Patient Medication Information: uses, side effects, how to take - Zuacta
ABOUT THIS MEDICATION
What the medication is used for:
ZUACTA (zucapsaicin) is used in conjunction with oral COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) for the relief of severe pain in adult patients with osteoarthritis of the knee, not controlled with oral COX-2 inhibitors or NSAIDs alone, for duration of no more than three months.
What it does:
ZUACTA is the brand name of a topical cream containing zucapaicsin. Zucapsaicin reduces the pain sensed from the knee it is believed by lowering certain body chemicals in the skin that cause pain.
Small nerves in your skin and joints contain chemicals called substance P. Substance P is the principal chemical which transmits pain sensation from the skin and joints to the brain.
When it should not be used:
You should not use ZUACTA if you have
A kown history of allergy (hypersensitivity) to zucapsaicin or
to any of the other ingredients of ZUACTA (see “What the nonmedicinal ingredients are” in this section).
Broken skin or open wounds over the knee(s) to which you
wish to apply ZUACTA.
What the medicinal ingredient is:
Zucapsaicin, 0.075%.
What the nonmedicinal ingredients are:
ZUACTA also contains benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, polyethylene glycol 100 stearate, purified water, sorbitol solution and, white petrolatum.
What dosage forms it comes in:
ZUACTA is a topical cream that is available in a 30 g and 60 g tube.
WARNINGS AND PRECAUTIONS
BEFORE you use ZUACTA talk to your doctor or pharmacist if:
You are or think that you may be pregnant, or are planning to
become pregnant;
- You are breast feeding;
- You have knee pain not due to osteoarthritis.
INTERACTIONS WITH THIS MEDICATION
Before using ZUACTA tell your doctor or pharmacist about your other medicines, including medicines obtained without a prescription.
You should avoid applying other lotions, creams or ointments to the areas of the skin that you are treating with ZUACTA.
PROPER USE OF THIS MEDICATION
Usual dose:
Always use ZUACTA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Apply ZUACTA to unbroken skin of the affected knee three times a day, evenly spaced throughout the waking hours, and not more often than every 4 hours.
Each time apply a pea sized amount to three separate areas around the affected knee(s) then gently rub in, using a circular motion to cover the entire surface (front, side, and back) of the affected knee(s). There should be no residue left on the skin. Areas treated with ZUACTA should not be bandaged or wrapped.
Hands should be washed with soap and warm water immediately after application of ZUACTA.
During application, avoid getting ZUACTA into eyes, lips or genital areas. If you experience a burning sensation in these areas, gently rinse with soap (no soap for the eyes) and cool water. Alternatively, wet a cloth with cold water and gently press it against the area until the sensation goes away.
Avoid taking a hot bath or shower just before or after applying ZUACTA as a burning sensation may result.
Overdose:
In case of overdose, contact your doctor, or poison control centre, or emergency room of the nearest hospital immediately.
Missed Dose:
The usual daily dosage schedule is to apply ZUACTA to painful knee joints three times daily. If you forget to apply ZUACTA, continue using it again as directed, but do not use it more frequently than three times daily. These applications should be at least 4 hours apart.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, ZUACTA can cause side effects.
Very common (that affect 1 person in 10 or more)
- burning sensation at the application site
IMPORTANT: PLEASE READ
PrZUACTA™ Product Monograph Page 21 of 21 Common (that affect 1 person in 100 or more)
- warmth at the application site
- loss of sensation at the application site
- itching at the application site
- irritation at the application site
- rash at the application site
- pain at the application site
- joint pain
- burning sensation
- headache
- cough
- sneezing
- eye irritation
Uncommon side effects (that affect less than 1 person in 100): Application site swelling, cold feeling, blisters, redness, skin dryness, stuffy nose, nasal irritation, throat irritation, arm/leg aches or pain, joint disorder, skin discoloration, flushing, itching, rash, shortness of breath, and sensitivity to the sun.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Uncommon* | Allergic reaction to the product (hives or skin rash which may cover large parts of your body, wheezing or shortness of breath, swelling of the face or tongue) | √ | √ | |
* Not observed in clinical studies involving almost 1000 subjects. Actual frequency may be rare or very rare.
This is not a complete list of side effects. For any unexpected effects while taking ZUACTA, contact your doctor or pharmacist.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
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- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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.
HOW TO STORE IT
Store between 15°C and 30°C (room temperature).
Keep out of the reach and sight of children and pets. The cap should be secured tightly to prevent accidental ingestion.
Do not use ZUACTA after the expiry date which is stated on the tube. The expiry date refers to the last day of that month. Once opened, the tube should be used within 6 weeks.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.sanofi-aventis.ca or by contacting the sponsor, sanofi-aventis Canada Inc., at: 1-800-265-7927