Mometasone Furoate/ Formoterol Fumarate Dihydrate

Registered South African indications:

• Asthma
• Chronic obstructive pulmonary disease

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Active treated/untreated or quiescent tuberculous infections of the respiratory tract

Cautions 

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Milk protein allergy
• Adrenal suppression 
• Immunosuppression
• History of psychiatric disorder
• Hypothalamic-pituitary adrenal axis suppression
• Untreated systemic infection
• Ocular herpes simplex
• Previous oral steroid use
• Physiological stress
• Thyrotoxicosis 
• Phaeochromocytoma 
• Hypertrophic obstructive cardiomyopathy
• Idiopathic subvalvular aortic stenosis
• Severe hypertension
• Aneurysm
• Ischaemic heart disease 
• Cardiac arrhythmias
• Tachyarrhythmias 
• Third degree atrioventricular block 
• Severe heart failure 
• Occlusive vascular disease 
• QT prolongation or risk factors thereof
• Diabetes mellitus
• Hypokalaemia 
• Hypoxia 
• Paradoxical bronchospasm 
• Seizures 

Forms avail. in SA and covered in this monograph: inh

Chronic asthma 

Mometasone Furoate/ Formoterol fumarate Dihydrate
50/5 (μg/inh)
100/5 (μg/inh)
200/5 (μg/inh)

• Inhaled (inh): 2 puffs, 12hrly; Max: 800/20μg/24hr

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Starting dose is based upon asthma severity and previous asthma therapy (including inhaled corticosteroid dosage)

Titrate dose after 2 weeks of therapy

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Titrate to lowest effective dose once asthma stability achieved

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Chronic obstructive pulmonary disease

Mometasone Furoate/ Formoterol Fumarate Dihydrate
100/5 (μg/inh)
200/5 (μg/inh)

• Inhaled (inh): 2 puffs, 12hrly

Paed. forms avail. in SA and covered in this monograph: inh

Chronic asthma 

Mometasone Furoate/ Formoterol fumarate Dihydrate
50/5 (μg/inh)
100/5 (μg/inh)
200/5 (μg/inh)

• Younger than 12 years: Not established for use
• Older than 12 years: See adult dosage

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• FDA Pregnancy Category C (Mometasone/ Formoterol)
• Caution; not recommended - Mometasone Furoate
• During pregnancy, treatment with mometasone should be performed only on the physician's order. Then however, the application on large body surface areas or over a prolonged period should be avoided
• There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation
• There are no adequate and well-controlled studies with mometasone in pregnant women and therefore the risk of such effects to the human foetus is still unknown. However, as with all topically applied glucocorticoids, the possibility that foetal growth may be affected by glucocorticoid passage through the placental barrier should be considered
• There may, therefore, be a very small risk of such effects in the human foetus
• Like other topically applied glucocorticoids, mometasone should be used in pregnany women only if the potential benefit justifies the potential risk to the mother or the foetus

Breastfeeding

• Caution (Mometasone/ Formoterol)
• Caution; not recommended - Mometasone furorate
• It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk
• Mometasone should be administered to breastfeeding mothers only after careful consideration of the benefit/risk relationship. If treatment with higher doses or long term application is indicated, breastfeeding should be discontinued

Renal impairment

•  Caution; no information available (Mometasone)

Hepatic impairment

• Caution; no information available (Mometasone)

Elderly

• No dose adjustment recommended (Mometasone/ Formoterol)

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Mometasone Furoate
Central Nervous System Disorders

• Headache
• Psychomotor hyperactivity
• Sleep disorders
• Anxiety
• Depression
• Aggression

Respiratory Disorders

• Acute asthma
• Pharyngitis
• Dysphonia

Immune, Blood and Lymphatic System Disorders

• Candidiasis
• Hypersensitivity reactions

Formoterol Fumarate
Central Nervous System Disorders

• Agitation 
• Anxiety 
• Nervousness 
• Restlessness 
• Insomnia 
• Headache 
• Tremor 
• Dizziness 
• Dysgeusia 
• Abnormal behaviour 
• Hallucination 
• Central nervous system stimulation 

Cardiovascular Disorders

• Palpitations 
• Tachycardia 
• Cardiac arrhythmias
• Peripheral oedema 
• Angina pectoris 
• QT prolongation 
• Hypertension  

Respiratory Disorders

• Bronchospasm 
• Throat irritation 
• Acute asthma exacerbation 
• Cough 
• Dyspnoea 

Gastrointestinal Disorders

• Dry mouth 
• Nausea 

Genitourinary Disorders

• Nephritis 

Endocrine and Metabolic Disorders

• Hypokalaemia
• Hyperglycaemia 

Musculoskeletal Disorders

• Muscle cramps 
• Myalgia 

Skin and Subcutaneous Tissue Disorders

• Rash 
• Hyperhidrosis 

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions  
• Thrombocytopenia 

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Mometasone Furoate

• CYP3A4 inhibitors

Formoterol Fumarate

• Sympathomimetics  
• Xanthine derivatives
• Steroids 
• QT prolonging agents  
• Halogenated hydrocarbons 
• Anticholinergics 
• Beta blockers 
• Monoamine oxidase inhibitors 
• Macrolides 
• Diuretics

None routine. Specific cases may require

• Serum potassium 
• Blood glucose 

Hazard

• Instruct patients not to smoke or go near naked flames - risk of severe burns
• Fabric (clothing, bedding, dressings, etc) that has been in contact with this product burns more easily and is a serious fire hazard
• Washing clothing and bedding may reduce produce build-up but not totally remove it

Mometasone furoate
Mometasone furoate is a glucocorticoid with anti-inflammatory properties. It is likely that its mechanism lies in its ability to inhibit the release of mediators of allergic reactions. Mometasone significantly inhibits the release of leukotrienes from leucocytes in allergic patients. 

Formoterol fumarate
Formoterol fumarate is a selective beta-2 adrenoceptor agonist that relaxes bronchial smooth muscle, resulting in bronchodilating effects in patients with reversible airways obstruction. 

COMBINATION PREPARATIONS

Mometasone furoate/ Formoterol fumarate dihydrate

Inhaler 50μg/5μg

• Dulera (MSD) originator

Inhaler 100μg/5μg

• Dulera (MSD) originator

Inhaler 200μg/5μg

• Dulera (MSD) originator