Galazolin Allergo - instructions for use, dose, side effects, contraindications

Excipients: cellulose microcrystalline and carmellose sodium (AviceE CL-611) - 2.00 mg, glycerol - 2.10 mg, polysorbate-80 - 0.01 mg, sodium citrate dihydrate 0.28 mg, citric acid monohydrate 0.20 mg , benzalkonium chloride - 0.02 mg, water for injection - up to 100.0 mg.

Description:

A suspension of white or almost white color, placed in a white bottle of high-density polyethylene, equipped with a metering aerosol pump, a plastic drive and a plastic nozzle for spraying, closed with a plastic lid.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.01.A.D.09 Mometasone

Pharmacodynamics:

Mometasone is a synthetic glucocorticosteroid (GCS) for topical application. Has anti-inflammatory and antiallergic effect when used in doses, in which systemic effects do not develop. It inhibits the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which causes a decrease in the release of arachidonic acid and, accordingly,suppression of synthesis of metabolic products of arachidonic acid - cyclic endoperoxides, prostaglandins. It prevents the accumulation of neutrophils, which reduces inflammatory exudate and production of lymphokines, inhibits the migration of macrophages, leads to a decrease in the processes of infiltration and granulation.

Reduces inflammation by reducing the formation of the chemotaxis substance (effect on the "late" allergy reaction), inhibits the development of an allergic reaction of immediate type (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 application of antigens to the mucosa of the nasal cavity, 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 (in comparison with placebo) of the level of histamine and eosinophil activity, as well as a decrease in the number of eosinophils, neutrophils and adhesion proteins of epithelial cells (as compared to the baseline level).

In clinical trials, it was found that mometasone furoate in the form of a nasal spray metered reduces the severity of nasal symptoms of seasonal and perennial allergic rhinitis (nasal obstruction, rhinorrhea, sneezing and itching). Reduction in the severity of symptoms of seasonal allergic rhinitis was noted within 11 hours after the first administration of the drug. The maximum favorable effect was usually observed within 1-2 weeks after the start of the drug application.

Therapy with mometasone in the form of a nasal spray significantly reduced nasal congestion in patients with seasonal allergic rhinitis.

Pharmacokinetics:

In intranasal application, the systemic bioavailability of mometasone furoate is <1% (with a sensitivity of 0.25 pg / ml). Mometasone furoate in the form of a suspension is very poorly absorbed in the gastrointestinal tract, and then a small amount of a suspension of mometasone which may get into the gastrointestinal tract when administered intranasally to urinary excretion, or bile exposed active primary metabolism.

Indications:

Treatment of seasonal and year-round allergic rhinitis in adults (elimination of symptoms,such as pain and a feeling of pressure in the area of the paranasal sinuses, nasal congestion, runny nose, sneezing, itching in the nose, lacrimation).

Contraindications:

Hypersensitivity to any of the components of the drug.

A recent surgery or injury to the nose with damage to the mucous membrane of the nasal cavity - until the wound is healed (due to the inhibitory effect of GCS on healing processes).

Children under 18 years.

Carefully:

Before using the drug, galazolin allergo should consult a doctor for tuberculosis infection (active or latent) respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with the defeat of the eyes (as an exception, the administration of the drug is possible with the listed infections as directed by the doctor), the presence of an untreated local infection involving the nasal cavity in the mucosa process.

Pregnancy and lactation:

Before using Halazolin Allergo during pregnancy and during breastfeeding it is necessary to consult a doctor.

Appropriately planned and well-controlled studies of the drug in pregnant women have not been conducted.As with other intranasal GCS, the preparation of Galazolin Allergo should be given to pregnant or breast-feeding patients only if the expected benefit of the drug justifies the potential risk to the fetus or baby. Infants whose mothers received SCS during pregnancy should be carefully screened for possible hypofunction of the adrenal glands.

Dosing and Administration:

Intranasally.

Inhalation of the suspension contained in the vial is carried out by means of a special dispensing nozzle on the vial.

Use the drug only according to the indications, the method of administration and the doses indicated in the instructions. If after 14 days of treatment no improvement occurs or the symptoms worsen, or new symptoms appear, you should consult your doctor. Without consultation with a doctor, the drug Galazolin Allergo should not be taken more than 3 months in a row.

The recommended dose of the drug is 2 inhalations (50 μg each) in each nostril 1 time per day (total daily dose - 200 μg). When the therapeutic effect for maintenance therapy is achieved, it is possible to reduce the dose to 1 inhalation in each nostril 1 time per day (the total daily dose is 100 μg).

The onset of the drug is usually observed clinically within 12 hours after the first use of the drug.

Recommendations for patients on the use of the drug

Before the first application of the nasal spray, it is necessary to carry out its "calibration".

Do not pierce the nasal applicator!

To perform the "calibration", it is necessary to press the metering nozzle 10 times, until splashes appear, indicating that the preparation is ready for use. If the medicinal product has not been used for 14 days or longer, you must press the dispensing nozzle 2 times until splashes appear.

1. Before applying the drug, it is necessary to clean the nasal passages.

2. Slightly shake the vial, then remove the nasal applicator cap.

3. Arrange the bottle between the thumb and forefinger so that the bottom of the bottle rests on the thumb, and the index and middle fingers are located on both sides of the lower part of the applicator (Fig. 1).

4. The nasal passage, in which the drug will not be administered, should be clamped with a finger, and the applicator should be inserted into the free nasal passage.Then slightly bend your head so that the bottle is in a vertical position (Fig. 2.3).

5. Lightly inhale through the open nasal passage and simultaneously press the nasal applicator once and enter the dose of the drug.

6. Exhale through the mouth.

When re-injecting the drug into the same nasal passage, repeat the operations described in paragraph 5-6.

If you inject the drug into another nasal passage, repeat steps 4-6.

After the end of the drug, wipe the upper part of the applicator with a clean cloth and put on the cap.

Cleaning the dispensing nozzle

It is important to clean the dispensing nozzle regularly to avoid incorrect dosing. Remove the cap that protects the nozzle from dust, then gently remove the spray tip. Thoroughly rinse the spray tip and the cap with warm water under the tap.

Do not attempt to open the nasal applicator with a needle or other sharp object, as this will damage the applicator, resulting in a risk of taking the wrong dose of the drug.

Dry the cap and tip in a warm place. After this, attach the spray tip to the bottle and put on the cap to protect it from dust.

When using the nasal spray for the first time after cleaning, it is necessary to re-calibrate by pressing the dosing nozzle 2 times.

Before each use, vigorously shake the bottle.

Side effects:

Undesirable effects associated with the use of the drug (≥1%), revealed during clinical trials in patients with allergic rhinitis or polyposis of the nose, and during the post-marketing use of the drug, regardless of the indication for use, are presented below. Undesirable reactions are listed in accordance with the classification of systemic-organic classes MedDRA. Within each system-organ class, adverse reactions are classified according to the frequency of occurrence. Nasal bleeding, as a rule, was moderate and stopped on their own, the frequency of their occurrence was slightly greater than when using placebo (5%), but equal to or less than with the appointment of other intranasal SCS, which were used as an active control (in some of them the incidence of nasal bleeding was up to 15%).The incidence of all other adverse events was comparable to the incidence of their occurrence with a placebo.

The frequency of unwanted reactions is given in accordance with the following classification: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1 / 10 000, <1/1000), very rarely (<1/10 000, including individual reports); for unwanted reactions during the post-registration period, the frequency is not established (can not be determined on the basis of available data).

Infectious and parasitic diseases: often - pharyngitis, upper respiratory tract infection *.

Immune system disorders: frequency is not established - reactions of hypersensitivity, including anaphylactic reactions, angioedema, bronchospasm, dyspnea.

Impaired nervous system: often a headache.

Disorders from the side of the organ of vision: frequency is not set - increase intraocular pressure, glaucoma, cataract.

Disturbances from the respiratory system, chest and mediastinal organs: very often - nosebleeds **; often - nosebleeds (ie, obvious bleeding,as well as secretion of blood-colored mucus or blood clots), a burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa; frequency not established - perforation of nasal septum.

Disorders from the gastrointestinal tract: often - irritation of the pharynx (sensation of irritation of the mucous membrane of the pharynx) **; frequency is not established - a violation of taste and smell.

* - was detected with the frequency of "rarely" with the drug 2 times a day with polyposis of the nose;

** - revealed with the use of the drug 2 times a day for polyposis of the nose.

If you experience side effects indicated in the instructions or are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

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

In case of overdose, see a doctor.

Interaction:

Combination therapy with loratadine was well tolerated by patients. At the same time, there was no evidence of any drug effect on the concentration of loratadine or its main metabolite in blood plasma. In these studies mometasone furoate in the blood plasma was not detected (with the sensitivity of the method of determining 50 pg / ml).

If you use the above or other medications (including OTC drugs) before using Halazolin Allergo, consult your doctor.

Special instructions:

The drug is indicated only for intranasal use.

The drug Galazolin Allergo should not be used for more than 3 months. If it is necessary to use the drug for more than 3 months, it is necessary to consult a doctor.

As with any long-term treatment, patients who use the nasal spray Galazolin Allergo for several months and longer should periodically undergo a medical examination for possible changes in the nasal mucosa. It is necessary to monitor patients receiving intranasal GCS for a long time.Possible development of growth retardation in children.

In case of development of a local fungal infection of the nose or pharynx, it may be necessary to stop the therapy with Galazolin Allergo and carry out special treatment. The long-lasting irritation of the nasal and pharyngeal mucosa can also serve as a basis for discontinuing treatment with the drug Galazolin Allergo.

With prolonged treatment with mometasone furoate in the form of a nasal spray, signs of suppression of the hypothalamic-pituitary-adrenal system were not observed. Patients who switch to the treatment with the drug Galazolin Allergo after long-term therapy with glucocorticosteroids of systemic action, require special attention. Abolition of systemic glucocorticosteroids in such patients can lead to insufficiency of adrenal function, the subsequent restoration of which can take up to several months. If signs of adrenal insufficiency appear, you should resume taking systemic glucocorticosteroids and take other necessary measures.

With the use of intranasal GCS, it is possible to develop systemic side effects, especially with prolonged use in high doses. The probability of these effects is much lower than when using oral GCS. Systemic side effects may vary both in individual patients and depending on the glucocorticosteroid drug used. Potential systemic effects include Cushing's syndrome, features kushingoida, suppression of adrenal function, growth retardation in children and adolescents, cataract, glaucoma and more rarely - a range of psychological or behavioral effects including psychomotor hyperactivity of, sleep disorders, anxiety, depression or aggression (particularly in children).

During the transition from the treatment of glucocorticoid systemic effects to the treatment of nasal spray Galazolin allergies in some patients may experience initial withdrawal symptoms of systemic corticosteroids (eg, pain in the joints and / or muscles, fatigue and depression), despite the decrease in the severity of symptoms associated with lesions the nasal mucosa.Such patients should be persuaded of the advisability of continuing treatment with the drug Galazolin Allergo. The transition from systemic to local glucocorticosteroids can also reveal already existing, but masked by the therapy of glucocorticosteroids systemic action, allergic diseases, such as allergic conjunctivitis and eczema. Patients treated with glucocorticosteroids have a potentially reduced immune reactivity and should be warned of the increased risk of infection in case of contact with patients suffering from certain infectious diseases (eg, chicken pox, measles) and the need for medical advice if such a contact has occurred. If signs of severe bacterial infection (eg fever, persistent and sharp pain on one side of the face or toothache, swelling in the orbital or periorbital area) appear, immediate medical attention is required.

When mometasone furoate was used as a nasal spray for 12 months, no signs of atrophy of the nasal mucosa were observed. Besides, mometasone furoate showed a tendency to promote the normalization of the histological pattern in the study of biopsies of the nasal mucosa.

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.

In the case of unilateral polyps of unusual and irregular shape, especially ulcerated and bleeding, an additional medical examination is necessary.

Effect on the ability to drive transp. cf. and fur:

There is no evidence of the effect of the drug on the ability to drive a car or moving machinery.

Form release / dosage:Spray nasal dosed with 50 mcg / dose.

Packaging:

140 doses of the suspension in a white bottle of high-density polyethylene, equipped with a metering aerosol pump, a plastic drive and a plastic nozzle for spraying, closed with a plastic lid.

On 1 bottle together with the instruction on medical application place in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

The vial should be used within 2 months.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004266

Date of registration:28.04.2017

Expiration Date:28.04.2022