Latisse(比马前列素眼科溶液)促睫毛生长与治疗秃发最好的药。                                 
ISSE是治療睫毛稀少症 (HYPOTRICHOSIS)的處方療程，有效促進睫毛自然生長，能為睫毛的成長週期注入更強生命力，延長睫毛生長期及生長期間增加新生睫毛的數量。讓它們變得更翹長、更濃密、更黑亮！睫毛稀少症是指睫毛不足或生長不當。
LATISSE重要安全資訊如果您正在使用，或曾經使用任何處理眼內壓問題的處方產品，就必須在醫生的嚴密監督下才能使用LATISSE。在LATISSE的臨床實驗報告中並未發現虹膜內的棕色色素加深，但有機會導致此情況發生，而其影響可能是永久的。同時，眼瞼肌膚顏色也有機會出現短暫加深的情況，停用後情況會逐漸改善。產品只適用於上眼睫毛的根部肌部份，切勿用於下眼瞼部份。如身體某部份的皮膚經常接觸到LATISSE，該處則可能出現毛髮增生的情況。如果您正遇上或曾經歷眼部問題，或曾進行眼科手術，請立刻諮詢醫生有關繼續使用LATISSE事宜。一般來說，使用LATISSE睫毛增長液最常出現的副作用，主要包括眼睛痕癢及/或眼紅。停止使用後，睫毛將會慢慢回復原貌。
推出至今，越多越多人有興趣認識我們的產品！無可否認，LATISSE是目前全球第一，也是唯一獲FDA (美國食品及藥物管理局)
認證的處方治療產品，能夠改善睫毛不足或數量不夠的問題，為睫毛的成長週期注入更強生命力，延長睫毛生長期及生長期間增加新生睫毛的數量，令它們變得更翹長、更濃密、更黑亮！
LATISSE就是與眾不同
LATISSE是全球唯一獲FDA (美國食品及藥物管理局)
認證的睫毛增生液。臨床實驗證明，它能使睫毛變得更長更濃密。同時，它也是現時唯一須醫生處方的睫毛生長產品。如有需要，您可向醫生查詢，看看是否適合！
LATISSE令睫毛變得更長、更濃密、更黑亮
LATISSE療程每天只需進行一次，並依照醫生的指示，局部用於上眼睫毛的根部肌膚部份。持續使用，效果會漸見顯著。4星期後，您會發現睫毛增長；16星期後，睫毛長度及密度得到全面提升。這不是錯覺！使用後，您將擁有更長更濃密的閃亮睫毛。
LATISSE如何締造成果
LATISSE能加速睫毛生長，主要因為當中的活性成份：比馬前列素(Bimatoprost)。雖然成份的運作機制不明，但專家相信LATISSE在睫毛生長期，能從兩方面發揮作用：第一方面，延長生長期的持續時間；第二方面，增加處於生長期的睫毛數量。
LATISSE背後的歷史
LATISSE是全球頂尖藥廠兼眼部護理專家Allergan多年來的研發療程，用以解決及改善睫毛稀少的問題。
LATISSE是治療睫毛稀少症 (HYPOTRICHOSIS) 的處方療程，有效促進睫毛自然生長，能為睫毛的成長週期注入更強生命力，延長睫毛生長期及生長期間增加新生睫毛的數量。讓它們變得更翹長、更濃密、更黑亮！睫毛稀少症是指睫毛不足或生長不當。
LATISSE重要安全資訊如果您正在使用，或曾經使用任何處理眼內壓問題的處方產品，就必須在醫生的嚴密監督下才能使用LATISSE。在LATISSE的臨床實驗報告中並未發現虹膜內的棕色色素加深，但有機會導致此情況發生，而其影響可能是永久的。

同時，眼瞼肌膚顏色也有機會出現短暫加深的情況，停用後情況會逐漸改善。產品只適用於上眼睫毛的根部肌部份，切勿用於下眼瞼部份。如身體某部份的皮膚經常接觸到LATISSE，該處則可能出現毛髮增生的情況。如果您正遇上或曾經歷眼部問題，或曾進行眼科手術，請立刻諮詢醫生有關繼續使用LATISSE事宜。一般來說，使用LATISSE睫毛增長液最常出現的副作用，主要包括眼睛痕癢及/或眼紅。停止使用後，睫毛將會慢慢回復原貌。
3mL 一瓶 可能够 60次
英国布拉德福德大学的研究发现，一种治疗眼疾眼药水所含的成分比马前列素（bimatoprost），或可助头发生长，解决脱发困扰。该成分已获准用於睫毛生长液，使睫毛量增加，长得更长更密。研究员已对人类头发作初步实验，发现头发在短短九日间增多了三分之一。
Latisse
3mL 一瓶 够 60次
每天搽一次, 每边眼捷毛, 只够一个月量

GENERIC
Bimatoprost
CLASS
Ocular Hypotensive/Glaucoma

BRANDS FOR THE ACTIVE INGREDIENT IN THIS DRUG
Lumigan, LATISSE

HIGHLIGHTS OF PRESCRIBING INFORMATION
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

INDICATIONS AND USAGE
LATISSE® is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. (1)

DOSAGE AND ADMINISTRATION
Apply nightly directly to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying applicators. Blot any excess solution beyond the eyelid margin. Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator. (2)
 
DOSAGE FORMS AND STRENGTHS
Bimatoprost ophthalmic solution 0.3 mg/mL. (3)
 
CONTRAINDICATIONS
Hypersensitivity. (4.1)
 
WARNINGS AND PRECAUTIONS
Concurrent administration of LATISSE® and IOP-lowering prostaglandin analogs in ocular hypertensive patients may decrease the IOP-lowering effect. Patients using these products concomitantly should be closely monitored for changes to their intraocular pressure. (5.1)

Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent. (5.2, 5.3)
 
ADVERSE REACTIONS
Most common adverse events (incidence approximately 3% - 4%) are eye pruritus, conjunctival hyperemia, and skin hyperpigmentation. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

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

2 DOSAGE AND 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, 5.3 and PATIENT COUNSELING INFORMATION, 17).

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.

3 DOSAGE FORMS AND STRENGTHS

Bimatoprost ophthalmic solution 0.3 mg/mL.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

LATISSE® is contraindicated in patients with hypersensitivity to bimatoprost or any other ingredient in this product.

5 WARNINGS AND PRECAUTIONS

5.1 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 COUNSELING INFORMATION, 17).

5.2 Iris Pigmentation

Increased iris pigmentation has occurred when the same formulation of bimatoprost ophthalmic solution (LUMIGAN®) was instilled directly onto the eye. Although iridal pigmentation was not reported in clinical studies with LATISSE®, 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 LATISSE® solution can be continued in patients who develop noticeably increased iris pigmentation.

Patients who receive treatment with LATISSE® should be informed of the possibility of increased pigmentation (see PATIENT COUNSELING INFORMATION, 17).

5.3 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.

5.4 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 COUNSELING INFORMATION, 17).

5.5 Intraocular Inflammation

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

5.6 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.

5.7 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 COUNSELING INFORMATION, 17).

5.8 Use with Contact Lenses

LATISSE® contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration (see PATIENT COUNSELING INFORMATION, 17).

6 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 pruritus, 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 (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.

8 USE IN SPECIFIC POPULATIONS

8.1 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.

8.3 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.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

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

11 DESCRIPTION

LATISSE® (bimatoprost ophthalmic solution) 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5-heptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is:

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.

12 CLINICAL PHARMACOLOGY

12.1 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.

12.3 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 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.

13 NONCLINICAL TOXICOLOGY

13.1 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.

14 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 1: 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 2

* a negative value is representative of eyelash darkening
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%

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.

16 HOW SUPPLIED/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 60 sterile, disposable applicators:

3 mL in a 5 mL bottle NDC 0023-3616-03

Storage: LATISSE® should be stored at 2° to 25°C (36° to 77°F).