LAMPRENE 100

Indications

• Leprosy (Hansen's disease)
• Multidrug-resistant tuberculosis (as part of combination therapy)

Dosage

Children: Refer to the BNF for Children for appropriate dosing in paediatric patients.

Adults: Refer to specific guidelines or the BNF for established dosing regimens.

Mechanism of action

Clofazamine works by intercalating into bacterial DNA, inhibiting its replication. It also binds to the mycobacterial cell wall, disrupting the integrity of the cell. Additionally, clofazamine has been found to influence the immune system by modulating the activity of T-cells and macrophages, promoting an immune response against the infection.

Pharmacodynamics

Clofazamine exhibits bactericidal and bacteriostatic activities against Mycobacterium leprae and Mycobacterium tuberculosis. It has a long half-life, allowing for sustained therapeutic levels in the body. The drug also possesses anti-inflammatory effects, which can contribute to the reduction of skin lesions and other inflammatory responses associated with leprosy.

Pharmacokinetics

Clofazamine is well absorbed from the gastrointestinal tract, with peak plasma concentrations occurring 3-5 hours after administration. It is highly lipophilic, leading to extensive tissue distribution, particularly in the liver and lungs. The drug is metabolized in the liver, primarily through oxidation. Its elimination half-life can range from several days to weeks, depending on individual patient factors and extent of use. Clofazamine is excreted mainly in the feces and to a lesser extent in urine.

Adverse effects

• Skin discoloration (pink to brown to black)
• Gastrointestinal disturbances (nausea, vomiting, diarrhea)
• Dry skin
• Fatigue
• Abdominal pain
• Pancreatitis
• Potential for QT prolongation

Interactions

• Caution when used with drugs that prolong the QT interval
• May enhance the effects of other anti-leprosy agents

Precautions

• Monitoring for skin changes and gastrointestinal symptoms is recommended
• Renal and hepatic function should be assessed before and during treatment
• Patients should be informed about the potential for skin discoloration

Pregnancy

Clofazamine should only be used during pregnancy if the potential benefit justifies the risk to the fetus. Its safety in pregnancy has not been established.

Breast-feeding

Clofazamine is excreted in breast milk. Caution should be exercised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

• Capsules (100 mg)