Apo-Nitroglycerin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-NITROGLYCERIN (nitroglycerin sublingual spray) is used in adults for the treatment of acute attacks of angina pectoris – chest pain which occurs when the heart muscle does not get as much blood (hence as much oxygen) as it needs.

What it does:

APO-NITROGLYCERIN belongs to a group of drugs, which reduce the oxygen demand of the heart.

When it should not be used:

Do not use APO-NITROGLYCERIN if you:

• Are allergic to nitroglycerin or any of the non-medicinal ingredients in the formulation or to any other medication of the same group of medicines called nitrates
• Have an eye disease called closed angle glaucoma
• Are having a heart attack (myocardial infarction)
• Have low iron levels in your blood or low red blood cell count (severe anemia)
• Have low blood pressure (hypotension) or a diagnosis of heart failure
• Have a condition caused by an increase in normal brain pressure (increased intracranial pressure)
• Are taking CIALIS^® (tadalafil), LEVITRA^® (vardenafil), VIAGRA^® (sildenafil citrate) or any similar medication for impotence (erectile dysfunction).
• Are taking ADEMPAS^® (riociguat) for high blood pressure in your lungs (chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH))

What the medicinal ingredient is:

Nitroglycerin

What the nonmedicinal ingredients are:

Dehydrated alcohol, medium chain monoglycerides, medium chain partial triglycerides, and peppermint oil

What dosage forms it comes in:

APO-NITROGLYCERIN is supplied in spray bottles delivering 200 metered doses of 0.4 mg nitroglycerin per spray emission.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Headaches or symptoms of low blood pressure, such as weakness or dizziness, especially when you go from lying/sitting to standing up, may be due to taking too much APO-

NITROGLYCERIN. You may also notice a bluish discolouration to your skin, especially around your lips and mouth. If these

symptoms occur, talk to your doctor, nurse, or pharmacists as your dose of APO-NITROGLYCERIN may need to be reduced.

BEFORE you use APO-NITROGLYCERIN talk to your doctor, nurse or pharmacist if you:

• are currently taking any other medications, whether on prescription or otherwise (see Interactions with this Medication section below).

• have headaches, weakness or dizziness

  especially when getting up suddenly from a laying down or sitting position, or symptoms of low blood pressure (hypotension).

• are breast feeding, pregnant, or think you might be pregnant.

• had a heart attack.
• Are less than 18 years old

Tolerance to APO-NITROGLYCERIN and similar drugs can occur after long periods of use. Chronic use can lead to angina attacks being brought on more easily. Do not suddenly stop using APO-NITROGLYCERIN. Talk to your doctor if you wish to discontinue using APO-NITROGLYCERIN.

Driving and using machines: Temporary dizziness may be associated with the use of APO-NITROGLYCERIN. Make sure you know how you react to this medicine before you drive, operate machinery, or do anything requiring you to be alert.

Avoid alcoholic beverages until you have discussed their use with your doctor.

The spray should be kept away from the eyes and it should not be inhaled.

INTERACTIONS WITH THIS MEDICATION

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.

Serious Drug Interactions

If you are currently taking medication for the treatment of impotence (erectile dysfunction) such as CIALIS^® (tadalafil), LEVITRA^® (vardenafil), VIAGRA^® (sildenafil citrate) or any other similar medication (PDE5 inhibitors), the use of APO-NITROGLYCERIN (nitroglycerin sublingual spray) may lead to extreme low blood pressure resulting in fainting, heart attack and death.

If you are being treated with any of these drugs and need APO-NITROGLYCERIN (e.g. in case of chest pain caused by an acute attack of angina pectoris) please seek emergency medical assistance immediately.

The following may interact with APO-

NITROGLYCERIN:

• Medications used to treat hypertension

  (high blood pressure) such as:

  • Diuretics (“water pills”)

  • Calcium Channel Blockers

    [medications used to treat conditions such as high blood pressure, angina (chest pain), and other heart conditions (e.g. diltiazem, nifedipine, verapamil)]

• Tricyclic antidepressants (e.g.: imipramine,

  amitriptyline, desipramine, nortriptyline)

• Antipsychotics (medications used to treat

  schizophrenia or bipolar depression)

• Medications used to relieve muscle spasms

  including tizanidine (e.g. Zanaflex)

• Alcoholic beverages (when combined with APO-

  NITROGLYCERIN it may cause your blood pressure to drop too low)

• Topical aesthetics prilocaine/lidocaine (e.g.

  EMLA^®)

• Medication used to treat pulmonary

  hypertension such as riociguat (e.g. Adempas)

• Sapropterin (a medication used to treat a

  disease called hyperphenylalaninemia)

• Dihydroergotamine (a medication used to treat

  migraine)

PROPER USE OF THIS MEDICATION

Ideally, you should sit and rest while taking this medication.

1. 1.

   Holding container in upright position, remove the plastic cover.

   DO NOT SHAKE.

2. 2.

   The container must be primed prior to the first use. To prime, point away from face, press the button firmly with the forefinger to release one spray. Repeat this 3 times. Now your container is primed and ready for use.

   Repriming is only necessary when the container has not been used for more than 14 days. To reprime, release 1 spray as directed previously. There is no need to reprime the container between more frequent usage.

   If the container has been

   maintained below freezing (0^oC), warm the container in your hand for two minutes and prime 4 times prior to use

3. 3. Hold the container upright with forefinger on top of the grooved button. There is no need to shake the container.
4. 4. Open your mouth and bring the container as close to it as possible.
5. 5.

   Press the button firmly with the forefinger to release the spray onto or under the tongue.

   DO NOT INHALE THE SPRAY.

   KEEP THE SPRAY AWAY FROM EYES.

6. 6. Release button and close mouth.
7. 7. If you require a second dose, repeat steps 4, 5 and 6.
8. 8. Replace the plastic cover.

When using this product for the first time, familiarize yourself with how to use it by testing the spray into the air (away from yourself and others). Get the feel of the finger resting on the groove button so that you can use the spray in the dark.

Usual adult dose:

APO-NITROGLYCERIN (nitroglycerin sublingual spray) should be taken as prescribed by your doctor.

During an anginal attack, one or two doses should be sprayed onto or under the tongue, without inhaling. Your doctor can help you to discover the exact dose which will be best for you. Administer at rest, ideally in the sitting position. A dose may be repeated twice at 5-10 minute intervals. If the pain persists, seek emergency medical assistance.

MAKE SURE THAT YOU HAVE A SPARE PUMPSPRAY READILY AVAILABLE (TO PREVENT RUNNING OUT WHEN NEEDED).

Overdose:

Symptoms of overdosage may include: flushing, headache, nausea, dizziness, and hypotension.

If you think you have taken too much APO-

NITROGLYCERIN Spray, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT

THEM

Along with its intended action, any medication, including APO-NITROGLYCERIN (nitroglycerin sublingual spray), may cause side effects. After you have started taking APO-NITROGLYCERIN, it is important that you tell your doctor at once about any unexplained symptom you might experience.

Side effects may include:

• Headache
• Sore throat and/or mouth, runny nose
• Restlessness

If any of these affects you severely, tell your doctor, nurse or pharmacist.

Serious side effects and what to do about them

Serious side effects and what to do about them

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

HOW TO STORE IT

Contains alcohol. Do not open container forcefully or burn after use. Do not spray toward flames. Do not place APO-NITROGLYCERIN (nitroglycerin sublingual spray) in hot water or near radiators, stoves or other sources of heat. Do not expose to temperature over 40°C. Store at room temperature 15ºC to 30ºC.

Keep in a safe place and out of the 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-NITROGLYCERIN:

• Talk to your healthcare professional

• Find the full product monograph that is prepared

  for healthcare professionals and includes this

  Consumer 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.

  Manufactured by: Manufactured for: Groupe Parima Apotex Inc.

  Montreal, Quebec Toronto, Ontario

Last revised: December 10, 2018

CIALIS^® is a registered trade-mark of ELI LILLY AND COMPANY.

LEVITRA^® is a registered trade-mark of BAYER AG VIAGRA^® is a registered trade-mark of PFIZER PRODUCTS INC.

EMLA^® is a registered trade-mark of the ASTRAZENECA group of companies.

ADEMPAS^® is a registered trade-mark of BAYER AG.