Ratio-Ipra Sal Udv: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ratio-IPRA SAL UDV Inhalation Solution is used to treat the wheezing or shortness of breath caused by COPD (chronic obstructive pulmonary disease which includes chronic bronchitis and emphysema).

COPD 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. In many patients that quit smoking, there are less symptoms and the course of the disease slows down or stops.

What it does:

ratio-IPRA SAL UDV Inhalation Solution is an anticholinergic drug which works by relaxing the muscle surrounding the bronchioles (airways to the lungs) and therefore helps to ease breathing problems.

ratio-IPRA SAL UDV Inhalation Solution begins to act within 5 to 15 minutes and peaks between 1 and 2 hours, lasting about 2 additional hours before declining. The effects of ratio-IPRA SAL UDV Inhalation Solution are still evident 8 hours after inhalation.

When it should not be used:

Do not take ratio-IPRA SAL UDV Inhalation Solution if you are allergic to ipratropium bromide or other drugs which are anticholinergic (contain atropine or its derivatives), salbutamol sulphate, or to any component of ratio-IPRA SAL UDV Inhalation Solution (see “What the nonmedicinal ingredients are”).

Do not use ratio-IPRA SAL UDV Inhalation Solution if you have a fast or irregular heart beat or have a thickened heart muscle due to various conditions.

What the medicinal ingredient is:

ratio-IPRA SAL UDV Inhalation Solution is a combination of ipratropium bromide monohydrate and salbutamol sulfate.

What the nonmedicinal ingredients are:

Non-medicinal ingredients include sodium chloride,

hydrochloric acid and purified water.

What dosage forms it comes in:

ratio-IPRA SAL UDV Inhalation Solution in unit dose vials is a combination of two bronchodilators: 0.50 mg ipratropium bromide (as ipratropium bromide monohydrate) and 2.5 mg salbutamol (as salbutamol sulphate) in a volume of 2.5 mL solution suitable for administration by inhalation by ventilator or compressor-driven nebulizer.

You may already be familiar with one or both of these bronchodilators, since they are also available separately, with a prescription as ATROVENT (ipratropium bromide) and Ventolin^® (salbutamol).

WARNINGS AND PRECAUTIONS

The solution is intended for inhalation only. Do not inject or drink.

Do not let the nebulized mist get into your eyes as this may cause blindness known as acute angle glaucoma. This may present as eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes. If any combination of these symptoms occurs, seek immediate medical attention. Patients with glaucoma should use swimming goggles or a nebulizer with a mouthpiece to prevent nebulized solution getting into the eyes.

BEFORE you use ratio-IPRA SAL UDV Inhalation Solution talk to your doctor or pharmacist if:

• you are pregnant or intend to become pregnant;

• you are breast feeding;
• you have any other health problems, including a thyroid condition, difficulty in urination, enlarged prostate and diabetes mellitus, raised blood pressure or a heart problem;
• you have eye problems, such as glaucoma, or eye pain;
• you are taking any other medications including eye drops or any medications you can buy without a prescription;
• you have any allergies or reactions to foods or drugs.
• you have a history of convulsions (uncontrolled shaking or seizures);
• you have a history of heart disease or angina;

• you have liver or kidney disease

  Your doctor will recommend when and how you should use ratio-IPRA SAL UDV Inhalation Solution (see "Proper Use of This Medication"). You must follow any other direction that your doctor has given you for the treatment and/or monitoring of your condition.

  Contact your doctor immediately if:

  • you require more than one dose to relieve your breathing problems;
  • your shortness of breath becomes worse;
  • you don’t get the same benefit from your medicine as you did before;
  • you have breathing difficulties and chest pain.

ratio-IPRA SAL UDV Inhalation Solution may cause dizziness, difficulty in focusing the eye, dilated pupils, and blurred vision. You should not drive or operate machinery if this occurs.

The use of ratio-IPRA SAL UDV Inhalation Solution may test positive for performance enhancement (doping) in athletic competition.

INTERACTIONS WITH THIS MEDICATION

DO NOT take any other medication without your doctor’s advice. Tell any other doctor, dentist, or pharmacist with whom you consult that you are using ratio-IPRA SAL UDV Inhalation Solution.

Do not mix ratio-IPRA SAL UDV Inhalation Solution with other drugs in the same nebulizer.

• If you use other anticholinergic drugs, ratio-IPRA SAL UDV

  Inhalation Solution should be used with caution because of possible additive effects.

• If you use xanthine derivatives and beta₂-adrenergic agents it may

  enhance the effect of ratio-IPRA SAL UDV Inhalation Solution.

• Do not use other sympathomimetic bronchodilators or epinephrine

  concomitantly with ratio-IPRA SAL UDV Inhalation Solution unless directed by your doctor.

• Do not use ratio-IPRA SAL UDV Inhalation Solution if you

  are being treated with monoamine oxidase inhibitors or tricyclic antidepressants unless directed by your doctor. PROPER USE OF THIS MEDICATION

  ratio-IPRA SAL UDV Inhalation Solution has been prescribed to treat your current condition. DO NOT give it to other people. Always use ratio-IPRA SAL UDV Inhalation Solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

  The unit dose vials are intended only for inhalation with suitable nebulising devices and should not be taken orally or administered parenterally. The content of the unit dose vials does not need to be diluted for nebulization.

Usual dose:

Adults (over 18 years of age)

Not recommended for use in children and adolescents under 18 years of age.

ratio-IPRA SAL UDV Inhalation solution in unit dose vials may be administered from a suitable nebulizer or an intermittent positive pressure ventilator. The recommended dosage is 1 unit dose vial (0.50 mg ipratropium bromide (as ipratropium

bromide monohydrate) and 2.5 mg salbutamol (as salbutamol sulphate) in 2.5 mL) three or four times daily.

If one unit dose vial does not improve your breathing difficulties, you may need another unit dose vial. If this is the case, you should contact your doctor or the nearest hospital.

If necessary, before use, doses may be diluted to a total nebulization volume of 3-5 mL with preservative free 0.9% sterile sodium chloride solution and used immediately. Discard any unused solution. Nebulize over 10-15 minutes at gas flow of 6-10L/min. Repeat every six hours as necessary.

ratio-IPRA SAL UDV Inhalation solution should be used only in a properly functioning and regularly maintained nebulizer. Before starting treatment, be certain that you are completely familiar with the use and proper care of your nebulizer.

Your doctor or pharmacist will tell you how to prepare your ratio-IPRA SAL UDV Inhalation Solution. If you are told to dilute ratio-IPRA SAL UDV solution, you must do so immediately before you plan to use the solution. Your doctor or pharmacist might instruct you to use sterile sodium chloride solution (0.9%) to dilute the ratio-IPRA SAL UDV Inhalation Solution if necessary.

1. 1. Open the pouch foil and detach one plastic vial by pulling it firmly from the strip.
2. 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. 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. 4. Using a syringe, add sodium chloride solution to the chamber if you have been directed to do so by your pharmacist or physician.

1. 5.

   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.

2. 6.

   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.

3. 7.

   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.

Make sure you use the vial soon after opening and use a fresh vial each time to prevent contamination (growth of harmful microorganisms). Partly used, opened or damaged unit dose vials should be discarded.

Do not mix ratio-IPRA SAL UDV Inhalation Solution with other drugs in the same nebuliser.

Overdose:

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

Missed dose:

If a dose is missed and no symptoms occur, the regular next dose according to the dosing schedule should be taken. If a dose is missed and respiratory symptoms are experienced, the missing dose should be taken and the dosing schedule according to the recommended dosage should be resumed. SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like any drug product, ratio-IPRA SAL UDV Inhalation Solution may cause unwanted effects along with the good effects. If you do experience any unusual or unwanted effects while you are using your Inhalation Solution, you should contact your doctor.

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

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.

ratio-IPRA SAL UDV Inhalation Solution contains a beta-agonist, and taking additional doses in the form of other single agent, beta-agonists (fenoterol [BEROTEC], salbutamol [Ventolin®] etc.) could cause harmful effects on the heart, lungs and circulatory system. Therefore do not take additional bronchodilators by inhalation with ratio-IPRA SAL UDV Inhalation Solution unless instructed to do so by your doctor or pharmacist.

Stop taking the medication and tell your doctor immediately if you notice any of the following:

• You are wheezy or have any other difficulties in breathing;
• You are having an allergic reaction – the signs may include skin rash, itching and nettle rash. In severe cases the signs include swelling of your tongue, lips and face, sudden difficulties in breathing and reduction of your blood pressure.

Other side effects include: heart problems such as fast or irregular heart beat or rate, decreased blood flow to the heart, feeling your heartbeat; eye disorders such as difficulty in focusing the eye, 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; muscle problems such as muscle cramps, muscle weakness, muscle pain; feeling weak; feeling nervous; mental disorder; tremor (shaking); impaired voice sounds; difficulty in passing urine; increased sweating; changes in blood pressure; low potassium levels in the blood; breathing problems such as difficulty in breathing, coughing bouts, swelling of the throat, and choking due to swelling of the muscles around the voice box; dry throat, wheezing after inhalation, swelling of the mouth and throat.

Very rarely, some people may experience chest pain (due to heart problems such as angina). Tell your doctor as soon as possible and stop using this medicine.

If you have any questions about ratio-IPRA SAL UDV Inhalation 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-IPRA SAL UDV Inhalation Solution, contact your doctor or pharmacist.

HOW TO STORE IT

Unopened unit dose vials of ratio-IPRA SAL UDV Inhalation Solution should be stored at room temperature (15-25°C). The vials should be protected from heat and light. Do not use if solution is discoloured. Keep out of reach of children.

Partly used, opened or damaged unit dose vials should 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 0701C Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reactions reporting guidelines are available on the MedEffect^TM Canada Website 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:

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

1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9.

Last revised: July 24, 2013.