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Rachel Picone, MS, APRN, WHNP-BC Identify indications, mechanism of action (MOA), adverse effects (AE) for androgens, estrogens and progestins Identify MOA, AE for medications used in erectile dysfunction Identify indications, MOA, AE for selected medications used during pregnancy, labor and birth Not responsible for GnRH analogs on the test! Male sex hormones testosterone and androsterone Induce masculinization by acting on target receptors in tissues Synthetic androgens are indicated in the treatment of: ◦ Hypogonadism (congenital or acquired) ◦ FTM transgendered persons desiring to transition hormonally ◦ Palliative treatment of advanced breast cancer in women ◦ Severe fibrocystic breast disease Edema Acne Sexual changes Decreased sperm production Gynecomastia Hirsutism Liver dysfunction Premature fusion of epiphyseal plates (stunting) Mood changes Increased LDL, decreased HDL Insulin resistance Illegal anabolic steroid use: psychosis, violence Danocrine (danazol) 100-400mg PO BID Android, Testred (methyltestosterone) PO, buccal Estratest (methylytestosterone w/ estrogen) PO Oxandrin (oxandrolone) PO 2.5-20 mg/day divided doses Depo-Testosterone (testosterone) IM, implant, buccal* Androderm, AndroGel (testosterone) transdermal patch, gel* *used in transgender therapy Indicated in treatment of erectile dysfunction MOA: smooth muscle relaxation, vasodilation Viagra (sildenafil) 50 mg po 1h before sex Levitra (vardenafil) 10 mg po before sex or 2.5mg po daily Cialis (tadalafil) 10 mg po 1h before sex Max frequency for all: once daily! Adverse Effects: ◦ Headache, flushing, hearing and vision changes, dizziness, tinnitus, nasal congestion, back pain ◦ Cardiovascular events (less than 2%): angina, syncope, tachycardia, hypotension Caution in: Concurrent use of nitrates, alpha-blockers Patients with cardiovascular disease Erection > 4hrs is a medical emergency! Female sex hormone responsible for feminization Important in menstrual cycle and pregnancy Important component in combined hormonal contraceptives Used in menopausal therapy (including surgically or radiation-induced menopause) MTF transgendered persons desiring to transition hormonally Hypogonadism Landmark 2002 study Postmenopausal estrogen therapy increases risk of heart attack, breast cancer, stroke and clot Estrogen should not be used to prevent cardiovascular disease Women with an intact uterus should not take systemic estrogen-only therapy due to risk of uterine cancer Women should take the smallest effective dose for the shortest possible time and annually review the decision with a provider Nausea Acne Increased triglycerides Liver abnormalities Changes in vaginal bleeding Increased headaches Visual changes Mood changes Breast tenderness Increased risk of gallbladder disease Increased risk of clot/VTE, stroke, MI Endometrial hyperplasia, cancer See contraceptive presentation! For relief of vasomotor sx and vaginal atrophy associated w/ menopause: Premarin (conjugated estrogen) PO Prempro, Premphase (conjugated estrogen w/ medroxyprogesterone) CombiPatch (estradiol/norethindrone) transdermal Estrace* (micronized estrogen) tablet or intravaginal cream Femring, Estring (estradiol) vaginal rings Estrasorb, EstroGel (estradiol) topical gel Vagifem (estradiol) intravaginal tablet Climara, Vivelle (estradiol) transdermal patches *used in transgender care Used to treat abnormal uterine bleeding Important component in combined hormonal contraception, or may be used alone for contraception Some use in postmenopausal therapy Breast and uterine cancer treatment Adjuvant therapy in cancer and AIDS as an appetite stimulant Menstrual irregularities Weight gain Edema Nausea Breast tenderness, nipple discharge Headache Mood changes Clot/VTE Decreased bone density with prolonged use See contraceptive presentation! Depo-Provera IM or SC Megace (megestrel) oral suspension Category A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Category C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Category D There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Category X Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. FDA Pregnancy Risk Categories. http://chemm.nlm.nih.gov/pregnancycategories.htm Pitocin (oxytocin) IV or IM Used to induce labor Stimulates uterine contractions In uterine atony or subinvolution, helpts uterus to contract and stop hemorrhage Risks include uterine rupture, placental abruption, fetal hypoxia and trauma, fetal death, amniotic fluid embolism, cervical laceration Prostin E2, Cervidil, Prepidil (dinoprostone, prostaglandin E2) Cytotec (misoprostol, prostaglandin E1 analog) : off label use, FDA-approved as a stomach ulcer treatment Used for cervical ripening in the induction of labor Used to stimulate uterine contractions in elective or therapeutic abortions “the abortion pill” Antiprogesterone used with misoprostol in medication abortions before 9 weeks Blocks the action of progesterone, which supports placenta and maintains pregnancy FDA-approved up to 49 days gestation (7 wks) for medication abortion with misoprostolrequires 3 visits High-quality clinical studies show that use up to 63 days (9 wks) with misoprostol taken at home is more efficacious with fewer side effectsrequires only 2 visits Methergine®, oral or injectable, IV Ergot alkaloid used in prevention and treatment of postpartum and postabortion hemorrhage MOA: uterine stimulant Not recommended prior to delivery of placenta, may cause retained placenta SE: nausea, vomiting, dizziness, headache, dyspnea, cardiac symptoms Tocolytic Classified as a bronchodilator, used off-label in preterm labor MOA: sympathomimetic action inhibits uterine contractions via smooth muscle relaxation Used in preterm labor with varying success May be used to buy more time for maternal betamethasone injections to enhance fetal lung maturity SE: tremors, tachycardia, headache, nausea Treatment of preeclampsia or eclampsia for prevention or control of seizures MOA: CNS depressant, blocks neuromuscular transmission, vasodilator, lowers BP AE: CNS depression, flaccid paralysis, circulatory collapse, severe hypotension, respiratory paralysis Contraindicated in heart block! Antidote: calcium gluconate IV Centers for Disease Control U.S. Medical Eligibility for Contraceptive Use (CDC US MEC) http://www.cdc.gov/reproductivehealth/Uninte ndedPregnancy/USMEC.htm Drugs and Lactation Database (LactMed) http://toxnet.nlm.nih.gov/cgibin/sis/htmlgen?LACT American College of Obstetrics and Gynecologists (ACOG). (2005). Medical management of abortion. National Guideline Clearinghouse. Accessed at www.guidelines.gov Woodrow, R., Colbert, B., & Smith, D. (2011). Essentials of pharmacology for health occupations. Clifton Park, NY: Delmar Cengage Learning. U.S. Department of Health and Human Services. (2008). FDA pregnancy risk categories. Accessed at http://chemm.nlm.nih.gov/pregnancycategories.ht m