Budoster Nazal Spray. scrapper. 100mcg / dose vials with 10ml dozir.klapanom

Description

Composition
Active substance:
1 dose comprises budesonide 100 mcg.
Excipients:
Dextrose 2.38 mg Avicel (microcrystalline cellulose and carmellose sodium in a ratio of 9: 1) 0.63 mg, 0.06 mg of potassium sorbate, 0.01 mg polysorbate 80, disodium edetate 0.005 mg Hydrochloric Acid to pH 4.5 , 47.8 mg of purified water.
Description:
White or almost white homogeneous suspension.
Product form:
Nasal spray metered 100 micrograms per dose.
200 doses of dark glass vial with a metering valve crimped aluminum ring closed by a protective cap.
1 bottle in cardboard pack together with instructions for use.
Contraindications
Fungal, bacterial and viral respiratory infections; active TB disease of the lungs; Hypersensitivity to budesonide or any other component of the formulation; Children up to age 6 years.
Precautions: recent surgery in the nasal cavity, the recent nose injury, tuberculosis.
Dosage
100 micrograms / dose
Indications
Prevention and treatment of seasonal and perennial allergic rhinitis;
Vasomotor rhinitis;
nasal polyps.
pharmachologic effect
Pharmacological group:
Glucocorticosteroids for local use.
Pharmacodynamics:
Glucocorticosteroid for intranasal use. It has a pronounced anti-inflammatory and antiallergic action. When used in therapeutic doses almost no resorptive action. Not mineralocorticoid activity, is well tolerated for prolonged use. The preparation has an inhibitory effect on the release of inflammatory mediators, reduces the number of mast cells and eosinophilic granulocytes. Budesonide reduces the release of toxic proteins from eosinophils, free radicals from the macrophages and lymphokines from lymphocytes. It also reduces the binding of adhesion molecules to endothelial cells, thus reducing the influx of leukocytes to the site of allergic inflammation. Budesonide increases the number (B-adrenoceptor smooth musculature. The drug inhibits phospholipase 2A activity that leads to the inhibition of synthesis of prostaglandins, leukotrienes and complete Freund’s adjuvant (CFA) inducing an inflammatory response. Budesonide also inhibited the synthesis of histamine, which leads to a decrease of its level in mast cells.
Budesonide reduces the severity of symptoms for allergic rhinitis, suppresses early and late phase allergic reactions and reduces inflammation in the upper airways. The therapeutic effect develops after an average of 5-7 days.
Pharmacokinetics:
Suction. After 400 g of budesonide inhalation maximum concentration (Sta “) in plasma is achieved within 0.7 hours and was 1 nmol / l. Only about 20% of the nasally administered dose reaches the systemic circulation.
Distribution. Due to the good tissue distribution and binding to plasma proteins, the apparent volume of distribution is 301 liters.
Metabolism. Systemic bioavailability of budesonide is low, since more than 90% of absorbed drug is inactivated in a single-stage process of metabolism in the liver. Glucocorticosteroid active metabolites does not exceed 1%. Withdrawal.
The half-life (T2) -. 2-2.8 hours is derived through the intestine as metabolites – 10% kidney – 70%. Budesonide concentration in plasma is increased in patients with liver disease.
Pregnancy and breast-feeding
Use of the drug during pregnancy Budoster® allowed only if the expected benefit to the mother outweighs the potential risk to the fetus.
If necessary, the appointment during lactation should stop breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
Side effects reported below may arise with the following frequency:
Very common:> 1/10
Common:> 1/100
special instructions
We do not recommend the use of budesonide nasal spray in patients with respiratory tract infections.
Patients should be informed that the effect of the use of budesonide nasal spray is achieved on average after 5-7 days.
If after three months of treatment, the symptoms do not decrease disease, medication should be discontinued.
When switching from treatment with systemic glucocorticosteroids on steroids for topical use there is the risk of adrenal insufficiency, and therefore requires caution in the period of recovery of the hypothalamic-pituitary-adrenal system. Canceling the drug should be by gradual reduction of the dose to normalize the function of the hypothalamic-pituitary-adrenal system. At the stage of reducing the dose in some patients may appear the symptoms of steroid withdrawal, such as pains in the muscles and / or joints, lethargy, depression. In identifying these symptoms may require a temporary increase in the dose of systemic glucocorticosteroids, and subsequently – further cancellation slower “pace”.
To achieve a therapeutic effect in allergic rhinitis requires regular administration of the drug.
It is recommended to monitor the growth of children receiving long-term treatment of nasal corticosteroids. If the child’s growth slows, the dose of nasal spray should be reduced.
Since steroids retard wound healing, care should sobl1odat Budoster® when administering the drug to patients who have recently undergone surgery or injury to the nose.
Avoid contact with budesonide nasal spray in the eyes. Budoster® does not affect the ability to drive a motor vehicle or machinery. During prolonged drug therapy is necessary to evaluate the state of the nasal mucosa. With long-term use of glucocorticoids for nasal use in children it is recommended to control the growth dynamic. When decelerating growth pediatrician must rethink the way the drug, to decrease the dose and the transition to the minimum therapeutic dose, in which is possible to control the symptoms of the disease.
Storage conditions
Store at a temperature not higher than 25 ° C. Do not freeze.
Keep out of the reach of children.
Dosing and Administration
Adults and children over 6 years at the beginning of therapy with 100 mcg in each nasal passage 2 times a day. The usual maintenance dose is 50 micrograms into each nostril two times a day or 100 micrograms into each nostril once a day 1 morning. The maintenance dose should be the lowest effective dose, eliminating rhinitis symptoms.
The maximum single dose is 200 micrograms (100 micrograms into each nostril), the maximum daily dose – 400 xg for no more than 3 months.
For full therapeutic effect of the drug Budoster® requires regular and correct application.
If a dose is missed the reception, it should be taken as soon as possible, but not later than 1 hour prior to the next dose.
Children drug is used under the supervision of an adult.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist