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Lamprene (Clofazimine) - Summary

 



LAMPRENE SUMMARY

Lamprene®

Lamprene, clofazimine, is an antileprosy agent available as soft gelatin capsules for oral administration. Each capsule contains 50 mg of micronized clofazimine suspended in an oil-wax base. Clofazimine is a substituted iminophenazine bright-red dye.

Lamprene is indicated in the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. Lamprene has not been demonstrated to be effective in the treatment of other leprosy-associated inflammatory reactions.

      Combination drug therapy has been recommended for initial treatment of multibacillary leprosy to prevent the development of drug resistance.


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NEWS HIGHLIGHTS

Media Articles Related to Lamprene (Clofazimine)

Leprosy
Source: MedicineNet Alopecia Areata Specialty [2009.06.11]
Title: Leprosy
Category: Diseases and Conditions
Created: 6/10/2009
Last Editorial Review: 6/11/2009

Thalidomide: Solving The 50-Year-Old Puzzle
Source: Cancer / Oncology News From Medical News Today [2009.11.18]
Research into the controversial drug thalidomide reveals that the mechanism through which the drug causes limb defects is the same process which causes it to damage internal organs and other tissues. The article, published in Bio-Essays, outlines the challenges surrounding thalidomide research and claims that confirmation of a 'common mechanism' could lead to new treatments for Leprosy, Crohn's Disease, AIDS and some forms of cancer.

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Published Studies Related to Lamprene (Clofazimine)

Two-year combination antibiotic therapy with clarithromycin, rifabutin, and clofazimine for Crohn's disease. [2007.06]
BACKGROUND & AIMS: Mycobacterium avium subspecies paratuberculosis has been proposed as a cause of Crohn's disease. We report a prospective, parallel, placebo-controlled, double-blind, randomized trial of 2 years of clarithromycin, rifabutin, and clofazimine in active Crohn's disease, with a further year of follow-up... CONCLUSIONS: Using combination antibiotic therapy with clarithromycin, rifabutin, and clofazimine for up to 2 years, we did not find evidence of a sustained benefit. This finding does not support a significant role for Mycobacterium avium subspecies paratuberculosis in the pathogenesis of Crohn's disease in the majority of patients. Short-term improvement was seen when this combination was added to corticosteroids, most likely because of nonspecific antibacterial effects.

Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus. [2005.10]
OBJECTIVE: To evaluate the efficacy of clofazimine (CFZ) compared with chloroquine diphosphate (CDP) for the treatment of cutaneous involvement in systemic lupus erythematosus (SLE)... CONCLUSION: These findings suggest that CFZ is equally as effective as CDP in controlling cutaneous lesions in SLE patients. However, we cannot exclude the possibility that the CFZ itself could be the cause of systemic lupus flare.

Treatment of recurrent aphthous stomatitis with clofazimine. [2009.11]
OBJECTIVE: The aim was to investigate the safety and efficacy of clofazimine for the treatment of recurrent aphthous stomatitis... CONCLUSION: Clofazimine should be considered for the treatment of recurrent aphthous stomatitis.

Use of clofazimine in dermatology. [2009.09]
Clofazimine is the riminophenazine dye that, due to its antibacterial and anti-inflammatory properties, has been used for several diseases. This article reviews all major characteristics and uses relating to clofazimine, from its pharmacology to its indications in several skin diseases, over and above its classical and well established use in the treatment of leprosy.

Nanoaggregates of a random amphiphilic polyanion to carry water-insoluble clofazimine in neutral aqueous media. [2009.02.15]
Clofazimine, an antibiotic drug active against mycobacteria and used for the treatment of leprosy, is a very weak base insoluble in neutral aqueous media... Despite its favorable in vitro characteristics, clofazimine entrapped within the lipophilic pockets born by the amphiphilic aggregates exhibited no antibiotic activity after administration to mice infected with Mycobacterium bovis BCG.

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Clinical Trials Related to Lamprene (Clofazimine)

A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease [Completed]
This study will examine the effectiveness of clofazimine in the prophylaxis of Mycobacterium avium complex infection in HIV infected individuals who are at risk to develop this untreatable opportunistic disease. In the absence of truly effective antiretroviral therapy, a potential mode of treatment of patients with HIV infection is to prevent the development of the life-threatening opportunistic infections. Current studies demonstrate a possible efficacy of clofazimine in the prophylaxis against Pneumocystis carinii pneumonia (PCP), the most common AIDS-defining opportunistic infection. Future studies will examine the potential for prophylaxis against the other opportunistic infections. This proposal hopes to define the role of prophylactic clofazimine in preventing the currently untreatable Mycobacterium avium complex infection. AMENDED: To include prophylaxis for Asymptomatic and ARC.

Clofazamine in the Long Term Treatment of Leprosy, Phase III [Available]
Clofazimine has shown effectiveness in the treatment of leprosy for many years. The World Health Organization and the National Hansen's Disease Program consider clofazamine to be standard therapy for treatment of multibacillary leprosy. In recent years, the availability of the drug has become limited and is currently available only under a research protocol and is considered "investigational." Use of Clofazamine in patients presenting with lepromatous leprosy is necessary for patients exhibiting nerve involvement or lesions resistant to other therapies. This drug will be used prospectively for patients who require treatment of leprosy as deemed appropriate by a Kaiser Permanente Southern California physician.

A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals. [Completed]
To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).

The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS [Completed]
PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC).

SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.

Uniform Multidrug Therapy Regimen for Leprosy Patients [Recruiting]
The purpose of this randomized trial is to verify if leprosy patients, despite of their classification, can be treated with the same regimen without compromising patient cure and acceptability of the treatment. At present, patients classified as multibacillary leprosy are treated for 12 months with three drugs, and patients classified as paucibacillary leprosy are treated for 6 months with two drugs. The study is going to test a unified regimen for paucibacillary and multibacillary patients by treating leprosy patients with three drugs for 6 doses.

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Page last updated: 2009-11-18

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