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PULMICORT Respules (Budesonide) 0.5 mg/2ml

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PULMICORT Respules is manufactured by AstraZeneca.
Price From: $29.00

PULMICORT Respules (Budesonide) 0.5 mg/2ml

What is Pulmicort Respules (budesonide inhalation)?
Budesonide is a steroid. It prevents the release of substances in the body that cause inflammation.Budesonide inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.Budesonide may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Pulmicort Respules (budesonide inhalation)?
Do not use budesonide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medicine to treat an asthma attack. Contact your doctor if your asthma symptoms do not improve after using budesonide inhalation for 2 weeks.Call your doctor right away if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.If you also use an oral steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about taking less and less of the steroid before stopping completely. 


What should I discuss with my healthcare provider before using Pulmicort Respules (budesonide inhalation)?
You should not take this medication if you are allergic to budesonide, or if you are having an acute asthma attack. Before using budesonide inhalation, tell your doctor if you are allergic to any drugs, or if you have:liver disease; osteoporosis;herpes simplex infection of your eyes;any type of bacterial, fungal, or viral infection; ora history of tuberculosis.FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Budesonide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Budesonide can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.Do not give this medicine to a child younger than 6 years old without the advice of a doctor. Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.


How should I use Pulmicort Respules (budesonide inhalation)?
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.Do not use budesonide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medicine to treat an asthma attack. Read all patient instructions that come with your inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.To reduce the chance of developing a yeast infection in your mouth, rinse your mouth with water after using budesonide inhalation. If you are using a nebulizer with a face mask, wash the mask area of your face after each use.If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about taking less and less of the steroid before stopping completely. Contact your doctor if your asthma symptoms do not improve after using budesonide inhalation for 2 weeks.Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.Call your doctor right away if you feel that this medicine makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor. To be sure budesonide inhalation is not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.Using a steroid can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill.


Store this medication at room temperature away from moisture and heat. Keep the cover on your inhaler device while not in use. Keep the strip of Pulmicort Respules in the foil envelope, protected from light until you are ready to use the medication. After tearing off one ampule, return the strip to the envelope to protect the remaining ampules from light. Store the foil envelope upright. Once you have opened an envelope, you must use the ampules within 2 weeks.


What happens if I miss a dose?


Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?
An overdose of budesonide inhalation is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.


What should I avoid while taking Pulmicort Respules (budesonide inhalation)?
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.


Side effects of Pulmicort Respules (budesonide inhalation) 
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: weakness, tired feeling, nausea, vomiting, feeling like you might pass out;wheezing or breathing problems after using this medication;worsening respiratory symptoms;ear pain with fever;vision problems; orchanges in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).


Less serious side effects may include:
white patches or sores inside your mouth or on your lips;runny or stuffy nose, sneezing;sore throat, cough;nausea, vomiting, diarrhea, stomach pain;nosebleed; orheadache.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 


What other drugs will affect Pulmicort Respules (budesonide inhalation)?
The following drugs can interact with budesonide. Tell your doctor if you are using any of these:HIV /AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);an antibiotic such as clarithromycin (Biaxin) or erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin);an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil); ora tricyclic antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.This list is not complete and there may be other drugs that can interact with budesonide inhalation. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Generic Name Budesonide
Search Name Pulmicort Brand 0.5 mg/2ml VIAL
Supply Name PULMICORT Respules
Brand Generic BRAND NAME
Presentation Respules
Dosage VIAL
USA Brand Pulmicort
Manufacture AstraZeneca India Pvt. Ltd.
Strength 0.5 mg/2ml
Search Terms Pulmicort ,PULMICORT Respules ,Budesonide
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

For the Consumer

Applies to budesonide: oral capsule delayed release, oral capsule extended release, oral tablet extended release

Other dosage forms:

inhalation aerosol liquid, inhalation aerosol powder, inhalation powder, inhalation solution, inhalation suspension
Along with its needed effects, budesonide (the active ingredient contained in Pulmicort Turbuhaler) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking budesonide:

More common
- Bruising easily
- chills
- colds
- cough or hoarseness
- fever
- flu-like symptoms
- sneezing
- sore throat

Less common
- Abdominal or stomach pain
- bladder pain
- bleeding after defecation
- bloody or cloudy urine
- blurred vision
- burning while urinating
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- convulsions
- cough producing mucus
- decreased urine
- diarrhea
- difficult or labored breathing
- difficult or painful urination
- dizziness
- dry mouth
- eye pain
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- general feeling of discomfort or illness
- headache
- heartburn
- increase in body movements
- increased thirst
- increased urge to urinate during the night
- irregular heartbeat
- joint pain
- loss of appetite
- lower back or side pain
- mood changes
- muscle aches and pains
- nausea or vomiting
- nervousness
- numbness or tingling in the hands, feet, or lips
- pain or discomfort in the chest, upper stomach, or throat
- pounding in the ears
- rectal bleeding
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- severe constipation
- shakiness in the legs, arms, hands, or feet
- shivering
- slow or fast heartbeat
- stomach cramps
- sweating
- swelling of the legs and feet
- swelling or puffiness of the face
- tightness in the chest
- trouble sleeping
- uncomfortable swelling around the anus
- unusual tiredness or weakness
- upper abdominal or stomach pain
- waking to urinate at night
- weight gain
- weight loss

Incidence not known
- Bulging soft spot on the head of an infant
- change in the ability to see colors, especially blue or yellow
- difficulty with swallowing
- hives
- itching
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash

Some side effects of budesonide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
- Acid or sour stomach
- belching
- blemishes on the skin
- heartburn
- indigestion
- pain or tenderness around the eyes and cheekbones
- pimples
- rounded or moon face
- stomach discomfort, upset, or pain
- stuffy nose

Less common
- Accumulation of pus
- agitation
- blistering, crusting, irritation, itching, or reddening of the skin
- bloated or full feeling
- change in hearing
- changes in vision
- cracked, dry, or scaly skin
- cracks in the skin at the corners of mouth
- difficulty having a bowel movement (stool)
- difficulty with moving
- dizziness or lightheadedness
- ear drainage
- earache or pain in the ear
- excess air or gas in the stomach or intestines
- feeling of constant movement of self or surroundings
- hair loss or thinning of the hair
- increased appetite
- increased hair growth, especially on the face
- lack or loss of strength
- loss of memory
- muscle pains or stiffness
- nervousness
- pain, swelling, or redness in the joints
- passing gas
- pinpoint red or purple spots on the skin
- pressure in the stomach
- problems with memory
- redness, swelling, or soreness of the tongue
- sensation of spinning
- skin rash
- skin rash, encrusted, scaly, and oozing
- sleepiness or unusual drowsiness
- sleeplessness
- soreness or redness around the fingernails and toenails
- swelling of the abdominal or stomach area
- swollen joints
- unable to sleep
- uterine bleeding between menstrual periods
USUAL ADULT DOSE FOR CROHN'S DISEASE - ACUTE

Mild to moderate active Crohn's Disease involving the ileum and or ascending colon:
9 mg orally once daily in the morning for up to 8 weeks. Treatment can be tapered to 6 mg daily for 2 weeks prior to complete cessation. For recurring episodes of active Crohn's Disease, repeated eight-week courses can be given. Following 8 week course(s) of treatment for active disease and once the patient's symptoms are controlled, 6 mg once daily is recommended for maintenance of clinical remission up to 3 months.

USUAL ADULT DOSE FOR ASTHMA - MAINTENANCE

Pulmicort Turbuhaler (200 mcg/inh):

Previously treated with bronchodilators alone:
I to 2 inhalations (200 mcg to 400 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.

Previously treated with inhaled corticosteroids:
I to 2 inhalations (200 mcg to 400 mcg) twice daily. Maximum dose: 4 inhalations (800 mcg) twice daily.

Previously treated with oral corticosteroids:
I to 4 inhalations (400 mcg to 800 mcg) twice daily. Maximum dose: 4 inhalations (800 mcg) twice daily.

Pulmicort Flexhaler (90 and 180 mcg/inh):
2 inhalations (360 mcg) twice daily. In some patients, a starting dose of 180 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.

USUAL ADULT DOSE FOR ULCERATIVE COLITIS

Uceris brand extended release tablets:
9 mg orally once daily in the morning

Duration of therapy: Up to 8 weeks

Comments: Uceris brand tablets should be swallowed whole and not chewed, crushed or broken.

Approved indication: Induction of remission in patients with active, mild to moderate ulcerative colitis.

USUAL PEDIATRIC DOSE FOR ASTHMA - MAINTENANCE

inhalation powder:
6 years or older:

Pulmicort Turbuhaler (200 mcg/inh):
Previously treated with bronchodilators alone or with inhaled corticosteroids:
I inhalation (200 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.
Previously treated with oral corticosteroids:
2 inhalations (400 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.

Pulmicort Flexhaler (90 and 180 mcg/inh):
1 inhalation (180 mcg) twice daily. In some patients, a starting dose of 360 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.

inhalation suspension:
1 to 8 years:
Previously treated with bronchodilators alone:
0.5 mg total daily dose given once or twice daily in divided doses. Maximum dose: 0.5 mg /day.
Previously treated with inhaled corticosteroids:
0.5 mg total daily dose given once or twice daily in divided doses. Maximum dose: 1 mg /day.
Previously treated with oral corticosteroids:
1 mg total daily dose given once or twice daily in divided doses. Maximum dose: 1 mg /day.

Symptomatic children not responding to nonsteroidal asthma medications: Initial: 0.25 mg once daily may be considered

USUAL PEDIATRIC DOSE FOR CROHN'S DISEASE - ACUTE

Limited data available; optimal dose and duration of treatment not established.
Children 6 years or older:
Active Crohn's disease (treatment): 9 mg/day given once daily for 7 to 8 weeks.
Maintenance of remission: 6 mg/day given once daily for 3 to 4 weeks.
Note: One study in children 10 to 19 years of age showed a trend for higher remission rates using an induction dose of 12 mg/day given once daily for 4 weeks, followed by 9 mg/day for 3 weeks, followed by 6 mg/day for 3 weeks.
Further studies are needed to establish optimal dosing regimen.

RENAL DOSE ADJUSTMENTS

Data not available

LIVER DOSE ADJUSTMENTS

Patients with moderate to severe liver disease should be monitored for increased signs and/or symptoms of hypercorticism.

DOSE ADJUSTMENTS

Doses should be titrated to the lowest effective dose once asthma is controlled.

DIALYSIS

Data not available