Estradiol Valerate)

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Injectable Delestrogen (Estradiol Valerate) Do not refrigerate this medication This medication is packaged with 1 vial of liquid Roll the bottle between your hands to loosen the liquid Peel the plastic covering that is around the top of the vial Clean the rubber stopper with alcohol Using a 1cc/ml syringe with a 1 ½” needle (make sure the needle is on securely) Pull the plunger back to your recommended dose With the needle pointing up, the top line of the black piece should be at your recommended dose (your nurse will instruct you on the dose that you are to take) Carefully remove the cap from the needle Insert the needle through the rubber stopper of the vial Invert the vial and pull the tip of your needle down close to the rubber stopper Push on the plunger injecting air into the vial Withdraw your recommended dose of delestrogen by pulling back slowly on the plunger (the liquid is thick go slow) Pull back past the recommended dose then push back up to the dose Remove the needle from the vial With the needle pointing up, pull back on the plunger to leave airspace at the top Recap and remove the needle Replace it with a new 1 ½ ’’needle Slowly push on the plunger to remove the airspace (until you see a drop at the top of the needle) Snap on any air bubbles to remove them (snap out what you can and do not worry about the rest they will not hurt you) Delestrogen is for intramuscular injection only Inject into the Muscle located in the upper outer quadrant of the buttocks Cleanse the area with alcohol, let the alcohol dry (do not blow on it) Hold the syringe like a pencil or a dart, the needle should be approximately 1 inch away from the skin, insert the entire needle quickly straight into skin (not hard but quick) Pull back slightly on the plunger (if no blood appears proceed if blood does appear remove the needle, replace it with a new needle and move your injection site slightly to the right or left) Inject the medication slowly Remove the needle and place entire syringe into a sharps container Wipe with gauze to remove blood from surface blood vessel and massage area to help dissipate the medication If you have any questions please contact Patient Educational Services at 781-434-6524 F-PE-5019 Rev. 0 .

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PRESCRIBING INFORMATION OGEN* (Estropipate) Tablets 0.75 Mg, 1.5
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HIGHLIGHTS of PRESCRIBING INFORMATION These Highlights Do
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights -----------------------WARNINGS AND PRECAUTIONS----------------------- do not include all the information needed to use ESTRADIOL VALERATE TABLETS, AND ESTRADIOL VALERATE AND DIENOGEST TABLETS safely and effectively. See full prescribing x 9DVFXODU ULVNV 6WRS HVWUDGLRO YDOHUDWH WDEOHWV DQG HVWUDGLRO YDOHUDWH information for ESTRADIOL VALERATE TABLETS, AND DQG GLHQRJHVW WDEOHWV LI D WKURPERWLF HYHQW RFFXUV 6WRS HVWUDGLRO ESTRADIOL VALERATE AND DIENOGEST TABLETS. YDOHUDWH WDEOHWV DQG HVWUDGLRO YDOHUDWH DQG GLHQRJHVW WDEOHWV DW OHDVW ZHHNV EHIRUH DQG WKURXJK ZHHNV DIWHU PDMRU VXUJHU\ 6WDUW HVWUDGLRO ESTRADIOL VALERATE tablets, and ESTRADIOL VALERATE and YDOHUDWH WDEOHWV DQG HVWUDGLRO YDOHUDWH DQG GLHQRJHVW WDEOHWV QR HDUOLHU DIENOGEST tablets, for oral use WKDQ ZHHNV DIWHU GHOLYHU\ LQ ZRPHQ ZKR DUH QRW EUHDVWIHHGLQJ x /LYHU GLVHDVH 'LVFRQWLQXH HVWUDGLRO YDOHUDWH WDEOHWV DQG Initial U.S. Approval: 2010 HVWUDGLRO YDOHUDWH DQG GLHQRJHVW WDEOHWV LI MDXQGLFH RFFXUV x +LJK EORRG SUHVVXUH 'R QRW SUHVFULEH HVWUDGLRO YDOHUDWH WDEOHWV WARNING: CIGARETTE SMOKING AND SERIOUS DQG HVWUDGLRO YDOHUDWH DQG GLHQRJHVW WDEOHWV IRU ZRPHQ ZLWK CARDIOVASCULAR EVENTS XQFRQWUROOHG K\SHUWHQVLRQ RU K\SHUWHQVLRQ ZLWK YDVFXODU See full prescribing information for complete boxed warning. GLVHDVH x Women over 35 years old who smoke should not use estradiol x &DUERK\GUDWH DQG OLSLG PHWDEROLF HIIHFWV 0RQLWRU SUHGLDEHWLF valerate tablets, and estradiol valerate and dienogest tablets. DQG GLDEHWLF ZRPHQ WDNLQJ HVWUDGLRO
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A Pharmaceutical Product for Hormone Replacement Therapy Comprising Tibolone Or a Derivative Thereof and Estradiol Or a Derivative Thereof
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Delestrogen® (Estradiol Valerate)
Delestrogen® (estradiol valerate) – Drug Shortage • The drug shortage of Par’s Delestrogen (estradiol valerate) and Perrigo’s generic estradiol valerate injection products are ongoing. Both products have been unavailable for at least 90 days. — Estimated availability of Delestrogen is the first quarter of 2017. — Estimated availability of generic estradiol valerate 20 mg/mL injection is early November 2016. Estimated availability of estradiol valerate 40 mg/mL injection is mid-November 2016. • Delestrogen is indicated for the following: — Treatment of moderate to severe vasomotor symptoms associated with the menopause. — Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. — Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. — Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Manufacturer Product Description Strength NDC# 10 mg/mL (5 mL); 42023-110-01; Delestrogen (estradiol valerate) 20 mg/mL (5 mL); Par 42023-111-01; injection 40 mg/mL (5 mL) 42023-112-01 multiple dose vials 20 mg/mL (5 mL); 0574-0870-05; Perrigo Estradiol valerate injection 40 mg/mL (5 mL) 0574-0872-05 multiple dose vials Action Plan • Information about the long-term drug shortage of Delestrogen and estradiol valerate injection will be communicated with clients. Formulary changes may be made, as appropriate. • Information regarding Delestrogen and estradiol valerate injection will be posted on the optumrx.com portals. optumrx.com OptumRx® specializes in the delivery, clinical management and affordability of prescription medications and consumer health products.
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Original Article Obstet Gynecol Sci 2016;59(1):32-38 http://dx.doi.org/10.5468/ogs.2016.59.1.32 pISSN 2287-8572 · eISSN 2287-8580 Effects of different add-back regimens on hypoestrogenic problems by postoperative gonadotropin-releasing hormone agonist treatment in endometriosis Dong-Yun Lee, Hyang Gi Park, Byung-Koo Yoon, DooSeok Choi Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea Objective To compare the efficacy of different add-back regimens on hypoestrogenic symptoms during postoperative gonadotropin-releasing hormone (GnRH) agonist treatment in endometriosis patients. Methods This prospective cohort study included reproductive-aged women who underwent conservative laparoscopic surgery for ovarian endometriosis and received add-back therapy during a 6-month course of GnRH agonist therapy after surgery. Participants received one of four different add-back regimens: 1 mg of estradiol valerate, 2.5 mg of tibolone, or a combination of 1 mg of estradiol and 2 mg of drospirenone or 0.5 mg of norethisterone acetate. Changes in quality of life, hypoestrogenic symptoms, and bone mineral density were compared according to add-back regimens. Results A total of 57 participants completed a 6-month course of GnRH agonist and add-back therapy. All components of quality of life did not differ across groups. However, within the same treatment group, social relationship factors decreased significantly with estradiol valerate and tibolone alone, and environmental factors decreased significantly with estradiol valerate alone. Menopausal Rating Scale score did not change significantly, but the incidence of hot flushes significantly decreased with a combination of estradiol and norethisterone acetate.
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SDS Will Be Revisited As More Data Become Available
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