Etacid
(Mometasone furoate)




COMPOSITION

1 g of suspension contains

Active substance: mometasone furoate 0.5 mg

Excipients: microcrystalline cellulose, carmellose sodium, sodium citrate, glycerol, citric acid monohydrate, polysorbate 80, benzalkonium chloride, purified water.

THERAPEUTIC INDICATIONS

- Prophylaxis and treatment of nasal symptoms (nasal blockage) of seasonal and perennial allergic rhinitis in adults, adolescents and children ≥2 years of age.

- As an adjunctive therapy of acute sinusitis in adults (including elderly patients) and children ≥2 years of age.

- treatment of acute rhinosinusitis without the symptoms of severe bacterial infection in adults and children ≥12 years of age.

- treatment of nasal polyps and associated symptoms including nasal blockage and anosmia in patients ≥18 years of age

CONTRAINDICATIONS

- hypersensitivity to any ingredients of the preparation:

- recent nasal surgery or trauma (until healing);

- age under 2 years old.

ADVERSE EFFECTS

Local reactions: nosebleeds (generally non-severe and they go away independently), epistaxis/blood-tinged mucus, epipharynx candidiasis, nasal ulceration.

Very rarely: cataract, glaucoma.

Very rarely: immunosuppressive reactions and growth deterioration due to hypothalamic-pituitary-adrenal system effects.

DOSAGE AND ADMINISTRATION

For intranasal use only. Avoid contact with eyes. Shake inhaler gently immediately prior to use.

Prior to initial use, the metered-dose pump spray must be primed with 10 actuations. Then the drug substance is supplied stereotypically. The pump should be reprimed in case of its non-use during 14 days and longer.

Prophylaxis and treatment of nasal symptoms (nasal blockage) of seasonal and perennial allergic rhinitis in adults, adolescents and children ≥2 years of age.

Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril once daily (daily dose is 200 µg).

Children (2-12 yrs.): 1 spray in each nostril once daily dose is 100 µg).

Clinical effect is usually observed 12 hours following the first administration.

Prophylaxis of Seasonal Allergic Rhinitis should be initiated 2-4 weeks prior to possible appearance of symptoms.

Adjunctive therapy of acute sinusitis in adults (including elderly patients) and children ≥2 years of age.

The usual recommended therapeutic dose is 2 actuations in each nostril twice daily (daily dose is 400 µg). If the symptoms are inadequately controlled, the dose may be increased to a daily dose of four sprays in each nostril twice daily (total daily dose of 800 micrograms). The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

Treatment of acute rhinosinusitis without the symptoms of severe bacterial infection in adults and children ≥12 years of age.

The usual recommended therapeutic dose is 2 actuations in each nostril twice daily (daily dose is 400 µg).

Treatment of nasal polyps and associated symptoms including nasal blockage and anosmia in patients ≥18 years of age

For the treatment of nasal polyps in patients over 18 years old: 2 actuations (100 µg) in each nostril twice daily (daily dose is 400 µg). In some groups of patients the effective dose is 2 actuations in each nostril once daily.

DRUG INTERACTIONS

No interactions were observed. Due to active metabolite in liver (CYP3A4) the concomitant use of mometasone furoate with ketoconazole may result in increased concentration of mometasone furoate in plasma.

PREGNANCY AND LACTATION

There are no adequate or well-controlled studies in pregnant women. Mometasone is not detected in plasma even in minimal concentrations following intranasal administration of maximal therapeutic dose, thus Etacid produces insufficient effect on fetus, and the potential toxicity for reproduction is low.

Etacid should not be used in pregnancy or lactation unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant.

MANUFACTURED FORM

Nasal spray, 18 g suspension in a polyethylene dosing bottle with a protective cap.

Bottle is supplied with a leaflet in a carton box.

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