Drug Monograph
Dulera
mometasone furoate / formoterol fumarate dihydrate
Pharmacokinetic Profile
Half-Life
MF ~5 h; FORM ~10 h
Metabolism
MF: CYP3A4; FORM: CYP2D6, 2C19, 2C9, 2A6
Protein Binding
MF 98–99%; FORM 61–64%
Bioavailability
MF <1% (systemic); FORM variable (inhaled)
Volume of Distribution
MF ~500 L (IV); FORM ~136 L (SS)
Clinical Information
Drug Class
ICS + LABA (combination inhaler)
Available Doses
50/5, 100/5, 200/5 mcg per actuation
Route
Oral inhalation (pMDI)
Renal Adjustment
Not required
Hepatic Adjustment
Monitor for increased systemic exposure
Pregnancy
No adequate studies; use if benefits outweigh risk
Lactation
Unknown; weigh benefits vs risks
Schedule / Legal Status
Prescription only (Rx); not scheduled
Generic Available
No
Indications
| Indication | Approved Population | Therapy Type | Status |
|---|---|---|---|
| Asthma — maintenance therapy | Age 5 years and older | Combination (ICS + LABA) | FDA Approved |
Mometasone-formoterol is specifically indicated for patients whose asthma is not adequately controlled on an inhaled corticosteroid alone, or whose disease severity warrants initiation with both an ICS and LABA from the outset. It is not a rescue inhaler and should never be used to treat acute bronchospasm. Patients should always have a short-acting beta-2 agonist available for symptom relief between scheduled doses.
Off-Label Uses
Exercise-induced bronchoconstriction (EIB) prophylaxis as maintenance therapy: Some clinicians use mometasone-formoterol as a maintenance strategy for patients with both persistent asthma and frequent EIB, leveraging the formoterol component’s rapid onset. Evidence quality: Low. Dedicated EIB prevention studies have not been conducted with this specific combination product.
Dosing
Adults and Adolescents (12 Years and Older)
| Clinical Scenario | Starting Dose | Maintenance Dose | Maximum Dose | Notes |
|---|---|---|---|---|
| Persistent asthma — previously on medium-dose ICS | 100/5 mcg, 2 puffs BID | 100/5 mcg, 2 puffs BID | 200/5 mcg, 2 puffs BID (800/20 mcg/day) | Reassess at 2 weeks; step up if inadequate control Based on prior ICS dose and symptom control |
| Persistent asthma — previously on high-dose ICS | 200/5 mcg, 2 puffs BID | 200/5 mcg, 2 puffs BID | 200/5 mcg, 2 puffs BID (800/20 mcg/day) | Already at maximum approved strength If control still inadequate, consider add-on therapy |
| Step-down after achieving control | Current effective dose | 100/5 mcg, 2 puffs BID | N/A | Titrate to lowest effective dose once stable Reassess periodically; consider ICS monotherapy if LABA can be withdrawn |
| Transition from oral corticosteroids | 200/5 mcg, 2 puffs BID | 200/5 mcg, 2 puffs BID | 200/5 mcg, 2 puffs BID (800/20 mcg/day) | Taper oral steroid slowly; monitor for adrenal insufficiency Wean gradually per clinical judgement; monitor lung function, symptoms, and signs of adrenal insufficiency |
Pediatric Patients (5 to Less Than 12 Years)
| Clinical Scenario | Starting Dose | Maintenance Dose | Maximum Dose | Notes |
|---|---|---|---|---|
| Persistent asthma — not controlled on ICS alone | 50/5 mcg, 2 puffs BID | 50/5 mcg, 2 puffs BID | 50/5 mcg, 2 puffs BID (200/20 mcg/day) | Only the 50/5 mcg strength is approved in this age group Monitor growth velocity; use lowest effective dose |
Clinical Pearl — Inhaler Technique and Priming
The pMDI must be shaken well before each inhalation and primed with 4 test sprays before first use or if unused for more than 5 days. After each dose, patients should rinse their mouth with water and spit (never swallow) to reduce oropharyngeal candidiasis risk. Onset of bronchodilation from the formoterol component occurs within 5 minutes, but full anti-inflammatory benefit from mometasone may require 1 week or longer.
Pharmacology
Mechanism of Action
Mometasone-formoterol combines two distinct pharmacological pathways to achieve asthma control. Mometasone furoate is a synthetic corticosteroid with potent topical anti-inflammatory activity in the airways. It suppresses multiple inflammatory cell types and mediators involved in asthma pathogenesis, including cytokine release, eosinophil recruitment, and airway oedema. The result is reduced bronchial hyperresponsiveness and decreased frequency and severity of exacerbations over weeks of sustained use.
Formoterol fumarate is a long-acting, selective beta-2 adrenergic receptor agonist. Upon binding to beta-2 receptors on airway smooth muscle, it activates adenylyl cyclase, increases intracellular cyclic AMP, and produces sustained bronchial smooth muscle relaxation for approximately 12 hours. Formoterol has a rapid onset of action (within minutes), distinguishing it from salmeterol. The combination provides both the rapid bronchodilation needed for symptom relief and the persistent anti-inflammatory effect required for long-term airway disease modification.
ADME Profile
| Parameter | Value | Clinical Implication |
|---|---|---|
| Absorption | MF: systemic bioavailability <1% (oral); lung deposition provides local effect. FORM: Tmax ~0.5–1 h (plasma) | Minimal systemic mometasone exposure at recommended doses; formoterol delivers rapid bronchodilation within 5 min |
| Distribution | MF: Vd ~500 L (IV), protein binding 98–99%. FORM: Vd ~136 L (steady state), protein binding 61–64% | Mometasone distributes extensively into tissues and is highly protein-bound, limiting free systemic drug; formoterol distributes moderately beyond plasma volume |
| Metabolism | MF: hepatic via CYP3A4 to multiple metabolites. FORM: O-demethylation via CYP2D6, 2C19, 2C9, 2A6; also direct glucuronidation | Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole) significantly increase mometasone systemic exposure; no clinically relevant formoterol CYP interactions expected |
| Elimination | MF: t½ ~5 h; primarily faecal (74%) and urinary (8%). FORM: t½ ~10 h; renal 62–73% (of inhaled dose as metabolites + unchanged drug) | Twice-daily dosing appropriate for both components; no dose adjustment for renal impairment needed |
Side Effects
1–10%
Common
| Adverse Effect | Incidence | Clinical Note |
|---|---|---|
| Nasopharyngitis | 3–5% | Most frequently reported adverse event across pivotal trials; generally mild and self-limiting |
| Sinusitis | 3–5% | Similar incidence to mometasone monotherapy in controlled trials; manage symptomatically |
| Headache | 3–5% | Occurred at comparable rates across all treatment arms including placebo; typically resolves spontaneously |
| Dysphonia | 3.8–5% | Higher incidence in the 52-week long-term trial (5% for 100/5 strength, 3.8% for 200/5); related to local corticosteroid deposition on the vocal cords |
| Oral candidiasis | 0.7–0.8% | Oropharyngeal thrush related to the ICS component; mouth rinsing after each dose substantially reduces risk (vs 0.5% placebo) |
| Influenza (pediatric 5–<12 y) | ≥3% | Reported in the pediatric 24-week trial at incidence ≥3% and more frequently than ICS alone |
| Upper respiratory tract infection (pediatric 5–<12 y) | ≥3% | Pediatric trial finding; overall pediatric safety profile similar to the older age group |
Serious
Serious (Regardless of Frequency)
| Adverse Effect | Estimated Frequency | Typical Onset | Required Action |
|---|---|---|---|
| Paradoxical bronchospasm | Rare | Immediately after inhalation | Treat with short-acting bronchodilator; permanently discontinue Dulera and switch to alternative |
| Anaphylaxis / severe hypersensitivity | Very rare (postmarketing) | Minutes to hours after dose | Emergency treatment; permanent discontinuation; do not rechallenge |
| Adrenal suppression / adrenal crisis | Rare; higher risk with supratherapeutic doses or systemic steroid transition | Weeks to months (cumulative) | Taper Dulera slowly; stress-dose hydrocortisone if crisis; endocrine referral for HPA axis testing |
| Cardiac arrhythmias (tachyarrhythmia, atrial fibrillation, ventricular extrasystoles) | Rare (postmarketing) | Variable; higher risk with excessive dosing | Discontinue if clinically significant; ECG monitoring; cardiology referral as needed |
| Severe hypokalemia | Rare | Days to weeks; potentiated by concurrent diuretics | Monitor potassium; replace aggressively if symptomatic; review concomitant drugs |
| Reduced bone mineral density | Uncommon; risk increases with long-term high-dose use | Months to years (cumulative ICS exposure) | DEXA scan in high-risk patients; lowest effective ICS dose; consider calcium/vitamin D supplementation |
| Growth suppression (pediatric) | Variable; dose-dependent | First year of treatment | Monitor growth regularly via stadiometry; use lowest effective dose; weigh benefit vs risk |
| Glaucoma / posterior subcapsular cataracts | Uncommon with inhaled route | Months to years of continuous use | Regular ophthalmological examinations; refer if visual symptoms develop |
Discontinuation
Discontinuation Rates
Adults / Adolescents (12-week to 26-week trials)
Low overall comparable to ICS monotherapy
Top reasons: Asthma exacerbation, adverse events (similar across treatment arms)
52-Week Safety Trial
Similar to active comparator
Notable finding: No clinically significant changes in blood chemistry, haematology, or ECG; dysphonia was more frequent with prolonged use but rarely led to discontinuation
| Reason for Discontinuation | Incidence | Context |
|---|---|---|
| Asthma exacerbation | Most common reason across all arms | Not dose-dependent; similar rate in ICS monotherapy and placebo groups |
| Adverse event (any) | Low; comparable to controls | No single adverse event predominated as a discontinuation driver in pivotal trials |
Managing Oral Candidiasis
Oropharyngeal candidiasis is a recognized complication of all inhaled corticosteroids, including the mometasone component of Dulera. Instruct every patient to rinse and spit after each dose, use a spacer if available (though Dulera is a pMDI without a dedicated spacer accessory), and report any persistent white patches or soreness in the mouth. If candidiasis develops, it can generally be treated with topical nystatin or clotrimazole troches while continuing Dulera, reserving oral fluconazole for resistant cases.
Drug Interactions
The primary metabolic pathway for the mometasone component is CYP3A4, making strong CYP3A4 inhibitors the most clinically significant drug interaction concern. Formoterol interactions largely relate to its beta-2 adrenergic pharmacology (QTc prolongation risk, hypokalemia, and antagonism by beta-blockers).
Major
Strong CYP3A4 Inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, cobicistat)
MechanismInhibition of CYP3A4-mediated mometasone metabolism
EffectMarkedly increased systemic mometasone exposure, raising the risk of Cushing syndrome and adrenal suppression
ManagementAvoid concomitant use when possible; if co-administration is unavoidable, monitor closely for systemic corticosteroid effects (weight gain, hyperglycaemia, HPA axis suppression)
FDA PI
Major
Non-selective Beta-Blockers (e.g., propranolol, carvedilol)
MechanismAntagonism of beta-2 receptors by non-selective beta-blockade
EffectLoss of formoterol bronchodilatory effect; risk of severe, potentially life-threatening bronchospasm
ManagementUse cardioselective beta-1 blockers (e.g., bisoprolol, metoprolol) with caution; reserve non-selective agents for compelling indications only
FDA PI
Moderate
QTc-Prolonging Drugs (e.g., tricyclic antidepressants, macrolide antibiotics, certain antiarrhythmics)
MechanismAdditive QTc interval prolongation with formoterol’s beta-adrenergic effects
EffectIncreased risk of ventricular arrhythmias including torsades de pointes
ManagementUse with extreme caution; obtain baseline and periodic ECG; correct electrolyte abnormalities (especially potassium and magnesium) before starting
FDA PI
Moderate
Loop / Thiazide Diuretics (e.g., furosemide, hydrochlorothiazide)
MechanismAdditive potassium depletion: diuretics increase renal potassium loss, formoterol causes intracellular potassium shift
EffectAugmented hypokalemia risk; may potentiate cardiac conduction changes
ManagementMonitor serum potassium at baseline and periodically; supplement if needed; watch for ECG changes
FDA PI
Moderate
MAO Inhibitors
MechanismDecreased metabolism of catecholamines; potentiation of sympathomimetic effects of formoterol
EffectHeightened cardiovascular stimulation (tachycardia, hypertension)
ManagementUse with extreme caution; monitor heart rate and blood pressure closely
FDA PI
Moderate
Xanthine Derivatives (e.g., theophylline)
MechanismAdditive hypokalemia and additive cardiac stimulation
EffectPotentiated ECG changes and electrolyte disturbance
ManagementMonitor theophylline levels, potassium, and ECG if concurrent use is required
FDA PI
Minor
Additional Adrenergic Agents
MechanismAdditive sympathomimetic stimulation
EffectPotentiated cardiovascular effects (palpitations, tremor, tachycardia)
ManagementAvoid concomitant LABAs; short-acting beta-agonists for rescue use are acceptable but monitor for additive effects
FDA PI
Minor
Halogenated Hydrocarbon Anaesthetics (e.g., halothane, sevoflurane)
MechanismSensitisation of myocardium to catecholamines by halogenated agents
EffectElevated risk of cardiac arrhythmias during anaesthesia
ManagementInform anaesthetist of Dulera use; consider holding morning dose on the day of surgery if safe
FDA PIMonitoring
-
Lung Function (FEV1 / PEF)
Baseline, 2–4 weeks, then every 3–6 months
Routine Assess response to therapy; if FEV1 does not improve at 2 weeks on 100/5, consider stepping up to 200/5 strength. Declining PEF or increasing rescue inhaler use signals loss of control. -
Oral Cavity
Each visit
Routine Inspect for oropharyngeal candidiasis or dysphonia. Reinforce mouth rinsing technique at each encounter. -
Growth (Pediatric)
Every 3–6 months
Routine Measure height via stadiometry at regular intervals. Compare to age-specific growth charts. Reduced growth velocity may warrant dose review or alternative therapy. -
Bone Mineral Density
Consider baseline DEXA in high-risk patients
Trigger-based Particularly important for patients with additional osteoporosis risk factors (postmenopausal women, prolonged immobility, family history, concurrent systemic steroids). Repeat DEXA if prolonged high-dose ICS use anticipated. -
Ophthalmological Exam
Baseline if risk factors, then periodically
Trigger-based Screen for glaucoma and cataracts, especially with long-term use or family history of ocular disease. Refer promptly if patient reports visual changes. -
Serum Potassium
When concurrent diuretics or digoxin
Trigger-based Formoterol can decrease serum potassium via intracellular shift. Check electrolytes if patient is on concomitant potassium-lowering agents, develops palpitations, or has cardiac history. -
HPA Axis Function
If clinical suspicion of adrenal suppression
Trigger-based Morning cortisol or cosyntropin stimulation test if features suggestive of adrenal insufficiency (fatigue, hypotension, weight loss) develop, particularly during systemic steroid taper or with strong CYP3A4 inhibitors.
Contraindications & Cautions
Absolute Contraindications
- Status asthmaticus or acute bronchospasm: Dulera is a controller medication with no role in treating acute asthma attacks. An inhaled short-acting beta-2 agonist (SABA) must be used for rescue.
- Known hypersensitivity to mometasone furoate, formoterol fumarate dihydrate, or any excipient in the formulation (including oleic acid or HFA-227 propellant).
Relative Contraindications (Specialist Input Recommended)
- Severe cardiovascular disease: Coronary insufficiency, cardiac arrhythmias, or hypertrophic obstructive cardiomyopathy — the beta-adrenergic stimulation from formoterol may worsen these conditions. Cardiology co-management is advisable.
- Active or quiescent tuberculosis: Inhaled corticosteroids may reactivate latent pulmonary TB; use only with appropriate anti-TB therapy and infectious disease input.
- Untreated systemic fungal, bacterial, or parasitic infections: Immunosuppressive effects of the ICS component may worsen uncontrolled infections.
- Pheochromocytoma or thyrotoxicosis: Formoterol’s adrenergic effects may precipitate hypertensive crises or thyroid storm.
Use with Caution
- Diabetes mellitus: Both components can contribute to hyperglycaemia (corticosteroid effect) and transiently elevated glucose (beta-agonist effect). Monitor glucose more frequently.
- Convulsive disorders: Beta-agonists can lower the seizure threshold; monitor closely in patients with epilepsy.
- Hepatic impairment: Mometasone is metabolised by CYP3A4 in the liver; impaired hepatic function may increase systemic exposure. Monitor for signs of hypercorticism.
- Concurrent use with other LABAs: Never combine Dulera with another LABA product (salmeterol, arformoterol, vilanterol-containing inhalers) to avoid beta-agonist overdose.
- Patients transferring from systemic corticosteroids: Risk of adrenal crisis during taper. Wean oral steroids slowly with careful monitoring of symptoms and HPA axis recovery.
- Patients exposed to chickenpox or measles: Immunosuppressed individuals may experience more severe courses; consider prophylaxis (VZIG or IG as appropriate).
FDA Class-Wide Regulatory Warning
LABA Use in Asthma — Serious Asthma-Related Events
LABA monotherapy (without an ICS) has been associated with an increased risk of asthma-related death, as demonstrated in the Salmeterol Multicenter Asthma Research Trial (SMART). This risk is considered a class effect of all LABAs when used alone. However, four large, 26-week safety trials (including one evaluating Dulera specifically) demonstrated that ICS/LABA fixed-dose combinations do not significantly increase the risk of serious asthma-related events compared with ICS alone. Based on these results, the FDA removed the boxed warning for ICS/LABA fixed-dose combinations in 2017. The current prescribing information retains detailed safety language in the Warnings and Precautions section. Clinicians should prescribe Dulera only for patients who require both an ICS and a LABA, and should periodically reassess whether step-down to ICS monotherapy is appropriate once asthma control is achieved.
Patient Counselling
Purpose of Therapy
Dulera is a long-term controller medication that prevents asthma symptoms when used every day. It contains two medicines working together: one reduces airway inflammation (mometasone) and the other keeps airway muscles relaxed (formoterol). It is not a rescue inhaler and will not relieve sudden breathing difficulty. Patients must always carry a separate short-acting rescue inhaler.
How to Take
Take exactly 2 puffs every morning and 2 puffs every evening, at approximately the same times each day. Shake the inhaler well for 5 seconds before each puff. Before first use, or if the inhaler has not been used for more than 5 days, prime it by spraying 4 test puffs into the air away from the face. After each dose (both puffs), rinse the mouth thoroughly with water and spit it out; do not swallow. This simple step helps prevent oral thrush.
Oral Thrush (Candidiasis)
Tell patient
White patches or soreness in the mouth and throat can occur from the steroid component. Rinsing the mouth after every dose is the most effective prevention. A spacer may also help but is not supplied with Dulera.
Call prescriber
If white patches develop in the mouth or throat, or if you experience difficulty swallowing or persistent sore throat.
Worsening Asthma or Need for Rescue Inhaler
Tell patient
If your asthma symptoms worsen gradually, or you find yourself using your rescue inhaler more often than usual, this indicates your asthma is not well controlled. Do not take extra puffs of Dulera to manage these symptoms.
Call prescriber
If rescue inhaler use increases, if symptoms are not improving after 1 week, or if your peak flow readings decline. Seek emergency care immediately if your rescue inhaler does not relieve sudden breathing difficulty.
Palpitations or Tremor
Tell patient
The formoterol component can occasionally cause a fast or pounding heartbeat, shakiness, or nervousness. These effects are generally mild and tend to lessen with continued use. Do not exceed the prescribed number of puffs.
Call prescriber
If you experience chest pain, rapid irregular heartbeat, severe tremor, or if these symptoms persist or worsen.
Hoarseness (Dysphonia)
Tell patient
Some voice changes or hoarseness can occur due to the corticosteroid depositing on the vocal cords. This is more likely with long-term use but is generally reversible with dose adjustment or improved technique.
Call prescriber
If hoarseness significantly affects your daily life, work, or if it persists for more than 2 weeks despite mouth rinsing.
Infections (Chickenpox, Measles Exposure)
Tell patient
Inhaled corticosteroids can slightly reduce your immune defences. If you have never had chickenpox or measles (or have not been vaccinated), avoid close contact with infected individuals.
Call prescriber
If you are exposed to chickenpox or measles while using Dulera, contact your healthcare provider immediately — preventive treatment may be needed.
Stopping or Changing Treatment
Tell patient
Never stop Dulera suddenly without medical advice, even if you feel well. Abruptly stopping an inhaled corticosteroid can lead to worsening asthma or, if transitioning from oral steroids, adrenal crisis. Your prescriber will guide any dose changes.
Call prescriber
If you experience unusual fatigue, weakness, dizziness, nausea, or vomiting after dose changes — these may indicate adrenal insufficiency.
Sources
Regulatory (PI / SmPC)
- Dulera (mometasone furoate and formoterol fumarate dihydrate) Prescribing Information. Organon LLC. Revised June 2025. https://www.organon.com/product/usa/pi_circulars/d/dulera/dulera_pi.pdf Primary source for all dosing, contraindications, adverse reaction incidence rates, and pharmacokinetic data in this monograph.
- Dulera FDA Label History. DailyMed / National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f399784-f257-4f31-b3dc-368bf2a1864d FDA-approved labelling archive including historical label revisions and boxed warning removal timeline.
- FDA Drug Safety Communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS). December 2017. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-review-finds-no-significant-increase-risk-serious-asthma-outcomes Regulatory basis for the removal of the LABA boxed warning from ICS/LABA fixed-dose combination labels.
Key Clinical Trials
- Nathan RA, Sorkness CA, Kosinski M, et al. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113(1):59-65. doi:10.1016/j.jaci.2003.09.008 Validation of the ACT tool used in asthma trials including Dulera studies to assess symptom control.
- Maspero JF, Nolte H, Cherrez-Ojeda I. Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. J Asthma. 2010;47(10):1106-1115. doi:10.3109/02770903.2010.517335 52-week active-comparator safety trial establishing long-term tolerability; dysphonia rates reported from this study.
- Weinstein SF, Corren J, Murphy K, et al. Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 mcg and 400/10 mcg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids. Allergy Asthma Proc. 2010;31(4):280-289. doi:10.2500/aap.2010.31.3374 Pivotal trial in patients on prior high-dose ICS demonstrating superiority of the combination over ICS alone.
- Peters SP, Bleecker ER, Canonica GW, et al. Serious asthma events with budesonide plus formoterol vs. budesonide alone. N Engl J Med. 2016;375(9):850-860. doi:10.1056/NEJMoa1511190 One of the four large safety trials contributing to the meta-analysis supporting removal of the LABA boxed warning.
Guidelines
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, 2024. https://ginasthma.org/gina-reports/ International guideline recommending step-wise approach to asthma therapy; ICS/LABA combinations are positioned as Step 3–4 therapy.
- National Asthma Education and Prevention Program (NAEPP). Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR-3). National Heart, Lung, and Blood Institute. 2007. Updated 2020 Focused Updates. https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma US national asthma guideline including recommendations for step-up therapy with ICS/LABA combinations.
Mechanistic / Basic Science
- Johnson M. Interactions between corticosteroids and beta2-agonists in asthma and chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2004;1(3):200-206. doi:10.1513/pats.200402-010MS Describes the molecular synergy between corticosteroids and LABAs, including upregulation of beta-2 receptor expression by glucocorticoids.
- Barnes PJ. Scientific rationale for inhaled combination therapy with long-acting beta2-agonists and corticosteroids. Eur Respir J. 2002;19(1):182-191. doi:10.1183/09031936.02.00283202 Foundational review explaining complementary mechanisms by which ICS and LABA together achieve greater asthma control than either agent alone.
Pharmacokinetics / Special Populations
- Affrime MB, Cuss F, Padhi D, et al. Bioavailability and metabolism of mometasone furoate following administration by metered-dose and dry-powder inhalers in healthy human volunteers. J Clin Pharmacol. 2000;40(11):1227-1236. doi:10.1177/009127000004001107 Establishes the very low systemic bioavailability (<1%) of inhaled mometasone furoate, supporting its favourable systemic safety profile.
- Rosenborg J, Larsson P, Tegner K, et al. Mass balance and metabolism of [3H]formoterol in healthy men after combined i.v. and oral administration. Drug Metab Dispos. 1999;27(10):1104-1116. https://pubmed.ncbi.nlm.nih.gov/10497135/ Characterises formoterol elimination pathways and confirms 62–73% renal excretion of drug-related material after inhalation.