FLOHALE 125 MCG 120 DOSES

Indications

Approved Uses

Maintenance (prophylactic) treatment of asthma; not for relief of acute bronchospasm.

Dosage & Administration

Dosing by Condition

Asthma maintenance: dose is individualized by severity and prior therapy; typical adult/adolescent dosing is twice daily, with low/medium/high daily dose ranges per guideline tables (product-specific regimens vary by inhaler strength). FLOHALE 125 µg is commonly used as 1-2 inhalations twice daily as prescribed (do not exceed the prescriber’s maximum).

Initial Dose

125-250 mcg twice daily for mild-to-moderate asthma

Maintenance Dose

88-440 mcg twice daily, titrated to the lowest effective dose that maintains asthma control.

Maximum Dose

1000 mcg twice daily (2000 mcg/day) in severe asthma

Children's Dosage

Children 4-16 years: 50-100 mcg twice daily (mild asthma); up to 200 mcg twice daily for more severe disease. Children under 4 years: not recommended for pMDI without spacer

How to Take

For inhalation use (pressurised metered-dose inhaler). Shake well before each actuation. Remove cap and check mouthpiece. Exhale fully away from the inhaler. Place mouthpiece in mouth with a good seal; start to inhale slowly and deeply and press the canister once, continuing to inhale. Hold breath ~10 seconds (or as long as comfortable), then exhale slowly. If a second puff is prescribed, wait ~30-60 seconds and repeat. Rinse mouth/gargle with water and spit after use. Use a spacer if prescribed or if coordination is difficult.

Side Effects

Common Side Effects

Oropharyngeal candidiasis, hoarseness, dysphonia, throat irritation, cough, headache, upper respiratory tract infections

Side Effect Frequency

Common (1-10%): oropharyngeal candidiasis, dysphonia/hoarseness, throat irritation, headache, cough. Uncommon (<1%): bruising, hypersensitivity reactions, adrenal suppression/Cushingoid features, growth retardation (children), decreased bone mineral density, cataract, glaucoma. Rare (<0.1%): paradoxical bronchospasm, angioedema/urticaria.

Safety & Warnings

Contraindications

Contraindicated in hypersensitivity to fluticasone propionate or any excipients; not indicated for primary treatment of status asthmaticus or acute bronchospasm (i.e., do not use for acute relief).

Warnings & Precautions

Not for acute symptom relief-ensure a rapid-acting bronchodilator is available; rinse mouth after use to reduce candidiasis/dysphonia; monitor for systemic corticosteroid effects (adrenal suppression, ocular effects, bone effects, growth in children) especially at high doses or with CYP3A4 inhibitors; caution in active/latent TB or untreated infections; consider pneumonia risk in COPD; consider spacer use to reduce oropharyngeal deposition.

Age Restriction

Asthma maintenance: generally approved/used in patients ≥4 years; the 125 mcg pMDI strength is typically positioned for adolescents/adults, while younger children often use lower strengths with a spacer.

Drug Interactions

Drug Interactions

Avoid or use extreme caution with strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat, ketoconazole, itraconazole; also macrolides like clarithromycin can increase exposure) due to risk of systemic corticosteroid effects (adrenal suppression/Cushingoid features).

Food Interaction

No clinically relevant food restrictions for inhaled use; avoid grapefruit juice is not routinely required.

Special Populations

Pregnancy

Category C

Breastfeeding

Caution

Children

Children 4-16 years: 50-100 mcg twice daily (mild asthma); up to 200 mcg twice daily for more severe disease. Children under 4 years: not recommended for pMDI without spacer

Storage & Patient Advice

Missed Dose

Take as soon as remembered; if it is almost time for the next dose, skip the missed dose and continue the regular schedule. Do not double the dose

Stopping the Medicine

Do not stop abruptly without medical advice; step-down/taper to the lowest effective dose, and taper more cautiously after prolonged high-dose use or if switching from systemic steroids.

Overdose

Acute inhalation overdose is usually unlikely to cause serious toxicity but may cause transient adrenal suppression; chronic excessive dosing can cause systemic corticosteroid effects (Cushingoid features, adrenal suppression)-manage supportively, assess adrenal function if indicated, and reduce dose gradually under supervision.

Patient Counseling

Controller medication: use regularly as prescribed; not a rescue inhaler for acute symptoms-keep a reliever available if prescribed. Demonstrate correct pMDI technique and consider spacer use if needed. Rinse/gargle and spit after each use to prevent thrush/hoarseness. Seek review if symptoms worsen, reliever use increases, or if signs of thrush, adrenal effects, or vision changes occur; report use of strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat, azole antifungals).

Monitoring Requirements

Assess asthma control and lung function (symptoms, reliever use, spirometry/peak flow) periodically; monitor for oral candidiasis/hoarseness; in children/adolescents monitor growth with long-term use; consider eye effects (cataract/glaucoma) and bone health with prolonged high-dose therapy; consider adrenal suppression if high-dose/prolonged use or with strong CYP3A4 inhibitors.

Pharmacology

Mechanism of Action

Inhaled corticosteroid: binds intracellular glucocorticoid receptors in airway cells, altering gene transcription to suppress inflammatory cytokines/mediators and reduce airway inflammation, edema, and hyperresponsiveness.

Onset of Action

Not for immediate relief; some improvement may occur within 12-24 hours, but clinically meaningful benefit typically develops over 1-2 weeks, with maximal effect often taking several weeks (up to ~4-6 weeks).

Duration of Effect

Approximately 12-24 hours per dose; typically administered twice daily for maintenance control.

Bioavailability

Systemic bioavailability after inhalation is low; the swallowed fraction has oral bioavailability <1% due to extensive first-pass metabolism (CYP3A4).

Metabolism

Extensive hepatic first-pass metabolism via CYP3A4 to inactive metabolites (major: 17β-carboxylic acid).

Product Information

Available Dosage Forms

For this product: pressurised inhalation (metered-dose inhaler).

Composition per Dose

Each actuation delivers 125mcg fluticasone propionate.

Generic Availability

Yes

OTC Alternatives

No OTC alternative for inhaled corticosteroid controller therapy.

Symptom Target

Asthma inflammation

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 27-05-2026