Substitution instrument to address shortage of Imdur Durules and Monodur Durules isosorbide mononitrate 120 mg modified release

TGA

The Therapeutic Goods Administration (TGA) has been notified of shortages of Imdur Durules and Monodur Durules isosorbide mononitrate 120 mg modified release tablets. The shortages are expected to continue until 19 December 2022.

Imdur Durules and Monodur Durules tablets are indicated for the prophylactic treatment of angina pectoris.

The TGA has made a Serious Scarcity Substitution Instrument (SSSI) to assist patients to access their medicine from their pharmacist without delay, ensure treatment is not interrupted and relieve workload pressure on prescribers and pharmacists.

The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Isosorbide Mononitrate) Instrument 2021 has been made to:

  • Declare registered medicines that contain 120 mg of isosorbide mononitrate that are modified release tablets as scarce medicines; and
  • Specify registered medicines that contain 60 mg of isosorbide mononitrate that are modified release tablets as substitutable medicines that pharmacists are permitted to dispense in substitution for the scarce medicines and specify the circumstances in which that substitution is permitted

The SSSI is in force from 18 September 2021 until 19 December 2022. The TGA may, however, revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified.

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