Desrinit, spray 50 mcg/dose 18 g 140 doses

Interaction

Concomitant use of mometasone with loratadine did not result in changes in plasma concentrations of loratadine or its main metabolite, with no detectable presence of mometasone in plasma even at minimal concentrations. In these studies, mometasone furoate was not detected in plasma (with a sensitivity of 50 pg/ml detection method). When concomitant use with CYP3A inhibitors, including cobicistat-containing drugs, the risk of systemic side effects increases. Their concomitant use should be avoided, except in cases when the potential benefit to the patient exceeds the possible risk of development of systemic side effects of corticosteroids. In case of concomitant use, the development of systemic side effects of corticosteroids in patients should be monitored.

Special Instructions

As with any treatment, patients using mometasone nasal spray dosage form for several months or longer should periodically be monitored by a physician for possible nasal mucosal changes.

Patients receiving intranasal GCS for a long time should be monitored. Growth retardation in children is possible. If growth retardation in children is detected, the dose of intranasal GCS should be reduced to the lowest dose that effectively controls symptoms. In addition, the patient should be referred to a pediatrician for consultation.

If a local fungal infection of the nose or pharynx develops, it may be necessary to discontinue therapy with mometazone in the dosage form of nasal spray and perform specific treatment. Persistent long-term irritation of the mucous membranes of the nose and pharynx may also serve as a reason for discontinuing treatment with mometazone in dosage form – nasal spray.

In placebo-controlled clinical studies in children when mometasone nasal spray dosage form was used in a daily dose of 100 mcg for one year, no growth retardation was observed in children.

There were no signs of suppression of hypothalamic-pituitary-adrenal function during long-term treatment with mometasone nasal spray.

Patients who switch to treatment with mometazone in dosage form nasal spray after long-term therapy with systemic glucocorticosteroids require special attention. Withdrawal of systemic glucocorticosteroids in such patients may lead to insufficiency of adrenal function, subsequent recovery of which may take up to several months. If signs of adrenal insufficiency appear, systemic glucocorticosteroids should be restarted and other necessary measures taken.

The use of intranasal GCS may result in systemic side effects, especially with prolonged use at high doses. The likelihood of these effects is significantly less than with oral GCS.

Systemic side effects may vary in individual patients and depending on the glucocorticosteroid drug used. Potential systemic effects include Cushing’s syndrome, characteristic cushingoid signs, suppression of adrenal function, growth retardation in children and adolescents, cataracts, glaucoma, and less commonly a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbance, anxiety, depression or aggression (especially in children).

During the transition from systemic glucocorticosteroid treatment to treatment with mometazone nasal spray, some patients may experience initial symptoms of withdrawal from systemic glucocorticosteroids (e.g., joint and/or muscle pain, fatigue and depression) despite a reduction in symptoms associated with nasal mucosal damage. If these symptoms occur, systemic glucocorticosteroids should be restarted and other necessary measures taken. Switching from systemic to topical glucocorticosteroids may also reveal pre-existing but masked systemic glucocorticosteroid therapy for allergic conditions such as allergic conjunctivitis and eczema.

Patients treated with glucocorticosteroids have potentially compromised immune reactivity and should be advised of their increased risk of exposure to certain infectious diseases (e.g., chickenpox, measles) and the need for medical consultation if this occurs.

If there are signs of a serious bacterial infection (e.g., fever, persistent or severe pain on one side of the face or toothache, swelling of the orbital or periorbital area), you should get immediate medical advice.

No signs of nasal mucosal atrophy have occurred when using mometasone in the dosage form nasal spray for 12 months. In addition, mometasone furoate tended to promote normalization of the histological picture in nasal mucosal biopsy specimens.

The efficacy and safety of mometasone has not been studied in the treatment of unilateral polyps, polyps associated with cystic fibrosis, and polyps that completely cover the nasal cavity.

If unilateral polyps of unusual or irregular shape, particularly ulcerated or bleeding polyps, are detected, further medical evaluation should be performed.

Sight disturbances have been reported with systemic and topical use of corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient to an ophthalmologist for evaluation of possible causes, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy (CCP).

Influence on ability to drive or operate machinery

There are no data on the effect of Desrinit drug on the ability to drive or operate moving machinery.

Contraindications

Hypersensitivity to mometazon or any of the drug components; childhood (in seasonal and year-round allergic rhinitis – under 2 years; in acute sinusitis or exacerbations of chronic sinusitis – under 12 years; in nasal polyposis – under 18 years); recent surgery or nasal trauma with damage of the nasal mucosa – until the wound healing (due to the inhibiting effect of GCS on healing processes).

Cautions

Desrinit should be used with caution in cases of tuberculosis infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic virus infection or infection caused by Herpes simplex with eye involvement (as an exception, the drug may be prescribed for the above infections as directed by a physician), the presence of untreated local infection with involvement of the nasal mucosa.

Side effects

Adverse events associated with the use of the drug (≥1%) identified during clinical trials in patients with allergic rhinitis or nasal polyposis and during post-registration use of the drug, regardless of the indication for use, are presented in Table 1. Adverse reactions are listed according to the MedDRA classification of systemic-organ classes. Within each system-organ class, adverse reactions are classified by frequency of occurrence.

Nasal bleeding was generally moderate and stopped on its own, with a slightly higher incidence than with placebo (5%) but equal to or lower than with other intranasal GCSs used as active controls (some had incidence rates of up to 15%). The incidence of all other adverse events was comparable to that of placebo administration.

The overall incidence of adverse events in patients treated for nasal polyposis was comparable to the incidence in patients with allergic rhinitis.

The overall incidence of adverse events in patients treated for acute rhinosinusitis was comparable to the incidence in patients with allergic rhinitis and when given placebo.

The use of intranasal GCS may cause systemic adverse effects, especially with long-term use of high-dose intranasal GCS (see section “Cautionary Note”).

Table 1

^* detected with a frequency of “rare” when the drug is used twice daily for nasal polyposis

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^** revealed when the drug is used twice daily for nasal polyposis

Children

Disorders of the respiratory system, thoracic and mediastinal organs: nasal bleeding (6%), nasal mucous membrane irritation (2%), sneezing (2%).

Nervous system disorders:headache (3%).

The incidence of these adverse events in children was comparable to that of placebo.

Overdose

In case of prolonged use of GCS in high doses, as well as in case of simultaneous use of several GCS, suppression of hypothalamic-pituitary-adrenal system function is possible. Due to the low systemic bioavailability of the drug (<1%, with a sensitivity of 0.25 pg/ml), it is unlikely that accidental or intentional overdose will require any measures other than observation with possible subsequent resumption of the drug at the recommended dose.

Pregnancy use

No specific studies have been performed on the safety of mometasone during pregnancy and breastfeeding. As with other nasal GCSs, Desrinit should be administered during pregnancy and breastfeeding only if the expected benefits of its use exceed the potential risk to the fetus and newborn. Newborns whose mothers used GCS during pregnancy should be carefully examined to detect possible adrenal hypofunction.

Similarities

Momat Reno, Nosefrin, Mometazon, Rialtris, Momeid