Ipravent: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

IPRAVENT 0.03% is used to treat the runny nose associated with perennial allergic or nonallergic rhinitis.

IPRAVENT 0.06% is used to treat the runny nose associated with the common cold.

IPRAVENT is intended to relieve your rhinorrhea (runny nose) with regular use. It is therefore important that you use IPRAVENT as prescribed by your physician. Some improvement in rhinorrhea is usually apparent during the first full day of treatment with IPRAVENT. However, maximum benefit may not occur for up to several weeks after treatment has started.

What it does:

IPRAVENT works to stop the glands in your nose from producing excessive nasal secretions. IPRAVENT must be prescribed by a doctor.

When it should not be used:

IPRAVENT should not be used by patients with a history of allergy to ipratropium bromide, or to any component of this formulation.

IPRAVENT 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 non-medicinal ingredients are)

What the medicinal ingredient is:

ipratropium bromide

What the non-medicinal ingredients are:

benzalkonium chloride, edetate disodium, hydrochloric acid, purified water, sodium chloride and sodium hydroxide.

What dosage forms it comes in:

IPRAVENT nasal spray 0.03% w/v

IPRAVENT nasal spray 0.06% w/v

WARNINGS AND PRECAUTIONS

BEFORE you use IPRAVENT 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, now or in the past;
• you have eye problems, such as predisposition to glaucoma;
• you have difficulty/trouble urinating or problems with your prostate;
• you are taking any other medications including eye drops or any medications you can buy without prescription;
• you have any allergies or reactions to foods or drugs.

IPRAVENT 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 Drugs that may interact with IPRAVENT include:

Other anticholinergic drugs.

PROPER USE OF THIS MEDICATION

Usual dose: Adults and children over 12 years of age

1. 1) Remove the clear plastic dust cap and the safety clip from the nasal spray pump. The safety clip prevents the accidental discharge of the spray in your pocket or purse.
2. 2)

   The nasal spray pump must be primed before

   IPRAVENT is used for the first time. To prime the pump, hold the bottle with your thumb at the base and your index and middle fingers on the white shoulder area. Make sure the bottle points upright and away from your eyes. Press your thumb firmly and quickly against the bottle seven times. The pump is now primed and can be used. Your pump should not have to be reprimed unless you have not used the medication for more than 24 hours; repriming the pump will only require one or two sprays.

1. 3)

   Before using IPRAVENT, blow your nose gently

   to clear your nostrils, if necessary.

4.) Close one nostril by gently placing your finger

against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril. Point the tip toward the back and outer side of the nose.

1. 5)

   Press firmly and quickly upwards with the

   thumb at the base while holding the white shoulder portion of the pump between your index and middle fingers. Following each spray, sniff deeply and breathe out through your mouth.

2. 6)

   After spraying the nostril and removing the

   unit, tilt your head backwards for a few seconds to let the spray spread over the back of the nose.

3. 7) Repeat steps 4 through 6 in the other nostril.
4. 8)

   Replace the clear plastic dust cap and safety

   clip.

5. 9)

   When the amount of IPRAVENT begins to run

   low, the amount of medication in each spray cannot be assured. Therefore, at some time before the medication is completely used up, you should consult your physician or pharmacist to determine whether a refill is needed. You should not take extra doses of IPRAVENT without consulting your physician.

TO CLEAN

If the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. Hold the nasal tip under running, warm tap water for about a minute.

Dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip.

Avoid spraying IPRAVENT in or around your eyes.

Should this occur, immediately flush your eyes with cool tap water for several minutes. If you accidentally spray IPRAVENT in your eyes, you may experience a temporary blurring of vision and increased sensitivity to light, which may last a few hours.

Do not exceed the number of sprays, or the length of use, prescribed by your doctor.

IPRAVENT has been prescribed to treat your current condition. Do not give it to other people.

Do not take other medication without your doctor’s advice.

Overdose:

If you think you have taken too much IPRAVENT, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take your dose, don’t worry. Take your next dose as usual. Do not double your dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like any other drug product, IPRAVENT may cause unwanted effects along with its good effects. If you do experience any of the unwanted effects listed below, you should contact your doctor. He/she may recommend that you lower your dose of IPRAVENT.

The most frequent side effects are headache, throat irritation, nasal discomfort, nasal dryness and nosebleeds.

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; dry throat, dry mouth, swelling

of the mouth and throat, increased wheezing or tightness in the chest or difficulty in breathing (bronchospasm); digestive problems like constipation, diarrhoea and vomiting; dizziness.

Some people can be allergic to medicines. If you have any of the following symptoms soon after taking IPRAVENT, 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.

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

HOW TO STORE IT

Store tightly closed at room temperature between 15°C to 30°C. Avoid excessive heat or freezing. Keep out of reach 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 IPRAVENT:

• 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 https://www.aapharma.ca/, or by calling 1-877-998-9097.

Last Revised: January 10, 2018