Tafen nasal - instructions for use, dose, side effects, contraindications

Name of component	amount
Name of component	To 10 ml of the suspension	For 1 dose
Active substance
Budesonide	10,000 mg	50.0 μg
Excipients
Methylparahydroxybenzoate	10,000 mg	50.0 μg
Propyl parahydroxybenzoate	2,000 mg	10.00 μg
Cellulose microcrystalline and carmellose sodium	110,000 mg	550.0 μg
Polysorbate-80	10,000 mg	50.0 μg
Simethicone Emulsion	10,000 mg	50.0 μg
Propylene glycol	1,000 grams	5,000 mg
Sucrose	3,000 grams	15,000 mg
Disodium Edetate	1,000 mg	5.0 μg
Hydrochloric acid	2,000 mg	10.0 mg
Water	7.145 g	35.725 mg

Description:white or almost white homogeneous suspension

Pharmacotherapeutic group:glucocorticosteroid for topical application

ATX: & nbsp

R.03.B.A.02 Budesonide

Pharmacodynamics:

Budesonide is a synthetic glucocorticosteroid drug with a pronounced anti-inflammatory, antiallergic effect.

When used in therapeutic doses, it practically does not exert a resorptive effect. It does not have mineralocorticoid activity, it is well tolerated with long-term treatment. The drug has an inhibitory effect on the release of mediators of the inflammatory reaction, increases the synthesis of anti-inflammatory proteins, reduces the number of mast cells and eosinophilic granulocytes, prevents marginal neutrophils, reduces inflammatory exudation and production of cytokines. Budesonide reduces the release of toxic proteins from eosinophils, free radicals from macrophages and lymphokines from lymphocytes. It also reduces the binding of adhesive molecules to endothelial cells, thus reducing the flow of leukocytes to the site of allergic inflammation. Budesonide increases the amount of alpha-adrenergic receptors on the surface of the membrane of smooth muscle cells of the vessels, thereby increasing the sensitivity to decongestants.

The drug inhibits the activity of phospholipase A2, which leads to inhibition of the synthesis of prostaglandins, leukotrienes and platelet activation factor inducing an inflammatory response. Budesonide also inhibits the synthesis of histamine, which leads to a decrease in its level in the mast cells. Improvement of the condition is noted on the second - third day after the start of treatment.

Tafen® nasal reduces the severity of symptoms in allergic rhinitis, suppresses the late and early phases of an allergic reaction, and reduces inflammation in the upper respiratory tract.

Pharmacokinetics:

After topical application of 400 mcg of budesonide, the maximum concentration of C_max in blood plasma is reached after about 30 minutes and is 1 nmol / l.

Only about 20% of the administered dose of the drug Tafen® nasal enters the systemic circulation. Due to good distribution in tissues and binding to blood plasma proteins, the volume of distribution is 301 liters. The binding with blood plasma proteins, mainly with albumin, is 86 - 90%.

Systemic bioavailability of budesonide is low, as more than 90% of the absorbed drug is inactivated during the "first pass" through the liver. Glucocorticoid activity of metabolites does not exceed 1%. Metabolites are excreted mainly by the kidneys (70%) and through the intestine (10%). The half-life (T_1/2) is 2 hours.

Indications:

- prevention and treatment of seasonal and all-year-round allergic rhinitis;

- prevention and treatment of vasomotor rhinitis;

- nasal polyps.

Contraindications:

- hypersensitivity to budesonide or excipients of the drug;

- active form of pulmonary tuberculosis;

- lactation period;

- Children under 6 years.

Carefully:fungal, bacterial and viral infections of the respiratory tract (always under constant control of the patient's condition and specific therapy);recent surgical interventions in the nasal cavity, recent nose trauma, neurotropic viral infections (shingles, herpes), pregnancy, cirrhosis, glaucoma, hypothyroidism.

Pregnancy and lactation:

The use of Tafen® nasal during pregnancy is allowed only if the expected benefit for the mother exceeds the possible risk to the fetus. The drug is able to penetrate into breast milk, so when treating this drug, nursing mothers are recommended to stop breastfeeding.

Dosing and Administration:

Adults and children over 6 years of age: initially 2 doses of 50 mcg budesonide in each nasal passage 2 times a day. The usual maintenance dose is 1 dose in each nasal passage 2 times a day or 2 doses in each nasal passage 1 time per day, in the morning. The maintenance dose should be the lowest effective dose that relieves the symptoms of rhinitis.

The maximum single dose of 200 mcg (100 mcg per each nasal passage), the maximum daily dose of 400 mcg for no more than 3 months.

A full therapeutic effect requires regular and correct application.

If the dose is missed, it should be taken as soon as possible, but not less than 1 hour before the next regular dose.

Information on the use of the drug Tafen® nasal.

With the correct application of nasal spray dosage Tafenk nasal, its therapeutic effect is fully manifested, and the undesirable effects are less pronounced.

1. First of all, carefully clean the nasal passages from the mucus, best of all with the help of physiological solution.

2. Remove the dustproof cap from the bottle.

3. Shake the bottle.

4. In the first application of Tafen® nasal, release a small amount of the drug into the air by pressing several times on the nozzle, while placing the index and middle fingers on the side strips of the vial and supporting the bottom with the thumb (the vial should be in an upright position).

You will see a small cloud of spray spray.

This procedure should be repeated if you have not used the drug for several days. If a dried product has accumulated in the nozzle hole, remove the nozzle and rinse it (as indicated in the "Cleaning" section).

5.Press the head forward and down. With your right hand, insert the nozzle into the left nasal passage towards its outer wall.

6.Click on the nozzle, releasing a metered dose of the drug, and simultaneously inhale through the nose.

7. With your left hand insert the nozzle into the right nasal passage towards its outer wall, press the nozzle and simultaneously inhale through the nose.

8. After applying the product, wipe the nozzle with a clean cloth and close the bottle with a cap. The bottle should be kept tightly closed in a vertical position.

Cleaning.

The nozzle and cap should be cleaned regularly.

Carefully remove the nozzle and cap, rinse with warm water and rinse with cold water, allow to air dry. Carefully place the nozzle in its original place and cover with a cap.

If a dried product has accumulated in the hole, hold the nozzle in a container of warm water, and then rinse as described above. Do not clean the nozzle hole with a needle or other sharp objects.

Side effects:

The drug Tafen® nasal in a dosage form - a nasal spray dosed, very rarely has side effects. According to the World Health Organization (WHO), adverse reactions

are classified according to their frequency of development as follows: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1 / 10000, <1/1000) and very rarely (< 1/10000);

the frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence

possible.

From the respiratory system:

very often: irritation of the mucous membrane of the nasal cavity. At the beginning of therapy for a short period of time, the following phenomena can occur: rhinorrhea and the formation of crusts on the mucosa, nosebleeds;

often: sneezing after the first use of the drug, dyspnoea, hoarseness of the voice, wheezing, pain in the nasal cavity, spotting from the nose.

From the immune system

very rarely: anaphylactic reactions.

From the gastrointestinal tract (GIT):

often: dryness of the mucous membrane of the throat.

From the side of the system of skin and subcutaneous fat:

rarely, hypersensitivity reactions of immediate and delayed type (including urticaria, hives, dermatitis, pruritus, angioedema).

General disorders and changes in the injection site: infrequently: candidiasis nasal cavity and upper airways, long-term use - atrophy of nasal mucosa, especially during prolonged therapy;

very rarely: ulceration of the mucous membrane of the nasal cavity,perforation of the nasal septum.

Some of the ENT symptoms can be disguised due to the use of glucocorticosteroids. With long-term administration of high doses of budesonide, the risk of systemic effects, including Cushing's syndrome, cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density, hypo- or hypercortisolism symptoms, cataract and glaucoma can not be ruled out.

Also possible: nausea, changes in taste, difficulty swallowing, anosmia, sensation palpitation, nasal congestion, dizziness, headache, sore throat, conjunctival hyperemia, myalgia, drowsiness, cough.

Less often, there may be deviations in psychological and behavioral patterns, including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggressiveness (especially in children).

Overdose:

Accidental overdose of the drug Tafen® nasal in the dosage form of the nasal dosed spray does not cause any obvious symptoms.

Acute overdose is unlikely.

With prolonged use of high doses, as well as with the simultaneous administration of other glucocorticosteroids, symptoms of hypercorticism may appear.In this case, the drug should be stopped, gradually reducing its dose.

Interaction:

The simultaneous use of the drug Tafen® nasal with inducers microsomal oxidation (phenobarbital, phenytoin, rifampicin) can reduce the effectiveness of the first.

Methandienone, estrogens, ketoconazole enhance the action of budesonide. Itracoazole can cause an increase plasma concentration of budesonide.

Special instructions:

It is recommended to avoid getting the drug Tafen® nasal in the eyes!

When switching from treatment with systemic glucocorticosteroids to nasal spray treatment, due to the risk of developing adrenal insufficiency, caution is required for the restoration of the function of the hypothalamic-pituitary-adrenal system (GGNS). The drug should be canceled by gradually reducing the dose until the function of the GGNS is normalized. At the dose reduction stage, some patients may experience withdrawal symptoms of systemic glucocorticosteroids, such as muscle and / or joint pain, apathy and depression. If such symptoms are detected, a temporary increase in the dose of systemic glucocorticosteroids may be required, and subsequently - a further abolition at a slower rate. Because the

glucocorticosteroids slow the healing of wounds, caution should be exercised when administering Tafen® nasal to patients who have recently undergone trauma or nose surgery. For a full therapeutic effect in allergic rhinitis, the drug should be used regularly. With prolonged therapy with Tafen® nasal, the condition of the nasal mucosa should be assessed at least once a year. There were reported cases of growth retardation in children receiving glucocorticosteroids for nasal administration at therapeutic doses. With prolonged use of glucocorticosteroids for nasal administration in children, dynamic growth control is recommended. If the growth is slowed down, the pediatrician should reconsider the way the drug is used, in order to reduce the dose and move to the minimum therapeutic dose at which control over the symptoms of the disease is possible.

The use of glucocorticosteroids for nasal administration at doses in excess of those recommended may lead to a significant inhibition of function adrenal glands. When the application is detected

glucocorticosteroids for nasal application in doses exceeding the recommended ones, it is necessary to take into account the need for additional use of systemic glucocorticosteroids during the period of adrenal function reduction or planned surgery.

Special precautions for the destruction of unused medicinal product

There is no need for special precautions for the destruction of the unused drug Tafen® nasal.

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

Due to the possibility of developing neuropsychiatric symptoms on the background of therapy with the drug Tafen®

nasal caution should be exercised when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed

psychomotor reactions.

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

Packaging:

For 10 ml in a vial of dark glass with a mechanical dosing device with a nozzle for the nose with a tip closed with a protective cap.

One bottle with instructions for medical use is placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Shelf life:

Shelf life 2 years.

The drug should not be used after the expiry date indicated on the package.

Terms of leave from pharmacies:On prescription