LAMPRENE Soft gelatin capsule Ref.[50443] Active ingredients: Chlofazimine

Multibacillary leprosy

LAMPRENE is administered as part of a multidrug therapy, in combination with dapsone and rifampicin for the treatment of multibacillary leprosy. Multidrug therapy (MDT) is necessary in order to prevent the emergence of resistant strains of Mycobacterium leprae.

For the treatment of leprosy, the WHO recommends the following regimens:

Table 1. MDT dosage:

This triple combination should be administered for 12 months (i.e.*12 consecutive 28-day treatment cycles). An additional 12 months of this triple combination may be necessary for MB patients showing evidence of relapse.

Children below 10 years

The dose should be adjusted according to body weight: 1 to 2 mg/kg clofazimine + 10 to 20 mg/kg rifampicin + 1 to 2 mg/kg dapsone. As an example, LAMPRENE (clofazimine) 100 mg soft gelatin capsule once a month under supervision + 50 mg twice a week as selfmedication + rifampicin 300 mg once a month under supervision + dapsone 25 mg once a day as selfmedication.

Treatment of children below 10 years of age is possible only if dapsone tablets of 25 mg are commercially available.

Patients with erythema nodosum leprosum (ENL)

Adults and children

If the patient develops erythema nodosum leprosum, treatment with dapsone and rifampicin should be continued as before, and the dosage of LAMPRENE 50/100 mg soft gelatin capsules should be raised to 200 to 300 mg per day, given under medical supervision. These high daily doses must not be given for longer than 3 months (see section 4.4 Special warnings and precautions for use). The dose of LAMPRENE 50/100 mg soft gelatin capsules should be gradually reduced, first to 100 mg twice daily for 12 weeks and then to 100 mg once daily for a further 12 to 24 weeks.

Multidrug-resistant tuberculosis (MDR-TB)

Dosage

For the treatment of pulmonary MDR-TB

Adults and adolescents:

• For adults weighing at least 30 kg, the recommended dosage is 100 mg/day.
• For adults weighing less than 30 kg, the recommended dosage is 50 mg/day.

Children (10 years of age and over):

• For children weighing at least 30 kg, the recommended dosage is 2-5 mg/kg/day, not exceeding 100 mg/day.
• For children weighing less than 30 kg, the recommended dosage is 2-5 mg/kg/day, not exceeding 50 mg/day. If a dose lower than 50 mg/day is required, the 50 mg dose can be given every other day.

Dosing in special populations

Safety and efficacy have not been established in HIV infected patients on antiretroviral therapy

Renal impairment

There are no data available in patients with renal impairment.

Caution is advised when administered to patients with renal impairment.

Hepatic impairment

There are no data available in patients with hepatic impairment. LAMPRENE 50/100 mg soft gelatin capsules should not be administered to patients with hepatic impairment (see section 4.4 Special warnings and precautions for use and section 5 Pharmacological properties).

No dosing recommendations can be made in the following groups of patients as efficacy and safety have not been established:

• Patients co-infected with HIV and treated for HIV infection
• Patients with hepatic impairment
• Women who are pregnant
• Patients co-infected with hepatitis B and/or C

Method of administration

LAMPRENE 50/100 mg soft gelatin capsules should be taken with a meal or with a glass of milk to ensure maximum absorption.

Please refer to the Torsades de pointes and QT prolongation subsection in the Special warnings and precautions for use section.

No specific data are available on the treatment of overdose with LAMPRENE 50/100 mg soft gelatin capsules. In cases of acute overdosage, symptomatic and supportive treatment may be given as required.

5 years.

Store at or below 25°C and protect from moisture.

Keep out of the reach of children.

LAMPRENE 50/100 mg soft gelatin capsules are either packaged in white to off-white high density polyethylene (HDPE) bottles with a HDPE screw cap with a yellow tamper proof ring, further packaged in paper board carton or can be packaged in low density polyethylene (LDPE) bags inserted in high density polyethylene (HDPE) bottle with a HDPE screw cap.

Kindly note that not all strengths may be marketed.

No special requirements.