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Latest Drugs
Women's Health and Obs/Gyn Drug Data - A-Z (Espanol)
Drug Class Description
Otras hormonas sexualesDrug Description
COMPRIMIDOSPresentation
Adultos, oral: 60 mg/24 horas. - Ancianos: No es necesario ajustar la dosis en pacientes de edad avanzada. - Normas para la correcta administración: Se puede administrar a cualquier hora del día, independientemente de las comidas (con o sin alimentos). En mujeres con una dieta baja en calcio se recomienda administrar suplementos de calcio.Indications
- Osteoporosis: Prevención y tratamiento de la osteoporosis en mujeres postmenopáusicas. Raloxifeno reduce de forma significativa el riesgo de fracturas vertebrales osteoporóticas, pero no de fracturas vertebrales. En el momento de elegir entre raloxifeno u otros tratamientos, incluyendo estrógenos, para una mujer postmenopáusica concreta, hay que tener en cuenta los síntomas de la menopáusia, los efectos sobre los tejidos uterino y mamario, así como los riesgos y beneficios cardiovasculares.Interactions
- Ampicilina: se ha registrado disminución en las concentraciones máximas (29%) de raloxifeno, aunque la absorción total y la eliminación no se ven afectadas. - Anticoagulantes orales (warfarina): se han observado leves acortamientos en el tiempo de protrombina (10%), por ello se debe monitorizar el tiempo de protrombina si se administran conjuntamente. - Resinas de intercambio iónico (colestiramina): se ha registrado disminución de la absorción (60%) y del ciclo enterohepático del raloxifeno, con posible inhibición de su efecto. No se recomienda su administración conjunta, y si es necesaria, separar lo más posible su administración. - Incrementa ligeramente las concentraciones de las globulinas transportadoras de hormonas, incluyendo globulinas transportadoras de esteroides sexuales (SHBG), de tiroxina (TBG) y de corticoides (CBG), con los correspondientes incrementos en las concentraciones totales de estas hormonas. Estos cambios no afectan a las concentraciones de hormonas libres.Adverse Reactions
Los efectos adversos suelen ser consecuencia de su acción antiestrogénica. Descripción e incidencia de las reacciones adversas más características que presentaron una diferencia siginificativa (p<0,05) en comparación con placebo, en el conjunto de todos los ensayos clínicos controlados realizados: - Frecuentemente: sofocos (24%, frente a un 18,2% en placebo), más frecuentes en los 6 pirmeros meses de tratamiento y raramente por primera vez después de ese periodo. - Ocasionalmente: edema periférico (3% con raloxifeno frente a 1,9% con placebo) con tendencia siginificativa dependiente de la dosis, episodios tromboembólicos (tromboembolismo venoso, embolismo pulmonar, trombosis venosa de la retina) (0,8%). El riesgo relativo fue de 2,49 (IC 1,23-5,02) en comparación con placebo. Otra reacción adversa observada fue calambres en las piernas (5,5% con raloxifeno, 1,9% con placebo). Las interrupciones del tratamiento como consecuencia de la aparición de reacciones adversas se rpodujo en el 10,7% de las pacientes tratadas con raloxifeno frente a un 11,1% con placebo. Se han notificado casos raros de aumentos moderados de AST y/o ALT en los que no se puede descartar una relación causal con raloxifeno. Se han notificado recuentos plaquetarios ligeramente disminuidos (6-10%) durante el tratamiento con raloxifeno.Manufacturer
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Related News
Study backs findings that some newer contraceptive pills more likely to cause VTE Women's Health and Obs/Gyn Page
A new study confirms earlier findings that certain oral contraceptive pills including those with desogestrel, gestodene, or drospirenone, including Safyral, from Bayer HealthCare, are more likely to cause serious blood clots (venous thromboembolism - VTE ) than others. The authors, led by Dr Øjvind Lidegaard from the University of Copenhagen, say that women on pills containing one of the newer types of progestogen hormone (drospirenone, desogestrel or gestodene) have double the risk of VTE than women on pills containing an older progestogen (levonorgestrel). The researchers reviewed data of the hormonal contraception patterns and first time VTE episodes for all Danish non-pregnant women between the ages of 15 and 49 from January 2001 until December 2009. Though the relative risk of VTE whilst taking the oral contraceptive pill is still low, compared with non-users of hormonal contraception, pills with levonorgestrel increase the risk of VTE threefold and pills with drospirenone, desogestrel or gestodene increase the risk sixfold. In absolute terms, the risk of VTE in current users of newer pills is about 10 per 10,000 women years. See: "Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9" Øjvind Lidegaard et al. British Medical Journal 2011;343:d6423 doi: 10.1136/bmj.d6423
Contraceptives containing Beyaz (Bayer Healthcare) show higher risk of blood clots Women's Health and Obs/Gyn Page
The use of oral Contraceptive pills that contain Beyaz (drospirenone), from Bayer Healthcare, is linked to a significantly higher risk of blood clots, both deep vein thrombosis and pulmonary embolism, according to an article in the Canadian Medical Association Journal. The study found that the use of Beyz-containing combined oral contraceptives was associated with a significantly increased risk of venous thrombotic events (deep vein thrombosis and pulmonary embolism) but not arterial thrombotic events (transient ischemic attack and cerebrovascular accident), relative to use of second- or third-generation combined oral contraceptives. Risk was highest in the early months of use. Older age, high blood pressure, high cholesterol, cancer and obesity were also risk factors for blood clots. The FDA will discuss the risks and benefits of these contraceptives at a meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Dec. 8, 2011. See: "Higher risk of venous thrombosis associated with drospirenone-containing oral contraceptives: a population-based cohort study" Naomi Gronich, Idit Lavi, Gad Rennert. CMAJ November 7, 2011 First published November 7, 2011, doi: 10.1503/cmaj.110463
Nomac/E2 is rejected by FDA as a contraceptive Women's Health and Obs/Gyn Page
Zoely/Nomac/E2 is a combined contraceptive pill (nomegestrol acetate (a progestogen) and estradiol (an oestrogen) which was approved by EMA for Teva Pharma on 17 July 2011 to be launched by year end and rejected by the FDA for Merck Inc. some days ago.
