Depoprovera fda prescribing information, side effects and uses. The nexplanon package insert lists other conditions, such as blood clots, as contraindications to its use, as those are contraindications to most hormonal contraceptives due to estrogen content. Teratogenicity and embryolethality occurred in animal reproduction studies with leflunomide at doses lower than the human. If a local anesthetic is used prior to injection of depo medrol, the anesthetic package insert. Depotestosterone is not indicated for use in children oct 30, 2018 2. According to the package insert, depoprovera should be used as a longterm birth control method that is, longer than two years only if other birth control methods are inadequate. It is a white to offwhite, odorless crystalline powder, stable in air, melting between 200 and 210 c. Depoprovera ci medroxyprogesterone acetate injectable suspension, for. Depot medroxyprogesterone acetate dmpa, a commonly used contraceptive, may worsen glucose tolerance in diabetics and those with lipodystrophy. Following a single 150 mg im dose of depoprovera contraceptive injection, medroxyprogesterone acetate concentrations. If you are unsure of the necessary steps to safely insert andor remove nexplanon, do not attempt the procedure. The woman should insert nuvaring on the first day of her menstrual bleeding. Depoprovera also causes the cervical mucous to thicken, making sperm less able to enter the uterus. Highlights of prescribing information these highlights do not.
Depoprovera contraceptive injection medroxyprogesterone. Rhod immune globulin human ultrafiltered plus 300 g. Selected practice recommendations for contraceptive use. See full prescribing information for depoprovera contraceptive. Jan 14, 2020 depo provera and depo subq provera 104 have similar benefits and risks. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. Intramuscular depot medroxyprogesterone acetate dmpaim is a popular contraceptive choice among adolescent women, and has contributed to the decline in teen pregnancy rates. Greenstones sdss are furnished as is without warranty of any kind, whether express or implied, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Greenstone assumes no liability of any kind that arises from your use of any of the sdss obtained through this site. Depo subq provera 104 is a new formulation of medroxyprogesterone acetate, which is the active ingredient in depo provera contraceptive injection medroxyprogesterone acetate injectable suspension, but with 30% less hormone. Depoprovera sterile aqueous suspension contains medroxyprogesterone acetate, which is a derivative of progesterone and is active by the parenteral and oral routes of administration. You should use depo subq provera 104 longterm for example, more than 2 years only if other methods of birth control or other treatments for endometriosis pain are not right for you.
The depo package insert lists other conditions, such as blood clots. Your bones may not recover completely when you stop using depoprovera ci. Depoprovera 150mgml injection sterile suspension for injection patient information leaflet pil by pfizer limited. May 15, 2015 the pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. Deposubq provera 104 medroxyprogesterone a cetate injectable suspension, for subcutaneous use. Get ready to add a new form of depo provera depot medroxyprogesterone acetate dmpa, pfizer, new york city to your formulary. To use depo provera or depo subq provera 104, youll need to visit your doctor or other health care provider. Depo subq provera 104 contraceptive injection suspension only. This patient information has been approved by the u. Save money on your depoprovera contraceptive injection, usp prescription by switching to tevas fdaapproved generic version, medroxyprogesterone acetate injectable suspension, usp. Instruct patient on risks and warnings associated with hormonal contraceptives see patient information. In patients taking lysodren, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. See the end of this leaflet for a complete list of ingredients in depoprovera ci.
Administer hydrocortisone, monitor for escalating signs of shock and discontinue. Minimum ppe required open capsule ppe requirements hazardous drug handling tablet minimum ppe required other drug name do not splitcrush do not split crush. Depoprovera is administered as an intramuscular injection once every three 3 months 12 weeks. The recommended dose is 150 mg of depoprovera ci every 3 months weeks administered by deep im injection in the gluteal or deltoid muscle. See full prescribing information for depoprovera ci. The injection is given during the first 5 days after the beginning of a normal menstrual period. According to the package insert, depo provera should be used as a longterm birth control method that is, longer than two years only if other birth control methods are inadequate.
Depo medrol is contraindicated in patients with known hypersensitivity to the product and its constituents. Depoprovera 150mgml injection sterile suspension for. Highlights of prescribing information provera contraceptive injection depo provera ci safely and effectively. Depo subq provera 104 dmpasc, which contains 104 mg medroxyprogesterone acetate, treats endometriosis pain as effectively as leuprolide acetate, but is associated with.
Arava may cause fetal harm when administered to a pregnant woman. Call the merck national service center at 18778884231. Highlights of prescribing information take with food. If a local anesthetic is used prior to injection of depo medrol, the anesthetic package insert should be read carefully and all. Selfadministration of subcutaneous depot medroxyprogesterone.
Food and drug administration to be provided to all patients. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. The impact of depo provera ci 150 mg use for up to 240 weeks 4. Depoprovera ci should not be used as a longterm birth control method i. What is a patient information leaflet and why is it useful. Depoprovera deppo provairah ci medroxyprogesterone acetate injectable suspension contraceptive injection. Priftin is only recommended for the treatment of active pulmonary tuberculosis caused by drugsusceptible organisms as part of regimens consisting of a 2month initial phase followed by a 4month. If she does not get her period within a week after taking the last active pill or removing the. Patient information depo provera sterile aqueous suspension is a progestational drug. Once you have had an injection of depo provera it lasts at least 12 weeks. Feb 11, 2020 depoprovera 150mgml injection sterile suspension for injection patient information leaflet pil by pfizer limited. How to give yourself a testosterone im injection 3 step 3. Initial irregular or prolonged bleeding some women have irregular or prolonged bleeding.
Depo subq provera 104 does not protect you from hiv aids and other infections spread through sex stis. Also find the package insert, announcements, resources, and ways to connect with pfizer medical. Depo medrol is an antiinflammatory glucocorticoid for intramuscular, intraarticular, soft tissue, or intralesional injection. When the vials are first removed from the refrigerator, a white precipitate may be observed in the diluent vial. Depo provera sterile aqueous suspension is available as 400 mgml in 2. This is not to say that you arent pregnant or couldnt get pregnant right now.
Depoprovera for intramuscular injection is available as 400 mgml. Patient information depoprovera sterile aqueous suspension. Depo provera ci medroxyprogesterone acetate injectable suspension, for intramuscular use. Antepartum fetalmaternal hemorrhage suspected or proven as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous. Depo medrol sterile aqueous suspension is contraindicated for intrathecal administration.
Highlights of prescribing information these highlights do. Videos demonstrating insertion and removal are available online for trained healthcare providers. Physician information depoprovera contraceptive injection. During the past 15 years, cdc has contributed to the development and updating of the who global family.
Depoprovera is given every 12 weeks as a single intramuscular injection of 1 ml 150 mg medroxyprogesterone acetate into the buttock or upper arm. See full prescribing information for deposubq provera 104. Depoprovera medroxyprogesterone acetate injectable. Effect of depot medroxyprogesterone acetate on glucose. Depotmedroxyprogesterone acetate world health organization. The depo package insert lists other conditions, such as blood clots, as contraindications to its use, because those are contraindications to most hormonal. This product information is intended only for residents of the united states. Greenstones sdss are furnished as is without warranty of any kind, whether express or implied, including, but not limited to, the implied warranties of merchantability and. However the world health organization reports nexplanon nexplanon is the most highlyeffective method of. Use of deposubq provera 104 is associated with significant loss of bone mineral density bmd. Side effects may last for a short time or for even longer.
Depoprovera medroxyprogesterone side effects, dosage. If you took an overdose, or if a child accidentally swallowed the medicine, immediately proceed to a hospital emergency room and bring the package. Patient information depoprovera sterile aqueous suspension is a progestational drug. Depoprovera fda prescribing information, side effects. The package insert for depo provera says that fertility is back to normal 6 months to a year after stopping the shots.
Depoprovera is given by injection by a doctor or nurse. Check the package containing the syringe, if the package. See full prescribing information for depo provera contraceptive injection. Prior to constituting ixempra for injection, the kit should be removed from the refrigerator and allowed to stand at room temperature for approximately 30. Following a single 150 mg im dose of medroxyprogesterone acetate injectable suspension in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate. Depoprovera ci medroxyprogesterone acetate fdaapproved. Minimum ppe required ppe requirements hazardous drug. Prior to constituting ixempra for injection, the kit should be removed from the refrigerator and allowed to stand at room temperature for approximately 30 minutes. The text of the patient insert for progestational drugs is set forth below. Prescribing information pdf, related formulations andor dosages, search, whats new. Also find the package insert, announcements, resources, and ways to connect with. Discard product if it contains particulate matter, is cloudy, or discolored store at controlled room temperature between 68 and 77.
Mhra approved an update to the sayana press label, adding the option for. Xulane norelgestromin and ethinyl estradiol transdermal system initial u. Tevas generic of depoprovera contraceptive injection, usp. Priftin should not be used in the treatment of active pulmonary tuberculosis caused by rifampinresistant strains. Highlights of prescribing information these highlights do not include all the information needed to use xulane safely and effectively. Depoprovera sterile aqueous suspension is available as 400 mgml in 2. It is made of synthetic progesterone and works by inhibiting monthly ovulation. Jul 22, 2019 depoprovera sterile aqueous suspension contains medroxyprogesterone acetate, which is a derivative of progesterone and is active by the parenteral and oral routes of administration. Call the merck national service center at 18778884231 if you have any questions.
This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in womens health. How to give a testosterone intramuscular im injection. Please see accompanying full prescribing information. Use of depoprovera ci was associated with a significant decline from baseline in bmd. Priftin is only recommended for the treatment of active pulmonary tuberculosis caused by drugsusceptible organisms as part of regimens consisting of a 2month initial phase followed by a 4month continuation phase. Injectable will be packaged in singleuse subcutaneous injection device. Highlights of prescribing information nexplanon safely and. Depo provera ci medroxyprogesterone acetate injectable suspension, for. Description depoprovera contraceptive injection contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Read this patient information carefully before you decide if depoprovera ci is right for you.
The longer you use depoprovera ci, the greater your loss of calcium from your bones. Spr, focuses on how contraceptive methods can be used and provides recommendations on optimal use of contraceptive methods for persons of all ages, including adolescents. The pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved. Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. It is unknown if use of depoprovera contraceptive injection during adolescence or early adulthood. Depo testosterone is not indicated for use in children depo. Depoprovera ci can cause serious side effects, including.
Uspi medroxyprogesterone acetate depoprovera clean. Depo provera medication page for healthcare professionals to search for scientific information on pfizer medications. Use of depoprovera ci may cause you to lose calcium stored in your bone and decrease your bone mass. May 15, 2005 pfizer said depo subq provera 104 would be widely available this month. Depoprovera contraceptive injection patients should be counseled that this product does not protect against hiv infection aids and other sexually transmitted diseases. Feb 07, 2019 the impact of depoprovera ci 150 mg use for up to 240 weeks 4. Aplisol tuberculin ppd, diluted is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. See full prescribing information for complete boxed warning. Deposubq provera 104 fda prescribing information, side. When switching from other contraceptive methods, medroxyprogesterone acetate should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, e. For subcutaneous sc administration only, never administer intramuscularly im or intravenously iv. This is more common on first starting to use depo provera and often improves with time.
1181 201 811 98 921 1289 922 670 168 346 902 753 1136 1430 666 886 56 569 196 1455 753 772 1525 137 129 338 1184 729 1399 1265 947 979 753 562 596 1106 1001 1418 1267 560 1187 1150 89 154 1481 198 1032 315 1154 278 1123