NADOLOL: ESTABILIDADE NA MANIPULAÇÃO MAGISTRAL

Nadolol 80 mg.......................................................................................................10 
Xarope Simples BP..........................................................................................24 mL 
Metilcelulose 1% HSC q.s.p............................................................................80 mL

Em recipiente adequado triturar os comprimidos de nadolol. Adicionar o xarope simples e misturar até a formação de uma pasta. Adicionar o veículo em porções geométricas, misturando após cada adição e completar o volume final. Estabilidade de 30 dias sob refrigeração. Uso oral.

Referência bibliográfica: Souza GB. Manipulação Magistral de Medicamentos em Pediatria. São Paulo. Pharmabooks. 2003.

PROYECTO DE DISPENSACIÓN DE JERINGAS DE METOTREXATO

Bautista Paloma FJ, Prieto Baños P, García-Avello Fernández-Cueto A, Martínez Turrión J, Baca Bocanegra B, Martínez Nieto PJ.

Hospital Virgen del Rocio. Sevilla. España.

OBJETIVOS Describir el diseño e implementación de un programa de elaboración y distribución de jeringas precargadas de metotrexato, para su dispensación a pacientes externos, en seguimiento por los servicios de reumatología y aparato digestivo por procesos inflamatorios crónicos, ante el desabastecimiento de preparados comerciales con esta presentación. Evaluar el ahorro económico que supone esta iniciativa.

MATERIAL Y MÉTODOS Se realizó una búsqueda bibliográfica para determinar la estabilidad del fármaco en jeringas de plástico, en diferentes condiciones de conservación. Se analizaron los consumos de metotrexato en jeringas precargadas en el conjunto del área hospitalaria y en cada zona básica de la misma, y se identificó a los pacientes en tratamiento, así como la dosis y pauta de cada uno de ellos. Se estableció un procedimiento de reenvasado en jeringas de polipropileno, trabajando en cabina de flujo laminar vertical, a partir de viales comerciales de metotrexato 5 g/200 ml. Se diseñó un circuito de almacenamiento y suministro, en el cual, tras la primera dispensación a cada paciente en el Servicio de Farmacia Hospitalaria, éste, para las sucesivas dosis, lo distribuye con una periodicidad bimensual a la Unidad de Farmacia del Distrito de Atención Primaria, quien, a su vez, mensualmente, lo envía, para su administración, al Centro de Salud correspondiente.

RESULTADOS Se obtuvo evidencia de que, en la oscuridad y a temperatura inferior a 25ºC, las jeringas precargadas de metotrexato 25 mg/mL son estables durante un periodo de 8 meses. Las necesidades bimensuales previstas de jeringas precargadas de metotrexato fueron de 2.700 unidades: 200 dosis de 7,5 mg, 700 dosis de 10 mg, 1.000 dosis de 15 mg, 500 dosis de 20 mg y 300 dosis de 25 mg. Teniendo en cuenta los costes de los viales de metotrexato de partida y de las jeringas precargadas comerciales a las que sustituyen las elaboradas, el impacto de ahorro mensual generado asciende a 34.000 €.

CONCLUSIONES Este proyecto ha permitido resolver el problema de desabastecimiento de metotrexato con el logro añadido de un importante ahorro económico para el Sistema de Salud.

Farm Hosp. 2013;Supl. 1:65-499

CURSO PROTOCOLO DE SEGURANÇA NA PRESCRIÇÃO, USO E ADMINISTRAÇÃO DE MEDICAMENTOS. PLANEJAMENTO, IMPLANTAÇÃO, MONITORAMENTO E AVALIAÇÃO.

DEVELOPMENT OF A SOTALOL HYDROCHLORIDE ORAL SOLUTION FOR PAEDIATRIC CARDIOLOGY PATIENTS

S Klovrzova, P Horak, Z Sklubalova, T Kriz, L Zahalka, L Matysova

University Hospital Motol, Hospital Pharmacy, Prague, Czech Republic; Faculty of Pharmacy, Pharmaceutical Technology, Hradec Kralove, Czech Republic; Faculty of Pharmacy, Analytical Chemistry, Hradec Kralove, Czech Republic


Background Antiarrhythmic beta blocker sotalol is highly effective in the treatment of supraventricular tachycardia in children; approximately 14,000 capsules containing various doses of sotalol hydrochloride were prepared in our pharmacy in the year 2012. No licensed paediatric dosage form with sotalol is available in Europe now.

Purpose To replace the extemporaneous preparation of sotalolcontaining capsules with oral liquid for children in hospital pharmacy conditions. To ensure safe formulation of the substance in terms of minimum excipients, suitable flavour, chemical and microbiological stability. To design and verify the method for routine quality control of the final product.

Materials and methods A paediatrics cardiologist was consulted about the development of 5 mg/ml sotalol hydrochloride solution. Potassium sorbate was used as a preservative, sucrose syrup as a sweetener, and citric acid to stabilise the pH value. The stability of the solution was evaluated over 6 months at refrigerated and room temperatures using a validated HPLC method; the pH was measured.

Results The HPLC method verified chemical stability of the solution at + 4°C for 180 days. The concentration of sotalol varied between 98.5-101.0%, potassium sorbate between 95.2-103.2%, the pH value was in a range of 4.16-4.19. In the hospital pharmacy, where the HPLC method is not available, silver nitrate potentiometric titration can be used to determine the sotalol hydrochloride concentration when preparing stock solutions.

Conclusions A stable oral liquid formulation of sotalol was developed and replaced the time-consuming preparation of capsules. The proposed solution has a six months shelf life in the refrigerator, suitable dosage flexibility and easy availability for the paediatric patients. Moreover, the treatment’s safety was increased due to the formulation with documented stability and improved quality control of the final product.

Eur J Hosp Pharm 2014:21(Suppl 1):A1–224

OFF-LABEL PRESCRIPTIONS IN THE NEONATAL INTENSIVE CARE UNIT AT MARSEILLES NORTH HOSPITAL

AE Fagour, M Desbourdes, N Colombini, R Vialet, M Buès-Charbit.

Hôpital Nord, Pharmacy, Marseilles, France; Hôpital Nord, Pediatric ICU, Marseilles, France

Background The availability of drugs specifi cally assessed for use in neonates is limited as evaluation is more diffi cult in neonates than in adults. The result is a widespread off-label use of drugs, especially in neonatal intensive care units. Such practise is an essential part of their care and should be based on the best available evidence.

Purpose To describe and analyse the off-label use of medicines in a neonatal intensive care unit.

Materials and Methods Prospective observational study conducted over three months, from 27 February 2012 to 27 May 2012. All the drugs prescribed were analysed with regard to their licence status for the: indication, dose, route of administration, mode of administration, age category, formulation (compounding of capsules, oral suspensions, eye drops), contraindications and warnings especified in the summary of product characteristics of the marketing authorization.

Results In total, 638 prescriptions, comprising 59 different medicines were written, 107 newborn babies were admitted (60 male, 47 female). Their age varied from 0 to 27 days (average: 2 days), their mean gestational age was of 34 weeks of amenorrhea (65% premature), their weight ranged from 630 g to 4700 g (average: 2230 g). A total of 487 prescriptions were written off label (76%), with 101 patients (94%) receiving at least one drug used off-label. Drugs were prescribed off-label mostly concerning the indication (48%), then came off-label use for the dose and the age category. The medicine most often prescribed off-label was caffeine citrate.

Conclusions Critically ill neonates are exposed to numerous medicines, a significant proportion of which are not yet approved for use in this vulnerable group of patients. Despite European initiatives aiming to promote greater awareness and research in the paediatric population, there is still a high percentage of unlicensed or off-label drug use in neonatal intensive care. This study underlines the need for clinical research and approval of the clinical data acquired within the neonatal population.

Reference Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

1ª Ed. 2014 Editora Medfarma
ISBN 9788589248136
Nº de págs.: 962
Capa flexível
Formato: 16 x 23 cm

    Manual de Medicamentos Citostáticos é um livro com todos os fundamentos necessários para uso pela Equipe Multiprofissional que atuam em Unidades ou Centros de Assistência de Alta Complexidade em Oncologia (CACON), que apresenta informações sobre medicamentos citostáticos para todos os estudantes e profissionais da área de saúde, com o objetivo de complementar uma abordagem multiprofissional ao paciente oncológico. Livro contendo 184 medicamentos e com os seguintes capítulos: glossário farmacêutico, glossário de oncologia, lista de abreviaturas e siglas, tabela geral de diluição, manipulação de drogas citostáticas, PGRSS com pictogramas e símbolos de identificação de grupos de resíduos, medicamentos com resumo das toxicidades e as monografias dos medicamentos. Neste sentido, o livro aborda as seguintes informações:  nome genérico do produto,  nomes comerciais, sinonímia e outras denominações, forma farmacêutica, categoria terapêutica, farmacocinética, posologia, reações adversas, regimes especiais de posologia, alertas de administração, precauções, interações medicamentosas, condutas na superdose, medidas após a contaminação acidental, protocolo para extravasamento, biossegurança ocupacional, normas internacionais de transporte do produto, PGRSS, estabilidade da solução reconstituída no frasco de vidro, concentração após reconstituição no frasco de vidro,  vias e formas de administração, diluentes, volume final e tempo de infusão, compatibilidade com as soluções e com os equipamentos,  incompatibilidade com as soluções e com os equipamentos, estabilidade em seringa plástica, estabilidade em bolsa plástica de PVC, poliolefina, PEBD e de EVA. Considero este livro uma futura publicação multiprofissional indispensável para todos os profissionais da área de saúde, que necessitam de informações atualizadas e precisas, abordando de maneira clara, simples e objetiva os estudos, principalmente, sobre protocolos para extravasamento, em condutas na superdose e na contaminação acidental, normas do PGRSS, assim como a diluição, compatibilidade e estabilidade de medicamentos citostáticos.

DEVELOPMENT OF A STABLE NYSTATIN ORAL SUSPENSION TO OVERCOME SHORTAGES OF THE COMMERCIAL MEDICINE

S Cirillo, MM Giacomotti, A Leggieri, F Bordino, D Chirio, M Gallarate.

ASLTO2 NORD, S.C. Farmacia Ospedaliera 1, Turin, Italy; ASLTO2, Farmacia Ospedaliera, Ospedale Maria Vittoria-Ospedale S.G. Bosco, Turin, Italy; Università degli Studi di Torino, Dipartimento di Scienza e Tecnologia del Farmaco, Turin, Italy

Background Nystatin is often used in the treatment of cutaneous, vaginal, mucosal and oesophageal Candida infections. It’s widely employed in cancer and immunocompromised patients suffering from mucositis. The unobtainability of the commercial oral suspension from July 2011 to February 2012 caused diffi culties in the provision of the medicine for these types of inpatients and outpatients.

Purpose With the aim of ensuring a safe continuity of treatment, liquid formulations of nystatin 100,000 IU/ml were developed as oral suspensions, due to the insolubility of the drug in water. The suspensions obtained were studied to assess their chemical-physical stability to fi nd the most suitable formulation.

Materials and Methods Nystatin was dispersed in water containing preservative using carboxymethyl cellulose (CMC) or tragacanth gum as suspending agents. The aqueous vehicles used were sucrose syrup or sorbitol syrup (for the treatment of diabetic or paediatric patients) fl avoured with raspberry fl avour. The fi nal pH was maintained in the 7.0–7.8 range. The suspensions obtained were submitted to stability studies determining their chemical-physical properties (mean particle sizes, viscosity, Zeta potential) and the active ingredient content (HPLC analysis) over a 3-month period.

Results Stable suspensions of nystatin were obtained with mean sizes slightly greater than 1 μm, with both suspending agents and vehicles. CMC and sucrose syrup-containing suspension, however, was more resistant to microbiological attack and it was chosen as the most suitable preparation. Particle sizes, Zeta potential and viscosity remained unchanged for at least 3 months at 25 and 40°C. The nystatin content in the suspension decreased by about 16% after the fi rst month and then remained constant over time.

Conclusions The development of a stable nystatin suspension was crucial to ensure continuity of care for patients with oral mucositis previously treated with a commercial formulation, whose temporary
lack offered new formulation challenges to the hospital

Reference Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

DEVELOPMENT OF PYRIDOXAL-5-PHOSPHATE HARD CAPSULES FOR PAEDIATRIC USE

C Serrano, P Joret, V Siorat, P Vaconsin, T Abarou, T Storme.
Hopital Robert Debre (Ap-Hp), Pharmacy, Paris, France

Background The active form of vitamin B6, called pyridoxal-5-phosphate (P5P), is an essential cofactor for several enzymes involved in various pathways of intermediary metabolism. PNPO is the rate-limiting enzyme in the synthesis of pyridoxal from vitamin B6 and a lack of activity causes dependency on an external source of pyridoxal. Epileptic seizure is the clinical outcome of P5P deficiency.

Purpose To provide a dosage form suitable for newborns and children. Capsules containing standardised P5P were compounded. Moreover, a fully soluble powder blend was formulated to fi ll the capsules and a method to determine the stability of the P5P content was developed.

Materials and Methods Dissolution assays were performed using oral syringes as nurses do. Time to complete dissolution and concentration were determined at each test. P5P content was determined by HPLC-UV (205 nm). The mobile phase consisted of phosphate buffer (0.05 M; pH 2.6) at a fl ow rate of 1 ml/min. The right active ingredient was tested by adding vitamin B6 to samples. Degradation by-products in stress conditions were also determined. The method was validated according to ICH recommendations.

Results Strengths were standardised at 10, 25, 50, 100 or 250 mg/capsule. The adopted blend is quickly solubilised in water and has a sweet taste. The HPLC readings were linear (r² = 0.9994) at the wavelength used, indicating good reproducibility and repeatability (SD = 0.46%). No matrix effect due to the diluent was observed.

Conclusions As P5P is a low toxicity compound, a test treatment with P5P is given to every newborn with idiopathic seizure before any treatment with standard antiepileptics. This method allows rapid routine assay of P5P. Stability testing of 3 compounded batches is ongoing.

No confl ict of interest.

Eur J Hosp Pharm 2013;20(Suppl 1):A1–A238

Zidovudina xarope

Zidovudina Cápsula 100 mg...................................................................................10 
Benzoato de Sódio..........................................................................................100 mg 
Glicerina.............................................................................................................5 mL 
Xarope de Cereja USP q.s.p...........................................................................100 mL

Em recipiente adequado triturar o pó retirado das cápsulas de zidovudina. Adicionar 40 mL de veículo e misturar para formar uma pasta fina e completar o volume. Estabilidade de 30 dias em temperatura ambientee sob refrigeração. Uso oral.

Referência bibliográfica: Buotempo F, Quiroga E, Parajó G, Mato G. Estabilidad de Zidovudina en una Suspensión Extemporánea Oral. Medicina Infantil. 1997;4(4):243-245.

Valganciclovir 60 mg/mL suspension orale

Centre Hospitalier Universitaire Vaudois

Service de pharmacie

Rue du Bugnon 46 CH-1011 LAUSANNE Tél dir. (021) 314 49 96

Fax (021) 314 42 99 E-mail Assistance.Pha@chuv.ch

 

VALGANCICLOVIR 60 mg/mL

 

Suspension orale avec sucre

Formule pour 120 ml

Valganciclovir (Valcyte® 450 mg)...................................................16 cpr = 7200 mg

Ora-Plus..........................................................................................................60 ml

Ora-Sweet.................................................................................................ad 120 m

 

Précautions: D’après le fabricant, les comprimés ne devraient être ni cassés ni écrasés, 

étant donné que le Valcyte est potentiellement tératogène et cancérigène chez l’homme.

 Il faut éviter tout contact direct entre la peau ou les muqueuses et les comprimés cassés

ou écrasés, et évitertoute inhalation de résidus en poudre. Mettre une blouse, des gants

 et un masque.

 

Mode opératoire: Dans un mortier, placer 16 comprimés de Valcyte 450 mg.Mesurer 60 ml d’Ora-Plus

 dans un cylindre gradué.Ajouter 5 ml de Ora-Plus dans le mortier, sur les comprimés.

 Broyer les comprimés afin de former une pâte.Ajouter Ora-Plus par portions et bien homogénéiser

 après chaque ajout.Transférer la suspension obtenue dans un cylindre gradué.

Compléter à 120 ml avec Ora-Sweet en rinçant le mortier et bien mélanger.

Distribuer dans un flacon de 200 ml. Expiration: 1 mois.Conditionnement: Flacon Veral 200 ml. 

Etiquette "Bien agiter!" Stockag: Frigo (2-8°C).

 

Références: Henkin et al., Stability of valganciclovir in extemporaneously compounded 

liquid formulations,Am J Health Syst Pharm.2003; 60: 687-690.

Manual de Drogas Injetáveis, 3ª edição

Manual de Drogas Injetáveis, 3ª edição. Atualizado com tabelas mL/hora ou mcg/kg/min para diversos medicamentos. pic.twitter.com/JY8biI80aN
— Gilberto B. Souza (@gilbertobarcelo) November 18, 2013

Hidroxiuréia: manipulação magistral

HIDROXICARBAMIDA

Hidroxicarbamida (Hidroxiuréia) Cápsula 500 mg................................................20

Água Destilada para Injetáveis.........................................................................50 mL

Xarope Simples USP q.s.p.............................................................................100 mL

Este produto deve ser preparado em área classificada, seguindo protocolo para reconstituição de soluções de drogas citostáticas. Em um recipiente adequado, pulverizar a hidroxiuréia. Adicionar parte da água destilada, levemente aquecida, e misturar para formar uma pasta. Filtrar. Completar o volume de 100 mL. Estabilidade de 28 dias em temperatura ambiente. Uso oral.

Referência bibliográfica: Heeney MM, Whorton MR, Howard TA, Johnson CA, Ware RE. Chemical and Functional Analysis of Hydroxyurea Oral Solutions. J Pediatr Hematol Oncol. 2004;26(3):179-184.

Manual de Drogas Injetáveis, 3ª edição. Lançamento no CONGRESSO DE FARMÁCIA HOSPITALAR em São Paulo, novembro de 2013 pic.twitter.com/IXD9qdJrxz
— gilberto souza (@gilbertobarcelo) October 24, 2013

Saliva Artificial

Metilcelulose......................................................................2 g 
Glicerol.............................................................................10 g
Nipagin Sódico................................................................0,1 g 
Flavorizante de Limão...................................................1 gota 
Água Purificada USP q.s.p...........................................470 mL

Em recipiente adequado, colocar a água em temperatura ambiente e com agitador magnético dissolver os sais. Incorporar a metilcelulose e aumentar a temperatura para 60º C e manter a agitação até o desaparecimento dos grumos. Incorporar o flavorizante de limão e completar o volume final. Deixar em repouso por 24 horas. Estocar sob refrigeração e proteger da luz.


Referência bibliográfica: Saliva Artificial. Servicio de Farmacia. Institut Catala d’Oncologia-Duran y Reynalds. Barcelona. 2013.

Metadona: estabilidade na manipulação magistral

Cloridrato de Metadona..........................................33 mg

Água Purificada USP................................................5 mL

Xarope Simples USP q.s.p....................................100 mL

Em recipiente adequado pesar o cloridrato de metadona e dissolver em água purificada. Filtrar e transferir a solução de metadona para um cálice graduado. Adicionar o veículo em porções geométricas, misturando após cada adição e completar o volume final. Estabilidade de 180 dias sob refrigeração. Uso oral.

Referência bibliográfica: Souza GB. Fórmulas Farmacêuticas Extemporâneas, 1ª ed. Editora Medfarma. São Paulo. 2012.