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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(me DROKS ee proe JES te rone)
Generic Available (U.S.)
Yes
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Secondary amenorrhea or abnormal uterine bleeding due to hormonal imbalance; reduction of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving conjugated estrogens; prevention of pregnancy; management of endometriosis-associated pain; adjunctive therapy and palliative treatment of recurrent and metastatic endometrial carcinoma
Use: Unlabeled
Treatment of low-grade endometrial stromal sarcoma
Pregnancy Risk Factor
X
Pregnancy Considerations
In general, there is not an increased risk of birth defects following inadvertent use of the injectable medroxyprogesterone contraceptives early in pregnancy. There is an increased risk of minor birth defects in children whose mothers take progesterones during the first 4 months of pregnancy. Hypospadias has been reported in male babies and mild masculinization of the external genitalia has been reported in female babies exposed during the first trimester. High doses are used to impair fertility. Ectopic pregnancies have been reported with use of the MPA contraceptive injection. Median time to conception/return to ovulation following discontinuation of MPA contraceptive injection is 10 months following the last injection.
Lactation
Enters breast milk
Breast-Feeding Considerations
Composition, quality, and quantity of breast milk are not affected; adverse developmental and behavioral effects have not been noted following exposure of infant to MPA while breast-feeding. The manufacturer does not recommend the use of MPA tablets in breastfeeding mothers.
Contraindications
Hypersensitivity to medroxyprogesterone or any component of the formulation; history of or current thrombophlebitis or venous thromboembolic disorders (including DVT, PE); cerebral vascular disease; severe hepatic dysfunction or disease; carcinoma of the breast or other estrogen- or progesterone-dependent neoplasia; undiagnosed vaginal bleeding; missed abortion, diagnostic test for pregnancy, pregnancy
Warnings/Precautions
Boxed warnings:
• Breast cancer: See “Concerns related to adverse effects” below.
• Bone mineral density loss: See “Concerns related to adverse effects” below.
• Cardiovascular disease: See “Disease-related concerns” below.
• Dementia: See “Concerns related to adverse effects” below.
• Long-term use: See “Other warnings/precautions” below.
• Patient education: See “Other warnings/precautions” below.
• Risks vs benefits: See “Other warnings/precautions” below.
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Anaphylaxis or anaphylactoid reactions have been reported with use of the injection; medication for the treatment of hypersensitivity reactions should be available for immediate use.
• Bone mineral density loss: [U.S. Boxed Warning]: Prolonged use of medroxyprogesterone contraceptive injection may result in a loss of bone mineral density (BMD). It is not known if use during adolescence or early adulthood will decrease peak bone mass accretion or increase the risk for osteoporotic fractures later in life. Loss is related to the duration of use, may not be completely reversible on discontinuation of the drug, and incidence is not significantly different between the SubQ and I.M. dosage forms. The impact on peak bone mass in adolescents should be weighed against the potential for unintended pregnancies in treatment decision. Consider alternative contraceptive methods in patients at risk for osteoporosis (eg, metabolic bone disease, family history of osteoporosis, chronic use of medications associated with osteoporosis such as corticosteroids).
• Breast cancer: [U.S. 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. Use is contraindicated in patients with known or suspected breast cancer.
• Dementia: [U.S. 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.
• Ectopic pregnancy: When used for contraception, the possibility of ectopic pregnancy should be considered in patients with abdominal pain.
• Endometrial carcinoma: MPA is used to reduce the risk of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving conjugated estrogens. 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.
• 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).
• Retinal vascular thrombosis: Discontinue pending examination in cases of sudden partial or complete vision loss, sudden onset of proptosis, diplopia, or migraine; discontinue permanently if papilledema or retinal vascular lesions are observed on examination.
• Vaginal bleeding: Unscheduled bleeding/spotting may occur. Presentation of irregular, unresolving vaginal bleeding following previously regular cycles warrants further evaluation including endometrial sampling, if indicated, to rule out malignancy.
• Weight gain: Contraceptive therapy with medroxyprogesterone commonly results in an average weight gain of ~2.5 kg after 1 year and ~3.7 kg after 2 years of treatment.
Disease-related concerns:
• Carbohydrate intolerance: May have adverse effects on glucose tolerance; use caution in women with diabetes.
• Cardiovascular disease: [U.S. 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. If thrombosis develops with contraceptive treatment, discontinue treatment (unless no other acceptable contraceptive alternative).
• Depression: Use with caution in patients with a history of depression.
• Diseases exacerbated by fluid retention: Use with caution in patients with diseases which may be exacerbated by fluid retention, including asthma, epilepsy, migraine, cardiac, or renal dysfunction.
• Hepatic dysfunction: MPA is extensively metabolized in the liver. Discontinue if jaundice develops or if acute or chronic hepatic disturbances occur. Use is contraindicated with severe hepatic disease.
• Osteoporosis: Consider other methods of birth control in women with (or at risk for) osteoporosis.
Special populations:
• Pediatrics: Not for use prior to menarche.
• Surgical patients: Whenever possible, progestins in combination with estrogens should be discontinued at least 4-6 weeks prior to and for 2 weeks following elective surgery associated with an increased risk of thromboembolism or during periods of prolonged immobilization.
Other warnings/precautions:
• Long-term use: [U.S. Boxed Warning]: Long-term use (ie, >2 years) should be limited to situations where other birth control methods are inadequate.
• Patient education: [U.S. Boxed Warning]: Inform patients that injectable contraceptives do not protect against HIV infection or other sexually-transmitted diseases.
• Risks vs benefits: [U.S. 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.
Adverse Reactions
Adverse effects as reported with any dosage form; percent ranges presented are noted with the MPA I.M. contraceptive injection:
>5%:
Central nervous system: Dizziness, headache, nervousness
Endocrine & metabolic: Libido decreased, menstrual irregularities (includes bleeding, amenorrhea, or both)
Gastrointestinal: Abdominal pain/discomfort, weight gain (>10 lbs at 24 months: 38%)
1% to 5%:
Cardiovascular: Edema
Central nervous system: Depression, fatigue, insomnia
Dermatologic: Acne, alopecia, rash
Endocrine & metabolic: Breast pain, hot flashes
Gastrointestinal: Bloating, nausea
Genitourinary: Dysmenorrhea, leukorrhea, vaginitis
Local: Injection site reaction (SubQ administration): Atrophy, induration, pain
Neuromuscular & skeletal: Arthralgia, backache, leg cramp, weakness
<1%, postmarketing, and/or case reports: Allergic reaction, anaphylaxis, anaphylactoid reactions, anemia, angioedema, anxiety, appetite changes, asthma, axillary swelling, blood dyscrasia, body odor, BMD loss, breast cancer, breast changes, cervical cancer, chest pain, chills, chloasma, cholestatic jaundice, deep vein thrombosis, diaphoresis, diarrhea, drowsiness, dry skin, dyspareunia, dyspnea, facial palsy, fainting, fever, galactorrhea, genitourinary infections, glucose tolerance decreased, hirsutism, hoarseness, jaundice, lack of return to fertility, lactation decreased, libido increased, melasma, nipple bleeding, oligomenorrhea, optic neuritis, osteoporosis, osteoporotic fractures, paralysis, paresthesia, pruritus, pulmonary embolus, rectal bleeding, retinal thrombosis, scleroderma, seizure, somnolence, syncope, tachycardia, thirst, thrombophlebitis, urticaria, uterine hyperplasia, vaginal cysts, varicose veins
In addition: Depo-Provera® aqueous suspension: Residual lump, sterile abscess, or skin discoloration at the injection
Metabolism/Transport Effects
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Induces CYP3A4 (weak/moderate)
Drug Interactions
Acitretin: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Given the potential for progestin-only preparations to fail to prevent pregnancy during acitretin therapy, such products should not be relied upon. Alternative, nonhormonal forms of contraception must be employed during acitretin therapy. Risk D: Consider therapy modification
Aminoglutethimide: May increase the metabolism of Progestins. Management: Progestin-containing contraceptives are not recommended; consider the use of alternative, nonhormonal contraceptives. Risk D: Consider therapy modification
Aprepitant: May decrease the serum concentration of Contraceptives (Progestins). Management: Alternative or additional methods of contraception should be used both during treatment with aprepitant or fosaprepitant and for at least one month following the last aprepitant/fosaprepitant dose. Risk D: Consider therapy modification
ARIPiprazole: CYP3A4 Inducers may decrease the serum concentration of ARIPiprazole. Management: Double aripiprazole dose when initiating concomitant therapy with a CYP3A4 inducer (e.g., carbamazepine). Monitor response and adjust aripiprazole dose as clinically indicated. If CYP3A4 inducer is discontinued, reduce aripiprazole dose to 10-15 mg/day. Risk D: Consider therapy modification
Artemether: May decrease the serum concentration of Contraceptives (Progestins). Management: Consider the use of an alternative (i.e., non-hormonal) means of contraception in all women of childbearing potential who are using artemether. Risk D: Consider therapy modification
Axitinib: CYP3A4 Inducers (Weakly to Moderately Effective) may decrease the serum concentration of Axitinib. Risk X: Avoid combination
Barbiturates: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. Risk D: Consider therapy modification
Benzodiazepines (metabolized by oxidation): Contraceptives (Progestins) may increase the serum concentration of Benzodiazepines (metabolized by oxidation). Risk C: Monitor therapy
Bexarotene: May decrease the serum concentration of Contraceptives (Progestins). Management: Women of childbearing potential receiving bexarotene should use two reliable forms of contraception (including at least one nonhormonal form). Risk D: Consider therapy modification
Bexarotene (Systemic): May decrease the serum concentration of Contraceptives (Progestins). Management: Women of childbearing potential receiving bexarotene should use two reliable forms of contraception (including at least one nonhormonal form). Risk D: Consider therapy modification
Bile Acid Sequestrants: May decrease the serum concentration of Contraceptives (Progestins). Management: Administer oral progestin-containing contraceptives at least 1-4 hours prior to or 4-6 hours after administration of a bile acid sequestrant. Risk D: Consider therapy modification
Boceprevir: May increase the serum concentration of Contraceptives (Progestins). Management: Do not rely on systemic hormonal contraceptives for contraception during treatment with boceprevir. Patients receiving combination regimens containing ribavirin should use two alternative effective means of contraception. Risk D: Consider therapy modification
Bosentan: May decrease the serum concentration of Contraceptives (Progestins). Management: Use an alternative (i.e., non-hormonal) means of contraception for all women of childbearing potential who are using bosentan, and do not rely on hormonal contraceptives alone. Risk D: Consider therapy modification
CarBAMazepine: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. Risk D: Consider therapy modification
Clobazam: May decrease the serum concentration of Contraceptives (Progestins). Risk D: Consider therapy modification
Conivaptan: May increase the serum concentration of CYP3A4 Substrates (Low risk). Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Felbamate: May decrease the serum concentration of Contraceptives (Progestins). Management: Contraceptive failure is possible. Use of an alternative, nonhormonal method of contraception is recommended. Risk D: Consider therapy modification
Fosaprepitant: May decrease the serum concentration of Contraceptives (Progestins). The active metabolite aprepitant is likely responsible for this effect. Management: Alternative or additional methods of contraception should be used both during treatment with aprepitant or fosaprepitant and for at least one month following the last aprepitant/fosaprepitant dose. Risk D: Consider therapy modification
Fosphenytoin: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Risk D: Consider therapy modification
Griseofulvin: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Risk X: Avoid combination
Herbs (Progestogenic Properties) (eg, Bloodroot, Yucca): May enhance the adverse/toxic effect of Progestins. Risk C: Monitor therapy
LamoTRIgine: May decrease the serum concentration of Contraceptives (Progestins). Management: Women using progestin-only “minipill” products may be at risk for contraceptive failure; it is unclear if other progestin-containing products would be significantly impacted. Alternative, non-hormonal, means of contraception are recommended. Risk D: Consider therapy modification
Mifepristone: May diminish the therapeutic effect of Contraceptives (Progestins). Mifepristone may increase the serum concentration of Contraceptives (Progestins). Management: Women of childbearing potential should use an effective, nonhormonal means of contraception during and 4 weeks following mifepristone treatment. Risk D: Consider therapy modification
Mycophenolate: May decrease the serum concentration of Contraceptives (Progestins). Management: Use of an additional or alternative (nonhormonal) method of contraception should be considered. Risk D: Consider therapy modification
Nevirapine: May decrease the serum concentration of Contraceptives (Progestins). Management: Instruct patients receiving nevirapine to use an alternative or additional nonhormonal contraceptive. Nevirapine product labeling however suggests that depo-medroxyprogesterone acetate may be used as a sole method of contraception. Risk D: Consider therapy modification
OXcarbazepine: May decrease the serum concentration of Contraceptives (Progestins). Management: Contraceptive failure is possible. Use of an additional or alternative, nonhormonal method of contraception is recommended. Risk D: Consider therapy modification
Phenytoin: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Risk D: Consider therapy modification
Prucalopride: May decrease the serum concentration of Contraceptives (Progestins). Risk D: Consider therapy modification
Retinoic Acid Derivatives: May diminish the therapeutic effect of Contraceptives (Progestins). Retinoic Acid Derivatives may decrease the serum concentration of Contraceptives (Progestins). Management: Two forms of effective contraception should be used in patients receiving retinoic acid derivatives. Particularly, microdosed progesterone-only preparations may be inadequately effective. Risk D: Consider therapy modification
Rifamycin Derivatives: May decrease the serum concentration of Contraceptives (Progestins). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Risk D: Consider therapy modification
Saxagliptin: CYP3A4 Inducers may decrease the serum concentration of Saxagliptin. Risk C: Monitor therapy
Selegiline: Contraceptives (Progestins) may increase the serum concentration of Selegiline. Risk C: Monitor therapy
St Johns Wort: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Consider using a product other than St John's wort. Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Risk D: Consider therapy modification
Telaprevir: May decrease the serum concentration of Contraceptives (Progestins). Management: Two different nonhormonal forms of contraception are required for women of childbearing potential taking telaprevir. Hormonal contraceptives may be less effective during concurrent telaprevir and for up to 2 weeks after telaprevir discontinuation. Risk D: Consider therapy modification
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Topiramate: May decrease the serum concentration of Contraceptives (Progestins). Management: Caution patients that this combination may be associated with reduced contraceptive effectiveness. Consider adding an additional (non-hormonal) contraceptive method. Risk D: Consider therapy modification
Tranexamic Acid: Contraceptives (Progestins) may enhance the thrombogenic effect of Tranexamic Acid. Management: Ensure that the potential benefits of concurrent therapy outweigh the increased risk of potential thrombosis that accompanies use of tranexamic acid with hormonal contraceptives. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Contraceptives (Progestins) may diminish the anticoagulant effect of Vitamin K Antagonists. In contrast, enhanced anticoagulant effects have also been noted with some products. Management: When possible, concomitant hormonal contraceptives and coumarin derivatives should be avoided in order to eliminate the risk of thromboembolic disorders. Consider using an alternative, nonhormonal contraceptive. Risk D: Consider therapy modification
Voriconazole: May increase the serum concentration of Contraceptives (Progestins). Contraceptives (Progestins) may increase the serum concentration of Voriconazole. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may increase risk of osteoporosis).
Food: Bioavailability of the oral tablet is increased when taken with food; half-life is unchanged.
Herb/Nutraceutical: St John's wort may diminish the therapeutic effect of progestin contraceptives (contraceptive failure is possible).
Storage
Store at controlled room temperature.
Mechanism of Action
Inhibits secretion of pituitary gonadotropins, which prevents follicular maturation and ovulation; causes endometrial thinning
Pharmacodynamics/Kinetics
Absorption: Oral: Well absorbed; I.M.: Slow
Protein binding: 86% to 90% primarily to albumin; does not bind to sex hormone-binding globulin
Metabolism: Extensively hepatic via hydroxylation and conjugation; forms metabolites
Half-life elimination: Oral: 12-17 hours; I.M. (Depo-Provera® Contraceptive): ~50 days; SubQ: ~40 days
Time to peak: Oral: 2-4 hours; I.M. (Depo-Provera® Contraceptive): ~3 weeks; SubQ: ~1 week
Excretion: Urine
Dosage
Adolescents and Adults:
Amenorrhea: Oral: 5-10 mg/day for 5-10 days
Abnormal uterine bleeding: Oral: 5-10 mg for 5-10 days starting on day 16 or 21 of cycle
Contraception:
Depo-Provera® Contraceptive: I.M.: 150 mg every 3 months
depo-subQ provera 104™: SubQ: 104 mg every 3 months (every 12-14 weeks)
Endometriosis (depo-subQ provera 104™): SubQ: 104 mg every 3 months (every 12-14 weeks)
Adults:
Endometrial carcinoma, recurrent or metastatic (adjunctive/palliative treatment) (Depo-Provera®): I.M.: 400-1000 mg/week
Accompanying cyclic estrogen therapy, postmenopausal: Oral: 5-10 mg for 12-14 consecutive days each month, starting on day 1 or day 16 of the cycle; lower doses may be used if given with estrogen continuously throughout the cycle
Dosing adjustment in hepatic impairment: Use is contraindicated with severe impairment. Discontinue with jaundice or if liver function disturbances occur. Consider lower dose or less frequent administration with mild-to-moderate impairment. Use of the contraceptive injection has not been studied in patients with hepatic impairment; consideration should be given to not readminister if jaundice develops
Administration: I.M.
Depo-Provera® Contraceptive: Administer first dose during the first 5 days of menstrual period, or within the first 5 days postpartum if not breast-feeding, or at the sixth week postpartum if breast-feeding exclusively. Shake vigorously prior to administration. Administer by deep I.M. injection in the gluteal or deltoid muscle. When switching from combined hormonal contraceptives (estrogen plus progestin), the first injection should be on the day after the last active tablet or (at the latest) the day after the final inactive tablet. When switching from other contraceptive methods, ensure continuous contraceptive coverage.
Administration: Other
SubQ: depo-subQ provera 104™: Administer first dose during the first 5 days of menstrual period, or at the sixth week postpartum if breast-feeding. Shake vigorously prior to administration. Administer by SubQ injection in the anterior thigh or abdomen; avoid boney areas and the umbilicus. Administer over 5-7 seconds. Do not rub the injection area. When switching from combined hormonal contraceptives (estrogen plus progestin), the first injection should be within 7 days after the last active pill, or removal of patch or ring. If switching from the I.M. to SubQ formulation, the next dose should be given within the prescribed dosing period for the I.M. injection to assure continuous coverage.
Monitoring Parameters
Before starting therapy, a physical exam with reference to the breasts and pelvis are recommended, including a Papanicolaou smear. Exam may be deferred if appropriate prior to administration of MPA contraceptive injection; pregnancy should be ruled out prior to use. Monitor patient closely for loss of vision; sudden onset of proptosis, diplopia, or migraine; signs and symptoms of thromboembolic disorders; signs or symptoms of depression; glucose in patients with diabetes; or blood pressure. BMD with long-term use (per manufacturer).
Adequate diagnostic measures, including endometrial sampling, if indicated, should be performed to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding.
Test Interactions
The following tests may be decreased: Steroid levels (plasma and urinary), gonadotropin levels, SHBG concentration, T3 uptake
The following tests may be increased: Protein-bound iodine, butanol extractable protein-bound iodine, Factors II, VII, VIII, IX, X
Pathologist should be advised of estrogen/progesterone therapy when specimens are submitted.
Dietary Considerations
Ensure adequate calcium and vitamin D intake
Patient Education
You may experience sensitivity to sunlight, dizziness, anxiety, depression, changes in appetite, hot flashes, or decreased libido or increased body hair (reversible when drug is discontinued). Maintain adequate hydration, unless instructed to restrict fluid intake. Report swelling of face, lips, or mouth; absent or altered menses; abdominal pain; vaginal itching, irritation, or discharge; heat, warmth, redness, or swelling of extremities; or sudden onset change in vision.
Dental Health: Effects on Dental Treatment
Progestins may predispose the patient to gingival bleeding.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause dizziness, headache, depression, insomnia, nervousness, irritability, and mood disturbances
Mental Health: Effects on Psychiatric Treatment
The Women's Health Initiative (WHI) Memory Study reported an increased risk of developing dementia in postmenopausal women ≥65 years of age during 4 years of treatment with oral conjugated equine estrogens and medroxyprogesterone acetate relative to placebo (1.8% vs 0.9%). Relative risk was 2.05 (95% CI 1.21-3.48). Therefore, estrogens and progestins should not be used for the prevention of dementia. The WHI also reported an increased risk of stroke (29 vs 21 per 10,000 women-years) compared to women receiving placebo. The increase in risk was observed after the first year and persisted. May cause hypertriglyceridemia; monitor in patients receiving antipsychotics especially clozapine, olanzapine, and quetiapine.
Nursing: Physical Assessment/Monitoring
Instruct patient on appropriate dose scheduling.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension, as acetate: 150 mg/mL (1 mL)
Depo-Provera®: 400 mg/mL (2.5 mL)
Depo-Provera® Contraceptive: 150 mg/mL (1 mL) [contains polysorbate 80]
depo-subQ provera 104®: 104 mg/0.65 mL (0.65 mL) [contains polysorbate 80]
Tablet, oral, as acetate: 2.5 mg, 5 mg, 10 mg
Provera®: 2.5 mg, 5 mg, 10 mg [scored]
Pricing: U.S. (www.drugstore.com)
Suspension (Depo-Provera)
150 mg/mL (1): $100.78
400 mg/mL (2.5): $191.59
Suspension (MedroxyPROGESTERone Acetate)
150 mg/mL (1): $52.99
Tablets (MedroxyPROGESTERone Acetate)
2.5 mg (30): $12.99
5 mg (90): $18.99
10 mg (30): $18.99
Tablets (Provera)
2.5 mg (30): $37.79
5 mg (30): $50.39
10 mg (30): $62.99
References
American College of Obstetricians and Gynecologists Committee on Gynecologic Practice, ACOG Committee Opinion No. 415: "Depot Medroxyprogesterone Acetate and Bone Effects," Obstet Gynecol, 2008, 112(3):727-30.
Anderson GL, Chlebowski RT, Aragaki AK, et al, "Conjugated Equine Oestrogen and Breast Cancer Incidence and Mortality in Postmenopausal Women With Hysterectomy: Extended Follow-Up of the Women's Health Initiative Randomised Placebo-Controlled Trial," Lancet Oncol, 2012 [epub ahead of print].
Anderson GL, Limacher M, Assaf AR, et al, "Effects of Conjugated Equine Estrogen In Postmenopausal Women With Hysterectomy: The Women's Health Initiative Randomized Controlled Trial." JAMA, 2004, 291(14):1701-12.
Chlebowski RT, Kuller LH, Prentice RL, et al, "Breast Cancer After Use of Estrogen Plus Progestin in Postmenopausal Women," N Engl J Med, 2009, 360(6):573-87.
Hsia J, Langer RD, Manson JE, et al, "Conjugated Equine Estrogens and Coronary Heart Disease: The Women's Health Initiative," Arch Intern Med, 2006, 166(3):357-65.
Mørch LS, Løkkegaard E, Andreasen AH, et al, “Hormone Therapy and Ovarian Cancer,” JAMA, 2009, 302(3):298-305.
National Comprehensive Cancer Network® (NCCN), “Clinical Practice Guidelines in Oncology™: Uterine Neoplasms,” Version 1.2011. Available at http://www.nccn.org/professionals/physician_gls/PDF/uterine.pdf
North American Menopause Society [NAMS], "The 2012 Hormone Therapy Position Statement of The North American Menopause Society," Menopause, 2012, 19(3):257-71.
Rossouw JE, Anderson GL, Prentice RL, et al, “Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principle Results From the Women's Health Initiative Randomized Controlled Trial,”JAMA, 2002, 288(3):321-33.
Shumaker SA, Legault C, Rapp SR, et al, “Estrogen Plus Progestin and the Incidence of Dementia and Mild Cognitive Impairment in Postmenopausal Women: The Women's Health Initiative Memory Study: A Randomized Controlled Trial,” JAMA, 2003, 289(20):2651-62.
Thigpen JT, Brady MF, Alvarez RD, et al, “Oral Medroxyprogesterone Acetate in the Treatment of Advanced or Recurrent Endometrial Carcinoma: A Dose-Response Study by the Gynecologic Oncology Group,” J Clin Oncol, 1999, 17(6):1736-44.
International Brand Names
Lexi-Comp.com
Last full review/revision April 2012
Content last modified April 2012
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