Data Animal data
ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). 8.2 Lactation Risk summary It is not known whether topical ocular treatment with Latisse 0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. In animal studies, bimatoprost has been shown to be present in breast milk of lactating rats at an intravenous dose (i.e., 1 mg/ kg) 324 times the recommended human ophthalmic dose (on a mg/m2 basis), however no animal data is available at clinically relevant doses. The developmental and health benefits of breast feeding should be considered along with the mother’s clinical need for Latisse 0.03% and any potential adverse effects on the breastfed child from Latisse 0.03%. 8.4 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 below. 8.5 Geriatric use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. IOP, you should only use Latisse under the close supervision of your physician. 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 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.
In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctive sac bilaterally once daily, based on AUC). The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on AUC). No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). In a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation d 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day. These effects were observed at exposures at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. The NOAEL for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the human systemic exposure following topical 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 one-grade increase on the four-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 eight-week, 12-week, and 16-week (primary endpoint) treatment durations. After the 16-week treatment period, a four-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. (Repetitions are being avoided; but some questions are germane.) 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. 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
DESIRABLE EQUIPMENT, SUPPLIES AND MATERIALS
If your salon is already set up for skin care services, your modifications will be minimal.
If not, it is relatively simple to create an area for this service. My own salon was very small, and we didn’t have the room to have a skin care area. I used a manicure table to set up my equipment
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