Tafen Nasal nasal spray 50 μg/dose, 10 ml for 200 doses — Made in Germany by Sandoz — Free Deliver

Pharmacological properties

Budesonide is a synthetic GCS with a pronounced anti-inflammatory and antiallergic effect. when used in therapeutic doses, it almost does not resorb. does not show mineralocorticoid activity, is well tolerated with prolonged treatment.

The preparation inhibits the release of inflammatory mediators, increases the synthesis of anti-inflammatory proteins, and reduces the number of mast cells and eosinophilic granulocytes. Budesonide reduces the release of toxic proteins from eosinophilic granulocytes, free radicals from macrophages and lymphokines from lymphocytes. It also reduces the binding of adhesive molecules to endothelial cells, and thus reduces the number of leukocytes at the site of allergic inflammation. Budesonide increases the number of smooth muscle beta-adrenergic receptors. The preparation inhibits the activity of phospholipase A2, which slows down the synthesis of prostaglandins, leukotrienes and PAF, which induce an inflammatory response. Budesonide also inhibits the synthesis of histamine, which leads to a decrease in its level in mast cells.

Tafen nasal reduces the severity of symptoms in allergic rhinitis by suppressing the late and early phases of the allergic reaction and reducing the severity of inflammation in the upper respiratory tract. Improvement of the condition is noted on the 2-3rd day after the start of treatment.

Budesonide is a mixture of two epimers in a 1: 1 ratio. Epimer 22R is 2–3 times more active than epimer 22S.

After inhalation of 400 μg of budesonide through the nose, the maximum concentration is reached after 0.7 hours and is 1 nmol / L in blood plasma. After inhalation through the nose, about 20% of the administered budesonide enters the systemic circulation.

The systemic bioavailability of budesonide is low, since about 90% of that part that has been absorbed is inactivated in the process of one-step metabolism in the liver. Epimers 22R and 22S are biotransformed to beta-hydroxybudesonide and alpha-hydroxyprednisolone, respectively. Metabolites exhibit less than 1% glucocorticoid activity; excreted by the kidneys (70%) and through the intestines. The half-life is 2-3 hours.

Indications

Prevention and treatment of seasonal and perennial allergic rhinitis, non-allergic rhinitis; polyps of the nasal cavity.

Application

Adults and children over 6 years old. the initial dose is 400 mcg of budesonide per day: 2 doses (100 mcg of budesonide) in each nostril 2 times a day. the usual maintenance dose is 200 mcg of budesonide per day: 1 dose (50 mcg of budesonide) in each nostril 2 times a day or 2 doses in each nostril 1 time per day in the morning. maintenance therapy should be at the lowest dose level that relieves the symptoms of rhinitis.

If a dose has been missed, it should be taken as soon as possible, but not less than 1 hour before taking the next dose. When you stop using the preparation, the dose is gradually reduced. With the correct use of Tafen nasal, the frequency of adverse reactions decreases and the therapeutic effect improves:

1. Clear the nasal passages (if possible with sodium chloride solution).

2. Remove the cap from the vial.

3. Shake the bottle.

4. When using the bottle for the first time, release some of the spray into the air. Press the nasal adapter down several times until a slight mist appears. The same procedure must be repeated if the preparation has not been used for several days. If the adapter is blocked, you need to gently push it in and clean it.

5. Tilt your head forward (so that you can see the toes). Insert the nozzle from the right side into the left nostril and point it towards the outer wall.

6. Press the adapter down to deliver a single dose of spray and inhale.

7. Insert the nozzle from the left side into the right nostril and direct it to the outer wall; squeeze out one dose of spray and inhale it.

8. After use, wipe the adapter with a clean cloth and replace the cap. Store the bottle in an upright position with the cap facing up.

Contraindications

Hypersensitivity to budesonide or any component of the preparation; untreated fungal, bacterial, or viral infection of the respiratory system; active form of pulmonary tuberculosis; age up to 6 years.

Side effects

Side effects are very rare and disappear quickly. sometimes there is irritation of the mucous membrane of the nose and throat, nosebleeds, and coughing. rarely - dry mouth, sneezing, weakness, dizziness. in isolated cases - nausea and skin reactions (dermatitis, urticaria, rash).

Exceeding the recommended doses or increased individual sensitivity may reveal symptoms of hypercortisolism (hyperfunction of the adrenal cortex).

Special instructions

With caution, they switch from the use of systemic corticosteroids to treatment with tafen nasal due to the risk of developing adrenal insufficiency. a rapid decrease in the dose of corticosteroids in patients with BA can provoke a serious worsening of the disease. the withdrawal of the preparation tafen nasal should be gradual.

GCS can mask signs of infection, and new infections can develop during their use. Patients with untreated fungal, bacterial or viral infections (transmitted by airborne droplets) require special attention.

Sometimes, concomitant treatment may be necessary to prevent the appearance of pathological symptoms from the organ of vision caused by allergic rhinitis.

With prolonged use of the preparation, it is recommended that the nasal mucosa be examined 1-2 times a year to determine the possible development of atrophic rhinitis or pharyngeal candidiasis.

In patients with cirrhosis of the liver or hypothyroidism, an increase in the systemic effect of budesonide is possible.

Due to the inhibitory effect of GCS on wound healing, Tafen nasal should be used with caution in patients with recent surgery or nasal trauma.

Application during pregnancy and lactation is possible only if absolutely necessary. In infants and nursing mothers who have used budesonide, it is necessary to exclude the presence of adrenal hypofunction.

Impact on psychophysical abilities. The preparation does not affect the ability to drive vehicles and other mechanisms.

Interactions

When using tafen nasal simultaneously with systemic corticosteroids, the risk of systemic side effects increases.

Overdose

Accidental overdose of the preparation does not lead to severe clinical symptoms. with prolonged use, the introduction of high doses or the use with other GCs, budesonide can cause systemic side effects characteristic of GCS. no cases of the development of Cushing's syndrome or the appearance of other symptoms and signs of hypercortisolism have been described when using budesonide in the form of a spray.

Storage conditions

At a temperature not higher than 25 ° C.