Names and pronunciation
(me-drox′ee-proe-jess′te-rone) Depo-Provera, Depo-SubQ Provera 104, Medroxy , Meprogest , Proclin , Provera
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Drug reference
(me-drox′ee-proe-jess′te-rone) Depo-Provera, Depo-SubQ Provera 104, Medroxy , Meprogest , Proclin , Provera
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Func. class.: Antineoplastic, hormone, contraceptive
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Chem. class.: Progesterone derivative
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Do not confuse: medroxyPROGESTERone/ methylPREDNISolone Provera/Proscar/Prozac
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ACTION: Inhibits secretion of pituitary gonadotropins, which prevents follicular maturation and ovulation; antineoplastic action against endometrial cancer
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USES: Uterine bleeding (abnormal); secondary amenorrhea; prevention of endometrial changes associated with estro- gen replacement therapy (ERT); contraceptive
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CONTRAINDICATIONS: Preg- nancy, hypersensitivity, reproductive can- cer, genital bleeding (abnormal, undiag- nosed), missed abortion, stroke, cerebrovascular disease, cervical cancer, hepatic disease, uterine/vaginal cancer
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Black Box Warning: Breast cancer, MI, stroke, thromboembolic disease, throm- bophlebitis Precautions: Breastfeeding, hyperten- sion, asthma, blood dyscrasias, gallblad- der disease, HF, diabetes mellitus, bone disease, depression, migraine headache, seizure disorders, renal/hepatic disease, family history of cancer of breast or reproductive tract, bone mineral density loss, ocular disorders, AIDS/HIV, alcohol- ism, children, hyperlipidemia, cardiac disease Black Box Warning: Dementia, osteo- porosis Black Box Warning: This product should not be given to those with breast cancer, MI, stroke, thromboembolic disorders; assess for these conditions before using • Bone mineral density loss: those tak- ing anticoagulants, corticosteroids with Depo-Provera or Depo-SubQ Provera are at greater risk Black Box Warning: Use of product shown to increase dementia in women ≥65 yr old; use may increase osteopo- rosis in long-term treatment; those who smoke also at greater risk; adequate cal- cium and vit D should be taken • Ectopic pregnancy: severe abdominal pain may indicate ectopic pregnancy if patient is pregnant Black Box Warning: Long-term use de- creases bone density; exercise, calcium, vitamin D, supplements can help lessen osteoporosis • Review package insert with patient; patient must understand all possible ad- verse reactions • Pregnancy/breastfeeding: not to use in pregnancy; to report suspected preg- nancy; that fertility returns 6-12 mo after discontinuing; not to breastfeed
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SIDE EFFECTS CNS: Dizziness, headache, migraines, depression, fatigue, nervousness CV: Thrombophlebitis, edema, thrombo- embolism, stroke, PE, MI GI: Nausea, increased weight, abdomi- nal pain GU: Amenorrhea, cervical erosion, break- through bleeding, dysmenorrhea, vaginal candidiasis, breast changes, vaginitis INTEG: Acne, hirsutism, alopecia, injec- tion-site reaction META: Hyperglycemia MS: Decreased bone density SYST: Angioedema, anaphylaxis, breast cancer
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INTERACTIONS Decrease: medroxyPROGESTERone ac- tion—strong CYP3A4 inducers (carBAMaze- pine, phenytoin, rifAMPin, rifabutin, PHE- Nobarbital); avoid concurrent use Increase: medroxyPROGESTERone level— strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole, atazanavir, indinavir, ritonavir, voriconazole), avoid using together Increase or Decrease: medroxyPROGES- TERone levels—NNRTIs, protease inhibi- tors; may diminish progestin level; to provide contraception use nonhormonal method Decrease: bone mineral density—anti- coagulants, corticosteroids Decrease: contraception—carBAMaze- pine, phenytoin, rifAMPin, rifabutin; avoid concurrent use, or use additional nonhormonal method of contraception Drug/Lab Test Increase: LFTs, HDL, triglycerides, coag- ulation tests Decrease: GTT Drug/Herb Decreased levels—St. John’s wort; avoid concurrent use
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DOSAGE AND ROUTES Secondary amenorrhea • Adult: PO 5-10 mg/day × 5-10 days, start during any time of menstrual cycle Uterine bleeding • Adult: PO 5-10 mg/day × 5-10 days starting on 16th or 21st day of menstrual cycle With ERT • Adult: PO 5-10 mg daily × 10-14 or more days/mo (sequential estrogen); 2.5-5 mg daily (continuous estrogen) Contraceptive • Adult (women): IM (contraceptive inj) 150 mg (Depo-Provera) q13wk; SUBCUT (depot SUBCUT; Depo-SubQ Provera 104 inj) 104 mg 12-14 wk, give first dose during the first 5 days of men- strual period, only within the first 5 days postpartum (no breastfeeding), only at 6th postpartum wk (breastfeeding) Endometriosis pain • Adult: SUBCUT 104 mg q12-14wk; begin on day 5 of normal menses; avoid use >2 yr Hot flashes/symptoms of menopause (unlabeled) • Adult (female): PO 20 mg/day; IM 150 mg monthly
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Available forms: Tabs 2.5, 5, 10 mg; inj susp, 104 mg/0.65 mL; 150, 400 mg/mL
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Administer: • Store in dark area PO route • Give without regard to food • Take missed dose as soon as possible unless close to next dose IM route • Visually inspect for particulate matter or discoloration before use Depo-Provera contraceptive injection suspension • IM only, never IV; use only 150 mg/mL vial • Instruct patient on risks and warnings associated with hormonal contraceptives (see Patient Information) • The possibility of pregnancy should be excluded before giving the first dose of medroxyPROGESTERone or whenever >14 wk has passed since the last dose • Do not dilute • Shake vigorously immediately before administration • Inject deeply into the gluteal or deltoid muscle; aspirate before injection to avoid injection into a blood vessel Depo-Provera sterile aqueous suspen- sion, preserved • IM only, never IV • Instruct patient on risks and warnings associated with progestin use (see Pa- tient Information) • Shake vigorously immediately before M use • When multidose vials are used, take special care to prevent contami- nation • Inject deeply into the gluteal or deltoid muscle; aspirate before injection SUBCUT route Depo-SubQ Provera 104 contraceptive injection suspension only • For subcut only, never give IM or IV • Instruct patient on risks and warnings associated with hormonal contraceptives (see Patient Information) • Shake vigorously for at least 1 min before use • Inject the entire contents of the pre- filled syringe subcut into the anterior thigh or abdomen, avoiding bony areas and the umbilicus; press lightly on the injection site with a clean cotton pad for a few seconds; do not rub the area
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Assess: • Menstrual history: duration of men- ses, bleeding, spotting, age at menarche, regularity; start on any day in those with amenorrhea, or on day 16 or 21 in dys- functional bleeding • Pelvic exam, Pap smear, pregnancy test before treatment, periodically • Severe allergic reaction, angioede- ma; have EPINEPHrine and resuscitative equipment available • Weight daily; notify prescriber of weekly weight gain >5 lb; bone mineral density • B/P at beginning of treatment and pe- riodically • Hepatic studies: ALT, AST, bilirubin base- line and periodically during long-term therapy; triglycerides, caution if preexisting elevation, product may exacerbate levels • Mental status: affect, mood, behavioral changes, depression
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Evaluate: • Therapeutic response: decreased ab- normal uterine bleeding, absence of amenorrhea
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To take with food if nausea occurs • To have complete physical exam, in- cluding reproductive exam, yearly • To avoid sunlight or to use sunscreen; photosensitivity can occur • To report breast lumps, vaginal bleeding, edema, jaundice, dark urine, clay-colored stools, dyspnea, headache, blurred vision, abdominal pain, sudden change in speech/ coordination, numbness or stiffness in legs, chest pain; males to report impo- tence, gynecomastia immediately • That product doesn’t protect against sexually transmitted diseases, including HIV • That injection (subcut) must be given q3mo for contraception; missing dose may lead to pregnancy
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PHARMACOKINETICS PO: Duration 3-5 days; IM duration 3-4 mo; excreted in urine and feces, breast milk; metabolized in liver, half-life 14.5 hr
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• Adult: PO 5-10 mg/day × 5-10 days, start during any time of menstrual cycle Uterine bleeding
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• Adult: PO 5-10 mg/day × 5-10 days starting on 16th or 21st day of menstrual cycle With ERT
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• Adult: PO 5-10 mg daily × 10-14 or more days/mo (sequential estrogen); 2.5-5 mg daily (continuous estrogen) Contraceptive
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• Adult (women): IM (contraceptive inj) 150 mg (Depo-Provera) q13wk; SUBCUT (depot SUBCUT; Depo-SubQ Provera 104 inj) 104 mg 12-14 wk, give first dose during the first 5 days of men- strual period, only within the first 5 days postpartum (no breastfeeding), only at 6th postpartum wk (breastfeeding) Endometriosis pain
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• Adult: SUBCUT 104 mg q12-14wk; begin on day 5 of normal menses; avoid use >2 yr Hot flashes/symptoms of menopause (unlabeled)
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• Adult (female): PO 20 mg/day; IM 150 mg monthly
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