Ludiomil stock breach until 2026, following a lot of prizes

A consultation is necessary in order to prescribe a replacement antidepressant.Yaraslau Saulevich / iStock / Getty Images Plus / via Getty Images

Lthe distribution, pharmacists and hospital pharmacists have been informed of the recall of all the lots of Ludiomil 25 mg and Ludiomil 75 mg film -coated tablet (Maprotiline) distributed on the French market until March 31, 2025 [1] :

• Ludiomil 25 mg film -coated tablet in 50 boxes (CIP 3400931402336) ludiomil stock breach until 2026, new

  • Lot F0016 – 05/2026
  • Lot F0017 – 10/2027

• Ludiomil 75 mg Fillet -coated tablet in 28 box (CIP 3400932229130) ludiomil stock breach until 2026,

This decision leads to a stock of Ludiomil (a rupture has already been reported since March – cf. our article of April 25. However, 2025); The provision of new lots is not planned for several months, and should intervene at the best of 2026. Similarly,

Abnormal nitrosamine rates – Ludiomil stock breach until 2026. – Ludiomil stock breach until 2026, new

Ludiomil stock breach until 2026, new

The recall is motivated by the presence of nitrosamine type impurities (N-Nitroso-Maprotiline) in the finished product at rates above the standards set by the European authorities [2].
&#13. “This defect has been identified on all the prizes currently on the market”explains the National Agency for the Safety of Medicines. Health Products (ANSM).

The laboratory is ludiomil stock breach until 2026, new currently studying the means to modify the manufacturing process of maprotiline. in order to reduce the level of nitrosamine in this medication.

Two possible options to replace Ludiomil: Amiriptylline. Mirtazapine – Ludiomil stock breach until 2026,

Currently 5,000 patients, ludiomil stock breach until 2026, mostly people over the age of 60, are treated by Ludiomil in France.

To avoid any interruption in their antidepressant treatment (cf. Framed). the ANSM has identified two replacement options. describes the driving to hold [2] :

• Replacement with amitriptyline (laroxyl, elavil, and amitriptyline substipharm): this is the alternative solution to favor. ATTRIPTYLINE is an imipramical antidepressant. a non -selective inhibitor of monoamine reuptake like Maprotiline.
• Replacement with mirtazapine (Norset and Generics): MIrtazapine is an antagonistic antidepressant α2 presynaptic of central action. Although not in the same class as Maprotiline. it was identified as a possible alternative due to ludiomil stock breach until 2026, new a comparable sedative action and a better tolerance profile than Maprotiline.

Replacement with amitriptyline: two possible methods

The replacement of ludiomil with amitriptyline is to be favored.

For patients under treatment by Ludiomil. the transition to amitriptyline can be envisaged in two modalities :

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• replacement at once (option to remember when the patient no longer has a ludiomil tablet): Maprotiline stop on D0 and J1 introduction from the therapeutic dose amitriptyline (this is possible because of their great similarity);
• replacement « progressive » over several daysto favor ludiomil stock breach until 2026, new for patients who would still have maprotiline, or if pharmacy stocks allow:

  • D1: Reduction of the dose of mapping of approximately 25 % (for example, go from 100 mg to 75 mg) and introduction of low-dose amitriptyline (25-50 mg/day),
  • Then decrease in mapprotiline (for example, go from 75 mg to 50 ludiomil stock breach until 2026, mg, then from 50 mg to 25 mg) and gradual increase in amitriptyline every 3 to 4 days.

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The maintenance dose of amitriptyline is the lowest effective dose; The maximum dose not to be exceeded is 150 MG per day divided into 2 doses.

Replacement with mirtazapine: a progressive scheme

For patients under treatment by Ludiomil. The transition to MIrtazapine must be progressive, that is to say by gradually increasing the dose of Mirtazapine over several days (up to 4 weeks) while reducing that of Maprotiline:

ludiomil stock breach until 2026, new
• D1: reduction of the dose of mapping of approximately 25 % (for example, go from 100 mg to 75 mg) and introduction of mirtazapine to 15 mg;
• Then decrease of 25 % of the Maprotiline every 3 to 4 days or every week up to 4 weeks (for example go from 75 mg to 50 mg, ludiomil stock breach until 2026, then from 50 mg to 25 mg) and progressive increase if necessary mirtazapine if good tolerance.

The effective daily dose of Mirtazapine is usually between 15 and 45 mg.

Replacement of Ludiomil: a consultation is essential

In this context of Ludiomil stock breach, to ensure continuity of antidepressant treatment, a consultation with the prescribing doctor is recommended without delay the date of the next renewal.

This consultation will identify the most suitable option for the replacement of Ludiomil. to establish a new prescription. ludiomil stock breach until 2026, new to set up a follow -up adapted to the transition period:

• If the patient no longer has a ludiomil tablet, transition to amitriptyline;
• If the patient still has a few ludiomil tablets, a progressive transition to amitriptyline or to mirtazapine.

No new treatment with Ludiomil should be initiated.

Patients should not suddenly interrupt their antidepressant treatment. at ludiomil stock breach until 2026. the risk of exposing themselves to withdrawal syndrome resulting in nausea, vomiting, abdominal pain, diarrhea, sleep disorders, anxiety, nervousness, headache and discomfort.

The ANSM stresses that “The brutal stop of treatment with Ludiomil can represent a greater risk than exposure to. nitrosamine impurities”.