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Mometasone Furoate


Pronunciation

 (moe MET a sone FYOOR oh ate)


U.S. Brand Names

 Elocon®; Nasonex®


Generic Available

 Yes: Ointment


Canadian Brand Names

 Elocom®; Nasonex®


Use

 Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (medium potency topical corticosteroid); treatment of nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age; prevention of nasal symptoms associated with seasonal allergic rhinitis in children 12 years of age and adults; treatment of nasal polyps in adults


Pregnancy Risk Factor

 C


Pregnancy Implications

 There are no adequate and well-controlled studies using topical mometasone during pregnancy. However, intrauterine growth retardation has been reported with some topical steroids. Avoid use of large amounts for long periods of time during pregnancy.


Lactation

 Excretion in breast milk unknown/use caution


Contraindications

 Hypersensitivity to mometasone or any component of the formulation; fungal, viral, or tubercular skin lesions, herpes simplex or zoster


Warnings/Precautions

Nasal: Use caution if replacing systemic corticosteroid with nasal; may cause symptoms of withdrawal or acute adrenal insufficiency May cause suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients; titrate to the lowest effective dose. May suppress the immune system, patients may be more susceptible to infection. Use with caution, if at all, in patients with systemic infections, active or quiescent tuberculosis infection, or ocular herpes simplex. Avoid exposure to chickenpox and measles.

Topical: May cause suppression of HPA axis, especially when used on large areas of the body, denuded areas, for prolonged periods of time or with an occlusive dressing. Pediatric patients may be more susceptible to systemic toxicity.


Adverse Reactions

Nasal:

>10%:

Central nervous system: Headache (17% to 26%)

Respiratory: Pharyngitis (10% to 12%), cough (7% to 13%), epistaxis (8% to 11%)

Miscellaneous: Viral infection (8% to 14%)

1% to 10%:

Cardiovascular: Chest pain

Endocrine & metabolic: Dysmenorrhea (1% to 5%)

Gastrointestinal: Vomiting (1% to 5%), diarrhea, dyspepsia, nausea

Neuromuscular & skeletal: Musculoskeletal pain (1% to 5%), arthralgia, myalgia

Ocular: Conjunctivitis

Otic: Earache, otitis media

Respiratory: Upper respiratory tract infection (5% to 6%), sinusitis (4% to 5%), asthma, bronchitis, nasal irritation, rhinitis, wheezing

Miscellaneous: Flu-like symptoms

<1%: Nasal candidiasis, nasal ulcers, oral candidiasis

Postmarketing and/or case reports: Anaphylaxis, angioedema, nasal burning and irritation, nasal septal perforation, smell disturbance (rare), taste disturbance (rare)

Topical:

1% to 10%: Dermatologic: Bacterial skin infection, burning, furunculosis, pruritus, skin atrophy, tingling/stinging

<1%: Folliculitis, glucocorticoid levels decreased (pediatric patients), moniliasis, paresthesia, skin depigmentation, skin atrophy

Postmarketing and/or case reports: Rosacea

Cataract formation, reduction in growth velocity, and HPA axis suppression have been reported with other corticosteroids


Drug Interactions

 Substrate of CYP3A4 (minor)

No drug interaction data reported.


Stability

Cream: Store between 2°C to 25°C (36°F to 77°F).

Lotion: Store between 2°C to 30°C (36°F to 86°F).

Nasal spray: Store at room temperature of 15°C to 30°C (59°F to 86°F); protect from light.

Ointment: Store at room temperature of 15°C to 30°C (59°F to 86°F).


Mechanism of Action

 May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins). Leukocytes and macrophages may have to be present for the initiation of responses mediated by the above substances. Inhibits the margination and subsequent cell migration to the area of injury, and also reverses the dilatation and increased vessel permeability in the area resulting in decreased access of cells to the sites of injury.


Pharmacodynamics/Kinetics

Absorption:

Nasal: Mometasone furoate monohydrate: Undetectable in plasma

Ointment: 0.7%; increased by occlusive dressings

Protein binding: Mometasone furoate: 98% to 99%

Metabolism: Mometasone furoate: Hepatic via CYP3A4; forms metabolite

Half-life elimination: I.V.: 5.8 hours

Excretion: Bile, urine


Dosage

Nasal spray:

Allergic rhinitis:

Children 2-11 years: 1 spray (50 mcg) in each nostril daily

Children 12 years and Adults: 2 sprays (100 mcg) in each nostril daily; when used for the prevention of allergic rhinitis, treatment should begin 2-4 weeks prior to pollen season

Nasal polyps: Adults: 2 sprays (100 mcg) in each nostril twice daily; 2 sprays (100 mcg) once daily may be effective in some patients

Topical: Apply sparingly, do not use occlusive dressings. Therapy should be discontinued when control is achieved; if no improvement is seen in 2 weeks, reassessment of diagnosis may be necessary.

Cream, ointment: Children 2 years and Adults: Apply a thin film to affected area once daily; do not use in pediatric patients for longer than 3 weeks

Lotion: Children 12 years and Adults: Apply a few drops to affected area once daily


Administration

Nasal spray: Prior to first use, prime pump by actuating 10 times or until fine spray appears; may store for a maximum of 1 week without repriming. Spray should be administered once or twice daily, at a regular interval. Shake well prior to use.

Topical: Apply sparingly; avoid eyes, face, underarms, and groin. Do not wrap or bandage affected area.


Monitoring Parameters

 HPA axis suppression


Patient Education

 For external use only. Inform prescriber of all prescription, OTC medications, or herbal products you are taking, and any allergies you have; do not take anything new during treatment without consulting prescriber. Use exactly as directed and for no longer than the period prescribed. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Nasal: Read complete instructions in package. Prime the pump as directed. Gently blow your nose to clear nostrils. Close one nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril. After the spray, breath gently inward through the nostril, then breath out through the mouth. Repeat in other nostril. You may experience headache, cough, or nosebleed. Report unusual chest pain, gastrointestinal upset, muscle pain, flu-like symptoms, other persistent adverse reactions, worsening of condition or failure to improve. Store at room temperature, away from light.

Topical: Do not use for eyes, mucous membranes, or open wounds. Use exactly as directed and for no longer than the period prescribed. Before using, wash and dry area gently. Apply in a thin layer (cream, ointment) or a few drops (lotion) and rub in lightly. Apply light dressing (if necessary) to area being treated. Do not use occlusive dressing unless so advised by prescriber. Avoid prolonged or excessive use around sensitive tissues, underarms, genital, or rectal areas. Avoid exposing treated area to direct sunlight (severe sunburn may occur). Inform prescriber if condition worsens (redness, swelling, irritation, signs of infection, or open sores) or fails to improve.


Dental Health: Effects on Dental Treatment

 No significant effects or complications reported


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 No information available to require special precautions


Mental Health: Effects on Mental Status

 None reported


Mental Health: Effects on Psychiatric Treatment

 None reported


Dosage Forms

Cream, topical (Elocon®): 0.1% (15 g, 45 g)

Lotion, topical (Elocon®): 0.1% (30 mL, 60 mL) [contains isopropyl alcohol 40%]

Ointment, topical (Elocon®): 0.1% (15 g, 45 g)

Suspension, intranasal spray (Nasonex®): 50 mcg/spray (17 g) [delivers 120 sprays; contains benzalkonium chloride]


International Brand Names

 Elocom® (CA); Nasonex® (CA)


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