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Thank you for entrusting in the compounding services at MD Custom Rx to help meet the unique medication needs of your patients. We are excited to share with you our monthly newsletter and look forward to continuing to be your medication problem solvers. Please don't ever hesitate to let us know how we can be of further assistance to you and your practice.
Sincerely,
John, Dan and Monica |
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Variability in BHRT Study Results
We regularly review the medical literature to most effectively meet the needs of our patients. Recently, there has been a paucity of information on compounded medications, and many of the studies which are published have failed to address key points which are pertinent when evaluating hormone replacement therapy:
- When topical preparations are used, most studies fail to mention the base. Selection of the right base is key to the success of any medication. While a PLO gel may be good for some topical medications, liposomal gels, cosmetic cream bases or specialized HRT bases may be more appropriate for other medications or hormones.
- Studies may report that one dosage form or route of administration is superior to another, without measuring hormone levels using a method that is appropriate for that route of administration (such as saliva or blood spot testing when hormones are administered topically).
- Perhaps the dose needs to be adjusted to provide the body with the same amount of hormones by a different route, which may have inherent advantages (such as topical therapy, which is not subject to first pass hepatic metabolism).
If you have read studies that raise questions or concerns, please contact our compounding pharmacist to discuss.
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Treatment of Postmenopausal Women with Topical Progesterone Creams and Gels
Despite low serum levels following the use of topical progesterone creams and gels, salivary and capillary blood levels are very high and a protective endometrium has been reported in a limited number of studies. According to Frank Stanczyk, PhD, of University of Southern California Keck School of Medicine, long-term studies with topical progesterone creams and gels are likely to provide valuable information for treatment of postmenopausal women.
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Progesterone Levels in Serum, Whole Blood, Saliva, and Capillary Blood
David Zava, PhD of ZRT Laboratory, Beaverton, OR, Frank Stanczyk, PhD et al. conducted a study to investigate the distribution of progesterone in venous whole blood, venous serum, fingertip capillary blood, and saliva after its topical application in both cream and gel formulations.
Postmenopausal women were randomized to receive 80 mg of progesterone cream or gel applied daily for 14 days, crossing over after a 14-day washout. On the last day of each treatment period, venous blood, fingertip capillary blood, and saliva were sampled frequently for 24 hours after the final application.
After progesterone cream or gel application, serum progesterone levels rose gradually, reaching a peak at 9 and 8 hours, respectively. Whole venous blood levels followed a pattern similar to that of serum but were considerably lower. Saliva progesterone showed a peak at 1 and 6 hours after cream and gel application, respectively, and Cmax (maximum drug concentration) was comparable with cream and gel. Saliva AUC (Area Under the Curve, which is directly proportional to the total amount of unchanged drug that reaches systemic circulation) was substantially higher than the corresponding AUC for serum or whole blood. In capillary blood, the AUC was also similar with both cream and gel formulations but was dramatically higher than the corresponding areas under the curve for venous serum and whole blood.
In conclusion, after application of topical progesterone, saliva and capillary blood levels are approximately 10-fold and 100-fold greater, respectively, than those seen in serum or whole blood. High capillary blood and saliva levels indicate high absorption and transport of progesterone to tissues. Reliance on serum levels of progesterone for monitoring topical dose could lead to underestimation of tissue levels and consequent overdose.
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Thyroid Hormone Replacement
Hormone replacement therapy often is focused on hormones such as estrogens, progesterone, DHEA and testosterone, but optimal hormone balance cannot be achieved without correcting thyroid hormone imbalances. The complexity of the relationships can be summarized as follows: menopause may modify the clinical expression of some thyroid diseases, particularly the autoimmune ones; and thyroid function is not directly involved in the pathogenesis of the complications of menopause. However, coronary atherosclerosis and osteoporosis may be aggravated in the presence of hyperthyroidism or hypothyroidism. Also, the effects of postmenopausal estrogen replacement on thyroxine requirements in women with hypothyroidism should be considered.
Thyroid hormone (T4, thyroxine) is produced by the thyroid gland in response to the release of thyroid stimulating hormone (TSH) from the pituitary gland. Triiodothyronine (T3), the active form of thyroid hormone is produced predominantly outside the thyroid parenchyma secondary to peripheral tissue deiodination of thyroxine (T4), with <20% being secreted directly from the thyroid. In hypothyroidism, either the thyroid's ability to make and release T4, or the body's ability to convert T4 to T3, becomes compromised often showing up in the form of elevated TSH.
With aging, the main changes regarding thyroid physiology and function are a reduction of thyroid iodine uptake, free thyroxine and free triiodothyronine synthesis, and catabolism of free thyroxine while reverse triiodothyronine (R-T3; a non-usable form of T3) increases. The level of thyroid stimulating hormone remains normal with sometimes a tendency to higher limits. These changes are present in both sexes without distinction.
The original form of thyroid hormone replacement was desiccated thyroid extract (Armour ThyroidŽ) which contained both T4 and T3 and was the only available treatment for hypothyroidism for almost 50 years. Levothyroxine sodium is synthetic form of T4 and has replaced desiccated thyroid for the treatment of primary hypothyroidism with the aim of relieving symptoms and normalizing serum TSH. Many physicians note that despite apparently adequate replacement therapy with levothyroxine, some hypothyroid patients remain symptomatic. Studies suggest that replacement therapy for hypothyroidism with levothyroxine alone does not ensure normal thyroid levels in all tissues, and that a combination of levothyroxine and T3 may be required for optimal thyroid replacement therapy. However, the only commercially available form of T3 for replacement therapy is synthetic liothyronine sodium. This immediate release formulation is rapidly absorbed and may result in higher than normal T3 concentrations throughout the body, causing serious side effects including heart palpitations. Because immediate release T3 is quickly metabolized, replacement of T3 with synthetic liothyronine requires multiple daily doses. Due to dosing problems and the significant potential for side effects, typically liothyronine is prescribed only in exceptional circumstances. Research indicates there is a need for sustained-release T3 preparations in order to avoid adverse cardiac effects. A study published in the New England Journal of Medicine reported that treatment with T4 plus T3 improved the quality of life for most hypothyroid patients.
Our compounding professionals work together with patients and their health care providers to customize medications in the specific strength and dosage form that is most appropriate to meet each patient's specific needs and solve medication problems. We welcome your questions.
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 At this Holiday Season, our thoughts turn gratefully to those who have made our progress possible. With Gratitude, have a very Merry Christmas and a Blessed New Year,
Dan, Monica & John
Please make note of our holiday hours:
Dec. 24th 9:30am - 1:00pm
Dec. 25th CLOSED
Dec. 26th 9:30am - 6:00pm
Dec. 31st 9:30am - 6:00pm
Jan. 1st CLOSED |
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