Patient Medication Information: uses, side effects, how to take - Ratio-Ipratropium Inhalation Solution
ABOUT THIS MEDICATION
What the medication is used for:
ratio-IPRATROPIUM UDV solution is a bronchodilator which relieves the wheezing and shortness of breath caused by chronic bronchitis or by asthma. For the treatment of asthma, ratio-IPRATROPIUM UDV solution must be used in conjunction with some other bronchodilating medication. ratio-IPRATROPIUM UDV solution is available only on prescription.
Before starting treatment with ratio-IPRATROPIUM UDV solution, be certain that you are completely familiar with the use and proper care of your nebulizer.
What is COPD?
COPD (Chronic Obstructive Pulmonary Disease) is a type of lung disease in which there is a permanent narrowing of the airways, leading to breathing difficulties. In many patients, this narrowing of the airways is a result of many years of cigarette smoking. Smoking cessation produces symptomatic benefits and will slow the progression of chronic bronchitis (which is a form of COPD). COPD can be helped by medication as well.
What is Asthma?
Asthma is a disease in which the airways can become temporarily narrowed, leading to breathing difficulties. This narrowing of the airways is due to inflammation, which causes swelling and irritation of the airways and tightening of the muscles around the airways. The narrowed airway can be relieved with the help of medication.
It is important to know that the treatment of COPD and Asthma may be different for each patient. Your doctor will most likely discuss with you the best plan for the treatment of your particular condition. This plan may include taking other medication(s) in addition to ratio-IPRATROPIUM UDV. It is necessary that you follow your physician's directions for the treatment of your condition. If you have any questions about how you should treat your condition at home, you should consult your doctor.
What it does:
ratio-IPRATROPIUM UDV belongs to a group of medicines known as “bronchodilators” which make breathing easier by opening your narrowed airways.
When it should not be used:
ratio-IPRATROPIUM UDV should not be used by patients with allergic reactions to ipratropium bromide, atropinics or any component of the drug.
If you do not get the expected relief from your treatment, you should contact your doctor.
What the medicinal ingredient is:
Ipratropium bromide
What the important nonmedicinal ingredients are: Non-medicinal ingredients include hydrochloric acid, purified water and sodium chloride
What dosage forms it comes in:
Inhalation Solution; 250 mcg of ipratropium bromide in 1 mL, 250 mcg of ipratropium bromide in 2 mL or 500 mcg of ipratropium bromide in 2 mL
WARNINGS AND PRECAUTIONS
BEFORE you use ratio-IPRATROPIUM UDV talk to your doctor or pharmacist if:
if you are pregnant or intend to become pregnant;
- if your are breast feeding;
- if you have any other health problems;
- if you are taking any other medications including those you can buy without a prescription and including eye drops;
- if you have any other medical problems such as difficult urination or enlarged prostate;
- if you have eye problems, such as glaucoma or eye pain;
- if you have any allergies or reactions to foods or drugs.
INTERACTIONS WITH THIS MEDICATION
Other medications may be affected by ratio-IPRATROPIUM UDV solution or may affect how ratio-IPRATROPIUM UDV solution works. Do not take any other medication, including over-the-counter medications or herbal products unless your doctor tells you to. Tell any other doctor, dentist or pharmacist that you talk to that you are taking ratio-IPRATROPIUM UDV solution.
PROPER USE OF THIS MEDICATION
- DO NOT exceed the prescribed dose or frequency of treatments.
Before you start to use ratio-IPRATROPIUM UDV
solution, read the following instructions carefully. Care should be taken to ensure that the nebulizer mask fits the face properly and that nebulized solution does not escape into the eyes. If you have any questions about using the nebulizer, check with your doctor or pharmacist.
ratio-IPRATROPIUM UDV (Ipratropium Bromide) Solution
2 mL Unit Dose Vial
250 mcg/mL
Each plastic vial contains 2 mL of ratio-IPRATROPIUM UDV solution. Each millilitre (mL) of solution contains 250 mcg (0.025%) ipratropium bromide in a isotonic solution.
125 mcg/mL
Each plastic vial contains 2 mL of ratio-IPRATROPIUM UDV solution. Each millilitre (mL) of solution contains 125 mcg (0.0125%) ipratropium bromide in a isotonic solution.
1 mL Unit Dose Vial
250 mcg/mL
Each plastic vial contains 1 mL of ratio-IPRATROPIUM UDV solution. Each millilitre (mL) of solution contains 250 mcg (0.025%) ipratropium bromide in a isotonic solution.
Before starting treatment with ratio-IPRATROPIUM UDV solution, be certain that you are completely familiar with the use and proper care of your nebulizer.
Usage Instructions:
Your doctor or pharmacist will tell you how to prepare your ratio-IPRATROPIUM UDV solution for inhalation. If you are told to dilute ratio-IPRATROPIUM UDV solution, you must do so immediately before you plan to use the solution.
In most cases, dilution of the dose with sterile preservative-free saline is not necessary. However, volumes of ratio-IPRATROPIUM UDV solution less than 2 mL are not appropriate for nebulization and must be diluted with saline or another suitable nebulizer solution to make up for a total fill volume of 2-5 mL.
- 1)
Detach one plastic vial by pulling it firmly from the strip.
- 2) Open the vial by twisting off the top. It is important that you use the contents of the vial as soon as possible after opening it.
- 3) Squeeze the contents of the plastic vial into your nebulizer chamber. If your doctor has instructed you to use less than one complete vial, use a syringe to withdraw the prescribed dose. Any solution left in the plastic vial must be thrown away.
- 4) If your doctor has instructed you to use another inhalation solution in combination with ratio-IPRATROPIUM UDV solution, you should add the appropriate amount of that solution to the nebulizer chamber as well.
- 5) Using a syringe, add sodium chloride solution to the chamber if you have been directed to do so by your pharmacist or physician.
- 6) Gently shake the nebulizer chamber and connect it to the mouthpiece or face mask. Then connect the nebulizer tube to the air or oxygen pump and begin therapy.
- 7) Breathe calmly and deeply through the mask or mouthpiece until no more mist is formed in the nebulizer chamber. This usually takes 10-15 minutes. It is very important to adjust the face mask, if required, to prevent the mist from getting in your eyes.
- 8) Follow the instructions provided by the nebulizer and air pump manufacturers for the proper care and maintenance of the equipment. Keep the nebulizer, nebulizer tube and face mask clean to minimize microbial contamination.
- 9) The unit dose vials should be stored at room temperature. The vials should be protected from heat and light.
Please remember:
- Do not exceed the prescribed dose or frequency of treatments.
- Do not mix this medication with any other medication in the nebulizer unless instructed to do so by your doctor or pharmacist.
- This medication has been prescribed for you and should not be given to other people.
- Keep out of the reach of children.
The solution is intended for inhalation only. Do not inject or drink it.
- Do not let the nebulized mist get into your eyes. Patients with glaucoma should use swimming goggles or a nebulizer with a mouthpiece to prevent nebulized solution getting into the eyes.
Overdose:
If you accidentally take too many puffs, you should get medical help immediately; either by calling the Regional Poison Control Centre, your doctor or by going to the nearest hospital (do not drive yourself). Always take the labelled medicine container with you.
Missed dose:
If a dose of this medication is missed, it is not necessary to make up the missed dose. Skip the missed dose and continue with the next scheduled dose. Do not double doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any drug product, ratio-IPRATROPIUM UDV solution may cause unwanted effects. Do not be alarmed by this list of possible side effects. You may not experience any of them. If you do experience any unusual or unwanted effects while you are using ratio-IPRATROPIUM UDV solution you should contact your doctor or pharmacist immediately.
Undesirable effects include: Headache, dizziness, constipation, vomiting, diarrhea, nausea, cough, dry mouth, irritation of mouth and/or throat, hoarseness, increased wheezing or tightness in the chest or sudden difficulties in breathing (bronchospasm), rapid or irregular heart beat, sensation of rapid or irregular heart beat, difficult urination, retention of urine, pain in the eyes, blurred vision, skin rash/hives, itchiness, difficulty in swallowing, swelling of the mouth, lips or face, hypersensitivity reaction.
If you experience a dry mouth or bad taste, sucking on a sour candy or rinsing your mouth may help. Check with your doctor if the dry mouth or bad taste persist or if you experience constipation for a prolonged period of time.
Remember to tell any other doctor, dentist or pharmacist you
consult that you are taking this medication.
If you have any questions about ratio-IPRATROPIUM UDV solution or your nebulizer, contact your doctor or pharmacist.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Increased wheezing or tightness in the chest or difficulty in breathing (bronchospasm) | T | ||
| Uncommon | Swelling of the tongue, lips or face | T | ||
| Difficulty in swallowing | T | |||
Fast or irregular heart beat | T | |||
| Blurred vision or pain in the eyes | T | |||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
Difficult or painful urination Skin rash | Talk with your doctor or pharmacist | |||
| T | ||||
| T | ||||
This is not a complete list of side effects. For any unexpected effects while taking ratio-IPRATROPIUM UDV solution, contact your doctor or pharmacist.
HOW TO STORE IT
Keep this medication out of the reach of children.
1 mL Unit Dose Vials
Store at 15-25oC. Protect from heat and light.
2 mL Unit Dose Vials
Store at 15-30oC. Protect from heat and light.
If required, the solution should be diluted with a preservative free sterile sodium chloride solution 0.9% and used immediately. Any solution remaining in the vial must be discarded.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor: ratiopharm inc., at :
17 800 Lapointe, Mirabel
Quebec, Canada, J7J 1P3
1-800-337-2584
Last revised: October 22, 2009
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program 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 Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigiliance Program does not provide medical advice.