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perchance Dermasorb AF Generic Name: clioquinol and hydrocortisone Dosage Form: cream with hydrating gel kit Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pricing & Coupons Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Dermasorb AF COMPLETE KIT Dermasorb AF Description Iodochlorhydroxyquin (Clioquinol) is an antifungal agent and a member of a family of drugs called hydroxyquinolines. Chemically, Iodochlorhydroxyquin is 5-chloro-7-iodo-quinolin-8-ol. Its structural formula is: The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3,20-dione, 11, 17,21-trihydroxy, (11β)- Its structural formula is: Each gram of Dermasorb AF contains 5mg Hydrocortisone USP and 30mg Iodochlorhydroxyquin USP in a cream base consisting of water, cetyl alcohol, stearyl alcohol, cetyl palmitate, sorbic acid, sodium lauryl sulfate, glycerin, and polysorbate-80. Slideshow Inherited Risk: The BRCA Gene Explained Dermasorb AF - Clinical Pharmacology Iodochlorhydroxyquin is a broad-spectrum antibacterial and antifungal. Its precise mechanism of action is unknown. Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and some evidence suggests a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of the topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE: Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows: Possibly effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; infantile eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation. CONTRAINDICATIONS: Risk-benefit should be considered when the following medical problems exist: Intolerance to iodochlorhydroxyquin, hydrocortisone, chloroxine, iodine, iodine-containing preparations, or related compounds Herpes simplex, vaccinia, eczema vaccinia, varicella, or other viral infections of the skin PRECAUTIONS: General Staining of skin and fabrics may occur. Additionally, there are rare reports of discoloration (yellowing) of hair and nails. Iodochlorhydroxyquin-Hydrocortisone may prove irritating to sensitized skin in rare cases. If irritation occurs, discontinue therapy. Check with physician if no improvement within 1 to 2 weeks. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing s syndrome, hyperglycemia, and glucosuria in some patients. Signs and symptoms of systemic toxicity, electrolyte imbalance, or adrenal suppression have not been reported with Iodochlorhydroxyquin-Hydrocortisone. Nevertheless, the possibility of suppression of the HPA axis during therapy should be kept in mind, especially when the drug is used under occlusive dressings, for a prolonged period, or for treating extensive cutaneous areas since significant absorption of corticosteroid may occur under these conditions, particularly in children and infants. Patients receiving a large dose of a potent topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. Iodochlorhydroxyquin may be absorbed through the skin and interfere with thyroid function test. Iodochlorhydroxyquin may cause significant elevation of protein-bound iodine (PBI) or butanol-extractable iodine (BEI) and a decrease in radioactive iodine (RAI) uptake. If such tests are contemplated, wait at least one month between discontinuation of therapy and performance of these tests. Prolonged use may result in overgrowth of nonsusceptible organisms requiring appropriate therapy. In the presence of systemic infections, appropriate systemic antibiotics should be used. Information for the Patient Patients using Iodochlorhydroxyquin-Hydrocortisone should receive the following information and instructions: 1. This medication is to be used as directed by the physician. 2. This medication is for external use only. Do not use in or around the eyes. This product is not for ophthalmic use. 3. Patients should be advised not to use this medication for any disorder other than for which it is prescribed. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. Laboratory Tests The following tests may be helpful in evaluating HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their use in pregnant women has not been absolutely established. Use of large amounts or for prolonged periods of time is not recommended since systemic absorption may occur. In laboratory animals, increases in incidence of fetal abnormalities have been associated with exposure of gestating females to topical corticosteroids, in some cases at rather low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Therefore, drugs of this class should not be used extensively on pregnant patients in large amounts or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of this drug could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when this class of drug is administered to a nursing woman. Pediatric Use Use is not recommended for infants or children up to 2 years of age. Iodochlorhydroxyquin may produce false-positive ferric chloride test results for phenylketonuria (PKU) if iodochlorhydroxyquin is present in the neonate s diaper or urine. Special care must be exercised in using this drug in a pediatric patient. It is recommended that only low-potency topical corticosteroids that are not fluorinated and that have a free 17-hydroxyl group be used in children unless there is a very specific indication for one of the other topical corticosteroids. As a general rule, pediatric therapy continuing for longer than 2 weeks and consisting of doses in excess of 2 daily applications (with low-potency corticosteroids) should be carefully evaluated by the physician. This is especially important if medication is applied to more than 5-10% of the body surface or if an occlusive dressing is used. A tight-fitting diaper or one covered with plastic pants may constitute an occlusive dressing. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. ADVERSE REACTIONS: There have been a few reports of rash and hypersensitivity as well as thinning of the skin with easy bruising. The following local adverse reactions have also been reported with topical corticosteroids and iodochlorhydroxyquin especially under occlusive dressings; burning; itching; irritation; dryness; folliculitis; blistering, peeling, redness, swelling; hypertrichosis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; maceration of the skin, secondary infection; skin atrophy; striae; miliaria or other signs of irritation not present before therapy. Discontinue therapy if any untoward reaction occurs. DOSAGE AND ADMINISTRATION: Apply a thin layer to the affected area 3 or 4 times daily. PACKAGING AND STORAGE: Store at room temperature 15 C- 30 C (59 F - 86 F) in original container. Protect from freezing. HOW SUPPLIED: DERMASORB AF (Hydrocortisone USP, 0.5%, Iodochlorhydroxyquin USP, 3%) Cream is supplied in: 1 ounce tube NDC 0316-1025-01 Rx Only PRINTED IN USA P6179.01 Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN, 37604 Dermasorb AF Complete Kit p618001 Established Pharmacological Class Substance Pharmacological Class Dermasorb Hydrating Serum Lotions, Oils, Powders, and Creams Dermasorb AF COMPLETE KIT clioquinol and hydrocortisone cream with hydrating gel kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0316-1025 Packaging # Item Code Package Description 1 NDC:0316-1025-01 1 KIT in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 28.4 g Part 2 1 TUBE 114 g Part 1 of 2 Dermasorb AF clioquinol and hydrocortisone cream cream Product Information Item Code (Source) NDC:0316-0203 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 5 mg in 1 g CLIOQUINOL (CLIOQUINOL) CLIOQUINOL 30 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER CETYL ALCOHOL GLYCERIN STEARYL ALCOHOL POLYSORBATE 80 SODIUM LAURYL SULFATE CETYL PALMITATE SORBIC ACID Packaging # Item Code Package Description 1 NDC:0316-0203-01 1 TUBE in 1 KIT 1 28.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/14/2013 Part 2 of 2 DERMASORB HYDRATING SERUM Product Information Ingredients Ingredient Name Quantity WATER UREA PROPYLENE GLYCOL CYCLOMETHICONE 5 CYCLOMETHICONE PEG/PPG-18/18 DIMETHICONE GLUCONOLACTONE AMMONIUM GLYCOLATE GLYCOLIC ACID DIMETHICONOL (40 CST) ARGININE CHLORPHENESIN PHENOXYETHANOL CAPRYLYL GLYCOL AMMONIA Packaging # Item Code Package Description 1 1 TUBE in 1 KIT 1 114 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/14/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/14/2013 Labeler - Crown Laboratories (079035945) Registrant - Crown Laboratories (079035945) Establishment Name Address ID/FEI Operations Crown Laboratories 079035945 manufacture(0316-1025) Revised: 11/2013 Crown Laboratories Next Interactions Print this page Add to My Med List More about Dermasorb AF (clioquinol / hydrocortisone topical) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Consumer resources Dermasorb AF Dermasorb AF Complete Kit Topical (Advanced Reading) Professional resources Other brands: Ala-Quin Other Formulations Dermasorb XM Dermasorb HC} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More Dermasorb AF Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } really fizzling out


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generally September 14, 2017 By Nadia Ghaffari, Founder of TeenzTalk.org We all remember the challenges and difficulties of high school even before the internet and social media! Raising a child today is hard; it doesn t come with a manual, and often, we feel like we are winging it. We know kids today are dealing with heavy subjects cyber-bullying, body shaming, community violence, abuse, neglect, unstable home lives, drug exposure, sexual identity exploration, immigration issues, and more. Kids can be moody, hard to read, and don t always want to talk. Emotions are a basic part of the human experience, but sometimes we struggle with how to deal with them effectively. Kids aren t any different. While access to mental health information is becoming more available in the age of information, we know that there is still a gap in mental health resources and information for teens and young adults. Nadia Ghaffari, Mental Health America s 2017 mPower Award Winner and Founder of TeenzTalk.org , asked the TeenzTalk community what they wish they could tell their younger selves in high school. Here s what they had to say: I would say to my younger self that it's OK if you get a bad grade on a test. If you keep worrying about it, it will prevent you from ever moving past it. You can still succeed in the class with a few bad tests. Communicate openly with your teacher about it and learn from past tests. I wish that I had known that fighting depression would be the hardest battle I d have to fight. I convinced my parents that it was imperative that I get counseling, and I went to a psychiatrist in early sophomore year. I wish I had known that I m worth more than a grade, a test score, or an award. This is what I would say to my younger self: you are worthy and your journey deserves to be heard. If I was to talk to my younger freshman self, I would say self-worth does not come from an Instagram like , a compliment, a grade, or a boy liking you. Confidence comes from yourSELF about your body, about recognizing your negative and positive qualities, about your genuine interests, and about your potential. I wish I knew that there was no need to compare myself to anyone. Instead my cares should have been reserved for what was important and mattered to me in my life. This became nurtured with changing my negative mentality into a positive outlook of wanting to be my best self. Accomplishments don t define you; overcoming insecurities and challenges is what builds character. I wish [teachers and parents] knew that my struggles can t be clearly explained in words. Sometimes emotions are so strong that they control everything I do, and I don t really have a say. In these times, please be patient with me. It s hard to know how to approach a young person who is struggling with issues you may not understand or relate to. However, it s important not to ignore it. Encourage communication, let that person know that they can talk to you, and provide them with an environment that is safe and supportive. Listen. Try not to overreact. And remember what it was like to be a teenager. Oftentimes they need your help, but don t know quite how to ask for it. Be patient, but address serious issues head-on. By providing supportive environments and teaching children and teens to recognize their emotions and address them in healthy ways, we can change lives. Need some tips on starting the conversation? Check out MHA s tools for parents and teens: Talking To Adolescents and Teens: Starting The Conversation Time To Talk: Talking To Your Parents Mental Health America s 2017 Back to School Toolkit aims to increase emotional intelligence and self-regulation through materials for parents, school personnel, and young people. Visit www.mentalhealthamerica.net/back-school to learn more. If you think your child is going through emotional or behavioral issues, MHA has an online screen that parents can take to see if their child is at risk at www.mhascreening.org and tips and information to help you get started with that important conversation with your child here . There are also serious signs that someone is in crisis and needs more immediate help. These include thoughts or plans of hurting oneself or another person. If you or someone you know is in crisis, call 1-800-273-TALK (8255), text MHA to 741-741 or call 911. Tags: back to school teens teenagers youth quotes kids emotional intelligence emotions matter BTS parents teachers depression Mental Health America Blog looking forward to


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lack of awareness Estrogens, Conjugated Class: Estrogens ATC Class: G03CA57 VA Class: HS300 Brands: Cenestin, Duavee, Enjuvia, Premarin, Premphase, Prempro Warning(s) Estrogens increase the risk of endometrial cancer in postmenopausal women. 101 104 105 106 107 121 (See Endometrial Cancer under Cautions.) Do not use estrogens with or without progestins for prevention of cardiovascular disease 101 104 105 106 107 121 (see Cardiovascular Risk Reduction under Uses and Cardiovascular Disorders under Cautions) or dementia (see Alzheimer s Disease under Uses). 101 104 105 107 The Women s Health Initiative (WHI) study of estrogen alone reported increased risks of stroke and DVT in postmenopausal women receiving approximately 7 years of therapy with conjugated estrogens 0.625 mg daily. 101 104 105 107 The WHI study of estrogen plus progestin reported increased risks of MI, stroke, invasive breast cancer, pulmonary embolism, and DVT in postmenopausal women receiving ≥5 years of therapy with conjugated estrogens 0.625 mg in conjunction with medroxyprogesterone acetate 2.5 mg daily. 101 104 105 106 107 The WHI Memory Study (WHIMS) reported increased risk of developing probable dementia in postmenopausal women ≥65 years of age receiving long-term therapy (4 5 years) with conjugated estrogens in conjunction with medroxyprogesterone acetate or conjugated estrogens alone. 101 104 105 107 Not known whether this finding also applies to younger postmenopausal women. 101 104 105 107 Other dosages of conjugated estrogens with medroxyprogesterone and other combinations or dosage forms of estrogens with progestin not studied in WHI trials; in the absence of comparable data, assume risks are similar. 101 104 105 107 Prescribe estrogens (with or without progestins) at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. 101 104 105 106 107 Introduction Mixture of estrogens available either as preparations that meet current official USP standards (i.e., conjugated estrogens USP) 101 105 107 108 109 or as nonofficial preparations (i.e., synthetic conjugated estrogens A and synthetic conjugated estrogens B, which are prepared synthetically from plant sources). 106 108 109 121 122 Uses for Estrogens, Conjugated Use of estrogens alone in postmenopausal women generally is referred to as estrogen replacement therapy (ERT); use of estrogens in combination with progestins usually is referred to as hormone replacement therapy (HRT) or postmenopausal hormone therapy. b Another therapeutic option involves use of estrogens in combination with an estrogen agonist-antagonist; this combination referred to as a tissue-selective estrogen complex (TSEC). 263 ERT Management of moderate to severe vasomotor symptoms associated with menopause. 101 106 107 121 262 266 Management of severe vaginal dryness, pain with sexual intercourse, and vulvar and vaginal atrophy associated with menopause. 101 105 106 107 266 If used solely for this indication, consider use of topical vaginal preparations. 101 105 106 107 266 Osteoporosis Prevention of osteoporosis. 100 101 107 262 Used adjunctively with other measures (e.g., diet, calcium, vitamin D, weight-bearing exercise, physical therapy) to retard further bone loss and progression of osteoporosis in postmenopausal women. 100 101 107 Estrogens are effective for prevention of osteoporosis but are associated with a number of adverse effects. 100 101 107 If prevention of postmenopausal osteoporosis is the sole indication for therapy, consider alternative therapy (e.g., alendronate, raloxifene, risedronate). 101 107 112 Has been effective in the treatment of osteoporosis in postmenopausal women. Formerly recommended as first-line therapy; however, recommendations on appropriate use of HRT have been revised based on WHI study findings. (See Boxed Warning.) Evaluate risks and benefits of long-term HRT use in the management of osteoporosis, taking into account the increased risk of breast cancer and cardiovascular disease, availability of other pharmacologic modalities (e.g., alendronate, calcitonin, calcium, raloxifene, risedronate, vitamin D), and life-style factors that can be modified. 101 107 Has been used in a limited number of anorexic women with chronic amenorrhea to reduce calcium loss † and, thereby, reduce risk of osteoporosis. Corticosteroid-induced Osteoporosis Has been used to prevent bone loss in postmenopausal women receiving low- to moderate-dose corticosteroid therapy † . Hypoestrogenism Treatment of hypoestrogenism secondary to hypogonadism, castration, or primary ovarian failure. 101 Used for induction of puberty in adolescents with pubertal delay due to hypogonadism. 101 Metastatic Breast Carcinoma Palliative treatment of metastatic breast cancer in selected women and men. 101 One of several second-line agents. a Prostate Carcinoma Palliative treatment of advanced androgen-dependent prostate carcinoma. 101 Abnormal Uterine Bleeding Treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology. 104 Cardiovascular Risk Reduction † ERT or HRT does not decrease the incidence of cardiovascular disease. 101 105 106 107 AHA, American College of Obstetricians and Gynecologists, FDA, and manufacturers recommend that hormone therapy not be used to prevent heart disease in healthy women (primary prevention) or to protect women with preexisting heart disease (secondary prevention). Alzheimer s Disease Prior use of HRT, but not current HRT unless such use exceeds 10 years, associated with reduced risk of Alzheimer s disease † . Estrogens have not been shown to prevent progression of Alzheimer s disease; American Academy of Neurology recommends that estrogens not be used for treatment of Alzheimer s disease. Initiation of ERT or HRT in women ≥65 years of age not associated with an improvement in cognitive function. Some women receiving ERT or HRT experience detrimental effects. Incidence of probable dementia in women receiving ERT or HRT was higher than that in women receiving placebo. (See Boxed Warning.) Use of ERT or HRT to prevent dementia or cognitive decline in women ≥65 years of age is not recommended. Postpartum Breast Engorgement Used in the past for prevention of postpartum breast engorgement † ; FDA has withdrawn approval of estrogen-containing drugs for this indication, since estrogens have not been shown to be safe for this use. 110 (See Lactation under Cautions.) Pregnancy Not effective for any purpose during pregnancy; use contraindicated in pregnant women. 101 104 105 106 107 121 (See Pregnancy under Cautions.) Estrogens, Conjugated Dosage and Administration General A progestin generally is added to estrogen therapy (HRT) in women with an intact uterus. 101 104 105 107 121 Addition of a progestin for ≥10 days per cycle of estrogen or daily with estrogen reduces incidence of endometrial hyperplasia and attendant risk of endometrial carcinoma in women with an intact uterus. 101 104 105 107 121 As an alternative to progestin, use of bazedoxifene (an estrogen agonist-antagonist) in fixed combination with conjugated estrogens reduces risk of endometrial hyperplasia. 261 262 263 ERT is appropriate in women who have undergone a hysterectomy (to avoid unnecessary exposure to progestins). 101 104 105 107 121 Administration Conjugated estrogens USP usually administered orally; may also administer intravaginally or by deep IM or slow IV injection. 101 104 105 107 Administer synthetic conjugated estrogens A and synthetic conjugated estrogens B orally. 106 121 Estrogen therapy generally is administered in a continuous daily dosage regimen or, alternatively, in a cyclic regimen. 101 105 107 When administered cyclically, estrogen usually is given once daily for 3 weeks followed by 1 week without the drug or once daily for 25 days followed by 5 days off; regimen is repeated as necessary. 101 105 When parenteral administration of conjugated estrogens USP is required, IV injection is preferred because of the more rapid response compared with IM injection. 104 Oral Administration Oral preparations containing medroxyprogesterone acetate in combination with conjugated estrogens USP as monophasic or biphasic regimens are commercially available in a mnemonic dispensing package to aid user in complying with the prescribed dosage schedule. 107 Oral preparation containing bazedoxifene acetate in fixed combination with conjugated estrogens is commercially available in a 30-day package including 2 blister packs of 15 tablets each. 262 IV Administration For solution and drug compatibility information, see Compatibility under Stability. Administer by direct IV injection. 104 Reconstitution Reconstitute vial containing 25 mg of conjugated estrogens USP with 5 mL of sterile water for injection. 104 Do not shake vigorously. 104 Administer immediately after reconstitution. 104 Rate of Administration Administer slowly (to avoid flushing reaction). 104 IM Administration Administer by deep IM injection. 104 Reconstitution Reconstitute vial containing 25 mg of conjugated estrogens USP with 5 mL of sterile water for injection. 104 Do not shake vigorously. 104 Administer immediately after reconstitution. 104 Vaginal Administration Administer intravaginally as a vaginal cream. 105 Dosage Individualize dosage according to the condition being treated and the tolerance and therapeutic response of the patient. 101 104 105 106 107 121 To minimize risk of adverse effects, use the lowest possible effective dosage. 101 104 105 106 107 121 Because of the potential increased risk of cardiovascular events, breast cancer, and venous thromboembolic events, limit estrogen, estrogen/progestin, or conjugated estrogens in fixed combination with bazedoxifene to the lowest effective doses and shortest duration of therapy consistent with treatment goals and risks for the individual woman. 101 104 105 107 121 262 Periodically reevaluate use of estrogen, estrogen/progestin, or conjugated estrogens in fixed combination with bazedoxifene (i.e., at 3- to 6-month intervals). 101 104 105 107 121 262 Pediatric Patients Hypoestrogenism Oral Conjugated estrogens USP: 0.15 mg daily may induce breast development. 101 Increase dosage at 6- to 12-month intervals to achieve appropriate bone age advancement and epiphyseal closure. 101 Conjugated estrogens USP: 0.625 mg daily (with progestins) sufficient to induce artificial cyclic menses and to maintain bone mineral density (BMD) after skeletal maturity. 101 Adults Estrogen Replacement Therapy Vasomotor Symptoms Oral Conjugated estrogens USP: Initially, 0.3 mg daily continuously or in cyclic regimen (25 days on, 5 days off). 101 Adjust dosage based on patient response. 101 Synthetic conjugated estrogens A: Initially, 0.45 mg daily. 106 May increase dosage up to 1.25 mg daily. 106 Synthetic conjugated estrogens B: Initially, 0.3 mg daily. 121 266 May increase dosage up to 1.25 mg daily. 266 Adjust dosage based on patient response. 121 266 Conjugated estrogens USP in fixed combination with medroxyprogesterone acetate (Prempro ), monophasic regimen: Initially, conjugated estrogens USP 0.3 mg with medroxyprogesterone acetate 1.5 mg daily. 107 Alternatively, conjugated estrogens USP 0.45 mg with medroxyprogesterone acetate 1.5 mg daily, conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 2.5 mg daily, or conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 5 mg daily. 107 Conjugated estrogens USP with medroxyprogesterone acetate (Premphase ), biphasic regimen: Conjugated estrogens USP 0.625 mg daily; medroxyprogesterone acetate 5 mg daily on days 15 28 of the cycle. 107 Conjugated estrogens in fixed combination with bazedoxifene acetate: Conjugated estrogens 0.45 mg with bazedoxifene 20 mg once daily. 262 Vulvar and Vaginal Atrophy Oral Conjugated estrogens USP: Initially, 0.3 mg daily continuously or in cyclic regimen (25 days on, 5 days off). 101 Adjust dosage based on patient response. 101 Synthetic conjugated estrogens A: 0.3 mg daily. 106 Synthetic conjugated estrogens B: 0.3 mg daily. 266 Conjugated estrogens USP in fixed combination with medroxyprogesterone acetate (Prempro ), monophasic regimen: Initially, conjugated estrogens USP 0.3 mg with medroxyprogesterone acetate 1.5 mg daily. 107 Alternatively, conjugated estrogens USP 0.45 mg with medroxyprogesterone acetate 1.5 mg daily, conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 2.5 mg daily, or conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 5 mg daily. 107 Conjugated estrogens USP with medroxyprogesterone acetate (Premphase ), biphasic regimen: Conjugated estrogens USP 0.625 mg daily; medroxyprogesterone acetate 5 mg daily on days 15 28 of the cycle. 107 Vaginal Conjugated estrogens USP: 0.5 2 g daily in cyclic regimen (3 weeks on, 1 week off). 105 Osteoporosis Prevention in Postmenopausal Women Oral Conjugated estrogens USP: Initially, 0.3 mg daily continuously or in cyclic regimen (25 days on, 5 days off). 101 Adjust dosage based on clinical and BMD response. 101 Conjugated estrogens USP in fixed combination with medroxyprogesterone acetate (Prempro ), monophasic regimen: Initially, conjugated estrogens USP 0.3 mg with medroxyprogesterone acetate 1.5 mg daily. 107 Alternatively, conjugated estrogens USP 0.45 mg with medroxyprogesterone acetate 1.5 mg daily, conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 2.5 mg daily, or conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 5 mg daily. 107 Adjust dosage based on clinical and BMD response. 107 Conjugated estrogens USP with medroxyprogesterone acetate (Premphase ), biphasic regimen: Conjugated estrogens USP 0.625 mg daily; medroxyprogesterone acetate 5 mg daily on days 15 28 of the cycle. 107 Conjugated estrogens in fixed combination with bazedoxifene acetate: Conjugated estrogens 0.45 mg with bazedoxifene 20 mg once daily. 262 Hypoestrogenism Female Hypogonadism Oral Conjugated estrogens USP: 0.3 0.625 mg daily in a cyclic regimen (3 weeks on, 1 week off). 101 Adjust dosage based on symptom severity and endometrial responsiveness. 101 Female Castration or Primary Ovarian Failure Oral Conjugated estrogens USP: 1.25 mg daily in a cyclic regimen. 101 Adjust dosage based on symptom severity and clinical response. 101 Metastatic Breast Carcinoma Oral Conjugated estrogens USP: 10 mg 3 times daily for ≥3 months. 101 Prostate Carcinoma Oral Conjugated estrogens USP: 1.25 2.5 mg 3 times daily. 101 Abnormal Uterine Bleeding IV or IM Conjugated estrogens USP: 25 mg; can repeat dose in 6 12 hours. 104 Cautions for Estrogens, Conjugated Contraindications Undiagnosed abnormal genital bleeding. 101 104 105 106 107 121 262 Known or suspected breast cancer or history of breast cancer (except when used for palliative treatment of metastatic disease in appropriately selected individuals). 101 104 105 106 107 121 262 Known or suspected estrogen-dependent neoplasia. 101 104 105 106 107 121 262 Active DVT or pulmonary embolism; history of DVT or pulmonary embolism. 101 104 105 106 107 121 262 Active or recent (within past year) arterial thromboembolic disease (e.g., stroke, MI). 101 104 105 106 107 121 262 Liver disease or impairment. 101 104 105 107 121 262 Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. 262 264 265 266 267 Known or suspected pregnancy. 101 104 105 106 107 121 262 Known hypersensitivity to estrogen or any ingredient in the formulation. 101 104 105 106 107 121 262 Warnings/Precautions Warnings Cardiovascular Disorders Estrogen/progestin therapy associated with increased risk of MI, stroke, DVT, and pulmonary embolism. 101 104 105 106 107 112 113 114 121 Estrogen therapy associated with increased risk of stroke and DVT. 101 104 105 107 262 (See Boxed Warning.) Discontinue estrogens immediately if any of these events occur or are suspected. 101 104 105 106 107 121 Use of ERT or HRT is not advised in women with a history of stroke or transient ischemic attacks. (See Contraindications under Cautions.) Appropriately manage risk factors for cardiovascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, obesity) and/or venous thromboembolism (personal or family history of venous thromboembolism, obesity, systemic lupus erythematosus). 101 104 105 106 107 121 (See Contraindications under Cautions.) Discontinue estrogens, whenever feasible, at least 4 6 weeks prior to surgery that is associated with an increased risk of thromboembolism or during prolonged immobilization. 101 104 105 106 107 121 262 Endometrial Cancer Use of unopposed estrogen therapy in women who have a uterus is associated with increased risk of endometrial cancer. 101 104 105 106 107 121 262 Clinical surveillance and evaluation are essential. 101 104 105 106 107 121 Perform diagnostic tests to rule out malignancy in women with undiagnosed, persistent or recurring abnormal vaginal bleeding. 101 104 105 106 107 121 Incidence of endometrial hyperplasia is reduced substantially when progestins are used concomitantly. 101 104 105 106 107 121 Concomitant use of estrogen agonist/antagonist bazedoxifene also reduces risk of endometrial hyperplasia associated with conjugated estrogens. 262 Breast Cancer HRT associated with increased risk of breast cancer 101 104 105 106 107 112 113 114 121 or increase in abnormal mammograms requiring further evaluation. 262 All postmenopausal women should receive yearly breast examinations by a clinician and perform monthly self-examinations. 101 104 105 106 107 121 262 Schedule periodic mammography based on patient age and risk factors. 101 104 105 106 107 121 262 Dementia ERT or HRT in women ≥65 years of age has been associated with increased risk of developing probable dementia. 101 104 105 107 121 262 Whether these findings apply to younger women is unknown. 101 104 105 107 121 (See Alzheimer s Disease under Uses.) Gallbladder Disease ERT associated with increased risk of gallbladder disease requiring surgery. 101 104 105 106 107 121 262 Hypercalcemia Estrogens may cause severe hypercalcemia in patients with breast cancer and bone metastases. 101 104 105 106 107 121 Discontinue the drug and initiate appropriate therapy to reduce serum calcium concentrations if hypercalcemia occurs. 101 104 105 106 107 121 Ocular Effects Retinal thrombosis reported. 101 104 105 106 107 121 262 Discontinue pending examination if sudden partial or complete loss of vision or sudden onset of proptosis, diplopia, or migraine occurs. 101 104 105 107 121 262 Discontinue estrogens if papilledema or retinal vascular lesions noted on examination. 101 104 105 106 107 104 105 121 262 General Precautions Elevated BP Rarely, substantial increases in BP attributed to idiosyncratic reactions to estrogen. 101 104 105 106 107 121 262 ERT generally is not associated with elevated BP. 101 104 105 107 121 Monitor BP at regular intervals. 101 104 105 106 107 121 Hypertriglyceridemia Estrogen therapy may be associated with increases in plasma triglyceride concentrations resulting in pancreatitis in women with increased serum lipids. 101 104 105 106 107 121 262 Consider discontinuance of therapy if pancreatitis occurs. 262 264 265 266 Fluid Retention Estrogens may cause some degree of fluid retention; use with caution and careful monitoring in patients with conditions that might be aggravated by fluid retention (e.g., cardiac or renal impairment). 101 104 105 106 107 121 262 Hypocalcemia Use with caution in patients with hypoparathyroidism since estrogen-induced hypocalcemia may occur. 101 104 105 106 107 121 262 264 265 266 Hereditary Angioedema Estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema. 262 264 265 266 267 Ovarian Cancer Long-term estrogen therapy associated with increased incidence of ovarian cancer in some epidemiologic studies. 101 104 105 106 107 121 262 Other studies did not show a clinically important association. 101 104 105 106 107 121 262 Endometriosis Estrogens may exacerbate endometriosis. 101 104 105 106 107 121 Malignant transformation of residual endometrial implants reported rarely in women receiving unopposed estrogen following hysterectomy. 101 104 105 107 Consider the addition of progestin in women with residual endometriosis following hysterectomy. 101 104 105 107 121 Other Conditions Estrogens may exacerbate asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas; use with caution in patients with these conditions. 101 104 105 107 121 262 Precautions Specific to Vaginal Administration Exposure to conjugated estrogens USP vaginal cream may weaken latex condoms. 105 Consider the potential for the cream to weaken and contribute to protective failure of latex or rubber condoms, diaphragms, or cervical caps. 105 Use of Fixed Combinations When a progestin is used in conjunction with estrogen therapy, consider the cautions, precautions, and contraindications associated with progestin therapy. 107 a When bazedoxifene is used in combination with conjugated estrogens, consider the usual cautions, precautions, contraindications, and interactions associated with bazedoxifene. 262 Cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) should be considered for each drug in the fixed combination. 262 Specific Populations Pregnancy Category X. 101 104 105 106 107 121 262 (See Contraindications under Cautions.) In utero exposure of females to diethylstilbestrol (DES [no longer commercially available in US]) is associated with increased risk of vaginal adenosis, squamous cell dysplasia of the cervix, and clear-cell vaginal cancer in later life. b In utero exposure of males to DES is associated with an increased risk of genital abnormalities and possibly testicular cancer later in life. b Women who receive DES during pregnancy may be at increased risk of breast cancer; causal relationship unproven. b Lactation Administration of estrogens to nursing women has been associated with decreased amounts and lower quality of milk. 101 104 105 106 107 121 262 Detectable amounts of estrogens have been identified in milk of women receiving these drugs. 101 104 105 106 107 121 262 Caution advised. 101 104 105 106 107 121 Conjugated estrogens/bazedoxifene in fixed combination not recommended for use in nursing women. 262 Pediatric Use Estrogen therapy has been used for induction of puberty in adolescents with some forms of pubertal delay. 101 Safety and efficacy of estrogens in children not otherwise established. 101 104 105 107 121 Use estrogen therapy with caution and careful monitoring if bone growth is not yet complete, since estrogens may cause premature epiphyseal closure. 101 Estrogen therapy in prepubertal girls induces premature breast development and vaginal cornification and may induce vaginal bleeding. 101 Estrogen therapy in boys may modify the normal pubertal process. 101 Geriatric Use No substantial differences in safety in women ≥65 years of age compared with younger women; increased incidence of stroke and invasive breast cancer reported in women≥75 years of age compared with younger women. 101 104 105 107 Conjugated estrogens/bazedoxifene in fixed combination not recommended for use in women ≥75 years of age. 262 Possible increased risk of developing probable dementia in women ≥65 years of age. (See Dementia under Cautions.) 101 104 105 107 Clinical studies of estrogens alone or in combination with a progestin did not include sufficient numbers of patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients. 101 104 105 107 Hepatic Impairment Estrogens may be poorly metabolized in patients with hepatic impairment. 101 104 105 106 107 121 (See Contraindications under Cautions.) Caution advised in patients with a history of cholestatic jaundice associated with previous estrogen use or with pregnancy; discontinue if jaundice recurs. 101 104 105 106 107 121 Renal Impairment Use with caution. 101 104 105 107 121 (See Fluid Retention under Cautions.) Common Adverse Effects Abdominal pain, asthenia, flatulence, leg cramps, pruritus, vaginal hemorrhage, vaginitis, vaginal moniliasis. 101 107 Interactions for Estrogens, Conjugated Appears to be metabolized partially by CYP3A4. 101 104 105 106 107 121 Drugs Affecting Hepatic Microsomal Enzymes CYP3A4 inhibitors: Potential pharmacokinetic interaction (increased plasma estrogen concentrations). 101 104 105 106 107 121 CYP3A4 inducers: Potential pharmacokinetic interaction (decreased plasma estrogen concentrations). 101 104 105 106 107 121 Specific Drugs and Foods Drug or Food Interaction Comments Anticoagulants, oral Possible decreased anticoagulant action b Monitor; increase warfarin dosage if required b Antifungals, azoles (itraconazole, ketoconazole) Possible increased plasma estrogen concentrations; increased potential for adverse effects 101 104 105 106 107 121 Carbamazepine Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding 101 104 105 106 107 121 Corticosteroids (hydrocortisone) Enhanced anti-inflammatory effects in patients with chronic inflammatory skin disease b Observe for signs of excessive corticosteroid effects; adjust corticosteroid dosage when initiating or discontinuing estrogen b Grapefruit juice Possible increased plasma estrogen concentrations; increased potential for adverse effects 101 104 105 106 107 121 Macrolide antibiotics (clarithromycin, erythromycin) Possible increased plasma estrogen concentrations; increased potential for adverse effects 101 104 105 106 107 121 Medroxyprogesterone Interaction unlikely 101 106 107 Phenobarbital Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding 101 104 105 106 107 121 Rifampin Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding 101 104 105 106 107 121 Ritonavir Possible increased plasma estrogen concentrations; increased potential for adverse effects 101 104 105 106 107 121 St. John s wort ( Hypericum perforatum ) Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding 101 104 105 106 107 121 Thyroid agents Increased thyroid-binding globulin concentrations 101 104 105 106 107 121 Increased dosages of thyroid replacement agents may be needed; monitor thyroid function 101 104 105 106 107 121 Estrogens, Conjugated Pharmacokinetics Absorption Bioavailability Conjugated estrogens are well absorbed through mucous membranes and from the GI tract. 101 104 105 106 107 121 Food Conjugated estrogens USP: High-fat meal does not affect extent of oral absorption. 107 Synthetic conjugated estrogens A: Effect of food unknown. 106 Synthetic conjugated estrogens B: Effects of food unknown. 121 Distribution Extent Widely distributed; highest concentrations found in sex hormone target organs. 101 104 105 106 107 121 Plasma Protein Binding 50 80%. b Elimination Metabolism Metabolized in the liver; the kidney, gonads, and muscle tissue involved to some extent. b Estrogens metabolized partially by CYP3A4. 101 104 105 106 107 121 Extensive metabolic conversion takes place in the liver (e.g., estradiol converted to estrone, both converted to estriol). 101 104 105 106 107 121 Estrogens undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the gut followed by reabsorption. 101 104 105 106 107 121 Elimination Route Estrogens and their metabolites excreted mainly in urine. 101 104 106 107 121 Half-life Conjugated estrogens: 10 28 hours. 101 106 107 Stability Storage Oral Tablets 20 25 C (may be exposed to 15 30 C). 101 106 107 121 Parenteral Powder for Injection 2 8 C. 104 Vaginal Cream 20 25 C (may be exposed to 15 30 C). 105 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Stated to be incompatible with protein hydrolysate, ascorbic acid, or any solution with an acid pH. 104 Solution Compatibility 104 Compatible Dextrose solutions Invert sugar solutions Sodium chloride 0.9% Drug Compatibility Y-Site CompatibilityHID Compatible Heparin sodium with hydrocortisone sodium succinate Potassium chloride Vitamin B complex with C Actions Conjugated estrogens USP is a mixture of conjugated equine estrogens obtained from natural sources and occurring as the sodium salts of the water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mare s urine. 101 It is a mixture of sodium estrone sulfate and sodium equilin sulfate that also contains 17α-dihydroequilin, 17α-estradiol, 17β-dihydroequilin, equilenin, 17α-dihydroequilenin, 17β-dihydroequilenin, δ 8,9 -dehydroestrone, and 17β-estradiol. 101 Synthetic conjugated estrogens A is a mixture of conjugated estrogens prepared synthetically from plant sources (i.e., soy and yams). 106 It contains the sodium salts of water-soluble estrogen sulfates blended into a 9-component mixture of estrone sulfate and sodium equilin sulfate as well as the concomitant components 17α-dihydroequilin, 17α-estradiol, 17β-dihydroequilin, 17α-dihydroequilenin, 17β-dihydroequilenin, equilenin, and 17β-estradiol as sodium sulfate conjugates. 106 Synthetic conjugated estrogens B is a mixture of conjugated estrogens prepared synthetically from plant sources. 121 122 It contains the sodium salts of water-soluble estrogen sulfates blended into a 10-component mixture of estrone sulfate and sodium equilin sulfate as well as the concomitant components 17α-dihydroequilin, 17α-estradiol, 17β-dihydroequilin, 17α-dihydroequilenin, 17β-dihydroequilenin, equilenin, 17β-estradiol, and δ 8,9 -dehydroestrone as sodium sulfate conjugates. 121 This mixture contains the 10 estrogenic substances present in currently available commercial preparations of conjugated estrogens USP. 121 Exogenous estrogens elicit, to varying degrees, all the pharmacologic responses usually produced by endogenous estrogens. a Advice to Patients Importance of providing patient a copy of the manufacturer s patient information. 101 104 105 106 107 121 Risk of cancer of the uterus in postmenopausal women. 101 104 105 106 107 121 Importance of reporting any unusual vaginal bleeding to clinicians. 101 104 105 106 107 121 Risk of MI, stroke, breast cancer, and venous thromboembolism. 101 104 105 106 107 121 Importance of not using estrogens to prevent heart disease, MI, or strokes. 101 104 105 106 107 121 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 101 104 105 106 107 121 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as concomitant illnesses. 101 104 105 106 107 121 Importance of informing patients of other important precautionary information. 101 104 105 106 107 121 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Conjugated Estrogens USP Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets 0.3 mg Premarin Pfizer 0.45 mg Premarin Pfizer 0.625 mg Premarin Pfizer 0.9 mg Premarin Pfizer 1.25 mg Premarin Pfizer Parenteral For injection 25 mg Premarin Intravenous Pfizer Vaginal Cream 0.0625% Premarin Pfizer Conjugated Estrogens Combinations Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets 0.45 mg with Bazedoxifene Acetate 20 mg (of bazedoxifene) Duavee Pfizer Tablets, monophasic regimen 0.3 mg with Medroxyprogesterone acetate 1.5 mg (28 tablets) Prempro Pfizer 0.45 mg with Medroxyprogesterone acetate 1.5 mg (28 tablets) Prempro Pfizer 0.625 mg with Medroxyprogesterone Acetate 2.5 mg (28 tablets) Prempro Pfizer 0.625 mg with Medroxyprogesterone Acetate 5 mg (28 tablets) Prempro Pfizer Tablets, biphasic regimen 0.625 mg (14 tablets Premarin ) and 0.625 mg with Medroxyprogesterone Acetate 5 mg (14 tablets) Premphase Pfizer Conjugated Estrogens A, Synthetic Routes Do is incredibly


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give you the chance (*this news item will not be available after 02/28/2018) By Robert Preidt Thursday, November 30, 2017 THURSDAY, Nov. 30, 2017 (HealthDay News) -- Bacterial resistance to the antibiotic ampicillin may have begun years before doctors started prescribing it in the early 1960s, a new study suggests. Ampicillin, a broad-spectrum penicillin, is widely used to treat many bacterial infections, including bladder and ear infections, pneumonia and gonorrhea. Resistance was likely triggered by overuse of penicillin in livestock in North America and Europe in the 1950s, according to researchers at the Pasteur Institute in Paris. Ampicillin was released on the market for humans in 1961. "Our findings suggest that antibiotic residues in farming environments such as soil, wastewater and manure may have a much greater impact on the spread of resistance than previously thought," said study leader Dr. Francois-Xavier Weill, a researcher at the institute. Many bacteria that cause serious infections in people have developed resistance to antibiotics such as ampicillin. And annual worldwide deaths from antibiotic resistance are expected to top 10 million by 2050, the researchers said in background notes. Because of these concerns, the World Health Organization recently called for an end to routine antibiotic use in healthy livestock. The new findings were published Nov. 29 in The Lancet Infectious Diseases . While the study can't identify a direct cause-and-effect relationship, Weill said it suggests that the nonclinical use of penicillin in livestock may have encouraged the evolution of resistance genes in the late 1950s. "There is an urgent need to re-evaluate the use of antibiotics in animals ... recognizing that bacteria know no borders," Weill said in a journal news release. "This must include close international monitoring and surveillance of resistance in both human and animal health." Antibiotic use as growth promoters has been gradually banned in Europe, without adverse effects on animal production, said the authors of a commentary accompanying the study. "Extensive use of antibiotics, however, continues in low-income and middle-income countries and in booming economies, particularly in intense farming such as that of fish and shellfish," wrote Sandra Van Puyvelde and colleagues from the Institute of Tropical Medicine Antwerp in Belgium. SOURCE: The Lancet Infectious Diseases , news release, Nov. 29, 2017 HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Antibiotics Recent Health News make money working from home


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achievement Calquence Generic Name: acalabrutinib (a KAL a BROO ti nib) Brand Name: Calquence Overview Professional Interactions Reviews Images More Support Group Q & A What is acalabrutinib? Acalabrutinib blocks the action of certain enzymes in the body, which can interfere with the growth and spread of cancer cells. Acalabrutinib is used to treat mantle cell lymphoma (a type of non-Hodgkin lymphoma) in adults. This medicine is given after other treatments have failed. Acalabrutinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, patients responded to this medicine. However, further studies are needed. Acalabrutinib may also be used for purposes not listed in this medication guide. Slideshow Hives: The What, Where, And Why Of This Bizarre Skin Condition What is the most important information I should know about acalabrutinib? This medicine can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop. Call your doctor at once if you have signs of bleeding inside your body, such as: dizziness, weakness, confusion, headache, speech problems, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds. What should I discuss with my healthcare provider before taking acalabrutinib? You should not use acalabrutinib if you are allergic to it. To make sure acalabrutinib is safe for you, tell your doctor if you have ever had: an active or chronic infection; a heart rhythm disorder; bleeding problems; or hepatitis B (acalabrutinib can cause this condition to come back or get worse). Taking acalabrutinib may increase your risk of developing other types of cancer, such as skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether acalabrutinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using acalabrutinib, and for at least 2 weeks after your last dose. How should I take acalabrutinib? Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Acalabrutinib is usually taken once every 12 hours until your body no longer responds to the medicine. Take this medicine with a full glass of water. You may take acalabrutinib with or without food. Do not chew, break, or open the acalabrutinib capsule. Swallow it whole. If you need surgery, tell the surgeon ahead of time that you are using acalabrutinib. You may need to stop using the medicine for a short time. While using acalabrutinib, you may need frequent blood tests. Store at room temperature away from moisture and heat. What happens if I miss a dose? Take the missed dose as soon as you remember. If you are more than 3 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking acalabrutinib? If you also take an antacid or stomach acid reducer (such as Zantac), take your acalabrutinib dose at least 2 hours before you take the stomach medicine. Avoid exposure to sunlight or tanning beds. Acalabrutinib can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Acalabrutinib side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: unusual bleeding (nose, mouth, vagina, or rectum), or any bleeding that will not stop; signs of bleeding inside your body--dizziness, weakness, confusion, problems with speech, prolonged headache, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds; heart rhythm problems--chest pain, shortness of breath, pounding heartbeats or fluttering in your chest, feeling light-headed; low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; signs of infection--fever, chills, tiredness, flu-like symptoms, cough with mucus, chest pain, trouble breathing; or signs of a serious brain infection--any change in your mental state, decreased vision, weakness on one side of your body, or problems with walking (may start gradually and get worse quickly). Your cancer treatments may be delayed or permanently discontinued if you have certain side effects. Common side effects may include: bruising; headache; muscle pain; diarrhea; or feeling tired. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. What other drugs will affect acalabrutinib? Many drugs can interact with acalabrutinib. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially: warfarin (Coumadin, Jantoven); an antibiotic or antifungal medicine; antiviral medicine to treat hepatitis C or HIV/AIDS; heart medication; or a stomach acid reducer--such as omeprazole, lansoprazole Nexium, Prevacid, Prilosec, Protonix, and others. This list is not complete and many other drugs can interact with acalabrutinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you. Next Professional Print this page Add to My Med List More about Calquence (acalabrutinib) Drug Images Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: multikinase inhibitors Consumer resources Calquence Professional resources Calquence (FDA) Related treatment guides Mantle Cell Lymphoma Where can I get more information? Your pharmacist can provide more information about acalabrutinib. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Date modified: December 03, 2017 Last reviewed: November 02, 2017 taking note of


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looking for hands and feet These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain fit


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similtaneously August 28, 2017 By Paul Gionfriddo, MHA National President & CEO, and Nathaniel Counts, MHA National Senior Policy Director The Interagency Serious Mental Illness Coordinating Committee (ISMICC) is a new change agent for mental health reform that was established by the 21st Century Cures Act, thanks to the incredible efforts of Senators Cassidy and Murphy and Representatives Murphy and Johnson. The ISMICC is made up of agency representatives and members of the public. It is charged with improving the federal government s coordinated response to serious mental illnesses. The Trump Administration did not choose any public members who have focused primarily on early identification or children s services. Nevertheless, two members of the ISMICC, Mary Giliberti from NAMI and author Pete Earley, have already reached out to MHA for our input. Here is what we told them. To promote early identification, the ISMICC must make a commitment to implementation of the US Preventive Services Task Force (USPSTF) recommendation to provide mental health screening to everyone over the age of 1 Despite a USPSTF recommendation for screening , rates of screening using a clinically valid tool and meaningful follow-up remain very low in America. MHA launched the most successful screening program in the nation, www.mhascreening.org to address this, and has been partnering with other mental health and substance use advocacy organizations to ask for inclusion of measures of screening rates and treatment outcomes in the CMS-AHIP Core Quality Measures Collaborative . We think that these measures, along with developmental and social growth factors, should be tied to value-based payments for all health systems and providers to incentivize detection at the earliest point and focus on recovery as the goal. Moving upstream, the ISMICC must facilitate a deeper commitment to the implementation of evidence-based preventive services in school. Last year the Departments of Health and Human Services (HHS) and Education (ED) released a seminal report Healthy Students, Promising Futures on how to better integrate health care into education. The Every Student Succeeds Act (ESSA) only amplified these opportunities . This is integration around evidence-based prevention that we need to accomplish, and the ISMICC should recommend that HHS and ED make it happen. MHA has partnered with Trust for America s Health and Healthy Schools Campaign to explore best practices and promising possibilities . HHS and ED should prioritize grant-making to states and communities that propose to leverage the ED and HHS investments toward better student educational and behavioral health outcomes. And they should support improved teacher education, so that teachers feel ready from their first day to meet the educational needs of their students with mental health concerns. For kids battling serious mental illnesses, the ISMICC must not ignore them, but recommend a reform of special education so that kids with serious emotional disturbance (SED) can be more easily identified and receive the services and supports they need. We are failing our kids with serious mental illnesses, because we frequently fail to take early stage mental illnesses seriously in our schools, waiting until crises occur. Only one child in every twenty-eight with a serious mental health concern is offered special education services for that concern. The reason is that special education funds are limited. This means inadequate funding is driving bad policy from the federal to the local level. This has to change. We favor saving schools money, while improving services to kids, by allowing health insurance to cover health-related costs mandated in individualized education programs. Also, it is time to align health care, child care, social and family, preschool, education, and job training resources so that we can treat the child as a whole, not just his or her labels and diagnoses. For adults who have been trapped in the revolving door of occasional hospitalization, frequent incarceration, and chronic homelessness, the ISMICC must recommend a prohibition of the incarceration of nonviolent offenders with mental illnesses, as well as a process for reducing felony charges to misdemeanors. The federal government should revise its own penal code to ensure that individuals with mental health conditions receive treatment, not punishment, and have access to a process for reducing felony charges related to untreated mental health conditions. This is because they often can t find jobs or housing with felonies in their past. The enormous savings that would result should be reinvested toward community-based mental health services and supports, as the RESET Act would do with many substance use-related offenses, and the Justice Reinvestment Initiative did at the state level. In addition, Department of Justice (DOJ) and HHS should only grant federal funds to states that invest them in mental health care including peer services for those who need it, rather than on high-cost cycles of crisis and incarceration. We congratulate the members of the ISMICC, and thank them for their willingness to serve. They have an opportunity to better the lives of people with serious mental illnesses before Stage 4 crises occur, and we live with the hope they will choose to do so. Tags: ISMICC 21st Century Cures Early Identification Prevention incarceration before stage 4 Mental Health America Blog are expecting


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locate Estrogens (Esterified) and Methyltestosterone Professional Interactions Reviews Images Q & A More Pronunciation (ES troe jenz es TER i fied & meth il tes TOS te rone) Index Terms Esterified Estrogen and Methyltestosterone Estratest Methyltestosterone and Esterified Estrogen Methyltestosterone and Oestrogen Oestrogen and Methyltestosterone Slideshow Memos on Menopause - What Every Woman Needs to Know Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Tablet, Oral: Covaryx H.S.: Esterified estrogens 0.625 mg and methyltestosterone 1.25 [contains tartrazine] Covaryx: Esterified estrogens 1.25 mg and methyltestosterone 2.5 mg [contains tartrazine] EEMT HS: Esterified estrogen 0.625 mg and methyltestosterone 1.25 mg EEMT: Esterified estrogen 1.25 mg and methyltestosterone 2.5 mg Generic: Esterified estrogen 0.625 mg and methyltestosterone 1.25 mg; esterified estrogens 1.25 mg and methyltestosterone 2.5 mg Brand Names: U.S. Covaryx Covaryx H.S. EEMT EEMT HS Pharmacologic Category Estrogen and Androgen Combination Pharmacology Conjugated estrogens: Activate estrogen receptors (DNA protein complex) located in estrogen-responsive tissues. Once activated, regulate transcription of certain genes leading to observed effects. Testosterone: Increases synthesis of DNA, RNA, and various proteins in target tissues Use: Labeled Indications Vasomotor symptoms associated with menopause: Treatment of moderate to severe vasomotor symptoms associated with menopause not improved by estrogens alone Contraindications Hypersensitivity to estrogens, methyltestosterone, or any component of the formulation; undiagnosed abnormal vaginal bleeding; DVT or PE (current or history of); active or history of arterial thromboembolic disease (eg, stroke, MI); carcinoma of the breast (known, suspected or history of), except in appropriately selected patients being treated for metastatic disease; estrogen-dependent tumor; hepatic dysfunction or disease; known or suspected pregnancy or breastfeeding due to possible masculinization of the female fetus or breastfed infant Dosing: Adult Vasomotor symptoms associated with menopause: Adults: Females: Oral: Usual dosage range (based on esterified estrogen component): 0.625 to 1.25 mg once daily administered cyclically (3 weeks on, then 1 week off) When treating postmenopausal women, use estrogens for the shortest duration possible at the lowest effective dose consistent with treatment goals. Reevaluate patients as clinically appropriate to determine if treatment is still necessary. The lowest dose that will control symptoms should be chosen. Dosage needs to be adjusted based upon the patient's response. Attempts to discontinue or taper medication should be made at 3- to 6-month intervals. Dosing: Geriatric Refer to adult dosing. Dosing: Renal Impairment No dosage adjustment provided in manufacturer's labeling; use with caution. Dosing: Hepatic Impairment No dosage adjustment provided in manufacturer's labeling; use with caution. Administration Administer with food at same time each day. Drug Interactions Ajmaline: Estrogen Derivatives may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Monitor therapy Ajmaline: Androgens may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Monitor therapy Anastrozole: Estrogen Derivatives may diminish the therapeutic effect of Anastrozole. Avoid combination Anthrax Immune Globulin (Human): Estrogen Derivatives may enhance the thrombogenic effect of Anthrax Immune Globulin (Human). Monitor therapy Anticoagulants: Estrogen Derivatives may diminish the anticoagulant effect of Anticoagulants. More specifically, the potential prothrombotic effects of some estrogens and progestin-estrogen combinations may counteract anticoagulant effects. Management: Carefully weigh the prospective benefits of estrogens against the potential increased risk of procoagulant effects and thromboembolism. Use is considered contraindicated under some circumstances. Refer to related guidelines for specific recommendations. Consider therapy modification Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy Ascorbic Acid: May increase the serum concentration of Estrogen Derivatives. Monitor therapy Blood Glucose Lowering Agents: Androgens may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy C1 inhibitors: Estrogen Derivatives may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy Cannabis: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy Chenodiol: Estrogen Derivatives may diminish the therapeutic effect of Chenodiol. Management: Monitor clinical response to chenodiol closely when used together with any estrogen derivative. Monitor therapy Corticosteroids (Systemic): Estrogen Derivatives may increase the serum concentration of Corticosteroids (Systemic). Monitor therapy Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Monitor therapy CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Consider therapy modification CYP1A2 Inducers (Moderate): May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification Cyproterone: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification Dantrolene: Estrogen Derivatives may enhance the hepatotoxic effect of Dantrolene. Monitor therapy Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy Dehydroepiandrosterone: May enhance the adverse/toxic effect of Estrogen Derivatives. Avoid combination Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification Exemestane: Estrogen Derivatives may diminish the therapeutic effect of Exemestane. Avoid combination Hemin: Estrogen Derivatives may diminish the therapeutic effect of Hemin. Avoid combination Herbs (Estrogenic Properties): May enhance the adverse/toxic effect of Estrogen Derivatives. Monitor therapy Hyaluronidase: Estrogen Derivatives may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving estrogens (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification Immune Globulin: Estrogen Derivatives may enhance the thrombogenic effect of Immune Globulin. Monitor therapy Indium 111 Capromab Pendetide: Estrogen Derivatives may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination LamoTRIgine: Estrogen Derivatives may decrease the serum concentration of LamoTRIgine. Monitor therapy Lenalidomide: Estrogen Derivatives may enhance the thrombogenic effect of Lenalidomide. Monitor therapy Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification Mivacurium: Estrogen Derivatives may increase the serum concentration of Mivacurium. Monitor therapy Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): May enhance the thrombogenic effect of Estrogen Derivatives. Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may increase the serum concentration of Estrogen Derivatives. Monitor therapy Ospemifene: Estrogen Derivatives may enhance the adverse/toxic effect of Ospemifene. Estrogen Derivatives may diminish the therapeutic effect of Ospemifene. Avoid combination Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Consider therapy modification Pomalidomide: May enhance the thrombogenic effect of Estrogen Derivatives. Management: Canadian pomalidomide labeling recommends caution with use of hormone replacement therapy and states that hormonal contraceptives are not recommended. US pomalidomide labeling does not contain these specific recommendations. Consider therapy modification ROPINIRole: Estrogen Derivatives may increase the serum concentration of ROPINIRole. Monitor therapy Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy Somatropin: Estrogen Derivatives may diminish the therapeutic effect of Somatropin. Shown to be a concern with oral hormone replacement therapy in postmenopausal women. Management: Monitor for reduced growth hormone efficacy. A larger somatropin dose may be required to reach treatment goal. This interaction does not appear to apply to non-orally administered estrogens (e.g., transdermal, vaginal ring). Consider therapy modification St John's Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification Succinylcholine: Estrogen Derivatives may increase the serum concentration of Succinylcholine. Monitor therapy Teriflunomide: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Monitor therapy Thalidomide: Estrogen Derivatives may enhance the thrombogenic effect of Thalidomide. Monitor therapy Theophylline Derivatives: Estrogen Derivatives may increase the serum concentration of Theophylline Derivatives. Exceptions: Dyphylline. Monitor therapy Thyroid Products: Estrogen Derivatives may diminish the therapeutic effect of Thyroid Products. Monitor therapy Tipranavir: Estrogen Derivatives may enhance the dermatologic adverse effect of Tipranavir. The combination of tipranavir/ritonavir and ethinyl estradiol/norethindrone was associated with a high incidence of skin rash. Tipranavir may decrease the serum concentration of Estrogen Derivatives. Management: Women using hormonal contraceptives should consider alternative, non-hormonal forms of contraception. Consider therapy modification Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy Ursodiol: Estrogen Derivatives may diminish the therapeutic effect of Ursodiol. Monitor therapy Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Consider therapy modification Adverse Reactions Refer to the Estrogens (Esterified) and the Testosterone monographs. ALERT: U.S. Boxed Warning Endometrial cancer: Estrogens have been reported to increase the risk of endometrial carcinoma. Three independent case control studies have reported an increased risk of endometrial cancer in postmenopausal women exposed to exogenous estrogens for prolonged periods. This risk was independent of the other known risk factors for endometrial cancer. These studies are further supported by the finding that incidence rates of endometrial cancer have increased sharply since 1969 in eight different areas of the United States with population-based cancer reporting systems, an increase which may be related to the rapidly expanding use of estrogens during the last decade. The three case control studies reported that the risk of endometrial cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk appears to depend on both duration of treatment and on estrogen dose. In view of these findings, when estrogens are used for the treatment of menopausal symptoms, the lowest dose that will control symptoms should be utilized and medication should be discontinued as soon as possible. When prolonged treatment is medically indicated, the patient should be reassessed on at least a semiannual basis to determine the need for continued therapy. Although the evidence must be considered preliminary, one study suggests that cyclic administration of low doses of estrogen may carry less risk than continuous administration;3 it therefore appears prudent to utilize such a regimen. Close clinical surveillance of all women taking estrogens is important. In all cases of undiagnosed persistent or recurring abnormal vaginal bleeding, adequate diagnostic measures should be undertaken to rule out malignancy. There is no evidence at present that natural estrogens are more or less hazardous than synthetic estrogens at equiestrogenic doses. Cardiovascular disease: This combination does not contain a progestin; it is an estrogen/androgen product. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. The Women s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. Breast cancer: The Women's Health Initiative (WHI) study reported increased risks of invasive breast cancer in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone (2.5 mg) relative to placebo. Dementia: The Women's Health Initiative Memory Study (WHIMS) a substudy of WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. Pregnancy: The use of female sex hormones, both estrogens and progestogens, during early pregnancy may seriously damage the offspring. It has been shown that females exposed in utero to diethylstilbestrol, a non-steroidal estrogen, have an increased risk of developing in later life a form of vaginal or cervical cancer that is ordinarily extremely rare. This risk has been estimated as not greater than 4 per 1,000 exposures. Furthermore, a high percentage of such exposed women (from 30 to 90 percent) have been found to have vaginal adenosis, epithelial changes of the vagina and cervix. Although these changes are histologically benign, it is not known whether they are precursors of malignancy. Although similar data are not available with the use of other estrogens, it cannot be presumed they would not induce similar changes. Several reports suggest an association between intrauterine exposure to female sex hormones and congenital anomalies, including congenital heart defects and limb reduction defects. One case control study estimated a 4.7-fold increased risk of limb reduction defects in infants exposed in utero to sex hormones (oral contraceptives, hormone withdrawal tests for pregnancy, or attempted treatment for threatened abortion). Some of these exposures were very short and involved only a few days of treatment. The data suggest that the risk of limb reduction defects in exposed fetuses is somewhat less than 1 per 1,000. In the past, female sex hormones have been used during pregnancy in an attempt to treat threatened or habitual abortion. There is considerable evidence that estrogens are ineffective for these indications, and there is no evidence from well controlled studies that progestogens are effective for these uses. If the combination of estrogens (esterified) and methyltestosterone is used during pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential risks. Risks vs benefits: Other doses of conjugated estrogens with medroxyprogesterone and other combinations of estrogens and progestins were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Warnings/Precautions Concerns related to adverse effects: Breast cancer: [US Boxed Warning]: Based on data from the Women s Health Initiative (WHI) studies, an increased risk of invasive breast cancer was observed in postmenopausal women using conjugated estrogens (CE) in combination with medroxyprogesterone acetate (MPA). This risk may be associated with duration of use and declines once combined therapy is discontinued (Chlebowski, 2009). The risk of invasive breast cancer was decreased in postmenopausal women with a hysterectomy using CE only, regardless of weight. However, the risk was not significantly decreased in women at high risk for breast cancer (family history of breast cancer, personal history of benign breast disease) (Anderson, 2012). An increase in abnormal mammogram findings has also been reported with estrogen alone or in combination with progestin therapy. Estrogen use may also lead to severe hypercalcemia in patients with breast cancer and bone metastases; discontinue estrogen if hypercalcemia occurs. Dementia: [US Boxed Warning]: Estrogens with or without progestin should not be used to prevent dementia. In the Women s Health Initiative Memory Study (WHIMS), an increased incidence of dementia was observed in women 65 years of age taking CE alone or in combination with MPA. Endometrial cancer: [US Boxed Warning]: The use of unopposed estrogen in women with an intact uterus is associated with an increased risk of endometrial cancer. The addition of a progestin to estrogen therapy may decrease the risk of endometrial hyperplasia, a precursor to endometrial cancer. Adequate diagnostic measures, including endometrial sampling if indicated, should be performed to rule out malignancy in postmenopausal women with undiagnosed abnormal vaginal bleeding. Estrogens may exacerbate endometriosis. Malignant transformation of residual endometrial implants has been reported posthysterectomy with unopposed estrogen therapy. Consider adding a progestin in women with residual endometriosis posthysterectomy. This combination product contains an estrogen and androgen; it does not contain a progestin. Inherited thrombophilia: Women with inherited thrombophilias (eg, protein C or S deficiency) may have increased risk of venous thromboembolism (DeSancho, 2010; van Vlijmen, 2011). Lipid effects: Estrogen compounds are generally associated with lipid effects such as increased HDL-cholesterol and decreased LDL-cholesterol. Triglycerides may also be increased; use with caution in patients with familial defects of lipoprotein metabolism. Testosterone may also alter serum cholesterol; use caution with history of MI or coronary artery disease. Ovarian cancer: Postmenopausal estrogen therapy and combined estrogen/progesterone therapy may increase the risk of ovarian cancer; however, the absolute risk to an individual woman is small. Although results from various studies are not consistent, risk does not appear to be significantly associated with the duration, route, or dose of therapy. In one study, the risk decreased after 2 years following discontinuation of therapy (Mørch, 2009). Although the risk of ovarian cancer is rare, women who are at an increased risk (eg, family history) should be counseled about the association (NAMS, 2012). Polycythemia: Testosterone may increase hematocrit requiring dose adjustment or discontinuation. Retinal vascular thrombosis: Estrogens may cause retinal vascular thrombosis; discontinue if migraine, loss of vision, proptosis, diplopia or other visual disturbances occur; discontinue permanently if papilledema or retinal vascular lesions are observed on examination. Disease-related concerns: Asthma: Use caution in patients with asthma; may exacerbate disease. Carbohydrate intolerance: May have adverse effects on glucose tolerance; use caution in women with diabetes. Cardiovascular disease: [US Boxed Warning]: Estrogens with or without progestin should not be used to prevent cardiovascular disease. Using data from the Women s Health Initiative (WHI) studies, an increased risk of deep vein thrombosis (DVT) and stroke has been reported with CE and an increased risk of DVT, stroke, pulmonary emboli (PE) and myocardial infarction (MI) has been reported with CE with MPA in postmenopausal women. Additional risk factors include diabetes mellitus, hypercholesterolemia, hypertension, SLE, obesity, tobacco use, and/or history of venous thromboembolism (VTE). Risk factors should be managed appropriately; discontinue use if adverse cardiovascular events occur or are suspected. Diseases exacerbated by fluid retention: Use with caution in patients with diseases which may be exacerbated by fluid retention, including cardiac or renal dysfunction. Epilepsy: Use caution with epilepsy; may exacerbate disease. Gallbladder disease: Use of postmenopausal estrogen may be associated with an increased risk of gallbladder disease requiring surgery. Hepatic dysfunction: Estrogens are poorly metabolized in patients with hepatic dysfunction. Use caution with a history of cholestatic jaundice associated with prior estrogen use or pregnancy. Discontinue if jaundice develops or if acute or chronic hepatic disturbances occur. Prolonged use of high doses of androgens has been associated with serious hepatic effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, jaundice). Hepatic hemangiomas: Use with caution in patients with hepatic hemangiomas; may exacerbate disease. Use is contraindicated with hepatic disease. Hereditary angioedema: Exogenous estrogens may exacerbate angioedema symptoms in women with hereditary angioedema. Hypocalcemia: Use with caution in patients with severe hypocalcemia. Migraine: Use caution with migraine; may exacerbate disease. Porphyria: Use with caution in patients with porphyria; may exacerbate disease. SLE: Use with caution in patients with SLE; may exacerbate disease. Concurrent drug therapy issues: Thyroid replacement therapy: Estrogens may increase thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels. Women on thyroid replacement therapy may require higher doses of thyroid hormone while receiving estrogens. Special populations: Elderly: Use testosterone with caution in elderly patients; may be at greater risk for fluid retention, transaminase elevations, and cardiac problems. Use estrogens with caution in elderly postmenopausal women due to potential of increased risk of breast and endometrial cancers, and risk of dementia. Pediatric: Prior to puberty, estrogens may cause premature closure of the epiphyses, premature breast development in girls, or gynecomastia in boys. Vaginal bleeding and vaginal cornification may also be induced in girls. Pregnant women: [US Boxed Warning]: Estrogens should not be used during pregnancy. Prescribing information states that the use of estrogens and progestins during early pregnancy may cause teratogenic effects. This is based on information from females exposed to diethylstilbestrol (DES) in utero and later developed a rare form of vaginal or cervical cancer. Product labeling also cites older literature associating limb reduction defects with oral contraceptives. In general, the use of estrogen and progestin, as in combination hormonal contraceptives, have not been associated with teratogenic effects when inadvertently taken early in pregnancy. However, testosterone may cause adverse effects, including masculinization of the female fetus, if used during pregnancy. This combination product is specifically contraindicated for use in pregnant women. Surgical patients: Whenever possible, should be discontinued at least 4-6 weeks prior to elective surgery associated with an increased risk of thromboembolism or during periods of prolonged immobilization. Dosage form specific issues: Tartrazine: Some products may contain tartrazine Other warnings/precautions: Appropriate use: Products containing estrogens (esterified) and methyltestosterone have not received pre-market approval by the FDA. Information in this monograph has been expanded beyond the available prescribing information Risks vs benefits: [US Boxed Warning]: Estrogens with or without progestin should be used for the shortest duration possible at the lowest effective dose consistent with treatment goals. Before prescribing estrogen therapy to postmenopausal women, the risks and benefits must be weighed for each patient. Women should be informed of these risks and benefits, as well as possible effects of progestin when added to estrogen therapy. Patients should be reevaluated as clinically appropriate to determine if treatment is still necessary. Available data related to treatment risks are from Women s Health Initiative (WHI) studies, which evaluated oral CE 0.625 mg with or without MPA 2.5 mg relative to placebo in postmenopausal women. Other combinations and dosage forms of estrogens and progestins were not studied. Outcomes reported from clinical trials using CE with or without MPA should be assumed to be similar for other doses and other dosage forms of estrogens and progestins until comparable data becomes available. Monitoring Parameters Routine physical examination that includes blood pressure and Papanicolaou smear, breast exam, mammogram. Monitor for signs of endometrial cancer. Adequate diagnostic measures, including endometrial sampling, if indicated, should be performed to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding. Monitor for loss of vision, sudden onset of proptosis, diplopia, migraine; signs and symptoms of thromboembolic disorders; glycemic control in patients with diabetes; lipid profiles in patients being treated for hyperlipidemias; thyroid function in patients on thyroid hormone replacement therapy; liver function tests; signs of virilization (eg, hirsutism, acne, deepening of voice, clitoromegaly) Menopausal symptoms: Assess need for therapy at 3- to 6-month intervals Pregnancy Risk Factor X Pregnancy Considerations [US Boxed Warning]: Estrogens should not be used during pregnancy. This product is specifically contraindicated during pregnancy. Refer to the Estrogens (Esterified) monograph and the Testosterone monograph for additional information. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience nausea, vomiting, cramps, bloating, hair loss, enlarged breasts, decreased libido, acne, or dark patches on face. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), edema, angina, shortness of breath, coughing up blood, severe headache, severe abdominal pain, severe dizziness, passing out, vision changes, bulging eyes, contact lens discomfort, lump in breast, breast soreness or pain, nipple discharge, vaginal bleeding, vaginitis, depression, mood changes, memory impairment, urinary retention or change in amount of urine passed, painful urination, deep voice, or increased facial hair (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about conjugated estrogens/methyltestosterone Drug Images Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: sex hormone combinations Related treatment guides Postmenopausal Symptoms} Drug Status Availability Discontinued X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug WADA Class Anti-Doping Classification Conjugated estrogens / methyltestosterone Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Sex hormone combinations Related Drugs sex hormone combinations Prempro , Lo Loestrin Fe , Estratest , Microgestin Fe 1 / 20 , Activella , Loestrin 24 Fe Postmenopausal Symptoms estradiol , Premarin , Estrace , Prempro , conjugated estrogens , Climara , Estrogel , Vivelle , Premarin Vaginal , Vivelle-Dot , Menest , Minivelle , Estratest , Delestrogen , Activella , Femring , Evamist , Lopreeza , CombiPatch , estradiol / norethindrone , Divigel , Mimvey , More... Conjugated estrogens / methyltestosterone Images Conjugated estrogens / methyltestosterone systemic conjugated estrogens 0.625 mg / methyltestosterone 5 mg (Ayerst 878 ) View larger images} } which on reflection


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