The role of natural progesterone in natural hormone replacement therapy

The Use and Utility of Low-dose Naltrexone Capsules for Patients with Fibromyalgia

Cote B et al., 2018·International journal of pharmaceutical compounding

Fibromyalgia is a syndrome associated with chronic, widespread musculoskeletal pain, fatigue, depression, and cognitive dysfunction. With few U.S. Food and Drug Administration-approved treatment options, there is evidence that low-dose naltrexone, an opioid antagonist approved for opioid and alcohol dependence at high doses, may have efficacy in the treatment of fibromyalgia and chronic pain. At the doses required for fibromyalgia treatment, naltrexone needs to be compounded, and no data currently exists regarding the long-term stability of low-dose naltrexone capsules. This limits pharmacies to a maximum beyond-use date of 180 days. Our study examined the stability of compounded capsules of low-dose naltrexone in Avicel over 360 days. Naltrexone was extracted from compounded capsules and assessed using reversed-phase high-performance liquid chromatography validated to differentiate between the degraded and undegraded naltrexone. United States Pharmacopeia guidelines state that compounded medications must remain within 10% of the labeled potency at all times during the assigned expiration date for a preparation. Our results show that low-dose naltrexone is stable for 360 days when stored at room temperature and away from light remaining within 90% to 110% of the labeled potency throughout the study period. Based on our study results, the beyond-use date for compounded low-dose naltrexone formulations stored at room temperature and protected from light can be extended to 1 year. The longer beyond-use dating allows patients greater flexibility in using these capsules during the flare-ups associated with fibromyalgia without needing a refill immediately at the onset of symptoms. In addition, it may help compounding pharmacies reduce waste associated with small-batch preparation of these capsules.

Low dose naltrexone: side effects and efficacy in gastrointestinal disorders

Ploesser J et al., 2010·International journal of pharmaceutical compounding

1. Int J Pharm Compd. 2010 Mar-Apr;14(2):171-3. side effects and efficacy in gastrointestinal disorders. Ploesser J(1), Weinstock LB, Thomas E. (1)St. Louis College of Pharmacy, St. Louis, Missouri. Use of low dose naltrexone has been advocated for a variety of medical problems. Only a few articles published in peer review effects of low dose naltrexone. The purpose of this frequency of adverse effects of low dose naltrexone treated for a variety of gastrointestinal disorders. to determine global efficacy in a retrospective survey. Patients (206) single gastroenterologist's clinical practice who were mailed a survey to evaluate the side effects and efficacy of naltrexone. Patients had either irritable bowel syndrome intestinal bacterial overgrowth, chronic idiopathic constipation, or inflammatory bowel disease. Patients with diarrhea were given 2.5 mg daily, constipation 2.5 mg twice daily, and inflammatory bowel disease 4.5 mg daily. In the patients who returned the survey, 47/121 (38.8%) had no side effects. 74/121 (61.2%) patients who had side effects, 58 complaints, and 32 had one or more gastrointestinal side effects. patients with side effects, 24/74 (32.4%) had short lived symptoms. naltrexone was terminated owing to side effects in 20/74 patients (27.0%). In 13 patients with idiopathic irritable bowel syndrome, 2 were markedly worse. In 85 patients with irritable bowel syndrome-small intestinal bacterial overgrowth, 15 were markedly improved, 32 were moderately worse, and 1 was markedly worse. In 12 patients with chronic constipation, 7 were markedly improved, 1 moderately improved, 1 was mildly improved, and 4 were unchanged. naltrexone frequently has side effects but in most is tolerable. be helpful for a member of patients with gastrointestinal disorders. 23965429

"Natural" isomolecular hormone replacement: an evidence-based medicine approach

Drisko JA, 2000·Int J Pharm Compd