Teva-Ipratropium Sterinebs: Uses, Side Effects and Dosage

What is TEVA-IPRATROPIUM STERINEBS used for:

TEVA-IPRATROPIUM STERINEBS is used:

• in adults for the maintenance treatment of chronic obstructive pulmonary disease (COPD) This includes chronic bronchitis and emphysema.
• in adults for the treatment of sudden breathlessness (bronchospasm) in COPD.
• in adults and children 5 years of age and older together with an inhaled beta2-adrenergic agonist, such as salbutamol, for the treatment of sudden breathlessness (bronchospasm) due to asthma.

If you have COPD and you are a smoker, it is important to quit smoking. This will help decrease the symptoms of COPD and potentially increase your lifespan.

How does TEVA-IPRATROPIUM STERINEBS work?

TEVA-IPRATROPIUM STERINEBS belongs to a group of medicines known as “bronchodilators”. They make breathing easier by opening your narrowed airways. This makes it easier for air to get in and out of the lungs.

What are the ingredients in TEVA-IPRATROPIUM STERINEBS?

Medicinal ingredients: ipratropium bromide

Non-medicinal ingredients: normal saline (9 mg/mL sodium chloride solution), hydrochloric acid

TEVA-IPRATROPIUM STERINEBS comes in the following dosage forms:

Inhalation solution; 250 mcg / mL, 500 mcg / 2 mL

Do not use TEVA-IPRATROPIUM STERINEBS if:

• you are allergic (hypersensitive) to ipratropium bromide, atropine or to any of the non-medicinal ingredients, or component of the container (see What are the ingredients in TEVA-IPRATROPIUM STERINEBS?).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you

take TEVA-IPRATROPIUM STERINEBS. Talk about any health conditions or problems you may have, including if you:

• are pregnant or planning to become pregnant

• are breastfeeding. It is not known if ipratropium bromide passes into breastmilk.
• are taking other medications to treat your breathing problems, such as ipratropium, tiotropium, glycopyrronium, aclidinium or umeclidinium
• have trouble passing urine or painful urination
• have an enlarged prostate
• have eye problems, such as glaucoma (increased pressure in your eye) or eye pain
• have the lung disease cystic fibrosis (CF)

Other warnings you should know about:

Worsening of your COPD or Asthma Symptoms: While you are taking TEVA-IPRATROPUM STERINEBS, get immediate medical help if:

• you have sudden or worsening shortness of breath, increased wheezing or tightness in the chest or difficulty in breathing.
• your asthma symptoms have gotten worse and are not relieved by your rescue medicine, even if there is short-term relief after using TEVA-IPRATROPIUM STERINEBS.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with TEVA-IPRATROPIUM STERINEBS:

• other medicines to treat breathing problems, such as ipratropium, tiotropium, glycopyrronium, aclidinium, umeclidinium

How to take TEVA-IPRATROPIUM STERINEBS:

• TEVA-IPRATROPIUM STERINEBS is for oral inhalation only.
• Take TEVA-IPRATROPIUM STERINEBS exactly how your healthcare professional has told you to.
• DO NOT use a higher dose than you have been prescribed or change the frequency of your treatments without talking to your healthcare professional.
• Before you start to use TEVA-IPRATROPIUM STERINEBS, read the Instructions for Use carefully. It is important that you are completely familiar with the use and proper care of your nebulizer.
• You must ensure that the nebulizer mask fits the face properly and that the nebulized solution does not escape into the eyes. If you have glaucoma you should use swimming goggles or a nebulizer with a mouthpiece to prevent the nebulized solution from getting into your eyes
• If you have any questions about using the nebulizer, talk to your healthcare professional.

Instructions for Use:

• TEVA-IPRATROPIUM STERINEBS is to be used in a compressed air or oxygen driven nebulizer.
• Your healthcare professional will tell you how to prepare your TEVA-IPRATROPIUM STERINEBS solution for inhalation.
• If your dose of TEVA-IPRATROPIUM STERINEBS is less than 2 mL you might be told to dilute the TEVA-IPRATROPIUM STERINEBS solution with sterile saline before you use it to make 2 – 5 mL of solution to be nebulized.
• If you are told to dilute TEVA-IPRATROPIUM STREINEBS, you must do this immediately before using the solution.
• Only mix TEVA-IPRATROPIUM STERINEBS with other medicines in the nebulizer if your healthcare professional has told you to.
• 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.

1. 3. Squeeze the contents of the plastic vial into your nebulizer chamber. If your healthcare professional has told you to use less than one complete vial, use a syringe to withdraw the correct amount. Any solution left in the plastic vial must be thrown away.

1. 4. If your healthcare professional has told you to use another inhalation solution in combination with TEVA-IPRATROPIUM STERINEBS, you should add the appropriate amount of that solution to the nebulizer chamber as well.
2. 5. If your healthcare professional has told you to, add sodium chloride solution, use a syringe to add it to the nebulizer chamber as well.

1. 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.

1. 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.

1. 8. Follow the instruction 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.

Usual dose:

Maintenance of COPD in Adults

The recommended dose is 500 mcg (2 vials of 250 mcg / mL or 1 vial of 500 mcg / 2mL) taken 3 -4 times per day.

Adults and children 12 years of age and older

The recommended single dose of TEVA-IPRATROPIUM STERINEBS is 250 mcg – 500 mcg (1 or 2 vials of 250 mcg / 1mL or 1 vial of 500 mcg / 2 mL).

Treatment may be repeated every 4 – 6 hours as needed.

The maximum recommended daily dose is 2 mg per day (8 vials of 250 mcg / mL or 4 vials of 500 mcg / 2 mL).

Children 5 to 12 years of age

The recommended single dose of TEVA-IPRATROPIUM STERINEBS is 125 mcg – 250 mcg (half a vial of 250 mcg / mL or 1 vial of 250 mcg / mL).

Treatment may be repeated every 4 – 6 hours as needed.

The maximum recommended daily dose is 1 mg per day (4 vials of 250 mcg / mL).

Overdose:

Missed Dose:

If a dose of this medication is missed, skip the missed dose and continue with the next scheduled dose. Do not take a double doses to make up for a missed dose.

What are possible side effects from using TEVA-IPRATROPIUM STERINEBS?

These are not all the possible side effects you may have when taking TEVA-IPRATROPIUM STERINEBS. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• headache
• dizziness
• constipation
• vomiting
• diarrhea
• nausea
• cough
• dry mouth
• irritation of mouth and/or throat
• hoarseness
• bad taste in the mouth
• tremor
• flushing
• skin rash
• trouble sleeping

If you experience a dry mouth or a bad taste, sucking on a sour candy or rinsing your mouth after taking TEVA-IPRATROPIUM STERINEBS may help.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Keep out of reach and sight of children.

• Unopened unit dose vials of TEVA-IPRATROPIUM STERINEBS should be stored at room temperature (between 15°C and 30°C) and protected from light.
• Diluted solution should be used immediately.
• Any solution remaining in the vial must be discarded.

If you want more information about TEVA-IPRATROPIUM STERINEBS:

• 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/drugproduct- database.html); the manufacturer’s website www.tevacanada.com, or by calling 1-800-268-4127 ext. 5005.

Last Revised: Feb. 01, 2022