Generic Medicines
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GENERIC NAME: budesonide
DRUG CLASS AND MECHANISM
Budesonide is a man-made glucocorticoid steroid related to the
naturally-occurring hormone, cortisol or hydrocortisone which is produced
in the adrenal glands. It is used for treating asthma by inhalation.
Glucocorticoid steroids such as cortisol or budesonide have potent
anti-inflammatory actions that reduces inflammation and hyper-reactivity
(spasm) of the airways caused by asthma. When used as an inhaler, the
budesonide goes directly to the inner lining of the inflamed airways to
exert its effects. Only 39% of an inhaled dose of budesonide is absorbed
into the body, and the absorbed budesonide contributes little to the
effects on the airways.
PRESCRIPTION: Yes
PREPARATIONS:
* Pulmicort Turbuhaler 200 mcg: each 200 mcg actuation delivers 160 mcg of
budesonide.
* Pulmicort Respules, 0.25 mg/2ml, 0.5 mg/2ml suspension, and 1 mg/2ml
PRESCRIBED FOR
The budesonide inhaler is used for the control of asthma in persons
requiring continuous, prolonged treatment. Such patients may include those
with frequent asthmatic episodes requiring bronchodilators, for example,
albuterol (Ventolin) or those with asthmatic episodes at night.
DOSING
Budesonide is used to prevent asthmatic attacks and should not be used
to treat an acute attack of asthma. The Turbuhaler is used for individuals
six years of age or older. Effects can be seen within 24 hours, but
maximum effects may not be seen for 1-2 weeks or longer. Doses vary
widely. Adults usually receive 1 to 4 actuations (puffs) twice daily.
Children usually receive 1 to 2 puffs twice daily. For those with mild
asthma, treatment once daily may be sufficient.
Pulmicort Respules are used for individuals 12 months to eight years of
age. Effects are seen in 2 to 8 days, but maximum effects may not be seen
for up to 4 to 6 weeks. Pulmicort Respules are used with a jet nebulizer.
They usually are taken as one or two doses for a total of 0.5-1 mg daily.
DRUG INTERACTIONS
Ketoconazole (Nizoral, Extina, Xolegel, Kuric) increases the
concentrations in blood of budesonide, and this may lead to an increase in
the side effects of budesonide. No drug interactions have been described
with inhaled budesonide.
USES
This is an anti-inflammatory medication (corticosteroid) used in the
prevention of asthma. It is not used to relieve an asthma attack. If an
asthma attack occurs, use other medication as prescribed.
HOW TO USE
This medication is inhaled into the lungs using a special inhaling
device. Follow the directions for using this medicine provided by your
doctor. This medicine comes with a patient information leaflet. Read it
carefully. If you are not sure how to use this device, reread the patient
information leaflet or ask your pharmacist. After the dose is loaded,
breathe out. Place the mouthpiece between your lips and breathe in rapidly
and deeply through your mouth. The drug will be inhaled as you breathe in.
Hold your breath for 10 seconds to assure it reaches deep into your lungs.
Slowly breathe out. Do not exhale into device. Replace the cover. If the
inhaler device is dropped, shaken, or you accidentally breathe into the
device after the dose has been loaded, you will lose your dose. Load and
inhale another dose. Do not use the inhaler if it has been damaged or if
the mouthpiece has become detached. If two inhalations are prescribed,
wait at least one minute between inhalations. If using other inhalers, use
this one (the corticosteroid) last and wait several minutes after using
the other(s) before using this one. To prevent dry mouth and hoarseness,
rinse your mouth after each use. Do not swallow the rinse solution. It is
important to practice good oral hygiene to prevent mouth infections while
using this medication. This medication works best if used consistently at
even intervals. It is usually used once in the morning and evening. Do not
increase your dose, use this more frequently or stop using this medication
without first consulting your doctor.
SIDE EFFECTS
The most commonly noted side effects associated with inhaled
budesonide are mild cough or wheezing; these effects may be minimized by
using a bronchodilator inhaler, for example, albuterol (Ventolin), prior
to the budesonide. Oral candidiasis or thrush (a fungal infection of the
throat) may occur in 1 in 25 persons who use budesonide without a spacer
device on the inhaler. The risk is even higher with large doses but is
less in children than in adults. Hoarseness or sore throat also may occur
in 1 in 10 persons. Using a spacer device on the inhaler and washing one's
mouth out with water following each use reduces the risk of both thrush
and hoarseness. Less commonly, alterations in voice may occur.
High doses of inhaled glucocorticoid steroids may decrease the formation
and increase the breakdown of bone leading to weakened bones and
ultimately osteoporosis and fractures. High doses may suppress the body's
ability to make its own natural glucocorticoid in the adrenal gland. It is
possible that these effects are shared by budesonide. People with
suppression of their adrenal glands (which can be tested for by the
doctor) need increased amounts of glucocorticoid steroids orally or
intravenously during periods of high physical stress, for example, during
infections, to prevent serious illness and shock.
Hypersensitivity reactions such as anaphylaxis, rash, contact dermatitis,
itching, angioedema, and bronchospasm have been reported with use of
inhaled budesonide. Use should be discontinued if such reactions occur.
OVERDOSE
If overdose is suspected, contact your local poison control center or
emergency room immediately. US residents can call the US national poison
hotline at 1-800-222-1222. Canadian residents should call their local
poison control center directly.
MISSED DOSE
If you miss a dose, use it as soon as remembered; do not use it if it
is near the time for the next dose, instead, skip the missed dose and
resume your usual dosing schedule. Do not "double-up" the dose to catch
up.
STORAGE
Always replace the cover. Store inhaler at room temperature between 59
and 86 degrees F (15 and 30 degrees C) in a dry place away from moisture.
Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.