Details for: VENTOLIN RESPIRATOR SOLUTION
Company: GLAXOSMITHKLINE INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02213486 | VENTOLIN RESPIRATOR SOLUTION | SALBUTAMOL (SALBUTAMOL SULFATE) | 5 MG / ML | SOLUTION | INHALATION |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
VENTOLIN NEBULES P.F.
VENTOLIN Respirator Solution
VENTOLIN Respirator Solution is used in Adults and Children 5 years or older. It treats severe, worsening breathing problems (bronchospasm) associated with:
- Chronic bronchitis
- Bronchial Asthma
Bronchospasm is a sudden worsening of shortness of breath and wheezing.
The safety and effectiveness of VENTOLIN Respirator Solution in children below the age of 5 years are not known.
VENTOLIN NEBULES P.F.
VENTOLIN NEBULES are used in Adults and Children 5 years or older. They treat severe, worsening breathing problems (bronchospasm) associated with:
- Chronic bronchitis
- Bronchial Asthma
Bronchospasm is a sudden worsening of shortness of breath and wheezing.
The safety and effectiveness of VENTOLIN NEBULES in children below the age of 5 years are not known.
What it does
VENTOLIN Respirator Solution
Salbutamol is one of a group of medicines called bronchodilators. Salbutamol relaxes the muscles in the walls of the small air passages in the lungs. This helps to open up the airways and so helps to relieve chest tightness, wheezing and cough so that you can breathe more easily.
VENTOLIN NEBULES P.F.
It can relieve chest tightness and wheezing if you have asthma or another chest illness.
Salbutamol is one of a group of medicines called bronchodilators. Salbutamol relaxes the muscles in the walls of the small air passages in the lungs. This helps to open up the airways and so helps to relieve chest tightness, wheezing and cough so that you can breathe more easily.
When it should not be used
VENTOLIN Respirator Solution
- Do not use VENTOLIN Respirator Solution if:
- you are allergic to it or any of the components of its formulation.
- your heart beats faster than normal.
- for the treatment of preterm labour or miscarriage.
VENTOLIN NEBULES P.F.
- Do not use VENTOLIN NEBULES:
- if you are allergic to it or any of the components of its formulation
- your heart beats faster than normal.
- for the treatment of preterm labour or miscarriage.
What the medicinal ingredient is
VENTOLIN Respirator Solution
Salbutamol sulphate.
VENTOLIN NEBULES P.F.
Salbutamol sulphate.
What the non-medicinal ingredients are
VENTOLIN Respirator Solution
Benzalkonium chloride, dilute sulphuric acid and water.
VENTOLIN NEBULES P.F.
Sodium chloride, dilute sulphuric acid and water.
What dosage form it comes in
VENTOLIN Respirator Solution
Solution for oral inhalation; 5 mg per mL.
VENTOLIN NEBULES P.F.
Solution for oral inhalation; 1 mg/mL, or 2 mg/mL.
- VENTOLIN NEBULES are:
- pre-diluted
- preservative free
- unit doses (each ampoule contains 1 dose that is ready for use)
Warnings and precautions
VENTOLIN NEBULES P.F.
VENTOLIN Respirator Solution
BEFORE you use VENTOLIN Respirator Solution talk to your doctor or pharmacist if:
- You have ever had to stop taking another medicine for this illness because you were allergic to it or because it caused problems.
- You are having treatment for a thyroid condition.
- You are having treatment for high blood pressure or a heart problem.
- You have diabetes.
- You have a past history of seizures.
- You have low levels of potassium in your blood (hypokalemia), especially if you are taking:
- Drugs known as xanthine derivatives (such as theophylline)
- Steroids to treat asthma
- Water pills (diuretics)
- You are pregnant or intend to become pregnant. Taking VENTOLIN Respirator Solution during pregnancy may cause harm to your baby. Your doctor will consider the benefit to you and the risk to your baby of taking VENTOLIN Respirator Solution while you're pregnant.
- You are breastfeeding. It is not known if VENTOLIN Respirator Solution passes into breast milk.
Rare cases of lactic acidosis (too much lactic acid in the blood) have been reported in patients receiving high doses of VENTOLIN Respirator Solution. If you suffer symptoms (see Serious Side Effects Table), contact your doctor immediately.
If the relief of wheezing or chest tightness is not as good as usual, or the effect lasts for less than three hours, tell your doctor as soon as possible. If you notice a sudden worsening of your shortness of breath and wheeze shortly after taking your medicine, tell your doctor as soon as possible. It may be that your chest condition is worsening and you may need to add another type of medicine to your treatment.
You should always carry other asthma medication with you to use immediately in case you experience an asthma attack.
Effects on Children
Children may experience:
- Changes in sleep patterns
- Changes in behaviour such as restlessness, excitability ( hyperactivity)
- Seeing or hearing things that are not there
VENTOLIN NEBULES P.F.
BEFORE you use VENTOLIN NEBULES talk to your doctor or pharmacist if:
- You have ever had to stop taking another medicine for this illness because you were allergic to it or because it caused problems.
- You are having treatment for a thyroid condition.
- You are having treatment for high blood pressure or a heart problem.
- You have diabetes.
- You have a past history of seizures.
- You have low levels of potassium in your blood (hypokalemia), especially if you are taking:
- Drugs known as xanthine derivatives (such as theophylline)
- Steroids to treat asthma
- Water pills (diuretics)
- You are pregnant or intend to become pregnant. Taking VENTOLIN NEBULES during pregnancy may cause harm to your baby. Your doctor will consider the benefit to you and the risk to your baby of taking VENTOLIN NEBULES while you're pregnant.
- You are breastfeeding. It is not known if VENTOLIN NEBULES passes into breast milk.
Rare cases of lactic acidosis (too much lactic acid in the blood) have been reported in patients receiving high doses of VENTOLIN NEBULES. If you suffer symptoms (see Serious Side Effects Table), contact your doctor immediately.
If the relief of wheezing or chest tightness is not as good as usual, or the effect lasts for less than three hours, tell your doctor as soon as possible. If you notice a sudden worsening of your shortness of breath and wheeze shortly after taking your medicine, tell your doctor as soon as possible. It may be that your chest condition is worsening and you may need to add another type of medicine to your treatment.
You should always carry other asthma medication with you to use immediately in case you experience an asthma attack.
Effects on Children
Children may experience:
- Changes in sleep patterns
- Changes in behaviour such as restlessness, excitability ( hyperactivity)
- Seeing or hearing things that are not there
Interactions with this medication
VENTOLIN Respirator Solution
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with VENTOLIN Respirator Solution:
- Anti-depressants
- Allergy medication
- Blood pressure-lowering drugs, including propanolol
- Diuretics (“water pills”)
- Bronchodilators used to open the airway (such as other asthma medication)
- Epinephrine
- Digoxin, a heart medication
VENTOLIN NEBULES P.F.
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with VENTOLIN NEBULES:
- Anti-depressants
- Allergy medication
- Blood pressure-lowering drugs, including propanolol
- Diuretics (“water pills”)
- Bronchodilators used to open the airway (such as other asthma medication)
- Epinephrine
- Digoxin, a heart medication
Proper use of this medication
VENTOLIN NEBULES P.F.
VENTOLIN Respirator Solution
VENTOLIN Respirator Solution should only be inhaled from a nebulizer. It must not be injected or swallowed.
Do not let the VENTOLIN Respirator Solution or the mist produced by the nebulizer, get in your eyes.
At home, VENTOLIN Respirator Solution should be diluted immediately before use.
Use your nebulizer in a well ventilated room. Some of the mist will be released into the air and may be breathed in by others.
Use VENTOLIN Respirator Solution only as directed by your doctor. During administration your doctor may want to monitor your blood.
The action of VENTOLIN Respirator Solution may last for up to 6 hours and should last at least 4 hours. You should call your doctor immediately if:
- the effects of one dose last less than 3 hours;
- you notice a sudden worsening of your shortness of breath
- your symptoms gets worse;
- your usual dose does not provide relief of wheezing or chest tightness;
- you need to use VENTOLIN Respirator Solution more often than before
These may be signs that your asthma or chest condition is getting worse. Your doctor may want to reassess your treatment plan.
Do not increase the dose or the number of times you use your medicine without asking your doctor, as this may make you feel worse.
When using VENTOLIN Respirator Solution, other medicines (including asthma medicines) should only be used when prescribed by your doctor.
Usual Dose
Adults and Adolescents 13 years and older: 0.5 to 1mL (2.5 to 5 mg of salbutamol).
Dilute in 2 to 5 mL or more of sterile normal saline. Treatment may be repeated every 4 to 6 hours to a maximum 4 times a day if necessary.
Children (5-12 years): 0.25 to 0.5 mL (1.25 to 2.5 mg of salbutamol).
Dilute in 2 to 5 mL or more of sterile normal saline.
Patients who have not improved on this dose may need 1 mL (5 mg salbutamol). Treatment may be repeated every 4 to 6 hours to a maximum 4 times a day if necessary.
How to Use VENTOLIN Respirator Solution
It is important that you use your VENTOLIN Respirator Solution properly. This will ensure that you receive the maximum benefit from your medicine. Make sure you know how, when and how much solution you should use. Follow your doctor’s instructions carefully. If you are not sure, ask your doctor.
- When preparing the solution for inhalation, use a graduated syringe to draw up VENTOLIN Respirator Solution from the bottle at the dose directed by your physician. Note: close the VENTOLIN bottle as soon as the solution is drawn into the syringe. Keep the bottle closed at all times and do not open it unnecessarily. Discard unused, diluted VENTOLIN Respirator Solution after each use.
- Inject the solution into the nebulizer through the appropriate opening.
- Draw into the syringe the amount of diluting fluid (sterile normal saline) directed by your physician and add it to the nebulizer.
1 mL of VENTOLIN Respirator Solution is usually diluted with 2 to 5 mL of sterile normal saline. - Gently shake the nebulizer and connect it with the mouthpiece or face mask.
- Connect the apparatus to the air pump or oxygen and start the treatment.
- Breathe calmly and evenly as much as possible until no more mist is formed in the nebulizing chamber. At this point, treatment is finished.
- Any unused solution in the nebulizer should be discarded.
Children - VENTOLIN Respirator Solution should be used under the supervision of an adult who understands the proper use of the nebulizer or respirator, and only as prescribed by the doctor.
Care of the VENTOLIN Respirator Solution and Nebulizer
Cleaning: after each use, clean the syringe and nebulizer as instructed in the nebulizer manual or as follows:
To clean the nebulizer:
- Disassemble the supply tube and the nebulizer.
- Wash in warm detergent solution. Rinse the tube with water.
- To wash the suction tubes:
- Place 3 mL of detergent solution in the vial, assemble the unit and operate for 2 minutes.
- Disassemble and rinse the vial with warm water, place 3 mL of warm water in the vial, assemble the unit and operate for 2 minutes.
- Disassemble and rinse with warm water.
- To dry the external passage:
- Connect the nebulizer tube to the pump with the supply tube.
- Turn the pump and blow air through for 1 minute.
- If there is evidence of clogging, clean the openings and tube connectors with the detergent, then rinse with water.
- Reassemble.
To clean the syringe:
- Clean the syringe and needle several times in detergent solution by alternatively drawing up and expelling the detergent solution.
- Repeat using a rinse of warm water.
- Dry the needle by drawing air into the syringe several times, by moving the plunger back and forth in the barrel of the syringe. Remove the needle.
- Remove the plunger from the syringe, allow to air dry.
- Keep unassembled needle, plunger and barrel of syringe wrapped in clean tissue, stored in a refrigerator along with the VENTOLIN bottle.
Follow all the instructions of the nebulizer and air pump manufacturers for the proper care and maintenance of the apparatus.
Overdose
If you accidentally take a larger dose than prescribed, you are more likely to get side effects like a faster heart beat, headaches and feeling shaky or restless. These effects usually wear off within a few hours, but you should tell your doctor as soon as possible.
Missed Dose
If you forget to inhale a dose do not worry: inhale the next dose at the time you would normally take it or inhale a dose sooner than when it is due if you become wheezy.
VENTOLIN NEBULES P.F.
VENTOLIN NEBULES should only be inhaled from a nebulizer. It must not be injected or swallowed.
Do not let the VENTOLIN NEBULES or the mist produced by the nebulizer, get in your eyes.
Use your nebulizer in a well ventilated room. Some of the mist will be released into the air and may be breathed in by others.
Use VENTOLIN NEBULES only as directed by your doctor. During administration your doctor may want to monitor your blood.
The action of VENTOLIN NEBULES may last for up to 6 hours and should last at least 4 hours.
You should call your doctor immediately if:
- the effects of one dose last less than 3 hours;
- you notice a sudden worsening of your shortness of breath
- your symptoms gets worse;
- your usual dose does not provide relief of wheezing or chest tightness;
- you need to use VENTOLIN NEBULES more often than before
These may be signs that your asthma or chest condition is getting worse. Your doctor may want to reassess your treatment plan.
Do not increase the dose or the number of times you use your medicine without asking your doctor, as this may make you feel worse.
When using VENTOLIN NEBULES, other medicines (including asthma medicines) should only be used when prescribed by your doctor.
Usual Dose
Adults and Adolescents 13 years and older: 1 ampoule (either 2.5 mg or 5 mg), repeated every 4 to 6 hours to a maximum 4 times a day if necessary.
Children (5-12 years): 1 ampoule (2.5 mg), repeated every 4 to 6 hours to a maximum 4 times a day if necessary.
Patients who have not improved on this does, may need 1 ampoule (5mg), repeated 4 times a day if necessary.
How to Use VENTOLIN NEBULES:
1. Prepare the nebulizer for filling according to the manufacturer’s instructions. | |
2. To open the foil pack lift the foil at the black arrow and peel (diagram 1). Do not peel the lid off completely. Remove the ampoules. | ![]() |
3. To detach a VENTOLIN NEBULES, push one ampoule downwards and away while holding the remaining ampoules securely (diagram 2). Return the remaining ampoules to the foil tray, cover the tray with the foil lid and place the tray back in the carton. | ![]() |
4. Holding the top of the ampoule securely, twist the body to open (diagram 3). | ![]() |
5. Place the open end of the ampoule well into the nebulizer cup and squeeze slowly (diagram 4). Ensure the contents are emptied into the nebulizer cup. | ![]() |
6. Gently shake the nebulizer and connect it with the mouthpiece or face mask. Connect the apparatus to the air pump or oxygen and start the treatment. | |
7. Breathe calmly and evenly as much as possible until no more mist is formed in the nebulizer chamber. At this point, treatment is finished. | |
8. After use discard any solution remaining in the nebulizer cup. |
Children - VENTOLIN NEBULES should be used under the supervision of an adult who understands the proper use of the nebulizer and only as prescribed by the doctor.
Care of the VENTOLIN NEBULES and Nebulizer
To clean the nebulizer:
After each use, clean the nebulizer as follows:
- Disassemble the supply tube and the nebulizer.
- Wash in warm detergent solution. Rinse the tube with water.
- To wash the suction tubes:
- Place 3 mL of detergent solution in the vial, assemble the unit and operate for 2 minutes.
- . Disassemble and rinse the vial with warm water, place 3 mL of warm water in the vial, assemble the unit and operate for 2 minutes
- Disassemble and rinse with warm water.
- To dry the external passage:
- Connect the nebulizer tube to the pump with the supply tube.
- Turn the pump and blow air through for 1 minute. If there is evidence of clogging, clean the openings and tube connectors with the detergent, then rinse with water.
- Reassemble.
Overdose
If you accidentally take a larger dose than prescribed, you are more likely to get side effects like a faster heart beat, headaches and feeling shaky or restless. These effects usually wear off within a few hours, but you should tell your doctor as soon as possible.
Missed Dose
If you forget to inhale a dose do not worry: inhale the next dose at the time you would normally take it or inhale a dose sooner than when it is due if you become wheezy.
Side effects and what to do about them
VENTOLIN NEBULES P.F.
VENTOLIN Respirator Solution
Side effects may include:
Effects on heart
- Hypertension
Effects on nervous system
- Headache
- Feeling a little shaky
- Feeling anxious or irritable
- Feeling tired or weak
- Trouble sleeping (insomnia)
- Hyperactivity in children
- Dizziness, vertigo
- Drowsiness
Effects on muscles and joints
- Muscle cramps
Other Effects
- Nausea and vomiting
- Chest pain or discomfort
- Flushing
- Difficulty urinating
- Unusual taste in your mouth
- Dry or irritated throat
Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
---|---|---|---|
Common | |||
Faster heart beat than usual | ✔; | ||
Uncommon | |||
Irregular heart beat (palpitations) | ✔; | ||
Rare | |||
Low level of potassium in your blood (hypokalemia) | ✔ | ||
Hallucinations in Children: see or hear things that are not there | ✔ | ||
Very Rare | |||
Bronchospasm: Increased wheezing or tightness in the chest or difficulty in breathing. | ✔ | ||
Allergic Reactions: (Hypersensitivity) Swelling of the eyelids, face, lips, tongue or throat, accompanied by difficulty in breathing, speaking or swallowing (signs of angioedema). Skin rash, skin eruption or other effect on the skin or eyes, itching or fever. Fainting when the blood pressure is too low (sign of hypotension). | ✔ | ||
Deep and rapid breathing, vomiting, abdominal pain, weight loss, fatigue, malaise (sign of lactic acidosis-too much lactic acid in the blood) | ✔ | ||
Irregular Heart Beat (atrial fibrillation, supraventricular tachycardia, extrasystoles) | ✔ |
This is not a complete list of side effects. If you have any unexpected effects after receiving VENTOLIN Respirator Solution, contact your doctor or pharmacist.
VENTOLIN NEBULES P.F.
Side effects may include:
Effects on heart
- Hypertension
Effects on nervous system
- Headache
- Feeling a little shaky
- Feeling anxious or irritable
- Feeling tired or weak
- Trouble sleeping (insomnia)
- Hyperactivity in children
- Dizziness, vertigo
- Drowsiness
Effects on muscles and joints
- Muscle cramps
Other Effects
- Nausea and vomiting
- Chest pain or discomfort
- Flushing
- Difficulty urinating
- Unusual taste in your mouth
- Dry or irritated throat
Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
---|---|---|---|
Common | |||
Faster heart beat than usual | ✔; | ||
Uncommon | |||
Irregular heart beat (palpitations) | ✔; | ||
Rare | |||
Low level of potassium in your blood (hypokalemia) | ✔ | ||
Hallucinations in Children: see or hear things that are not there | ✔ | ||
Very Rare | |||
Bronchospasm: Increased wheezing or tightness in the chest or difficulty in breathing. | ✔ | ||
Allergic Reactions: (Hypersensitivity) Swelling of the eyelids, face, lips, tongue or throat, accompanied by difficulty in breathing, speaking or swallowing (signs of angioedema). Skin rash, skin eruption or other effect on the skin or eyes, itching or fever. Fainting when the blood pressure is too low (sign of hypotension). | ✔ | ||
Deep and rapid breathing, vomiting, abdominal pain, weight loss, fatigue, malaise (sign of lactic acidosis-too much lactic acid in the blood) | ✔ | ||
Irregular Heart Beat (atrial fibrillation, supraventricular tachycardia, extrasystoles) | ✔ |
This is not a complete list of side effects. If you have any unexpected effects after receiving VENTOLIN NEBULES, contact your doctor or pharmacist.
How to store
VENTOLIN Respirator Solution
Keep out of sight and reach of children.
Keep the VENTOLIN Respirator Solution in a dry place and store them between 15°C to 25°C. Protect from light.
One month after opening the bottle, throw away any solution which is left over.
VENTOLIN NEBULES P.F.
Keep out of sight and reach of children.
When VENTOLIN NEBULES are required, open only one foil pack at a time. Use all 5 ampoules before opening the next foil pack. Record the date when the foil pack is first opened. Discard any unused ampoules after 3 months.
Store VENTOLIN NEBULES between 2-25°C. Protect from light.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 1908C
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
You may need to read this leaflet again. PLEASE DO NOT THROW IT AWAY until you have finished your medicine.
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.gsk.ca
or by contacting the sponsor, GlaxoSmithKline Inc., at
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc.
Last revised: November 17, 2017
© 2017 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies.