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20 dezembro 2011
19 dezembro 2011
07 dezembro 2011
Cyclophosphamide solution
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Corticoresistant nephritic syndrome in paediatric patient: treatment with cyclophosphamide solution. What formulation is the best?
A. Oliver Noguera, J.C. Pérez Pons, M. Sanz Muñoz, C. March Frontera, M. Nigorra Caro, J. Nicolas Picó, J. Serrano Lopez de las Hazas, M. Vilanova Boltó
Hospital Son Llatzer, Pharmacy, Palma Mallorca, Spain
Precedents: Patient 30 month-old with corticoresistant nephrotic syndrome. First line of treatment oral prednisolone 60mg/m2/24h, 12 weeks failed.Mendoza protocol started: single intravenous doses metilprednisolone 30mg/Kg/día IV c/48h, increasing
administration intervals to 2 months for 78 weeks. Second relapse week 10 in treatment. Paediatric Department asked pharmacy for oral cyclophosphamide preparation. Normal dosage 2-3 mg/Kg/d (maximum total daily dose 170 mg/Kg, 8-12 weeks). Aim seek and assess the most suitable individualized formula for oral cyclophosphamide preparation re effectiveness in our patient.
Methods: Bibliographical search carried out: Pub med ("cyclophosphamide" (Mesh),drug stability"(Mesh)), Manual of compounded formulations of the others hospital and paediatric dosage handbook 14th edition. Patient’s clinical history in paediatrician’s records checked, assessing effectiveness and suitability.
Results: 4 individualized formulae found: 3 syrups (2 of 20mg/Ml, 1 of 2mg/ml), capsules of 10, 25mg. 1g ciclophosphamide vial (Genoxal®) used in each. Capsules ruled out (70 day stability), due to production complexity and intensive handling.2 syrups containing elixir as vehicle rejected due to ethanol content. Chosen syrup formula (20mg/ml)-simple syrup, distilled water and cherry essence. Reconstitution of Genoxal vial with 20ml of distilled water and subsequent mixing with simple syrup (15ml) and distilled water (15ml) solution carried out in enclosed chamber. Expiry time 7 days under refrigeration. Identified as cytostatic. Unused medication returned weekly for destruction following cytostatic protocol. Daily dosage 1, 4 ml (28mg) for 11 weeks (whole treatment), showed no adverse effects. Patient in biochemical and clinical remission from weeks 3 to 13. Currently following third Mendoza protocol guideline, having suffered another relapse.
Conclusions: Typical problems in drug use for paediatric patients are lack of
suitable dosages and oral presentations. Formula was accepted by doctor, well tolerated by patient; simple production and innocuous nature make it most suitable.
Reference: 14th Congress EAHP. Barcelona. Spain. 2009
Corticoresistant nephritic syndrome in paediatric patient: treatment with cyclophosphamide solution. What formulation is the best?
A. Oliver Noguera, J.C. Pérez Pons, M. Sanz Muñoz, C. March Frontera, M. Nigorra Caro, J. Nicolas Picó, J. Serrano Lopez de las Hazas, M. Vilanova Boltó
Hospital Son Llatzer, Pharmacy, Palma Mallorca, Spain
Precedents: Patient 30 month-old with corticoresistant nephrotic syndrome. First line of treatment oral prednisolone 60mg/m2/24h, 12 weeks failed.Mendoza protocol started: single intravenous doses metilprednisolone 30mg/Kg/día IV c/48h, increasing
administration intervals to 2 months for 78 weeks. Second relapse week 10 in treatment. Paediatric Department asked pharmacy for oral cyclophosphamide preparation. Normal dosage 2-3 mg/Kg/d (maximum total daily dose 170 mg/Kg, 8-12 weeks). Aim seek and assess the most suitable individualized formula for oral cyclophosphamide preparation re effectiveness in our patient.
Methods: Bibliographical search carried out: Pub med ("cyclophosphamide" (Mesh),drug stability"(Mesh)), Manual of compounded formulations of the others hospital and paediatric dosage handbook 14th edition. Patient’s clinical history in paediatrician’s records checked, assessing effectiveness and suitability.
Results: 4 individualized formulae found: 3 syrups (2 of 20mg/Ml, 1 of 2mg/ml), capsules of 10, 25mg. 1g ciclophosphamide vial (Genoxal®) used in each. Capsules ruled out (70 day stability), due to production complexity and intensive handling.2 syrups containing elixir as vehicle rejected due to ethanol content. Chosen syrup formula (20mg/ml)-simple syrup, distilled water and cherry essence. Reconstitution of Genoxal vial with 20ml of distilled water and subsequent mixing with simple syrup (15ml) and distilled water (15ml) solution carried out in enclosed chamber. Expiry time 7 days under refrigeration. Identified as cytostatic. Unused medication returned weekly for destruction following cytostatic protocol. Daily dosage 1, 4 ml (28mg) for 11 weeks (whole treatment), showed no adverse effects. Patient in biochemical and clinical remission from weeks 3 to 13. Currently following third Mendoza protocol guideline, having suffered another relapse.
Conclusions: Typical problems in drug use for paediatric patients are lack of
suitable dosages and oral presentations. Formula was accepted by doctor, well tolerated by patient; simple production and innocuous nature make it most suitable.
Reference: 14th Congress EAHP. Barcelona. Spain. 2009
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