Each 1ml contains 150mg medroxyprogesterone acetate. Medroxyprogesterone acetate api manufacturers suppliers. Depoprovera sterile aqueous suspension chemical family. The intramuscular is given by injection shot in the buttock or upper arm muscle. Women who use medroxyprogesterone acetate contraceptive injection may lose. Medroxyprogesterone is a synthetic derivative of progesterone administered as an acetate salt medroxyprogesterone acetate with antiestrogenic activity. Medroxyprogesterone acetate is a synthetic, acetate derivative of the sex hormone progesterone. Depotmedroxyprogesterone acetate world health organization. Medroxyprogesterone acetate injectable suspension, 400 mgml trade name.
Medroxyprogesterone acetate api dmfs us drug master. Depoprovera medroxyprogesterone acetate product monograph page 7 of 53 note. Medroxyprogesterone acetate polyethylene glycol version. Depoprovera ci medroxyprogesterone acetate injectable suspension, for intramuscular use. We evaluated the pharmacokinetic profile of medroxyprogesterone acetate mpa following injection of deposubq provera 104 in the upper arm, a preferred injection site in developing countries. Medroxyprogesterone acetate, also known as depot medroxyprogesterone acetate in injectable form and sold under the brand name depoprovera among others, is a hormonal medication of the progestin type. Medroxyprogesterone acetate injectable suspension, usp ordering 150 mg per ml information 1 ml prefilled syringe ndc 5976245382 sales code f000158826 unit of sale syringe units per case 48 shipping case outer dimensions lxwxh 15. Germany trgs 900 twas mgm3 medroxyprogesterone acetate 2ugm3, skin no data available water for injection germany dfg mak mgm3 average molecular weight 200600 no data available slovakia oel twa mg. Serum medroxyprogesterone acetate mpa concentrations and ovarian function following intramuscular injection of depompa. The subcutaneous is given in the abdomen or thighs.
Injection site abscess and injection site infections have been reported. It is also used to treat endometriosis, abnormal uterine bleeding, abnormal sexuality in. Depot medroxyprogesterone acetate, dpma, contraception, depo provera, ralovera, depo, progestin only, birth control, progestogen, progesterone, im injection note. Pharmacokinetics of depot medroxyprogesterone acetate contraception. Periodic administration of depot medroxyprogesterone acetate dmpa by. Provera medroxyprogesterone acetate dose, indications. Read the patient information leaflet provided by your pharmacist before you start using this product and each time you get a. List of drug master files dmf of medroxyprogesterone acetate active pharmaceutical ingredient api submitted to the u. It is a longacting contraceptive agent to be administered by deep intramuscular injection as described in the comparator smpcpil.
Instruct patient in correct method of monthly breast selfexamination. When used in high doses, medroxyprogesterone acetate depot suspension injection is an antifertility drug in females, inducing temporary infertility, and a return to ovulation and baseline fertility may be delayed after stopping treatment. Patients receiving medroxyprogesterone for cancer may notreceiveppi. I have received a pamphlet included with each injection that has information about the benefits and risks of dmpa and how to use dmpa. Depoprovera contraceptive injection ci, which is used as birth control. Additional guidance on submission requirements for. Dmpa is a longacting hormonal form of birth control. Summary statement of the proposal for inclusion, change or deletion.
Medroxyprogesterone acetate contraceptive injection should not be used as a longterm birth control method i. Dmpa is a sterile suspension of medroxyprogesterone acetate mpa in aqueous medium. It is used as a method of birth control and as a part of menopausal hormone therapy. The abdomen and thigh are recommended injection sites in the label for deposubq provera 104. See full prescribing information for complete boxed warning. Pharmacokinetics of subcutaneous depot medroxyprogesterone. Mixture relevant identified uses of the substance or mixture and uses advised against intended use. Fda website list of drug master files dmf of medroxyprogesterone acetate active pharmaceutical ingredient api submitted to the u. Medroxyprogesterone acetate inhibits in the usual dose range the secretion of pituitary gonadotropin which, in turn, prevents follicular maturation and ovulation. Medroxyprogesterone acetate injectable suspension, usp. The control group consisted of women who did not use depoprovera. Women who use depoprovera contraceptive injection depoprovera ci may lose significant bone mineral density. Depoprovera medroxyprogesterone acetate injection, suspension pharmacia and upjohn company llchighlights of prescribing information these highlights do not include all the information needed to use depoprovera ci safely and effectively.
As with any im injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to. Depot medroxyprogesterone acetate dmpa king edward. If a patient had more than three dominant follicles, 2,000 iu of hcg was administered, while for patients with no more than three. See full prescribing information for depoprovera ci. Read the patient information leaflet provided by your pharmacist before you start using medroxyprogesterone and each. Effects of longterm use of depomedroxyprogesterone. Neonates from unexpected pregnancies that occur 1 to 2 months after injection of medroxyprogesterone acetate injectable suspension, usp may be at an increased risk of low birth weight, which, in turn, is associated with an increased risk of neonatal death. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing. Medroxyprogesterone acetate injectable suspension usp page 7 of 51 4 years and who were under 35 years of age. Please read all of this leaflet carefully before you start using this medicine because it contains important information for you. Depot medroxyprogesterone acetate, dpma, contraception, depo provera. Depoprovera for intramuscular injection is available as 400 mgml medroxyprogesterone acetate.
Medroxyprogesterone acetate medroxyprogesterone acetate xml. Medroxyprogesterone acetate 150mg ml injection medroxyprogesterone acetate sterile suspension for injection information for doctors and pharmacists for further information consult the summary of product characteristics description depoprovera is a white, sterile suspension for injection. Medroxyprogesterone acetate 150mgml suspension whopar part 4 december 2019 for injection mylan laboratories limited, rh074 section 6 updated. The recommended dose is 150 mg of depoprovera ci every 3 months weeks administered by deep intramuscular im injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection. It contains medroxyprogesterone acetate, which is similar to the natural progesterone produced by the ovaries during the second half of the menstrual cycle. Medroxyprogesterone injection is a hormone medication thats available as three brandname drugs. Dmpa is a weak androgenic progestin that is administered as a single 150mg intramuscular i. According to the eoi, 1 ml of the depot injection presented in a vial is invited, implying single use. Medroxyprogesterone acetate is an odorless white to offwhite microcrystalline powder. Stability and reactivity reactivity hazardous reactions will not occur under normal conditions. However, the overall rr for women who have ever used medroxyprogesterone acetate was only 1.
The recommended dose is 150 mg of medroxyprogesterone acetate every 3 months weeks administered by deep intramuscular im injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection. Depoprovera contraceptive injection contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Uspi medroxyprogesterone acetate depoprovera clean. Pharmaceutical product used for menstrual irregularities details of the supplier of the safety data sheet 2. Advise patient to keep a 1mo supply of medroxyprogesterone available at all times. Guidance on bioequivalence studies for reproductive health. Medroxyprogesterone is a prescription drug indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.
Dmpa is metabolized in the liver with the rate of metab. As a do all progestins, medroxyprogesterone binds to and activates nuclear receptors which subsequently bind to and activate target genes for transcription. Oklahoma state department of health 012018 revised contraceptive injection dmpa 1 contraceptive injection depot medroxyprogesterone acetate dmpa i. Because of its prolonged action and the resulting difficulty in predicting the time of withdrawal bleeding following injection, medroxyprogesterone acetate is not.
The attributable risk is low because such pregnancies are uncommon. Medroxyprogesterone is also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are. Medroxyprogesterone 17 acetate nci04 medroxyprogesterone acetate is a steroid ester. The aim of the present work is to develop sustained release parenteral drug delivery system of contraceptive drug i.
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