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BIMATOPROST solution


  1. Patient Information
  2. What Is Bimatoprost Ophthalmic Solution?
  3. Who Should Not Take Bimatoprost Ophthalmic Solution?
  4. Are There Any Special Warnings Associated With Bimatoprost Ophthalmic Solution Use?
  5. Who Should I Tell That I Am Using Bimatoprost Ophthalmic Solution?
  6. What Should I Do If I Get Bimatoprost Ophthalmic Solution In My Eye?
  7. What Are The Possible Side Effects Of Bimatoprost Ophthalmic Solution?
  8. How Do I Use Bimatoprost Ophthalmic Solution?
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. Manufactured By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Nightly Application

Inform patients that bimatoprost ophthalmic solution should be applied every night using only the accompanying sterile applicators. They should start by ensuring their face is clean, all makeup is removed, and their contact lenses removed (if applicable). Then, carefully place one drop of bimatoprost ophthalmic solution on the disposable sterile applicator and brush cautiously along the skin of the upper eyelid margin at the base of the eyelashes. If any bimatoprost ophthalmic solution gets into the eye proper, it will not cause harm. The eye should not be rinsed.

Additional applications of bimatoprost ophthalmic solution will not increase the growth of eyelashes.

Inform patients not to apply to the lower eyelash line. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material.

The onset of effect is gradual but is not significant in the majority of patients until 2 months. Counsel patients that the effect is not permanent and can be expected to gradually return to the original level upon discontinuation of treatment with bimatoprost ophthalmic solution.

Handling the Bottle and Applicator

Instruct patients that the bimatoprost ophthalmic solution bottle must be maintained intact and to avoid allowing the tip of the bottle or applicator to contact surrounding structures, fingers, or any other unintended surface in order to avoid contamination of the bottle or applicator by common bacteria known to cause ocular infections. Instruct patients to only use the applicator supplied with the product once and then discard since reuse could result in using a contaminated applicator. Serious infections may result from using contaminated solutions or applicators.

Potential for Intraocular Pressure Effects

Bimatoprost ophthalmic solution may lower intraocular pressure although not to a level that will cause clinical harm.

In patients using *LUMIGANor other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of bimatoprost ophthalmic solution may interfere with the desired reduction in IOP. Patients using prostaglandin analogs for IOP reduction should only use bimatoprost ophthalmic solution after consulting with their physician.

Potential for Eyelid Skin Darkening

Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution.

Potential for Iris Darkening

Advise patients about the potential for increased brown iris pigmentation which is likely to be permanent. Increased iris pigmentation has occurred when bimatoprost ophthalmic solution was administered.

Potential for Unexpected Hair Growth or Eyelash Changes

Inform patients of the possibility of hair growth occurring outside of the target treatment area if bimatoprost ophthalmic solution repeatedly touches the same area of skin outside the treatment area. They should also be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are likely reversible upon discontinuation of treatment.

When to

Hypotrichosis is another name for having inadequate or not enough eyelashes.

What Is Bimatoprost Ophthalmic Solution? 

Bimatoprost ophthalmic solution is a prescription treatment for hypotrichosis used to grow eyelashes, making them longer, thicker and darker.

Who Should Not Take Bimatoprost Ophthalmic Solution? 

Do not use bimatoprost ophthalmic solution if you are allergic to one of its ingredients.

Are There Any Special Warnings Associated With Bimatoprost Ophthalmic Solution Use? 

Bimatoprost ophthalmic solution is intended foruse on the skin of the upper eyelid margins at the base of the eyelashes. Refer to Illustration 2 below.DO NOT APPLYto the lower eyelid. If you are using *LUMIGANor other products in the same class for elevated intraocular pressure (IOP), or if you have a history of abnormal IOP, you should only use bimatoprost ophthalmic solution under the close supervision of your physician.

Bimatoprost ophthalmic solution use may cause darkening of the eyelid skin which may be reversible. Bimatoprost ophthalmic solution use may also cause increased brown pigmentation of the colored part of the eye which is likely to be permanent.

It is possible for hair growth to occur in other areas of your skin that bimatoprost ophthalmic solution frequently touches. Any excess solution outside the upper eyelid margin 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 bimatoprost ophthalmic solution.

Who Should I Tell That I Am Using Bimatoprost Ophthalmic Solution? 

You should tell your physician you are using bimatoprost ophthalmic solution especially if you have a history of eye pressure problems.

You should also tell anyone conducting an eye pressure screening that you are using bimatoprost ophthalmic solution.

What Should I Do If I Get Bimatoprost Ophthalmic Solution In My Eye? 

Bimatoprost ophthalmic solution is an ophthalmic drug product. Bimatoprost ophthalmic solution is not expected to cause harm if it gets into the eye proper. Do not attempt to rinse your eye in this situation.

What Are The Possible Side Effects Of Bimatoprost Ophthalmic Solution? 

The most common side effects after using bimatoprost ophthalmic solution are an itching sensation in the eyes and/or eye redness. This was reported in approximately 4% of patients. Bimatoprost ophthalmic solution may cause other less common side effects which typically occur on the skin close to where bimatoprost ophthalmic solution is applied, or in the eyes. These include skin darkening, eye irritation, dryness of the eyes, and redness of the eyelids.

If you develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, you should immediately

If you stop using bimatoprost ophthalmic solution, your eyelashes are expected to return to their previous appearance over several weeks to months.

Any eyelid skin darkening is expected to reverse after several weeks to months.

Any darkening of the colored part of the eye known as the iris is NOT expected to reverse and is likely permanent.

How Do I Use Bimatoprost Ophthalmic Solution? 

The recommended dosage is one application nightly to the skin of the upper eyelid margin at the base of the eyelashes only.

Once nightly, start by ensuring your face is clean, makeup and contact lenses are removed. Remove an applicator from its tray. Then, holding the sterile applicator horizontally, place one drop of bimatoprost ophthalmic solution on the area of the applicator closest to the tip but not on the tip (

Active Ingredient: 

bimatoprost

Inactive Ingredients: 

benzalkonium chloride; citric acid; purified water; sodium chloride; and sodium phosphate, dibasic. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH during its shelf life ranges from 6.8 - 7.8.

Rx only

Manufactured By: 

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 912:00 09/17

*LUMIGANis a registered trademark of Allergan, Inc.



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