Budecton
(Budesonide )




COMPOSITION

Budecton 200 mcg:

A capsule contains:

Active ingredients:

Budesonide 200 mcg

Excipients: lactose monohydrate.

Film coating composition: gelatin, red iron oxide, titanium dioxide.

Budecton 400 mcg:

A capsule contains:

Active ingredients:

Budesonide 400 mcg

Excipients: lactose monohydrate.

Film coating composition: gelatin, black iron oxide, red iron oxide, titanium dioxide).

THERAPEUTIC INDICATIONS

- bronchial asthma requiring maintenance glucocorticosteroid therapy;

- COPB.

CONTRAINDICATIONS

- hypersensitivity to any component of the drug;

- active tuberculosis;

- children under 6 years old.

ADVERSE EFFECTS

Endocrine disorders

Rare: Adrenal suppression, Cushing’s syndrome, hypercorticism, growth retardation in children and adolescents

Eye disorders

Rare: Cataract, glaucoma

Immune system disorders

Rare: Hypersensitivity reactions, rash, urticaria, angioedema, pruritus

Psychiatric disorders

Rare: Abnormal behaviour (described in children)

Musculoskeletal and connective tissue disorders

Rare: Decrease in bone mineral density

Respiratory, thoracic and mediastinal disorders

Common: coughing;

Rare: Bronchospasm paradoxical, oral candidiasis, throat irritation, dysphonia subsiding after therapy withdrawal or down-titration of dose.

DOSAGE AND ADMINISTRATION

Budecton is indicated for inhalation and should not be administered orally. Pharmaceutical form of the medicine is capsules containing inhalation powder applied only using the special device  included into the package. Due to capsule destruction, the capsule shell may enter the mouth or throat after the inhalation. To minimize this event, the capsule should not be actuated more than once. Take the capsule out of blister immediately before the administration.
1 dose (200 mcg or 400 mcg) corresponds to one inhalation.
The dose should be adapted to the requirements of each individual, the severity of the disease and the clinical response of the patient. The dose should be adjusted until control is achieved and then should be titrated to the lowest dose at which effective control of disease is maintained.
Adults and children/adolescents over 12 years of age: 200 micrograms of budesonide 1 or 2 times daily. Maximum daily dose is 1600 microgram of budesonide daily.
Children aged 6-12 years: 200 mcg of budesonide 1-2 times daily. Maximum daily dose is 800 mcg of budesonide in several divided doses. The administration should be performed only under adults control. Budecton is intended for long-term therapy which should be prescribed individually.
However, extreme mucous congestion and inflammatory processes may obstruct the bronchial passages to such an extent that budesonide cannot fully exert its local effects. In such cases, inhaled therapy with budesonide should be supplemented with a short course of systemic corticosteroids. Inhalation doses are continued after gradually reducing the dose of systemic corticosteroids.
Patients receiving systemic treatment with corticosteroids should be switched to Budecton at a time when their symptoms are under control. In these patients, whose adrenocortical function is usually impaired, systemic treatment with corticosteroids must not be stopped abruptly. At the beginning of the switchover, a high dose of Budecton up to 1600 mcg per day should be given in addition to the systemic corticosteroids for about 7 to 10 days. Then, the daily dose of the systemic corticosteroid can be reduced gradually (e.g. 2.5 milligram corticosteroid each 1-2 weeks).
Patients should be advised to contact their doctor if their asthma deteriorates (increased frequency of short acting inhaled bronchodilator treatment or persistent respiratory symptoms). The patient should be reassessed and the need for increased anti inflammatory therapy, an increase in the dose of inhaled or oral corticosteroid, should be considered.
COPD: the recommended dose of Budecton is 400 microgram twice daily. Patients who have positive response to therapy during the first 3-6 months of treatment, may be subjected to long-term therapy with Budecton.
Budecton should be used under the supervision of adults. It is required to be ensured that a child performs inhalation technique in a proper way.
To reduce the risk of oral irritation and hoarseness, as well as to decrease the risk of systemic adverse effects it is recommended that  the mouth is rinsed with water after each inhalation.

The following steps for usage of inhaler are required:
1. Pull off the cap from the inhaler.
2. Hold the base of the inhaler firmly and turn the mouthpiece in the direction of the arrow on the bottom of the mouthpiece to open.
3. Place the capsule in the capsule-shaped compartment in the base of the inhaler (it is capsule-shaped). It is important that you remove the capsule from the blister pack only immediately before you use it.
4. Twist the mouthpiece to the closed position.
5. Keeping the inhaler upright, firmly squeeze the red buttons on the sides once only. This will pierce the capsule. Release the buttons.
On this stage capsule destruction may occur while needling it, resulting in the penetration of small pieces of capsule into mouth or throat. In order to prevent complete destruction of capsule, the following requirements should be followed: capsule should not be punctured more than once, storage conditions should be maintained, the capsule should be taken out of blister immediately before the inhalation.
6. Breathe out fully.
7. Place the mouthpiece in your mouth and tilt your head slightly backwards. Close your lips around the mouthpiece and breathe in as quickly and as deeply as you can. As you breathe in, you will inhale the medicine into your lungs. You should hear the capsule spinning in the inhaler. If you do not hear this whirring noise, the capsule may be stuck in the compartment. If this occurs, open the inhaler and loosen the capsule by prising it out of the compartment. Do not try to loosen the capsule by repeatedly pressing the buttons.
8. If you hear the whirring noise, hold your breath for as long as you comfortably can while taking the inhaler out of your mouth. Then breathe normally. Open the inhaler to see if any powder is still in the capsule. If there is still powder in the capsule repeat steps 6 to 8.
9. After use, tip out the empty capsule and close the mouthpiece. Replace the cap. If you need to clean the inhaler, wipe the mouthpiece and capsule compartment with a dry cloth or a clean soft brush.

DRUG INTERACTIONS
Due to very low plasma concentration by inhalation, clinically significant drug interactions with other medicinal products is quite unlikely.
Concomitant administration of known inhibitors of CYP3A4 (e.g. itraconazole, ketoconazole, ritonavir, nelfinavir, amiodarone, clarythromycin) may inhibit the metabolism of, and increase the systemic exposure to budesonide. If these products are administered together, adrenal cortical function should be monitored and the dose of budesonide adjusted according to the response.
Concomitant administration of strong inducers of CYP3A4 (e.g. rifampicin, phenobarbital, phenytoin) may increase the metabolism of, and decrease the systemic exposure to budesonide.
Methadrostenol and estrogens potentiate the effect of budesonide.
PREGNANCY AND LACTATION
As with other drugs the administration of budesonide during pregnancy requires that the benefits for the mother are weighed against the risks for the foetus.
 
MANUFACTURED FORM
Inhalation powder capsules.
10 capsules in a blister.
6 blisters with a leaflet in a carton box.

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