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 (19)
- 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.
- 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.
- 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 (73)
- 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.
- atogepant
medroxyprogesterone will decrease the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- axitinib
medroxyprogesterone decreases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
- 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.
- dienogest/estradiol valerate
medroxyprogesterone will decrease the level or effect of dienogest/estradiol valerate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Advise women to use alternative method of contraception or back-up method when moderate or weak enzyme inducer is used with combination contraceptives. Back-up contraception should be continued for 28 days after discontinuing medication to ensure contraceptive reliability.
- 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.
- isavuconazonium sulfate
medroxyprogesterone will decrease the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
- linagliptin
medroxyprogesterone will increase the level or effect of linagliptin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Use of alternative treatments is strongly recommended when linagliptin is to be administered with a CYP3A4 inducer
- 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.
- maraviroc
medroxyprogesterone increases levels of maraviroc by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity.
- 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.
- modafinil
modafinil 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.
- 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.
medroxyprogesterone will decrease the level or effect of tazemetostat 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.
- ubrogepant
medroxyprogesterone will decrease the level or effect of ubrogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Dose adjustment is recommended with concomitant use of ubrogepant and moderate and weak CYP3A4 inducers. (see Dosage Modifications)
Minor (2)
- 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 |
|---|---|---|---|
| Depo-SubQ provera 104 subcutaneous - | 104 mg/0.65 mL solution |  | |
| Provera oral - | 2.5 mg tablet |  | |
| Provera oral - | 5 mg tablet |  | |
| Provera oral - | 10 mg tablet |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL vial |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL vial |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL solution |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL solution |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL vial |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL vial |  | |
| medroxyprogesterone intramuscular - | 150 mg/mL vial |  | |
| 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 oral - | 5 mg tablet |  | |
| medroxyprogesterone oral - | 10 mg tablet |  | |
| medroxyprogesterone oral - | 5 mg tablet |  | |
| medroxyprogesterone oral - | 2.5 mg tablet |  | |
| medroxyprogesterone oral - | 2.5 mg tablet | | |
| medroxyprogesterone oral - | 10 mg tablet |  | |
| medroxyprogesterone oral - | 2.5 mg tablet |  | |
| medroxyprogesterone oral - | 5 mg tablet | | |
| medroxyprogesterone oral - | 10 mg tablet | |
Copyright © 2010 First DataBank, Inc.
Patient Handout
medroxyprogesterone subcutaneous
MEDROXYPROGESTERONE ACETATE (CONTRACEPTIVE) - SUBCUTANEOUS
(med-ROX-ee-proe-JES-ter-one AS-e-tate)
COMMON BRAND NAME(S): Depo-SubQ Provera
WARNING: This medication may cause serious bone loss which may not return to normal after you stop using it. The risk of bone loss increases with longer use of this medication. An important time when your bones continue to build up is during your teenage and young adult years. Use of this medication may increase the risk of weak/brittle bones (osteoporosis), which can lead to broken bones when you are older. Talk with your doctor about the risks and benefits of this medication and other birth control choices.Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.This medication should not be used longer than 2 years for birth control or for treatment of endometriosis unless other methods/treatments will not work for you.
USES: This medication is used to prevent pregnancy. Medroxyprogesterone is like a natural hormone made by the body.Medroxyprogesterone is also used to treat endometriosis. It works by lowering the amount of certain hormones in the body and decreasing the growth of abnormal tissues that cause endometriosis. This helps reduce pain and other symptoms.Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using medroxyprogesterone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection under the skin in the stomach area or upper thigh as directed by your doctor, usually once every 3 months. Before starting this medication, you must have a negative pregnancy test. The first injection is usually given during the first 5 days of your menstrual period or 6 weeks after the delivery of your baby if you are breast-feeding. Follow your doctor's exact instructions if you are switching from another birth control method. Repeat the same dose every 12 to 14 weeks.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.Be sure the medication is at room temperature before use. Shake the syringe well for at least 1 minute before each injection.Use this medication regularly to get the most benefit from it. If more than 14 weeks pass between injections, you could become pregnant. Use a form of non-hormonal birth control (such as condoms, diaphragm, spermicide) to prevent pregnancy until you can get the next injection. Your doctor may direct you to first have a pregnancy test before your next injection.
SIDE EFFECTS: Nausea, bloating, headache, changes in appetite, weight gain, tiredness, swelling, acne, hot flashes, breast tenderness, or irritation/pain at the injection site may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Your periods may stop completely after you have been using this medication for about a year. If this occurs, your periods will normally return after you stop using this medication. If you miss a period and have missed an injection, or if more than 14 weeks pass between injections and you think you might be pregnant, contact your doctor for a pregnancy test.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.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as new/worsening depression), changes in sexual interest/ability, swelling of the ankles/feet, bone pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding), persistent nausea/vomiting, severe stomach/abdominal/pelvic pain, unusual weakness/tiredness, dark urine, yellowing skin/eyes, seizure.This medication may increase your risk of breast cancer. Tell your doctor right away if you have symptoms such as a lump in the breast, nipple discharge. Ask your doctor for more details.This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if you have: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.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 using medroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), unexplained vaginal bleeding, asthma, abnormal breast exam, personal or family history of cancer (especially breast or cervical cancer), daily use of alcohol/tobacco, depression, diabetes, eating disorder (anorexia), heart problems (such as heart failure, irregular heartbeat, previous heart attack), high blood pressure, kidney disease, liver disease (including tumors), high cholesterol or triglyceride (blood fat) levels, migraines, seizures, stroke or "mini" stroke (transient ischemic attack), personal or family history of bone disease (such as osteoporosis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).It may take longer for you to become pregnant after you stop using this medication. Consult your doctor.This medication must 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: warfarin.Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.This medication may interfere with certain laboratory tests (including certain hormone levels, blood tests for clotting factors, thyroid/liver function tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
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.
NOTES: Do not share this medication with others.Keep all regular medical and laboratory appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Your doctor may test your bone density while you are using this medication. Be sure to get enough vitamin D and calcium in your diet. Ask your doctor or pharmacist about calcium/vitamin D supplements to help keep your bones healthy. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose and more than 14 weeks have passed between injections, ask your doctor right away for instructions. You will need a pregnancy test to make sure you are not pregnant before getting another injection. Other birth control methods (such as spermicide, condoms) must be used to protect you from getting pregnant until you can get the next injection.
STORAGE: Store at room temperature away from light and moisture. Do not refrigerate. Do not store in the bathroom. Do not reuse single-use syringes. Discard any unused portion. 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 November 2021. Copyright(c) 2021 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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