Drugs Details

Drugs Info of Latisse
Drugs Details
  • Drugs Type  : Multum
  • Date : 9th Jan 2015 11:10 pm
  • Brand Name : Latisse
  • Generic Name : bimatoprost topical ophthalmic (Pronunciation: bye MAT oh prost TOP ik al off THAL mik)
Descriptions

Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. LATISSE® is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg.

Contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride 0.05 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 -7.8.

What are the possible side effects of bimatoprost topical ophthalmic (Latisse)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using bimatoprost topical ophthalmic and call your doctor at once if you have:

  • severe burning or itching of your eyes;
  • severe redness or swelling in or around your eye;
  • vision problems, eye pain, seeing halos around lights;
  • oozing or discharge from your eye; or
  • increased sensitivity to light.

Bimatoprost topical ophthalmic may cause a gradual...

Read All Potential Side Effects and See Pictures of Latisse »

What are the precautions when taking bimatoprost ophthalmic solution 0.03% for hypotrichosis (Latisse)?

Before using bimatoprost, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as latanoprost, travoprost); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye pressure problems (such as glaucoma), other eye problems (such as macular edema, iritis, uveitis, lens extraction/aphakia).

If you develop a new eye condition (such as infection, eye surgery, eye injury) while using this medication, discuss with your doctor whether you should start using a new bottle.

If...

Read All Potential Precautions of Latisse »

This monograph has been modified to include the generic and brand name in many instances.

Indications

LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness

Dosage Administration

Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of LATISSE® (bimatoprost ophthalmic solution) 0.03% on the disposable sterile applicator supplied with the package and apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. The upper lid margin in the area of lash growth should feel lightly moist without runoff. Blot any excess solution runoff outside the upper eyelid margin with a tissue or other absorbent cloth. Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator.

Do not reuse applicators and do not use any other brush/applicator to apply LATISSE® .

Do not apply to the lower eyelash line [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].

Additional applications of LATISSE® will not increase the growth of eyelashes.

Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level.

How Supplied

Dosage Forms And Strengths

Bimatoprost ophthalmic solution 0.3 mg/mL.

Storage And Handling

LATISSE® (bimatoprost ophthalmic solution) 0.03% is supplied sterile in opaque white low density polyethylene dispenser bottles and tips with turquoise polystyrene caps accompanied by sterile, disposable applicators:

1.5 mL in a 5 mL bottle with 40 applicators NDC 0023-3616-15
3 mL in a 5 mL bottle with 70 applicators NDC 0023-3616-70
5 mL in a 5 mL bottle with 140 applicators NDC 0023-3616-05

Storage

Store at 2-25°C (36-77°F).

Allergan, Inc. Revised: Sep 2014

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Studies Experience

The following information is based on clinical trial results from a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment.

The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema. These reactions occurred in less than 4% of patients.

Adverse reactions reported with bimatoprost ophthalmic solution (LUMIGAN®) for the reduction of intraocular pressure include, ocular dryness, visual disturbance, ocular burning, foreign body sensation, eye pain, blepharitis, cataract, superficial punctate keratitis, eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, increases in iris pigmentation, conjunctival edema, abnormal hair growth, iritis, infections (primarily colds and upper respiratory tract infections), headaches, and asthenia.

Postmarketing Experience

The following reactions have been identified during postmarketing use of LATISSE® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to LATISSE®, or a combination of these factors, include: eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few lashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular, erythematous, skin discoloration (periorbital), and vision blurred.

Read the Latisse (bimatoprost ophthalmic solution 0.03% for hypotrichosis) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Effects On Intraocular Pressure

Bimatoprost ophthalmic solution (LUMIGAN®) lowers intraocular pressure (IOP) when instilled directly to the eye in patients with elevated IOP. In clinical trials, in patients with or without elevated IOP, LATISSE® lowered IOP, however, the magnitude of the reduction was not cause for clinical concern.

In ocular hypertension studies with LUMIGAN®, it has been shown that exposure of the eye to more than one dose of bimatoprost daily may decrease the intraocular pressure lowering effect. In patients using LUMIGAN® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure [see PATIENT INFORMATION].

Iris Pigmentation

Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent [see ADVERSE REACTIONS and PATIENT INFORMATION].

The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long term effects of increased pigmentation are not known. Iris color changes seen with administration of bimatoprost ophthalmic solution may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. Treatment with LATISSE® solution can be continued in patients who develop noticeably increased iris pigmentation.

Lid Pigmentation

Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients [see PATIENT INFORMATION].

Hair Growth Outside The Treatment Area

There is the potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with the skin surface. It is important to apply LATISSE® only to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators, and to carefully blot any excess LATISSE® from the eyelid margin to avoid it running onto the cheek or other skin areas [see PATIENT INFORMATION].

Intraocular Inflammation

LATISSE® solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

Macular Edema

Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution (LUMIGAN®) for elevated IOP. LATISSE® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Contamination Of LATISSE® Or Applicators

The LATISSE® bottle must be kept intact during use. It is important to use LATISSE® solution as instructed, by placing one drop on the single-use-per-eye applicator. The bottle tip should not be allowed to contact any other surface since it could become contaminated. The accompanying sterile applicators should only be used on one eye and then discarded since reuse of applicators increases the potential for contamination and infections. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products [see PATIENT INFORMATION].

Use With Contact Lenses

LATISSE® contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration [see PATIENT INFORMATION].

Patient Counseling Information

Nightly Application

Inform patients that LATISSE® (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 LATISSE® 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 LATISSE® solution gets into the eye proper, it will not cause harm. The eye should not be rinsed.

Additional applications of LATISSE® 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 LATISSE® .

Handling The Bottle And Applicator

Instruct patients that the LATISSE® 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

LATISSE® may lower intraocular pressure although not to a level that will cause clinical harm.

In patients using LUMIGAN® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs for IOP reduction should only use LATISSE® 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 LATISSE® .

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 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 LATISSE® 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 Seek Physician Advice

Advise patients that if they 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, they should immediately seek their physician's advice concerning the continued use of LATISSE®. Patients on IOP-lowering medications should not use LATISSE® without prior consultation with their physician.

Use With Contact Lenses

Advise patients that LATISSE® solution contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to application of LATISSE® and may be reinserted 15 minutes following its administration.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (approximately 192 and 291 times the recommended human exposure based on blood AUC levels after topical corneal and/or conjunctival sac administration respectively) for 104 weeks.

Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests.

Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Teratogenic effects

In embryo/fetal developmental studies in pregnant mice and rats, abortion was observed at oral doses of bimatoprost which achieved at least 33 or 97 times, respectively, the maximum intended human exposure (based on blood AUC levels after topical ophthalmic administration to the cornea or conjunctival sac).

At doses at least 41 times the maximum intended human exposure, the gestation length was reduced in the dams, the incidence of dead fetuses, late resorptions, peri-and postnatal pup mortality was increased, and pup body weights were reduced.

There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. Because animal reproductive studies are not always predictive of human response, LATISSE® should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether LATISSE® solution is excreted in human milk, although in animal studies, bimatoprost has been shown to be excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when LATISSE® is administered to a nursing woman.

Pediatric Use

Use of LATISSE® was evaluated in a sixteen week double-masked, randomized, vehicle-controlled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who had hypotrichosis with no associated medical condition. No new safety issues were observed. The results of the Global Eyelash Assessment are provided in Table 1.

Table 1: Number (%) of subjects with at least a 1-grade increase from baseline at month 4 in Global Eyelash Assessment

  Age Range (years) LATISSE® Vehicle Difference (95% CI)
Adolescents with hypotrichosis (N=40) 15 - 17 19/26
(73%)
1/14
(7%)
66%
(44%, 88%)
Post Chemotherapy Pediatric Patients (N=16) 5 - 17 11/13
(85%)
3/3
(100%)
-15%
(-35%, 4%)
Alopecia Areata Pediatric Patients (N=15) 5 - 17 4/9
(44%)
2/6
(33%)
11%
(-39%, 61%)

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

None

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

Bimatoprost is a structural prostaglandin analog. Although the precise mechanism of action is unknown the growth of eyelashes is believed to occur by increasing the percent of hairs in, and the duration of the anagen or growth phase.

Pharmacokinetics

Absorption

After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily into both eyes (cornea and/or conjunctival sac) of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025 ng/mL) in most subjects within 1.5 hours after dosing. Mean Cmax and AUC0-24hr values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng•hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing. There was no significant systemic drug accumulation over time.

Distribution

Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of 0.67 L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma.

Metabolism

Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation. Bimatoprost then undergoes oxidation, N-deethylation, and glucuronidation to form a diverse variety of metabolites.

Elimination

Following an intravenous dose of radiolabeled bimatoprost (3.12 mcg/kg) to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL and decreased rapidly with an elimination half-life of approximately 45 minutes. The total blood clearance of bimatoprost was 1.5 L/hr/kg. Up to 67% of the administered dose was excreted in the urine while 25% of the dose was recovered in the feces.

Clinical Studies

LATISSE® solution was evaluated for its effect on overall eyelash prominence in a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment. The primary efficacy endpoint in this study was an increase in overall eyelash prominence as measured by at least a 1-grade increase on the 4-point Global Eyelash Assessment (GEA) scale, from baseline to the end of the treatment period (week 16). LATISSE® was more effective than vehicle as measured by the GEA score, with statistically significant differences seen at 8-week, 12-week, and 16-week (primary endpoint) treatment durations.

Table 2 : Number (%) of subjects with at least a 1-grade increase from baseline in Global Eyelash Assessment (Primary Efficacy Endpoint – Week 16)

Week LATISSE®
N=137
N (%)
Vehicle
N=141
N (%)
1 7 (5%) 3 (2%)
4 20 (15%) 11 (8%)
8 69 (50%) 21 (15%)
12 95 (69%) 28 (20%)
16 107 (78%) 26 (18%)
20 103 (79%) 27 (21%)

In this study, patients were also evaluated for the effect of LATISSE® solution on the length, thickness and darkness of their eyelashes. Improvements from baseline in eyelash growth as measured by digital image analysis assessing eyelash length, fullness/thickness, and darkness were statistically significantly more pronounced in the bimatoprost group at weeks 8, 12, and 16.

Table 3

Efficacy endpoint at Week 16 (Mean Change from Baseline) LATISSE® Vehicle
Eyelash growth (length) (mm; % increase) N=137
1.4; 25%
N=141
0.1; 2%
Fullness/thickness (mm²; % increase) N=136
0.7; 106%
N=140
0.1; 12%
Eyelash darkness (intensity*; % increase in darkness) N=135
-20.2; -18%
N=138
-3.6; -3%
* a negative value is representative of eyelash darkening

After the 16-week treatment period, a 4-week post-treatment period followed during which the effects of bimatoprost started to return toward baseline. The effect on eyelash growth is expected to abate following longer term discontinuation.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

LATISSE®
[la teece]
(bimatoprost) Ophthalmic Solution 0.03%

Read the Patient Information that comes with LATISSE® before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your physician about your treatment.

What is hypotrichosis of the eyelashes?

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

What is LATISSE® solution?

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

Who should NOT take LATISSE®?

Do not use LATISSE® solution if you are allergic to one of its ingredients.

Are there any special warnings associated with LATISSE® use?

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

LATISSE® use may cause darkening of the eyelid skin which may be reversible. LATISSE® 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 LATISSE® 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 LATISSE®.

Who should I tell that I am using LATISSE®?

You should tell your physician you are using LATISSE® especially if you have a history of eye pressure problems.

You should also tell anyone conducting an eye pressure screening that you are using LATISSE®.

What should I do if I get LATISSE® in my eye?

LATISSE® solution is an ophthalmic drug product. LATISSE® 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 LATISSE®?

The most common side effects after using LATISSE® solution are an itching sensation in the eyes and/or eye redness. This was reported in approximately 4% of patients. LATISSE® solution may cause other less common side effects which typically occur on the skin close to where

LATISSE® 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 seek your physician's advice concerning the continued use of LATISSE® solution.

What happens if I stop using LATISSE®?

If you stop using LATISSE®, 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 LATISSE®?

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 LATISSE® on the area of the applicator closest to the tip but not on the tip (see Illustration 1). Then immediately draw the applicator carefully across the skin of the upper eyelid margin at the base of the eyelashes (where the eyelashes meet the skin) going from the inner part of your lash line to the outer part (see Illustration 2). Blot any excess solution beyond the eyelid margin. Dispose of the applicator after one use.

Repeat for the opposite upper eyelid margin using a new sterile applicator. This helps minimize any potential for contamination from one eyelid to another.

Illustration 1

Place one drop of LATISSE® on the area of the applicator closest to the tip - Illustration

Illustration 2

LATISSE® application - Illustration

DO NOT APPLY in your eye or to the lower lid. ONLY use the sterile applicators supplied with LATISSE® to apply the product. If you miss a dose, don't try to “catch up.” Just apply LATISSE® solution the next evening. Fifty percent of patients treated with LATISSE® in a clinical study saw significant improvement by 2 months after starting treatment.

If any LATISSE® solution gets into the eye proper, it is not expected to cause harm. The eye should not be rinsed.

Don't allow the tip of the bottle or applicator to contact surrounding structures, fingers, or any other unintended surface in order to avoid contamination by common bacteria known to cause infections.

Contact lenses should be removed prior to application of LATISSE® and may be reinserted 15 minutes following its administration.

Use of LATISSE® more than once a day will not increase the growth of eyelashes more than use once a day.

Store LATISSE® solution at 36-77°F (2-25°C).

General Information about LATISSE®

Prescription treatments are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use LATISSE® solution for a condition for which it was not prescribed. Do not give LATISSE® to other people. It may not be appropriate for them to use.

This leaflet summarizes the most important information about LATISSE® solution. If you would like more information, talk with your physician. You can also call Allergan's product information department at 1-800-433-8871.

What are the ingredients in LATISSE®?

Active ingredient: bimatoprost

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

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

BIMATOPROST SOLUTION - TOPICAL

 

(bye-MAT-oh-prost)

 

COMMON BRAND NAME(S): Latisse

 

USES: This medication is used to treat patients with not enough or inadequate eyelashes. Bimatoprost makes the eyelashes more noticeable by causing more eyelashes to grow and making them longer, thicker, and darker. Bimatoprost is similar to a natural chemical in the body (prostaglandin).

Bimatoprost is also used to treat glaucoma. If you are already using or are directed to use bimatoprost to treat glaucoma, be careful not to get this eyelash medication into your eyes. Getting extra bimatoprost in your eyes may make it less effective for treating glaucoma. Talk to your doctor or pharmacist for more details.

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using bimatoprost and each time you get a refill. Learn how to properly apply this medication. If you have any questions, consult your doctor or pharmacist.

Use this medication once daily in the evening or as directed by your doctor.

To apply this medication, first wash your hands and face. Remove any makeup and contact lenses. Contact lenses may be reinserted 15 minutes after applying this medication. Place one drop of this medication onto the provided applicator. Then immediately draw the applicator carefully across the skin of the upper eyelid margin at the bottom of the eyelashes going from the inner part of your lash line to the outer part. Blot any excess solution that is applied beyond the eyelid margin. Throw away the applicator after applying the medication. Repeat with a new applicator for the other upper eyelid. This medication is not for use on the lower eyelids.

If any medication gets into the eye, do not rinse your eye. It is not likely to cause any harm if this medication gets into the eye, because it is the same medication that is used in the eyes to treat glaucoma.

To avoid contamination, do not touch the dropper tip or let it touch your eyelashes or any other surface. Do not rinse the dropper. Replace the dropper cap after each use, and keep the cap tightly closed.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each evening. Do not use more of this medication than recommended. Using more will not make this medication work faster. It may take up to 2 months before the full benefits of using this medication are seen.

When this medication is stopped, expect the appearance of the eyelashes to return to the way they looked before starting treatment with bimatoprost.

It is possible that the effects between your two sets of eyelashes may not be the same. There may be differences in eyelash length, thickness, fullness, color, number or direction of growth. If any of these occur, talk to your doctor.

Consumer Overview Side Effect

SIDE EFFECTS: Eye redness/discomfort/itching/dryness or eyelid redness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

It is possible for hair growth to happen in other areas of your skin where this medication frequently touches. Be sure to wipe any extra medication after applying it to the eyelash margins (see also How to Use section).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

It has been shown that when this medication is applied directly into the eyes to treat glaucoma, it may slowly (over months to years) cause brown discoloration of the colored portion of the eye (iris). This effect has not been shown to occur when this medication is used to improve eyelash appearance. However, bimatoprost may also cause eyelid changes or a darkening of the skin around the base of the eyelashes. These changes may be permanent, but the long-term effects are uncertain. Tell your doctor if this occurs.

Tell your doctor immediately if any of these unlikely but serious side effects occur: eye pain, suspected eye infection (discharge, unusual redness, swelling of eyes), rapid vision changes (such as loss of vision).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Latisse (bimatoprost ophthalmic solution 0.03% for hypotrichosis) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using bimatoprost, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as latanoprost, travoprost); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye pressure problems (such as glaucoma), other eye problems (such as macular edema, iritis, uveitis, lens extraction/aphakia).

If you develop a new eye condition (such as infection, eye surgery, eye injury) while using this medication, discuss with your doctor whether you should start using a new bottle.

If you are having your eye pressure tested, tell the testing personnel (such as optometrist or ophthalmologist) that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain glaucoma eye drops (such as bimatoprost, latanoprost, travoprost).

This is not a complete list of possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it for another condition unless told to do so by your doctor.

 

MISSED DOSE: If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store between 36-77 degrees F (2-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Latisse

Generic Name: bimatoprost topical ophthalmic (Pronunciation: bye MAT oh prost TOP ik al off THAL mik)

  • What is bimatoprost topical ophthalmic (Latisse)?
  • What are the possible side effects of bimatoprost topical ophthalmic (Latisse)?
  • What is the most important information I should know about bimatoprost topical ophthalmic (Latisse)?
  • What should I discuss with my healthcare provider before using bimatoprost topical ophthalmic (Latisse)?
  • How should I use bimatoprost topical ophthalmic (Latisse)?
  • What happens if I miss a dose (Latisse)?
  • What happens if I overdose (Latisse)?
  • What should I avoid while using bimatoprost topical ophthalmic (Latisse)?
  • What other drugs will affect bimatoprost topical ophthalmic (Latisse)?
  • Where can I get more information?

What is bimatoprost topical ophthalmic (Latisse)?

Bimatoprost topical ophthalmic is a manmade form of a naturally occurring substance called a prostaglandin.

Bimatoprost topical ophthalmic is used to treat hypotrichosis (abnormal growth of the eyelashes). This medicine helps increase the growth, length, thickness, and darkness of eyelashes.

Bimatoprost topical ophthalmic may also be used for purposes not listed in this medication guide.

What are the possible side effects of bimatoprost topical ophthalmic (Latisse)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using bimatoprost topical ophthalmic and call your doctor at once if you have:

  • severe burning or itching of your eyes;
  • severe redness or swelling in or around your eye;
  • vision problems, eye pain, seeing halos around lights;
  • oozing or discharge from your eye; or
  • increased sensitivity to light.

Bimatoprost topical ophthalmic may cause a gradual change in the color of your eyes or eyelids. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Eye color changes may be permanent even after your treatment ends.

Common side effects may include:

  • mild eye discomfort;
  • dry or watery eyes; or
  • mild eye redness or puffy eyelids.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Latisse (bimatoprost ophthalmic solution 0.03% for hypotrichosis) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about bimatoprost topical ophthalmic (Latisse)?

Bimatoprost topical ophthalmic is used to help increase eyelash growth in people with hypotrichosis (abnormal growth of the eyelashes).

Stop using bimatoprost topical ophthalmic and call your doctor at once if this medicine causes severe eye irritation, eye pain, or vision changes.

Side Effects Centers
  • Latisse

Patient Detailed How Take

What should I discuss with my healthcare provider before using bimatoprost topical ophthalmic (Latisse)?

You should not use this medication if you are allergic to bimatoprost.

To make sure bimatoprost topical ophthalmic is safe for you, tell your doctor if you have:

  • a history of glaucoma or increased pressure inside your eyes;
  • uveitis;
  • any swelling or infection in or around your eye; or
  • a history of eye injury or eye surgery.

FDA pregnancy category C. It is not known whether bimatoprost topical ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether bimatoprost topical ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without medical advice.

How should I use bimatoprost topical ophthalmic (Latisse)?

This medicine is usually applied each night. Follow all directions on your prescription label. Do not use this medicine in larger amounts than recommended. Using more of this medicine will not make it more effective.

Do not use this medication while wearing contact lenses. Bimatoprost topical ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

Wash and thoroughly dry your face before using this medicine. Remove all makeup.

Use only the disposable applicators provided with your medicine to apply it. Do not use the same applicator to treat both eyes. Throw away an applicator after one use.

Apply the medicine directly to the skin of your upper eyelid at the base of your eyelashes. Do not use on the lower eyelid. Use a clean tissue to gently blot any medicine that drips from your eyelids.

Do not place this medicine directly into your eye.

Do not touch the tip of the medicine dropper. A contaminated dropper can infect your eye, which could lead to serious vision problems.

It may take up to 2 months before your lash growth improves. The effects of this medicine are not permanent. Your eyelash growth will return to its pretreatment levels after you stop using bimatoprost topical ophthalmic.

Tell your doctor at once if you have an eye injury, if you develop an eye infection, or if you plan to have eye surgery.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Side Effects Centers
  • Latisse

Patient Detailed Avoid Taking

What happens if I miss a dose (Latisse)?

Skip the missed dose and wait until the next night to apply the medicine. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Latisse)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using bimatoprost topical ophthalmic (Latisse)?

Avoid getting this medicine on any skin areas outside the base of your eyelashes. Increased hair growth can occur on any skin surface that comes into contact with bimatoprost topical ophthalmic.

If this medication gets directly in your eyes, rinse with water.

What other drugs will affect bimatoprost topical ophthalmic (Latisse)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied bimatoprost. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

Your pharmacist can provide more information about bimatoprost topical ophthalmic.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.01. Revision date: 3/14/2013.

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Side Effects Centers
  • Latisse

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