药品英文名
 
Clofazimine
 
药品别名
 
氯苯吩嗪、克风敏、亚甲吩嗪、亚甲基吩嗪、氯法齐鸣、Hansepran、Lamprene、Riminophenazine、NSC-141046
 
药物剂型
 
胶囊或胶丸剂：50mg，100mg。
 
药理作用
 
氯法齐明对麻风杆菌、结核杆菌和其他多种分枝杆菌有强大的抑制活性，其抑制结核杆菌和牛型结核杆菌的MIC为0.1～3.3μg/ml，对鸟分枝杆菌的MIC为0.5～2.0μg/ml，其杀菌速度与氨苯砜相仿，30～60天可杀灭96%～99%的麻风杆菌。为治疗瘤型麻风病的首选药物，包括对氨苯砜耐药的菌株。本品为吩嗪类染料，可抑制DNA依赖RNA聚合酶，阻止RNA的合成抑制细菌蛋白质的合成，抑制或杀灭分枝杆菌的生长。本品在大剂量时才显示有抗炎作用，可能与稳定溶酶体膜有关。可抑制麻风的结节红斑反应，但作用仅在用药后2～4周才缓慢出现。
 
药动学
 
注射给药吸收缓慢，口服吸收率个体差异较大，吸收率在45%～62%，其吸收受剂型的影响较大，将微粒胶结晶和油脂基质制成胶囊口服，吸收率可提高至70%。吸收后分布不均匀，由于药物具有高亲脂性，主要沉积于脂肪组织和网状内皮系统的细胞内，被全身的巨噬细胞摄取，分布至肠系膜淋巴结、肾上腺、皮下脂肪、肝、胆、胆汁、小肠、脾、肌肉、骨骼和皮肤中，不易穿透血-脑脊液屏障。每天口服100mg或300mg，平均血浆药物浓度为0.7μg/ml或1μg/ml。每天口服100mg或300mg，平均血浆药物浓度为0.7μg/ml或1μg/ml。每天口服300mg，连续2个月或更长时间，血浆峰浓度为1.8～3.5μg/ml。自组织中释放很慢，排泄也极缓慢，反复给药的血浆半衰期约70天。24h内以原形药物或代谢产物经尿液中排出微量，仅占口服剂量的0.01%～0.41%，3天后11%～66%由粪便中排出，少量由痰液、汗液、皮脂和乳汁中排出。
适应证
 
用于治疗菌检阳性的各型麻风患者，能控制反复发作的麻风反应。对瘤型麻风和其他类型的麻风有一定的疗效，对砜类耐药的麻风病亦有效，常与利福平、乙硫异烟胺或丙硫异烟胺合并应用。

另对结核、结节性红斑、痤疮、脓疮性皮肤病、类天疱疮、坏死性皮肤病等也有疗效。皮肤病如盘状红斑狼疮、坏疽性脓皮症、掌跖脓疱病等。
 
禁忌证
 
对本品过敏者禁用。
 
注意事项
 
1.慎用：肝肾功能不全者慎用。胃及十二指肠溃疡者慎用。母乳中可含有药物，妊娠及哺乳妇女慎用。

2.为减少药物反应宜与牛奶同时服用。初始治疗时为减少或防止耐药性的产生，可与一种或几种抗麻风药物联合应用。用药期间出现持续性的恶心、呕吐、腹痛症状者应及时减量、延长给药间隔时间或停药。
不良反应
 
1.皮肤红染及色素沉着：

最常见，多在用药后2～4周出现，以6～12个月时最明显。开始皮肤呈淡红色，以后变为棕褐色至紫黑色，以暴露部位更加明显。另外眼结膜、尿液、痰、汗液均呈现红色。氯法齐明可通过胎盘和进入乳汁，使新生儿和乳儿皮肤染色。皮肤红染及色素沉着的程度与剂量、疗程成正比，停药后可逐渐消退。
2.皮肤干燥及鱼鳞病样改变：

多在用药后2～3个月出现，以四肢伸侧(特别是下肢)最为明显，停药后3个月左右逐渐消退，外用润肤剂可减轻症状。
3.消化道反应：

少数患者有恶心、呕吐、厌食、腹痛、便秘和腹泻等不良反应，一般均较轻微，不影响治疗，将氯法齐明改为进食时服用可减轻症状。腹痛严重者应停药。
4.其他：

嗜睡、眩晕、失眠等。
 
用法用量
 
口服：
1.用于耐氨苯砜的各型麻风病患者，每次50～100mg，每天1次．与一种或几种抗麻风药合用。
2.用于伴有红斑结节麻风反应的各型麻风病，对有神经损害或皮肤溃疡凶兆者每天100mg～300mg，有助于减少或撤除泼尼松(每天40～50mg)，待反应控制后，逐渐减量至每天100mg，为使组织内达到足够的药物浓度，用药2个月后才逐渐减少泼尼松的用量；对无神经损害或皮肤溃疡凶兆者按耐氨苯砜治疗。
3.用于氨苯砜敏感的各型麻风病，可与其他2种抗麻风药联合治疗，如可能3药合用，至少3年以上，直至皮肤涂片检查转阴，成人最大剂量为每天300mg，儿童剂量尚未确定。
4.用于耐药的结核和非结核性分枝杆菌病，每次100mg，每天3次，与抗结核药联合应用。
5.治疗多菌性麻风：氯法齐明每月1次，300mg，监督服，并每天50mg，自服，与利福平、DDS组成联合化疗方案、疗程至少2个月，或至皮肤涂片查菌转阴为上。
6.治疗麻风反应：应从较大剂量开始，每天200～400mg，当反应控制后逐渐减量，对严重病例，在开始阶段应配合糖皮质激素治疗。
7.治疗其他皮肤病：每天100～400mg口服，病情控制后逐渐减量。
 
药物相应作用
 
治疗麻风病初始时，可暂时加重麻风反应，对严重病例可选用肾上腺皮质激素联合应用，以减少反应。
 
专家点评
 
本品为治疗瘤型麻风病的首选药物。临床也多用于对砜类药物不能耐受的患者。此外，本品对慢性盘状红斑狼疮、皮肤溃疡、坏疽性脓皮病也有一定的疗效。氯法齐明对麻风有肯定疗效，对于耐砜类药的瘤型患者疗效亦很明显，表现为皮损减轻，细菌形态指数明显下降。

氯法齐明对麻风性结节性红斑既有预防作用，又有治疗作用，用该药治疗的瘤型患者，麻风性结节性红斑的发生率及严重程度明显低于DDS治疗者，对于长期依赖糖皮质激素的麻风结节性红斑，用氯法齐明治疗后可逐渐撤掉糖皮质激素。另外氯法齐明对Ⅰ型麻风反应的神经炎亦有疗效。

LAMPRENE 50 mg  100 caps
 
LAMPRENE 100 mg 100 caps

LampreneGeneric Name: clofazimine (Oral route)

kloe-FAZ-i-meen

Commonly used brand name(s):

In the U.S.

Lamprene
Available Dosage Forms:

Capsule
Therapeutic Class: Leprostatic

Uses For Lamprene
Clofazimine is taken to treat leprosy (Hansen's disease). It is sometimes given with other medicines for leprosy. When this medicine is used to treat ``flare-ups'' of leprosy, it may be given with a cortisone-like medicine. Clofazimine may also be used for other problems as determined by your doctor.

This medicine is available only with your doctor's prescription.

Before Using Lamprene
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of clofazimine in children with use in other age groups.

Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of clofazimine in the elderly with use in other age groups.

Pregnancy

Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aluminum Hydroxide
Magnesium Hydroxide
Phenytoin
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Orange Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Liver disease—Clofazimine may on rare occasion cause hepatitis and liver disease
Stomach or intestinal problems, history of—Clofazimine often causes some stomach upset, but on rare occasion may cause severe, sharp abdominal pain and burning, which may be a sign of a serious side effect
Proper Use of Lamprene
Clofazimine should be taken with meals or milk.

To help clear up your leprosy completely, it is very important that you keep taking clofazimine for the full time of treatment , even if you begin to feel better after a few months. You may have to take it every day for as long as 2 years to life. If you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at the same time every day. If you need help in planning the best time to take your medicine, check with your health care professional.

Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For the treatment of leprosy (Hansen's disease) :
Adults and teenagers: 50 to 100 milligrams once a day. This medicine must be taken with other medicines for the treatment of Hansen's disease.
Children: Dose must be determined by the doctor.
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Lamprene
If your symptoms do not improve within 1 to 3 months, or if they become worse, check with your doctor. It may take up to 6 months before the full benefit of this medicine is seen.

Clofazimine may cause pink or red to brownish-black discoloration of the skin within a few weeks after you start taking it. Because of the skin discoloration, some patients may become depressed. The discoloration will go away when you stop taking this medicine. However, it may take several months or years for the skin to clear up completely. If skin discoloration causes you to feel very depressed or to have thoughts of suicide, check with your doctor immediately.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well. If these reactions are especially bothersome, check with your doctor.

Clofazimine may cause your skin to become more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
Wear protective clothing, including a hat. Also, wear sunglasses.
Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
Do not use a sunlamp or tanning bed or booth.
If you have a severe reaction, check with your doctor .

Clofazimine may also cause dry, rough, or scaly skin. A skin cream, lotion, or oil may help to treat this problem.

Lamprene Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
Bloody or black, tarry stools
colicky or burning abdominal or stomach pain
mental depression
yellow eyes or skin—may be an orange color if already have a pink to brownish-black skin or eye discoloration
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Diarrhea
dry, rough, or scaly skin
loss of appetite
nausea or vomiting
pink or red to brownish-black discoloration of skin and eyes
skin rash and itching
Less common or rare
Changes in taste
dryness, burning, itching, or irritation of the eyes
increased sensitivity of skin to sunlight
Clofazimine commonly causes discoloration of the feces, lining of the eyelids, sputum, sweat, tears, and urine. Usually this side effect does not require medical attention, but the discoloration may not go away. However, clofazimine may also cause bloody or black, tarry stools. This side effect may be a symptom of serious bleeding problems that do require medical attention.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.