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3PC-033 Labelling without strength for a pharmaceutical preparation used in a blinded dosage adjustment of clozapine
  1. C Giraudeau1,
  2. J Jost1,
  3. M Strumia1,
  4. G Arnaud1,
  5. P Brosset2,
  6. V Ratsimbazafy1
  1. 1Dupuytren University Hospital, Pharmacy, 87000 Limoges, France
  2. 2Mother and Child Hospital, Paediatry, 87000 Limoges, France


Background Among other items, pharmaceutical preparations labelling must mention the strength of the active ingredient.

However, the clinical state of a 17-years-old patient on clozapine for schizophrenia required a blinded dosage adjustment to be successful.

Purpose Our aim was to prepare clozapine capsules, different strengths, macroscopically not discernible.

Material and methods The consent of the patient and his parents had been obtained.

In the absence of pure pharmaceutical raw material, the feasibility study (Good Preparation Practices) revealed crushability of the available tablets. They were micronised with a RETSCH RM 200 mortar apparatus for 4 min, particle size <3 mm.

The initial prescription (one capsule 165 mg in the morning, one capsule 260 mg in the evening, for 15 days) led us to prepare 15 capsules of size 00 (translucent) for the morning and 15 capsules size 000 (opaque red) for the evening. Excipient (lactose) was added if required.

The dose adjustment criterion was the clinical state of the patient.

Results The obligations for labelling had been fulfilled except for the strength, replaced by morning clozapine or evening clozapine. The clinical evaluation induced a first increase (+12%) of the morning dose after 5 weeks.

The correct dose was found after 9 weeks with +27% of the daily dose, targeted in the morning, without the patient’s fear of the changes. White blood cell counts every 4 weeks were normal. At the last dose increase, the volume of the powder necessitated to change the capsules from 00 to 000 and ivory colour (instead of translucent, not available). Nevertheless, these macroscopic changes did not have a nocebo effect.

Blinding required a double circuit of prescriptions: those given by the prescriber to the patient mentioning ‘morning capsule: 1, evening capsule: 1’ to be taken daily and those which were intended for us, specifying the strengths.

Conclusion All items required in the pharmaceutical preparations labelling must be fulfilled exhaustively to avoid any confusion. However, exceptionally and transiently, a labelling not mentioning the strength was relevant in helping the prescriber to manage a dosage adjustment and to achieve the desired clinical outcomes.

References and/or acknowledgements No conflict of interest.

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