Adverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil

Abstract

BACKGROUND:After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control. Hence, new alternative schemes and monitoring of adverse effects to avoid treatment abandonment are important considerations. OBJECTIVE:Describe the side effects of a multidrug regimen containing minocycline, ofloxacin, and clofazimine in multibacillary leprosy patients.METHODS:We conducted a prospective, descriptive, and observational study with multibacillary patients, including cases of intolerance to standard MDT and relapses. The study was carried out at Fundação Alfredo da Matta (Alfredo da Matta Foundation), in Manaus, Amazonas, from April 2010 to January 2012. The patients received alternative therapy, which consisted of daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin, and 50mg of clofazimine and a supervised monthly dose of 300mg of clofazimine for six months, followed by eighteen months of daily doses of ofloxacin 400mg, clofazimine 50mg, and a supervised monthly dose of clofazimine 300mg. Results: Twenty-one cases were included. Mild and transitory side effects occurred in 33.3% of patients. Of the total episodes, 45.9% were attributed to ofloxacin and they included abdominal pain, nausea, vomiting, headache, and insomnia; 21.6% were due to clofazimine, with 100% of patients presenting skin pigmentation. The mean time for the development of adverse effects after beginning the therapy was 15.2 days. CONCLUSION:All patients tolerated the drugs well, and compliance was satisfactory, with no serious events. Unlike other standard MDT studies had shown, no treatment was stopped due to side effects. Nevertheless, patient follow-up and studies with bigger samples are necessary to guarantee the efficacy and safety of the alternative regimen as a second-line scheme in multi-drug therapy.

Alternate Anti-Leprosy Regimen for Multidrug Therapy Refractory Leprosy: A Retrospective Study from a Tertiary Care Center in North India

“…19,20 There is a dearth of studies assessing the effectiveness of alternative/newer regimens in the management of leprosy in the last few decades. In a prospective study on 21 MB patients using the same alternative regimen as used in the present study, Maia et al 21 found that all patients tolerated the drugs well, with satisfactory compliance, and no events adverse enough to warrant discontinuation of the treatment were noted.…”

Synthesis, characterization and DNA-binding properties of Ru(II) complexes coordinated by ofloxacin as potential antitumor agents

“…Ofloxacin is one of the most frequently used 4-quinolone synthetic antibiotics and exhibits a good distribution pattern in low dose levels [3]. Ofloxacin is used in the treatment of several infectious diseases, such as typhoid fever, meningococcal infection, and recently, multibacillary leprosy [4][5][6]. The use of ofloxacin for urinary tract infection treatment has increased in the past decade because this antibiotic has excellent efficacy and increases resistance to older agents, such as trimethoprim and sulfamethoxazole [7].…”

Minocycline induced hyperpigmentation in lepromatous patches: case report

“…A 22years old male patient of Hansen's disease (Borderline Lepromatous) symptomatic for last 01year presented with multiple erythematous and hypopigmented normoasthetic plaques and macules distributed over back and extremities ( Figure 1) along with multiple thickened nerves. 1 A slit skin smear for AFB (L) was positive with a Bacteriological Index (BI) of 6+. Histopathological examination from a biopsy done from back revealed multiple foamy histiocytes with ZN stain for AFB (L) showing numerous leprae bacilli.…”