Patient Medication Information: uses, side effects, how to take - Ventolin I.M. Injection 0.5mg Salbutamol in 1 mL (500mcg/mL)
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed a medicine called VENTOLIN® I.M. injection for you. It is used to help breathing problems in:
$ Asthma
$ Other chest illnesses.
VENTOLIN® I.M. injection must only be administered by a health professional. It may be injected into muscle tissue or into a vein. Do not try to use VENTOLIN® I.M. injection on your own.
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.M. injection if:
$ you are allergic to it or any of the components of its
formulation (see what the important nonmedicinical ingredients are)
$ your heart beats faster than normal
$ you are at risk of miscarriage
What the medicinal ingredient is:
VENTOLIN® I.M. injection contains the active ingredient, salbutamol sulphate.
What the important nonmedicinal ingredients are:
VENTOLIN® I.M. injection contains sodium chloride, sulphuric acid and/or sodium hydroxide and water.
What dosage forms it comes in:
VENTOLIN® I.M. injection comes in ampules of 1 mL each containing 0.5 mg of Salbutamol as Salbutamol Sulphate.
WARNINGS AND PRECAUTIONS
Before you use VENTOLIN® I.M. injection, 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.
- you are having treatment for a thyroid condition.
- you are having treatment for high blood pressure or a heart problem.
- if you have diabetes.
- if you have a past history of seizures.
if you are pregnant or breastfeeding.
Rare cases of lactic acidosis (too much lactic acid in the blood) have been reported in patients receiving high doses of VENTOLIN® I.M. injection. If you suffer symptoms (see Serious Side Effects Table), contact your doctor immediately.
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.
Your doctor may decide not to prescribe this medicine during the first three months of pregnancy, or if you are breast feeding a baby. However, there may be circumstances when your doctor advises you differently.
Labour and delivery
It has been reported that high doses of VENTOLIN®
(salbutamol) injection can slow down labour (uterine contractions), but VENTOLIN® is not approved for the treatment of premature labour in Canada. Due to the risk of heart and circulation side effects (see Side Effects And What To Do About Them) and so as to avoid interference with uterine contractions, VENTOLIN® injection should be used with caution if given to pregnant patients with breathing problems during labour.
INTERACTIONS WITH THIS MEDICATION
Make sure that your doctor knows what other medicines you are taking (such as those for depression, allergies, other airway-opening medications (e.g. other asthma medications), blood pressure and heart medications, and water pills (diuretics), etc.), including those you can buy without a prescription as well as herbal and alternative medicines.
PROPER USE OF THIS MEDICATION
VENTOLIN® I.M. injection should not be self administered by an individual. It should be administered under the supervision of a health professional.
Usual dose:
500 micrograms (8 micrograms/kg body weight) every 4 hours as required.
Maximum daily dose: 2000 micrograms
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Very occasionally, some people feel a little shaky or have a headache or notice that their heart is beating a little faster and/or more forcefully than usual after using VENTOLIN®. Muscle cramps can occur, although these are quite rare. These effects usually wear off within a few hours, but you should tell your doctor as soon as possible. If you have chest pain, if your heart beat feels irregular, or feel unwell in any other way or have any symptoms that you do not understand, you should contact your doctor immediately.
Tell your doctor at once if you develop breathlessness, wheezing, chest pain or cough as these may be signs of increased fluid in the lungs (pulmonary edema). Chest pain may also be a sign of reduced blood supply to the heart muscle (myocardial ischaemia).
This is not a complete list of side effects. If you have any unexpected effects after receiving VENTOLIN® I.M. injection, contact your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||
| HAPPEN AND WHAT TO DO ABOUT THEM |
* If you think you have these side effects, it is important that you seek medical advice from your doctor immediately.
HOW TO STORE IT
Keep VENTOLIN® I.M. injection away from light and store between 15°C and 30°C.
| Symptom/effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist* | ||
| Only if severe | In all cases | |||
| Very Rare | Increased wheezing or tightness in the chest or difficulty in breathing (sign of bronchospasm). | 9 | ||
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). | 9 | |||
Deep and rapid breathing, vomiting, abdominal pain, weight loss, fatigue, malaise (sign of lactic acidosis-too much lactic acid in the blood) | 9 | |||
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
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
Last revised: November 16, 2006
© 2006 GlaxoSmithKline Inc. All Rights Reserved
®VENTOLIN is a registered trademark, used under license by GlaxoSmithKline Inc.