Details for: VENTOLIN I.V. INFUSION SOLUTION
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02213451 | VENTOLIN I.V. INFUSION SOLUTION 5.0MG SALBUTAMOL IN 5ML (1000MCG/ML) | SALBUTAMOL (SALBUTAMOL SULFATE) | 1 MG / ML | SOLUTION | INTRAVENOUS |
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® I.V. infusion solution is used in adults to:
- relieve severe bronchospasm in patients with sudden worsening of chronic bronchitis or bronchial asthma
- treat asthma flare ups, including acute severe asthma attacks.
The safety and effectiveness of VENTOLIN® I.V. infusion solution in children under the age of 18 are not known.
What it does
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
Do not use VENTOLIN® I.V. infusion solution:
- if you are allergic to salbutamol sulphate or any of the components of its formulation
- if your heart beats faster than normal
- for the treatment of preterm labour or miscarriage.
What the medicinal ingredient is
Salbutamol sulphate.
What the non-medicinal ingredients are
Sodium chloride, sulphuric acid and/or sodium hydroxide, water for injection.
What dosage form it comes in
Solution for injection; 5 mg/5 mL.
Warnings and precautions
Warnings and Precautions
Before you are given VENTOLIN® I.V. infusion solution, talk to your doctor or pharmacist if you:
- Have ever had to stop taking other medications for this illness because you were allergic to them or they caused problems.
- Are having treatment for a thyroid condition.
- Are having treatment for chest pain, high blood pressure or another heart problem.
- Have diabetes. Diabetic patients may need some additional blood sugar tests.
- Have a past history of seizures.
- 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)
- Are pregnant or intend to become pregnant. Taking VENTOLIN® I.V. infusion 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® I.V. infusion solution while you're pregnant
- Are breastfeeding. It is not known if VENTOLIN® I.V. infusion solution passes into breast milk
If you notice that your shortness of breath or wheeze is becoming worse, tell your doctor as soon as possible. If the relief of wheezing or chest tightness is not as good as usual, 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.
Labour and delivery
High doses of VENTOLIN® I.V. infusion solution can slow down labour (delay the delivery of the baby). In Canada, VENTOLIN® I.V. infusion solution is not approved for the treatment of women who have unexpectedly gone into early labour (premature labour). Due to the risk of heart and circulation side effects and to avoid interference with uterine contractions, VENTOLIN® I.V. infusion solution should be used with caution if given to pregnant patients with breathing problems during labour.
Interactions with this medication
VENTOLIN® I.V. infusion solution should not be mixed with any other medicine.
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® I.V. infusion 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
Proper use of this medication
VENTOLIN® I.V. infusion solution must only be administered by a health professional. It is given into your vein by continuous intravenous infusion. Do not try to use VENTOLIN® I.V. infusion solution on your own.
VENTOLIN® I.V. infusion solution will be diluted before it is given to you.
You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.
When using VENTOLIN® I.V. infusion solution, other medicines (including asthma medicines) should only be used when prescribed by your doctor.
Usual Adult Dose
Continuous intravenous infusion.
Your doctor or nurse will find information about how to dilute the medicine in Part I of this Product Monograph.
Overdose
If you are accidentally given a larger dose than recommended, you are more likely to get side effects like a faster heart beat, headaches, nausea, vomiting and feeling shaky or restless. These effects usually wear off within a few hours, but talk to your doctor as soon as possible as you may have to stop treatment with VENTOLIN® I.V. infusion solution.
Rare cases of lactic acidosis (too much lactic acid in the blood) have been reported in patients receiving high doses of VENTOLIN® I.V. infusion solution. If you suffer symptoms (see Serious Side Effects Table), contact your doctor immediately.
Side effects and what to do about them
Side effects may include:
- feeling a little shaky
- headache
- faster heart beat than usual, hypertension, palpitation
- muscle cramps, tremor
- sweating
- dizziness, vertigo
- flushing
- nausea and vomiting
- feeling tired or weak
- insomnia
- drowsiness
- restlessness
- irritability
- trouble urinating
- hyperactivity in children
- unusual taste
- drying/irritation in your throat
- chest pain or discomfort
- rash, hives
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Very Rare | |||
| Allergic Reactions: sudden wheeziness and chest pain or tightness; or swelling of the eyelids, face, lips, tongue or throat. | ✔ | ||
| Lactic Acidosis: Deep and rapid breathing, vomiting, abdominal pain, weight loss, fatigue, malaise (sign of lactic acidosis-too much lactic acid in the blood) | ✔ | ||
| Rare | |||
| Low Blood Potassium (hypokalemia): muscle weakness and muscle spasms | ✔ | ||
| Cardiac Arrhythmias: heart beat is uneven or it gives an extra beat. | ✔ | ||
| Very Common | |||
| Tachycardia: fast heart beat | ✔ | ||
This is not a complete list of side effects. If you have any unexpected effects after receiving VENTOLIN® I.V. infusion solution, contact your doctor or pharmacist.
How to store
Keep out of sight and reach of children.
Keep VENTOLIN® I.V. infusion solution away from light and store between 15°C and 30°C.
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 three 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 0701E
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 obtained by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc.
Last revised: July 3, 2014
© 2014 GlaxoSmithKline Inc. All Rights Reserved
®VENTOLIN is a registered trademark, used under license by GlaxoSmithKline Inc.