Exprog-M is used to prevent pregnancy. It is a birth control method that works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.
Exprog-M does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
Exprog-M is also used with other medicines to help relieve symptoms of inoperable, recurrent, and metastatic (cancer that has already spread) endometrial or kidney cancer.
Exprog-M is to be administered only by or under the immediate supervision of your doctor.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Exprog-M (MPA) Injectable Suspension, USP is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use MPA Injectable Suspension, USP long-term.
How should I use Exprog-M?
Use Exprog-M (subcutaneous) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Exprog-M (subcutaneous). Talk to your pharmacist if you have questions about this information.
Exprog-M (subcutaneous) is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Exprog-M (subcutaneous) at home, a health care provider will teach you how to use it. Be sure you understand how to use Exprog-M (subcutaneous). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Exprog-M (subcutaneous) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Be sure you know when you should begin using Exprog-M (subcutaneous) according to your doctor's instructions. Discuss any questions or concerns with your doctor.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
Exprog-M (subcutaneous) is given every 12 to 14 weeks. It is very important that you return to your doctor's office for your next injection promptly at the end of the 12 to 14 week interval. If it has been more than 14 weeks since your last dose of Exprog-M (subcutaneous), contact your doctor. You may need to have a pregnancy test before receiving another dose.
If you miss a dose of Exprog-M (subcutaneous), contact your doctor right away.
Ask your health care provider any questions you may have about how to use Exprog-M (subcutaneous).
Uses of Exprog-M in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Abnormal uterine bleeding (tablet): Treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.
Amenorrhea, secondary (tablet): Treatment of secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.
Contraception (104 mg per 0.65 mL and 150 mg/mL injection): Prevention of pregnancy in females of reproductive potential.
Endometrial hyperplasia prevention (tablet): Prevention of endometrial hyperplasia in nonhysterectomized postmenopausal persons receiving daily oral conjugated estrogens 0.625 mg. Note: Due to safety considerations, when a progesterone is needed, use of micronized progesterone is preferred over Exprog-M (AACE [Goodman 2011]; AACE/ACE [Cobin 2017])
Endometriosis (104 mg/0.65 mL injection): Management of endometriosis-associated pain.
Off Label Uses
Abnormal uterine bleeding, acute
Data from a randomized, open-label clinical study support the use of oral Exprog-M in the treatment of acute uterine bleeding in nonpregnant, hemodynamically stable premenopausal women requiring emergent medical intervention. Additional data may be necessary to further define the role of Exprog-M in the management of this condition.
Each mL of suspension (vial) contains medroxyprogesterone acetate 150 mg, polyethylene glycol 3350 28.9 mg, polysorbate 80 2.41 mg, sodium chloride 8.68 mg, methylparaben 1.37 mg, propylparaben 0.15 mg and water for injection.
Each mL of suspension (prefilled syringe) contains medroxyprogesterone acetate 150 mg, polyethylene glycol 3350 28.5 mg, polysorbate 80 2.37 mg, sodium chloride 8.56 mg, methylparaben 1.35 mg, propylparaben 0.147 mg and water for injection.
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
Exprog-M is pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-,(6α).
Exprog-M contraceptive injection contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Exprog-M is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder that is stable in air and that melts between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.
Prevention of Pregnancy: The recommended dose is 150 mg of Exprog-M contraceptive injection every 3 months (13 weeks) administered by deep IM injection in the gluteal or deltoid muscle. Exprog-M should not be used as a long-term birth control method (ie, >2 years) unless other birth control methods are considered inadequate. Dosage does not need to be adjusted for body weight.
To ensure the patient is not pregnant at the time of the 1st injection, the 1st injection should be given only during the first 5 days of a normal menstrual period; only within the first 5-days postpartum if not breastfeeding; and if exclusively breastfeeding, only at the 6th postpartum week. If the time interval between injections is >13 weeks, the physician should determine that the patient is not pregnant before administering the drug. The efficacy of Exprog-M contraceptive injection depends on adherence to the dosage schedule of administration.
Switching from Other Methods of Contraception: When switching from other contraceptive methods, Exprog-M should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods (eg, patients switching from oral contraceptives should have their 1st injection of Exprog-M on the day after the last active tablet or at the latest, on the day following the final inactive tablet).
Administration: Exprog-M contraceptive injection should be shaken just before use to ensure that the dose being administered represents a uniform suspension.
Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products: If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives.
Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, and topiramate.
HIV-Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV-protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with NNRTIs.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
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 Exprog-M contraceptive injection:
Plasma and urinary steroid levels are decreased (eg, 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 Exprog-M 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.
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the 2 clinical trials with Exprog-M, over 3900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of Exprog-M. The population studied ranges in from 15-51 years, of which 46% were White, 50% non-White and 4.9% Unknown race. The patients received Exprog-M mg every 3-months (90 days). The median study duration was 13 months with a range of 1-84 months. Fifty eight percent (58%) of patients remained in the study after 13 months and 34% after 24 months.
Adverse reactions that were reported by >5% of subjects are: Body as a Whole*: Headache (16.5%), abdominal pain/discomfort (11.2%).
Metabolic/Nutritional*: Increased weight >10 lbs at 24 months (37.7%).
Urogenital*: Menstrual irregularities [bleeding (57.3% at 12 months, 32.1% at 24 months), amenorrhea (55% at 12 months, 68% at 24 months)].
Adverse reactions that were reported between 1% and 5% of subjects are: Body as a Whole*: Asthenia/fatigue (4.2%), backache (2.2%), dysmenorrhea (1.7%), hot flashes (1%).
Digestive*: Nausea (3.3%), bloating (2.3%).
Metabolic/Nutritional*: Edema (2.2%).
Musculoskeletal*: Leg cramps (3.7%), arthralgia (1%).
Nervous*: Depression (1.5%), insomnia (1%).
Skin and Appendages*: Acne (1.2%), no hair growth/alopecia (1.1%), rash (1.1%).
Urogenital*: Leukorrhea (2.9%), breast pain (2.8%), vaginitis (1.2%).
*Body system represented from COSTART medical dictionary.
Adverse reactions leading to study discontinuation in ≥2% subjects are bleeding (8.2%), amenorrhea (2.1%), weight gain (2%).
Post-Marketing Experience: The following adverse reactions have been identified during post approval use of Exprog-M.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking Exprog-M.
Adverse reactions reported during post-marketing experience are: Body as Whole*: Chest pain, Allergic reactions, fever, injection site pain, chills, axillary swelling.
Skin and Appendages*: Hirsutism, excessive sweating and body odor, dry skin, scleroderma.
Urogenital*: Cervical and breast cancer, lack of return to fertility, unexpected pregnancy, prevention of lactation, changes in breast size, breast lumps or nipple bleeding, galactorrhea, melasma, chloasma, increased libido, uterine hyperplasia, genitourinary infections, vaginal cysts, dyspareunia.
Known hypersensitivity to Exprog-M or any other ingredients of Exprog-M.
Known or suspected pregnancy or as a diagnostic test for pregnancy. Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. Known or suspected malignancy of breast. Significant liver disease. Undiagnosed vaginal bleeding.
Exprog-M should not be used as a long-term birth control method (ie, >2 years) unless other birth control methods are considered inadequate.
Use in pregnancy: Exprog-M should not be administered during pregnancy.
DailyMed. "MEDROXYPROGESTERONE ACETATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Exprog-M are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Exprog-M. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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