Patient Medication Information: uses, side effects, how to take - Taro-Budesonide
ABOUT THIS MEDICATION
What the medication is used for:
TARO-BUDESONIDE is the brand name for an inhaled drug called budesonide. It belongs to a group of medicines
called corticosteroids which are used to reduce
inflammation.
What it does:
Asthma is caused by inflammation in the airways. TARO- BUDESONIDE reduces and prevents this inflammation. In
some cases, several weeks of regular use may be needed
before the full effect is seen.
When it should not be used:
TARO-BUDESONIDE will not relieve an asthma attack that has already started. Many inhalers contain fast-acting bronchodilators to provide rapid relief. If your doctor prescribed one of these, you should follow his or her directions when you have an acute attack of asthma.
What the medicinal ingredient is:
TARO-BUDESONIDE contains budesonide as the active
ingredient and comes in concentrations of 0.125 mg/mL,
0.25 mg/mL and 0.5 mg/mL.
Each ampoule contains 2 mL. This means that 1 ampoule of the 0.125 mg/mL strength contains 0.25 mg of active drug. One ampoule of the 0.25 mg/mL strength contains 0.5 mg of active drug. One ampoule of the 0.5 mg/mL strength contains 1.0 mg of active drug.
What the non-medicinal ingredients are:
TARO-BUDESONIDE contains the following non- medicinal ingredients: citric acid, disodium edetate, polysorbate 80, sodium chloride, sodium citrate, water for injection.
Check with your doctor if you think you may be allergic to any of these non-medicinal ingredients.
What dosage forms it comes in:
TARO-BUDESONIDE is a suspension for inhalation.
WARNINGS AND PRECAUTIONS
BEFORE you use TARO-BUDESONIDE talk to your doctor or pharmacist:
about all health problems you have now or have had in the past, especially if you have had lung tuberculosis
or any other recent infection or liver problems;
- about other medicines you take, including ones you can buy without a prescription;
- if you take, or have taken steroid medicines within the past several months;
if you are pregnant, plan to become pregnant, or are breast-feeding;
if you are allergic to ‘non-medicinal’ substances like food products, preservatives or dyes, which may be present in TARO-BUDESONIDE. See ‘What the
non-medicinal ingredients are’
- if you have ever had a bad, unusual or allergic reaction to any medicine containing budesonide;
While taking TARO-BUDESONIDE; if you develop an infection or a respiratory infection, contact your doctor to see if you can continue taking TARO-BUDESONIDE.
Do not take TARO-BUDESONIDE
if you are allergic to budesonide or to the other ingredients in TARO-BUDESONIDE. See ‘What the
non-medicinal ingredients are’.
- To treat a sudden attack of breathlessness. You will probably need a different kind of medicine (i.e. a fast acting relief medication) in a different colour puffer than may already have been given to you. If you have more than one medicine, be careful not to confuse them.
- If you have an untreated infection (fungal, bacterial, or viral) or tuberculosis in the respiratory tract.
INTERACTIONS WITH THIS MEDICATION
If you take medications against fungal infections or Ritonavir (medication used to treat HIV infection or AIDS). These medications may interact with TARO- BUDESONIDE.
PROPER USE OF THIS MEDICATION
How to take TARO-BUDESONIDE properly:
TARO-BUDESONIDE is for use in a nebulizer or respirator. Do not use in an ultrasonic nebulizer. Be sure
you know how to use your nebulizer or respirator before you start this drug.
Nebulization should take place using a gas flow (oxygen or compressed air) of 6 to 10 L/minute. A suitable volume fill for most nebulizers is 2 to 4 mL.
It is important that you use TARO-BUDESONIDE daily as recommended by your doctor, even when you feel well. Do not take more doses than prescribed by your doctor. Using more can increase the chance of unwanted effects. Contact your doctor right away if your asthma seems worse.
Before use, check to make sure the strength on the label matches the strength your doctor prescribed.
Follow these directions for each dose of TARO- BUDESONIDE:
- 1. Remove one TARO-BUDESONIDE from a sheet of 5 units. Return the other units to the envelope.
- 2. Gently shake the unit.
- 3. Open by holding the unit upright and twisting off the top ‘wing’.
- 4. Slowly squeeze the contents of the unit into the nebulizer cup. If you only need to use half the contents of a unit, add sterile saline to the cup as instructed by your doctor or pharmacist. Before you use the rest of the unit for the next dose, swirl it gently.
- 5. Connect one end of the cup to the face mask or mouthpiece, and the other end to the air pump.
- 6.
Just before you start treatment, gently shake the
contents of the cup again. Then start the treatment.
- 7. Breathe calmly and evenly until no more mist comes out (about 10-15 minutes).
- 8. Rinse your mouth and spit out as soon as you are done.
- 9. If you use a face mask, wash your face after treatment.
Cleaning: When you have finished, you have to clean the nebulizer. Wash the cup and the mouth piece or mask in warm water, using a mild detergent. Rinse well. Dry by connecting the nebulizer cup to the compressor or to the air
inlet. See the manufacturer’s instructions for complete details.
Usual dose:
The dosage of TARO-BUDESONIDE is individual. Follow your doctor’s directions carefully. They may differ from the information in this leaflet.
Suggested doses are:
Initially:
Children (3 months to 12 years): 0.25 to 0.5 mg twice daily.
Adults: usually 1 to 2 mg twice daily.
Maintenance:
After the desired effect has been obtained, your doctor can reduce your dose to the smallest amount necessary to control your asthma symptoms.
Dosage Table:
| Dose in mg | Volume of TARO-BUDESONIDE | |||||||||||
| 0.125 mg/mL | 0.25 mg/mL | 0.5 mg/mL | ||||||||||
| 0.125 mg | 1 mL* (½ unit) | - | - | |||||||||
| 0.25 mg | 2 mL (1 unit) | 1 mL* (½ unit) | - | |||||||||
| 0.5 mg | 4 mL (2 units) | 2 mL (1 unit) | - | |||||||||
| 0.75 mg | - | 3 mL (1½ units) | - | |||||||||
| 1 mg | - | - | 2 mL (1 unit) | |||||||||
| 1.5 mg | - | - | 3 mL (1½ units) | |||||||||
| 2 mg | - | - | 4 mL (2 units) | |||||||||
*This should be mixed with 0.9% saline to a volume of 2 mL
Missed dose:
If you miss a dose of TARO-BUDESONIDE, take it as soon as possible. Then go back to your regular schedule. If it is almost time for your next dose, skip the missed dose and take the next dose on time.
Never take a double dose of TARO-BUDESONIDE to make up for ones you missed. If you are still unsure, check with your doctor or pharmacist to see what you should do.
Do not stop treatment with TARO-BUDESONIDE abruptly. Treatment should be tapered off gradually.
Overdose:
If you think you have taken too much TARO- BUDESONIDE contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medication, TARO-BUDESONIDE may cause side effects in some people.
The most common side effects are cough, throat irritation, thrush (fungal infection) in the mouth and hoarseness. Other side effects that may occur are bad taste, headache, nausea, dryness of the throat, tiredness, thirst and diarrhea. Skin irritation on the face has been reported in a few cases when a nebulizer with a face mask has been used. This can be prevented by washing the face after use of the face mask, or applying a thin layer of Vaseline® on the face, before using the mask.
In rare cases, skin reactions like rash, nervousness, restlessness, depression, behavioural disturbances, bruising, and a feeling of tightness of the airways may occur. Severe allergic reactions may also occur in rare cases following the use of TARO-BUDESONIDE.
If you take TARO-BUDESONIDE for a long period and at higher doses you may develop symptoms of adrenal insufficiency. If you develop symptoms such as tiredness, headache, nausea, vomiting, pain in muscles and joints, please contact your doctor.
A slowing of growth in children may occur.
Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. If any side effects bother you, please contact your doctor.
This is not a complete list of side effects. For any unexpected effects while taking TARO-BUDESONIDE, contact your doctor or pharmacist.
Do not stop taking TARO-BUDESONIDE on your own. Your doctor may want to slowly reduce your dose, especially if you have been using TARO-BUDESONIDE for a long time. Although rare, symptoms of steroid withdrawal (i.e. fatigue, muscle or joint aches) may occur if TARO-BUDESONIDE is stopped too quickly.
If you have to go into hospital for an operation, take your TARO-BUDESONIDE with you and tell your doctor what medicine(s) you are taking.
HOW TO STORE IT
Remember to keep TARO-BUDESONIDE well out of the reach and sight of children when you are not using it.
Always keep unopened units in the foil envelope so they are well protected from light.
Do not use TARO-BUDESONIDE after the expiry date marked on the foil envelope and outer carton.
Record the date when the foil envelope is first opened.
Do not use units from a foil envelope that has been opened for 3 months or more.
If you are only required to use half the contents of a unit, the remainder must be used within 12 hours after
the unit has been opened. If you do not use a full unit for each dose, protect the rest from light.
Store TARO-BUDESONIDE at 5-30°C in an upright position. Keep protected from light. Once envelope is opened, use ampoules within 3 months. Opened ampoules must be used within 12 hours.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health- canada/services/drugs-health-products/medeffect- canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
If you want more information about TARO-BUDESONIDE:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.taro.ca, or by calling 1-800-268-1975.
Date prepared: November 19, 2019