Application Information

This drug has been submitted to the FDA under the reference 017553/001.

Names and composition

"PROGESTASERT" is the commercial name of a drug composed of PROGESTERONE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
017553/001 PROGESTASERT PROGESTERONE INSERT, EXTENDED RELEASE/INTRAUTERINE 38MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
009238/001 PROGESTERONE PROGESTERONE INJECTABLE/INJECTION 50MG per ML
009238/002 PROGESTERONE PROGESTERONE INJECTABLE/INJECTION 25MG per ML
017362/002 PROGESTERONE PROGESTERONE INJECTABLE/INJECTION 50MG per ML
017553/001 PROGESTASERT PROGESTERONE INSERT, EXTENDED RELEASE/INTRAUTERINE 38MG
019781/001 PROMETRIUM PROGESTERONE CAPSULE/ORAL 100MG
019781/002 PROMETRIUM PROGESTERONE CAPSULE/ORAL 200MG
019781/003 PROMETRIUM PROGESTERONE CAPSULE/ORAL 300MG
020701/001 CRINONE PROGESTERONE GEL/VAGINAL 4%
020701/002 CRINONE PROGESTERONE GEL/VAGINAL 8%
020756/001 CRINONE PROGESTERONE GEL/VAGINAL 8%
020843/001 PROMETRIUM PROGESTERONE CAPSULE/ ORAL 100MG
020843/002 PROMETRIUM PROGESTERONE CAPSULE/ ORAL 200MG
020843/003 PROMETRIUM PROGESTERONE CAPSULE/ ORAL 300MG
022057/001 ENDOMETRIN PROGESTERONE INSERT/VAGINAL 100MG
075906/001 PROGESTERONE PROGESTERONE INJECTABLE/INJECTION 50MG per ML
090845/001 PROGESTERONE PROGESTERONE INJECTABLE/INJECTION 50MG per ML
091033/001 PROGESTERONE PROGESTERONE INJECTABLE/INJECTION 50MG per ML
200456/001 PROGESTERONE PROGESTERONE CAPSULE/ORAL 100MG
200456/002 PROGESTERONE PROGESTERONE CAPSULE/ORAL 200MG
200900/001 PROGESTERONE PROGESTERONE CAPSULE/ORAL 100MG
200900/002 PROGESTERONE PROGESTERONE CAPSULE/ORAL 200MG
202121/001 PROGESTERONE PROGESTERONE CAPSULE/ORAL 100MG
202121/002 PROGESTERONE PROGESTERONE CAPSULE/ORAL 200MG
208801/001 PROGESTERONE PROGESTERONE CAPSULE/ORAL 100MG
208801/002 PROGESTERONE PROGESTERONE CAPSULE/ORAL 200MG

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Answered questions

Birth Control while Breastfeeding?
Does anyone know of a birth control pill that is safe during breastfeeding? Asked by Forest Fu 1 year ago.

as far as i know the mini pill is the best Progestin-only contraceptives are the preferred choice for breastfeeding mothers when something hormonal is desired or necessary. Progestin-only contraceptives come in several different forms: * the progestin-only pill (POP) also called the "mini-pill" (Micronor, Errin, Nor-QD, Ovrette, Microval, etc) * the birth control injection (Depo Provera) * the progesterone-releasing IUD (Mirena, Progestasert) * the birth control implant (Norplant, Implanon). Milk supply: For most mothers, progestin-only forms of contraception do not cause problems with milk supply if started after the 6th-8th week postpartum and if given at normal doses. However, there are many reports (most anecdotal but nevertheless worth paying attention to) that some women do experience supply problems with these pills, so if you choose this method you still need to proceed with some caution. If you're interested in one of the longer lasting progestin-only forms of birth control (the Depo-Provera shot lasts at least 12 weeks, but effects may be seen up to a year; the Mirena/Progestasert IUD and the Norplant implant can last up to 5 years), it may be a good idea to do a trial of progestin-only pills (mini-pill) for a month or more before deciding on the longer-term form of birth control. If you find that you are among the women whose supply drops significantly due to progestin-only birth control, you can simply discontinue the pills - rather than struggling with low milk supply for several months until the shot wears off or you get the implant or IUD removed. Do note that the Mirena/Progestasert IUD delivers its hormone directly to the lining of the uterus, which only leads to a slight increase in progesterone levels in the blood stream (much lower than that found with the progesterone-only pill). As a result, there is much less chance of side effects from the progesterone than from the Depo-Provera shot or mini-pill. Milk composition: At higher doses than normal this type of pill can affect the content of breastmilk. At these higher doses it has been shown to decrease the protein/nitrogen and lactose content of the milk. At regular doses, this does not seem to be as likely. it really recommends you dont take any pill on till you are at least 6 weeks postpartum im breast feeding and my son is nearly 18 months we have been ttc for about 5 months to no avail which is unusual for us Answered by Bradford Secrest 1 year ago.

I too am breastfeeding and the only type of pill you can take is a progesterone only pill and even those can decrease your milk supply. An IUD is probably your best bet. Just research all your options. With me, I couldn't have an IUD so we are taking our chances with no birth control. Answered by Willow Pfalzgraf 1 year ago.

Most doctors prefer the mini pill Micron. That's what I was prescribed but I haven't taken it because I'm afraid it will lessen my milk supply. I've heard from some moms that it has done that so I'm just staying away from it! Answered by Burton Maslowski 1 year ago.

You should ask your doctor about it... but I asked a few weeks ago (I am due and plan to breast feed) and my doctor told me they do have birth control that is very low dose and I believe it is only estrogen... no progesterone... or its the other way around... im not sure.:) but there is definitely something out there for you! Answered by Melodi Spiker 1 year ago.

you can take birth control that does not contain estrogen. the "mini pill" contains only progesterone, and is safe. IUD's are safe, as well as the depo shot. Answered by Shela Ruliffson 1 year ago.

Yes, the "mini Pill" is a progesterone only pill and is compatible with nursing. It is not as effective, however. Your ob/gyn can prescribe it Answered by Julee Downs 1 year ago.

I forget the name of the pill I was on but it began with a M. It is low estrogen ask you ob just to be sure!! Answered by Karol Pederzani 1 year ago.

Progesterone only pills are usually presribed. Answered by Mauro Stiebel 1 year ago.

i wouldn't risk taking any bc while breastfeeding Answered by Vinita Lifschitz 1 year ago.

im taking the nor-q-d tab Answered by Marvin Daylong 1 year ago.


Which birth control methods are safe while breast feeding?
I want to get on BC as soon as I give birth to avoid having babies back to back at such a young age but I also want to breastfeed.....My ideal BC would be the shot or the implant (arm), I WILL NOT put anything in my uterus so absolutely NO iud's....which methods are safe while breastfeeding...thanks ladies... Asked by Tracee Nienhuis 1 year ago.

Progestin-only contraceptives are the preferred choice for breastfeeding mothers when something hormonal is desired or necessary. Progestin-only contraceptives come in several different forms: * the progestin-only pill (POP) also called the "mini-pill" (Micronor, Errin, Nor-QD, Ovrette, Microval, etc) * the birth control injection (Depo Provera) * the progesterone-releasing IUD (Mirena, Progestasert) * the birth control implant (Norplant, Implanon). Milk supply: For most mothers, progestin-only forms of contraception do not cause problems with milk supply if started after the 6th-8th week postpartum and if given at normal doses. However, there are many reports (most anecdotal but nevertheless worth paying attention to) that some women do experience supply problems with these pills, so if you choose this method you still need to proceed with some caution. If you're interested in one of the longer lasting progestin-only forms of birth control (the Depo-Provera shot lasts at least 12 weeks, but effects may be seen up to a year; the Mirena/Progestasert IUD and the Norplant implant can last up to 5 years), it may be a good idea to do a trial of progestin-only pills (mini-pill) for a month or more before deciding on the longer-term form of birth control. If you find that you are among the women whose supply drops significantly due to progestin-only birth control, you can simply discontinue the pills - rather than struggling with low milk supply for several months until the shot wears off or you get the implant or IUD removed. Do note that the Mirena/Progestasert IUD delivers its hormone directly to the lining of the uterus, which only leads to a slight increase in progesterone levels in the blood stream (much lower than that found with the progesterone-only pill). As a result, there is much less chance of side effects from the progesterone than from the Depo-Provera shot or mini-pill. Milk composition: At higher doses than normal this type of pill can affect the content of breastmilk. At these higher doses it has been shown to decrease the protein/nitrogen and lactose content of the milk. At regular doses, this does not seem to be as likely. Safety: Progestin (progesterone) is approved by the AAP for use in breastfeeding mothers. See below for additional information on side effects related to lactation. **I was one of those women that had supply issues with Depo-Provera, though I did not have the same issue with the mini-pill.** Answered by Lucius Kroeger 1 year ago.

Not all men are that bad. They all suck, in my opinion (my husband included), but some are a lot better than others. I want to get my tubes tied and I want my husband to get a vasectomy someday, but he's only (almost) 21 and I just turned 19. I didn't want kids, but my bc pills didn't work so great, I guess. I love my daughter but I don't want anymore. Anyway, I'm on Camila bc pills right now, just until my Mirena gets to my OB/GYN office. That'll be about 3 weeks. Camila is a progestin only pill, or "mini pill." The Mirena is an IUC that you can leave in for up to 5 years or have it removed whenever if you decide to have more children. Answered by Cinderella Greenburg 1 year ago.

Ask your doctor, most BC is safe for nursing moms however the ones you are willing to do have hormones and will drop your milk production quiet abit. Answered by Jeanette Calowell 1 year ago.

you should ask your doctor what forms are safest. I know that your doctor won't let you have any birth control until after your post-natal bleeding stops. Answered by Dung Pintar 1 year ago.


Did you know that when you are on the pill?
Ok ladies (and men if there are any who answered)...I just wanted to throw a controversial question out there (doesn't mean I believe this necessarily)...no need to get defensive. Asked by Ardis Halon 1 year ago.

When you take birth control pill...what it essentially does is prevent a fertilized egg from attaching to the uterus. So basically you can still get pregnant, but if it does its job it prevents the fertilized egg from attaching to the uterus. This is why some women get pregnant while on the pill. So basically it can cause an early abortion if you get pregnant...I don't think most women know how their birth control truly works. My question is this...were you aware of how the pill actually prevents pregnancy? Just curious...I am not condemning anyone for using the pill. Answered by Helaine Able 1 year ago.

I know it isn't 100%...that is my point. What I am saying is this: the purpose of the pill is to prevent a fertilized egg (you are already pregnant) from attaching to the uterine wall. So if you are sexually active and use nothing but the pill, your likelyhood of getting pregnant while ovulating is high...but what the pill is SUPPOSE to do is prevent that fertilized egg from attaching. So it is causing an early abortion...I guess I just wanted comments on what people think about this. Answered by Arden Swalley 1 year ago.

You're incorrect. The pill keeps you from ovulating. No ovulation=no egg to be fertilized=no pregnancy. The pill also thickens cervical mucus, making it less likely that any sperm will reach the fallopian tubes. And it also makes uterine conditions less conducive to implantation in the unlikely event that you do ovulate and any sperm make it to the egg. But the pill does NOT cause abortions. There certainly are cases of women who become pregnant while taking the pill, but the vast majority of those women were taking the pill incorrectly--they missed a pill, or a few pills, or they weren't taking the pill at the same time of day, every day. And in those cases, where women continued taking birth control pills because they had no idea that they were pregnant, the babies turn out fine. No early abortions. To a previous poster: Catholics that eschew birth control do so because they believe that sex without the willingness to bear children is a sin. Not because they believe that the pill causes abortions. Answered by Janette Reinwald 1 year ago.

The pill is not the only type of BC that does this. Nuvaring does the same thing and yes I knew that but it didnt stop me because I didnt want to become pregnant at that time and I am married and didnt want to use a condom to have sex with my own husband. But the pill and other types of BC are actually suppose to prevent ovulation and not that it does every single time. But having the thicker mucus and all that is just a back up protection so if an egg does get fertilized it wont implant. And would it really be called an "Abortion" if they embryo doesnt implant?? Its not considered a baby or fetus yet. So I dont see it as an "early abortion". Its better than relying on just condoms or Not being on BC at all. Answered by Markita Rowlins 1 year ago.

The Pill usually contains two hormones, estrogen and progestogen, which act like the hormones found naturally in your own body. It is sometimes called the Combined Oral Contraceptive (COC). Taken daily, the hormones in the Pill prevent your ovaries from ovulation, or releasing eggs. Pregnancy is prevented since there are no eggs to fertilize. The Pill also causes changes in the lining of the uterus and the mucus of the cervix, which further discourages pregnancy. Answered by Ian Merisier 1 year ago.

The pill tricks your body into thinking that it is already pregnant...you are not supposed to ovulate when taking the pill. And how early is a baby considered a baby anyway? Do you consider an egg a baby and if so is sperm as well? Then condoms are also abortions. Answered by Geneva Daller 1 year ago.

i asked a question about this recently. I'm not sure completely how it works because doctors don't tell you this and if you go online it's not doctors telling you, it's regular people, mainly Christians... (I'm a christian) i am on the pill but want to go off... are there any websites where actual doctors tell you and not just normal people speculating? my first pregnancy was while on the pill. Answered by Lucila Hamming 1 year ago.

Where did you get your info. that that's how the pill works? I'd like to see a reputable link... As the poster below said, about.com is often not reputable. Also, I hope you're realizing that there are some women who do know what birth control does to their bodies. Maybe next time you feel like stirring something up, YOU'LL do your research first. :o) Answered by Cecilia Schweigert 1 year ago.

Yes, any hormone contraceptive, be it the pill, patches or injections make the lining of your uterus unsuitable for implantation. There for if you do so happen to ovulate & the egg is fertilized, you will "self-abort" I guess this gives pro-lifers something to think about? Is it really an abortion or a miscarriage? Answered by Bethany Beck 1 year ago.

The Pill (generally) works by inhibiting ovulation, so you don't produce any eggs to begin with. And even if an egg is released and fertilized but expelled before it attaches to the uterus, it would not be considered an abortion because no pregnancy took place. Pregnancy begins at implantation. Why do you assume women are so naive about how their bodies work? Answered by Britteny Zappolo 1 year ago.


Did you know that some types of birth control cause a woman to have an abortion every month?
So that no one can attack the source in an effort to refute this assertion, here is the Physicians Desk Reference's product information as listed by Ortho, one of the two largest manufacturers of the Pill, under Ortho-Cept: Combination oral contraceptives act by suppression of gonadotropins. Although the... Asked by Victorina Huntley 1 year ago.

Also, I think people mix up the definitions of "abortion" and "miscarriage" often. Miscarriage - the expulsion of a fetus before it is viable, esp. between the third and seventh months of pregnancy; SPONTANEOUS abortion. Abortion - noun - Also called VOLUNTARY abortion. The removal of an embryo or fetus from the uterus in order to end a pregnancy. 2. Any of various surgical methods for terminating a pregnancy, esp. during the first six months. Answered by Ike Kunz 1 year ago.

They cause abortions by; First, many fail in their claim to stop ovulation (release of an egg from the ovary). This is called "break through". Second, in the case of "break through" and subsequent fertilization, they then prevent the fertilized egg (which those who are pro-life is the beginning of the human life) from attaching to the lining of the uterus, which would allow the life to continue. Barrier methods, used at least two at a time for added insurance, are successful at preventing fertilization to occur in the first place, thus preventing the "need" to kill that life. Chemical methods are also associated with various kinds of cancer, can cause nausea in women leading to sporadic use on the recommended schedule (leading to unwanted pregnancy), and IUDs have been shown to cause uterine cancer and damage to the uterus. Answered by Melaine Szilagyi 1 year ago.

So that no one can attack the source in an effort to refute this assertion, here is the Physicians Desk Reference's product information as listed by Ortho, one of the two largest manufacturers of the Pill, under Ortho-Cept: Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus, which increase the difficulty of sperm entry into the uterus, and changes in the endometrium which reduce the likelihood of implantation. (The PDR, 1995, page 1775). If you believe that life begins at conception/fertilization, then you have to accept that The Pill can cause an abortion if it fails to stop ovulation and if there is a sperm present to fertilize the egg, creating a HUMAN BEING in the fallopian tubes. Answered by Bob Desimone 1 year ago.

They should if they don't. Pro-Lifers would also have to opposed to IVF, as not all of the fertilized eggs are used. I'm pro choice so my input wouldn't help this much. Answered by Albert Shuker 1 year ago.

The Rhythm Method is NOT reliable form of birth control. Not all women ovulate the same time every month and even if they take their BBT religiously there is a margin for error. Catholic doctors will tell patients that certain forms of birth control cause miscarriages (They are NOT, NOT, NOT abortions) in order to keep their patients from using them. Also, this website is just a bunch of garbage. It was probably created by some over zealous religious nut that think everyone should pop out 20 kids whether or not they can feed or clothe them. Answered by Elinor Whish 1 year ago.

Do your realize or even care that by reducing the number of acceptable methods of birth control that you are increasing the number of unwanted pregnancies that usually result in child abuse or neglect? Have you given any thought at all to that child's quality of life? Do you realize that the rhythm method is barely better than no birth control at all? Answered by Merlyn Bawks 1 year ago.

I am happy for your stance & respect your right to voice your opinion. I am a firm believer in a womans right to choose. You are wrong in the assumption that birth control causes an abortion every month. You would have to get pregnant every month for this to happen. Go back and do some more reaearch before you begin spouting your propaganda. Answered by Randolph Clemmens 1 year ago.

The majority of the methods you mention prevent the fertilisation of the egg, therefore it cannot be an abortion, otherwise you would have to define the menstrual cycle as a series of abortions, which is obviously idiotic. Answered by Kerri Devara 1 year ago.

so going by your logic every time a woman has her period she is in essence murdering a potential child because she did not attempt to fertilize that dropped egg. Is it also considered murder for a man who masturbates as he is releasing millions of sperm which are technically, according to you, millions of little babies just waiting breathlessly to be born? Your going downhill fast miss margaret w. Your questions are becoming even more amusing to read... Answered by Dong Mounce 1 year ago.

If the IUD causes abortion then can you answer me one question????? Am I carrying a 3y.o fetus since I haven't had a period in 3 years there is no way to "flush" a pregnancy away! or does it disintegrate into thin air. Pick up any medical book and gain some "MEDICAL" knowledge not sum assumption (that hasn't been proved) ______________________________________... EDIT So your telling me a futus is re-absorbed into my body every month!!!! ;) ok Answered by Shirleen Duncker 1 year ago.

The source you site is nothing but women oppressing propaganda. Your ignorance and hatred is overwhelming. Please do us all a favor and undergo a permanent form of birth control for yourself. Then if you want to have kids please adopt those children neglected by mothers who were not adequately educated about birth control due to the propaganda you are spouting. Answered by Deadra Nevarez 1 year ago.

How does birth control cause abortion? I think you might mean miscarriage. Answered by Frida Frushour 1 year ago.

my doc told me about this, but it's not for abortion it's a birth control that prevent a women from getting pregnant. Answered by Annamarie Holderby 1 year ago.


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