Postmenopausal Hormone Therapy

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

Brand Name Generic Name Available Strengths e Estrogen Type of (Dosing Interval for Source 1 Estrogen 1 Topicals) e Estradiol-containing products 2,3,6 Activella estradiol/norethindrone 0.5 mg estradiol and Synthetic Human a U.S. only acetate tablet 0.1 mg norethindrone, generic available 1 mg estradiol and 0.5 mg norethindrone Alora estradiol transdermal 0.025 mg/24 hr, Synthetic Human a U.S. only system 0.05 mg/24 hr, (twice weekly) 0.075 mg/24 hr, 0.1 mg/24 hr Angeliq estradiol/drospirenone 0.5 mg estradiol and Synthetic Human a tablet 0.25 mg drospirenone (U.S.),g 1 mg estradiol and 0.5 mg drospirenone (U.S.), 1 mg estradiol and 1 mg drospirenone (Canada) Climara estradiol transdermal 0.025 mg/24 hr, Synthetic Human a generic system 0.0375 mg/24 hr (U.S. only), available-U.S. (once weekly) 0.05 mg/24 hr, 0.06 mg/24 hr (U.S. only), 0.075 mg/24 hr, 0.1 mg/24 hr Climara Pro estradiol/levonorgestrel 0.045 mg estradiol and Synthetic Human a transdermal system 0.015 mg levonorgestrel/24 hr (once weekly) CombiPatch estradiol/norethindrone 0.05 mg estradiol and Synthetic Human a U.S. only acetate transdermal 0.14 mg norethindrone/24 hr, system 0.05 mg estradiol and (twice weekly) 0.25 mg norethindrone/24 hr Divigel 17-beta-estradiol 0.1% Synthetic Human a U.S. only transdermal gel (0.25 g/packet = 0.25 mg estradiol, (once daily) 0.5 g/packet = 0.5 mg estradiol, 1 g/packet = 1 mg estradiol) Elestrin estradiol gel 0.06% Synthetic Human a U.S. only (once daily) (estradiol 0.53 mg/metered dose) Estrace 17-beta-estradiol, 0.5 mg, 1 mg, 2 mg Synthetic Human a generic micronized tablet available-U.S. Estrace 17-beta-estradiol 0.01% estradiol Synthetic Human a vaginal cream vaginal cream (0.1 mg/gram) U.S. only (varies) Estraderm estradiol transdermal 0.025 mg/24 hr, Synthetic Human a Canada only system 0.1 mg/24 hr generic available (twice weekly)

More. . . Copyright © 2012 by Therapeutic Research Center P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com ~ www.pharmacytechniciansletter.com (PL Detail-Document #280506: Page 2 of 5)

Brand Name Generic Name Available Strengths e Estrogen Type of (Dosing Interval for Source 1 Estrogen 1 Topicals) e Estradiol-containing products,2,3,6 continued Estradot estradiol transdermal 0.025 mg/24 hr, 0.0375 mg/24 hr, Synthetic Human a Canada only system 0.05 mg/24 hr, 0.075 mg/24 hr, (twice weekly) 0.1 mg/24 hr

Estrasorb estradiol topical emulsion 0.25% Synthetic Human a U.S. only (once daily)

Estring 17-beta-estradiol 0.0075 mg/24 hr Synthetic Human a vaginal ring (once every three months)

EstroGel 17-beta-estradiol 0.06% Synthetic Human a micronized gel (estradiol 0.75 mg/metered dose) (once daily) Evamist 17-beta-estradiol Estradiol 1.53 mg/spray Synthetic Human a U.S. only transdermal spray (once daily)

Femhrt ethinyl estradiol/ 0.0025 mg ethinyl estradiol and Synthetic Human a norethindrone acetate 0.5 mg norethindrone (U.S. only), tablet 0.005 mg ethinyl estradiol and 1 mg norethindrone Femring estradiol acetate vaginal 0.05 mg/24 hr, Synthetic Human a U.S. only ring 0.1 mg/24 hr (once every three months) Femtrace estradiol acetate tablet 0.45 mg, 0.9 mg Synthetic Human a U.S. only

Menostar estradiol transdermal 14 mcg/24 hr Synthetic Human a U.S. only system (once weekly) Oesclim estradiol transdermal 0.025 mg/24 hr, Synthetic Human a Canada only system 0.0375 mg/24 hr, (twice weekly) 0.05 mg/24 hr, 0.075 mg/24 hr, 0.1 mg/24 hr Prefest estradiol/norgestimate 1 mg estradiol and Synthetic Human a U.S. only tablet 1 mg estradiol/0.09 mg norgestimate b

estradiol hemihydrate 10 mcg estradiol, Synthetic Human a Vagifem vaginal tablet 25 mcg estradiol (Canada only) (twice weekly) Vivelle-Dot estradiol transdermal 0.025 mg/24 hr, Synthetic Human a U.S. only system 0.0375 mg/24 hr, (twice weekly) 0.05 mg/24 hr, 0.075 mg/24 hr, 0.1 mg/24 hr

(PL Detail-Document #280506: Page 3 of 5)

Brand Name Generic Name Available Strengths e Estrogen Type of (Dosing Interval for Source 1 Estrogen 1 Topicals) e Conjugated estrogens-containing products 2,3,6 C.E.S. synthetic conjugated 0.3 mg, 0.625 mg, 0.9 mg, 1.25 mg Synthetic, Equine Canada only estrogens tablet plant-derived generic available Cenestin synthetic conjugated 0.3 mg, 0.45 mg, 0.625 mg, Synthetic, Equine U.S. only estrogens, A tablet 0.9 mg, 1.25 mg plant-derived Enjuvia synthetic conjugated 0.3 mg, 0.45 mg, 0.625 mg, Synthetic, Equine U.S. only estrogens, B tablet 0.9 mg, 1.25 mg plant-derived PMS- conjugated estrogens 0.3 mg, 0.625 mg, 0.9 mg, 1.25 mg Pregnant mare Equine Conjugated tablet urine-derived Estrogens Canada only Premarin conjugated estrogens 0.3 mg, 0.45 mg (U.S. only), Pregnant mare Equine tablet 0.625 mg, 0.9 mg (U.S. only), urine-derived 1.25 mg Premarin conjugated estrogens 0.625 mg/gram Pregnant mare Equine vaginal cream vaginal cream urine-derived (once daily) Premphase conjugated estrogens/ 0.625 mg conjugated estrogens and Pregnant mare Equine U.S. only medroxyprogesterone 0.625 mg conjugated estrogens/ urine-derived acetate tablet 5 mg medroxyprogesterone c Prempro conjugated estrogens/ 0.3 mg conjugated estrogens and Pregnant mare Equine U.S. only medroxyprogesterone 1.5 mg medroxyprogesterone, urine-derived acetate tablet 0.45 mg conjugated estrogens and 1.5 mg medroxyprogesterone, 0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone, 0.625 mg conjugated estrogens and 5 mg medroxyprogesterone Esterified estrogen-containing products 2,3,6 Covaryx f esterified estrogens/ 1.25 mg esterified estrogens and Synthetic Equine U.S. only methyltestosterone tablet 2.5 mg methyltestosterone generic available Covaryx HS f esterified estrogens/ 0.625 mg esterified estrogens and Synthetic Equine U.S. only methyltestosterone tablet 1.25 mg methyltestosterone generic available Estragyn d estrone vaginal cream 1 mg/gram Synthetic Human a vaginal cream (once daily) soy-derived Canada only Menest esterified estrogens tablet 0.3 mg, 0.625 mg, 1.25 mg, 2.5 mg Synthetic Human a + U.S. only 75% to 85% estrone soy-derived Equine + 6% to 15% equilin

Estropipate-containing products (piperazine estrone sulfate) 2,3,6 Ogen estropipate tablet 0.75 mg ( Ogen .625 ), Synthetic Human a generic 1.5 mg ( Ogen 1.25 ), available-U.S. 3 mg ( Ogen 2.5 )

(PL Detail-Document #280506: Page 4 of 5)

Brand Name Generic Name Available Strengths e Estrogen Type of (Dosing Interval for Source 1 Estrogen 1 Topicals) e 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 Variable Human a estradiol, but can vary by pharmacy Triest 4,5 tri-estrogen Typically 1 mg estriol/0.125 mg Variable Human a estradiol/0.125 mg estrone

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 conjugated estrogens followed by 14 days of 0.625 mg conjugated estrogens 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- 3. Drugs@FDA. Document: Stacy A. Hester, R.Ph., BCPS, http://www.accessdata.fda.gov/scripts/cder/drugsat fda/. (Accessed April 12, 2012). Assistant Editor 4. PL Detail-Document , Bioidentical Hormones. Pharmacist’s Letter/Prescriber’s Letter . October References 2003. 1. North American Menopause Society. Menopause 5. Boothby L, Doering PL, Kipersztok S. Bioidentical practice; a clinician’s guide. Section G. Hormonal hormone therapy: a review. Menopause drugs. October 2007 (Edition 3). 2004;11:356-67. http://www.menopause.org/Portals/0/Content/PDF/ 6. Health Canada. Drug product database online G.pdf. (Accessed April 12, 2012). query. http://webprod.hc-sc.gc.ca/dpd-bdpp/index- 2. Electronic Orange Book. Approved products with eng.jsp. (Accessed April 12, 2012). therapeutic equivalence evaluation. Current 7. Product information for Prefest . Teva. Sellersville, through February 2012. PA 18960. September 2010. http://www.fda.gov/cder/ob/. (Accessed April 12, 8. Product information for Premphase . Wyeth. 2012). 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…

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