Description
Beclomethasone is used to help control the symptoms of asthma and improve breathing. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.
Beclomethasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Aerosol Liquid
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of inhaled QVAR® inhaler in children 5 years of age and older and inhaled QVAR® Redihaler™ in children 4 years of age and older. Safety and efficacy have not been established in children younger than 5 years of age for QVAR® inhaler and in children younger than 4 years of age for QVAR® Redihaler™.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled beclomethasone in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution for patients receiving inhaled beclomethasone.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Desmopressin
- Mifepristone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aspirin
- Bemiparin
- Carbamazepine
- Cosyntropin
- Ethinyl Estradiol
- Fosphenytoin
- Insulin Aspart, Recombinant
- Lutetium Lu 177 Dotatate
- Macimorelin
- Nadroparin
- Phenytoin
- Sargramostim
- Somatrogon-ghla
- Upadacitinib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Auranofin
- Rotavirus Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Asthma attack, acute or
- Bronchospasm (difficulty with breathing), acute—Should not be used in patients with these conditions.
- Cataracts or
- Glaucoma—Use with caution. May make these conditions worse.
- Chickenpox (including recent exposure) or
- Herpes simplex (virus) infection of the eye or
- Infections (virus, bacteria, fungus, or parasite) or
- Measles or
- Tuberculosis, active or history of—Inhaled beclomethasone can reduce the body's ability to fight off these infections.
- Immobilization for long periods of time or
- Osteoporosis, family history of—Beclomethasone may make your bones weaker and increase the chance of a broken bone after a minor fall or injury.
Proper Use
Inhaled beclomethasone is used to prevent asthma attacks. It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.
Inhaled beclomethasone is used with a special inhaler that comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the QVAR® inhaler or QVAR® Redihaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.
Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.
In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.
Do not stop using this medicine or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor.
To use the QVAR® inhaler:
- Do not use the inhaler for this medicine with any other medicine. Do not remove the canister from the actuator.
- Remove the cap and look at the mouthpiece to make sure it is clean.
- Before you use an inhaler for the first time, prime it by pointing it away from your face and spraying into the air 2 times. If the inhaler has not been used for 10 days or longer, prime it again.
- To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
- While pressing down firmly and fully on the metal canister, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
- Take the inhaler out of your mouth. Hold your breath for about 10 seconds, then breathe out slowly.
- If you are supposed to use more than one puff, wait 1 to 2 minutes before inhaling the second puff. Repeat these steps for the next puff.
- Wipe the mouthpiece dry with a cloth or tissue. Do not wash it with water. Put the cap back on right away.
- Gargle and rinse your mouth with water after each dose.
- The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the count is 0. You may not receive the right amount of medicine.
To use the QVAR® Redihaler™:
- Take the inhaler out of the carton before you use it for the first time.
- Do not use the inhaler for this medicine with any other medicine.
- This medicine does not require priming. Do not shake the inhaler. Do not use it with a spacer or volume holding chamber.
- Always use the inhaler in an upright position with the mouthpiece facing downwards.
- Do not open the white cap of the inhaler or leave it open unless you are ready to use it. Close the cap before each use or if it has been left open for more than 2 minutes.
- To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it.
- Breathe in through your mouth as deeply as you can until you have taken a full deep breath.
- Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
- Close the white cap to prepare for the next inhalation.
- If your doctor has told you to take more than 1 inhalation per dose, make sure the cap is closed and repeat the previous steps.
- Keep the inhaler dry and clean at all times. Gently wipe the mouthpiece with a dry cloth or tissue as needed. Do not wash or put any part of the inhaler in water.
- The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the dose counter displays 0 after opening the carton.
Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For inhalation dosage form (aerosol):
- QVAR® inhaler:
- For preventing an asthma attack:
- For patients who have received bronchodilators alone:
- Adults and children 12 years of age and older—At first, one puff two times a day. Each puff contains 40 or 80 micrograms (mcg) of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 320 mcg two times a day.
- Children 5 to 11 years of age—At first, one puff two times a day. Each puff contains 40 mcg of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mcg two times a day.
- Children younger than 5 years of age—Use and dose must be determined by your doctor.
- For patients who have received inhaled corticosteroids:
- Adults and children 12 years of age and older—At first, one to two puffs two times a day. Each puff contains 40 or 80 micrograms (mcg) of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 320 mcg two times a day.
- Children 5 to 11 years of age—At first, one puff two times a day. Each puff contains 40 mcg of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mcg two times a day.
- Children younger than 5 years of age—Use and dose must be determined by your doctor.
- For patients who have received bronchodilators alone:
- For preventing an asthma attack:
- QVAR® Redihaler™:
- For preventing an asthma attack:
- For patients who have not received inhaled corticosteroids:
- Adults and children 12 years of age and older—At first, 40 to 80 micrograms (mcg) beclomethasone 2 times a day. The doses should be at least 12 hours apart. Your doctor may increase your dose as needed. However, the dose is usually not more than 320 mcg two times a day.
- Children 4 to 11 years of age—At first, 40 mcg of beclomethasone 2 times a day. The doses should be at least 12 hours apart. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mcg two times a day.
- Children younger than 4 years of age—Use and dose must be determined by your doctor.
- For patients who have not received inhaled corticosteroids:
- For preventing an asthma attack:
- QVAR® inhaler:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose of QVAR® Redihaler™, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
If you will be using this medicine for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.
This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child have white patches in the mouth or throat, or pain when eating or swallowing.
You should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.
Talk with your doctor or get medical care right away if:
- Your or your child's symptoms do not improve after using this medicine for 2 weeks or if they become worse.
- You or your child have a big decrease in your peak flow when measured as directed by your doctor.
Using too much of this medicine or using it for a long time may cause problems with your adrenal gland. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Follow your doctor's directions carefully if you are switching from an oral corticosteroid to this medicine.
Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.
This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. This may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine. Use a short acting inhaler right away to treat your symptoms.
If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.
This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.
This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.
Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine 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:
More common
- Body aches or pain
- congestion
- cough
- difficulty with breathing
- dryness or soreness of the throat
- fever
- hoarseness
- runny nose
- tender, swollen glands in the neck
- trouble swallowing
- voice changes
Incidence not known
- Attack, assault, or force
- blindness
- blurred vision
- changes in behavior
- chills
- darkening of the skin
- decreased vision
- diarrhea
- dizziness
- eye pain
- fainting
- headache
- loss of appetite
- lower back or side pain
- mental depression
- nausea
- painful or difficult urination
- skin rash
- sore mouth or tongue
- tearing
- thoughts of killing oneself
- unusual tiredness or weakness
- vomiting
- white patches in the mouth or on the tongue
Some side effects 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:
Less common
- Cramps
- heavy bleeding
- pain
- pain or tenderness around the eyes and cheekbones
- stuffy or runny nose
- tightness of the chest
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20113003
