Dosing & Uses
Dosage Forms & Strengths
tablet
- 2.5mg
- 5mg
- 10mg
injectable IM suspension
- 150mg/mL
- 400mg/mL
prefilled syringe suspension
- 104mg/0.65mL
Metastatic Endometrial Carcinoma
Depo-Provera only
Indicated for adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial carcinoma
400-1000 mg IM qWeek initially
Metastatic Renal Carcinoma
Depo-Provera only
Indicated for adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic renal carcinoma
400-1000 mg IM qWeek initially
Secondary Amenorrhea
Provera only
Indicated for secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer
5 or 10 mg PO qDay for 5-10 days; therapy may start at any time
Progestin withdrawal bleeding usually occurs within 3-7 days after discontinuing medroxyprogesterone
Abnormal Uterine Bleeding
Provera only
Indicated for abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer
5 or 10 mg PO qDay for 5-10 days; begin day 16 or 21 of the menstrual cycle
Progestin withdrawal bleeding usually occurs within 3-7 days after discontinuing medroxyprogesterone
Endometrial Hyperplasia Reduction
Provera only
Indicated for prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625-mg tablets
5 or 10 mg PO qDay for 12-14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day or 16th day of the cycle; start at the lowest dose
Lowest effective dose has not been determined
Contraception
Depo-Provera SubQ 104 only
Indicated for prevention of pregnancy in females of reproductive potential
104 mg SC every 12-14 weeks
Sexually active women who have regular menses: Administer first injection only during the first 5 days of a normal menstrual period
Breastfeeding women: Administer first injection during or after the sixth postpartum week
Use for >2 years is not recommended (unless other birth control methods or medical therapies for endometriosis-associated pain are considered inadequate) due to the impact on bone mineral density (BMD) with long-term use
Endometriosis-Associated Pain
Depo-Provera SubQ 104 only
Indicated for prevention of pregnancy in females of reproductive potential
104 mg SC every 12-14 weeks
Sexually active women who have regular menses: Administer first injection only during the first 5 days of a normal menstrual period
Breastfeeding women: Administer first injection during or after the sixth postpartum week
Use for >2 years is not recommended (unless other birth control methods or medical therapies for endometriosis-associated pain are considered inadequate) due to the impact on bone mineral density (BMD) with long-term use
Immune Thrombocytopenic Purpura (Orphan)
Orphan indication sponsor
- ZaBeCor Pharmaceutical Company, LLC; 821 Westview Street; Philadelphia, PA 19119
Dosage Modifications
Renal impairment
- IM or PO: Not studied
Hepatic impairment
-
IM
- Do not use by women with significant liver disease; discontinue if jaundice or disturbances of liver function occur
-
PO
- Majority of medroxyprogesterone (MPA) is eliminated via hepatic metabolism
- In patients with advanced liver disease, MPA disposition was significantly altered (reduced elimination)
In patients with fatty liver, the mean percent dose excreted in the 24-hr urine as intact MPA after a 10 mg or 100 mg dose was 7.3% and 6.4%, respectively
Dosing Considerations
Switching from another method of contraception to Depo-SubQ Provera 104
- Combined hormonal contraceptives: Administer first SC injection within 7 days after the last day of using the combined hormonal contraceptive method (ie, within 7 days after taking the last active pill)
- Implant: Administer the first SC injection on the day of implant removal
- Contraceptive vaginal ring or transdermal system: Administer the first SC injection on the day the next ring or transdermal system should be inserted or applied
- Depot medroxyprogesterone acetate injectable suspension for IM use (DMPA-IM): Administer SC injection 12-14 weeks after the last dose of DMPA-IM
-
Intrauterine device (IUD) or intrauterine System (IUS)
- Administer first SC injection on the day of IUD/IUS removal
- If IUD/IUS is not removed on the first day of the menstrual cycle, use a nonhormonal backup method of birth control for the first 7 days after SC administration
Limitations of use
Depo-SubQ Provera
- Not recommended as a long-term (ie, >2 years) birth control method or therapy for endometriosis-associated pain unless other options are considered inadequate
Contraception
Depo-Provera SubQ 104 only
Indicated for prevention of pregnancy in females of reproductive potential
104 mg SC every 12-14 weeks
Sexually active women who have regular menses: Administer first injection only during the first 5 days of a normal menstrual period
Breastfeeding women: Administer first injection during or after the sixth postpartum week
Use for >2 years is not recommended (unless other birth control methods or medical therapies for endometriosis-associated pain are considered inadequate) due to the impact on bone mineral density (BMD) with long-term use
Endometriosis-Associated Pain
Depo-Provera SubQ 104 only
Indicated for prevention of pregnancy in females of reproductive potential
104 mg SC every 12-14 weeks
Sexually active women who have regular menses: Administer first injection only during the first 5 days of a normal menstrual period
Breastfeeding women: Administer first injection during or after the sixth postpartum week
Use for >2 years is not recommended (unless other birth control methods or medical therapies for endometriosis-associated pain are considered inadequate) due to the impact on bone mineral density (BMD) with long-term use
Dosage Modifications
Renal impairment
IM or PO: Not studied
Hepatic impairment
-
IM
- Do not use by women with significant liver disease; discontinue if jaundice or disturbances of liver function occur
-
PO
- Majority of medroxyprogesterone (MPA) is eliminated via hepatic metabolism
- In patients with advanced liver disease, MPA disposition was significantly altered (reduced elimination)
- In patients with fatty liver, the mean percent dose excreted in the 24-hr urine as intact MPA after a 10 mg or 100 mg dose was 7.3% and 6.4%, respectively
Dosing Considerations
Switching from another method of contraception to Depo-SubQ Provera 104
- Combined hormonal contraceptives: Administer first SC injection within 7 days after the last day of using the combined hormonal contraceptive method (ie, within 7 days after taking the last active pill)
- Implant: Administer the first SC injection on the day of implant removal
- Contraceptive vaginal ring or transdermal system: Administer the first SC injection on the day the next ring or transdermal system should be inserted or applied
- Depot medroxyprogesterone acetate injectable suspension for IM use (DMPA-IM): Administer SC injection 12-14 weeks after the last dose of DMPA-IM
- Intrauterine device (IUD) or intrauterine System (IUS) H5
- Administer first SC injection on the day of IUD/IUS removal
- If IUD/IUS is not removed on the first day of the menstrual cycle, use a nonhormonal backup method of birth control for the first 7 days after SC administration
Limitations of use
-
Depo-SubQ Provera
- Not recommended as a long-term (ie, >2 years) birth control method or therapy for endometriosis-associated pain unless other options are considered inadequate
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (21)
- abametapir
abametapir will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.
- acitretin
acitretin decreases effects of medroxyprogesterone by unknown mechanism. Avoid or Use Alternate Drug. Contraceptive failure may result.
- apalutamide
apalutamide will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- brigatinib
brigatinib will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Brigatinib induces CYP3A4 in vitro. Coadministration of hormonal contraceptives with brigatinib can result in decreased concentrations and loss of efficacy. Brigatinib can cause fetal harm. Women should use an effective nonhormonal method of contraception during treatment and for at least 4 months after the last brigatinib dose.
- darunavir
darunavir will decrease the level or effect of medroxyprogesterone by unspecified interaction mechanism. Avoid or Use Alternate Drug. Oral formulation only
- fexinidazole
fexinidazole will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.
- idelalisib
idelalisib will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- ivosidenib
ivosidenib will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
- lesinurad
lesinurad decreases effects of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Use additional methods of nonhormonal contraception. Do not rely on hormonal contraception alone when taking lesinurad.
- lorlatinib
lorlatinib will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- mavacamten
mavacamten will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Progestin and ethinyl estradiol are CYP3A4 substrates. Mavacamten may decrease systemic exposures of ethinyl estradiol and progestin, which may lead to contraceptive failure or an increase in breakthrough bleeding. Advise patients to use a contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) or add nonhormonal contraception (eg, condoms) during coadministration and for 4 months after last mavacamten dose.
- mifepristone
mifepristone will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.
- nelfinavir
nelfinavir will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- pacritinib
medroxyprogesterone will decrease the level or effect of pacritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ribociclib
ribociclib will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ritonavir
ritonavir will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- saquinavir
saquinavir will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- sugammadex sodium
sugammadex sodium decreases effects of medroxyprogesterone by receptor binding competition. Avoid or Use Alternate Drug. In vitro binding studies showed that sugammadex may bind to progestogen, thereby decreasing progestogen exposure. Therefore, a sugammadex bolus dose is considered to be equivalent to missing dose(s) of hormonal contraceptives containing an estrogen or progestogen. If an oral contraceptive is taken on the same day of sugammadex, or the patient has a transdermal or implant hormonal contraceptive, the patient must use an additional, nonhormonal contraceptive method or back-up method of contraception (eg, condoms and spermicides) for the next 7 days.
- tucatinib
tucatinib will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- voriconazole
voriconazole will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- voxelotor
voxelotor will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.
Monitor Closely (67)
- albiglutide
medroxyprogesterone decreases effects of albiglutide by pharmacodynamic antagonism. Use Caution/Monitor. Medroxyprogesterone may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- amobarbital
amobarbital will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- armodafinil
armodafinil will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- atazanavir
atazanavir, medroxyprogesterone. Either decreases effects of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternatives if available.
- bosentan
bosentan will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- carbamazepine
carbamazepine will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Contraceptirve failure possible
- cenobamate
cenobamate will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
- ceritinib
ceritinib will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- clarithromycin
clarithromycin will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- clobazam
clobazam will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Clobazam is a weak CYP3A4 inducer; effectiveness of hormonal contraceptives may be diminished when given concurrently with clobazam. Additional non-hormonal forms of contraception are recommended.
- crofelemer
crofelemer increases levels of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.
- dabrafenib
dabrafenib will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.
- darunavir
darunavir will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- dexamethasone
dexamethasone will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- efavirenz
efavirenz will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- elagolix
elagolix decreases levels of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.
- encorafenib
encorafenib, medroxyprogesterone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.
- enzalutamide
enzalutamide will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptive failure possible. Use alternative if available.
- etravirine
etravirine will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- exenatide injectable solution
medroxyprogesterone decreases effects of exenatide injectable solution by pharmacodynamic antagonism. Use Caution/Monitor. Estrogens may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Montior for glycemic control in diabetic patients.
- exenatide injectable suspension
medroxyprogesterone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Estrogens may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- fedratinib
fedratinib will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- fosamprenavir
fosamprenavir will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fosphenytoin
fosphenytoin will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- grapefruit
grapefruit will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternative if available.
- iloperidone
iloperidone increases levels of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.
- imatinib
imatinib will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- indinavir
indinavir will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- insulin degludec
medroxyprogesterone decreases effects of insulin degludec by pharmacodynamic antagonism. Use Caution/Monitor. Progestins may impair glucose tolerance.
- insulin degludec/insulin aspart
medroxyprogesterone decreases effects of insulin degludec/insulin aspart by pharmacodynamic antagonism. Use Caution/Monitor. Progestins may impair glucose tolerance.
- insulin inhaled
medroxyprogesterone decreases effects of insulin inhaled by pharmacodynamic antagonism. Use Caution/Monitor. Progestins may impair glucose tolerance.
- isoniazid
isoniazid will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- istradefylline
istradefylline will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
- itraconazole
itraconazole will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ketoconazole
ketoconazole will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lamotrigine
medroxyprogesterone will decrease the level or effect of lamotrigine by increasing hepatic clearance. Use Caution/Monitor. Combination oral contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation.
- levoketoconazole
levoketoconazole will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- liraglutide
medroxyprogesterone decreases effects of liraglutide by pharmacodynamic antagonism. Use Caution/Monitor. Medroxyprogesterone may decrease hypoglycemic effects of antidiabetics by impairing glucose tolerance. Monitor for glycemic control in diabetic patients.
- lopinavir
lopinavir will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lumacaftor/ivacaftor
lumacaftor/ivacaftor will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- metformin
medroxyprogesterone decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor.
- mitotane
mitotane decreases levels of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.
- nafcillin
nafcillin will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- nefazodone
nefazodone will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nevirapine
nevirapine will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nicardipine
nicardipine will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternative if available.
- oxcarbazepine
oxcarbazepine will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- pentobarbital
pentobarbital will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- phenobarbital
phenobarbital will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Contraceptirve failure possible
- phenytoin
phenytoin will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Contraceptirve failure possible
- posaconazole
posaconazole will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternative if available.
- primidone
primidone will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- quinidine
quinidine will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternative if available.
- rifabutin
rifabutin will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Contraceptirve failure possible. Use alternative if available.
- rifampin
rifampin will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Contraceptirve failure possible
- rifapentine
rifapentine will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Contraceptirve failure possible
- rucaparib
rucaparib will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- secobarbital
secobarbital will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- siponimod
siponimod and medroxyprogesterone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- St John's Wort
St John's Wort will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Contraceptirve failure possible
- stiripentol
stiripentol, medroxyprogesterone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
- tazemetostat
tazemetostat will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- tesamorelin
tesamorelin will decrease the level or effect of medroxyprogesterone by altering metabolism. Use Caution/Monitor. Use alternative contraception
- tipranavir
tipranavir will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternative if available.
Minor (6)
- acetazolamide
acetazolamide will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cyclophosphamide
cyclophosphamide will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- larotrectinib
larotrectinib will increase the level or effect of medroxyprogesterone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- maitake
maitake increases effects of medroxyprogesterone by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).
- taurine
medroxyprogesterone decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.
Adverse Effects
>10%
SC
- Dysfunctional uterine bleeding (irregular, increase, decrease, spotting) (18%)
1-10%
SC
- Headache (9%)
- Increased weight (7%)
- Amenorrhea (6%)
- Injection site reactions (6%)
- Vaginitis, including candidiasis and bacterial (5%)
- Abdominal pain (4%)
- Urinary tract infections (4%)
- Acne (4%)
- Depression (3%)
- Decreased libido (3%)
- Nausea (3%)
- Back pain (3%)
- Breast pain/tenderness (2%)
- Fatigue (2%)
- Anxiety (1%)
- Irritability (1%)
- Dizziness (1%)
<1%
SC
- Breast lump
- Anemia
- Drug hypersensitivity
- Weight decreased
- Fluid retention
- Facial palsy
- Syncope
- Paresthesia
- Somnolence
- Tachycardia
- Hot flushes
- Asthma
- Dyspnea
- Diarrhea
- Abdominal distension
- Urticaria
- Pruritus
- Dry skin
- Dysmenorrhea
- Galactorrhea
- Dyspareunia
- Chest pain
Frequency Not Defined
IM
- Breakthrough bleeding
- Spotting
- Change in menstrual flow
- Amenorrhea
- Changes in cervical erosion and cervical secretions
- Breast tenderness and galactorrhea
- Erectile dysfunction
- Headache
- Dizziness
- Somnolence
- Convulsions
- Nervousness
- Euphoria
- Mental depression
- Insomnia
- Edema
- Pyrexia
- Fatigue
- Malaise
- Injection site reaction (eg, pain/tenderness, persistent atrophy/indentation/dimpling)
- Change in weight
- Cholestatic jaundice
- Skin sensitivity reactions
- Acne
- Alopecia
- Hirsutism
- Rash (allergic) with and without pruritus
- Anaphylactoid reactions
- Angioedema
- Nausea
- Corticoid-like effects (eg, Cushingoid syndrome)
- Hypercalcemia
PO
- Genitourinary system: Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions
- Breast: Breast tenderness, mastodynia, galactorrhea
- Cardiovascular: Thromboembolic disorders (eg, thrombophlebitis, pulmonary embolism)
- Gastrointestinal: Nausea, cholestatic jaundice
- Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
- Eyes: Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.
- Central nervous system: Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
- Miscellaneous: Hypersensitivity reactions (for example, anaphylaxis and anaphylactoid reactions, angioedema), rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance.
Estrogen plus progestin therapy
- Genitourinary system: Abnormal uterine bleeding/spotting, or flow; breakthrough bleeding; spotting; dysmenorrheal/pelvic pain; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.
- Breasts: Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
- Cardiovascular: Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
- Gastrointestinal: Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.
- Skin: Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
- Eyes: Retinal vascular thrombosis, intolerance to contact lenses.
- Central nervous system: Headache, migraine, dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
- Miscellaneous: Increase or decrease in weight, reduced carbohydrate tolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides
Warnings
Black Box Warnings
Bone mineral density loss (injection)
- Women who IM or SC medroxyprogesterone may lose significant bone mineral density
- Bone loss is greater with increasing duration of use and may not be completely reversible
- It is unknown if SC or IM use during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life
- IM or SC use is not recommended as a long-term (ie, longer than 2 years) birth control method or medical therapy for endometriosis-associated pain unless other options are considered inadequate
Cardiovascular risks (oral)
- Estrogens with progestins should not be used to prevent cardiovascular disease
- Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary embolism, and DVT in postmenopausal women aged 50-79 years undergoing 5.6 years of treatment with oral conjugated estrogens (CE) 0.625 mg/day plus medroxyprogesterone acetate (MPA) 2.5 mg/day versus placebo
Breast cancer
- Estrogen plus progestin substudy has demonstrated increased risk of invasive breast cancer
Dementia risks (oral)
- Estrogens with progestins should not be used to prevent dementia
- Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of probable dementia in postmenopausal women aged 65 years or older undergoing 4 years of treatment with CE 0.625 mg/day plus MPA 2.5 mg/day versus placebo
- In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins
- Therefore, 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
Contraindications
Undiagnosed abnormal genital 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 arterial thromboembolic disease (eg, stroke, MI), or a history of these conditions
Known anaphylactic reaction or angioedema
Known liver impairment or disease
Known or suspected pregnancy
Cautions
Use caution in patients with asthma, diabetes mellitus, history of depression, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas
Therapy reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD); BMD should be evaluated when a woman needs to continue to receive therapy long-term; in adolescents, interpretation of BMD results should take into account patient age and skeletal maturity
Prolonged use of SC or IM use may result in significant loss of bone density; long-term use is not recommended (ie, >2 years) as birth control method or medical therapy for endometriosis-associated pain unless other options considered inadequate
In women with osteoporosis risk factors, other birth control methods or therapies for endometriosis-associated pain should be considered risk/benefit analysis for SC use; SC can pose an additional risk in patients with risk factors for osteoporosis (eg, metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis, or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids)
Consider ectopic pregnancy if a woman receiving therapy becomes pregnant or complains of severe abdominal pain
Provide emergency medical treatment if anaphylaxis occurs
Not for use in children prior to menarche
Inform medroxyprogesterone contraceptive does not protect against HIV infection and other sexually transmitted diseases
Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer
In some epidemiologic studies, use of estrogen plus progestin and estrogen-only products, in particular for 5 or more years, has been associated with increased risk of ovarian cancer; however, duration of exposure associated with increased risk is not consistent across all epidemiologic studies and some report no association
Depression and other mood disorders have been reported; discontinue if it occurs
Most women experienced changes in menstrual bleeding patterns, such as amenorrhea, irregular unpredictable spotting or bleeding, prolonged spotting or bleeding, or heavy bleeding; in cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated
Monitor blood pressure at regular intervals with estrogen plus progestin therapy
In women with preexisting hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis; consider discontinuation of treatment if pancreatitis occurs
Progestins may cause some degree of fluid retention; women with condition influenced by fluid retention including epilepsy, migraine, asthma, cardiac or renal dysfunction, require careful observation
Estrogen therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur
Therapy should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis; diplopia or migraine; if examination reveals papilledema or retinal vascular lesions, medication should be withdrawn
Patients may exhibit suppressed adrenal function; medroxyprogesterone acetate may have cortisol-like glucocorticoid activity and provide negative feedback to hypothalamus or pituitary; this may result in decreased plasma cortisol levels, decreased cortisol secretion, and low plasma ACTH levels; use of sterile aqueous suspension may, due to its cortisol-like glucocorticoid activity, also produce Cushingoid symptoms such as weight gain, edema/fluid retention, and facial swelling
Monitor patients for hepatic dysfunction periodically and temporarily interrupt therapy if patient develops hepatic dysfunction; do not resume use until markers of liver function return to normal
Any multidose use of vials may lead to contamination unless strict aseptic technique is observed
Treatment with progestin may mask the onset of the climacteric
Persistent injection site reactions may occur after administration due to inadvertent SC administration or release of drug into SC space while removing the needle
Some patients receiving progestins may exhibit a decrease in glucose tolerance; therefore, patients with diabetes may be at greater risk of hyperglycemia
Delayed return of ovulation or fertility
- Return to ovulation is likely to be delayed after stopping SC injection
- Median time to ovulation was 10 months after last injection
- Earliest return to ovulation was 6 months after last injection
Cardiovascular disorders
- An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy
- Discontinue estrogen plus progestin therapy immediately if any of these events occur or be suspected,
- Risk factors for arterial vascular disease (eg, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) should be managed appropriately
Malignant neoplasms
- Studies of addition of progestin for ≥10 days of cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone; possible risks associated with the use of progestins with estrogens compared to estrogen-alone regimens include an increased risk of breast cancer
- Monitor women with a strong family history of breast cancer
- Use may mask onset of menopause in women treated for endometrial cancer
Pregnancy & Lactation
Pregnancy
There is no use for medroxyprogesterone in pregnancy and therefore should be discontinued during pregnant
Women who may have been exposed to medroxyprogesterone injections had little or no increased risk of birth defects in early pregnancy
It is unknown whether medroxyprogesterone acetate can cause fetal harm when administered to a pregnant woman
Fertility
- Medroxyprogesterone acetate at high doses is an antifertility drug and high doses would be expected to impair fertility until discontinuing treatment
Lactation
Published studies report the presence of medroxyprogesterone acetate in human milk
Exercise caution when medroxyprogesterone acetate is administered to a nursing woman
Although medroxyprogesterone acetate is detectable in the milk of mothers receiving DMPA-IM, milk composition, quality, and amount do not appear to be adversely affected
Effects on milk production and lactation initiation/duration remain unclear when administered before 6 weeks after delivery
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Progestin inhibits the secretion of gonadotropins, which primarily prevents follicular maturation and ovulation and causes thickening cervical mucus; these actions contribute to its contraceptive effects
Suppression of serum estradiol concentrations is likely to be responsible for the therapeutic effect on endometriosis-associated pain
Absorption
Peak plasma concentration
- Oral (single dose): 1.01 ng/mL (2 x 10-mg doses); 0.805 ng/mL (8 x 2.5-mg doses)
- Oral (multiple doses): 0.71 ng/mL (10-mg dose)
Peak plasma time
- Oral (single dose): 2.65 ng/mL (2 x 10-mg doses); 2.22 ng/mL (8 x 2.5-mg doses)
- Oral (multiple doses): 2.83 ng/mL (10-mg dose)
AUC
- Oral (single dose): 6.95 ng/mL (2 x 10-mg doses); 5.62 ng/mL (8 x 2.5-mg doses)
- Oral (multiple doses): 6.01 ng/mL (10-mg dose)
Distribution
Protein bound: ~90%
Vd
- Oral (single dose): 78,024 L (2 x 10-mg doses); 62,748 L (8 x 2.5-mg doses)
- Oral (multiple doses): 40,654 ng/mL (10-mg dose)
Metabolism
- Following oral dosing, MPA is extensively metabolized in the liver via hydroxylation, with subsequent conjugation and elimination in the urine
Elimination
Half-life
- Oral (single dose): 12.1 hr (2 x 10-mg doses); 11.6 hr (8 x 2.5-mg doses)
- Oral (multiple doses): 16.6 ng/mL (10-mg dose)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Provera oral - | 2.5 mg tablet |  | |
| Provera oral - | 10 mg tablet |  | |
| Provera oral - | 5 mg tablet |  | |
| medroxyprogesterone oral - | 10 mg tablet |  | |
| medroxyprogesterone oral - | 2.5 mg tablet |  | |
| medroxyprogesterone oral - | 10 mg tablet |  | |
| medroxyprogesterone oral - | 5 mg tablet | | |
| medroxyprogesterone oral - | 10 mg tablet | | |
| medroxyprogesterone oral - | 2.5 mg tablet | | |
| medroxyprogesterone oral - | 5 mg tablet |  | |
| medroxyprogesterone oral - | 2.5 mg tablet |  | |
| medroxyprogesterone oral - | 5 mg tablet |  | |
| Depo-Provera intramuscular - | 400 mg/mL vial |  | |
| Depo-Provera intramuscular - | 150 mg/mL solution |  | |
| Depo-Provera intramuscular - | 150 mg/mL vial |  | |
| Depo-Provera intramuscular - | 150 mg/mL vial |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL solution |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL vial |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL vial |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL vial |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL solution |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL vial |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL vial |  | |
| Depo-SubQ provera 104 subcutaneous - | 104 mg/0.65 mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
medroxyprogesterone oral
MEDROXYPROGESTERONE - ORAL
(med-ROX-ee-proe-JES-ter-one)
COMMON BRAND NAME(S): Provera
WARNING: Medroxyprogesterone is sometimes used with another medication (a type of estrogen) as combination hormone replacement therapy (HRT) in women after menopause. Combination HRT can rarely cause very serious side effects such as heart disease (for example, heart attacks), stroke, serious blood clots (possibly in the lungs and legs), dementia, and breast cancer. Some of these risks appear to depend on the length of treatment and other factors. Combination HRT should be used for the shortest possible length of time at the lowest effective dose so you can obtain the benefits and minimize the chance of serious side effects from long-term treatment. Combination HRT should not be used to prevent heart disease or dementia. Discuss the risks and benefits of treatment and your personal health history with your doctor. If you take combination HRT, check with your doctor regularly (for example, every 3-6 months) to see if you still need to take it.If you use this medication for an extended period, you should have a complete physical exam at regular intervals (for example, once a year) or as directed by your doctor. See Notes section.
USES: Medroxyprogesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes and is given to replace the hormone when your body is not making enough of it. This medication has several uses. In women who are not pregnant and not going through menopause, this medication is used to treat abnormal bleeding from the uterus and to restore normal menstrual periods in women who have stopped having them for several months (amenorrhea).Medroxyprogesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (such as hot flashes). Medroxyprogesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus.This medication must not be used to test for pregnancy.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth as directed by your doctor. Follow the dosing schedule carefully. Ask your doctor if you have any questions. The dosage is based on your medical condition and response to therapy.For use in combination hormone replacement therapy with estrogens, take this medication usually once daily for the prescribed number of days each month as directed.For the treatment of stopped menstrual periods (amenorrhea) and abnormal bleeding from the uterus, take this drug usually once daily for 5-10 days during the second half of the planned menstrual cycle or as directed by your doctor. Withdrawal bleeding usually occurs within 3-7 days after you stop taking the medication.Inform your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, drowsiness, or weight gain/loss may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: unusual vaginal bleeding (such as spotting, breakthrough bleeding), mental/mood changes (such as depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, unusual tiredness.This medication may rarely cause very serious (possibly fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs, blindness). Get medical help right away if you experience any of the following: chest/jaw/left arm pain, weakness on one side of the body, trouble speaking, sudden vision changes (such as blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking medroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Some Canadian brands of this product may contain inactive ingredients (such as soybean), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, bleeding in the brain, liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), family medical history (especially breast lumps and cancer), kidney disease, obesity, heart disease (such as past heart attacks, coronary artery disease, congestive heart failure), high blood pressure, seizures, migraine headaches, asthma, high blood levels of cholesterol/fats, depression, diabetes, strokes.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (such as on a long plane flight). You may need to stop the medication for a time or take special precautions because of the increased risk for blood clots. Ask your doctor for more details.Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.This drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: aminoglutethimide.Other medications can affect the removal of medroxyprogesterone from your body, which may affect how medroxyprogesterone works. Examples include rifamycins (such as rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin).This medication can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this medication.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe nausea and vomiting.
NOTES: Do not share this medication with others.Keep all appointments with your doctor and the laboratory. You should have a complete physical examination that includes blood pressure measurements and breast/pelvic examinations at regular intervals (such as once a year) or as directed by your doctor. Follow your doctor's instructions on how to examine your own breasts and report any lumps right away. You should also be regularly screened for cervical cancer (for example, by having a Pap test) and have periodic mammograms as determined by your doctor. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised July 2022. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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