"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
See PRECAUTIONS for possible adverse effects on the fetus
Reproductive System and Breast Disorders
- breakthrough bleeding
- change in menstrual flow
- changes in cervical erosion and cervical secretions
- breast tenderness and galactorrhea
- erectile dysfunction
Nervous System Disorders
- mental depression
General Disorders and Administration Site Conditions
- injection site reaction, injection site pain/tenderness, injection site persistent atrophy/indentation/dimpling, lipodystrophy acquired, injection site nodule/lump
- change in weight (increase or decrease)
Skin And Subcutaneous Tissue Disorders
- skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash
- acne, alopecia and hirsutism
- rash (allergic) with and without pruritis
Immune System Disorders
- corticoid-like effects (e.g., Cushingoid syndrome)
Metabolism And Nutrition Disorders
A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g. retinal thrombosis and optic neuritis.
The following adverse reactions have been observed in patients receiving estrogenprogestin combination drugs:
- rise in blood pressure in susceptible individuals
- premenstrual syndrome
- changes in libido
- changes in appetite
- cystitis-like syndrome
- loss of scalp hair
- erythema multiforma
- erythema nodosum
- hemorrhagic eruption
The following laboratory results may be altered by the use of estrogen-progestin combination drugs:
- increased sulfobromophthalein retention and other hepatic function tests
- coagulation tests: increase in prothrombin factors VII, VIII, IX, and X
- metyrapone test
- pregnanediol determinations
- thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values
Read the Depo-Provera (medroxyprogesterone) Side Effects Center for a complete guide to possible side effects
Aminoglutethimide administered concomitantly with DEPO-PROVERA Sterile Aqueous Suspension may significantly depress the serum concentrations of medroxyprogesterone acetate. DEPO-PROVERA users should be warned of the possibility of decreased efficacy with the use of this or any related drugs.
Medroxyprogesterone acetate is metabolized primarily by hydroxylation via the CYP3A4. Though no formal drug interaction trials have been conducted, concomitant administration of strong CYP3A inhibitors is expected to increase concentrations of medroxyprogesterone acetate, whereas the concomitant administration of strong CYP3A inducers is expected to decrease medroxyprogesterone acetate concentrations. Therefore, coadministration with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort) should be avoided.
Laboratory Test Interactions
The pathologist should be advised of progestin therapy when relevant specimens are submitted. The following laboratory tests may be affected by progestins including DEPOPROVERA Sterile Aqueous Suspension:
- Plasma and urinary steroid levels are decreased (e.g. progesterone, estradiol, pregnanediol, testosterone, cortisol).
- Gonadotropin levels are decreased.
- Sex-hormone binding globulin concentrations are decreased.
- Protein bound iodine and butanol extractable protein bound iodine may increase. T3 uptake values may decrease.
- Coagulation test values for prothrombin (Factor II), and Factors VII, VIII, IX, and X may increase.
- Sulfobromophthalein and other liver function test values may be increased.
- The effects of medroxyprogesterone acetate on lipid metabolism are inconsistent. Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol have been observed in studies.
Read the Depo-Provera Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/28/2016
Additional Depo-Provera Information
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