Nitrol: Uses, Side Effects and Dosage

Serious Warnings and Precautions

Do NOT take any medication for the treatment of impotence (erectile dysfunction) such as VIAGRA* (sildenafil citrate), CIALIS* (tadalafil), LEVITRA* or STAXYN* (vardenafil) while using NITROL. Using NITROL together with medication for erectile dysfunction can result in life-threatening low blood pressure (hypotension) causing fainting, heart attack and death.

What is NITROL used for?

NITROL is used in adults to prevent angina (chest pain).

NITROL is not intended to be used for acute angina attacks. Sublingual nitroglycerin medications should be used if you are having an acute angina attack.

How does NITROL work?

NITROL is an ointment applied directly on the skin. The nitroglycerin passes through the skin, allowing medication to be absorbed directly into the bloodstream. Nitroglycerin causes the blood vessels to relax and increases the supply of blood and oxygen to the heart reducing the likeliness of having an angina attack.

NITROL usually begins to work within 15 minutes from the time of its application. The reason for this is that it takes about 10-15 minutes for nitroglycerin to diffuse through the skin and get into the bloodstream.

What are the ingredients in NITROL?

Medicinal ingredient: 2% Nitroglycerin

Non-medicinal ingredients: Lanolin, petrolatum and purified water

NITROL comes in the following dosage forms:

Ointment: 2% w/w

Do not use NITROL if you:

• are allergic to nitroglycerin, nitrates, or to any non-medicinal ingredient in the formulation
• have severe anemia (low iron levels in your blood or low red blood cell count)
• are taking medications used to treat high blood pressure in your lungs such as ADEMPAS* (riociguat), REVATIO* (sildenafil citrate) or ADCIRCA* (tadalafil)
• have had a recent heart attack, or other serious heart problems, stroke or head injury
• have low blood pressure (hypotension)
• are taking medication for erectile dysfunction such as VIAGRA* (sildenafil citrate), CIALIS* (tadalafil), LEVITRA* or STAXYN* (vardenafil)
• experience lightheadedness, dizziness or fainting when going from lying or sitting to standing up (postural hypotension)
• have narrowing of the heart valves
• have an eye disease called closed angle glaucoma or any other condition that increases the pressure in your eyes
• have a condition caused by an increase in normal brain pressure (increased intracranial pressure).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NITROL. Talk about any health conditions or problems you may have, including if you:

• have heart failure
• have low blood pressure or take diuretics (“water pills”)
• have lung disease

• are breast feeding, pregnant or intend to become pregnant. Your healthcare professional will decide whether you should use NITROL and what extra care should be taken during its use

• are less than 18 years old or older than 65 years of age
• are dehydrated or suffer from excessive vomiting, diarrhea or sweating
• have angina due to hypertrophic cardiomyopathy

Other warnings you should know about:

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to NITROL. Dizziness, lightheadedness, or fainting can occur, especially after the first dose and when the dose is increased.

Tolerance to NITROL 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 NITROL. Talk to your healthcare professional if you wish to discontinue using NITROL.

NITROL is not for use in children.

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

Serious Drug Interactions

If you are currently taking medications for the treatment of impotence (erectile dysfunction), such as sildenafil citrate, tadalafil, or vardenafil, or any other similar medication (PDE5 inhibitors), the use of NITROL 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 NITROL (e.g. in case of chest pain caused by an acute attack of angina) please seek emergency medical assistance immediately.

The following may interact with NITROL:

• Do not take any drugs used to treat erectile dysfunction such as VIAGRA* (sildenafil citrate), CIALIS* (tadalafil), LEVITRA* or STAXYN* (vardenafil) if you are using NITROL
• Do not use NITROL if you are taking drugs used to treat high blood pressure in your lungs such as ADEMPAS* (riociguat), REVATIO* (sildenafil citrate) or ADCIRCA* (tadalafil)
• Other drugs that may have the same effect as NITROL

• Drugs used to treat high blood pressure, such as:

  • Diuretics (“water pills”)
  • Calcium Channel Blockers (e.g. diltiazem, nifedipine, verapamil)
  • ACE Inhibitors
  • Beta-Blockers
• Drugs used to treat depression called “tricyclic antidepressants”
• Tranquilizers

• Alcohol

• Drugs used to treat migraine headaches (e.g. dihydroergotamine)
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling (e.g. ibuprofen, naproxen, celecoxib and aspirin).

How to use NITROL:

• NITROL can be applied to any area of the body. Most patients prefer the chest but it can be applied to the wrist, arm, back, chest, thigh, or calf.
• Apply NITROL lightly to the skin by spreading it thinly onto the chosen body part. Do NOT rub NITROL into the skin. Rubbing NITROL into the skin can cause too much of the drug to be absorbed which can cause unwanted effects.
• Once applied to the skin NITROL should be covered with the Appli-Ruler paper, plastic kitchen wrap or other suitable material. This can be held in place with adhesive or transparent tape, a tennis sweatband or other homemade stretch bands (cut portions of stretch socks make suitable cover-ups). Covering the area where NITROL has been applied allows the drug to enter the bloodstream in a controlled manner which provides the best control of your symptoms. It also prevents soiling of clothing. Do NOT use tight elastic bands to hold the cover in place that might stop normal blood flow.

• Before applying the next dose of NITROL, wipe off any remaining ointment from the skin where the previous dose was applied. Cleaning the area with soap and water will also protect

  • clothing.
• NITROL can cause a slight reddening of the skin in the area where it is applied, especially when applied to an area recently in contact with adhesive tape. The redness is temporary and generally disappears within a few hours.

Using the Appli-Ruler to determine your dose:

1. 1. Using the Appli-Ruler, measure 1.25 cm (1/2 inch) of NITROL and apply it to the skin as explained above.
2. 2. Wait 30 minutes to see if a headache develops.
3. 3. If a headache does not develop, increase the dose by 1.25 cm (1/2 inch) increments every 30 minutes until persistent headache develops.
4. 4. After the dose which produced a headache has been determined, reduce the dose by 1.25 cm (1/2 inch). This amount of NITROL is your proper dose.

Usual adult dose:

1. 1. The usual adult dose is 2.5 to 5 cm (1 to 2 inches).
2. 2. The dose may be applied every 3-8 hours.

Overdose:

Symptoms of overdosage may include: flushing, headache, nausea, dizziness and low blood pressure.

What are possible side effects from using NITROL?

These are not all the possible side effects you may feel when taking NITROL. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

Side effects may include:

• Headache
• Flushing of the face
• Nausea
• Vomiting
• Rash, redness, itching and/or burning in the area where the ointment is applied.

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, talk to your healthcare professional.

Reporting Side Effects

Storage:

Keep NITROL tubes tightly closed and store at room temperature (15 – 30 ˚C).

Keep out of reach and sight of children.

If you want more information about NITROL:

• 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 (http://www.hc-sc.gc.ca); the manufacturer’s website http://www.paladinlabs.com,

  or by calling 1-888-867-7426.

Last Revised: August 26, 2015

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