软膏，外部使用：

Santyl：250单位/ g（30g，90g）

药理

胶原酶是由溶组织梭菌发酵产生的酶，并且与其他蛋白水解酶的不同之处在于其酶促作用对坏死组织中天然和变性胶原蛋白具有高度特异性;胶原酶不会攻击健康组织中的胶原蛋白或新形成的肉芽组织。因此，胶原酶对于清除碎屑，形成肉芽组织，以及随后的皮肤溃疡和严重烧伤区域的上皮化是有效的。

使用：

皮肤溃疡：缓解慢性皮肤溃疡和严重烧伤的区域。

禁忌

对胶原酶或制剂任何组分的局部或全身超敏反应。

剂量：成人

皮肤溃疡：局部：每天一次（或更频繁，如果敷料变脏）直到坏死组织清创完成并肉芽组织完好。如果感染存在，在应用胶原酶之前涂抹适当的局部用抗生素。如果感染仍然存在，则停止使用胶原酶直至感染缓解。

剂量：肾脏损害

制造商的标签中没有提供剂量调整;目前还不知道胶原酶在局部应用后是否全身吸收。

剂量：肝损伤

制造商的标签中没有提供剂量调整;目前还不知道胶原酶在局部应用后是否全身吸收。

在使用前，通过用生理盐水或其他兼容清洁液（例如Dakin's溶液）饱和的纱布垫轻轻擦拭，然后用生理盐水冲洗，清洁碎屑和消化材料的伤口;含有重金属离子（如汞，银）的清洁剂和防腐剂或浸泡剂可能会降低胶原酶的酶活性，应避免使用。酶活性在6至8的pH范围内是最佳的;应采取预防措施以确保施用地点的最佳pH值。

直接将胶原酶应用于伤口或无菌纱布垫，然后施用于伤口并固定。如果存在厚焦痂，在使用前考虑使用＃10刀片进行交叉阴影，以允许与坏死碎片进行更多表面接触;尽可能用镊子和剪刀去除松散的碎屑。应该小心地将应用限制在伤口的区域;当施用不限于伤口时，周围组织可能出现短暂性红斑。

警告/注意事项

有关不利影响的担忧：

•局部效应：偶尔会在周围组织中观察到轻微的短暂性红斑，特别是当施用不限于伤口时。

特殊人群：

•衰弱的患者：清除酶可能会增加菌血症的风险;监测全身性细菌感染的衰弱患者。

监视参数

全身细菌感染的体征和症状

怀孕考虑

目前还不知道胶原酶在局部应用后是否全身吸收。

患者教育

•讨论与治疗有关的患者对药物和副作用的具体使用。 （HCAHPS：在这次住院期间，您是否给过任何您以前没有服用过的药物？在给您任何新药之前，医院工作人员多长时间告诉您该药的用途？医院工作人员多长时间一次描述可能的副作用一种你能理解的方式？）

•让患者立即向开处方者报告感染迹象（HCAHPS）。

•对患者进行有意义的反应（例如喘鸣，胸闷，发烧，瘙痒，严重咳嗽，皮肤蓝色，癫痫发作，或面部，嘴唇，舌头或喉咙肿胀）的征兆。注意：这不是所有副作用的综合列表。患者应咨询开药者有关其他问题。

预期用途和免责声明：不应打印并提供给患者。此信息旨在作为医护人员在与患者讨论药物时使用的简明初始参考。你最终必须依靠自己的判断力，经验和判断力来诊断，治疗和建议患者。

Medically reviewed on March 25, 2018

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Santyl: 250 units/g (30 g, 90 g)

· Santyl

· Enzyme, Topical Debridement

Collagenase is an enzyme derived from the fermentation by Clostridium histolyticum and differs from other proteolytic enzymes in that its enzymatic action has a high specificity for native and denatured collagen in necrotic tissue; collagenase will not attack collagen in healthy tissue or newly formed granulation tissue. Therefore, collagenase is effective for the removal of detritus, formation of granulation tissue, and subsequent epithelization of dermal ulcers and severely burned areas.

Topical: Unknown

Dermal ulcers: Debriding chronic dermal ulcers and severely burned areas.

Local or systemic hypersensitivity to collagenase or any component of the formulation.

Dermal ulcers: Topical: Apply once daily (or more frequently if the dressing becomes soiled) until debridement of necrotic tissue is complete and granulation tissue is well established. If infection is present, apply an appropriate topical antibiotic prior to the application of collagenase. If the infection persists despite treatment, discontinue use of collagenase until remission of the infection.

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling; it is not known if collagenase is absorbed systemically following topical application.

There are no dosage adjustments provided in the manufacturer’s labeling; it is not known if collagenase is absorbed systemically following topical application.

Prior to application, cleanse the wound of debris and digested material by gently rubbing with a gauze pad saturated with normal saline or another compatible cleansing solution (eg, Dakin’s solution) followed by a normal saline rinse; detergents and antiseptics or soaks containing heavy metal ions (eg, mercury, silver) may decrease the enzymatic activity of collagenase and should be avoided. The enzymatic activity is optimal at a pH range of 6 to 8; precautions should be taken to ensure optimal pH at the application site.

Apply collagenase directly to the wound or to a sterile gauze pad and then apply to the wound and secure. If a thick eschar is present, consider crosshatching with a #10 blade prior to application to allow for more surface contact with necrotic debris; remove as much loosened detritus as can be done readily with forceps and scissors. Application should be carefully confined to the area of the wound; transient erythema may occur in surrounding tissue when application is not confined to the wound.

Do not store above 25˚C (77˚F).

There are no known significant interactions.

Frequency not defined.

Local: Application site burning, application site irritation, application site pain

<1%, postmarketing and/or case reports: Hypersensitivity reaction

Concerns related to adverse effects:

• Local effects: A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when application was not confined to the wound.

Special populations:

• Debilitated patients: Debriding enzymes may increase the risk of bacteremia; monitor debilitated patients for systemic bacterial infections.

Signs and symptoms of systemic bacterial infection

It is not known if collagenase is absorbed systemically following topical application.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of infection (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.