Nasal Products


Etacid (Nasal spray)
(mometasone furoate 0.5 mg)

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.

SPECIAL INDICATIONS
Etacid should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections or ocular herpes simplex. Following 12 months of treatment with Etacid there was no evidence of atrophy of the nasal mucosa; also, mometasone furoate tended to reverse the nasal mucosa closer to a normal histologic phenotype. As with any long-term treatment, patients using Etacid over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localized fungal infection of the nose or pharynx develops, discontinuance of Etacid therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing Etacid. If intranasal corticosteroids are used in dosage higher than recommended or in patients with increased sensitivity, suppression of endogenous production of corticosteroids may occur. In this case Etacid should be gradually withdrawn. Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs (if symptoms of severe bacterial infections occur - temperature rise, strong unilateral pains in the area of face or tooth pain, orbital or periorbital swelling/edema or deterioration following initial improvement. Nasal corticosteroids may lead to glaucoma and cataracts development. That is why changes in visual function in patients including the patients with increased intraocular pressure or history of cataract shall be monitored carefully. Corticosteroids intake may result in growth deterioration when used in children. Growth control should be performed.

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.

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.

SPECIAL INDICATIONS
Because the systemic bioavailability of Etacid is < 1% overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage. Long-term administration of excessive doses of corticosteroids may lead to suppression of HPA axis function. Overdose may occur in case of improper use (swallowing). Mometasone furoate is very poorly absorbed, and the small amount that may be swallowed and absorbed undergoes extensive first-pass hepatic metabolism.

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


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