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Indication and Clinical Profile

Spinosad topical suspension 0.9% is approved for the treatment of head lice infestation in patients aged ≥4 years. Head lice, a common problem among U.S. schoolchildren, are spread mainly by direct head-to-head contact with someone who already has head lice. Spinosad provides an alternative to OTC shampoos containing pyrethrin or permethrin and prescription medications including malathion, lindane, and benzyl alcohol lotion.

The safety and effectiveness of spinosad were established in two multicenter, randomized, controlled studies involving 1,038 subjects aged ≥6 months with head lice infestation. A total of 552 subjects received a 10-minute spinosad treatment; the remaining subjects were treated with permethrin. Subjects treated on day 0 returned for efficacy evaluation on day 7. Spinosad subjects with live lice present on day 7 received a second treatment. Subjects who were lice free on day 7 returned on day 14 for evaluation. Subjects with live lice and those who received a second treatment returned on days 14 and 21. The proportion of subjects who were lice free 14 days after the final application of spinosad was approximately 86%, versus 44% of subjects receiving permethrin.

Pharmacology and Pharmacokinetics^9,10

Spinosad, which is derived from fermentation of Saccharopolyspora spinosa, is a mixture of spinosyn A and spinosyn D in a ratio of 5 to 1 (FIGURE 5). This natural product kills susceptible species by causing rapid excitation of the insect's nervous system. Spinosad must be ingested by the insect; therefore, it has little effect on nontarget predatory insects. It is relatively fast acting, with insect death occurring within 1 to 2 days; insect mortality appears to be 100%.

In pharmacokinetic studies, subjects who received a single scalp treatment of spinosad showed no measurable plasma levels of drug. The bioavailability of benzyl alcohol from the product formulation was not determined in these subjects.

Adverse Reactions and Drug Interactions^9,10

Common adverse events associated with spinosad therapy include redness or irritation of the eyes and skin. Spinosad is not approved for use in children aged <4 years. It is especially important not to use the product in infants because it contains benzyl alcohol, which has been associated with serious adverse reactions, including death, when applied topically in children aged <6 months. Spinosad is a Pregnancy Category B drug. Because of the lack of systemic absorption, no drug interactions are anticipated with other medications.

Dosage and Administration^9,10

Spinosad is supplied as a 0.9%, viscous, slightly opaque, light orange–colored suspension. It should be applied to cover dry scalp and then to dry hair. After 10 minutes, the covered areas should be thoroughly rinsed with warm water. If live lice are seen 7 days after the first treatment, a second treatment should be applied. The drug product is not for oral, ophthalmic, or intravaginal use.

美國食品和藥物管理局今天批准Natroba（多殺菌素）局部暫停 0.9％，為治療頭蝨患者年齡 4歲以上。

頭蝨寄生昆蟲的發現對人的頭部，眉毛，睫毛和。它們寄生於人的血液，每天數次，但不知道引起疾病。頭蝨的傳播主要是通過直接頭對頭接觸的人誰已經有頭蝨。蝨子移動爬行，並且可以輕鬆旅行從孩子孩子，因為孩子玩緊密結合起來，經常在大集團。

“Natroba提供了另一種選擇的外用治療頭蝨的侵擾，這是特別多見於兒童人口，”尤莉說貝茨，醫學博士，主任，辦公室藥品審評三在FDA的中心藥物評價和研究。 “頭蝨是一種常見的問題，學童在美國。”

Natroba是一種外用藥物的產品，應只適用於兒童的頭皮或頭髮。本產品應嚴格按照規定使用由專業醫務人員。

安 全性和有效性的Natroba局部暫停 0.9％，已經建立了兩個多中心，隨機，主動對照研究。一共有552受試者 10分鐘的治療與 Natroba。如果被發現活蝨一個星期後，第二次治療應用。受試者的比例誰是蝨子無14天最終處理後的Natroba約為 86％比44％的對照組。

常見的不良事件報告包括發紅或刺激眼睛和皮膚。

安全在以下兒童患者的年齡為 4年尚未建立。雖然 Natroba不批准用於兒童年齡小於 4年，它是特別重要的是不要使用，因為在嬰兒產品中含有苯甲醇。苯甲醇一直伴隨著嚴重的不良反應，包括死亡，外用時對皮膚的兒童年齡小於 6個月。

Natroba為 ParaPRO製造有限責任公司的卡梅爾，工業