Administración de amoxicilina a un paciente con mononucleosis infecciosa. Reporte de un caso de reacción adversa / Amoxicillin administration to a patient with infectious mononucleosis. Report of an adverse reaction case

Objetivo: Describir un caso clínico de un paciente tratado con amoxicilina (AMX) mientras cursaba una infección viral, en el que se detectaron errores de medicación (EM) y reacciones adversas a medicamentos (RAM). Descripción del caso clínico: Paciente masculino de 7 años y 23 kg concurrió a la guardia del hospital presentando fatiga, fiebre y ganglios linfáticos inflamados. Se diagnosticó faringitis bacteriana y se indicó AMX 50 mg/kg/día vía oral/8 h. Al día siguiente, el paciente fue nuevamente al hospital presentando rash cutáneo en todo el cuerpo. Se advirtió evento adverso (EA) por diagnóstico erróneo y se diagnosticó mononucleosis infecciosa (MI). Se suspendió la AMX y hubo remisión del rash. Un farmacéutico hospitalario realizó la imputación utilizando el algoritmo de Naranjo (puntaje 5-8) y notificó al Sistema Unificado de Farmacovigilancia de Córdoba. Discusión: Es fundamental el diagnóstico adecuado de la MI para evitar el uso inapropiado de antibióticos ante una infección viral. En el caso descripto ocurrió un EM en la etapa de prescripción, debido al diagnóstico incorrecto, y una RAM por el uso de AMX. El puntaje obtenido permitió catalogar a esta RAM como probable, no pudiendo ser considerada definida/probada por no haber reexposición; aunque el EA apareció luego de la administración de un fármaco sospechoso y no existieron causas alternativas para explicar esta reacción. Además, el EA desapareció tras suspender la AMX. Esto enfatiza el rol protagónico del farmacéutico para promover la seguridad de pacientes y la importancia de las notificaciones. (AU)

Goal: To describe a clinical case of a patient treated with amoxicillin (AMX) while he had a viral infection. In this case, medication error (ME) as well as adverse drug reaction (ADR) were detected. Description of the clinical case: A 7-year-old, 23-kg male patient attended to the hospital with the following symptoms: fatigue, fever and swollen lymph nodes. Pharyngitis caused by bacteria was diagnosed and orally administration of AMX 50 mg/kg/day each 8 h was indicated. One day later, the patient returned to the hospital with skin rash throughout the body. An adverse event (AE) was noticed due to an error in the diagnosis, which was corrected and infectious mononucleosis (MI) was detected. AMX was suspended and remission of the rash was observed. A hospital pharmacist performed the imputation using the Naranjo algorithm (score 5-8) and notified to the Sistema Unificado de Farmacovigilancia of Cordoba. Discussion: Proper diagnosis of IM is essential to avoid inappropriate use of antibiotics when the patients present viral infections. In this clinical case, a ME occurred at the prescription, due to the incorrect diagnosis, and an ADR because of the use of AMX. The score obtained allowed us to classify this ADR as probable, and it could not be considered definite/proven because there was no re-exposure. However, the AE occurred after the administration of a suspected drug and there were no alternative causes to explain this reaction. In addition, the AE disappeared after suspending the AMX. This emphasizes the leading role of the pharmacist in promoting patient safety and the relevance of notifications. (AU)

Urinary excretion of ciprofloxacin after administration of extended release tablets in healthy volunteers. Swellable drug-polyelectrolyte matrix versus bilayer tablets.

This paper builds on a previous paper in which new ciprofloxacin extended-release tablets were developed based on a ciprofloxacin-based swellable drug polyelectrolyte matrix (SDPM-CIP). The matrix contains a molecular dispersion of ciprofloxacin ionically bonded to the acidic groups of carbomer, forming the polyelectrolyte-drug complex CB-CIP. This formulation showed that the release profile of the ciprofloxacin bilayer tablets currently commercialised can be achieved with a simpler strategy. Thus, since ciprofloxacin urine concentrations are associated with the clinical cure of urinary tract infections, the goal of this work was to compare the urinary excretion of SDPM-CIP tablets with those of the CIPRO XR® bilayer tablets. A batch of SDPM-CIP tablets was manufactured by the wet granulation method and the CB-CIP ionic complex was obtained in situ. Fasted healthy volunteers received a single oral dose of 500 mg ciprofloxacin of either formulation in a randomised crossover study. Urinary concentrations were assessed by HPLC at intervals up to 36 h. Pharmacokinetic parameters (rate of urinary excretion, maximum urine excretion rate, tmax, area under the curve, amount and percentage of the ciprofloxacin dose excreted in urine) showed no statistical differences between both formulations at any of the time intervals of collection. The processing conditions to obtain SDPM-CIP tablets are easy to scale up since they involve technology currently employed in the pharmaceutical industry and the process is less challenging to implement. In addition, SDPM-CIP tablets met pharmacopoeial quality specifications.

Multinuclear solid state NMR investigation of two polymorphic forms of ciprofloxacin-saccharinate.

Two polymorphic forms of a novel pharmaceutical compound, ciprofloxacin-saccharinate (CIP-SAC), are analyzed using one dimensional (1D) and two dimensional (2D) (1)H nuclear magnetic resonance (NMR) at fast magic angle spinning (MAS). Additionally (15)N spectroscopy and (1)H-(13)C correlation experiments were performed to complement our conclusions. The 1D (1)H NMR spectra of CIP and complexes reveal valuable information about the ionic bonding between ciprofloxacin and saccharine. Additionally, these spectra allow us to perform a clear characterization of each solid form, giving the number of molecules per unit cell in one of the polymorphs. From 2D (1)H-(1)H spectra obtained through double quantum correlations we can arrive at important conclusions about the hydrogen bonding, conformation, and intra and inter-molecular interactions present in these compounds. Comparing and contrasting the (1)H-(1)H correlation data obtained for both polymorphic forms and taking into account the single crystal structure data existing for the solid form CIP-SAC (II) was possible to extract some conclusions on the polymorph CIP-SAC (I) where no single crystal information is available. (1)H MAS NMR is shown to be an important tool in the field of polymorphism and for the characterization of multicomponent pharmaceutical compounds.

Crystallographic, thermal and spectroscopic characterization of a ciprofloxacin saccharinate polymorph.

A new polymorphic form of ciprofloxacin saccharinate (CIP-SAC II) is presented, and compared with CIP-SAC I, a different polymorph which we had previously reported. The characterization techniques used were single crystal and powder X-ray diffraction, differential scanning calorimetry, thermogravimetry analysis and infrared and (13)C solid-state nuclear magnetic resonance spectroscopy. The results obtained from these techniques are consistent. Differential scanning calorimetry and thermogravimetric analysis showed that the reaction between the precursors is completed and the crystalline forms of both salts obtained (I and II) are highly pure. Infrared spectroscopy gave clear evidence of a salt formation. Solid-state nuclear magnetic resonance spectroscopy would indicate some degree of qualitative similarity in the intermolecular interaction scheme in both polymorphs, while thermal analysis data might indicate a difference in quantitative terms. A thorough single crystal structure determination of the new form CIP-SAC II allowed disclosing the most important inter- and intramolecular interactions.