Details for: SANDOZ DORZOLAMIDE
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02316307 | SANDOZ DORZOLAMIDE | DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) | 2 % | SOLUTION | OPHTHALMIC |
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
Sandoz Dorzolamide is the brand name for the medication dorzolamide hydrochloride available only on prescription through your doctor. Sandoz Dorzolamide is an ophthalmic carbonic anhydrase inhibitor. Sandoz Dorzolamide is prescribed to lower the raised pressure in your eye(s) because you have increased pressure in your eye(s) or glaucoma.
What it does
Sandoz Dorzolamide inhibits the enzyme carbonic anhydrase to reduce production of the watery secretion of the eye, which helps reduce the pressure in your eye.
Remember – This medicine is prescribed for the particular condition that you have. Do not give this medicine to other people, nor use it for any other condition.
When it should not be used
Do not use this medicine after the date shown on the container.
Do not use Sandoz Dorzolamide if you:
- are allergic to any of its components (see What the important nonmedicinal ingredients are).
- have severe kidney problems.
- are taking oral carbonic anhydrase inhibitors.
What the medicinal ingredient is
2% dorzolamide present as the hydrochloride salt, a sulphonamide-related compound.
What the non-medicinal ingredients are
Benzalkonium chloride (as a preservative), hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide and water for injection.
What dosage form it comes in
Sandoz Dorzolamide 2% are sterile eye drops supplied in a white LDPE plastic DROP-TAINER® bottle, a white dropper tip and an orange polypropylene cap.
Warnings and precautions
This medicine may not be suitable for some patients. So, tell your doctor if you think any of the following applies to you:
If you have any medical problems now or have had any in the past, including eye (corneal) defects, or previous eye surgery while using dorzolamide;
- If you are using any other medications (see INTERACTIONS WITH THIS MEDICATION).
- If you have any allergies to any medications.
- Sandoz Dorzolamide contains the preservative benzalkonium chloride. If you wear contact lenses, you should consult your doctor before using Sandoz Dorzolamide. Do not administer while wearing (soft) contact lenses. Remove lenses before application and reinsert no earlier than 15 minutes after use.
- If you are pregnant or intend to become pregnant.
- If you are breast feeding or intend to breast feed.
- If you have now or have had in the past kidney or liver problems.
If any of the following occur during treatment with Sandoz Dorzolamide, consult your doctor immediately.
- If you suspect that Sandoz Dorzolamide is causing an allergic reaction such as skin rash or itching or other reactions in the eye, such as conjunctivitis.
- If you develop any eye infection or any eye irritation or any new eye problem such as redness of the eye or swelling of the eyelids.
- If you have an eye surgery or if you suffer an eye injury.
- If you have severe skin reactions with symptoms such as blisters, peeling skin, red/purple rash, skin lesions and sores, and associated fever, sore throat.
SANDOZ DORZOLAMIDE IS NOT RECOMMENDED FOR CHILDREN.
In studies with dorzolamide hydrochloride ophthalmic solution, the effect of dorzolamide hydrochloride was similar in both elderly and younger adult patients.
Interactions with this medication
Your doctor also needs to know about drugs (including eye drops) that you are using or plan to use, including drugs obtained without a prescription, in particular, large doses of ASA (acetylsalicylic acid) or sulfa drugs.
Proper use of this medication
- Do not start taking any other medicines unless you have discussed the matter with your doctor.
- If more than one topical ophthalmic drug is being utilized, the drugs should be administered at least ten minutes apart.
- If your doctor has recommended you use Sandoz Dorzolamide with a beta-blocker eye drop to lower eye pressure, then the dose is one drop of Sandoz Dorzolamide in the affected eye(s) in the morning and in the evening.
- Do not change the dosage of the drug without consulting your doctor. If you must stop treatment, contact your doctor immediately.
- Do not allow the tip of the container to touch the eye or areas around the eye. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the container, keep the tip of the container away from contact with any surface.
Usual Adult Dose
The appropriate dosage and duration of treatment will be established by your doctor.
When Sandoz Dorzolamide is used alone, the dose is one drop in the affected eye(s) in the morning, in the afternoon and in the evening.
Overdose
Missed Dose
It is important to apply Sandoz Dorzolamide as prescribed by your doctor. If you miss a dose, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule.
How to Use The DROP-TAINER®* BOTTLE
KEEP YOUR HEAD TILTED BACKWARD AND CLOSE YOUR EYE TO ALLOW ABSORPTION OF THE MEDICATION INTO THE EYE.
10. Repeat 6, 7, 8, & 9 with other eye if instructed to do so.
11. Replace screw cap by turning until firmly touching the bottle.
Ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. If you think that your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.
The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
After you have used all doses, there will be some Dorzolamide 2% ophthalmic solution left in the bottle. You should not be concerned since an extra amount of Dorzolamide 2% ophthalmic solution has been added and you will get the full amount of Dorzolamide 2% ophthalmic solution that your doctor prescribed. Do not attempt to remove excess medicine from the bottle.
Side effects and what to do about them
Any medicine may have unintended or undesirable effects, socalled side effects.
You may experience eye symptoms such as burning and stinging, blurred vision, itching, tearing, redness of the eye(s), eye pain, or swelling or crusting of the eyelids. You may sense a bitter taste after putting in your eye drops.
Other side effects may include headache, nosebleed, dry mouth, nausea, tiredness, kidney stones and rarely, rash such as severe skin reactions. If you develop a severe skin reaction with symptoms such as blisters, peeling skin, red/purple rash, skin lesions and sores, and associated fever, sore throat, stop taking this medication immediately and contact your physician.
There have been postmarketing experience reports of allergic reactions to dorzolamide hydrochloride with symptoms such as tissue swelling, difficulty in breathing, itching, and urticaria (raised skin rash). If this occurs, stop taking this medication and contact your doctor.
Your doctor or pharmacist has a complete list of the possible side effects from this medication. Please tell your doctor or pharmacist promptly about any unusual symptom.
Possible side effects such as visual disturbances may affect the ability to drive and use machines.
If the contents of the container are swallowed, you should contact your doctor immediately.
This is not a complete list of side effects. For any unexpected effects while taking Sandoz Dorzolamide contact your doctor or pharmacist.
How to store
Store at 2 °C - 25°C. Protect from light. Keep away from children.
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
This document, plus the full product monograph prepared for
health professionals, can be obtained by contacting the sponsor,
Sandoz Canada Inc., at: 1-800-361-3062
or
by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8
or by e-mail at : medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last revised: January 31, 2012