Vitaros: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Vitaros is used in the treatment of male erectile dysfunction (ED). Erectile dysfunction is the inability to attain or maintain an erection sufficient for sexual intercourse.

What it does:

Vitaros cream works by inducing local relaxation of blood vessels (vasodilation) allowing blood to fill and engorge the penis thereby causing an erection.

When it should not be used:

You should not use Vitaros if you have any of the following conditions:

• Known hypersensitivity to alprostadil or any of the

  ingredients in Vitaros.

• Have conditions that might predispose you to priapism

  (erections lasting longer than 4 hours), such as sickle cell anemia or trait, thrombocythemia, polycythemia or multiple myeloma or, leukemia.

• Abnormal penile anatomy such as severe hypospadias, or

  anatomical deformation of the penis, such as curvature, and if you have acute or chronic urethritis (inflammation of the urethra), urinary tract infection or balanitis (inflammation/ infection of the glans of the penis).

• Prone to venous thrombosis or if you have a

  hyperviscosity syndrome and are therefore at increased risk of priapism (erections lasting 4 or more hours).

• Have been advised not to undertake sexual activity.

• Vitaros should not be used for sexual intercourse with

  pregnant or breast feeding women unless you or your partner uses a condom barrier.

• A history of orthostatic hypotension, syncopal (fainting)

  episodes or presyncopal symptoms (dizziness), or history of myocardial infarction (heart attack).

What the medicinal ingredient is:

alprostadil

What the important nonmedicinal ingredients are:

dodecyl-2-N,N-dimethylaminopropionate hydrochloride

What dosage forms it comes in:

Vitaros is a topical cream. Vitaros cream is available in two strengths 220 mcg or 330 mcg alprostadil per 100 mg of cream. It comes in a unit dose dispenser (Fig. 1) which is packaged in a foil pouch. Each unit dose delivers either 220 mcg of 330 mcg alprostadil for one-time use.

Fig. 1: Diagram of dispenser

WARNINGS AND PRECAUTIONS

Vitaros will not protect you or your partner from sexually transmitted infections (STIs) including human immunodeficiency virus (HIV/AIDS) and human papilloma virus (HPV). For protection against STIs, it is advisable to use latex condoms. Vitaros does not prevent pregnancy.

Vitaros is not to be used in oral sex (fellatio).

BEFORE you use Vitaros talk to your doctor or pharmacist if:

• have heart disease, low blood pressure. Vitaros causes low blood pressure and syncope (fainting)

• have conditions that might predispose you to priapism

  (erections lasting longer than 4 hours)

• have liver problems
• have kidney problems
• have a stroke
• have lung disease
• have a penile implant

While using Vitaros:

Do not drive a car or engage in hazardous tasks within 1 to 2 hours after using Vitaros because Vitaros can cause dizziness or fainting.

You must use a latex condom every time you have sexual intercourse with a female partner who is pregnant or can get pregnant or breast feeding.

It is also recommended that the female partner who can get pregnant (child bearing potential) must use effective birth control

methods. Although Vitaros has not been studied in human pregnancy.

Vitaros is not recommended for use in patients under 18 years of age.

INTERACTIONS WITH THIS MEDICATION

Always tell your doctor or pharmacist about all the medicines you take or have taken, including prescription and non-prescription medicines, vitamins and herbal supplements. Also tell your doctor if you are taking any other treatment for erectile dysfunction.

PROPER USE OF THIS MEDICATION

Your doctor and you should discuss to decide the proper dose for you. Do not use Vitaros until your doctor has shown you the right way to use it.

Usual dose: one 220 mcg or 330 mcg unit dose to be applied to

the tip of the penis within 5 to 30 minutes prior to attempting intercourse. Do not insert the dispenser tip into the penis opening. The effect may last up to 1 to 2 hours. Do not use more than one application of Vitaros in a 24 hours period.

HOW TO USE VITAROS:

1. 1.

   Wash your hands before applying Vitaros. Remove the dispenser

   from the foil pouch by tearing fully across from the notched edge. Remove the dispenser from the pouch. Save the pouch for discarding the dispenser later. Remove the cap from the tip of the dispenser using your thumb and forefinger. See Fig. 2.

2. 2.

   Grasp the tip of the penis with one hand and gently manipulate

   to widen the opening (urethra) of the penis. See Fig. 3 (Note: If you are not circumcised, first retract and hold the foreskin back prior to widening the opening of the penis).

3. 3.

   Hold the barrel of the dispenser between your fingers and place

   the tip of the dispenser over the opening of the penis and slowly (over 5 to 10 seconds) push down the plunger with your finger until all of the cream is expelled from the dispenser barrel. Note: Do not insert the tip of the dispenser into the penis. See Fig. 4.

4. 4.

   Hold the penis in an upright position for approximately 30

   seconds in order to allow the cream to penetrate. Any excess cream covering the opening may be rubbed gently into the surrounding application site (glans) with the tip of the finger. The amount of excess cream will vary depending on the patient and it is not unusual that up to half of the dose will remain at the edge of the opening.

5. 5.

   Remember, each Vitaros dose is good for a single

   administration only. Replace the cap on the dispenser and place in the opened foil pouch, fold and discard as normal household waste.

   1. 6. Vitaros cream may be irritating to the eyes. Wash your hands after applying the cream.

OVERDOSE

If you have used more Vitaros than you should, contact your doctor or poison control centre.

Figure 2

Opening of penis

Figure 3 Plunger

Barrel

Tip

Protective

Cap

Press down on plunger to deposit cream into opening of penis

Figure 4

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines Vitaros can cause some side effects.

Very Common side effects:

• local aching, burning or pain and erythema (redness) Common side effects:
• balanitis (inflammation or infection of the glands of the penis)

• penis disorders (prolonged or extended erections, throbbing,

  numbness, excessive rigidity, lack of sensation of penis tip)

• tingling, itching, swelling (edema), an abnormal penis

  sensitivity (hyperesthesia)

• light-headedness, dizziness

Uncommon side effects:

• fainting (syncope)
• low blood pressure (hypotension)
• vertigo
• pain, pelvic pain
• irritation, urethra
• rapid, pulse (tachycardia)
• priapism (erections longer than 4 hours)

Priapism is a persistent erection lasting more than 4 hours and is a serious condition that requires prompt treatment by a doctor. IF YOUR ERECTION IS RIGID FOR MORE THAN 4 HOURS, CALL YOUR DOCTOR IMMEDIATELY.

Side effects of Vitaros in female partners of the male patients: Common side effects:

• vaginal burning
• vaginitis (inflammation)

• vulvovaginal disorders (itching, burning, stinging, pain,

  spasms or discharge)

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

HOW TO STORE IT

Keep Vitaros out of the reach of children.

This product has a limited shelf-life. Before use, check the expiration date on the package. Do not use if product has expired.

Vitaros should be stored in a refrigerator (at 2°C to 8°C or 36°F to 46°F) and should not be kept at room temperature (not more than 30°C or 86°F) more than 7 days prior to use. It is very important that Vitaros not be exposed to temperatures above 30°C or 86°F since this will make Vitaros less effective. Vitaros should not be stored at high temperatures or placed in direct sunlight.

Storage When Traveling

When traveling, Vitaros can be stored in a portable ice pack or cooler. Do not store in the trunk of a car or in baggage storage areas where Vitaros may be exposed to extremes in elevated temperature.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

You can report any suspected adverse reactions associated with the use of health products in the Canada Vigilance Program by one of the following 3 ways:

Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and:

1. 1. Fax toll-free to 1-866-678-6789, or
2. 2.

   Mail to: Canada Vigilance Program

   Health Canada

   Postal Locator 0701C

   Ottawa, ON K1A0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at

www.healthcanada.gc.ca/medeffect.

Note: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.abbott.ca

or http://www.vitaros.ca

or by contacting the sponsor, BGP Pharma Inc., Saint-Laurent, Qc H4S 1Z1 at 1-800-699-9948.

Vitaros^TM is a trademark of NexMed International Limited.

Last revised: January 8, 2015