Universal reference book for medicines
Name of the drug: TAFEN ® NAZAL (TAFEN NASAL)

Active substance: budesonide

Type: GCS for intranasal administration

Manufacturer: LEK dd (Slovenia)
Composition, form of production and packaging

Spray nasal dosed in the form of a homogeneous suspension of white or almost white.

1 dose

budesonide 50 μg

[PRING] methyl parahydroxybenzoate 50 μg, propyl parahydroxybenzoate 10 μg, microcrystalline cellulose and carmellose sodium 550 μg, polysorbate 80-50 μg, simethicone emulsion 50 μg, propylene glycol 5 mg, sucrose 15 mg, disodium edetate 5 μg, Hydrochloric acid - 10 mg, water - 35.725 mg.

200 doses (10 ml) - vials of dark glass (1) with a mechanical dosing device with a nozzle for the nose with a tip - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

GCS for intranasal administration.
Has a pronounced anti-inflammatory and antiallergic effect. When used in therapeutic doses, it practically does not exert a resorptive effect. 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. 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 number of β-adrenoreceptors of smooth muscle.The drug inhibits the activity of phospholipase 2A, which leads to inhibition of the synthesis of prostaglandins, leukotrienes and PAA, inducing an inflammatory reaction. Budesonide also inhibits the synthesis of histamine, which leads to a decrease in its level in the mast cells.
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.
Improvement of the condition is noted on 2-3 days after the beginning of treatment.
PHARMACOKINETICS

Suction

After inhalation, 400 μg Budesonide C max in plasma is reached within 0.7 hours and is 1 nmol / L.

Only about 20% of the intranasally administered dose enters the systemic circulation.

Distribution

Due to a good distribution in tissues and binding to plasma proteins, V d is 301 liters.

Metabolism

Systemic bioavailability of budesonide is low;
More than 90% of the absorbed drug is inactivated during the single-stage metabolism in the liver. Glucocorticoid activity of metabolites does not exceed 1%.
Excretion

Metabolites are excreted mainly with urine (70%) and with feces.
T 1/2 is 2-3 hours.
INDICATIONS

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

- non-allergic rhinitis;

polyps of the nose.

DOSING MODE

Adults and children over the age of 6 years at the beginning of therapy are given 2 doses (50 μg Budesonide) per nostril 2 times / day.
The usual maintenance dose is 1 dose in each nostril 2 times / day or 2 doses in each nostril 1 time / day, in the morning. The maintenance dose should be the lowest effective dose that relieves the symptoms of rhinitis.
The maximum single dose is 200 μg (100 μg per each nostril), the maximum daily dose is 400 μg 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.

SIDE EFFECT

On the part of the respiratory system: irritation of the mucous membrane of the nose and throat, nosebleeds, cough;
less marked dryness of the nasal mucosa, sneezing.
Dermatological reactions: dermatitis, hives, rash are noted.

Other: fatigue, dizziness.

In exceptional cases, when nasal corticosteroids were used, nasal septum perforation, angioedema, loss of smell, tachycardia, and growth retardation were noted.

With the use of the drug, side effects develop very rarely and are of a transient nature.

CONTRAINDICATIONS

- fungal, bacterial and viral infections of the respiratory tract;

- active form of pulmonary tuberculosis;

- hypersensitivity to budesonide or any other component of the drug.

PREGNANCY AND LACTATION

Use of the drug Tafen® nasal during pregnancy is allowed only if the expected benefit for the mother exceeds the possible risk to the fetus.

If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

APPLICATION FOR CHILDREN

The drug is prescribed for children older than 6 years.

SPECIAL INSTRUCTIONS

When switching from treatment with systemic GCS to nasal spray treatment, due to the risk of developing adrenal insufficiency, caution is required for the recovery period of the function of the hypothalamic-pituitary-adrenal system.

Because SCS slows wound healing, caution should be exercised in appointing Tafen® nasal to patients who have recently undergone trauma or nose surgery.

For a full therapeutic effect in allergic rhinitis, it is required to take the drug on a regular basis.

It is recommended to avoid contact with eyes.

Impact on the ability to drive vehicles and manage mechanisms

Tafen® nasal does not affect the ability to drive a car or machinery.

OVERDOSE

Accidental overdose of the drug Tafen® nasal 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 SCS symptoms of hypercorticism may appear.

In this case, the drug should be stopped, gradually reducing its dose.

DRUG INTERACTION

The simultaneous use of the drug Tafen ® Nazal with inducers of microsomal oxidation (phenobarbital, phenytoin, rifampicin) may reduce the effectiveness of the former.

Methandrostenolone, estrogens, ketoconazole increase the effect of budesonide.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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