Deltybatm 50 mg FC tablets
PDF Leaflet Revision Date: 27 September 2024
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of pulmonary multi-drug-resistant tuberculosis (MDR-TB).
Dosage (summary)
Adults: 100 mg twice daily for 24 weeks; Children 30-50 kg: 50 mg twice daily.
Special Populations
- Elderly patients (> 65 years)
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Not recommended in pregnancy; unknown if excreted in breast milk.
Key Drug Interactions
- Strong CYP3A4 inducers (e.g., carbamazepine)
- QT prolonging medications
Contraindications
- Hypersensitivity to delamanid
- Severe hepatic impairment
- Cardiac failure
- Uncontrolled dysrhythmias
- QT prolongation
Common side effects
- Nausea
- Vomiting
- Headache
- Insomnia
- Dizziness
Counselling Points
- Take with food
- Avoid in pregnancy
- Monitor for cardiac symptoms
Serious warnings
- QT prolongation risk
- Monitor ECG monthly during treatment
Important Disclaimer
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