Apo-Ipravent Sterules: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-IPRAVENT is used to treat the wheezing or shortness of breath caused by COPD (chronic obstructive pulmonary disease which includes chronic bronchitis and emphysema). For the treatment of asthma, APO-IPRAVENT must be used in conjunction with some other bronchodilating medication. APO-IPRAVENT contains 250 mcg/mL (0.025%) ipratropium bromide and the preservatives benzalkonium chloride and disodium ethylene diamine tetraacetic acid (EDTA-disodium).

What it does:

APO-IPRAVENT belongs to a group of medicines known as “bronchodilators” which make breathing easier by opening your narrowed airways.

When it should not be used:

APO-IPRAVENT 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 non-medicinal ingredients are:

Benzalkonium chloride solution (50% w/v), edetate disodium dihydrate, hydrochloric acid, purified water and sodium chloride

What dosage forms it comes in:

Nebulizer Solution; 20 mL Bottle

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 APO-IPRAVENT talk to your doctor or pharmacist if you:

• are pregnant or intend to become pregnant;

• are breastfeeding;
• are having treatment for a thyroid or adrenal gland condition;
• are having treatment for high blood pressure, angina or a heart problem;
• have diabetes;

• 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)
• have eye problems, such as glaucoma or eye pain;
• are taking any other medications, including eye drops or any medications you can buy without a prescription;
• have difficulty in urination;
• have enlarged prostate;
• have any allergies or reactions to foods or drugs;
• have a history of convulsions (uncontrolled shaking or seizures);
• have liver or kidney disease.

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;
• you experience difficulty with urination.

APO-IPRAVENT may cause dizziness, difficulty in focusing the eye, dilated pupils, and blurred vision. You should not drive or operate machinery if this occurs.

INTERACTIONS WITH THIS MEDICATION

Do not mix APO-IPRAVENT with other drugs in the same nebulizer.

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 APO-IPRAVENT:

• digitalis;
• other anticholinergic drugs, such as ipratropium bromide and beta₂-adrenergic agents such as salbutamol;
• beta blockers, such as propranolol;
• xanthine derivatives such as theophylline;
• monoamine oxidase inhibitors such as isocarboxazid;
• tricyclic antidepressants such as amitriptyline;
• epinephrine;
• certain diuretics or “water pills” such as furosemide, hydrochlorothiazide.

PROPER USE OF THIS MEDICATION

APO-IPRAVENT should only be inhaled from a nebulizer. It must not be injected or swallowed.

Do not let the APO-IPRAVENT or the mist produced by the nebulizer, get in your eyes.

Use your nebulizer in a well ventilated room. Some of the mist will be released into the air and may be breathed in by others.

Use APO-IPRAVENT only as directed by your doctor. During administration your doctor may want to monitor your blood.

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

APO-IPRAVENT should be used only in a properly functioning and regularly maintained nebulizer or an intermittent positive pressure ventilator. Before starting treatment, be certain that you are completely familiar with the use and proper care of your nebulizer. The content of the bottle does not need to be diluted for nebulization.

Usage Instructions:

Your doctor or pharmacist will tell you how to prepare your APO-IPRAVENT nebulizer solution. Your doctor or pharmacist might instruct you to use sterile sodium chloride solution (0.9%) to dilute the APO-IPRAVENT solution. If you are told to dilute APO-IPRAVENT solution, you must do so immediately before you plan to use the solution. If necessary, 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 4-6 hours as necessary.

.

1. 1) Immediately before you plan to use the nebulizer, using a syringe, withdraw the prescribed dose, usually ½ to 2 mL (cc), of APO-IPRAVENT from the bottle and add to the nebulizer chamber. Do not store the prescribed dose in the syringe for later use.
2. 2) If your doctor has instructed you to use another inhalation solution in combination with APO-IPRAVENT, you should add the appropriate amount of that solution to the nebulizer chamber as well.
3. 3) Add sodium chloride solution to the chamber, if you have been directed to do so by your physician or pharmacist.

1. 4) 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.

1. 5) 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.

1. 6) Store your re-capped bottle of APO-IPRAVENT and sodium chloride solution in the refrigerator until the next treatment.
2. 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.

Do not mix APO-IPRAVENT with other drugs in the same nebulizer.

Keep out of the reach of children.

Overdose:

If you think you have taken too much APO-IPRAVENT, contact your healthcare professional, 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

Side effects may include:

• wheezing after inhalation;
• headache, dizziness;
• nausea (feeling sick), digestive problems like constipation, diarrhoea and vomitng;.
• muscle problems such as cramps weakness, pain, feeling weak, tremor (shaking);
• feeling nervous;
• mental disorder;
• impaired voice sounds;
• increased sweating;
• bronchitis and upper respiratory tract infection (a cold)
• throat irritation, cough, dry mouth or throat, 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.

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.

If you have any questions about APO-lPRAVENT or your nebulizer, contact your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking APO-IPRAVENT contact your doctor or pharmacist.

HOW TO STORE IT

Keep this medication out of the reach of children.

Unopened bottles of APO-IPRAVENT should be stored at controlled room temperature (between 15°C and 30°C). Solutions diluted with preservative free sterile Sodium Chloride Inhalation Solution, USP 0.9% should be used within 24 hours from time of dilution when stored at room temperature and within 48 hours when stored in the refrigerator.

MORE INFORMATION

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:

1-800-667-4708

This leaflet can also be found at: http://www.apotex.ca/products.

Last revised: February 07, 2017

Reporting Side Effects

PART III: CONSUMER INFORMATION

APO-IPRAVENT

Ipratropium Bromide Nebulizer Solution

(2 mL Sterules)

Read this leaflet carefully before you start taking APO-IPRAVENT sterules and each time you get a refill. This leaflet is a summary and will not tell you everything about APO-IPRAVENT sterules. Talk to your doctor, nurse or pharmacist about your medical information about APO-IPRAVENT sterules.

ABOUT THIS MEDICATION

What the medication is used for:

APO-IPRAVENT is used to treat the wheezing or shortness of breath caused by COPD (chronic obstructive pulmonary disease which includes chronic bronchitis and emphysema). For the treatment of asthma, APO-IPRAVENT must be used in conjunction with some other bronchodilating medication.

What it does:

APO-IPRAVENT sterules belong to a group of medicines known as “bronchodilators” which make breathing easier by opening your narrowed airways.

When it should not be used:

APO-IPRAVENT 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 non-medicinal ingredients are:

Hydrochloric acid, sodium chloride and water for injection

What dosage forms it comes in:

Nebulizer Solution; 2 mL Sterules

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 APO-IPRAVENT talk to your doctor or pharmacist if you:

• are pregnant or intend to become pregnant;
• are breastfeeding;
• are having treatment for a thyroid or adrenal gland condition;
• are having treatment for high blood pressure, angina or a heart problem;
• have diabetes;

• 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)
• have eye problems, such as glaucoma, or eye pain;
• are taking any other medications, including eye drops or any medications you can buy without a prescription;
• have difficulty in urination;
• have enlarged prostate;
• have any allergies or reactions to foods or drugs;
• have a history of convulsions (uncontrolled shaking or seizures);
• have liver or kidney disease.

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;
• you experience difficulty with urination.

APO-IPRAVENT may cause dizziness, difficulty in focusing the eye, dilated pupils, and blurred vision. You should not drive or operate machinery if this occurs.

INTERACTIONS WITH THIS MEDICATION

Do not mix APO-IPRAVENT with other drugs in the same nebulizer.

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 APO-IPRAVENT:

• digitalis;
• other anticholinergic drugs, such as ipratropium bromide and other beta₂-adrenergic agents such as salbutamol;
• beta blockers, such as propranolol;
• xanthine derivatives such as theophylline;
• monoamine oxidase inhibitors such as isocarboxazid;
• tricyclic antidepressants such as amitriptyline;
• epinephrine;
• certain diuretics or “water pills” such as furosemide, hydrochlorothiazide.

PROPER USE OF THIS MEDICATION

APO-IPRAVENT should only be inhaled from a nebulizer. It must not be injected or swallowed.

Do not let the APO-IPRAVENT or the mist produced by the nebulizer, get in your eyes.

Use your nebulizer in a well ventilated room. Some of the mist will be released into the air and may be breathed in by others.

Use APO-IPRAVENT only as directed by your doctor. During administration your doctor may want to monitor your blood.

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

APO-IPRAVENT should be used only in a properly functioning and regularly maintained nebulizer or an intermittent positive pressure ventilator. Before starting treatment, be certain that you are completely familiar with the use and proper care of your nebulizer. The content of the bottle does not need to be diluted for nebulization.

APO-IPRAVENT (Ipratropium Bromide) Solution:

2 mL Sterules

250 mcg/mL

Each sterule contains 2 mL of APO-IPRAVENT Solution. Each millilitre (mL) of solution contains 250 mcg (0.025%) ipratropium bromide in an isotonic solution.

125 mcg/mL

Each sterule contains 2 mL of APO-IPRAVENT Solution. Each millilitre (mL) of solution contains 125 mcg (0.0125%) ipratropium bromide in an isotonic solution.

Usage Instructions

Your doctor or pharmacist will tell you how to prepare your APO-IPRAVENT nebulizer solution. Your doctor or pharmacist might instruct you to use sterile sodium chloride solution (0.9%) to dilute the APO-IPRAVENT solution. If you are told to dilute APO-IPRAVENT, you must do so immediately before you plan to use the solution. If necessary, 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 4-6 hours as necessary.

1. 1) The contents of APO-IPRAVENT STERULES are to be inhaled from a nebulizer. Do not open the foil pouch until the sterules are required.
2. 2) To open the foil pouch, tear the foil at the centre and peel downwards (Diagram 1). Do not peel the foil-wrap off the pouch completely. Remove the sterules.

1. 3) To detach an APO-IPRAVENT Sterule, push one sterule downwards and away while holding the remaining sterules securely (Diagram 2). Record the date when the foil pouch is first opened using a regular ballpoint pen. Return the remaining sterules to the foil pouch and place the pouch back in the carton.

1. 4) Holding the top of the sterule securely, twist the body to open (Diagram 3). It is important that you use the contents of the sterule as soon as possible after opening it.

1. 5) Place the open end of the sterule well into the nebulizer cup and squeeze slowly (Diagram 4). Squeeze the contents of the sterule into your nebulizer chamber. If your doctor has instructed you to use less than one complete sterule, use a syringe to withdraw the prescribed dose. Any solution left in the sterule must be thrown away.

1. 6) If your doctor has instructed you to use another inhalation solution in combination with APO-IPRAVENT, you should add the appropriate amount of that solution to the nebulizer chamber as well.
2. 7)

   Using a syringe, add sodium chloride solution to the chamber if you have been directed to do so by your pharmacist or physician.

   1. 8) Gently shake the nebulizer chamber and connect it to the mouthpiece or the face mask. Then connect the nebulizer tube to the air or oxygen pump and begin therapy.
   2. 9) 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. 10) 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.
   4. 11) The sterules should be stored at room temperature (15°C to 25°C). The sterules should be protected from heat and light. Discard any unused sterules in opened foil pouches after 3 months.

Do not mix APO-IPRAVENT with other drugs in the same nebulizer.

Keep out of the reach of children.

Overdose:

If you think you have taken too much APO-IPRAVENT, contact your healthcare professional, 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

Side effects may include:

• wheezing after inhalation;
• headache, dizziness
• nausea (feeling sick), digestive problems like constipation, diarrhoea and vomiting;
• muscle problems such as cramps
• weakness, pain, feeling weak, tremor (shaking);
• feeling nervous;
• mental disorder;
• impaired voice sounds;
• increased sweating;
• bronchitis and upper respiratory tract infection (a cold)
• throat irritation, cough, dry mouth or throat, 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.

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.

If you have any questions about APO-lPRAVENT or your nebulizer, contact your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking APO-IPRAVENT, contact your doctor or pharmacist.

HOW TO STORE IT

Keep this medication out of the reach of children.

Unopened sterules of APO-IPRAVENT should be stored at controlled room temperature (between 15°C and 25°C) and protected 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 sterule must be discarded.

MORE INFORMATION

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:

1-800-667-4708

This leaflet can also be found at: http://www.apotex.ca/products.

Last revised: February 07, 2017

Reporting Side Effects