TAFEN bother
Active material: Budesonide
When ATH: R01AD05
CCF: GCS for intranasal use
ICD-10 codes (testimony): J00, J30.1, J30.3, J31, J33
When CSF: 04.04.01
Manufacturer: LEK d.d. (Slovenia)
PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING
Spray nazalynыy dozirovannыy In the form of a white or almost white homogeneous suspension.
| 1 dose | |
| budesonide * | 50 g |
Excipients: metilparagidroksiʙenzoat, propilparagidroksibenzoat, Microcrystalline cellulose/sodium carboxymethyl cellulose, polysorbate 80, Simeton-emulsion, propylene glycol, sucrose, dinatrievaya soly ЭDTA, hydrochloric acid, Purified water.
200 doses – vials of dark glass (1) with a mechanical dosing device, with a nozzle for a nose and an ender – packs cardboard.
* international non-proprietary name, recommended by the WHO – ʙudezonid.
Pharmacological action
GCS for intranasal use. Has a pronounced anti -inflammatory and anti -allergic effect. When used in therapeutic doses, it practically does not have a resorbative effect. Possesses mineralokortikoidna activity, well tolerated with prolonged 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 amount of mast cells and eosinophilic granulocytes. Budesonide reduces the release of toxic proteins from eosinophils, free radicals from macrophages and lymphocyte lymphocytes. It also reduces the binding of adhesive molecules with endothelial cells, thus, Reducing the flow of leukocytes to the place of allergic inflammation. Budesonide increases the number of β-adrenergic receptors of smooth muscles. The drug inhibits the activity of phospholipase 2a, which leads to inhibition of the synthesis of prostaglandins, leukotrienov and Paf, inducing an inflammatory reaction. Budesonide also inhibits histamine synthesis, which leads to a decrease in its level in mast cells.
Taphen® Nazal 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. Improving the state is noted on 2-3 day after the start of treatment.
Pharmacokinetics
Absorption
After inhalation 400 MKG Budesonid C.max plasma achieved for 0.7 h and is 1 nmoli /.
Only about 20% intranasally introduced dose enters the system blood flow.
Distribution
Thanks to good distribution in the tissues and binding with plasma proteins Vd is 301 l.
Metabolism
Systemic bioavailability of Budesonide is low, tk. more 90% The absorbed drug is inactivated in the process of single -stage metabolism in the liver. Glucocorticoid activity of metabolites does not exceed 1%.
Deduction
Metabolites are excreted mainly with urine (70%) and faeces. T1/2 is 2-3 no.
Testimony
- prevention and treatment of seasonal and year -round allergic rhinitis;
- Neallergic rhinitis;
- Polyps of the nose.
Dosage regimen
Adults and children over the age of 6 years At the beginning of therapy is prescribed 2 dose (by 50 MKG BiteSonida) in each nostril 2 times / day. The usual supporting dose is 1 dose in every nostril 2 times / day or 2 dose in each nostril 1 time / day, morning. The maintenance dose should be the lowest effective dose, removal symptoms of rhinitis.
The maximum single dose is 200 g (by 100 mcg in each nostril), the maximum daily dose – 400 mcg for no more 3 months.
For a complete therapeutic effect, regular and correct use is required.
If dose is missed, It should be taken as soon as possible, but not less than 1 h to the adoption of the next next dose.
Side effect
The respiratory system: irritation of the mucous membrane of the nose and throat, nose bleed, cough; Less commonly noted the dryness of the mucous membrane of the nose, chikhaniye.
Dermatological reactions: Dermatitis is noted, hives, rash.
Other: fatigue, dizziness.
In exceptional cases, when using nasal corticosteroids, perforation of the nasal septum was noted, angioedema, anosmia, tachycardia, Slow down growth.
When using the drug, side effects develop very rarely and are transient in nature.
Contraindications
-fungal, Bacterial and viral infections of the respiratory tract;
-active form of pulmonary tuberculosis;
- increased sensitivity to Budesonida or any other component of the drug.
Pregnancy and lactation
The use of Tafen® Nazal during pregnancy is allowed only, If the expected benefit for the mother exceeds the possible risk to the fetus.
If necessary, the appointment during lactation breastfeeding should be discontinued.
Cautions
When moving from treatment with systemic CC for 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 GKS slows healing wounds, Caution should be observed when prescribing tafen® Nazal to patients, recently suffered an injury or nasal operation.
For a complete therapeutic effect with allergic rhinitis, it is necessary to regularly take the drug.
It is recommended to avoid getting into the eye.
Effects on ability to drive vehicles and management mechanisms
Taphen® Nazal does not affect the ability to drive a car or mechanisms.
Overdose
Random overdose of the drug Tafen® Nazal does not cause any obvious symptoms. Acute overdose is unlikely.
With prolonged use of high doses, as well as with the simultaneous use of other GKS, symptoms of hypercorticism may appear.
In this case, taking the drug should be stopped, gradually reducing the dose.
Drug Interactions
Simultaneous use of Tafen® Nazal with micosomal oxidation inducers (phenobarbital, phenytoin, rifampicin) can reduce the effectiveness of the first.
Methandrostenolone, Estrogens, Ketokonazole enhances the effect of Budesonide.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children at or above 25 ° C. Shelf life - 2 year.
