PL Detail-Document #280506 This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER May 2012 Postmenopausal Hormone Therapy Brand Name Estradiol-containing products 2,3,6 Activella Alora Angeliq Climara Climara Pro CombiPatch Divigel Elestrin Estrace Estrace Estraderm estradiol/norethindrone acetate estradiol/drospirenone estradiol/levonorgestrel transdermal estradiol/norethindrone acetate transdermal transdermal gel estradiol gel, micronized (varies) 0.5 mg estradiol and 0.1 mg norethindrone, 0.5 mg norethindrone 0.5 mg estradiol and 0.25 mg drospirenone (U.S.), g 0.5 mg drospirenone (U.S.), 1 mg drospirenone (Canada) 0.0375 mg/24 hr (), 0.06 mg/24 hr (), 0.045 mg estradiol and 0.015 mg levonorgestrel/24 hr 1 0.05 mg estradiol and 0.14 mg norethindrone/24 hr, 0.05 mg estradiol and 0.25 mg norethindrone/24 hr 0.1% (0.25 g/packet = 0.25 mg estradiol, 0.5 g/packet = 0.5 mg estradiol, 1 g/packet = 1 mg estradiol) 0.06% (estradiol 0.53 mg/metered dose) 0.5 mg, 1 mg, 2 mg 0.01% estradiol (0.1 mg/gram)
(PL Detail-Document #280506: Page 2 of 5) Brand Name Estradiol-containing products, 2,3,6 continued Estradot 0.0375 mg/24 hr, 1 Estrasorb Estring EstroGel Evamist estradiol topical emulsion vaginal ring (once every three months) micronized gel transdermal spray 0.25% 0.0075 mg/24 hr 0.06% (estradiol 0.75 mg/metered dose) Estradiol 1.53 mg/spray Femhrt Femring Femtrace ethinyl estradiol/ norethindrone acetate estradiol acetate vaginal ring (once every three months) 0.0025 mg ethinyl estradiol and 0.5 mg norethindrone (), 0.005 mg ethinyl estradiol and 1 mg norethindrone estradiol acetate 0.45 mg, 0.9 mg Menostar Oesclim Prefest estradiol/norgestimate 14 mcg/24 hr 0.0375 mg/24 hr, 1 mg estradiol/0.09 mg norgestimate b Vagifem Vivelle-Dot estradiol hemihydrate vaginal 10 mcg estradiol, 25 mcg estradiol () 0.0375 mg/24 hr,
(PL Detail-Document #280506: Page 3 of 5) Brand Name Conjugated estrogens-containing products 2,3,6 C.E.S. Cenestin Enjuvia PMS- Conjugated s Premarin Premarin Premphase Prempro estrogens estrogens, A estrogens, B / medroxyprogesterone acetate / medroxyprogesterone acetate Esterified estrogen-containing products 2,3,6 Covaryx f esterified estrogens/ methyltestosterone Covaryx HS f Estragyn d Menest esterified estrogens/ methyltestosterone estrone esterified estrogens 75% to 85% estrone + 6% to 15% equilin 0.3 mg, 0.625 mg, 0.9 mg, 1.25 mg, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, 1.25 mg, 0.3 mg, 0.45 mg, 0.625 mg,, 0.9 mg, 1.25 mg 0.3 mg, 0.625 mg, 0.9 mg, 1.25 mg 0.3 mg, 0.45 mg (), 0.625 mg, 0.9 mg (), 1.25 mg 0.625 mg/gram 0.625 mg and 0.625 mg / 5 mg medroxyprogesterone c 0.3 mg and 1.5 mg medroxyprogesterone, 0.45 mg and 1.5 mg medroxyprogesterone, 0.625 mg and 2.5 mg medroxyprogesterone, 0.625 mg and 5 mg medroxyprogesterone 1.25 mg esterified estrogens and 2.5 mg methyltestosterone 0.625 mg esterified estrogens and 1.25 mg methyltestosterone 1 mg/gram soy-derived 0.3 mg, 0.625 mg, 1.25 mg, 2.5 mg soy-derived 1 + Estropipate-containing products (piperazine estrone sulfate) 2,3,6 Ogen estropipate 0.75 mg (Ogen.625), 1.5 mg (Ogen 1.25), 3 mg (Ogen 2.5)
Brand Name (PL Detail-Document #280506: Page 4 of 5) 1 Compounded estrogen products (See FDA statement concerning the unapproved drug ESTRIOL [http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm183088.ht m]) Biest 4,5 bi-estrogen Typically 2 mg estriol/0.5 mg estradiol, but can vary by pharmacy Triest 4,5 tri-estrogen Typically 1 mg estriol/0.125 mg estradiol/0.125 mg estrone Variable Variable a. Human or bioidentical implies exogenous hormones that are identical to endogenous hormones found in humans. b. Regimen consists of continuous cycles of three days of 1 mg estradiol followed by three days 1 mg estradiol and 0.09 mg norgestimate. 7 c. Regimen consists of continuous cycle of 14 days of 0.625 mg followed by 14 days of 0.625 mg and 5 mg medroxyprogesterone. 8 d. Formerly marketed as Neo-Estrone by Neolab. e. Dose frequency and formulation information from most current product labeling at time of publication. f. Considered an unapproved drug by the FDA. g. New low-dose Angeliq (0.5/0.25) is expected to be available in the U.S. summer 2012. Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and internet links in this article were current as of the date of publication.
(PL Detail-Document #280506: Page 5 of 5) Project Leader in preparation of this PL Detail- Document: Stacy A. Hester, R.Ph., BCPS, Assistant Editor References 1. North American Menopause Society. Menopause practice; a clinician s guide. Section G. Hormonal drugs. October 2007 (Edition 3). http://www.menopause.org/portals/0/content/pdf/ G.pdf. (Accessed April 12, 2012). 2. Electronic Orange Book. Approved products with therapeutic equivalence evaluation. Current through February 2012. http://www.fda.gov/cder/ob/. (Accessed April 12, 2012). 3. Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/drugsat fda/. (Accessed April 12, 2012). 4. PL Detail-Document, Bioidentical Hormones. Pharmacist s Letter/Prescriber s Letter. October 2003. 5. Boothby L, Doering PL, Kipersztok S. Bioidentical hormone therapy: a review. Menopause 2004;11:356-67. 6. Health Canada. Drug product database online query. http://webprod.hc-sc.gc.ca/dpd-bdpp/indexeng.jsp. (Accessed April 12, 2012). 7. Product information for Prefest. Teva. Sellersville, PA 18960. September 2010. 8. Product information for Premphase. Wyeth. Philadelphia, PA 19101. May 2011. Cite this document as follows: PL Detail-Document, Postmenopausal Hormone Therapy. Pharmacist s Letter/Prescriber s Letter. May 2012. Evidence and Recommendations You Can Trust 3120 West March Lane, P.O. Box 8190, Stockton, CA 95208 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249 Subscribers to the Letter can get PL Detail-Documents, like this one, on any topic covered in any issue by going to www.pharmacistsletter.com, www.prescribersletter.com, or www.pharmacytechniciansletter.com