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Clofazimine
Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Clofazimine belongs to the pharmacological class of Phenazine Derivatives.
Clofazimine has been approved to relieve symptoms and also for the treatment and maintenance of Erythema nodosum leprosum, Leprosy, lepromatous, Mycobacterial infection, Tuberculosis, drug-resistant.
The absorption of clofazimine after oral administration in leprosy patients ranges from 45 to 62%. Clofazimine, being highly lipophilic, primarily accumulates in fatty tissues and cells of the reticuloendothelial system. It is taken up by macrophages and distributed throughout the body. Crystalized deposits of clofazimine have been detected in various organs and tissues, including the mesenteric lymph nodes, adrenals, subcutaneous fat, liver, bile, gall bladder, spleen, small intestine, muscles, bones, and skin.After repeated oral doses of clofazimine, three metabolites have been identified in the urine. The pharmacological activity of these metabolites remains unclear. Metabolite I may be formed through the hydrolytic dehalogenation of clofazimine, while metabolite II is believed to be produced through a hydrolytic deamination reaction followed by glucuronidation. Elimination of clofazimine occurs partly through the feces, which may involve excretion in the bile. A small amount of the drug is also eliminated in the sputum, sebum, and sweat. The excretion of unchanged clofazimine and its metabolites in a 24-hour urine collection is minimal.
The common side effects involved in using Clofazimine are Changes in skin color, Dry and scaly skin, Rash, Itching, Abdominal pain, Diarrhea, Nausea, Vomiting, Food intolerances, Eye irritation or burning, Eye dryness, Itchy eyes, Eye discoloration.
Clofazimine is available in the form of Capsules.
Clofazimine is approved in Germany, Japan, Malaysia, India, the U.K., the U.S., and China.
Clofazimine belongs to the pharmacological class of Phenazine Derivatives.
The precise mechanism(s) of action of clofazimine have not been fully understood, but it is believed to exert its antimicrobial activity by targeting the bacterial membrane. It was previously believed that its lipophilicity contributed to the generation of intracellular reactive oxygen species (ROS), such as H2O2 and superoxide, through redox cycling. These ROS were thought to play a role in the antimicrobial effect of clofazimine. However, a more recent and compelling theory suggests that clofazimine interacts with bacterial membrane phospholipids, leading to the production of antimicrobial lysophospholipids. The combined effects of clofazimine and lysophospholipids destabilize the bacterial membrane, interfering with K+ uptake and ultimately disrupting ATP production, resulting in bactericidal efficacy. Clofazimine also exhibits anti-inflammatory activity by inhibiting the activation and proliferation of T-lymphocytes. The mechanisms underlying this activity are multifaceted. One proposed mechanism is the direct antagonism of T-cell Kv 1.3 potassium channels. Additionally, clofazimine indirectly acts by promoting the release of E-series prostaglandins and reactive oxygen species from neutrophils and monocytes, which are bystander cells involved in the inflammatory response
Clofazimine has been approved to relieve symptoms and also for the treatment and maintenance of Erythema nodosum leprosum, Leprosy, lepromatous, Mycobacterial infection, Tuberculosis, drug-resistant.
When clofazimine is taken together with a meal, a dose of 200mg led to a maximum concentration (Cmax) of 0.41 mg/L, reached at 8 hours after administration. On the other hand, when clofazimine was taken on an empty stomach, the Cmax was 30% lower and reached at 12 hours.
Clofazimine is found to be available in the form of Capsules.
Clofazimine can be used in the following treatment:
- Erythema nodosum leprosum
- Leprosy, lepromatous
- Mycobacterial infection
- Tuberculosis, drug-resistant
Clofazimine can help to relieve symptoms and also for the treatment and maintenance of Erythema nodosum leprosum, Leprosy, lepromatous, Mycobacterial infection, Tuberculosis, drug-resistant.
Clofazimine is approved for use in the following clinical indications:
- Erythema nodosum leprosum
- Leprosy, lepromatous
- Mycobacterial infection
- Tuberculosis, drug-resistant
- Aphthous Ulcers, Severe (off-label use):
- Oral:
- Initial: Begin with a daily dose of 25 mg for 3 days.
- Increase the dose by 25 mg daily every 3 days up to 100 mg daily for 3 days.
- Subsequently, increase the dose by 25 mg daily every 7 days up to 150 mg daily.
- Administer in 2 divided doses (75 mg dose is given in 3 divided doses).
- Maintenance: Use a dosage of 100 to 150 mg daily in 2 divided doses, with or without concomitant colchicine.
- Bullous Systemic Lupus Erythematosus (off-label use):
- Oral: Start with a dose of 50 mg once daily initially, with or without immunosuppressive therapy.
- The dosage range is 25 to 200 mg daily.
- Dermatitis Herpetiformis (adjunctive agent):
- Oral:
- Initial: Begin with a daily dose of 25 to 50 mg.
- Increase the dose as needed to achieve a range of 100 to 200 mg daily for full control.
- Once the rash is under control, gradually taper the dose to a minimum maintenance dosage based on clinical response.
- Immune Thrombocytopenia (alternative agent) (off-label use):
- Oral: Administer a dosage of 50 to 100 mg daily or 1 to 2 mg/kg/day.
- The duration of therapy should be at least 21 days.
- Leprosy:
- Oral: Use a daily dose of 100 mg as part of an appropriate combination regimen.
- The treatment duration is 12 months for tuberculoid (paucibacillary) disease and 24 months for lepromatous (multibacillary) disease.
- Pemphigus Vulgaris (adjunctive agent) (off-label use):
- Oral:
- Begin with a daily dose of 25 mg for 7 days.
- Increase the dose by 25 mg daily every 7 days up to 100 mg daily for 7 days (4 weeks total therapy).
- Administer in 2 divided doses (a 75 mg dose is given in 3 divided doses).
- The usual dose range is 50 to 200 mg daily.
- Taper and discontinue gradually based on lesion response.
- Pneumocystis Pneumonia in Patients with HIV (alternative agent) (off-label use):
- Oral:
- Prophylaxis (primary or secondary): Administer 100 mg once daily or in 2 divided doses as monotherapy.
- Prophylaxis in combination with weekly pyrimethamine and leucovorin: Use a dosage of 50 mg daily or 200 mg weekly.
- Treatment for mild to moderate disease: Administer 100 mg once daily in combination with trimethoprim for 21 days.
- Pyoderma Gangrenosum (alternative agent) (off-label use):
- Oral: Use a dosage of 50 to 200 mg daily.
- Relapsing Polychondritis (off-label use):
- Oral: Administer a daily dosage of 25 to 200 mg.
- T. Gondii Encephalitis in Patients with HIV (alternative to preferred therapy) (off-label use):
- Primary prophylaxis: Administer 50 mg daily or 200 mg weekly in combination with weekly pyrimethamine and leucovorin.
- Continue until CD4 count is >200 cells/mm3 for >3 months in response to antiretroviral therapy (ART).
Acne Vulgaris:
Important Considerations: This treatment is recommended for patients who have not responded adequately to initial treatments (Ref). Avoid using it simultaneously with benzoyl peroxide, as it may cause temporary yellow-orange discoloration of the skin and facial hair.
Topical Treatment:
- Gel 5%: Apply a small amount, equivalent to the size of a pea, in a thin layer to the affected areas twice daily.
- Gel 7.5%: Apply a small amount, equivalent to the size of a pea, in a thin layer to the entire face once daily. It may also be applied to other affected areas of the body once daily.
- Capsules: 50mg
Capsules.
Dosage Adjustments in Hepatic Impairment Patients:
Use caution when administering to patients with hepatic impairment (Child-Pugh classes A, B, and C), considering the balance between potential benefits and risks.
Dosage Adjustments in Pediatric Patients:
Leprosy, Lepromatous (Multibacillary):
- National Hansen Disease Program Dosing:
- Children and Adolescents: Oral: 1 mg/kg/dose once daily for 24 months; maximum dose: 50 mg/dose. If needed, doses of 2 mg/kg/dose every other day are acceptable based on dosage form constraints.
- World Health Organization Dosing:
- Children <10 years: Oral: 50 mg twice weekly and 100 mg once monthly for 12 months.
- Children ≥10 years and Adolescents <15 years:
- <40 kg: Oral: 50 mg twice weekly and 100 mg once monthly for 12 months.
- ≥40 kg: Oral: 50 mg once every other day and 150 mg once monthly for 12 months.
- Adolescents ≥15 years: Oral: 50 mg once daily and 300 mg once monthly for 12 months.
Mycobacterial Infection:
- Odontogenic Infection, Osteomyelitis:
- Children 3 to 9 years: Oral: 1 mg/kg/dose once daily as part of a combination regimen.
- Pulmonary Infection in Patients without Cystic Fibrosis:
- Children and Adolescents: Oral: 3 to 5 mg/kg/dose once daily as part of a combination regimen; maximum dose: 100 mg/dose.
- Pulmonary Infection in Patients with Cystic Fibrosis:
- Children and Adolescents: Oral: 1 to 2 mg/kg/dose once daily as part of a combination regimen; maximum dose: 100 mg/dose.
Tuberculosis, Active; Treatment:
- Tuberculosis, Active (Drug-Resistant); Treatment:
- Children and Adolescents: Oral: 2 to 5 mg/kg/dose once daily as part of a combination regimen; maximum dose: 100 mg/dose. Higher doses may be administered every other day if needed based on dosage form constraints.
Clofazimine may be contraindicated under the following conditions:
- Clofazimine is contraindicated in patients who have demonstrated hypersensitivity to the drug.
Abdominal Obstruction and Other Gastrointestinal Adverse Reactions:
Clofazimine may lead to the accumulation of crystals in various organs, including the mesenteric lymph nodes, intestinal mucosa, spleen, and liver. This deposition in the intestinal mucosa can result in intestinal obstruction, potentially requiring exploratory laparotomy. Cases of splenic infarction, gastrointestinal bleeding, and even death have been reported. If a patient experiences abdominal pain, nausea, vomiting, or diarrhea, appropriate medical investigations should be initiated, and the daily dose of Clofazimine may need to be reduced, the dosing interval increased, or the drug discontinued. High doses of Clofazimine (>100 mg daily) should be administered for the shortest duration possible (less than 3 months) and under close medical supervision.
QT Prolongation:
There have been reports of Torsade de Pointes and QT prolongation in patients receiving Clofazimine at a daily dose higher than 100 mg or in combination with medications known to prolong the QT interval. Patients with QT prolongation or Torsade de Pointes should be closely monitored under medical supervision, including regular electrocardiograms (ECGs) to assess for QT prolongation and cardiac rhythm disturbances. It is important to monitor ECGs in patients concurrently taking Clofazimine and bedaquiline, discontinuing Clofazimine if clinically significant ventricular arrhythmia is observed or if the QTcF interval exceeds 500 ms. If syncope occurs, an ECG should be obtained to detect QT prolongation.
Skin and Body Fluid Discoloration and Other Skin Reactions:
Clofazimine can cause skin discoloration ranging from orange-pink to brownish-black, affecting not only the skin but also the conjunctivae, tears, sweat, sputum, urine, and feces in 75-100% of patients. Patients should be advised that skin discoloration is likely to occur and that it may take several months or even years to reverse after completing therapy. Other skin reactions associated with Clofazimine treatment include ichthyosis, dry skin, and pruritus (itchiness).
Psychological Effects of Skin Discoloration:
Skin discoloration resulting from Clofazimine therapy has been associated with reports of depression and suicidal ideation. Patients should be informed about the possibility of skin discoloration and closely monitored for signs of depression or suicidal thoughts during Clofazimine therapy.
Alcohol Warning
- It is important to exercise caution and avoid consuming alcohol while taking Clofazimine Alcohol may interact with fosfomycin and potentially lead to adverse effects or reduce the effectiveness of the medication.
- Drinking alcohol while on fosfomycin treatment can increase the risk of side effects such as nausea, vomiting, dizziness, and gastrointestinal disturbances. Additionally, alcohol consumption can impair liver function, which may impact the body's ability to metabolize and eliminate fosfomycin effectively.
Breast Feeding Warning
Clofazimine, the active ingredient in Clofazimine, is excreted in human milk. Breastfed neonates of mothers taking clofazimine may experience skin discoloration.
When considering the use of Clofazimine in breastfeeding mothers, it is important to weigh the developmental and health benefits of breastfeeding against the mother's clinical requirement for Clofazimine and any possible adverse effects on the breastfed infant, both from Clofazimine itself and the underlying maternal condition.
Pregnancy Warning
Pregnancy:
Teratogenic Effects - Category C
I. Use in Pregnant Women
● Insufficient data on Clofazimine use in pregnant women to determine associated risk
● Adverse effects observed in mice, including fetal skull ossification retardation, increased abortions and stillbirths, and impaired neonatal survival, after prenatal exposure to Clofazimine at a dose equivalent to 0.6 times the maximum recommended human daily dose
● Pregnant women should be informed about the potential risk to the fetus
II. Background Risk and Clinical Considerations
● Unknown background risk of major birth defects and miscarriage for the indicated population
● Estimated background risk of major birth defects in the general U.S. population is 2-4%, and the risk of miscarriage is 15-20% of clinically recognized pregnancies
● Fetal/neonatal adverse reactions: Pigmentation of infants' skin at birth when born to mothers who received Clofazimine during pregnancy
● Limited data on the reversibility of discoloration, with observations indicating gradual fading over the first year
III. Data
A. Human Data
No studies on Clofazimine use in pregnant women
Reports indicate deep pigmentation of infants' skin at birth when born to women who received Clofazimine during pregnancy
Use Clofazimine during pregnancy only if the potential benefit justifies the fetal risk
B. Animal Data
Embryofetal toxicity studies conducted in rats, rabbits, and mice
Mice showed Clofazimine-induced embryotoxicity and fetotoxicity, including fetal skull ossification retardation, increased abortions and stillbirths, and impaired neonatal survival at a dose equivalent to 0.6 times the maximum recommended human daily dose
Offspring of mice showed skin and fatty tissue discoloration attributed to clofazimine presence in maternal milk
No developmental effects observed in rats or rabbits at doses up to 2.4 and 1.5 times the maximum recommended human daily dose, respectively
Animal studies conducted according to standards at the time of initial drug approval (1986) and not under current regulatory standards.
The adverse reactions related to Clofazimine can be categorized as follows:
Common:
● Skin discoloration (orange-pink to brownish-black)
● Dry and scaly skin
● Rash
● Itching
● Abdominal pain
● Nausea
● Vomiting
● Diarrhea
● Increased sweating
● Changes in color of urine/stool/mucus
Less common:
● Eye irritation or burning
● Eye dryness
● Itchy eyes
● Eye discoloration
● Elevated blood sugar levels
● Food intolerances
Rare:
● QT prolongation (affecting the electrical activity of the heart)
● Torsade de Pointes (a type of irregular heart rhythm)
● Hepatic dysfunction (liver impairment)
● Severe abdominal obstruction
● Impaired neonatal survival (observed in animal studies)
● Retardation of fetal skull ossification (observed in animal studies)
● Increased incidences of abortions and stillbirths (observed in animal studies)
Effect of Clofazimine on Substrates of CYP3A:
Concomitant use of Clofazimine may affect drugs that are metabolized by CYP3A4/5 enzymes. This can result in increased concentrations of these drugs, potentially leading to an increased risk of toxicity. It is important to monitor for any signs of drug toxicity when Clofazimine is used together with these medications.
Drugs that Prolong QT Interval:
There have been reports of QT prolongation and Torsade de Pointes in patients receiving Clofazimine along with other medications known to prolong the QT interval, such as bedaquiline. Regular electrocardiograms (ECGs) should be performed to monitor for any QT prolongation when Clofazimine is administered in combination with these QT prolonging drugs.
The following are the side effects involving Clofazimine:
● Changes in skin color
● Dry and scaly skin
● Rash
● Itching
● Abdominal pain
● Diarrhea
● Nausea
● Vomiting
● Food intolerances
● Eye irritation or burning
● Eye dryness
● Itchy eyes
● Eye discoloration
● Changes in color of urine/stool/mucus
● Elevated blood sugar
● Sweating
Pregnancy:
Teratogenic Effects - Category C
I. Use in Pregnant Women
● Insufficient data on Clofazimine use in pregnant women to determine associated risk
● Adverse effects observed in mice, including fetal skull ossification retardation, increased abortions and stillbirths, and impaired neonatal survival, after prenatal exposure to Clofazimine at a dose equivalent to 0.6 times the maximum recommended human daily dose
● Pregnant women should be informed about the potential risk to the fetus
II. Background Risk and Clinical Considerations
● Unknown background risk of major birth defects and miscarriage for the indicated population
● Estimated background risk of major birth defects in the general U.S. population is 2-4%, and the risk of miscarriage is 15-20% of clinically recognized pregnancies
● Fetal/neonatal adverse reactions: Pigmentation of infants' skin at birth when born to mothers who received Clofazimine during pregnancy
● Limited data on the reversibility of discoloration, with observations indicating gradual fading over the first year
III. Data
A. Human Data
No studies on Clofazimine use in pregnant women
Reports indicate deep pigmentation of infants' skin at birth when born to women who received Clofazimine during pregnancy
Use Clofazimine during pregnancy only if the potential benefit justifies the fetal risk
B. Animal Data
Embryofetal toxicity studies conducted in rats, rabbits, and mice
Mice showed Clofazimine-induced embryotoxicity and fetotoxicity, including fetal skull ossification retardation, increased abortions and stillbirths, and impaired neonatal survival at a dose equivalent to 0.6 times the maximum recommended human daily dose
Offspring of mice showed skin and fatty tissue discoloration attributed to clofazimine presence in maternal milk
No developmental effects observed in rats or rabbits at doses up to 2.4 and 1.5 times the maximum recommended human daily dose, respectively
Animal studies conducted according to standards at the time of initial drug approval (1986) and not under current regulatory standards
Lactation:
Clofazimine, the active ingredient in Clofazimine, is excreted in human milk. Breastfed neonates of mothers taking clofazimine may experience skin discoloration.
When considering the use of Clofazimine in breastfeeding mothers, it is important to weigh the developmental and health benefits of breastfeeding against the mother's clinical requirement for Clofazimine and any possible adverse effects on the breastfed infant, both from Clofazimine itself and the underlying maternal condition.
Pediatric:
The safety and efficacy of Clofazimine have not been established in pediatric patients.
Geriatric Use:
The clinical trials conducted on Clofazimine did not involve an adequate number of individuals aged 65 and older to ascertain potential differences in response compared to younger subjects. However, based on available clinical experience, there have been no observed variations in responses between elderly and younger patients. When prescribing Clofazimine to elderly patients, it is advisable to exercise caution in dose selection. Typically, initiating treatment at the lower end of the dosage range is recommended due to the higher likelihood of decreased hepatic, renal, or cardiac function, as well as the presence of concurrent illnesses or other drug therapies.
Physicians should be knowledgeable as well as vigilant about the treatment and identification of overdosage of Clofazimine.
There is no specific information regarding the treatment of Clofazimine overdose. However, in the event of an overdose, it is recommended to empty the stomach through methods such as inducing vomiting or gastric lavage. Supportive symptomatic treatment should also be provided.
Pharmacodynamics:
Clofazimine exerts a slow bactericidal effect on Mycobacterium leprae (Hansen's bacillus) primarily by targeting the bacterial outer membrane. It may also impact the bacterial respiratory chain and ion transporters. Additionally, it possesses anti-inflammatory properties by suppressing T-lymphocyte activity. Due to its extended residence time in the body, clofazimine has a relatively long duration of action, necessitating daily administration.
In approximately 75-100% of patients receiving clofazimine, there may be a noticeable skin color change ranging from orange-pink to brownish-black, affecting the skin, conjunctivae, and bodily fluids. The reversal of skin discoloration may take several months or even years after discontinuation of therapy. Clofazimine has been associated with abdominal obstruction, including potentially fatal cases, caused by the accumulation of the drug and the formation of crystals in the intestinal mucosa. If patients experience abdominal pain and nausea/vomiting, prompt investigation is necessary, and the dosage of clofazimine should be reduced or discontinued if it is determined to be the cause.
Patients with hepatic dysfunction should avoid the use of clofazimine.
Pharmacokinetics:
Absorption:
● The absorption of clofazimine in leprosy patients ranges from 45% to 62%.
Effect of Food:
● Under fed conditions, the time taken to reach the peak plasma concentration (median Tmax) of clofazimine decreases from 12 hours to 8 hours compared to the fasted state.
Distribution:
● Clofazimine, being lipophilic, predominantly deposits in fatty tissue and cells of the reticuloendothelial system.
● Macrophages throughout the body uptake clofazimine.
● Autopsies of leprosy patients who received Clofazimine revealed that clofazimine crystals were mainly found in the mesenteric lymph nodes, adrenals, subcutaneous fat, liver, bile, gall bladder, spleen, small intestine, muscles, bones, and skin.
● Clofazimine binds to alpha- and primarily beta-lipoproteins in serum, with saturation occurring at plasma concentrations of approximately 10 mcg/mL. Binding to gamma-globulin and albumin is minimal.
Elimination:
● The average elimination half-life of clofazimine is approximately 25 days (ranging from 6.5 to 160 days) in leprosy patients after repeated oral doses of 50 or 100 mg of Clofazimine.
Metabolism:
● Limited information is available regarding the metabolism of clofazimine.
● Three clofazimine metabolites were detected in urine following repeated oral doses of Clofazimine.
Excretion:
● Following a single dose of 300 mg Clofazimine, the elimination of unchanged clofazimine and its metabolites in a 24-hour urine collection is negligible.
● The excretion of the ingested drug via feces may occur, possibly through the bile.
● A small amount of clofazimine is also eliminated in sputum, sebum, and sweat.
- Lost Haworth CS, Banks J, Capstick T, et al. In the article titled "British Thoracic Society guidelines for the management of non-tuberculous mycobacterial pulmonary disease (NTM-PD)" published in Thorax in 2017, the authors present guidelines for the management of NTM-PD. (PubMed 29054853)
- The Health Resources and Services Administration (HRSA) provides recommended treatment regimens for the National Hansen's Disease (Leprosy) Program. The information can be accessed on their website at http://www.hansensdisease/diagnosis/recommendedtreatment.html. (Accessed on July 13, 2020)
- The HRSA's National Hansen's Disease Programs (NHDP) has published a guide to the management of Hansen's disease in 2018. The guide can be found at https://www.hrsa.gov/sites/default/files/hrsa/hansens-disease/hansens-disease-guide-management.pdf. (Accessed September 14, 2021)
- The NHDP also provides information on recommended treatment regimens, available at https://www.hrsa.gov/hansens-disease/diagnosis/recommended-treatment.html. (Accessed September 14, 2021)
- Holdiness MR. In a review article published in Clinical Pharmacokinetics in 1989, Holdiness discusses the clinical pharmacokinetics of clofazimine. (PubMed 2656045)
- The prescribing information for Clofazimine (clofazimine) is provided by Novartis Pharmaceuticals and can be found in the package insert. (January 2019)
- Legendre DP, Muzny CA, Swiatlo E. In a paper published in Pharmacotherapy in 2012, Legendre et al. discuss current and future pharmacotherapy for Hansen's disease and its related immunologic reactions. (PubMed 22392826)
- Miele K, Bamrah Morris S, Tepper NK. In the article titled "Tuberculosis in pregnancy" published in Obstetrics & Gynecology in 2020, Miele et al. provide information on tuberculosis in pregnancy. (PubMed 32459437)
- Nahid P, Mase SR, Migliori GB, et al. The American Thoracic Society (ATS), Centers for Disease Control and Prevention (CDC), European Respiratory Society (ERS), and Infectious Diseases Society of America (IDSA) have jointly published a clinical practice guideline on the treatment of drug-resistant tuberculosis in the American Journal of Respiratory and Critical Care Medicine in 2019. (PubMed 31729908)
- Ozturk Z, Tatliparmak A. In a case report published in Dermatologic Therapy in 2017, Ozturk and Tatliparmak discuss the treatment of leprosy during pregnancy and breastfeeding. (PubMed 27549245)
- Schluger NW, Heysell SK, Friedland G. In the UpToDate database, Schluger et al. provide information on the treatment of drug-resistant pulmonary tuberculosis. (Accessed September 18, 2020)
- Szeto W, Garcia-Buitrago MT, Abbo L, Rosenblatt JD, Moshiree B, Morris MI. In an article published in Open Forum Infectious Diseases in 2016, Szeto et al. discuss clofazimine enteropathy as a rare complication of mycobacterial therapy. (PubMed 27800519)
- The US Food and Drug Administration (FDA) has issued a Drug Safety Communication regarding Clofazimine (clofazimine). The information can be found on the FDA's MedWatch website at http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm514749.htm. (Accessed November 11, 2016)
- Venkatesan K, Mathur A, Girdhar A, Girdhar BK. In a study published in the Leprosy Review in 1997, Venkatesan et al. investigate the excretion of clofazimine in human milk in leprosy patients. (PubMed 9364825)
- The World Health Organization (WHO) provides information on drugs used in leprosy in their document available at http://apps.who.int/medicinedocs/pdf/h2988e/h2988e.pdf. (Accessed April 6, 2016)
- The WHO has published guidelines for the diagnosis, treatment, and prevention of leprosy in 2018. The guidelines can be accessed at https://apps.who.int/iris/handle/10665/274127. (Accessed September 14, 2021)
- World Health Organization. WHO Expert Committee on Leprosy. In the World Health Organization Technical Report Series published in 2012, the WHO Expert Committee on Leprosy provides information on leprosy. (PubMed 22970604)
- The WHO has also published model prescribing information for drugs used in leprosy in 1998. The information can be found at https://apps.who.int/iris/handle/10665/64636. (Accessed September 14, 2021)
- World Health Organization (WHO). In their consolidated guidelines on tuberculosis, Module 4: treatment - drug-resistant tuberculosis treatment, published in 2020, the WHO provides information on the treatment of drug-resistant tuberculosis. (https://www.who.int/publications/i/item/9789240007048) (Accessed July 13, 2020)
- https://my.clevelandclinic.org/health/drugs/20574-clofazimine-capsules#:~:text=Clofazimine is a medication that,glass of water as directed.
- https://www.mayoclinic.org/drugs-supplements/clofazimine-oral-route/side-effects/drg-20063096?p=1
- https://reference.medscape.com/drug/clofazimine-342661
- https://hivclinic.ca/main/drugs_fact_files/clofazimine.pdf
- https://pubchem.ncbi.nlm.nih.gov/compound/Clofazimine
- https://go.drugbank.com/drugs/DB00845
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019500s014lbl.pdf
- https://www.drugs.com/cons/clofazimine.html
- https://www.rxlist.com/Clofazimine-drug.html
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