Ditamal^® (Spray) Instructions for Use

Marketing Authorization Holder

World Medicine İlaç San. ve Tic. A.Ş. (Turkey)

ATC Code

R01AD09 (Mometasone)

Active Substance

Mometasone (Rec.INN registered by WHO)

Dosage Form

Ditamal®

Dosed nasal spray 50 mcg/dose: bottle 140 doses 1 pc.

Dosage Form, Packaging, and Composition

Dosed nasal spray as a white or almost white suspension.

Excipients: glycerol – 2100 mcg, Avicel RC-591 (microcrystalline cellulose, sodium carboxymethylcellulose) – 2000 mcg, sodium citrate dihydrate – 280 mcg, citric acid monohydrate – 200 mcg, benzalkonium chloride – 20 mcg, polysorbate 80 – 10 mcg, purified water – 95340 mcg.

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

Clinical-Pharmacological Group

Topical 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, accordingly, 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 allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).

In studies with provocative tests with 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 decrease (compared to placebo) in the level of histamine 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.

A small amount of mometasone that may enter the gastrointestinal tract during intranasal administration undergoes active primary metabolism before being excreted in the 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 treatment); 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.

For adults (18 years and older) with seasonal or perennial allergic rhinitis: The usual starting dose is 100 mcg (2 sprays) in each nostril once daily, for a total daily dose of 200 mcg.

For adolescents (12-17 years) with seasonal or perennial allergic rhinitis: The recommended dose is 100 mcg (2 sprays) in each nostril once daily.

For children (2-11 years) with allergic rhinitis: The recommended dose is 50 mcg (1 spray) in each nostril once daily, for a total daily dose of 100 mcg.

For acute sinusitis or exacerbation of chronic sinusitis in adults and adolescents 12 years and older: Use as an adjunct to antibiotics. The dose is 200 mcg (2 sprays in each nostril) twice daily, for a total daily dose of 400 mcg.

For prevention of seasonal allergic rhinitis in adults and adolescents 12 years and older: Begin treatment 2-4 weeks before the anticipated start of pollen season. The dose is 100 mcg (2 sprays) in each nostril once daily.

For nasal polyposis in adults 18 years and older: The recommended dose is 200 mcg (2 sprays) in each nostril twice daily, for a total daily dose of 800 mcg.

After symptoms are controlled, reduce the dose to the minimum effective amount to maintain symptom control.

The maximum total daily dose should not exceed 800 mcg.

Prime the spray pump before first use or if not used for 14 days or more.

Shake the bottle gently before each use.

Blow your nose before administration.

Avoid spraying directly onto the nasal septum.

Adverse Reactions

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

Gastrointestinal disorders Common – pharyngeal irritation (sensation of pharyngeal mucosal irritation); 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 case of tuberculosis 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 as directed by a doctor), the presence of an untreated local infection involving the nasal mucosa.

Use in Pregnancy and Lactation

Adequate and well-controlled studies of 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 symptoms of adrenal cortex 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 stop treatment and start specific treatment.

Persistent irritation of the nasal and pharyngeal mucosa for a long time is an indication for drug discontinuation.

If a patient develops 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 to restore the function of the hypothalamic-pituitary-adrenal system.

During stressful situations, including trauma, surgery, infectious diseases, or a severe attack of bronchial asthma, 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 to intranasal mometasone, concomitant allergic diseases may manifest, the symptoms of which were previously suppressed by the use of systemic corticosteroids.

During this period, some patients may experience signs of withdrawal of systemic glucocorticosteroids, including muscle and/or joint pain, depression, feeling tired, even though 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 withdrawal should be carried out more smoothly in the future.

Patients receiving glucocorticosteroids or other immunosuppressants should be advised to avoid contact with patients with certain infections (chickenpox, measles) and be sure to 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

It is recommended to regularly monitor the growth of children receiving long-term therapy with mometasone.

If growth retardation occurs, the ongoing therapy should be reviewed in order to reduce the dose of mometasone to the minimum effective dose that allows control of disease symptoms.

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, drugs 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.