Amiodarone
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Drug reference
Clofazimine
Riminophenazine antimycobacterial/anti-inflammatory · Antileprotic
Also known as Lamprene, B663
START
Leprosy MDT: 50 mg daily + 300 mg monthly (supervised); ENL 100–300 mg/day short-term
TYPICAL MAX
300 mg/day (short-term ENL); avoid prolonged high dose (enteropathy)
STOP IF
Severe abdominal pain/obstruction (crystalline enteropathy), severe QT prolongation, severe depression
WATCH
GI symptoms (enteropathy — limit high-dose duration), ECG/QT if with bedaquiline, counsel reversible discoloration, mood
CDSCO approvedSchedule HJan AushadhiATC J04BA01
KDIGO 2024 + manufacturer label
- ONSET
- 4h · absorption (effect over weeks)
- PEAK
- 8h · Cmax
- t½
- 10w · terminal t½ (~70 days)
- DURATION
- 1d · daily dosing (tissue depot long)
EXCRETION
Mainly biliary/faecal; minimal renal, very slow
route + CYP
INTERACTIONS
12 major
SEVERE in our sources
PREGNANCY
Use if benefit outweighs risk (leprosy/MDR-TB) — neonatal skin pigmentation reported; generally continued in leprosy MDT
FDA category + note
Top interactionssee all 12 →
- AmiodaroneSevereDatabaseDDInter
- AmisulprideSevereDatabaseDDInter
- AnagrelideSevereDatabaseDDInter
- Arsenic TrioxideSevereDatabaseDDInter
Available in India
12 branded formulations. Look up specific brands in the Drugs workspace.
Jan Aushadhi — generic available at GoI pharmacies
Mechanism
Binds mycobacterial DNA inhibiting replication and generates antimicrobial reactive oxygen species; also membrane-disrupting and anti-inflammatory (suppresses erythema nodosum leprosum); highly lipophilic with marked tissue accumulation.
Indications
Multibacillary leprosy (WHO multidrug therapy component)Erythema nodosum leprosum (type 2 lepra reaction)Multidrug-resistant tuberculosis (regimen component, increasingly used)Mycobacterium avium complex (adjunct)
Dosing
- Adult
- Leprosy MDT: 50 mg PO daily + 300 mg once monthly (supervised). ENL reaction: 100–300 mg/day (limit ≤300 mg/day, ≤3 months at higher doses). MDR-TB: 50–100 mg/day per regimen.
- Pediatric
- Weight-based per WHO leprosy/TB regimens (specialist).
- Renal adjustment
- No specific adjustment (minimal renal excretion).
- Hepatic adjustment
- Caution in hepatic impairment; monitor LFTs.
- Geriatric
- No specific adjustment; monitor.
- Max dose
- 300 mg/day (short-term, ENL) — avoid prolonged high dose (enteropathy)
Pharmacokinetics
Onset
Antimycobacterial over weeks; anti-inflammatory (ENL) several weeks
Peak effect
Cmax ~4–12 h; tissue accumulation over months
Duration
Very long (tissue depot)
Half-life
~70 days (terminal — extensive tissue/fat accumulation)
Bioavailability
~45–70% (food increases absorption)
Protein binding
High (lipophilic, tissue-bound)
Metabolism
Limited hepatic
Excretion
Mainly biliary/faecal; minimal renal (very slow)
Contraindications
- Hypersensitivity to clofazimine
- Caution: significant GI disease, hepatic impairment, QT-prolonging context, depression
Side effects
Common
Reddish-brown to black skin/conjunctival/secretion discoloration (reversible over months–years)Dry skin, ichthyosis, pruritusGI: abdominal pain, nausea, diarrhoeaRed-discoloured urine/sweat/tears
Serious
- Crystalline enteropathy / severe abdominal pain, bowel obstruction (high dose, prolonged)
- QT prolongation (esp. with bedaquiline/other QT drugs in MDR-TB)
- Splenic infarction, GI bleeding (rare, high dose)
- Severe photosensitivity; depression/suicidality (skin-discoloration-related)
Pregnancy & lactation
Pregnancy
Use if benefit outweighs risk (leprosy/MDR-TB) — neonatal skin pigmentation reported; generally continued in leprosy MDT
Lactation
Excreted in milk → infant skin discoloration; continue leprosy therapy with awareness
Drug interactions
Amisulpride
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Anagrelide
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Arsenic Trioxide
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Bedaquiline
Severe
Database
Additive QT prolongation (MDR-TB regimens)
ECG monitoring; correct electrolytes; weigh regimen
Source: Kimi deep-research + Cla
Bepridil
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Cabozantinib
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Ceritinib
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Chloroquine
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Cisapride
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Citalopram
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Clozapine
Severe
Database
Drug interaction classified as: synergy
Source: DDInter
Related guidelines
Ask House about Clofazimine
Continue into a citation-backed clinical answer with the drug context already attached.
Sources: KD Tripathi 7e, Goodman & Gilman 14e, Harrison 22e, Katzung·Verified: 2026-05-19 · House clinical team·Cockpit curated: 2026-05-19