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TEVA-BUDESONIDE is a brand name for Budesonide, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE................................................................................ 3 CONTRAINDICATIONS.................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
During clinical trials, the most common side effects were cough, throat irritation and hoarseness (2-4%). Bad taste, headache, nausea and dryness of the throat were reported less frequently. Other side effects reported on occasion during budesonide treatment were tiredness, thirst, and diarrhea.
In rare cases, anaphylactic reactions have been reported following the use of budesonide. Facial skin irritation has occurred in a few cases when a nebulizer with a face mask has been used. To prevent irritation, the facial skin should be washed after use of the face mask.
) may, in rare cases, occur in association with local corticosteroid therapy. In rare cases, skin bruising has been reported following treatment with inhaled glucocorticosteroids. As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind.
If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. Systemic effects and oropharyngeal complications caused by budesonide were found to be dose- dependent. In rare cases signs or symptoms of systemic glucocorticosteroid effect, including hypofunction of the adrenal gland and reduction of growth velocity, may occur with inhaled glucocorticosteroids, depending on dose, exposure time, concomitant and previous steroid exposure, and individual sensitivity.
Candidiasis has been reported by some patients and may occur at therapeutic doses. In rare cases, budesonide may provoke bronchoconstriction in hyperreactive patients. In patients in whom systemic steroids are reduced or stopped, withdrawal symptoms due to decreased systemic activity occur frequently (see DOSAGE AND ADMINISTRATION: Clinical Management).
Post-Market Adverse Drug Reactions Psychiatric symptoms such as nervousness, restlessness and depression as well as behavioural disturbances in children have been observed. Cases of growth suppression have been reported for budesonide.
DRUG INTERACTIONS Budesonide has not been observed to interact with any drug used for the treatment of asthma. Cimetidine The kinetics of budesonide were investigated in a study of healthy subjects without and with cimetidine, 1000 mg daily.
3 vs. 1 nmol/L and 10 vs. 12%, respectively) indicated a slight inhibitory effect on hepatic metabolism of budesonide, caused by cimetidine. This should be of little clinical importance. Teva-Budesonide Product Monograph Page 8 of 22 CYP3A4 Inhibitors The metabolism of budesonide is primarily mediated by CYP3A4, a subfamily of cytochrome P450.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. ketoconazole and itraconazole) increase the systemic exposure to budesonide. Therefore, concomitant use of budesonide and ritonavir or azole antifungals should be avoided, unless the potential benefit outweighs the risk of systemic corticosteroid side-effects.
DOSAGE AND ADMINISTRATION Dosing Considerations TEVA-BUDESONIDE should be administered from suitable nebulizers. Due to a low output of budesonide, ultrasonic nebulizers should not be used. The amount of budesonide suspension delivered to the patient in a nebulizer is variable and dependent upon several factors, including the following: • nebulization time, • volume fill, • the characteristics of the nebulizing equipment, • the inspiratory/expiratory ratio and tidal volume of the patient, • the use of either a face-mask or a mouth piece.
Data from ex vivo studies have estimated that the dose of nebulized budesonide delivered to the patient varies between 9-19% of the nominal dose. The nebulization time and the dose delivered are dependent on flow rate, volume of nebulizer chamber and volume fill.
Nebulization should take place using a gas flow (oxygen or compressed air) of 6 to 10 L/minute and the suspension nebulized over a 10 to 15 minute period. A suitable volume fill for most nebulizers is 2-4 mL. The manufacturer's instructions concerning cleaning and maintenance of the nebulizer should be strictly followed.
NOTE:
Patients should be instructed to rinse their mouths out with water after each nebulization treatment. This will help prevent the occurrence of candidiasis and potential systemic effects. Cleansing dentures has the same effect. Recommended Dose and Dosage Adjustment Initial Dose The dosage of TEVA-BUDESONIDE is individual.
5 mg twice daily. In some cases, the dosage may be further increased up to 1 mg twice daily. Adults: usually 1 to 2 mg twice daily. In some cases, the dosage may be further increased. Maintenance Dose The maintenance dose is individual.
After the desired clinical effect has been obtained, the maintenance dose should be gradually reduced to the smallest amount necessary for control of symptoms. 9% saline to a volume of 2 mL. In patients where an increased therapeutic effect is desired, an increased dose of TEVA- BUDESONIDE is recommended because of the lower risk of systemic effects as compared with a combined treatment with oral glucocorticosteroids.
If only half the contents of an ampoule are used, add Sterile Normal Saline to make up the required volume fill. Clinical Management Patients - Non-Steroid Dependent Treatment with the recommended doses of budesonide usually gives a therapeutic effect within 10 days.
However, certain patients might have an excessive collection of mucous secretion in the bronchi which reduces the penetration of budesonide into the bronchial mucosa. In these cases, it is desirable to initially […]