Description
Bimatoprost eye drops and eye gel are used to lower pressure inside the eye caused by open-angle glaucoma or ocular (eye) hypertension.
Bimatoprost eye drops is also used to treat eyelash hypotrichosis (not enough eyelashes) by increasing their growth and making the eyelashes longer, thicker, and darker.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
- Implant
- Gel/Jelly
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of bimatoprost for treatment of open-angle glaucoma or ocular hypertension in the pediatric population. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of bimatoprost for eyelash growth in the pediatric population. Safety and efficacy have not been established.
Because of safety concerns, the use of bimatoprost to treat open-angle glaucoma or ocular hypertension in children and teenagers younger than 16 years of age is not recommended.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bimatoprost eye drops or eye gel in the elderly.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Aphakia (no lens in the eyes) or
- Torn artificial lens in the eyes—Use with caution. May increase the risk of a serious side effect called macular edema.
- Certain types of glaucoma (angle-closure, inflammatory, or neovascular)—Not normally used in patients with these conditions. Let your doctor know if you have these conditions.
- Cornea transplant (eg, Descemet’s Stripping Automated Endothelial Keratoplasty (DSAEK), recent or
- Eye infection, active or suspected or
- Fuchs’ Dystrophy (cornea problem)—Durysta™ should not be given in patients with these conditions.
- Eye disease (eg, iritis or uveitis), history of—Use with caution. May make these conditions worse.
Proper Use
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
Durysta™ is to be given by a healthcare professional in a clinic or hospital. This medicine comes as an implant that is injected directly to your eye.
Remove contact lenses before you use the eye drops. Wait for at least 15 minutes before putting the contact lenses back in.
To use Lumigan® eye drops or Zolymbus™ eye gel:
- The bottle is only partially full to provide proper drop control.
- First, wash your hands. Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 to 2 minutes to allow the medicine to be absorbed by the eye.
- Remove any excess solution around the eye with a clean tissue, being careful not to touch the eye.
- If you think you did not get the drop of medicine into your eye properly, repeat the directions with another drop.
- Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
To use Latisse™ solution for eyelash growth:
- Make sure your face is clean and remove your make-up and contact lenses before using this medicine.
- Always wash your hands before and after using this medicine.
- Place one drop of the solution on the disposable sterile applicator and apply it evenly along the skin of the upper eyelid margin at the base of the eyelashes.
- Remove any excess solution around the eyes with a tissue or any absorbent cloth.
- Repeat for the other upper eyelid margin using a new applicator.
- Do not apply this medicine on the lower eyelashes.
- Dispose of the applicator after each use.
To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines.
This medicine comes with patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
If you are using more than one eye product, apply these medicines at least 5 minutes apart.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For ophthalmic dosage form (eye drops):
- For glaucoma or ocular hypertension:
- Adults and children 16 years of age and older—One drop in the affected eye(s) once a day in the evening.
- Children younger than 16 years of age—Use is not recommended.
- For eyelash growth:
- Adults—Apply one drop each in the upper eyelids every night.
- Children—Use and dose must be determined by your doctor.
- For glaucoma or ocular hypertension:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
If you miss a dose of Latisse™ solution or Zolymbus™ eye gel, skip the missed dose and go back to your regular schedule. Do not use extra medicine to make up for a missed dose.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
You may store the medicine in the refrigerator or at room temperature.
Store Zolymbus™ eye gel in its original foil pouch. You may store the single-dose containers in the opened foil pouch at room temperature for up to 14 days. Throw away unused medicine in the opened foil pouch after 14 days.
Precautions
It is very important that your eye doctor (ophthalmologist) check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor. These signs may mean that you are allergic to bimatoprost.
Check with your doctor if you have an injury, trauma, or infection in your eye or if you are scheduled to have an eye surgery. Your doctor may want you to use a fresh bottle of bimatoprost in case the present bottle has become contaminated during use.
If you are using this medicine for eyelash growth, be careful to apply as directed and wipe off any excess that comes into contact with other skin areas. There is a chance for hair growth in other areas this medicine comes into contact with.
While you are using this medicine, the iris (colored part) of your treated eye(s) may slowly become darker in color. The change in color of the iris is noticeable usually within several months or years from the start of treatment with bimatoprost. Check with your doctor if you have any concerns about this.
Your eyelashes may become longer and thicker. These changes to the lashes usually reverse after stopping the treatment. Also, these changes to the lashes will affect only the eye being treated with bimatoprost. Check with your doctor if you have any concerns about this.
This medicine may cause eye swelling (eg, macular edema). Check with your doctor right away if you have blurred vision or other vision problems.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Blindness
- bloody eye
- blurred or decreased vision
- change in color vision
- color changes in the skin around the eyes
- difficulty seeing at night
- disturbed color perception
- double vision
- dry eyes
- eye color changes
- fever or chills
- halos around lights
- lack or loss of strength
- loss of vision
- night blindness
- overbright appearance of lights
- redness, burning, dry, or itching eyes
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- tunnel vision
Incidence not known
- Blurred vision
- dizziness
- drainage from eyes
- drooping upper eyelids
- headache
- increased sensitivity of eyes to sunlight
- nervousness
- pounding in the ears
- raising of the upper eyelid
- slow or fast heartbeat
- swelling around the eyes
- watering of the eyes
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Body aches or pain
- cough
- difficulty with breathing
- ear congestion
- loss of voice
- redness of the white part of eyes or inside of the eyelids
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common
- Eye discharge or excessive tearing
- eye strain
- feeling of having something in the eye
- increase in hair growth
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20062270