Patient Medication Information: uses, side effects, how to take - Apo-Bimatoprost (Apotex, PM 00066384)
What is APO-BIMATOPROST used for?
APO-BIMATOPROST eye drops are used to reduce high pressure in the eye in adult patients with open-angle glaucoma or ocular hypertension. If the high pressure is not reduced, it could eventually damage your sight.
How does APO-BIMATOPROST work?
APO-BIMATOPROST is an antiglaucoma preparation. It belongs to a group of medicines called prostamides. Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. Bimatoprost ophthalmic solution works by increasing the flow of liquid that is drained. This reduces the pressure inside the eye.
What are the ingredients in APO-BIMATOPROST?
Medicinal ingredients: Bimatoprost
Non-medicinal ingredients: Benzalkonium chloride, as preservative; citric acid anhydrous, sodium chloride, sodium phosphate dibasic anhydrous, Sodium hydroxide and/or hydrochloric acid may be added to adjust pH and water for injection.
APO-BIMATOPROST comes in the following dosage forms:
Ophthalmic solution, 0.03% w/v
Do not use APO-BIMATOPROST if:
- you are allergic to bimatoprost, to any of the other ingredients, or to any of the parts of the container (see section What are the ingredients).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-BIMATOPROST. Talk about any health conditions or problems you may have, including if you:
- are taking, or have recently taken, any other medicines. Using APO-BIMATOPROST with other medicines or other antiglaucoma products may reduce their effectiveness.
are pregnant or planning to become pregnant. You should ask your healthcare professional for advice before taking any medicine.
- are breastfeeding or planning to breastfeed. Ask your healthcare professional how to feed your baby while using APO-BIMATOPROST.
- have an active eye infection, inflammation (e.g. uveitis) or any other eye condition.
- develop another eye condition (an injury or an infection).
- need to have eye surgery.
- have liver or kidney problems.
Other warnings you should know about:
Changes in Eye and Eyelid Color
APO-BIMATOPROST has been associated with iris pigmentation (change in the colored part of the eye). This is likely to be permanent. The change may be more noticeable if you are only treating one eye. Taking too much APO-BIMATOPROST (overdose) may contribute to iris pigmentation.
APO-BIMATOPROST use may also cause darkening of the eyelid skin which may be reversible in most patients.
Hair Growth
It is possible for hair growth to occur in areas of your skin that APO-BIMATOPROST frequently touches. Any excess solution that drips from the eye should be blotted with a tissue or other absorbent material to reduce the chance of this from happening. It is also possible for a difference in eyelash length, thickness, fullness, pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur between eyes. These differences, should they occur, will usually go away if you stop using APO-BIMATOPROST.
Changes in Vision
Using APO-BIMATOPROST may temporarily blur your vision. Do not drive or use machines until your vision has cleared.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-BIMATOPROST:
No drug interaction studies have been done with APO-BIMATOPROST.
How to take APO-BIMATOPROST:
- Do not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
- Always use APO-BIMATOPROST exactly as your healthcare professional has instructed you.
- APO-BIMATOPROST contains a preservative called benzalkonium chloride which may discolor soft contact lenses. If you wear contact lenses, remove them before using APO-BIMATOPROST. Wait 15 minutes after using the drops before you put your lenses back in.
- If you use APO-BIMATOPROST with another eye drop, wait at least five minutes after using APO-BIMATOPROST before using the other drops.
- To help prevent infections, 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-BIMATOPROST properly:
- 1. Wash your hands. Tilt your head back and look at the ceiling. (See Illustration 1)
- 2. Gently pull down the lower eyelid 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 the lower lid, and close your eye for 30 seconds. (See Illustration 4)
- 5. Repeat steps 1 – 4 in the other eye if both eyes need treatment.
Usual dose:
The recommended dose is one drop of APO-BIMATOPROST in each eye that needs treatment, once daily, in the evening.
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-BIMATOPROST, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
If you accidentally use too many drops, just go back to your regular once a day dosing the next day.
Missed Dose:
If you forget to take APO-BIMATOPROST, use a single drop as soon as you remember, and then go back to your regular routine. Do not take two doses to make up for the one that you missed.
What are possible side effects from using APO-BIMATOPROST?
These are not all the possible side effects you may feel when taking APO-BIMATOPROST. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Longer eyelashes, change in eyelash color
- Eye irritation, redness, itching, dryness
- Burning or stinging sensation in the eye
- Feeling that something is in your eye
- Eye pain
- Eye discharge
- Abnormal vision
- Red and itchy eyelids
- Darkening of the eyelid
- Inflammation of the eyelid
- Small breaks in the surface of the eye
- Sensitivity to light
- Tearing
- Tired eyes
- Dizziness
- Headache
Some patients (fewer than 2 in every 100) experience a change in iris color (iris pigmentation). The change is a darkening, with the eyes becoming more brown. This usually happens during the first year of treatment. Eye darkening is expected to increase as long as APO-BIMATOPROST is used. It is not known what this change means over the long term. Talk to your healthcare professional if you notice a change in your iris color.
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.
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. |
Storage:
APO-BIMATOPROST should be stored in the original container at room temperature 15°C to 30°C. Discard unused solution at the end of treatment.
Do not use the drops after the expiry date (marked “Exp”) on the bottle and the box.
Keep out of reach and sight of children.
If you want more information about APO-BIMATOPROST:
- 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); Find the Patient Medication information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.