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NORFLOXACINE ZENTIVA (norfloxacine) - Gastrointestinal infections

Opinions on drugs - Posted on May 22 2023

Reason for request

Indication extension

New indication(s).

Key points

Favourable opinion for reimbursement only “in the primary and secondary prophylaxis of spontaneous bacterial peritonitis in patients with cirrhosis complicated by severe low-protein ascites (< 15 g/L) and associated with impaired liver function (Child-Pugh class C)”.

 

Role in the care pathway?

NORFLOXACINE ZENTIVA (norfloxacin) is a reference therapeutic option based on the opinions of learned societies (SPILF - French-speaking Society for Infectious Diseases, AFEF – French Association for Liver Studies), for the primary and secondary prophylactic treatment of spontaneous bacterial peritonitis in patients with cirrhosis complicated by severe low-protein ascites (< 15 g/L) and associated with impaired liver function (Child-Pugh class C).

In this indication, the treatment regimen recommended by national and European learned societies is a daily oral dose of 400 mg of norfloxacin as long-term treatment6,7,12.

The prescription of NORFLOXACINE ZENTIVA (norfloxacin) must take into account the risk of emergence of resistant bacteria, particularly in the event of quinolone prophylaxis with a long duration of treatment and in patients with significant acquired or passive immunosuppression (e.g. corticosteroid therapy). In addition, in hospitalised patients, the risk of carrying methicillin-resistant Staphylococcus aureus (MRSA) is increased by prior antibiotic prophylaxis with norfloxacin14.

The Summary of Product Characteristics (SmPC) and the Risk Management Plan (RMP) must be followed.

The use of this medicinal product in pregnant or breast-feeding women must comply with the SmPC (http://lecrat.fr/).

Within the scope included in the MA but not retained for reimbursement:

NORFLOXACINE ZENTIVA (norfloxacin) has no role in the other MA situations.

 

Special recommendations

Special recommendations in view of the quality and safety of care requirements related to the medicinal product

In view of the product’s specificities in terms of safety (risk of tendinopathy, QT interval prolongation, aortic aneurysm or dissection), the risk of emergence of resistant bacteria, particularly in the event of quinolone prophylaxis with a long duration of treatment and in patients with significant acquired or passive immunosuppression (e.g. corticosteroid therapy), and in order to guarantee the restricted use of NORFLOXACINE ZENTIVA (norfloxacin), it is proposed that initial prescription be reserved for specialists in the management of spontaneous bacterial peritonitis, i.e. hepato-gastroenterology specialists, infectious diseases specialists, internal medicine specialists and intensive care specialists.


Clinical Benefit
Low

The clinical benefit of NORFLOXACINE ZENTIVA (norfloxacin) 400 mg film-coated tablets is low only in the primary and secondary prophylaxis of spontaneous bacterial peritonitis in patients with cirrhosis complicated by severe low-protein ascites (< 15 g/L) and associated with impaired liver function (Child-Pugh class C).
Insufficient

The clinical benefit of NORFLOXACINE ZENTIVA (norfloxacin) 400 mg film-coated tablets is insufficient to justify public funding in the other MA situations.

Clinical Added Value
no clinical added value

Considering:

  • the partially met medical need in the preventive treatment of spontaneous bacterial peritonitis and its recurrence in cirrhosis patients;
  • the bibliographic data available, with a low level of evidence, showing an efficacy of norfloxacin in the prevention of SBP and its recurrence in patients with cirrhosis complicated by severe low-protein ascites (< 15 g/L) and associated with impaired liver function (Child-Pugh class C);
  • its well-established use in national and international medical practice;

But:

  • the absence of any demonstrated superiority of norfloxacin compared to the other antibiotics currently recommended (ciprofloxacin, sulfamethoxazole/trimethoprim);
  • a safety profile well known to include adverse reactions such as neurological and psychological disorders and rare but serious musculoskeletal system disorders that are persistent, disabling and potentially irreversible;
  • the risk of emergence of resistant bacteria, particularly in the event of long-term
    treatment in immunocompromised patients;

the Transparency Committee deems that NORFLOXACINE ZENTIVA (norfloxacin) 400 mg film-coated tablets provide no clinical added value (CAV V) in the prevention of spontaneous bacterial peritonitis and its recurrence in patients with cirrhosis complicated by severe low-protein ascites (< 15 g/L) and associated with impaired liver function (Child-Pugh class C).
Not applicable

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