Budesonide capsules

What are budesonide capsules?

BUDESONIDE (Entocort EC®) is a corticosteroid. It is used in the treatment of Crohn's disease, which is an inflammatory bowel disease. Generic budesonide capsules are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cataracts or glaucoma

• Cushing's syndrome

• diabetes

• heart problems or previous heart attack

• high blood pressure

• infection such as herpes, measles, tuberculosis, or chickenpox

• liver disease

• myasthenia gravis

• osteoporosis

• psychosis or other mental health problems

• recent surgery

• stomach or intestinal disease, including colitis

• an unusual or allergic reaction to budesonide, other corticosteroids, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I take this medicine?

Take budesonide capsules by mouth. Follow the directions on the prescription label. Swallow the capsules with a drink of water. Do not chew, crush, or break open the capsules. The capsules need to be swallowed whole. If you are only taking budesonide once a day, take it in the morning, which is the time your body normally secretes cortisol. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose and remember within an hour or so, take it as soon as you remember. If it is almost time for your next dose, take only that dose and continue with your regular schedule. Do not take double or extra doses.

What drug(s) may interact with oral budesonide?

• anastrozole

• antacids

• barbiturates, medicines used for inducing sleep or treating seizures

• bosentan

• calcium supplements

• certain antifungals, like fluconazole, griseofulvin, itraconazole, ketoconazole, miconazole and oxiconazole

• certain heart medicines like diltiazem, mibefradil, nicardipine and verapamil

• cyclosporine

• danazol

• diltiazem

• certain antibiotics like erythromycin, clarithromycin, nafcillin and troleandomycin

• dexamethasone

• ethosuximide

• grapefruit juice

• isoniazid, INH

• medicines used for seizures such as carbamazepine, ethosuximide, fosphenytoin, phenytoin

• medicines used for ulcers or stomach acid, such as cimetidine or omeprazole

• modafinil

• norfloxacin

• quinidine

• quinine

• rifabutin

• rifampin

• rifapentine

• some HIV medicines, for example indinavir, nelfinavir, ritonavir or saquinqvir

• some medicines for depression, such as fluoxetine, fluvoxamine or nefazodone

• St. John's wort

• troglitazone

• vaccines

• zafirlukast

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking oral budesonide?

If you are taking budesonide regularly, avoid contact with people who have an infection. You may have an increased risk from infection while taking budesonide. Tell your prescriber or health care professional if you are exposed to anyone with measles or chickenpox or if you develop sores or blisters that do not heal properly.

People who are taking certain dosages of budesonide may need to avoid immunization with certain vaccines or may need to have changes in their vaccination schedules to ensure adequate protection from certain diseases. Make sure to tell your prescriber or health care professional that you are taking budesonide before receiving any vaccine.

If you are going to have surgery, tell your prescriber or health care professional that you are taking oral budesonide.

Your body may lose potassium while you are taking oral budesonide. Ask your prescriber or health care professional about your diet.

Corticosteroids like budesonide may affect your blood sugar. If you have diabetes, check with your prescriber or health care professional if you need help adjusting the dose of your medicine for diabetes.

Alcohol, grapefruit, and grapefruit juice can increase the risk of getting serious side effects while you are taking budesonide. Avoid grapefruit, grapefruit juice, and alcoholic drinks while taking budesonide.

What side effects may I notice from taking oral budesonide?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• bloody or black, tarry stools

• confusion, excitement, restlessness, a false sense of well-being

• eye pain, decreased or blurred vision

• fever, sore throat, sneezing, cough, or other signs of infection, wounds that will not heal

• frequent passing of urine or painful passing of urine

• hair loss

• hemorrhoids

• increased thirst

• irregular heartbeat, chest pain or high blood pressure

• menstrual problems

• severe mood swings

• muscle cramps or weakness

• numbness or tingling in fingers, toes or other areas

• pain in hips, back, ribs, arms, shoulders, or legs

• rounding out of face

• skin problems, acne, thin and shiny skin

• stomach pain

• swelling of feet or lower legs

• unusual bruising

• unusual tiredness or weakness

• vomiting

• weight gain or weight loss

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• dizziness or drowsiness

• headache

• increased or decreased appetite

• increased sweating

• nausea

• nervousness or difficulty sleeping

• upset stomach

• increased growth of hair on the face or body

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Budesonide inhalation powder

What is budesonide inhalation powder?

BUDESONIDE (Pulmicort Turbuhaler®) is a corticosteroid for treating respiratory problems. It helps to decrease the inflammation, swelling, and irritation in your lungs that is caused by asthma or other lung diseases. Regular use of budesonide inhalation powder will help prevent asthma attacks, but it is not for rapid relief of asthma attacks. Generic budesonide inhalation powder is not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• Cushing's syndrome

• infection such as herpes, or tuberculosis

• recent surgery or trauma

• an unusual or allergic reaction to budesonide, steroids, milk, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Budesonide is for inhalation through the mouth. Follow the directions on the prescription label. A new inhaler should be primed before use. Follow the priming instructions that come with the inhaler. The instructions will also tell you what position to hold the inhaler when loading or inhaling a dose. Always hold the inhaler in the appropriate position so that no medication is lost.

Load the dose as instructed. Do not shake the inhaler after loading it. Turn your head away from the inhaler and breathe out. Place the mouthpiece between your lips and inhale deeply and forcefully. You may not taste or feel the medication. Remove the inhaler from your mouth and exhale. Do not blow or exhale into the mouthpiece. Do not chew or bite on the mouthpiece. If more than one dose is required, repeat the steps above. Rinse your mouth with water; do not swallow the water.

Keep your inhaler clean and dry at all times. Do not use the inhaler if it has been damaged or if the mouthpiece has become detached.

Contact your pediatrician or health care professional regarding the use of this medicine in children less than 6 years of age. Special care may be needed.

What if I miss a dose?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, use only that dose and continue with your regular schedule, spacing doses evenly. Do not use double or extra doses.

What drug(s) may interact with budesonide?

No interactions have been recorded. Do not use other inhalation aerosols at the same time as budesonide unless prescribed by your prescriber or health care professional.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking budesonide?

Visit your prescriber or health care professional for regular checks on your progress. Carry an identification card with your name, the type and dose of corticosteroid you are taking, and your prescriber's name and address. It can take up to 4 weeks before you see the full effect of budesonide. Budesonide is intended for regular use. It will not cure your condition, but can help to reduce asthma symptoms. Budesonide will not relieve an acute asthma attack. If you have an asthma attack you should still use your budesonide at the usual time, but use another medicine to treat the attack. Do not stop using budesonide except on your prescriber's advice.

If you are transferred from steroid tablets taken by mouth to steroid inhaler , you may need additional doses of steroid tablets during periods of stress. Always follow your prescriber's advice.

If you need surgery, or have any kind of accident or stress, tell the prescriber or health care professional that you are using budesonide.

If you are also using a bronchodilator inhaler (such as albuterol) use that inhaler first. Wait a few minutes before using budesonide.

Tell your prescriber or health care professional if you are exposed to anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

People who are taking certain dosages of budesonide may need to avoid immunization with certain vaccines or may need to have changes in their vaccination schedules to ensure adequate protection from certain diseases. Make sure to tell your prescriber or health care professional that you are taking budesonide before receiving any vaccine.

What side effects may I notice from using budesonide?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• chest pain or tightness

• fever or chills

• skin rash and itching (hives)

• sore mouth, with cream or white curd-like patches in the mouth or throat

• troubled breathing or wheezing

• unusual swelling

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• coughing, hoarseness

• dry mouth

• loss of taste, or unpleasant taste

Where can I keep my medicine?

Keep out of the reach of children.

Store in a dry place at room temperature between 20—25 degrees C ( 68—77 degrees F). Throw away after the expiration date.

Budesonide inhalation solution

What is budesonide inhalation solution?

BUDESONIDE (Pulmicort® Respules™) is a corticosteroid for treating respiratory problems. It helps to reduce recurring symptoms of asthma, but it is not for rapid relief of asthma attacks. Generic budesonide inhalation solution are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• Cushing's syndrome

• infection such as herpes, or tuberculosis

• recent surgery or trauma

• an unusual or allergic reaction to budesonide, steroids, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Budesonide is for inhalation through the mouth using a nebulizer machine. Follow the directions on the prescription label and the manufacturer's instructions on using the nebulizer. If possible, gargle or rinse your mouth with water after the last dose; do not swallow the water. Do not use more than the recommended dose.

Contact your pediatrician or health care professional regarding the use of this medicine in children less than 1 year of age. Special care may be needed.

What if I miss a dose?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, use only that dose and continue with your regular schedule, spacing doses evenly. Do not use double or extra doses.

What drug(s) may interact with budesonide?

No interactions have been recorded. Do not mix budesonide with other nebulized solutions.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking budesonide?

Visit your prescriber or health care professional for regular checks on your progress. Carry an identification card with your name, the type and dose of corticosteroid you are taking, and your prescriber's name and address. It can take up to 6 weeks before you see the full effect of budesonide. Budesonide is intended for regular use. It will not cure your condition, but can help to reduce asthmatic symptoms. Budesonide will not relieve an acute asthma attack. However, if you have an asthma attack go on using budesonide at the usual time, but use another medicine to treat the attack. Do not stop using budesonide except on your prescriber's advice.

If you are transferred from steroid tablets taken by mouth to steroid aerosol, you may need additional doses of steroid tablets during periods of stress. Always follow your prescriber's advice.

If you need surgery, or have any kind of accident or stress, tell the prescriber or health care professional that you are using budesonide.

If you are also using a bronchodilator (such as albuterol) use that first. Wait a few minutes before using budesonide.

Tell your prescriber or health care professional if you are exposed to anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

People who are taking certain dosages of budesonide may need to avoid immunization with certain vaccines or may need to have changes in their vaccination schedules to ensure adequate protection from certain diseases. Make sure to tell your prescriber or health care professional that you are taking budesonide before receiving any vaccine.

What side effects may I notice from using budesonide?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• chest pain or tightness

• fever or chills

• skin rash and itching (hives)

• sore mouth, with cream or white curd-like patches in the mouth or throat

• troubled breathing or wheezing

• unusual swelling

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• coughing, hoarseness

• dry mouth

• headache

• loss of taste, or unpleasant taste

Where can I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15—30 degrees C (59—86 degrees F). When the aluminum package has been opened, the shelf life of the unused Respules™ is 2 weeks when protected from light. Unused Respules™ should be returned to the aluminum foil envelope right away to protect them from light. Any opened Respule™ should be used promptly. Throw away after the expiration date.

Budesonide nasal spray

What is budesonide nasal spray?

BUDESONIDE (Rhinocort® Aqua™ Nasal Spray) relieves inflammation and congestion of a stuffy nose caused by hay fever and other allergies. Generic budesonide nasal sprays are not yet available.

NOTE: Rhinocort® Nasal Inhaler has been discontinued in the US.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• Cushing's syndrome

• diabetes mellitus

• glaucoma

• infection such as an eye or sinus infection, or herpes or tuberculosis

• recent nasal surgery or trauma

• an unusual or allergic reaction to budesonide, other steroids, or any other food or medicine, sulfites, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Rhinocort® Aqua™spray is only for use in the nose. Prior to the first use, you will need to prime the Rhinocort® Aqua™ spray by pumping the spray 8 times into the air. Follow the directions on the prescription label. Shake the spray well before each use. To use, first blow nose gently. Close one nostril, then, with head upright, spray the medicine into the other nostril. Sniff briskly while squeezing the bottle quickly and firmly. After use, rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle. Dry with a clean tissue. Replace the cap directly after cleaning. Do not use the nasal spray for more than one person. Do not use extra doses or use more of this medicine than your prescriber or health care professional has prescribed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. Rhinocort® Aqua™ is given to children as young as 6 years of age.

What if I miss a dose?

If you miss a dose and remember within an hour or so, use it as soon as you remember. If it is almost time for your next dose, use only that dose and continue with your regular schedule. Be sure to space doses evenly. Do not use double or extra doses.

What drug(s) may interact with budesonide?

No interactions have been recorded. Do not use other nasal sprays or nasal inhalations with budesonide unless prescribed by your prescriber or health care professional.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking budesonide?

An improvement in your symptoms may occur as soon as 24 hours after starting this medicine but it may take several days to reach maximum benefit. Tell your prescriber or health care professional if your symptoms do not improve within 2—3 weeks or if they get worse. Do not stop using budesonide except on your prescriber's advice.

This medicine may make your mouth dry. Chewing sugarless gum, sucking hard candy, and drinking plenty of water will help.

Tell your prescriber or health care professional if you notice white patches or sores in your mouth or nose while you are being treated with budesonide.

What side effects may I notice from using budesonide?

Serious side effects with budesonide nasal spray are rare but may occur. Side effects that you should report to your prescriber or health care professional as soon as possible:

Rare:

• signs of allergic reactions, such as chest tightness, difficulty breathing or swallowing, swelling of the tongue, lips, or eyelids, skin rash , itching, or hives, or wheezing.

• frequent nose bleeds

• severe nasal pain

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

Less common:

• indigestion or bad taste in the mouth

More common:

• a feeling of mild burning, dryness, or irritation inside the nose

• dry mouth, sore throat

• increased cough

• occasional nose bleed

Where can I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20—25 degrees C (68—77 degrees F). Protect from heat, moisture, and direct light. Throw away any unused medicine after the expiration date.