Allergomex (Spray) Instructions for Use

Marketing Authorization Holder

Fortiva Med, LLC (Republic of Belarus)

ATC Code

R01AD09 (Mometasone)

Active Substance

Mometasone (Rec.INN registered by WHO)

Dosage Form

Allergomex

Metered-dose nasal spray 50 mcg/dose: 140 dose bottle (18 g suspension)

Dosage Form, Packaging, and Composition

Metered-dose nasal spray as an opaque white or almost white suspension, free from foreign particles.

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

18 g (140 doses) – high-density polyethylene bottles with a dosing device (1) – cardboard packs.

Clinical-Pharmacological Group

Intranasal corticosteroids

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Intranasal glucocorticosteroid. It has anti-inflammatory and anti-allergic effects.

The mechanism of anti-allergic and anti-inflammatory action is due to the ability to inhibit the release of inflammatory mediators. It increases the production of lipomodulin, which is an inhibitor of phospholipase A, which causes a decrease in the release of arachidonic acid and, consequently, inhibition of the synthesis of arachidonic acid metabolites – cyclic endoperoxides, prostaglandins. It prevents the marginal accumulation of neutrophils, which reduces inflammatory exudate and the production of lymphokines, inhibits macrophage migration, and leads to a reduction in infiltration and granulation processes. It reduces inflammation by reducing the formation of chemotaxis substance (effect on late allergic reactions), inhibits the development of an immediate-type allergic reaction (due to inhibition of the production of arachidonic acid metabolites and reduced release of inflammatory mediators from mast cells).

In studies with provocative tests involving antigen application to the nasal mucosa, high anti-inflammatory activity of mometasone was demonstrated, both in the early and late stages of the allergic reaction. This was confirmed by a reduction (compared to placebo) in histamine levels and eosinophil activity, as well as a decrease (compared to baseline) in the number of eosinophils, neutrophils, and epithelial cell adhesion proteins.

Pharmacokinetics

With intranasal use, the systemic bioavailability of mometasone furoate is <1% (with a determination method sensitivity of 0.25 pg/ml). Mometasone is very poorly absorbed from the gastrointestinal tract. The small amount of mometasone that may enter the gastrointestinal tract upon intranasal administration undergoes active primary metabolism before excretion in urine or bile.

Indications

Treatment of seasonal and perennial allergic rhinitis in adults, adolescents, and children from 2 years of age; acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents from 12 years of age (as an adjunct to antibiotic therapy); acute rhinosinusitis with mild to moderate symptoms without signs of severe bacterial infection in patients aged 12 years and older; prevention of moderate to severe seasonal allergic rhinitis in adults and adolescents from 12 years of age; nasal polyposis accompanied by impaired nasal breathing and sense of smell in adults (from 18 years).

ICD codes

Dosage Regimen

Administer intranasally. The total daily dose ranges from 100 mcg to 800 mcg.

For seasonal and perennial allergic rhinitis in adults and adolescents 12 years and older: administer 200 mcg once daily as two sprays (50 mcg each) in each nostril. For severe symptoms, initiate with 400 mcg once daily. Upon symptom control, reduce to 100 mcg once daily.

For seasonal and perennial allergic rhinitis in children aged 2 to 11 years: administer 100 mcg once daily as one spray in each nostril.

For prevention of seasonal allergic rhinitis in adults and adolescents 12 years and older: initiate treatment 2-4 weeks before the anticipated pollen season. Administer 200 mcg once daily as two sprays in each nostril.

For acute sinusitis or exacerbation of chronic sinusitis in adults and adolescents 12 years and older: use as an adjunct to antibiotic therapy. Administer 400 mcg twice daily as two sprays in each nostril in the morning and evening.

For acute rhinosinusitis with mild to moderate symptoms in patients 12 years and older: administer 400 mcg once daily as two sprays in each nostril.

For nasal polyposis in adults 18 years and older: administer 400 mcg twice daily as two sprays in each nostril in the morning and evening. Following polyp reduction, a maintenance dose of 200 mcg once daily may be used.

Prime the spray before first use by pressing the pump 10 times until a fine mist appears. If unused for 14 days or more, re-prime with 2 sprays. Direct the spray slightly away from the nasal septum. Avoid spraying directly into the eyes.

The maximum daily dose should not exceed 800 mcg. Titrate to the lowest effective dose for maintenance therapy. Regularly assess the need for continued treatment.

Adverse Reactions

Infections and infestations Common – pharyngitis, upper respiratory tract infections.

Immune system disorders Frequency not known – hypersensitivity reactions, including anaphylactic reactions, angioedema, bronchospasm, dyspnea.

Nervous system disorders: Common – headache; in children – headache (6%).

Eye disorders Frequency not known – increased intraocular pressure, glaucoma, cataract, blurred vision.

Respiratory, thoracic and mediastinal disorders Very common – epistaxis; Common – epistaxis, sensation of burning in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa; Frequency not known – nasal septum perforation. In children – epistaxis (6%), irritation of the nasal mucosa (2%), sneezing (2%).

Gastrointestinal disorders Common – pharyngeal irritation (sensation of irritation of the pharyngeal mucosa); Frequency not known – taste and smell disorders.

Contraindications

Hypersensitivity to mometasone; recent surgery or nasal trauma with damage to the nasal mucosa – until the wound has healed (due to the inhibitory effect of glucocorticosteroids on healing processes); children and adolescents under 18 years of age with nasal polyposis; children under 12 years of age with acute sinusitis or exacerbation of chronic sinusitis; children under 2 years of age with seasonal and perennial allergic rhinitis.

With caution

In tuberculous infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye involvement (as an exception, the drug may be prescribed for these infections on the advice of a physician), the presence of an untreated local infection involving the nasal mucosa.

Use in Pregnancy and Lactation

Adequate and well-controlled studies on the use of mometasone during pregnancy have not been conducted. It is not known whether Mometasone is excreted in breast milk.

Intranasal use of mometasone during pregnancy and breastfeeding is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or breastfed infant.

Newborns whose mothers received glucocorticosteroids during pregnancy should be monitored for possible signs of adrenal insufficiency.

Pediatric Use

Used in children over 2 years of age according to indications.

Contraindications: children and adolescents under 18 years of age with nasal polyposis; children under 12 years of age with acute sinusitis or exacerbation of chronic sinusitis; children under 2 years of age with seasonal and perennial allergic rhinitis.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

With long-term intranasal use of mometasone, periodic examination of the nasal mucosa by an ENT doctor is necessary. If a local bacterial or fungal infection of the nose or pharynx develops, it is recommended to discontinue treatment and initiate specific therapy. Persistent irritation of the nasal and pharyngeal mucosa is an indication for drug withdrawal.

If a patient experiences symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist to assess possible causes, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been reported after the use of systemic and topical corticosteroids.

Particular caution is required when switching from systemic glucocorticosteroids to intranasal mometasone due to the possible risk of adrenal insufficiency. After discontinuation of systemic glucocorticosteroids, it takes several months for the hypothalamic-pituitary-adrenal system function to recover.

During stressful situations, including trauma, surgery, infectious diseases, or a severe asthma attack, patients who have previously received systemic glucocorticosteroids require an additional short course of systemic glucocorticosteroids, which are then gradually withdrawn as symptoms subside.

When switching from systemic glucocorticosteroids, concomitant allergic diseases, the symptoms of which were previously suppressed by the use of systemic corticosteroids, may manifest during intranasal use of mometasone. During this period, some patients may experience signs of systemic corticosteroid withdrawal, including muscle and/or joint pain, depression, feeling of fatigue, despite the fact that lung function indicators are stable or even improving. If signs of adrenal insufficiency occur, the dose of systemic glucocorticosteroids should be temporarily increased, and their subsequent withdrawal should be carried out more smoothly.

Patients receiving glucocorticosteroids or other immunosuppressants should be advised to avoid contact with patients with certain infections (chickenpox, measles) and must consult a doctor if such contact occurs (especially important when used in adolescents over 12 years of age).

To maintain a low potential for suppression of the hypothalamic-pituitary-adrenal system, recommended doses should not be exceeded, and the dose of mometasone should be titrated for each patient to achieve the minimum effective dose.

When using mometasone, it should be taken into account that the effect on cortisol production may vary among different patients.

The occurrence of candidiasis may require appropriate antifungal therapy or discontinuation of mometasone.

Use in pediatrics

Growth should be regularly monitored in children receiving long-term therapy with mometasone. If growth retardation occurs, the therapy should be reconsidered to reduce the dose of mometasone to the minimum effective dose that controls the symptoms of the disease.

In placebo-controlled clinical studies in children with intranasal use of mometasone at a dose of 100 mcg/day for one year, no growth retardation was observed.

Drug Interactions

Concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, medicinal products containing cobicistat) may increase the risk of systemic side effects. Concomitant administration of these drugs should be avoided, unless the benefits of treatment outweigh the risk of systemic side effects of the corticosteroid. In this case, the patient should be carefully monitored for the occurrence of systemic side effects of corticosteroids.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.