Budesonide

(byoo des' oh nide) 

P  - Caution when used during pregnancy

L  - Caution when used during lactation

Molecule Info

 
Indication & Dosage Oral
Inflammatory bowel disease
Adult: Active disease: 9 mg daily; up to 8 wk, reduce dose before stopping therapy. Recurring episodes of active disease: May repeat an 8-wk course. Maintenance of remission: 6 mg once daily, for up to 3 mth; thereafter, gradually reduce dose before stopping treatment. 
Hepatic impairment: Dose reduction may be needed. 
Nasal
Treatment and prophylaxis of rhinitis
Adult: Initially, 200 mcg into each nostril daily, reduced to 100 mcg into each nostril daily until symptoms are controlled. Or initially, 100 mcg into each nostril bid.
Nasal
Nasal polyps
Adult: 100 mcg bid into each nostril up to 3 mth.
Inhalation
Asthma
Adult: MDI: 400 mcg daily in 2 divided doses, increased up to 1.6 mg daily in severe cases. Maintenance: 200-400 mcg daily. As dry powd inhaler: 200-800 mcg daily in single dose or 2 divided doses. As nebulised solution: Usual dose: 1-2 mg inhaled bid. Maintenance dose: 0.5-1 mg bid.
Child: MDI: 50-400 mcg bid. Nebulised solution: 3 mth-12 yr: Initially, 0.5-1 mg bid. Maintenance dose: 0.25-0.5 mg bid. 
Max Dosage: Adult: Dry powd inhaler: 800 mcg bid.

Special Populations: Budesonide is not indicated for acute attacks of asthma. Patients should be instructed to rinse the mouth with water after each dosing.
Administration Should be taken with food. Swallow whole, do not chew/crush. Avoid grapefruit juice.
Contraindications Hypersensitivity. Acute infections uncontrolled by antimicrobial chemotherapy.
Special Precautions Active or doubtfully quiescent tuberculosis, paradoxical bronchospasm; children, elderly; pregnancy, lactation.
Adverse Drug Reactions Loss of skin collagen and SC atrophy; local hypopigmentation of deeply pigmented skin; dryness, irritation, epistaxis, rarely ulceration or perforation of the nasal septum; smell and taste disturbances; hoarseness and candidiasis of the mouth or throat.
Pregnancy Category (US FDA) ROUTE(S) : Inhalation / Nasal
Category B
: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).
 
ROUTE(S) : PO / Rectal
Category C
: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Storage Inhalation: Store at 20-25°C. Nasal: Store at 20-25°C. Oral: Store at 20-25°C.
Pharmacology Budesonide controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes, fibroblasts, reverses capillary permeability and lysosomal stabilisation at the cellular level to prevent or control inflammation.
Absorption: Rapid and almost complete after oral admin but has poor systemic availability.
Metabolism: Undergoes first-pass metabolism.
ATC Classification R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticooids. 
D07AC09 - budesonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases. 
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation. 
R01AD05 - budesonide ; Belongs to the class of topical corticosteroids used as nasal decongestants.

Brand/Product Info


Total Products : 5     
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
AERONID HFA Beximco Pharmaceuticals Ltd Budesonide BP 200mg/actuation, 200 MDI Inhaler 1's: 400.00 MRP
BUDESON-200 The Acme Laboratories Ltd. Budesonide BP 200mcg/rotacap Inhaler (MDI) 30 MDI: 90.00 MRP
Budicort 0.5 Incepta Pharmaceuticals Limited Each 2 ml ampoule contains Budesonide BP 0.5 mg Nebuliser Suspension 1x5's:MRP 200 Tk
Budicort Nasal Incepta Pharmaceuticals Limited 120 metered doses of Budesonide BP. Each actuation delivers Budesonide BP 100mcg Nasal Spray 120 Metered Dose:MRP 250 Tk
PULMICORT Opsonin Pharma Limited Budesonide 100mcg/actuation MD Spray 120 metered dose: 250.00 MRP

Gen. MedInfo

IMPORTANT WARNING:

If you are switching (or have recently switched) from an oral corticosteroid such as budesonide, betamethasone, dexamethasone, methylprednisolone, prednisolone, or prednisone to budesonide inhalation and suffer an injury, infection, or a severe asthma attack, take a full dose of the oral corticosteroid (even if you have been gradually decreasing the dose) and call your doctor for more directions.

Always carry an identification card that says you may need supplementary doses of an oral corticosteroid during periods of stress (injuries, infections, and severe asthma attacks). Ask your pharmacist or doctor how to get this card. List your name, medical problems, drugs and dosages, and doctor's name and telephone number on the card. Include the name of the oral corticosteroid and the full dose you took before decreasing it.

 

Why is this medication prescribed?

Budesonide is used to prevent wheezing, shortness of breath, and troubled breathing caused by severe asthma and other lung diseases. It belongs to a class of drugs called corticosteroids.

This medication is also used to treat symptoms of stuffiness and runny nose due to allergies. It is in a class of drugs called corticosteroids (cortisone-like drugs).

This medication is sometimes prescribed for other uses; ask your doctor for more information.

How should this medicine be used?

Budesonide Oral Inhalation

Budesonide may come as a powder to inhale by mouth. Budesonide is usually inhaled once or twice a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use budesonide exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Budesonide controls symptoms of asthma and other lung diseases but does not cure them. Improvement in your asthma may occur as soon as 24 hours after taking the medication, but full effects may not be seen for 1 to 2 weeks after taking it regularly. Continue to use budesonide even if you feel well. Do not stop using budesonide without talking to your doctor. Call your doctor if your symptoms do not improve during the first 2 weeks or if they get worse.

Do not use budesonide for rapid relief of asthma attacks. If you do not have another inhaler for prompt relief of breathing difficulties, ask your doctor to prescribe one. If your doctor has prescribed a bronchodilator (a drug to be inhaled for rapid relief of difficult breathing such as salbutamol/albuterol [Ventolin]), use it several minutes before you use your budesonide. This helps the budesonide get into the deeper parts of your lungs. Call your doctor immediately if your asthma is not responding to usual treatment.

Before you use budesonide the first time, read the written directions that come with it. Ask your doctor, pharmacist, or respiratory therapist to show you the right way to use the inhaler. Practice using the inhaler in front of him or her, so you are sure you are doing it the right way.

To use the inhaler, follow these steps:

  1. Turn the protective cover and lift it off.

  2. The first time you use a new budesonide inhaler you must prime it. To do this, hold the inhaler upright (with mouthpiece up), then twist the brown grip fully to the right as far as it will go, then back again fully to the left. You will hear a click. Repeat. The unit is now primed and ready to load the first dose. You do not have to prime the inhaler again after this, even if you do not use it for a long time.

  3. Holding the inhaler upright, load the first dose by turning the grip fully to the right and fully to the left until it clicks.

  4. Turn your head away from the inhaler and breathe out. Do not blow or exhale into the inhaler. Do not shake the inhaler after loading it.

  5. Hold the inhaler in the upright (mouthpiece up) or horizontal position. Place the mouthpiece between your lips well into your mouth, past your front teeth. Tilt your head slightly back. Close your lips tightly around the mouthpiece and inhale deeply and forcefully. Be sure that the mist goes into your throat and is not blocked by your teeth or tongue. Adults giving the treatment to young children may hold the child's nose closed to be sure that the medication goes into the child's throat.

  6. Remove the inhaler from your mouth and hold your breath for about 10 seconds. Do not exhale through the inhaler.

  7. If you take two puffs (inhalations), wait 2 minutes before taking the second puff.

  8. For the next puff and all other puffs, you do not have to prime the inhaler. However, it must be loaded in the upright position right before its use. Turn the grip fully to the right and then fully to the left until it clicks.

  9. Replace the protective cap on the inhaler. After each treatment, rinse your mouth with water, but do not swallow the water.

Keep the inhaler clean and dry at all times. Do not bite or chew the mouthpiece. Do not use Pulmicort Turbuhaler with a spacer.

Budesonide Nasal Spray

Budesonide may come as an aerosol nasal spray to be sprayed in the nose. Budesonide is usually used once or twice a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use budesonide exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Budesonide treats symptoms in your nose; you may need other drugs if you have other allergy symptoms. Do not stop taking budesonide without talking to your doctor.

Do not use budesonide if you have recently had a sinus infection, nasal bleeding, or surgery inside your nose.

If you have recently stopped taking a corticosteroid drug by mouth, tell your doctor if you have joint pain, muscle pain, depression, or tiredness. These symptoms may mean that you have too little corticosteroid in your body.

Before you use budesonide for the first time, read the written directions that come with it. Ask your doctor, pharmacist, or respiratory therapist to show you how to use the nasal spray, and practice using it in front of them. Follow these steps:

  1. Blow your nose.

  2. Open the canister by turning the arrow.

  3. Shake the canister well, both before and between sprays.

  4. Plug one nostril and place the end of the inhaler in the other nostril. Hold your breath and squeeze down on the canister to release the drug into your nose. If your doctor prescribes a second spray, repeat these steps with the inhaler in the other nostril.

  5. Close the canister.

 What special precautions should I follow?

Before using budesonide inhalation powder,

  • tell your doctor if you are allergic to budesonide or any other drugs.
  • tell your doctor what prescription and nonprescription medications you are taking, especially arthritis medications; aspirin; cimetidine; digoxin; diuretics ('water pills'); estrogen; ketoconazole (Nizoral); oral contraceptives (birth control pills); oral corticosteroids; phenobarbital; phenytoin; rifampin; theophylline; and vitamins or herbal products.
  • if you have a fungal infection (other than on your skin), or any other type of infection, do not use budesonide without talking to your doctor.
  • tell your doctor if you have or have ever had diabetes; thyroid problems; high blood pressure; mental illness; myasthenia gravis; osteoporosis; herpes eye infection; seizures; tuberculosis; ulcers; or liver, kidney, intestinal, or heart disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using budesonide, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking budesonide.
  • avoid exposure to chicken pox and measles. If you are exposed to them while using budesonide, call your doctor. Do not have a vaccination or other immunization unless directed to by your doctor.

What special dietary instructions should I follow? 

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Budesonide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • dry or irritated mouth or throat

  • cough

  • difficult or painful speech

  • dizziness

  • difficulty falling asleep or staying asleep

  • neck pain

  • stomach pain

If you experience any of the following symptoms, call your doctor immediately:

  • vision problems

  • white spots or sores in your mouth

  • swollen face, lower legs, or ankles

  • cold or infection that lasts a long time

  • muscle weakness

  • increased difficulty in breathing

  • skin rash

  • unusual bleeding or bruising

  • fever

  • sore throat

  • pain during urination

  • muscle aches

If you have been switched from oral corticosteroids to budesonide and are slowly tapering off your dose of the oral medication and you experience any of the following symptoms, call your doctor immediately:

  • joint or muscle pain

  • increased difficulty in breathing

  • tiredness

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What other information should I know?

Keep all appointments with your doctor and the laboratory.

If your sputum (the stuff that you cough up during an asthma attack) thickens or changes color from clear white to yellow, green, or gray, call your doctor; these may be signs of an infection.

Only a small amount of the budesonide powder is released into your lungs when you inhale. Therefore, you may not taste or sense the presence of any medication, but the medication will be working in your lungs.

When there are 20 doses left in the budesonide inhaler, a red mark will appear in the indicator window. This is the time to get your budesonide inhaler refilled. When the red mark reaches the bottom of the window, your inhaler is empty. Discard it. (You may still hear a sound if you shake it; this sound is not the medication. It is the drying agent inside the inhaler.)

Breathing or inhalation devices require regular cleaning. Follow the written directions for care and cleaning that comes with the inhaler.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

 


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.