Deltybatm 50 mg FC tablets

Deltybatm 50 mg FC tablets

S4
PDF Leaflet Revision Date: 27 September 2024

API: Delamanid | Company: Viatris Healthcare

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

Only Available on the App

To ensure the fastest, most secure experience, this feature is exclusively available on the free Medinsert mobile app.

Download the App. Its Free!
On This Page
Deltybatm 50 mg FC tablets
1/-

Connecting to Document Server

Decrypting and optimizing pharmaceutical leaflet...

Medinsert AI

Hello! I am Medinsert Ai. What would you like to know about this professional information leaftleft?
App Icon

Medinsert Mobile App

3000+ Package Inserts on the go.

VIEW