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Xandrox Minoxidil 15% 生髮水溶液的問&答

[日期:2010-11-15] 來源:本站原創  作者:站長

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簡介

Q. 什麼是 Xandrox15?

A. Xandrox15是Regrowth公司獨特的產品用於治療雄性禿頭症,含有重量15% minoxidil與5% azelaic acid(杜鵑花酸).Xandrox15有125mL瓶裝.每mL的Xandrox15含有150mg minoxidil與50mg的azelaic acid(杜鵑花酸).

Q. 為何Xandrox15 被認為是一種突破性的重大產品?

A. 這是第一種以液體為基礎,並超過5%濃度的minoxidil溶液.Minoxidil被認為只能溶解於以酒精基礎的溶液並且溶解限度約略小於5%.要製造一個穩定的,高濃縮的minoxidil溶液,需要數年的實驗,研究以及發展.但結果是值得的.Xandrox15是一種透明的,淡琥珀色的,極穩定的溶液,含有15% minoxidil與被證明對MPB(雄型典型禿頭症)有效的5% azelaic acid(杜鵑花酸).

Q. Regrowth,已經推出Xandrox 12.5%乳液.那Xandrox15的優點在哪裡?

A. (1)方便性.溶液會比乳液更容易塗抹到頭皮上.滴管的尖端能直接的置於頭皮上並使覆蓋於髮束上浪費掉的溶液降到最小.反之,乳液能夠方便的擦在頭皮上頭髮稀少或頭髮小型化的區域,溶液則能被使用於頭皮上任何的地方,包括大面積的稀疏頭髮區域.

(2) 穩定性.其實溶液在超過100o F (38o C)時有分散的趨勢,Xandrox15從凝固點到沸點溫度200o F (93o C)都是穩定的.所以不論是把Xandrox15儲存於室內,室外甚至於你的車內都沒有問題.

(3) 有效性.促進頭髮生長效益與局部minoxidil的劑量是相關的.額外的2.5% minoxidil濃度結合以酒精為基礎的Xandrox 15%的易於吸收性,將更能使以經萎縮的毛囊恢復健康成長並且製造出永久毛.

Q. Xandrox15的效用是不是比Xandrox 12.5%乳液更好?

A. 這當然是可能的.在雄性禿頭症的治療上,局部minoxidil的效用跟劑量是相關的,這是廣泛的被接受的論調.在我們的測試群組中.使用 Xandrox15 者比使用Xandrox 12.5%長出更多的頭髮.這顯示出使用minoxidil刺激毛囊生長頭髮是有門檻,這個門檻的高低是與病人的基因對MPB的素質與毛囊縮小化的時間長度相關的.

Q. 使用125mL瓶裝Xandrox15是否有特別注意事項?

A. 因為乙醇的揮發性的關係,不使用時應該要緊蓋上瓶蓋.此溶液在寬大的溫度範圍內是極度的穩定,並且被測試過短暫的暴露於10o到 200o華氏(-12o to 93o 攝氏)是不會引起品質變化的.Xandrox15最好保持在室溫下.


藥理學(Pharmacology)

Q. Xandrox15會比較容易被皮膚真皮層吸收嗎?

A. 是的,乙醇是少數能自由滲入皮膚的一種物質{酒精(乙醇)對人體皮膚的滲透係數(permeability coefficient)是8 x 10 –8 mol/cm2} 並且它是負載著minoxidil一起進入皮膚.酒精的滲透性造成的增強效應對於minoxidil的吸收扮演了一個重要的角色外用的minoxidil 吸收效率與傳播媒介的性質相關.當揮發性高的成分比例高時,吸收效益就會更佳,特別是乙醇的濃度高於50%時(最高達 90%).

Q. 為何不用3ml的5%Xandrox來代替Xandrox15?

A. 3mL的5%落建中的minoxidil量與1mL的Xandrox15是一樣的.然而,就吸收效率而言,你最好還是用Xandrox15.因為 (1)Xandrox中為基礎的 80%酒精能讓minoxidil得到顯著而較有效的傳輸到需要的毛囊;(2)有較好的病患適用率,你每天用一次1mL Xandrox15回復頭髮的機會比每天用3次1mL 5%minoxidil的機會要更大;(3)價格,3 mL的of 5% minoxidil比起1 mL的Xandrox15更貴;並且最重要的是(4)萎縮的毛囊對於minoxidil有反應並且再生成一根永久髮束,有一個最低門檻而濃度15%的 minoxidil溶液比起5% minoxidil更能讓毛囊再次生長出永久毛.

遺憾的是第二個活性成分,大部分的杜鵑花酸(azelaic acid) 3mL 5%Xandrox (150mg)將被浪費掉.Xandrox15中的50mg的杜鵑花酸已經足夠有效阻擋DHT在頭皮上的合成.

Q. Xandrox15乾掉時是否會留下任何殘餘在頭皮?

A. 當酒精被吸收進入頭皮後,將有一點很薄一層的甘油,minoxidil以及杜鵑花酸的殘餘.這些殘餘的minoxidil儲存了有益的源頭讓頭皮在 Xandrox15即使乾了後仍持續吸收minoxidil.如果只在晚上用Xandrox15並且使用小量,你可以使的頭皮上的殘餘降到最少,並且同時使得minoxidil的吸收達到最高.


配方組成(Formualtion)

Q. 乙醇在Xandrox15基底佔的比重為多少?

A. 基底溶液中包含80%的酒精與20%甘油.

Q. Xandrox15有沒有一點"油膩"的感覺?

A. 由於Xandrox15基礎溶液包含80%的乙醇,Xandrox15溶液吸收快速並且不會殘留任何油亮的光澤在頭皮上.酒精/甘油的組合是遠比會讓人有油膩感的落建超強配方5%與其他的5%minoxidil溶液要好得多(他們是用50%丙二醇,30%的酒精,與20%的水為基礎溶液).

Q. 為何用甘油(glycerin)替代用在大多數minoxidil溶液 防腐用的丙二醇(propylene glycol)?

A. 有相當多的病患,可能有10%,左右對於丙二醇有不好的皮膚反應.另外,對於甘油會有不良反應的人數則極為罕見.,甘油通常用來作為皮膚濕潤劑.濕潤劑能吸引水份到皮膚上.以甘油為主要成分的肥皂在高級的SPA以及度假勝地因此原因被提供.

Q. 為何不加維他命B6以及鋅到Xandrox15中?

A. 其實在vitro實驗中展現了加入維他命B6以及鋅到杜鵑花酸時能夠幫助用少量的杜鵑花酸能阻礙DHT在皮膚上的合成, 但是沒有任何的研究是有關於外用維他命B6的吸收動力學.很多大學的藥學系裡徹底的研究以診斷會議中都沒有釋出任何有關外用維他命B6的吸收,效率以及安全性方面的資訊.沒有這些極其重要的資料,如果加入維他命B6到對抗雄性禿的minoxidil/杜鵑花酸溶液中將是不付責任也不合理的.

有一些研究關於用外用鋅.然而,鋅與minoxidil/azelaic acid反映時將會形成不能融解的鹽類,使得所有的成分變成無效的..

為了這些原因,決定用杜鵑花酸作為所有Xandrox產品中的配方,它能夠在超過99%病患身上,有效的阻擋DHT在頭皮的合成.

Q. 為何不加維他命A酸(Retinoic acid)到Xandrox15中?

A. Retinoic acid在minoxidil溶液只含有2%濃度minoxidil時(落建),曾經是一種非常重要的輔助成分.當高濃度 minoxidil溶液時,將不需要在加入雷婷酸,他可能會讓效果下降多過幫助.雷婷酸是一種化學的脫皮劑,他能造成皮膚乾,剝落,發紅以及頭皮過敏.並且,長期使用雷婷酸(retinoic acid)將會造成皮膚對陽光傷害更過敏.

Q. 為何用杜鵑花酸(azelaic acid)而非其它媒介來降低頭皮DHT?

A. 用來對付雄性禿的外用藥水的首選是結合spironolactone與minoxidil在溶液中.不幸的是,他門在同一溶液中並不相容.其他的替代物如 emu oil,葡萄子萃取(grape seed extract),亞麻油酸(linoleic acid),綠茶(green tea),鉅棕櫚(saw palmetto),等等.也許能降低頭皮 DHT,但是並沒有令人信賴的研究能證明他們的價值.在藥理學上杜鵑花酸這方面的的作用被長久記載以及證明.

Q. 在一個論壇中有人提到杜鵑花酸( azelaic acid )有抗增生(anti-proliferative)與細胞毒性特性(cytotoxic properties).那是真的嗎?

A. 抗增生表示他能防止細胞的增生而細胞毒性則表示他殺死細胞.因此,這個問題的答案是"是"!但是用一種有利的角度來看.杜鵑花酸的抗增生以及細胞毒性只對惡性腫瘤細胞以及致病細菌發生作用.如果你仔細讀引用的文章(Exp Dermatol. 1995 Apr;4(2):79-81. Effect of azelaic acid on melanoma cells in culture. Lemic-Stojcevic L, Nias AH, Breathnach AS. ; Anticancer Res. 1990 Nov-Dec;10(6):1599-602. Cytotoxic activity of azelaic acid against human melanoma primary cultures and established cell lines. Zaffaroni N, Villa R,?Silvestro L, Sanfilippo O, Silvestrini R.; Biochem Pharmacol. 1985 May 15;34(10):1653-8. Activity of azelaic acid on cultures of lymphoma- and leukemia-derived cell lines, normal resting and stimulated lymphocytes and 3T3 fibroblasts. Picardo M, Passi S, Sirianni MC, Fiorilli M, Russo GD, Cortesi E, Barile G, Breathnach AS, Nazzaro-Porro M) ,你會發現杜鵑花酸在皮膚上的"抗增生","細胞毒性"只作用在惡性腫瘤與致病細菌上面,事實上這樣的生化作用使得杜鵑花酸被廣泛的認定為一種有益的藥物.沒有任何證據甚至案是杜鵑花酸會傷害法毛囊細胞.相反的.杜鵑花酸常被用來使角質化( keratinization)的症狀正常化,以及杜鵑花酸的副作用之一多毛症(hypertrichosis).


使用指引

Q. 如何把Xandrox15塗在頭皮?

A. 1mL的Xandrox15應該每天塗在頭皮1次.每一瓶的Xandrox15都附有一個校正過的藥用滴管讓病人得以方便的把1ml的Xandrox15 溶液塗在頭皮.滴管:把滴管的尖端直接置於頭皮上擠壓橡皮泡使其是放出少量的Xandrox15.把總共1ml的溶液分配到所有受到雄性禿影響的頭皮上. 指尖能幫助藥水的擴散以及現制住不流向其他的區域.每次使用後必須洗手.

Q. 當塗用Xandrox15時,是否頭皮必須是溼的或是乾的?

A. 頭皮可以是乾的或是溼的,但是頭皮不應當溼到那種會稀釋或是洗去minoxidil/azelaic acid的程度..

Q. 使用過Xandrox15多久可以淋浴或是洗頭?

A. 為了達到最佳的minoxidil與azelaic acid吸收效果,等待1小時.基礎溶液中高濃度的乙醇為能幫助頭皮快速吸收minoxidil.

Q. 是否為了造型的目的把頭髮弄濕會影響Xandrox15%的效率.

A. 不會,只要你不把頭髮弄成會溼到洗去Xandrox15的程度就可以.

Q. 用吹風機吹乾頭髮是否會影響到Xandrox15的功效?

A. 建議先吹乾頭髮再用Xandrox15.不然,吹乾頭髮時會造成大部份的Xandrox15揮發掉而非被吸收.塗1mL的Xandrox15在頭皮上並不會對髮型造成很大的改變.

Q. 對於Xandrox15瓶底形成了凝結物我該怎摸辦?

A. 由於Xandrox15是一種高度飽和的minoxidil溶液,很難得會有機會在瓶底形成沉澱物.如果這事情發生,改好瓶蓋把Xandrox15放到熱水中讓他緩緩加熱到近沸點並且用力的搖動瓶身,只要Xandrox15的瓶蓋是緊閉的他就能在熱水保持相久的時間,直到所有的minoxidil都回到溶液中.


和其他產品一起使用

Q . 一天使用二次Xandrox15,會不會比和較低濃度的minoxidil溶液輪流使用,效果更加來的要好?

A. 可能會,可是這麼做是不必須也不適當的,Xandrox15的效果結合了5% Xandrox或5% Minoxidil溶液,通常以此治療雄性禿已足夠得到最理想的效果。

Q . Xandrox15可以和5% Xandrox一起使用嗎?

A. 可以的,一天塗抹一次任一個溶液1毫升,再塗抹另一個溶液時,至少需間隔8個小時,Xandrox溶液含有0.025 %的A酸,應該在晚上塗抹,Xandrox15應該在早上塗抹 。

Q . Xandrox15可以和5% Minoxidil溶液一起使用嗎?

A. 可以的,一天塗抹一次任一個溶液1毫升,再塗抹另一個溶液時,至少需間隔8個小時,若想進一步減少頭皮DHT的數量和作用的話,塗抹5% Minoxidil溶液之後,再塗抹5% Spironolactone乳液。

Q . 5% Spironolactone乳液應該和Xandrox15一起使用嗎?

A. 對大多數的患者來說,這不是必須的,Xandrox15中的杜鵑花酸可以抑制幾乎所有案例的綜合DHT,然而,如果某人選擇使用不含杜鵑花酸的5% Minoxidil溶液,當作一天中的第二次塗抹,然後再額外使用5% Spironolactone乳液,這樣的使用方式是適當的,大多數的患者都在晚上使用5% Spironolactone乳液,第一次應該塗抹Xandrox15溶液,等待10到15分鐘部分乾燥之後,然後直接在塗抹過Xandrox15溶液的區域上,再塗抹薄薄一層的5% Spironolactone乳液 。

Q . 患者一開始就使用Xandrox15治療雄性禿適當嗎?

A. 不適當,通常大多數的患者將Xandrox 5%溶液或是5% Minoxidil溶液和5% Spironolactone乳液一起使用,就會得到令人滿意的回應,但是在使用任一個方法至少六個月以後,改善就不令人滿意了,然後患者可能會考慮在頭髮生長情況不佳的禿處使用Xandrox15 。

為什麼患者不應該一開始就使用Xandrox15來治療雄性禿的第二個原因,是因為外用的minoxidil會使已經處在休止期的頭髮在期末之前就掉落,頭髮會被較粗的頭髮替代,會觀察到掉髮增加,但是只是暫時的,可能只是心理作用。


副作用和禁忌

Q . 由於minoxidil引起的全身影響,每天使用Xandrox15,該注意的安全事項?

A. minoxidil需要20 奈克/毫升的血清濃度,會對人類身體引起血液動力或人類身體的其他全身影響,外部塗抹1毫升的Xandrox15,可以使minoxidil 的吸收量(範圍0.3 – 4.5%)達到平均1.4%,minoxidil 的血清濃度會在血清中達到~4 奈克 / 毫升,由於一天使用一次 Xandrox15,所以大約有5摺篇幅的minoxidil 全身影響的安全事項,最理想的結果是建議一天塗抹二次外用的minoxidil,一次的劑量是1毫升的Xandrox15,與第二次的劑量至少需間隔8個小時,應該使用1毫升較低濃度的Xandrox 5%或5% Minoxidil,如果一天中第二次是使用5% Minoxidil的話,和外用的spironolactone一起使用,將會抑制DHT,並且刺激已塗抹處的頭髮生長。

Xandrox 12.5%乳液的全身性副作用的發生率是,每1500個患者中低於1個。

Q . 使用Minoxidil的全身性影響和可能的副作用是什麼?

A. 口服的Minoxidil是當作降血壓的藥物使用,所以最常見的全身性影響是心跳加速(心臟速度增加)和姿態性低血壓(站立時的頭昏眼花),其他的副作用可能包括水腫、胸痛和臉部浮腫,使用口服Minoxidil不會引起 心包膜積水(心臟周圍積水)的案例發生 。

Q . Xandrox15中酒精的使用量有害嗎?

A. 不完全是,每天最多會塗抹1毫升的Xandrox15和1毫升的其他minoxidil溶液,乙基酒精的揮發性,會在每次外部塗抹後的一個小時以內揮發,塗抹的區域應小於200平方公分,皮膚吸收了80%的乙基酒精溶液,會低於50毫克,相形之下,酒精量會低於1毫升的酒(10%的酒精),皮膚的揮發不會危害安全。

Q . 如果患者對minoxidil 起全身性的副作用,應該怎麼處理?

A. 患者應該立刻停止使用所有含有minoxidil的外用溶液,幾天之內,副作用就會減輕。停止使用外用的minoxidil,大約95%被吸收的 minoxidil,會在4天內消除。

Q . 有需要避免使用Xandrox15的患者嗎?

A. 有的,有任何心臟病史的患者不應該使用Xandrox15,以及已知對minoxidil有負面反應的患者也應該避免使用Xandrox15。


PACKAGE INSERT

XANDROX15

THE SOLUTION

XANDROX15 is a custom formulated solution containing 15% minoxidil and 5% azelaic acid.?Xandrox15 is prescribed and dispensed exclusively for the patients of Regrowth, LLC to treat areas of alopecia androgenetica that are or have been resistant to other forms of therapy


Minoxidil 15%

Description: Minoxidil topical solution is a non-specific hair growth stimulant. Minoxidil appears as a white or off-white, odorless crystalline solid that is soluble in water to the extent of approximately 2 mg/mL, but more readily soluble in glycerin or ethanol. The chemical name for minoxidil is 2, 4-pyrimidinediamine, 6-(1-piperinedinyl)-, 3-oxide (MW= 209.25). Xandrox15 contains 150 mg minoxidil per milliliter.

Clinical Pharmacology: Minoxidil topical solutions stimulate hair growth in individuals with androgenetic alopecia, typically expressed in males as thinning of the hair at the vertex, crown, temporal and/or frontal areas and in females usually as diffuse hair loss or thinning in the frontoparietal areas. The exact mechanism by which minoxidil stimulates hair growth is not known but is thought to have a direct effect on the hair follicle to sustain the anagen phase of the hair cycle. It has also been shown to have a vasodilatory effect on the scalp. Although minoxidil is a direct acting peripheral arterial dilator that reduces blood pressure by decreasing peripheral vascular resistance, the vasodilating effect of minoxidil has not been proven to directly result in hair growth.?The failure to detect evidence of systemic effects during treatment with topical minoxidil reflects the poor absorption of topical minoxidil, which averages about 1.4% (range 0.3 to 4.5%) from normal intact scalp. Since it requires 20 ng / mL of serum to have any systemic effects in the human body and allowing for an average absorption rate of 1.4%, there remains a greater than 5-fold safety margin in the use of Xandrox15.?Following cessation of topical dosing of minoxidil, approximately 95% of systemically absorbed minoxidil is eliminated within four days. Minoxidil and its metabolites are excreted principally in the urine.

Indications and Usage: Xandrox15 topical solution is indicated for the treatment of alopecia androgenetica in men and women.?At least four months of once daily applications are usually required before evidence of hair growth can be expected. Even in patients for whom topical minoxidil does not seem effective for restoring hair loss, for most patients it will prevent further thinning and loss due to alopecia androgenetica.

Contraindications: Xandrox15 is contraindicated for any patient with a hypersensitivity to any of the components of the preparation.?Xandrox15 should also not be used by any patient with a known cardiac abnormality.

Warnings: Although extensive use of topical minoxidil has not revealed evidence that enough minoxidil is absorbed to have systemic effects, greater absorption or individual variability or sensitivity could theoretically cause a systemic effect. If systemic effects were to occur, patients with underlying heart disease would be at particular risk. Minoxidil could also have additive effects with other therapies in patients being treated for hypertension.

Drug Interactions: There are no known drug interactions associated with the use of a topical minoxidil solution.

Adverse Reactions: In placebo controlled trials, the rate of adverse reactions were no more common, other than dermatologic events such as irritation and allergic dermatitis.

Overdosage: There have been no reported cases of overdosage resulting from topical minoxidil administration. Minoxidil and its metabolites are hemodialyzable.?


Azelaic Acid 5%

Description: Azelaic acid is a naturally occurring saturated dicarboxylic acid with the chemical name of 1,7-heptanedicarboxylic acid and a molecular weight of 188.22. Azelaic acid is a dietary component of whole grain cereals and animal products.?

Clinical Pharmacology: The exact mechanism of action of azelaic acid is not known.?Azelaic acid at high concentrations is bactericidal. In vitro, azelaic acid acted as a scavenger of oxy radicals and inhibits a variety of oxidoreductive enzymes including 5-alpha reductase.?Azelaic acid (0.1 to 3.0 mmol/l) has been shown to produce a competitive concentration dependent inhibition of 5-alpha reductase activity in homogenates of human foreskin.?The multiple actions of azelaic acid cause a normalization of keratinization and a decrease in the free fatty acid content of skin surface lipids.

Pharmacodynamics: Following a single application to human skin, 3% to 5% of the azelaic acid penetrates into the strateum corneum (up to 10% is present in the dermis and epidermis). There is negligible cutaneous metabolism after topical application.?Approximately 4% of topically applied azelaic acid is systemically absorbed and mainly excreted unchanged in the urine. The half-life is approximately 12 hours after topical dosing, indicating percutaneous absorption rate-limited kinetics. After topical treatment with azelaic acid, plasma concentration and urinary excretion are not significantly different from baseline levels.

Contraindications: XANDROX15 is contraindicated in individuals who have known hypersensitivity to any of its components.

Warnings: There have been isolated reports of hypopigmentation after use of azelaic acid, although there is no depigmenting effect on normal melanocytes.

Precautions: If sensitivity or severe irritation develops with the use of XANDROX15, treatment should be discontinued. The most common adverse reactions occurring in approximately 1%-5% of patients were pruritis, burning, stinging and tingling, usually at the start of treatment.?These reactions may last 5 to 20 minutes, especially if the skin is inflamed or broken. The adverse effects commonly subside if treatment is continued. Other adverse reactions such as erythema, dryness, rash, peeling, irritation and dermatitis were reported in less than 1% of patients. The following additional adverse experiences have been rarely reported: worsening of asthma, vitilago hypopigmentation, hypertrichosis and reddening (signs of keratosis pilaris). Note: azelaic acid will consistently lighten hyperpigmented skin (skin that is darker than normal for a given individual) but will not typically lighten skin beyond its normal color. Rarely, patients with dark complexions may notice hypopigmentation of skin. There are no systemic adverse effects.

Considerations: Azelaic acid is normally found in the human diet and is not considered to be a carcinogenic substance.?Mutagenicity studies are negative and animal studies have shown no adverse effects on fertility or reproduction. Human problems have not been reported during pregnancy.

Dosage and Administration: Hair and scalp can be dry or hydrated prior to topical application of XANDROX15. A total daily dose of 1 mL should be applied to the affected areas of the scalp where regrowth of hair has been resistant to treatment.?Each bottle of Xandrox15 is accompanied with a medicine dropper calibrated at 1mL If you choose to use the dropper, place the tip of the dropper onto the scalp and squeeze the rubber bulb to release a small amount of Xandrox15.?Divide the total 1mL quantity into as many smaller aliquots as are required to moisten/wet the scalp in all the areas affected by MPB.?The fingertips can be used to spread the liquid within the desired areas and/or to restrict the flow to other areas.?Wash hands thereafter.

Regrowth, LLC offers a 2 oz. Plastic bottle with a custom fitted dauber applicator with a protective overcap.?Xandrox15 can be transferred to the applicator bottle and dispensed by inverting the dauber and gliding it across the scalp, while gently squeezing the plastic bottle.?Four side-to-side passes over the scalp approximates dispensing 1ml of Xandrox15 solution.?Although the amount of solution being dispensed cannot be precisely calibrated using the dauber applicator, if only enough liquid is applied to moisten the affected areas, there is minimal chance of utilizing excessive amounts of Xandrox15.

Daily applications for four months or longer may be required before evidence of hair growth is observed. Onset and degree of hair growth is variable among patients. XANDROX15 is best used in conjunction with lower concentration Xandrox solutions and/or lower concentration minoxidil solutions along with an agent to decrease the DHT in the scalp.?Topical minoxidil should be applied to the scalp twice/day at least 8 hours apart.

How Supplied: XANDROX15 is available in 125mL bottles and is dispensed exclusively by Regrowth, LLC.

Storage:?XANDROX15 solution is best kept at normal room temperatures. XANDROX15 can be kept for up to 24 months without deterioration or loss of efficacy.



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