Product Name：Budesonide Aerosol
Nombre del Producto: Budesonida Aerosol para inhalación
Administration and dosage
The dosage of SUNDENT BUDESONIDE 200 mcg and SUNDENT BUDESONIDE 50 mcg should be individualized. At the beginning of the treatment with inhaled glucocorticoids, during periods of grave asthma and while the treatment with oral glucocorticoids is reduced or stopped the dose should be: Aldo-Unión Budesonide 200 mcg: 200 mcg (one inhalation) twice a day, in the morning and in the afternoon. During the periods of grave asthma the daily dose can be increased up to 1600 mcg, which is equivalent to one or two inhalations up to 4 times a day. Once the desired clinical effects have been achieved, the maintenance dose should be gradually reduced up to the minimum quantity needed for the control of the symptoms.
Aldo-Unión Budesonide 50 mcg: children aged 2-7: 200-400 mcg/day divided into 2-4 administrations. Children older than 7:200-800 mcg/day divided into 2-4 administrations. The maintenance dose is individual and it should be as small as possible. The administration twice a day (morning and night) is normally enough. In patients who need a bigger therapeutic effect it is recommended to increase the dose of SUNDENT BUDESONIDE 50 mcg as the risk of eventual systemic effects is small in comparison with a treatment combined with oral glucocorticosteroids.
SUNDENT BUDESONIDE 200 mcg and SUNDENT BUDESONIDE 50 mcg:
- In oral corticoids non dependant patients:
A treatment with the recommended doses normally shows the results after 7 days. However, in certain patients with excessive bronchial mucosa secretion, it is advisable to administer simultaneously, for one or two weeks, an oral corticosteroid whose dose will be gradually reduced until continuing only with the therapy with budesonide. The asthmatic exacerbations produced by bacterial infections should be controlled with an antibiotic therapy, and possibly, increasing the dose of budesonide, or administering systemic corticosteroids if needed.
- In oral corticoid dependant patients:
The change of the treatment with oral steroids with the treatment with budesonide should be carried out when the patient is in a stable phase. For about 10 days a high dose of budesonide will be administered together with the oral corticoid used until then. Later, the dose of the oral corticoid will be reduced (for example: 2.5 mg of prednisolone or equivalent, each month) to the minimum possible level. In many cases, the oral corticoid can be completely withdrawn and the patient can be left under the treatment with budesonide only.
After each dosage the patient should wash his mouth with water.
BUDESONIDE 200 mcg SUNDENT and BUDESONIDE 50 mcg SUNDENT are contraindicated in patients with a history of hypersensitivity to any of its components.
Warnings and special precautions of use
BUDESONIDE 200 mcg SUNDENT and BUDESONIDE 50 mcg SUNDENT:
These preparations should be administered with great precaution in patients with lung tuberculosis or with fungical or viral infections of the respiratory airways. The change from an oral treatment with corticosteroids to a treatment with budesonide, should be carried out with special precaution, mainly due to the slow normalization of the hypothalamic-hypophyseal-adrenal function, previously altered by the oral therapy with corticoids. It may take some months for this normalization to be reached. During this change in medication, patients may recuperate the old symptoms (rhinitis, eczema) or suffer fatigue, headaches, muscular or articulation aches and occasionally nausea and vomits. In these cases a complementary symptomatic treatment should be carried out. Patients who have been treated with systemic steroids for long periods of time or at high doses may have cortico-suprarenal suppression. The cortico-suprarenal function of these patients should be regularly checked and the systemic steroids dose should be carefully reduced. This preparation is not indicated for the treatment of acute asthmatic crisis. The treatment with budesonide should not be suddenly stopped.
Warning: The use of this preparation by sportspeople may give a positive analytic result in a doping control.
Interactions with other medicaments
The only interaction reported so far is the possible influence of the cimetidine on the pharmacokinetics and the pharmacodynamics of budesonide after the oral concomitant and intravenous administration; nevertheless it has little clinical importance. It is not known the possible interaction with other medicaments.
Pregnancy and lactation
Pregnancy: There is not enough evidence about the safety in pregnant women. The administration of corticoids to pregnant animals may cause abnormalities in the development of the fetus, including cleft palate and delay in the intrauterine growth. In consequence there is a risk, even though it is small, of appearing such effects in the human fetus. The use of budesonide by the inhalatory route during pregnancy in humans requires that the potential benefits outweigh the risks.
Lactation: There have not been carried out specific studies on the transference to the milk in breast-feds animals. The use of budesonide in mothers during the lactation period requires considering the therapeutic benefits of the medicament as contrasted with the potential risks for the mother and for the child.
Effects on the ability to drive vehicles and operate machinery
SUNDENT BUDESONIDE 200 mcg and SUNDENT BUDESONIDE 50 mcg do not produce effects on the ability to drive vehicles and operate machinery.
Occasionally, cases of slight throat irritation, cough and hoarseness have been, reported. Some cases of overinfection with Candida in the oropharyngeal cavity have also been reported. In most of the cases it responds to a topical antifungical therapy, with no need for interrupting the treatment with budesonide. In exceptional cases allergic skin reactions have been reported (urticaria, rash, dermatitis) associated with the use of topical corticosteroids.
The chance of occurring paradoxical bronchospasm with an increase in wheezes after the administration should be taken into account. Should this occur, stop the administration immediately and establish an alternative therapy.
Should any hypercorticism indicative symptoms appear, such as edema, full moon face, etc., the corresponding electrolytic imbalance will have to be corrected, with the help of diuretics that do not affect potassium, such as spironolactone and triamterene.
The administration by the oral or inhalatory route of high doses of corticoids for a long period of time may lead to the suppression of the hypothalamic-hypophyseal-corticosuprarenal axis.
Pharmacodynamic properties: Therapeutic group: R03A1. Budesonide is a non-halogenated corticosteroid effective in the treatment of asthma due to its antiinflammatory power. In pharmacological and clinical studies, budesonide has proved to have, for a wide range of doses, a favorable relation between local antiinflammatory activity and systemic corticoid type side effects. This is due to the fact that budesonide is quickly inactivated in the liver after its systemic absorption.
On the other hand, budesonide exerts an antianaphylactic and antiinflammatory effect that is evident in the reduction of the bronchoconstriction produced by both immediate and retarded allergic reactions.
It has also been evidenced that budesonide reduces the respiratory reactivity to histamine and methacholine in hyperreactive patients.
Budesonide administered by the inhalatory route is quickly absorbed by the mucosa and lung parenchyma. After the administration by the inhalatory route budesonide is quickly detected in the blood, which shows that the medicament is absorbed in an intact way through the respiratory tract. This high initial plasmatic concentration also shows a minimum metabolism of the medicament in the lung. The plasmatic half-life of intact budesonide is 2,0 ± 0,2 hours, this value is similar to the one found after the intravenous administration of the medicament (2,8 ± 1,1 hours). Budesonide undergoes an extensive first-pass metabolism in the liver through an oxidizing and reducing biotransformation giving rise to two biologically inactive metabolites, which are responsible for the very low systemic action of budesonide. The binding to plasmatic proteins is 88,0%. The elimination studies carried out in humans, administering 3H-budesonide by the inhalatory route, prove a main excretion of radioactivity by the urinary route (32%) and faeces (15%).
Preclinical safety data
Budesonide, orally administered to rodents, has a DL50 greater than 1000 mg/kg; administered to rodents by the subcutaneous route, the DL50 of budesonide is greater than 50 mg/kg. In subcutaneous administration to rats for a period of 6 months with high doses of up to 80 mcg/kg/day, budesonide induces the characteristic changes of the long-term treatment with corticosteroids, such as growth delay, immunosuppression, hepatic disorders and urinary retention.
List of excipients: Oleic acid, sorbitantrioleate, trichlorofluormethane and dichlorodifluormethane.
The shelf life of the product, packaged for its commercialization is: 2 years.
Special storage precautions
Store it under 30ºC. As with other aerosols, the therapeutic effects may diminish if the aerosol container is cooled. Protect it from direct sunlight and do not freeze. The aerosol container should not be perforated, broken or burnt, even when it is apparently empty.
Nature and content of the container
Aerosol container manufactured with an alloy of aluminium of 0.46 mm of thickness, fitted with a metering valve (50 mcl/application).
200 mcg SUNDENT BUDESONIDE: 10 ml Metering Aerosol (200 doses of 200 mcg of budesonide/dose), with an oral adapter.
BUDESONIDE 50 mcg SUNDENT: 10 ml Metering Aerosol (200 doses of 50 mcg of Budesonide/dose), with an oral adapter.
Instructions of use/handling
1. Check that the aerosol is well assembled to the plastic adapter. Shake the unit and remove the white cover.
2. Hold the bottle in Inverted position between the thumb and the index finger. Introduce the mouthpiece into the mouth, pressing the lips round it.
3. Perform a deep exhalation (expel the air through the nose) and afterwards perform a deep breath through the mouth, pressing at the same time the between the fingers making just one actuation.
4. Remove the device from the mouth and keep the inhaled air for some seconds. Exhale slowly and keep away the bottle, replacing the cover.
Optionally inhalation chambers can be used in order to make a better use of the dose and help the medicament to reach the lungs.
Dispensation and reimbursement conditions
With medical prescription.
We are considered as one of the leading manufacturers and suppliers of budesonide aerosol. With the aid of our technologically advanced manufacturing section, we are able to offer customers budesonide aerosol products which are tested on various quality parameters in order to supply flawless range at the customers' end.