Patient Medication Information: uses, side effects, how to take - Apo-Gatifloxacin
What is APO-GATIFLOXACIN used for?
APO-GATIFLOXACIN is used to treat the signs and symptoms of bacterial conjunctivitis (pink eye).
Antibacterial drugs like APO-GATIFLOXACIN treat only bacterial infections. They do not treat viral infections.
How does APO-GATIFLOXACIN work?
APO-GATIFLOXACIN is an antibiotic that kills and stops the growth of bacteria in the eye.
What are the ingredients in APO-GATIFLOXACIN?
Medicinal ingredient: gatifloxacin, which is a member of the group of antibiotics known as “quinolones”.
Non-medicinal ingredients: benzalkonium chloride, as preservative, edetate disodium, sodium chloride and water for injection. It may also contain hydrochloric acid and or sodium hydroxide.
APO-GATIFLOXACIN comes in the following dosage forms:
Ophthalmic solution, 0.3% w/v
Do not use APO-GATIFLOXACIN if:
- 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 (See section What are the ingredients in APO-GATIFLOXACIN).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-GATIFLOXACIN. 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 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.
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.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
There are no known relevant interactions at this time.
How to take APO-GATIFLOXACIN:
- Use APO-GATIFLOXACIN 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 should be used exactly as directed.
- Misuse or overuse of APO-GATIFLOXACIN could lead to the growth of bacteria that will not be killed by APO-GATIFLOXACIN (resistance). This means that APO-GATIFLOXACIN 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 these steps to use APO-GATIFLOXACIN properly for each eye that needs treatment:
- 1. Wash your hands. Tilt your head back and look at the ceiling. (See Illustration 1)
- 2. Gently pull down your lower eyelid down to create a small pocket. (See Illustration 2)
- 3. 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)
- 4. Let go of your lower eyelid, and close your eye for 30 seconds. (See Illustration 4)
- 5. 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 is swallowed, contact your healthcare professional or poison control centre.
If you accidentally add too many drops to your eye, APO-GATIFLOXACIN may be flushed from your eye(s) with warm water.
| If you think you, or a person you are caring for, have taken too much APO-GATIFLOXACIN, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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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.
What are possible side effects from using APO-GATIFLOXACIN?
These are not all the possible side effects you may have when taking APO-GATIFLOXACIN. 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
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNKNOWN | |||
| Allergic reaction: difficulty breathing, difficulty swallowing, fever, hives, itchy skin, rash, swelling of your tongue or throat, swelling or redness of the skin | ✓ | ||
| Corneal melts and perforation (damage to a part of your eye): vision loss, eye pain and leakage that may be mistaken as tears | ✓ | ||
| 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 | ✓ | ||
| 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, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
Keep the dispensing container tightly closed when not in use. Store at room temperature 15°C to 30°C, protect from freezing.
Discard container 28 days after opening.
Do not use APO-GATIFLOXACIN after the expiration date (marked “EXP”) on the bottle and the box.
Keep out of reach and sight of children.
If you want more information about APO-GATIFLOXACIN:
- 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer's website (http://www.apotex.ca/products), or by calling 1-800-667-4708.