FLIXOTIDE 125/MCG EVOHALER 120/DOSES

Indications

Approved Uses

Maintenance (prophylactic) treatment of asthma (adults and children); not for acute bronchospasm. COPD is not an approved indication for fluticasone-only inhalers (COPD use is typically in fixed-dose combination with a LABA).

Dosage & Administration

Maximum Dose

Adults: up to 2000 mcg/day (1000 mcg twice daily) in severe asthma; Children 4-16 years: up to 400 mcg/day (200 mcg twice daily) for Evohaler.

How to Take

For inhalation use (pressurised metered-dose inhaler). Shake well before each actuation, remove cap, exhale gently away from the inhaler, seal lips around mouthpiece, start to inhale slowly and deeply and press the canister once, continue inhaling, hold breath ~10 seconds (or as long as comfortable), then exhale. If another puff is prescribed, wait ~30 seconds and repeat. Use a spacer (and face mask in young children) if recommended. Rinse mouth/gargle and spit after use.

How to Prepare

Prime before first use by actuating into the air (commonly 2 sprays); re-prime if not used for several days (often ≥1 week) per the specific product leaflet; shake well before each actuation.

Side Effects

Common Side Effects

Oropharyngeal candidiasis (thrush), dysphonia/hoarseness, throat irritation, cough; less commonly headache and easy bruising/skin thinning (especially with higher doses/long-term use).

Side Effect Frequency

Very common: oral/oropharyngeal candidiasis. Common: dysphonia/hoarseness, throat irritation, cough. Uncommon/rare: paradoxical bronchospasm, hypersensitivity reactions; with high doses/long-term use: systemic corticosteroid effects (adrenal suppression/Cushingoid features), reduced bone mineral density, cataract, glaucoma, hyperglycemia; children: possible growth suppression.

Safety & Warnings

Warnings & Precautions

Not for acute bronchospasm-ensure a reliever (SABA) is available; rinse mouth/spit after use to reduce oral candidiasis/hoarseness; monitor for systemic corticosteroid effects at high doses or with CYP3A4 inhibitors (adrenal suppression, bone/eye effects); extra caution when stepping down from oral steroids (risk of adrenal insufficiency/unmasking eosinophilic disease); monitor growth in children; consider spacer to improve delivery and reduce oropharyngeal effects; monitor for pneumonia in COPD.

Age Restriction

Approved for asthma maintenance in children ≥4 years (125 mcg strength typically used from 4 years); use in <4 years is not routinely licensed and should be specialist-directed if considered.

Drug Interactions

Drug Interactions

Major: strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat, ketoconazole, itraconazole, clarithromycin) markedly increase systemic fluticasone exposure → adrenal suppression/Cushing’s; additive systemic steroid effects with other corticosteroids. Routine vaccine restrictions are not required at usual ICS doses.

Food Interaction

No clinically relevant food restrictions; however, avoid/limit grapefruit juice is not routinely required for inhaled fluticasone, though strong CYP3A4 inhibition (including large grapefruit intake) could theoretically increase systemic exposure.

Special Populations

Pregnancy

Caution

Breastfeeding

Safe

Storage & Patient Advice

Preparation Instructions

Prime before first use by actuating into the air (commonly 2 sprays); re-prime if not used for several days (often ≥1 week) per the specific product leaflet; shake well before each actuation.

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop abruptly; step down/taper under medical supervision, especially after high-dose/prolonged use or when switching from systemic steroids.

Overdose

Acute overdose: usually transient adrenal suppression; manage supportively and monitor if large exposure. Chronic excessive dosing: risk of adrenal suppression/Cushingoid features-evaluate HPA axis and manage clinically (including stress-dose steroids if adrenal insufficiency is present).

Patient Counseling

Preventer inhaler: use regularly as prescribed (not for acute relief); keep a reliever inhaler for sudden symptoms; rinse/gargle and spit after use; ensure correct technique and consider spacer; seek review if symptoms worsen or reliever use increases; do not stop abruptly without clinician advice; report thrush/hoarseness and visual changes with long-term/high-dose use.

Monitoring Requirements

Monitor asthma control and lung function (symptoms, reliever use, peak flow/spirometry as appropriate); check for oral candidiasis/hoarseness and inhaler technique/adherence; monitor growth in children on long-term therapy; consider adrenal suppression, bone effects, and ocular effects (cataract/glaucoma) with prolonged high-dose use or interacting drugs.

Pharmacology

Mechanism of Action

Inhaled fluticasone propionate is a corticosteroid that binds glucocorticoid receptors to downregulate airway inflammatory gene transcription, reducing inflammatory cell activity/mediators, airway edema, mucus, and bronchial hyperresponsiveness.

Onset of Action

Some improvement may be noticed within ~24 hours, but clinically meaningful benefit typically develops over several days, with maximal effect often in 1-2 weeks of regular use.

Bioavailability

Systemic bioavailability after inhalation is low; lung deposition is device/technique-dependent (often ~10-30% of the nominal dose reaches the lungs), and swallowed fraction has negligible oral bioavailability (<1%) due to extensive first-pass metabolism.

Metabolism

Extensive first-pass metabolism (liver and gut) primarily via CYP3A4 to an inactive metabolite (17β-carboxylic acid).

Product Information

Available Dosage Forms

Fluticasone propionate inhalation products are available as a pressurised metered-dose inhaler (Evohaler) and as dry powder inhaler; fluticasone propionate nebuliser suspension is available but not as this Evohaler product.

Composition per Dose

Each actuation: 125 mcg fluticasone propionate; propellant: HFA-134a (norflurane)

Generic Availability

Yes

OTC Alternatives

No OTC alternative for inhaled corticosteroid (ICS) controller therapy; appropriate alternatives are prescription-only ICS or ICS/LABA options per asthma guidelines.

Symptom Target

Asthma

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 21-07-2026