Budecort Budesonide 200 mcg Powder for Inhalation 100 doses
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Dosage/Direction for Use
Initially, at the beginning of inhaled corticosteroid therapy, for therapy during periods of severe asthma or when scaling down or withdrawing oral corticosteroids the dosage should be: Children aged 6 years and older: 100-800 micrograms per day, divided into 2-4 inhalations. With daily doses up to 400 micrograms the full dose may be given in one administration.
Adults: The normal dose range is 200-800 micrograms per day, divided into 2-4 inhalations. In more severe cases daily doses of up to 1600 micrograms may be needed. With daily doses up to 400 micrograms the full dose may be given in one administration.
The maintenance dose should be the lowest possible.
Following a single dose an effect may be expected after a few hours. The full therapeutic effect is only achieved after a few weeks of treatment. Treatment with Budesonide (BUDECORT TURBUHALER) is prophylactic therapy with no demonstrated effect on acute disorders.
Clinical trials indicate that a larger amount of budesonide is deposited in the lungs when administered with Budesonide (BUDECORT TURBUHALER), compared with Budesonide (Budecort pMDI). If a patient in a stable phase is transferred from Budesonide (BUDECORT pMDI) to Budesonide (BUDECORT TURBUHALER) a reduction in dose may therefore be appropriate.
In patients in whom an increased therapeutic effect is desired, in general an increase of the Budesonide (BUDECORT TURBUHALER) dose is to be recommended in preference to combination treatment with oral corticosteroids because of the lower risk of systemic side effects.
Patients dependent on oral steroids: When transfer from oral steroids is initiated the patient must be in a relatively stable condition. A high dose of Budesonide (Budecort) is given in combination with the previously used oral steroid dose for 10 days. After that, the oral dose should be gradually reduced by e.g. 2.5 mg prednisolone or equivalent per month to the lowest possible level. The oral steroid can often be discontinued entirely.
There is no experience of treatment of patients with impaired hepatic or renal function. Since budesonide is predominantly eliminated through hepatic metabolism, increased exposure may be expected in patients with severe cirrhosis of the liver.
Instructions for correct use of Turbuhaler: Turbuhaler is inspiratory flow-driven which means that, when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note: It is important to instruct the patient: To carefully read the instructions for use: "How to use Budesonide (BUDECORT TURBUHALER)".
To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
Never to breath out through the mouthpiece.
To rinse the mouth out with water after inhaling the prescribed dose to minimise the risk of oropharyngeal thrush.
It is possible that the patient will not taste or perceive any medicine when Budesonide (BUDECORT TURBUHALER) is used; this is because such a small amount of substance is dispensed.
Respules: Bronchial asthma: The dosage of Budesonide (BUDECORT RESPULES) Nebulizing Suspension is individual, and should be titrated to the lowest effective maintenance dose once control of asthma is achieved.
Administration can be once or twice daily. Once daily administration can be used for daily doses of 250 mcg - 1000 mcg.
Recommended initial dose: Adults/Elderly: 1000 mcg - 2000 mcg total daily dose.
Children 6 months or older: 250 mcg - 500 mcg total daily dose. In patients depending on oral glucocorticosteroids, a higher starting dose, e.g., 1000 mcg total daily dose may be considered.
Maintenance dose: In all patients it is desirable to titrate to the lowest effective maintenance dose once control of asthma is achieved.
Dose-range maintenance dose: Adults/Elderly: 500 - 4000 mcg total daily dose. In very severe cases the dose may be further increased.
Children 6 months or older: 250 - 2000 mcg total daily dose.
Respules: Acute overdosage with Budesonide (BUDECORT RESPULES) Nebulizing Suspension, even in excessive doses, is not expected to be a clinical problem.
Use In Pregnancy & Lactation
During pregnancy the aim must be the lowest effective dose of budesonide while taking account of the risk of a worsening of the asthma.
Lactation: It is not known whether budesonide passes into breast milk.
Respules: Results from a large prospective epidemiological study and from world-wide post marketing experience indicate no adverse effects of inhaled budesonide during pregnancy on the health of the foetus/newborn child.
As with other drugs the administration of budesonide during pregnancy requires that the benefits for the mother be weighed against the risks for the foetus. Inhaled glucocorticosteroids should be considered for the treatment of asthma because of the lower systemic effects compared with oral glucocorticosteroids required to achieve similar pulmonary responses.
Budesonide is excreted in breast milk. However, at therapeutic doses of Budesonide (BUDECORT RESPULES) Nebulizing Suspension no effects on the suckling child are anticipated. Budesonide (BUDECORT RESPULES) Nebulizing Suspension can be used during breast feeding.
In isolated cases signs or symptoms of systemic glucocorticoid effects may occur, including adrenal hypofunction.
Isolated cases of bruising have occurred.
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, probably depending on dose, exposure time, concomitant and previous steroid exposure, and individual sensitivity.
Facial skin irritation has occurred in some cases when a nebuliser with a face mask has been used. To prevent irritation the facial skin should be washed with water after use of the face mask.
Ketoconazole 200 mg once daily increased the plasma concentrations of oral budesonide (3 mg in a single dose) on average six-fold when administered concomitantly. When ketoconazole was administered 12 hours after budesonide, the concentration was increased on average three-fold. Information about this interaction is lacking for inhaled budesonide, but markedly increased plasma levels are also expected in such cases. The combination should be avoided since data to support dose recommendations are lacking. If this is not possible, the time interval between administration of ketoconazole and budesonide should be as long as possible. A reduction of the budesonide dose must also be considered. Other potent inhibitors of CYP3A4, i.e. itraconazole also cause a marked increase in the plasma levels of budesonide.
Respules: Budesonide has not been observed to interact with any drug used for the treatment of asthma.
The metabolism of budesonide is primarily mediated by CYP3A4, a subfamily of cytochrome P450. Inhibitors of this enzyme, eg, ketoconazole and itraconazole, can therefore increase systemic exposure to budesonide; see Precautions.
At recommended doses, cimetidine has slight but clinically insignificant effect on the pharmacokinetics of oral budesonide.
Caution For Usage
Turbuhaler is a multidose inhaler from which the drug is administered without the use of additives. When the patient breathes in through Turbuhaler the powder is delivered to the lungs. It is therefore important that the patient inhales forcefully and deeply through the mouthpiece.
Turbuhaler is very easy to use. Simply follow the instructions given as follows.
1. Unscrew and lift off the cover.
2. Hold the inhaler upright with the grip downwards. Load the inhaler with a dose by turning the grip as far as it will go and then back to the original position.
3. Breathe out. Do not breathe out through the inhaler.
4. Place the mouthpiece gently between the teeth, close lips and breathe in forcefully and deeply through the mouth. Do not chew or bite on the mouthpiece. Do not use Turbuhaler if it has been damaged or if the mouthpiece has become detached.
5. Before breathing out, remove the inhaler from the mouth.
If more than one dose has been prescribed, repeat steps 2-5.
6. Replace the cover.
7. Rinse the mouth out with water after inhaling the prescribed dose.
NOTE: Never breathe out through the mouthpiece.
Always replace the cover properly after use.
As the amount of the powder dispensed is very small, the patient may not be able to taste it after inhalation. However, the patient can still be confident that the dose has been inhaled if the patient has followed the instructions.
Cleaning: Clean the outside of the mouthpiece regularly (weekly) with a dry tissue.
Do not use water for cleaning the mouthpiece.
Dose indicator: When a red mark is first seen in the indicator window there are approximately 20 doses left. When the red mark has reached the lower edge of the window the inhaler will no longer deliver the correct amount of medicine, and should be discarded. The sound heard as the patient shakes the inhaler is not produced by the medication but by a drying agent.
Disposal: Always be sure to dispose of the used Turbuhaler responsibly in the recommended way, since some of the medicine will remain inside it.
Respules: See Dosage & Administration.
How to use Budesonide Respules: 1) Before use, re-suspend the contents of the sterile single dose by using a gentle swirling motion.
2) Hold the sterile single dose unit upright and open by twisting off the wing.
3) Place the open (i.e. 1 mL) of the single dose units are to be used, withdraw the desired volume and discard any remaining portion.
NOTE: 1. Rinse the mouth out with water after each dosing occasion.
2. If the patient uses a facemask, make sure that the mask fits tightly while the patient is inhaling.
3. Wash the face after the treatment.
Cleaning: The nebulizer chamber and the mouthpiece, or the facemask, should be cleaned after each use. Wash the parts in hot tap water using a mild detergent or according to the instructions supplied by the manufacturer of the nebulizer. Rinse well and dry by connecting the nebulizer chamber to the compressor of air inlet.
Incompatibilities: No known incompatibilities. For proven compatible products, see Dosage & Administration.
Store with the cover tightly closed.
Respules: Store at a temperature not exceeding 30°C. Do not freeze.
Store in an upright position and protected from light. After opening of the aluminium foil envelope, the unused single dose units should be kept in the envelope to protect them from light.
Shelf-life: After opening the envelope, single dose units should be used within 3 months.
Opened single dose units should be used within 12 hours. Please note that if only 1 mL is used the remaining volume is not sterile.
Pharmacology: Pharmacodynamics: Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect.
Turbuhaler: The precise mechanism of action of glucocorticosteroids in the treatment of asthma is not fully understood. Anti-inflammatory effects such as inhibited release of inflammatory mediators and inhibition of cytokine-mediated immune response are probably important. The activity of budesonide, measured as its affinity for glucocorticosteroid receptors is approx. 15 times higher than that of prednisolone.
Budesonide has anti-inflammatory effects shown as reduced bronchial obstruction during both the early and the late phase of an allergic reaction. In hyper-reactive patients budesonide reduces the histamine and metacholine reactivity in the airways.
Studies have shown that the earlier budesonide treatment is initiated after the onset of asthma, the better lung function can be expected.
Studies in healthy volunteers with Budesonide (BUDECORT TURBUHALER) have shown dose-related effects on plasma and urinary cortisol. At recommended doses, Budesonide (BUDECORT TURBUHALER), causes significantly less effect on the adrenal function than prednisone 10 mg, as shown by ACTH tests.
In children over the age of 3 years, no systemic effects have been detected with doses up to 400 micrograms per day. In the range 400-800 micrograms per day biochemical signs of a systemic effect may occur. With daily doses in excess of 800 micrograms such signs are common.
Asthma, like inhaled corticosteroids, can delay growth. However, studies in children and adolescents who were treated with budesonide for a long period (up to 11 years) show that the patients reach the expected adult height.
Inhalation therapy with budesonide is effective in preventing exercise-induced asthma.