Adult Dosing

Secondary amenorrhea

• 5-10 mg PO Daily x 5-10 days; start at any time in cycle

Dysfunctional uterine bleeding

• 5-10 mg PO Daily x 5-10 days starting on day 16 or day 21 of menstrual cycle

Reduction of endometrial hyperplasia; postmenopausal women receiving estrogen

• Monophasic regimen: 2.5-5 mg PO Daily with 0.625 mg conj. estrogens
• Biphasic regimen: 5-10 mg PO Daily for 12-14 consecutive days per month with 0.625 mg conj. estrogens

Pediatric Dosing

• Safety and efficacy in pediatrics have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer
• For reduction of the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving oral conjugated estrogens of 0.625 mg/day

• Hypersensitivity to any of the ingredients of the product
• Undiagnosed abnormal vaginal bleeding
• Known, suspected, or history of breast cancer
• Known or suspected estrogen or progesterone dependent neoplasia
• Active DVT/PE or a history of these conditions
• Active or recent (within the last 1yr) arterial thromboembolic disease (e.g. stroke/MI/PE)
• Known liver dysfunction or disease
• Missed abortion
• As a diagnostic test for pregnancy
• Known or suspected pregnancy

• Avoid usage of estrogens with progestins for the prevention of cardiovascular disease or dementia
• Increased risk of MI, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) have occurred in postmenopausal women (50-79 yrs of age) during 5.6 yrs of therapy with daily oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo has occurred
• Increased risk of developing probable dementia in postmenopausal women 65 yrs of age during 4 yrs of therapy with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo has occurred
• These risks may be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Prescribe estrogens with or without progestins at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Mild-moderate impairment: Decrease dose or frequency; dose adjustments not defined
• Severe impairment: Contraindicated

• An increased risk of stroke, deep vein thrombosis (DVT), pulmonary embolism, and MI has occurred with estrogen plus progestin therapy. On occurrence or suspicion of these events immediately discontinue estrogen plus progestin therapy. Appropriately manage risk factors for arterial vascular disease and/or venous thromboembolism, obesity and systemic lupus erythematosus
• Increased risk of stroke have occurred in women receiving daily conjugated estrogens (CE 0.625 mg) plus medroxyprogesterone acetate (MPA 2.5mg) compared to women receiving placebo
• Risk of coronary heart disease and venous thromboembolism (VTE) is associated with this drug
• Risk of breast cancer may increase with duration of use and appear to return to baseline in about 5 yrs after ceasing therapy. Increase in abnormal mammograms may occur; further evaluation is essential in such case. Perform yearly breast examinations in women and advise them to perform monthly breast self-examinations. Schedule mammography examinations based on patient age, risk factors, and prior mammogram results
• Increased risk of endometrial cancer may occur with duration of use. Risk may increase 15-24 folds for 5-10 yrs or more. Risk may persist for at least 8-15 yrs after discontinuation of therapy
• Undertake adequate diagnostic measures, including endometrial sampling when essential to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding
• Increased risk for development of ovarian cancer exists
• Dementia may occur in patients undergoing therapy with this drug
• Discontinue medication pending examination on sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia or migraine. Permanently discontinue therapy if examination reveals papilledema or retinal vascular lesions
• Increased risk of breast cancer, adverse effects on lipoprotein metabolism (lowering HDL, raising LDL) and impairment of glucose tolerance may occur with the use of progestins with estrogens
• Undertake adequate diagnostic measures in cases of undiagnosed abnormal vaginal bleeding
• Monitor blood pressure at regular intervals
• Plasma triglycerides may be elevated leading to pancreatitis and other complications in patients with pre-existing hypertriglyceridemia
• Exercise caution in patients having a history of cholestatic jaundice associated with past estrogen use or with pregnancy. Discontinue medication on recurrence of such event
• Edema may occur. Carefully observe patients who have conditions which might be influenced by this factor, such as cardiac or renal dysfunction
• Exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas may occur. Use cautiously in women with these conditions
• Increased risk of minor birth defects may occur in children whose mothers were exposed to progestins during the first trimester of pregnancy
• Monitor BP, pap smear, pelvic examination at baseline; then q12 month; and monitor serum triglycerides and glucose closely on presence of diabetes mellitus
• Severe hypercalcemia has been reported

Cautions: Use cautiously in

• History of liver disease
• Renal disease
• CV disease
• Hypertension
• CHF
• Dementia
• Seizure disorder
• History of depression
• Asthma
• Hypocalcemia

Pregnancy Category:X

Breastfeeding: Medroxyprogesterone acetate is considered the hormonal contraceptive of choice during all stages of lactation. Does not does not adversely affect the composition of milk, the growth and development of the infant, or the milk supply. Administration sooner than 3 days postpartum may inhibit lactogenesis and interfere with the establishment of lactation. It is prudent to administer this drug no sooner than 3 days postpartum when lactation is established. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 March 2011). Manufacturer suggests to avoid using this drug during lactation.

• CV: Thromboembolism, thrombophlebitis, pulmonary embolism, MI, hypertension, edema
• CNS: Stroke, headache, asthenia, depression, insomnia, somnolence, dizziness, nervousness, migraine, chorea, mood disturbances, irritability, exacerbation of epilepsy, dementia
• GI: Hepatic adenoma, gallbladder disease, cholestatic jaundice, nausea, vomiting, abdominal cramps, weight changes, bloating, appetite changes, pancreatitis, enlargement of hepatic hemangiomas
• ENDO: Breast tenderness, breast enlargement, nipple discharge, galactorrhea, decreased glucose tolerance
• DERM: Rash, urticaria, pruritus, hirsutism, alopecia, acne, chloasma, melasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, angioedema
• GU: Abnormal uterine bleeding, menstrual irregularities, amenorrhea, breakthrough bleeding, spotting, changes in libido, breast cancer, mastodynia, changes in cervical erosion and cervical secretions, changes in cervical ectropion, ovarian cancer, endometrial hyperplasia, endometrial cancer, dysmenorrheal/pelvic pain, increase in size of uterine leiomyomata, vaginitis, vaginal candidiasis, breast pain, fibrocystic breast changes
• EENT: Neuro-ocular lesions, retinal thrombosis, optic neuritis, intolerance to contact lenses
• METABOLIC: Hypocalcemia, increased triglycerides
• RESP: Exacerbation of asthma
• MUSC: Arthalgias, leg cramps
• MISC: Pyrexia, fatigue, aggravation of porphyria, anaphylactoid/anaplylactic reactions

• Progestin; inhibits pituitary gonadotropin release, prevents follicular maturation and ovulation, transforms proliferative into secretory endometrium; maintains pregnancy
• Rapidly absorbed
• Metabolized by liver; CYP450: Unknown
• Excreted in urine
• Half-life: 16.6 hrs

US Trade Name(s)

• Provera

US Availability

medroxyprogesterone (generic)

• TABS: 2.5, 5, 10 mg

Provera

• TABS: 2.5, 5, 10 mg

Canadian Trade Name(s)

• Apo-medroxy
• Gen-medroxy
• Medroxy
• Novo-medrone
• Provera
• Provera Pak

Canadian Availability

medroxyprogesterone (generic)

• TABS: 2.5, 5, 10 mg

Apo-medroxy, Provera

• TABS: 2.5, 5, 10, 100 mg

Gen-medroxy, Novo-medrone

• TABS: 2.5, 5, 10 mg

Medroxy

• TABS: 2.5, 5 mg

Provera Pak

• TABS: 5, 10 mg

UK Trade Name(s)

• Climanor
• Provera

UK Availability

Climanor

• TABS: 5 mg

Provera

• TABS: 2.5, 5, 10, 100, 200, 400 mg

Australian Trade Name(s)

• Medroxyhexal
• Provera
• Ralovera

Australian Availability

Medroxyhexal

• TABS: 10 mg

Provera

• TABS: 2.5, 5, 10, 100, 200, 250, 500 mg

Ralovera

• TABS: 5, 10 mg

[Outline]

Endocrine/Metabolic

Sex Hormones

Progestins

Obstetrics/Gynecology

Sex Hormones

Progestins

Hematology/Oncology

Antineoplastics

Hormones/Antineoplastics

Pricing data from www.DrugStore.com in U.S.A.

• Provera 2.5 MG TABS [Bottle] (PFIZER U.S.)
  30 mg = $37.79
  90 mg = $97.62
• Provera 10 MG TABS [Bottle] (PFIZER U.S.)
  30 mg = $62.99
  90 mg = $178.48
• Provera 5 MG TABS [Bottle] (PFIZER U.S.)
  30 mg = $50.39
  90 mg = $142.78

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Medroxyprogesterone 10 MG Oral Tablet (BARR LABORATORIES, INC.)
• Medroxyprogesterone 10 MG Oral Tablet (Greenstone LLC)
• Medroxyprogesterone 2.5 MG Oral Tablet (BARR LABORATORIES, INC.)
• Medroxyprogesterone 2.5 MG Oral Tablet (Greenstone LLC)
• Medroxyprogesterone 5 MG Oral Tablet (BARR LABORATORIES, INC.)
• Medroxyprogesterone 5 MG Oral Tablet (Greenstone LLC)
• Provera 10 MG Oral Tablet (Pharmacia and Upjohn Company)
• Provera 2.5 MG Oral Tablet (Pharmacia and Upjohn Company)
• Provera 5 MG Oral Tablet (Pharmacia and Upjohn Company)