Rapamune (sirolimus) tablets and oral solution - Pfizer Limited - Revised SPC

Source: eMC (electronic Medicines Compendium) Area: Other Library Updates> SPC Changes Section 4.5 Interaction with other medicinal products and other forms of interaction has been updated to include potential interactions with CYP3A4 inhibitors, which may decrease the metabolism of sirolimus and increase sirolimus blood levels. Such inhibitors include e.g. certain antifungals (e.g. clotrimazole, fluconazole, itraconazole, voriconazole), certain antibiotics (e.g.  troleandomycin, telithromycin, clarithromycin), certain protease inhibitors (e.g. ritonavir, indinavir, boceprevir, telaprevir),  nicardipine, bromocriptine, cimetidine, and danazol.   Section 4.8 Undesirable effects has also been updated to include ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) as potential side effects.   Please see link to the SPC for full prescribing information  
Source: NeLM - SPC Changes - Category: Drugs & Pharmacology Source Type: news

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Abstract Menopause is characterized by permanent cessation of menstrual periods and is clinically diagnosed after 12 months of complete amenorrhea. It occurs at a median age of 51 years alongside the physiological process of aging, although it can happen at an earlier age for other medical conditions or after surgery (surgical menopause). Due to reduced circulating estrogens and progesterone, the reproductive organs undergo progressive atrophy. This physiologic process of aging is also present at an endometrial level; without the cyclic hormonal actions of the menstrual cycle, the endometrium during ...
Source: Climacteric - Category: Geriatrics Authors: Tags: Climacteric Source Type: research
ez A Abstract OBJECTIVES: Relationships between weight and fertility are well known. The aim of this study is to assess the prevalence of lifetime eating disorder (ED) in a sample of infertile women seeking a specific infertility treatment, pulsatile gonadotropin-releasing hormone (pGnRH) treatment, and to compare it to the prevalence of lifetime ED in a sample of infertile women seeking other types of assisted reproductive technology (ART) treatments. DESIGN: Non-randomized, observational study including infertile female patients. Two-group design including consecutive women treated with GnRH pump (pGnRH) or...
Source: Eating and weight disorders : EWD - Category: Eating Disorders & Weight Management Authors: Tags: Eat Weight Disord Source Type: research
Objective: The aim of the study was to evaluate the effect of a single-capsule 17β-estradiol/progesterone (E2/P4), TX-001HR, on endometrial safety, to report on amenorrhea and bleeding patterns of users, and to identify predictors of amenorrhea. Methods: The REPLENISH trial (NCT01942668) evaluated use of TX-001HR in menopausal women (40-65 y) with vasomotor symptoms (VMS) and a uterus. Women were randomized to daily E2/P4 (mg/mg: 1/100, 0.5/100, 0.5/50, or 0.25/50), or placebo for 12 months. Incidence rate of endometrial hyperplasia was calculated from endometrial biopsies conducted at screening and study complet...
Source: Menopause - Category: OBGYN Tags: Original Studies Source Type: research
Hypothalamic amenorrhea is common in adolescents and young adults (AYAs) with anorexia nervosa (AN), and ovarian reserve is not routinely assessed as part of routine clinical care. Multiple neuroendocrine alterations occur with AN, and appear to impair reproductive health. AN leads to higher rates of fertility problems, later age at childbearing, and increased rates of obstetrical complications. How or when AN negatively influences future fertility is unclear. We sought to determine whether biomarkers of ovarian reserve were impacted in AYA with AN.
Source: Journal of Pediatric and Adolescent Gynecology - Category: OBGYN Authors: Source Type: research
Distal vaginal atresia is a rare but psychosocially difficult congenital malformation that is often not recognized until a young patient presents with primary amenorrhea and typically concurrent abdominal pain. Vaginal atresia, or the failure of the vaginal plate to canalize, occurs secondary to failure of the urogenital sinus to form the lower portion of the vagina. The definitive management of distal vaginal atresia involves surgical drainage of the hematocolpos followed by anastomosis of the vaginal mucosa with the perineum.
Source: Journal of Pediatric and Adolescent Gynecology - Category: OBGYN Authors: Source Type: research
Transverse Vaginal Septums (TVS) are congenital, obstructive anomalies of the female genital tract typically presenting with abdominal pain and amenorrhea around menarche. Currently, the literature surrounding surgical management is scarce and poorly described. As well, both early and long term postoperative complications are common owing to the complexity of the surgical repair. Lastly, often these patients require intensive vaginal dilation schedules postoperatively, the details and outcomes of which are poorly described.
Source: Journal of Pediatric and Adolescent Gynecology - Category: OBGYN Authors: Source Type: research
Mayer-rokitansky-kuster-hauser (MRKH) syndrome is a congenital condition affecting 1 in 5000 females that results in vaginal agenesis. Mullerian anomalies such as those found in MRKH are also associated with MURCS (M üllerian duct aplasia–renal agenesis–cervicothoracic somite dysplasia) which is phenotypically similar to VACTERL (vertebral defects, anal atresia, cardiac defects, TE fistula, renal dysplasia, limb anomalies). All three of these conditions are believed to be multifactorial in nature, with pati ents having a typical chromosome complement.
Source: Journal of Pediatric and Adolescent Gynecology - Category: OBGYN Authors: Source Type: research
Approximately 1:4000 women are diagnosed with M üllerian agenesis, typically when they are evaluated for primary amenorrhea. The most common conditions associated with Müllerian agenesis are Mayer-Rokitansky-Küster-Hauser syndrome (MRKH) and Androgen Insensitivity Syndrome (AIS). A serum testosterone and karyotype should be performed to differ entiate between these 46,XX and 46,XY conditions. With the advent of direct-to-consumer genetic testing companies, patients may discover they have a 46,XY karyotype without genetic counseling to explain the implications.
Source: Journal of Pediatric and Adolescent Gynecology - Category: OBGYN Authors: Source Type: research
Horm Metab Res 2020; 52: 186-193 DOI: 10.1055/a-1100-706617-Hydroxylase-deficiency (17OHD) is a rare form of congenital adrenal hyperplasia. The aim of the work was to study clinical, biochemical, and the follow up of 17OHD patients and evaluate the function and structure of CYP17A1 mutations. Brazilian patients (three 46, XX and four 46, XY; 17±1.9 years) with combined 17-hydroxylase/17,20-lyase deficiency were evaluated. CYP17A1 gene was sequenced. Functional analysis was performed transfecting COS7 cells, which were exposed to progesterone or 17α-hydroxypregnolone ...
Source: Hormone and Metabolic Research - Category: Endocrinology Authors: Tags: Endocrine Care Source Type: research
The reproductive function of humans is regulated by several sex hormones which are secreted in synergy with the circadian timing of the body. Sleep patterns produce generic signatures that physiologically drive the synthesis, secretion, and metabolism of hormones necessary for reproduction. Sleep deprivation among men and women is increasingly reported as one of the causes of infertility. In animal models, sleep disturbances impair the secretion of sexual hormones thereby leading to a decrease in testosterone level, reduced sperm motility and apoptosis of the Leydig cells in male rats. Sleep deprivation generates stressful...
Source: Journal of Circadian Rhythms - Category: Biology Source Type: research
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