These highlights do not include all the information needed to use LATISSE� safely and effectively. See full prescribing information for LATISSE�.LATISSE� (bimatoprost ophthalmic solution) 0.03% Initial U.S. Approval: 2001
Latisse Information
Product Code 54868-6053 Company Name Physicians Total Care, Inc. Dosage From SOLUTION/ DROPS Strength 0.3 mg Active Ingredient BIMATOPROST
Latisse (Bimatoprost) Dosage And Administration
Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of (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
Do not apply to the lower eyelash line (see 5.3 and 17).
Additional applications of will not increase the growth of eyelashes.
Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level.
Latisse (Bimatoprost) Dosage Forms And Strengths
Bimatoprost ophthalmic solution 0.3 mg/mL.
Latisse (Bimatoprost) Warnings And Precautions
Bimatoprost ophthalmic solution 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, lowered IOP, however, the magnitude of the reduction was not cause for clinical concern.
In ocular hypertension studies with 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 or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including for IOP reduction should only use after consulting with their physician and should be monitored for changes to their intraocular pressure (see ).
Increased iris pigmentation has occurred when the same formulation of bimatoprost ophthalmic solution ( was instilled directly onto the eye. Although iridal pigmentation was not reported in clinical studies with , patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent.
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 solution can be continued in patients who develop noticeably increased iris pigmentation.
Patients who receive treatment with should be informed of the possibility of increased pigmentation (see ).
Latisse (Bimatoprost)
Latisse (Bimatoprost)
PATIENT COUNSELING INFORMATION,
Latisse (Bimatoprost) Adverse Reactions
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 events were eye pruritis, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and erythema of the eyelid. These events occurred in less than 4% of patients.
Adverse reactions reported with bimatoprost ophthalmic solution ( ) for the reduction of intraocular pressure include, ocular dryness, visual disturbance, ocular burning, foreign body sensation, eye pain, blepharitis, cataract, superficial punctuate 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.
Latisse (Bimatoprost) Use In Specific Populations
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, should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Latisse (Bimatoprost) Description
Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg.
Latisse (Bimatoprost) Clinical Pharmacology
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 C and AUC 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 μg/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.
Latisse (Bimatoprost) Clinical Studies
In this study, patients were also evaluated for the effect of 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.
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.
Latisse (Bimatoprost) Patient Counseling Information
Patients should be informed 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 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 solution gets into the eye proper, it will not cause harm. The eye should not be rinsed.
Additional applications of will not increase the growth of eyelashes.
Patients should be informed 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. Patients should be counseled that the effect is not permanent and can be expected to gradually return to the original level upon discontinuation of treatment with .
Latisse (Bimatoprost)
In patients using or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of may interfere with the desired reduction in IOP. Patients using prostaglandin analogs for IOP reduction should only use after consulting with their physician.
Latisse (Bimatoprost) . Fda-approved Patient Package Insert
Read the Patient Information that comes with 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.
Hypotrichosis is another name for having inadequate or not enough eyelashes.
Do not use solution if you are allergic to one of its ingredients.
It is possible for hair growth to occur in other areas of your skin that 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 .
You should tell your physician you are using especially if you have a history of eye pressure problems.
You should also tell anyone conducting an eye pressure screening that you are using .
The most common side effects after using solution are an itching sensation in the eyes and/or eye redness. This was reported in approximately 4% of patients. solution may cause other less common side effects which typically occur on the skin close to where 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 solution.
If you stop using , 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.
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 on the area of the applicator closest to the tip but not on the tip (see ). 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 ). 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.
If any 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 and may be reinserted 15 minutes following its administration.
Use of more than once a day will not increase the growth of eyelashes more than use once a day.
Store solution at 36° to 77°F (2° to 25°C).
This leaflet summarizes the most important information about 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.
© 2009 Allergan, Inc.Irvine, CA 92612 marks owned by Allergan, Inc. U.S. Patents 6,403,649; 7,351,404; and 7,388,029
72041US11A
Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146
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