Tafen nasal, spray 50 µg/dose, 200 doses

Composition

1 dose of nasal spray contains:

Active ingredients:  

budesonide (budesonide) 50 mcg.

Auxiliary substances:  

methyl parahydroxybenzoate,

propyl parahydroxybenzoate,

microcrystalline cellulose/sodium carboxymethylcellulose,

polysorbate 80,

simethicone emulsion,

propylene glycol,

sucrose,

EDTA disodium salt,

hydrochloric acid,

purified water.

Pharmacological action

Pharmacodynamics

CORTICOSTEROIDS for intranasal use. It has a pronounced anti-inflammatory and anti-allergic effect. When used in therapeutic doses, it has practically no resorptive effect. It does not have mineralocorticoid activity and is well tolerated during long-term treatment.

The drug has an inhibitory effect on the release of inflammatory mediators, 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 white blood cells to the site of allergic inflammation.

Budesonide increases the number of smooth muscle beta-adrenergic receptors. The drug inhibits the activity of phospholipase 2A, which leads to inhibition of 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, suppresses the late and early phases of an allergic reaction, and reduces inflammation in the upper respiratory tract. Improvement of the condition is noted for 2-3 days after the start of treatment.

Pharmacokinetics

Suction

After inhalation of 400 mcg of _budesonide, the plasma cmax 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 its good distribution in tissues and binding to plasma proteins, Vd is 301 liters.

Metabolism

The systemic bioavailability of budesonide is low, since more than 90% of the absorbed drug is inactivated during single-step metabolism in the liver. The glucocorticoid activity of metabolites does not exceed 1%.

Deduction

Metabolites are mainly excreted in the urine (70%) and feces. T _1/2 is 2-3 hours.

Indications

• Prevention and treatment of seasonal and year-round allergic rhinitis;
• non-allergic rhinitis;
• nasal polyps.

Use during pregnancy and lactation

The use of Tafen nasal during pregnancy is allowed only if the expected benefit to the mother exceeds the possible risk to the fetus.

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

Contraindications

• Hypersensitivity to budesonide or any other component of the drug;
• fungal, bacterial and viral infections of the respiratory tract;
• active form of pulmonary tuberculosis.

Side effects

From the respiratory system: irritation of the mucous membrane of the nose and throat, nosebleeds, coughing; less often, dryness of the nasal mucosa, sneezing are noted.

Dermatological reactions: dermatitis, urticaria, rash are noted.

Other: fatigue, dizziness.

In exceptional cases, nasal septum perforation, angioedema, loss of smell, tachycardia, and growth retardation have been reported with nasal corticosteroids.

When using the drug, side effects develop very rarely and are transient.

Interaction

Concomitant use of Tafen Nasal with inducers of microsomal oxidation (phenobarbital, phenytoin, rifampicin) may reduce the effectiveness of the former.

Methandrostenolone, estrogens, ketoconazole enhance the effect of budesonide.

How to take, course of use and dosage

Adults and children over the age of 6 years at the beginning of therapy are prescribed 2 doses (50 mcg budesonide) in each 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 to relieve the symptoms of rhinitis.

The maximum single dose is 200 mcg (100 mcg in each nostril), the maximum daily dose is 400 mcg for no more than 3 months.

For a full therapeutic effect, regular and correct use is required.

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

Overdose

Accidental overdose of Tafen nasal does not cause any obvious symptoms. Acute overdose is unlikely.

Symptoms: with prolonged use of high doses, as well as with the simultaneous use of other corticosteroids, symptoms of hypercorticism may appear.

Treatment: in this case, the drug should be discontinued, gradually reducing its dose.

Special instructions

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

Since CORTICOSTEROIDS slow wound healing, caution should be exercised when prescribing Tafen nasal to patients who have recently had a nasal injury or surgery.

For a full therapeutic effect in allergic rhinitis, you need to take the drug regularly.

It is recommended to avoid contact with the eyes.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

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

Form of production

Nasal spray

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Budesonide

Conditions of release from pharmacies

By prescription

Dosage form

nasal spray

Description

For pregnant women as prescribed by a doctor, For adults as prescribed by a doctor

Indications

Allergic Rhinitis, Allergies, Nasal Polyposis