Application Information

This drug has been submitted to the FDA under the reference 017439/001.

Names and composition

"HYDROXYPROGESTERONE CAPROATE" is the commercial name of a drug composed of HYDROXYPROGESTERONE CAPROATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
017439/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML
017439/002 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML
018004/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML
089330/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE Injectable/ Injection 125MG per ML
089331/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE Injectable/ Injection 250MG per ML
200271/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
010347/002 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
010347/004 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
016911/001 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
016911/002 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
017439/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML
017439/002 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML
018004/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML
021945/001 MAKENA HYDROXYPROGESTERONE CAPROATE SOLUTION/INTRAMUSCULAR 1250MG per 5ML (250MG per ML)
021945/002 MAKENA PRESERVATIVE FREE HYDROXYPROGESTERONE CAPROATE SOLUTION/INTRAMUSCULAR 250MG per ML (250MG per ML)
021945/003 MAKENA PRESERVATIVE FREE HYDROXYPROGESTERONE CAPROATE SOLUTION/INTRAMUSCULAR 250MG per ML (250MG per ML)
089330/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE Injectable/ Injection 125MG per ML
089331/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE Injectable/ Injection 250MG per ML
200271/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML

Ask a doctor

A licensed doctor will try to answer your question for free as quickly as possible. Free of charge during the beta period.

Answered questions

URGENT...17-alpha hydroxyprogesterone caproate DURING PREGNANCY?
I would like to know if anyone has been given 17 alpha hydroxyprogesterone caproate to prevent pre-term birth. My doctor suggested but when I asked him about the possible effects on the baby he said "none....(pause)...that I know about). I called the FDA and is not an approved drug. I have to make a decision... Asked by Jan Markve 1 year ago.

I would like to know if anyone has been given 17 alpha hydroxyprogesterone caproate to prevent pre-term birth. My doctor suggested but when I asked him about the possible effects on the baby he said "none....(pause)...that I know about). I called the FDA and is not an approved drug. I have to make a decision between now and next week to start the shots...I am concerned about negative effects on the baby and the effectiveness of this drug....If you know anything about it, NOT FROM WIKIPEDIA or websites like that, please let me know, I will appreciate your help Answered by Gale Quesenberry 1 year ago.

Is this a shot that you have to get? I was gives progesterone shots to prevent pre-term labor. I actually started dilating when I was 20 weeks pregnant and received a cerclage. I had to get that shot is my butt every week. Not to mention a pump with a tube that was attached to my leg that dispensed medicine every 4 hours. None of that crap worked. I still ended up giving birth at 32 weeks. My daughter healthy, but my Dr's put me through a lot of crap to "prevent" pre-term labor and none of it worked!! Answered by Pok Roys 1 year ago.


How effective is an injection that is given in the wrong location and not deep enough?
My doctor has ordered alpha-hydroxyprogesterone caproate injections to be given IM. Every time I get my injections the medical assistant is giving them waist high and they are not deep. Could this compromise the effectiveness of my injection? Should I express my concern to my doctor? Asked by Katerine Ello 1 year ago.

You need to tell the doc if only so that the MA gets proper training in giving injections--I suspect you are not the only one getting injections in the wrong place. Medications that need to be IM need the blood supply of the muscle to get fully absorbed, which fat does not have (sounds like you are getting them sub cutaneously), so yes, it is possible to get less effective release & absorbtion of medication. Certain meds need to be placed in other areas of the body to not result in damage to the wrong type of tissue as well, due to their pH, quantity etc. Others need to be in certain areas (ie TB) to stimulate the correct response to be considered accurate. So yes, please discuss with the MD--to sort yourself out and to benefit others getting injections. Answered by Jule Lavette 1 year ago.

IM- means intramuscular it needs to be in a muscle and deep. Waist high is a little to high. I don't believe that a MA can give injections that is beyond their scope of practice. Insist on a RN or LPN (LVN) to give you the injections. If a MA is passing themselves off as a nurse then they are practicing nursing w/o a license and can be reported to the state board of nursing. Answered by Claude Pullan 1 year ago.

Yes and you should also do some research yourself on Google. Try to stick to medical sites though, because some sites give you incorrect information. Answered by Mabel Ingold 1 year ago.

Ask your doctor, to be sure that they are given right. Answered by Nadine Vallelonga 1 year ago.


Why do OBs prescribe bedrest for high risk pregnancies after cerclage and regular hydroprogesterone shots?
Asked by Lenora Prchal 1 year ago.

Were you looking for a more clinical answer than "it helps prevent preterm labor?" Really, that should be something your doctor answers for you. Starting with Hydroxyprogesterone (if that's what you're referring to) these shots are often used to give moms a boost of synthetic progesterone so that their own body sustains the pregnancy. All this is doing is replicating what our own bodies produce naturally in the third trimester of pregnancy (from the adrenal glands.) The idea again, is that a woman who is starting labor too early needs some help STAYING pregnant. The other thing you need to know is the side-effects of taking any drug during pregnancy. What we know about 17-hydroxyprogesterone caproate has so far been poorly reported, with a CHANCE of higher incidence of miscarriage (ironically). That's another good reason to have this discussion with your OB. The cerclage is more of a manual solution whereby the cervix which is beginning to open prematurely is held shut by a few stitches. Bed rest is often prescribed because the additional weight and pressure of the baby (and force of gravity) on the cervix while upright can be more than the stitches can bear. I'm not a doctor but I do my research as an educator - hope that is helpful. Again, have in-depth discussions with your OB if you haven't already regarding the procedures and meds you are undergoing. Answered by Alida Andueza 1 year ago.

this could rely on what is making the being pregnant prime hazard. I'd ask the physician what boundaries are going to be located on our mattress relaxation. If it demands to be that hubby alterations mattress pans... Oh Well, you could have received your self and a little one to fear approximately. You're now not going to be pregnant for ever and you'll be able to be in a position to transport round extra as soon as the little one is borne. Good success Answered by Sanda Jourdan 1 year ago.

What do you mean why? It would be because its a "high risk pregnancy" and they are trying everything to prevent preterm labor. Answered by Melonie Garnand 1 year ago.


Preeclampsia?
Thank you so much! That makes sense now, the whole preeclampsia thing threw me!! :) Asked by Earleen Howarter 1 year ago.

I got a shot for this yesterday, which is actually confusing me now...because everything I'm reading isn't making sense to me. I went to the doctor because of a small amount of blood I've been getting daily for a little over a week. Anyway - - Now then, they are going to give me this shot until I'm about 36 weeks every week until then. I'm almost 15 weeks now. My question is, does anyone know anything about this. AND, if anyone has had this, are there like side effects to the shot to myself. I'm sure its not harmful to the baby...but today I have felt a little over the top, which isn't normal. Very emotional, I've probably cried like 10 times today, and normally I'll only cry like 2 times a week! :) Haha. Anyway - - Any information would be awesome. I'm horrible at googleing things, also personal experiences are awesome too! I asked earlier and didn't get any answers. Thank you everyone!! :D Congrats on all your babies to be! :D:D Answered by Malik Ruppel 1 year ago.

Preeclampsia is a condition in which you have elevated blood pressure along with protein in your urine. This entity is diagnosed after 20 weeks and if you are only at 15 weeks, then make sure that your doctor has the correct diagnosis. One can have pregnancy induced hypertension, with is elevated blood pressure without protein in urine, before 20 weeks. Regardless, in preeclampsia, they give steroid shots which are used to mature the babies lungs as one of the frequent complications of preeclampsia is premature labor and delivery. These have the short term side effects but won't cause any permanent changes. Good luck! Answered by Lavera Dorenfeld 1 year ago.


URGENT...17-alpha hydroxyprogesterone caproate DURING PREGNANCY?
I would like to know if anyone has been given 17 alpha hydroxyprogesterone caproate to prevent pre-term birth. My doctor suggested but when I asked him about the possible effects on the baby he said "none....(pause)...that I know about). I called the FDA and is not an approved drug. I have to make a decision... Asked by Dessie Rathgeber 1 year ago.

I would like to know if anyone has been given 17 alpha hydroxyprogesterone caproate to prevent pre-term birth. My doctor suggested but when I asked him about the possible effects on the baby he said "none....(pause)...that I know about). I called the FDA and is not an approved drug. I have to make a decision between now and next week to start the shots...I am concerned about negative effects on the baby and the effectiveness of this drug....If you know anything about it, NOT FROM WIKIPEDIA or websites like that, please let me know, I will appreciate your help Answered by Marita Jeangilles 1 year ago.

Is this a shot that you have to get? I was gives progesterone shots to prevent pre-term labor. I actually started dilating when I was 20 weeks pregnant and received a cerclage. I had to get that shot is my butt every week. Not to mention a pump with a tube that was attached to my leg that dispensed medicine every 4 hours. None of that crap worked. I still ended up giving birth at 32 weeks. My daughter healthy, but my Dr's put me through a lot of crap to "prevent" pre-term labor and none of it worked!! Answered by Yesenia Huard 1 year ago.


How effective is an injection that is given in the wrong location and not deep enough?
My doctor has ordered alpha-hydroxyprogesterone caproate injections to be given IM. Every time I get my injections the medical assistant is giving them waist high and they are not deep. Could this compromise the effectiveness of my injection? Should I express my concern to my doctor? Asked by Tanna Buco 1 year ago.

You need to tell the doc if only so that the MA gets proper training in giving injections--I suspect you are not the only one getting injections in the wrong place. Medications that need to be IM need the blood supply of the muscle to get fully absorbed, which fat does not have (sounds like you are getting them sub cutaneously), so yes, it is possible to get less effective release & absorbtion of medication. Certain meds need to be placed in other areas of the body to not result in damage to the wrong type of tissue as well, due to their pH, quantity etc. Others need to be in certain areas (ie TB) to stimulate the correct response to be considered accurate. So yes, please discuss with the MD--to sort yourself out and to benefit others getting injections. Answered by Sylvia Leroy 1 year ago.

IM- means intramuscular it needs to be in a muscle and deep. Waist high is a little to high. I don't believe that a MA can give injections that is beyond their scope of practice. Insist on a RN or LPN (LVN) to give you the injections. If a MA is passing themselves off as a nurse then they are practicing nursing w/o a license and can be reported to the state board of nursing. Answered by Gladis Tabbert 1 year ago.

Yes and you should also do some research yourself on Google. Try to stick to medical sites though, because some sites give you incorrect information. Answered by Yuriko Mcnevin 1 year ago.

Ask your doctor, to be sure that they are given right. Answered by Keena Koppang 1 year ago.


Why do OBs prescribe bedrest for high risk pregnancies after cerclage and regular hydroprogesterone shots?
Asked by Shelton Kops 1 year ago.

Were you looking for a more clinical answer than "it helps prevent preterm labor?" Really, that should be something your doctor answers for you. Starting with Hydroxyprogesterone (if that's what you're referring to) these shots are often used to give moms a boost of synthetic progesterone so that their own body sustains the pregnancy. All this is doing is replicating what our own bodies produce naturally in the third trimester of pregnancy (from the adrenal glands.) The idea again, is that a woman who is starting labor too early needs some help STAYING pregnant. The other thing you need to know is the side-effects of taking any drug during pregnancy. What we know about 17-hydroxyprogesterone caproate has so far been poorly reported, with a CHANCE of higher incidence of miscarriage (ironically). That's another good reason to have this discussion with your OB. The cerclage is more of a manual solution whereby the cervix which is beginning to open prematurely is held shut by a few stitches. Bed rest is often prescribed because the additional weight and pressure of the baby (and force of gravity) on the cervix while upright can be more than the stitches can bear. I'm not a doctor but I do my research as an educator - hope that is helpful. Again, have in-depth discussions with your OB if you haven't already regarding the procedures and meds you are undergoing. Answered by Zana Breitenbucher 1 year ago.

this could rely on what is making the being pregnant prime hazard. I'd ask the physician what boundaries are going to be located on our mattress relaxation. If it demands to be that hubby alterations mattress pans... Oh Well, you could have received your self and a little one to fear approximately. You're now not going to be pregnant for ever and you'll be able to be in a position to transport round extra as soon as the little one is borne. Good success Answered by Daisey Gorter 1 year ago.

What do you mean why? It would be because its a "high risk pregnancy" and they are trying everything to prevent preterm labor. Answered by Anastasia Aymond 1 year ago.


Preeclampsia?
Thank you so much! That makes sense now, the whole preeclampsia thing threw me!! :) Asked by Russel Allnutt 1 year ago.

I got a shot for this yesterday, which is actually confusing me now...because everything I'm reading isn't making sense to me. I went to the doctor because of a small amount of blood I've been getting daily for a little over a week. Anyway - - Now then, they are going to give me this shot until I'm about 36 weeks every week until then. I'm almost 15 weeks now. My question is, does anyone know anything about this. AND, if anyone has had this, are there like side effects to the shot to myself. I'm sure its not harmful to the baby...but today I have felt a little over the top, which isn't normal. Very emotional, I've probably cried like 10 times today, and normally I'll only cry like 2 times a week! :) Haha. Anyway - - Any information would be awesome. I'm horrible at googleing things, also personal experiences are awesome too! I asked earlier and didn't get any answers. Thank you everyone!! :D Congrats on all your babies to be! :D:D Answered by Lorette Rummell 1 year ago.

Preeclampsia is a condition in which you have elevated blood pressure along with protein in your urine. This entity is diagnosed after 20 weeks and if you are only at 15 weeks, then make sure that your doctor has the correct diagnosis. One can have pregnancy induced hypertension, with is elevated blood pressure without protein in urine, before 20 weeks. Regardless, in preeclampsia, they give steroid shots which are used to mature the babies lungs as one of the frequent complications of preeclampsia is premature labor and delivery. These have the short term side effects but won't cause any permanent changes. Good luck! Answered by Candance Oliven 1 year ago.


URGENT...17-alpha hydroxyprogesterone caproate DURING PREGNANCY?
I would like to know if anyone has been given 17 alpha hydroxyprogesterone caproate to prevent pre-term birth. My doctor suggested but when I asked him about the possible effects on the baby he said "none....(pause)...that I know about). I called the FDA and is not an approved drug. I have to make a decision... Asked by Alverta Calkins 1 year ago.

I would like to know if anyone has been given 17 alpha hydroxyprogesterone caproate to prevent pre-term birth. My doctor suggested but when I asked him about the possible effects on the baby he said "none....(pause)...that I know about). I called the FDA and is not an approved drug. I have to make a decision between now and next week to start the shots...I am concerned about negative effects on the baby and the effectiveness of this drug....If you know anything about it, NOT FROM WIKIPEDIA or websites like that, please let me know, I will appreciate your help Answered by Haywood Pashea 1 year ago.

Is this a shot that you have to get? I was gives progesterone shots to prevent pre-term labor. I actually started dilating when I was 20 weeks pregnant and received a cerclage. I had to get that shot is my butt every week. Not to mention a pump with a tube that was attached to my leg that dispensed medicine every 4 hours. None of that crap worked. I still ended up giving birth at 32 weeks. My daughter healthy, but my Dr's put me through a lot of crap to "prevent" pre-term labor and none of it worked!! Answered by Kelsi Hirt 1 year ago.


How effective is an injection that is given in the wrong location and not deep enough?
My doctor has ordered alpha-hydroxyprogesterone caproate injections to be given IM. Every time I get my injections the medical assistant is giving them waist high and they are not deep. Could this compromise the effectiveness of my injection? Should I express my concern to my doctor? Asked by Brandi Blankley 1 year ago.

You need to tell the doc if only so that the MA gets proper training in giving injections--I suspect you are not the only one getting injections in the wrong place. Medications that need to be IM need the blood supply of the muscle to get fully absorbed, which fat does not have (sounds like you are getting them sub cutaneously), so yes, it is possible to get less effective release & absorbtion of medication. Certain meds need to be placed in other areas of the body to not result in damage to the wrong type of tissue as well, due to their pH, quantity etc. Others need to be in certain areas (ie TB) to stimulate the correct response to be considered accurate. So yes, please discuss with the MD--to sort yourself out and to benefit others getting injections. Answered by Whitney Koetting 1 year ago.

IM- means intramuscular it needs to be in a muscle and deep. Waist high is a little to high. I don't believe that a MA can give injections that is beyond their scope of practice. Insist on a RN or LPN (LVN) to give you the injections. If a MA is passing themselves off as a nurse then they are practicing nursing w/o a license and can be reported to the state board of nursing. Answered by Ramona Wilbers 1 year ago.

Yes and you should also do some research yourself on Google. Try to stick to medical sites though, because some sites give you incorrect information. Answered by Carl Lokken 1 year ago.

Ask your doctor, to be sure that they are given right. Answered by Ronnie Portlock 1 year ago.


Why do OBs prescribe bedrest for high risk pregnancies after cerclage and regular hydroprogesterone shots?
Asked by Russell Alpers 1 year ago.

Were you looking for a more clinical answer than "it helps prevent preterm labor?" Really, that should be something your doctor answers for you. Starting with Hydroxyprogesterone (if that's what you're referring to) these shots are often used to give moms a boost of synthetic progesterone so that their own body sustains the pregnancy. All this is doing is replicating what our own bodies produce naturally in the third trimester of pregnancy (from the adrenal glands.) The idea again, is that a woman who is starting labor too early needs some help STAYING pregnant. The other thing you need to know is the side-effects of taking any drug during pregnancy. What we know about 17-hydroxyprogesterone caproate has so far been poorly reported, with a CHANCE of higher incidence of miscarriage (ironically). That's another good reason to have this discussion with your OB. The cerclage is more of a manual solution whereby the cervix which is beginning to open prematurely is held shut by a few stitches. Bed rest is often prescribed because the additional weight and pressure of the baby (and force of gravity) on the cervix while upright can be more than the stitches can bear. I'm not a doctor but I do my research as an educator - hope that is helpful. Again, have in-depth discussions with your OB if you haven't already regarding the procedures and meds you are undergoing. Answered by Son Mchaney 1 year ago.

this could rely on what is making the being pregnant prime hazard. I'd ask the physician what boundaries are going to be located on our mattress relaxation. If it demands to be that hubby alterations mattress pans... Oh Well, you could have received your self and a little one to fear approximately. You're now not going to be pregnant for ever and you'll be able to be in a position to transport round extra as soon as the little one is borne. Good success Answered by Alena Mong 1 year ago.

What do you mean why? It would be because its a "high risk pregnancy" and they are trying everything to prevent preterm labor. Answered by Sima Weslow 1 year ago.


Preeclampsia?
Thank you so much! That makes sense now, the whole preeclampsia thing threw me!! :) Asked by Tonisha Daughetee 1 year ago.

I got a shot for this yesterday, which is actually confusing me now...because everything I'm reading isn't making sense to me. I went to the doctor because of a small amount of blood I've been getting daily for a little over a week. Anyway - - Now then, they are going to give me this shot until I'm about 36 weeks every week until then. I'm almost 15 weeks now. My question is, does anyone know anything about this. AND, if anyone has had this, are there like side effects to the shot to myself. I'm sure its not harmful to the baby...but today I have felt a little over the top, which isn't normal. Very emotional, I've probably cried like 10 times today, and normally I'll only cry like 2 times a week! :) Haha. Anyway - - Any information would be awesome. I'm horrible at googleing things, also personal experiences are awesome too! I asked earlier and didn't get any answers. Thank you everyone!! :D Congrats on all your babies to be! :D:D Answered by Tashia Kindley 1 year ago.

Preeclampsia is a condition in which you have elevated blood pressure along with protein in your urine. This entity is diagnosed after 20 weeks and if you are only at 15 weeks, then make sure that your doctor has the correct diagnosis. One can have pregnancy induced hypertension, with is elevated blood pressure without protein in urine, before 20 weeks. Regardless, in preeclampsia, they give steroid shots which are used to mature the babies lungs as one of the frequent complications of preeclampsia is premature labor and delivery. These have the short term side effects but won't cause any permanent changes. Good luck! Answered by Stacy Johar 1 year ago.


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