Clofazimine Dosage

Usual Adult Dose for Leprosy - Dapsone-Resistant

DAPSONE-SENSITIVE LEPROMATOUS (MULTIBACILLARY) LEPROSY: 100 mg orally once a day with meals, in combination with two other antileprosy drugs

• Duration of therapy: For at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate antileprosy drug

DAPSONE-RESISTANT LEPROMATOUS LEPROSY: 100 mg orally once a day with meals, in combination with one or more other antileprosy drugs

• Duration of therapy: For 3 years, followed by monotherapy with 100 mg orally once a day

LEPROMATOUS LEPROSY COMPLICATED BY ERYTHEMA NODOSUM LEPROSUM REACTIONS: 100 mg to 200 mg orally once a day, in conjunction with baseline antileprosy treatment and steroids as clinically indicated

• Once erythema nodosum reaction is controlled, taper doses of 200 mg down to 100 mg orally once a day.
• Duration of therapy: Administer doses greater than 100 mg per day for the shortest duration possible (i.e., less than 3 months) and only under close medical supervision

Comments:

• To prevent the development of drug-resistance, this drug should be used only as a part of combination therapy for initial treatment of lepromatous (multibacillary) leprosy.
• Dose selection for older adults should be cautious and start at the lower end of dosing range.
• Dose adjustments are not required in HIV-positive and immunocompromised patients.
• Perform a pregnancy test in females of reproductive potential prior to treatment administration.

Use: In combination with other antileprosy drugs, for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy, and lepromatous leprosy complicated by erythema nodosum leprosum

Usual Adult Dose for Leprosy - Dapsone-Sensitive

DAPSONE-SENSITIVE LEPROMATOUS (MULTIBACILLARY) LEPROSY: 100 mg orally once a day with meals, in combination with two other antileprosy drugs

• Duration of therapy: For at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate antileprosy drug

DAPSONE-RESISTANT LEPROMATOUS LEPROSY: 100 mg orally once a day with meals, in combination with one or more other antileprosy drugs

• Duration of therapy: For 3 years, followed by monotherapy with 100 mg orally once a day

LEPROMATOUS LEPROSY COMPLICATED BY ERYTHEMA NODOSUM LEPROSUM REACTIONS: 100 mg to 200 mg orally once a day, in conjunction with baseline antileprosy treatment and steroids as clinically indicated

• Once erythema nodosum reaction is controlled, taper doses of 200 mg down to 100 mg orally once a day.
• Duration of therapy: Administer doses greater than 100 mg per day for the shortest duration possible (i.e., less than 3 months) and only under close medical supervision

Comments:

• To prevent the development of drug-resistance, this drug should be used only as a part of combination therapy for initial treatment of lepromatous (multibacillary) leprosy.
• Dose selection for older adults should be cautious and start at the lower end of dosing range.
• Dose adjustments are not required in HIV-positive and immunocompromised patients.
• Perform a pregnancy test in females of reproductive potential prior to treatment administration.

Use: In combination with other antileprosy drugs, for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy, and lepromatous leprosy complicated by erythema nodosum leprosum

Usual Adult Dose for Leprosy - Erythema Nodosum Leprosum

DAPSONE-SENSITIVE LEPROMATOUS (MULTIBACILLARY) LEPROSY: 100 mg orally once a day with meals, in combination with two other antileprosy drugs

• Duration of therapy: For at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate antileprosy drug

DAPSONE-RESISTANT LEPROMATOUS LEPROSY: 100 mg orally once a day with meals, in combination with one or more other antileprosy drugs

• Duration of therapy: For 3 years, followed by monotherapy with 100 mg orally once a day

LEPROMATOUS LEPROSY COMPLICATED BY ERYTHEMA NODOSUM LEPROSUM REACTIONS: 100 mg to 200 mg orally once a day, in conjunction with baseline antileprosy treatment and steroids as clinically indicated

• Once erythema nodosum reaction is controlled, taper doses of 200 mg down to 100 mg orally once a day.
• Duration of therapy: Administer doses greater than 100 mg per day for the shortest duration possible (i.e., less than 3 months) and only under close medical supervision

Comments:

• To prevent the development of drug-resistance, this drug should be used only as a part of combination therapy for initial treatment of lepromatous (multibacillary) leprosy.
• Dose selection for older adults should be cautious and start at the lower end of dosing range.
• Dose adjustments are not required in HIV-positive and immunocompromised patients.
• Perform a pregnancy test in females of reproductive potential prior to treatment administration.

Use: In combination with other antileprosy drugs, for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy, and lepromatous leprosy complicated by erythema nodosum leprosum

Usual Adult Dose for Leprosy - Lepromatous

DAPSONE-SENSITIVE LEPROMATOUS (MULTIBACILLARY) LEPROSY: 100 mg orally once a day with meals, in combination with two other antileprosy drugs

• Duration of therapy: For at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate antileprosy drug

DAPSONE-RESISTANT LEPROMATOUS LEPROSY: 100 mg orally once a day with meals, in combination with one or more other antileprosy drugs

• Duration of therapy: For 3 years, followed by monotherapy with 100 mg orally once a day

LEPROMATOUS LEPROSY COMPLICATED BY ERYTHEMA NODOSUM LEPROSUM REACTIONS: 100 mg to 200 mg orally once a day, in conjunction with baseline antileprosy treatment and steroids as clinically indicated

• Once erythema nodosum reaction is controlled, taper doses of 200 mg down to 100 mg orally once a day.
• Duration of therapy: Administer doses greater than 100 mg per day for the shortest duration possible (i.e., less than 3 months) and only under close medical supervision

Comments:

• To prevent the development of drug-resistance, this drug should be used only as a part of combination therapy for initial treatment of lepromatous (multibacillary) leprosy.
• Dose selection for older adults should be cautious and start at the lower end of dosing range.
• Dose adjustments are not required in HIV-positive and immunocompromised patients.
• Perform a pregnancy test in females of reproductive potential prior to treatment administration.

Use: In combination with other antileprosy drugs, for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy, and lepromatous leprosy complicated by erythema nodosum leprosum

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction: Caution recommended.

Liver Dose Adjustments

Mild, moderate, or severe liver dysfunction (Child-Pugh A, B or C): Avoid use unless benefit outweighs risk.

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component or to any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For oral use
• Administer therapy with meals.

Storage requirements:

• Do not store above 25C (77F).
• Protect from moisture; dispense in a tight container.

General:

• This drug may not be commercially available and/or require access through a special program.
• For further guidance on the treatment of leprosy and/or to obtain this drug, contact the National Hansen's Disease Clinical Center at 1-800-642-2477 or http://www.hrsa.gov/hansensdisease/clinicalcenter.html.

Monitoring:

• Cardiovascular: ECGs to detect QT prolongation and cardiac rhythm disturbances (during therapy in patients with high daily doses and/or with concomitant use of QT prolonging medications or bedaquiline)
• Psychiatric: For psychological effects (e.g., depression or suicidal ideation) due to skin discoloration (during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Counseling Information).
• Recognize the importance of compliance with regimen in order to prevent drug resistance, improve cure rate, and prevent the infection of other people.
• Understand that this drug may cause discoloration of skin, conjunctivae, tears, sweat, sputum, urine, and feces; discoloration may take months to years to resolve after treatment discontinuation.
• Report abdominal pain or gastrointestinal symptoms.
• Use effective contraception (females) or condoms during intercourse (males) during treatment and for 4 months after the last dose.

Further information

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

Medical Disclaimer