Details for: VERKAZIA
Company: SANTEN INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02484137 | VERKAZIA | CYCLOSPORINE | 0.1 % / W/V | EMULSION | OPHTHALMIC |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Verkazia is used in children [4 years through adolescents (12 to 18 years of age)] to treat a severe form of eye allergy called “vernal keratoconjunctivitis”.
What it does
Verkazia is thought to:
- Lower the production of chemicals that cause inflammation (swelling).
- Reduce inflammation in the cornea (clear layer at the front of the eye) and conjunctiva (thin membrane covering the eye).
When it should not be used
Do not use Verkazia if you:
- are allergic to cyclosporine or any of the other ingredients in Verkazia (listed above).
- have an eye infection.
- have a cancer or a precancerous condition in or around your eye.
What the medicinal ingredient is
cyclosporine
What the non-medicinal ingredients are
Cetalkonium chloride, glycerol, medium-chain triglycerides, poloxamer 188, tyloxapol, sodium hydroxide (to adjust pH), water for injection.
What dosage form it comes in
Eye drop emulsion (liquid mixture), 0.1% w/v.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Verkazia. Talk about any health conditions or problems you may have, including if you:
- have a history of herpes, chickenpox, shingles, or another similar virus in or near your eye.
- have any other kind of eye disease.
Contact lenses: Verkazia has not been studied in patients wearing contact lenses. If you wear contact lenses, using Verkazia is not recommended.
Pregnancy and breastfeeding: If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, talk to your healthcare professional before using Verkazia.
Do not use Verkazia if you are pregnant. If you might become pregnant while using this medicine, you must use birth control.
Verkazia may pass into breast milk in very small amounts. If you are breastfeeding talk to your healthcare professional before using Verkazia.
Driving and using machines: After using Verkazia, your vision might be blurry for a while. If this happens, wait until your vision clears before you drive or use machines.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with Verkazia:
Talk to your healthcare professional if you are using eye drops that contain steroids. They
might increase the risk of side effects if used with Verkazia.
Proper use of this medication
How to take Verkazia:
- Verkazia is for use in the eyes only.
- Always use Verkazia exactly as your healthcare professional has told you. Ask your healthcare professional if you are not sure.
- Do not stop using Verkazia without talking to your healthcare professional. If you stop using Verkazia your eye allergy could get worse, and this could lead to problems with your vision.
- If you are using any other eye drops wait at least 15 minutes after using them before using Verkazia.
Usual Dose
The recommended dose for children (4 -18) is 1 drop of Verkazia in the affected eye(s) 4 times
a day (morning, noon, afternoon and evening).
Adults should help children when starting treatment, especially if the child is younger than 10
years old. Adults should continue to help until the child is able to properly use Verkazia alone.
Instructions for use:
Follow these instructions carefully. Ask your healthcare professional if there is anything you do
not understand.
1. Wash your hands.
2. Open the aluminum pouch, which contains 5 single-dose containers.
3. Take 1 single-dose container from the aluminum pouch. Leave the remaining containers in
the pouch.
4. Gently shake the single-dose container.
5. Twist off the cap (picture A).
6. Pull down your lower eyelid (picture B).
7. Tilt your head back and look up at the ceiling.
8. Gently squeeze 1 drop of the medicine onto your eye. Make sure that the tip of the container
does not touch your eye. If a drop misses your eye, try again.
9. Blink a few times so that the medicine spreads across your eye.
10. After using Verkazia, press the corner of your eye closest to your nose and gently close the
eyelid for 2 minutes (picture C). This stops Verkazia from getting into the rest of the body.
11. If you need to use drops in both eyes, repeat steps 6 to 10 for your other eye. There is
enough medicine in one single-dose container to use in both eyes.
12. Throw away the empty container after use. If there is any unused medicine, return the
container to the pharmacy for disposal.
Overdose
If you put more Verkazia onto your eye than you should, rinse your eye with water. Do not apply any more drops until your next regular dose.
Missed Dose
If you forget to use Verkazia, skip that dose and continue with the next dose as planned. Do not double your dose to make up for the dose you forgot.
Side effects and what to do about them
These are not all the side effects you may feel when taking Verkazia. If you experience any
side effects not listed here, contact your healthcare professional. The most common side
effects while using Verkazia occur in and around the eyes.
Side effects may include:
- Eye pain
- Itching or redness in or around the eye
- Irritation and discomfort in or around the eye, including a feeling that there is something in your eye
- Increased watering of the eye
- Reduced vision
- Runny nose, sore throat and other symptoms of the common cold
- Ear pain
- Cough
- Headache
- Swelling and redness on the edge of the eyelid
How to store
Do not freeze. Store Verkazia below 30°C.
Do not use Verkazia after the expiration date that appears on the outer carton, pouch and
single-dose container after "EXP". The expiration date is the last day of that month.
After opening the pouch, keep single-dose containers in the pouch to protect from light and
avoid evaporation. Any opened single-dose container with any medicine left over should be
thrown out immediately after use.
Keep out of reach and sight of children.
Do not throw away any medicines via wastewater or household waste. Return unused
medicine to your pharmacist for disposal.
Reporting 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 three ways:
- 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 ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
If you want more information about Verkazia:
- Talk to your healthcare professional.
- This document plus the full product monograph, prepared for healthcare professionals can be found by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website (www.santencanada.ca), or by calling 1-855-7-SANTEN (1-855-772-6836).
Last Revised DEC-21-2018.