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calendary March 7, 2024

Safety updates for drugs containing acetazolamide

In January 2024, the Russian Ministry of Health, together with the expert center of the Federal State Budgetary Institution “SCEEMP”, published an information letter with recommendations for updating documentation for consumers of diuretics containing acetazolamide as an active substance.

Acetazolamide is an inhibitor of the carbonic anhydrase enzyme with weak diuretic activity. Acetazolamide preparations are used to eliminate edema syndrome, relieve an acute attack of glaucoma, in acute “high-altitude” illness to reduce acclimatization time and some other conditions.

The regulator recommends updating the summary of product characteristics (SmPC), package information leaflet (PIL) and instructions for medical use (IFU) as follows:

  1. In section 4.4. of the SmPC (if any) and in the “Special Instructions” section of the IFU (if any), additionally provide the following information: “Cases of choroidal effusion/choroidal detachment have been reported after the use of acetazolamide. Symptoms include a sudden decrease in visual acuity or eye pain, which may occur within a few hours of starting treatment with acetazolamide. If choroidal effusion/choroidal detachment is suspected, acetazolamide should be discontinued as soon as possible.”;
  2. In section 4.8. SmPC (if any) and in the section “Side effects” of IFU (if any) in the system-organ class (SOC) “Vision disorders” additionally provide the following information: “frequency unknown - choroidal effusion, choroidal detachment ";
  3. In section 2 of PIL (if any) in the subsection “Special instructions and precautions”, additionally provide the most significant information for the patient about the risk of developing choroidal effusion and choroidal detachment when taking the drug;
  4. In section 4 of PIL (if any), additionally provide information about choroidal effusion and choroidal detachment in the list of the most severe adverse reactions that require stopping the drug and immediately contacting a doctor.

There are 3 trade names of Russian-made acetazolamide available in Russia.

References:
  1. https://grls.rosminzdrav.ru/
  2. https://grls.rosminzdrav.ru/Forum//Files/244897/%D0%98%D0%BD%D1%84_%D0%BF%D0%B8%D1%81%D1%8C%D0%BC%D0%BE_%D0%B0%D1%86%D0%B5%D1%82%D0%B0%D0%B7%D0%BE%D0%BB%D0%B0%D0%BC%D0%B8%D0%Bpdf

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