Apo-Salvent-Ipravent Sterules: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-SALVENT IPRAVENT STERULES is used to treat the wheezing or shortness of breath caused by COPD (chronic obstructive pulmonary disease which includes chronic bronchitis and emphysema).

What it does:

APO-SALVENT IPRAVENT STERULES is a combination of two drugs that are bronchodilators: ipratropium bromide (an anticholinergic) and salbutamol (a beta-agonist). APO-SALVENT IPRAVENT STERULES works by relaxing the muscle surrounding the bronchi (airways in the lungs) and therefore helps to ease breathing problems.

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

When it should not be used:

Do not take APO-SALVENT IPRAVENT STERULES

• if you are allergic to ipratropium bromide or

  other drugs which are anticholinergic (contain atropine or its derivatives), salbutamol sulfate, or to any component of APO-SALVENT IPRAVENT STERULES (see “What the non-medicinal ingredients are”);

• if you have a fast or irregular heart beat or have

  a thickened heart muscle due to various conditions;

• if you are under 18 years of age.

What the medicinal ingredients are:

Ipratropium bromide monohydrate and salbutamol sulfate.

What the non-medicinal ingredients are:

Hydrochloric acid, sodium chloride and water for injection.

What dosage forms it comes in:

APO-SALVENT IPRAVENT STERULES is supplied in plastic single dose units in strips of 10, each containing 3 mg salbutamol sulfate (equivalent to 2.5 mg salbutamol base) and 0.5 mg ipratropium bromide anhydrous (as monohydrate) in a 2.5 mL isotonic preservative-free sterile solution for inhalation.

APO-SALVENT IPRAVENT STERULES is for administration by inhalation by ventilator or compressor-driven nebulizer.

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-SALVENT IPRAVENT STERULES talk to your doctor or pharmacist if you:

• are pregnant or intend to become pregnant;

• are breast feeding;
• 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-SALVENT IPRAVENT STERULES 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 APO-SALVENT IPRAVENT STERULES may test positive for performance enhancement (doping) in athletic competition.

INTERACTIONS WITH THIS MEDICATION

Do not mix APO-SALVENT IPRAVENT STERULES 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-SALVENT IPRAVENT STERULES:

• digitalis;

• other anticholinergic drugs, such as

  ipratropium bromide and other beta₂-adrenergic agents such as salbutamol, the individual ingredients of APO-SALVENT IPRAVENT STERULES;

• 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-SALVENT IPRAVENT STERULES should only be inhaled from a nebulizer. It must not be

injected or swallowed.

Do not let the APO-SALVENT IPRAVENT STERULES 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-SALVENT IPRAVENT STERULES only as directed by your doctor. During

administration your doctor may want to monitor your blood.

Treatment with APO-SALVENT IPRAVENT STERULES is to be initiated and administered under medical supervision (e.g. in the hospital setting). Home based treatment can be recommended in exceptional cases (severe symptoms or experienced patients requiring higher doses) when a low dose rapid acting beta-agonist bronchodilator has been insufficient in providing relief after consultation with an experienced physician. Administration should be stopped when sufficient symptom relief is achieved.

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

APO-SALVENT IPRAVENT STERULES 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 unit dose sterules does not need to be diluted for nebulization.

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

Usual Adult dose:

The recommended dosage is 1 unit dose sterule (0.50 mg ipratropium bromide (as ipratropium bromide monohydrate) and 2.5 mg salbutamol (as salbutamol sulfate) in 2.5 mL) three or four times daily.

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

Your doctor or pharmacist will tell you how to prepare your APO-SALVENT IPRAVENT STERULES inhalation solution. Your doctor or pharmacist might instruct you to use sterile sodium chloride solution (0.9%) to dilute the APO-SALVENT IPRAVENT STERULES solution. If you are told to dilute APO-SALVENT IPRAVENT STERULES, 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 to 5 mL with preservative free 0.9% sterile sodium chloride solution and used immediately. Discard any unused solution. Nebulize over 10 to 15 minutes at gas flow of 6 to 10 L/min. Repeat every six hours as necessary.

Please read and carefully follow these instructions:

1.

The contents of APO-SALVENT IPRAVENT STERULES are to be inhaled from a nebulizer. Do not open the foil pouch until the sterules are required.

2.

To open the foil pouch, tear the foil at the centre and peel downwards. Do not peel the foil-wrap of the pouch

completely. Remove the sterules.

3.

To detach an APO-SALVENT IPRAVENT STERULES push one sterule downwards and away while holding the remaining sterules securely. Return the remaining sterules to the foil pouch and place the pouch back in the carton.

4.

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

5.

Place the open end of the sterule well into the

nebulizer cup and

squeeze slowly. 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-SALVENT IPRAVENT STERULES solution, 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.
3. 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.
4. 9.

   Breathe calmly and deeply through the mask or mouthpiece until no more mist is formed in the nebulizer chamber. This usually takes 10 to 15 minutes.

   It is very important to adjust the face mask, if required, to prevent the mist from getting in your eyes.

5. 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.

6. 11.

   The sterules should be stored at room

   temperature 15°C to 25°C, protected from heat and light. Discard any unused sterules in opened foil pouches after 3 months.

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

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

Overdose:

If you think you have taken too much APO-SALVENT IPRAVENT STERULES, 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.

APO-SALVENT IPRAVENT STERULES contains a beta-agonist, and taking additional doses in the form of other single agent, beta-agonists (fenoterol, salbutamol, etc.) could cause harmful effects on the heart, lungs and circulatory system. Therefore do not take additional bronchodilators by inhalation with APO-SALVENT IPRAVENT STERULES 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.

APO-SALVENT IPRAVENT STERULES can cause abnormal blood test results for hypokalemia and/or ketoacidosis. Your doctor will decide when to perform blood tests and will interpret the results.

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

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

HOW TO STORE IT

The sterules should be stored at room temperature 15°C to 25°C, protected from heat and light. Discard any unused sterules in opened foil pouches after 3 months. Keep out of reach and sight of children.

REPORTING SIDE EFFECTS

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about APO-SALVENT IPRAVENT STERULES:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-

  products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: June 22, 2018