical bronchospasm, hypersensitivity reactions; systemic corticosteroid effects (e.g., adrenal suppression, bruising) are uncommon and more likely with higher doses/long-term use.

Safety & Warnings

Contraindications

Contraindicated in hypersensitivity to budesonide, formoterol, or excipients (including lactose/milk proteins in DPI products); not indicated for relief of acute bronchospasm/status asthmaticus.

Warnings & Precautions

Not for acute bronchospasm (ensure rescue SABA); rinse mouth to reduce candidiasis; monitor for systemic corticosteroid effects (adrenal suppression, bone density, growth in children, ocular effects) with long-term/high-dose use; caution in cardiovascular disease, diabetes, thyrotoxicosis, seizure disorders, hypokalemia; consider infection risk (TB/untreated fungal/viral) and pneumonia risk in COPD; review drug interactions (CYP3A4 inhibitors, beta-blockers).

Age Restriction

Asthma: approved for patients ≥6 years; not approved for <6 years (COPD indication is adult only).

Drug Interactions

Drug Interactions

Key interactions: strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole/ritonavir/cobicistat/clarithromycin) ↑ budesonide systemic exposure; beta-blockers may blunt bronchodilation; diuretics may worsen hypokalemia; MAOIs/TCAs and other sympathomimetics may potentiate cardiovascular effects; caution with QT-prolonging drugs.

Special Populations

Children

Children 6-11 years: Budesonide/Formoterol 80/4.5 mcg, 1-2 inhalations twice daily (lower strength only). Not approved for children under 6 years.

Elderly

Standard adult dosing; no specific dose adjustment required, but monitor for systemic corticosteroid effects and cardiovascular effects of formoterol

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly without clinician review; step-down/taper to the lowest effective dose once control is maintained (avoid sudden withdrawal especially after high-dose/prolonged ICS or recent systemic steroids).

Overdose

Overdose may cause beta-agonist effects (tremor, tachycardia/palpitations, headache), metabolic effects (hypokalemia, hyperglycemia), and with chronic excess ICS: adrenal suppression/Cushingoid features; management is supportive with monitoring (K+, glucose, ECG) and urgent medical evaluation.

Patient Counseling

Use regularly as prescribed (controller); ensure correct Turbuhaler loading and a forceful/deep inhalation; do not exhale into the device; rinse/gargle and spit after use; keep a written action plan and seek care if needing frequent extra doses or worsening symptoms; do not stop abruptly without clinician advice; store below 25°C and replace when the dose counter reaches zero.

Monitoring Requirements

Monitor symptom control and lung function (e.g., peak flow/FEV1), exacerbations and reliever use; check for oral candidiasis and dysphonia; monitor for LABA effects (heart rate, tremor) and serum potassium in high-risk patients; with long-term/high-dose ICS monitor bone health, ocular effects (cataract/glaucoma), and adrenal suppression risk; monitor growth in children/adolescents.

Pharmacology

Mechanism of Action

Budesonide (ICS) activates glucocorticoid receptors to reduce airway inflammation and hyperresponsiveness; formoterol (LABA) stimulates beta-2 receptors to increase cAMP and relax bronchial smooth muscle, providing sustained bronchodilation.

Product Information

Available Dosage Forms

Inhalation powder (Turbuhaler), Pressurized metered-dose inhaler (pMDI/Aerosol)

Composition per Dose

Each delivered dose: 80 micrograms budesonide and 4.5 micrograms formoterol fumarate dihydrate.

OTC Alternatives

No OTC alternative

Symptom Target

Multi-symptom

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 06-07-2026