Mometasone Furoate

Registered South African indications:

• Symptoms of seasonal allergic rhinitis
• Symptoms of perennial allergic rhinitis

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Lactation
• Children under 2 years of age
• Presence of untreated localised infection involving the nasal mucosa, such as herpes simplex (nas)
• Patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred (nas)

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Presence of untreated localised infection involving the nasal mucosa, such as herpes simplex
• Patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred

• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (Recommendations in other jurisdictions)
• Immunosuppression
• Fungal infections
• Nasal septum perforation
• Unilateral polyps
• Polyps associated with cystic fibrosis
• Obstructive polyps
• High doses for prolonged periods

Forms avail. in SA and covered in this monograph: nas, aqs

South African registered indications and dosages

Seasonal allergic rhinitis
Perennial allergic rhinitis

• Nasal (nas, aqs): Initial: 100μg per nostril, dly; Maintenance: 50μg per nostril, dly once symptoms are controlled; If symptoms inadequately controlled: 200μg per nostril, dly, with a recommended dose reduction once symptoms are controlled; Max: 400μg/24hrs (total dose) 

1 spray = 50μg

For patients with a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment is recommended prior to the anticipated start of the pollen season

Method of administration:
Prior to administration of the first dose, the container should be shaken well, and the pump actuated until a uniform spray is obtained (approximately 10 times, refer to product specific professional information). If the spray pump has not been used for 14 days or longer, it should be re-primed with 2 actuations, until a uniform spray is observed, before the next use. No priming subsequent to the initial priming is required with regular use. Shake the container well before each use

Although mometasone furoate will control nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms, particularly ocular symptoms

Paed. form avail. in SA and covered in this monograph: nas, aqs

South African registered indications and dosages

Seasonal allergic rhinitis
Perennial allergic rhinitis

Younger than 2 years

• Contraindicated

Between 2-11 years

• Nasal (nas, aqs): 50μg per nostril, dly; Max: 100μg/24hrs (total dose)

Older than 12 years

• See adult dosage

1 spray = 50μg

For patients with a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment is recommended prior to the anticipated start of the pollen season

Safety and efficacy in children below 2 years have not been demonstrated

Administration to young children should be aided by an adult

Method of administration:
Prior to administration of the first dose, the container should be shaken well, and the pump actuated until a uniform spray is obtained (approximately 10 times depending on product used, refer to product specific professional information). If the spray pump has not been used for 14 days or longer, it should be re-primed with 2 actuations, until a uniform spray is observed, before the next use. No priming subsequent to the initial priming is required with regular use. Shake the container well before each use

Although mometasone furoate will control nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms, particularly ocular symptoms

Pregnancy

South African recommendations

• Contraindicated
• Mometasone furoate should not be used during pregnancy
• Studies in animals have shown reproductive toxicity. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism

Recommendations in other jurisdictions

• Caution; not recommended
• There are no or limited amount of data from the use of mometasone furoate in pregnant women. Studies in animals have shown reproductive toxicity
• As with other nasal corticosteroid preparations, mometasone furoate nasal spray should not be used in pregnancy unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism

Breastfeeding

South African recommendations

• Contraindicated
• Mometasone furoate should not be used during lactation
• It is unknown whether mometasone furoate is excreted in human milk

Recommendations in other jurisdictions

• Caution; not recommended
• It is unknown whether mometasone furoate is excreted in human milk
• As with other nasal corticosteroid preparations, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from mometasone furoate nasal spray therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

Recommendations below are applicable to South Africa and other jurisdictions

• There are no clinical data concerning the effect of mometasone furoate on fertility. Animal studies have shown reproductive toxicity, but no effects on fertility

• No dose adjustment recommended

• No dose adjustment recommended

• No dose adjustment recommended

Central Nervous System Disorders

• Headache

Respiratory Disorders

• Rhinitis
• Epistaxis
• Nasal burning
• Nasal irritation
• Nasal ulceration
• Nasal septum perforation
• Angioedema
• Bronchospasm
• Dyspnoea
• Pharyngitis
• Upper respiratory tract infection

Gastrointestinal Disorders

• Throat irritation

Endocrine and Metabolic Disorders

• Hypothalamic-pituitary-adrenal axis suppression

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

Sensory Disorders

• Disturbances of taste and smell
• Glaucoma
• Increased intraocular pressure
• Cataracts
• Conjunctivitis
• Dry eyes

No information available

None routine. Specific cases may require

• Growth (children and adolescents)
• Signs and symptoms of
  - HPA axis suppression
  - Adrenal insufficiency
  - Cataracts
  - Glaucoma
  - Adverse effects (nasal)

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

Nasal spray (per spray) 50μg

• Mometasone Clicks nasal spray (Sandoz)
• Monact (Actor Pharma)
• Nasonex (MSD) originator
• Netrin NS (Trinity Pharma)
• Nexomist (Cipla Medpro)
• Rhinimet (Unicorn Pharmaceuticals)
• Rinelon (MSD)
• Zilfone nasal spray (Sandoz)
• Zomate NS (Trinity Pharma)

Also available in the following forms: Inhaler, cream, ointment and lotion