Details for: APO-GATIFLOXACIN
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02327260 | APO-GATIFLOXACIN | GATIFLOXACIN (GATIFLOXACIN HEMIHYDRATE) | 0.3 % | 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
APO-GATIFLOXACIN ophthalmic solution is used to treat the signs and symptoms of bacterial conjunctivitis (pink eye).
Antibacterial drugs like APO-GATIFLOXACIN ophthalmic solution treat only bacterial infections. They do not treat viral infections.
What it does
APO-GATIFLOXACIN ophthalmic solution is an antibiotic that kills and stops the growth of bacteria in the eye.
When it should not be used
Do not use APO-GATIFLOXACIN ophthalmic solution if you:
- have ever had an allergic reaction to TEQUIN™ (gatifloxacin) Tablets or I.V., or any medicine in the group of antibiotics known as “quinolones”, such as CIPRO® (ciprofloxacin), LEVAQUIN® (levofloxacin), AVELOX® (moxifloxacin), OCUFLOX® (ofloxacin), or NOROXIN® (norfloxacin).
- are allergic to any component of APO-GATIFLOXACIN ophthalmic solution (See section What are the ingredients in APO-GATIFLOXACIN ophthalmic solution).
What the medicinal ingredient is
Medicinal ingredient: gatifloxacin, which is a member of the group of antibiotics known as “quinolones”.
What the non-medicinal ingredients are
Nonmedicinal ingredients: benzalkonium chloride as preservative, edetate disodium, sodium chloride and water for injection. It may also contain hydrochloric acid and or sodium hydroxide.
What dosage form it comes in
Ophthalmic solution, 0.3% w/v
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you use APO-GATIFLOXACIN ophthalmic solution. Talk about any health conditions or problems you may have, including if you:
- wear soft contact lenses ·
- have allergies to any medications.
- are pregnant or intend to become pregnant
- are breast-feeding or intend to breast-feed
Other warnings you should know about:
Do not use any other eye (ophthalmic) medicines without talking to your healthcare professional.
If you develop pain or swelling in your tendons, stop using APO-GATIFLOXACIN ophthalmic solution and get immediate medical help. This is more likely to happen if you are elderly or taking corticosteroids at the same time as APO-GATIFLOXACIN ophthalmic solution.
Contact Lenses
You should not wear contact lenses when you are suffering bacterial conjunctivitis (pink eye). APO-GATIFLOXACIN contains a preservative called benzalkonium chloride. It may discolour your soft contact lenses. If you must wear contact lenses, remove them before using APO-GATIFLOXACIN. Wait 15 minutes after using the drops before you put your lenses back in.
Driving and using machines
Your vision may be temporarily blurred after using APO-GATIFLOXACIN. Wait until you can see clearly before driving or using machines.
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Proper use of this medication
- Use APO-GATIFLOXACIN ophthalmic solution as directed by your healthcare professional. Do not change the dosage of the drug without consulting your healthcare professional. If you stop treatment contact your healthcare professional immediately.
- Although you may feel better early in the treatment, APO-GATIFLOXACIN ophthalmic solution should be used exactly as directed.
- Misuse or overuse of APO-GATIFLOXACIN ophthalmic solution could lead to the growth of bacteria that will not be killed by APO-GATIFLOXACIN ophthalmic solution (resistance). This means that APO-GATIFLOXACIN ophthalmic solution may not work for you in the future.
- Do not share your medicine.
- To help prevent infections and eye injury, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle immediately after you have used it.
Follow the following steps to use APO-GATIFLOXACIN ophthalmic solution properly for each eye that needs treatment:
- Wash your hands. Tilt your head back and look at the ceiling. (See Illustration1)
- Gently pull down your lower eyelid down to create a small pocket. (See Illustration 2)
- Turn the bottle upside down and squeeze it gently to release one drop into the eyelid pocket. If a drop misses your eye, try again. (See Illustration 3)
- Let go of your lower eyelid, and close your eye for 30 seconds. (See Illustration 4)
- Repeat steps 1 to 4 in the other eye if both eyes need treatment.
Usual dose
On days 1 and 2, instill one drop every two hours in the affected eye(s) while awake, up to 8 times daily.
On days 3 to 7, instill one drop four times daily in the affected eye(s) while awake. Doses should be evenly spaced throughout the day.
Overdose
If APO-GATIFLOXACIN ophthalmic solution is swallowed, contact your healthcare professional or poison control centre.
If you accidentally add too many drops to the eye, APO-GATIFLOXACIN ophthalmic solution may be flushed from the eye(s) with warm water.
If you think you have used too much APO-GATIFLOXACIN ophthalmic solution, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
If you forget to apply your eye drops at your normal time, apply them as soon as you remember. Then go back to the original schedule as directed by your healthcare professional. Don’t try to catch up on missed drops by applying more than one dose at a time.
Side effects and what to do about them
These are not all the possible side effects you may feel when using APO-GATIFLOXACIN ophthalmic solution. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- altered sense of taste
- blurred vision
- dizziness
- light sensitivity
- nausea
- runny nose
- sneezing
- sore throat
- spots on the cornea
- swelling or other disorders of the area around the cornea
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Allergic Reaction: difficulty breathing, difficulty swallowing, fever, hives, itchy skin, rash, swelling of your tongue or throat, swelling or redness of the skin | ✔ | ||
| Eye irritation or any new eye problems such as: dryness of the eye, swelling or redness of the eyelid, tearing or eye discharge, decreased vision, or eye pain | ✔ | ||
| Corneal melts and perforation (damage to a part of your eye): vision loss, eye pain and leakage that may be mistaken as tears | ✔ | ||
| Stevens-Johnson Syndrome (life-threatening skin condition): blisters, rash, skin peeling, especially in mouth and eyes, skin pain | ✔ |
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.
How to store
Keep the dispensing container tightly closed when not in use. Store at room temperature 15ºC to 30ºC, protect from freezing.
Discard container 28 days after opening.
Do not use APO-GATIFLOXACIN ophthalmic solution after the expiration date (marked “EXP”) on the bottle and the box.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about APO-GATIFLOXACIN ophthalmic solution:
- 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 (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); Find the Patient Medication Information on the manufacturer's website http://www.apotex.ca/products, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: February 3, 2020