Ratio-Ipratropium Udv: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ratio-IPRATROPIUM UDV 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 must be used in conjunction with some other bronchodilating medication. ratio-IPRATROPIUM UDV is available only on prescription.

Before starting treatment with ratio-IPRATROPIUM UDV, 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 doctor'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.

ratio-IPRATROPIUM UDV should not be used by patients with allergic reaction to ipratropium bromide, atropinics (atropine or atropine-like drugs) or to any component of the drug (See What the nonmedicinal ingredients are)

What the medicinal ingredient is:

Ipratropium bromide

What the nonmedicinal ingredients are:

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 you 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.

ratio-IPRATROPIUM UDV may cause dizziness, difficulty in focusing the eyes, dilated pupils, and blurred vision. You should not drive or operate machinery if this occurs.

INTERACTIONS WITH THIS MEDICATION

Other medications may be affected by ratio-IPRATROPIUM UDV or may affect how ratio-IPRATROPIUM UDV 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.

PROPER USE OF THIS MEDICATION

• For adults and children over 6 years of age.

• DO NOT exceed the prescribed dose or frequency of

  treatments.

• Before you start to use ratio-IPRATROPIUM UDV, 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. 1)

   Detach one plastic vial by pulling it firmly from the strip.

   1. 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.
   2. 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.
   3. 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.
   4. 5) Using a syringe, add sodium chloride solution to the chamber if you have been directed to do so by your pharmacist or physician.
   5. 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.
   6. 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.
   7. 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.
   8. 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:

In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional poison control centre, even if there are no symptoms. 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.

The most frequent side effects are headache, throat irritation, cough, dry mouth, nausea (feeling sick), dizziness and digestive problems like constipation, diarrhoea and vomiting.

Other side effects include: increased heart rate and a feeling that your heart is beating fast , heart problems such as fast or irregular heart beat ;eye disorders such as difficulty in focusing the eyes, seeing halos, swelling of the cornea, build up or increased pressure in the eye, dilated pupils, swelling of the blood vessels in the conjunctiva (outermost layer of the eye and inner surface of the eyelids), blurred vision, eye pain; difficulty in passing urine; swelling of the muscles around the voice box; swelling of the mouth and throat; dry throat and increased wheezing or tightness in the chest or difficulty in breathing (bronchospasm). Some people can be allergic to medicines. If you have any of the following symptoms soon after taking ratio-IPRATROPIUM UDV solution, stop taking this medicine and tell your doctor immediately or go the nearest hospital:

• Sudden wheeziness and chest pain or tightness

• Sudden difficulty in breathing and reduction in your

  blood pressure

• Swelling of eyelids, face, tongue or throat
• Lumpy skin rash, or “hives” anywhere on the body.

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 persists 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.

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 15-25^oC. Protect from heat and light.

2 mL Unit Dose Vials

Store at 15-30^oC. 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.

REPORTING SUSPECTED 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 0701D

  Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor: Teva Canada Limited at:

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

1-800-268-4127 ext 1255005 (English)

1-877-777-9117 (French)

or druginfo@tevacanada.com

Last revised: July 24, 2013.