NORETHINDRONE
Drugs in Pregnancy and Lactation.
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Name: NORETHINDRONE
Class: Progestogenic Hormone
Risk Factor: XM
Fetal Risk Summary
Norethindrone is a progestogen derived from 19-nortestosterone. It is used in oral contraceptives and hormonal pregnancy tests (no longer available in the United States). Masculinization of the female fetus has been associated with norethindrone (1,2 and 3). One researcher observed an 18% incidence of masculinization of female infants born to mothers given norethindrone (2). A more conservative estimate for the incidence of masculinization caused by synthetic progestogens has been reported as 0.3% (4).
The Collaborative Perinatal Project monitored 866 mother-child pairs with 1st trimester exposure to progestational agents (including 132 with exposure to norethindrone) (5, pp. 389, 391). Evidence of an increased risk of malformation was found for norethindrone. An increase in the expected frequency of cardiovascular defects and hypospadias was also observed for progestational agents as a group (5, p. 394; 6). Re-evaluation of these data in terms of timing of exposure, vaginal bleeding in early pregnancy, and previous maternal obstetric history, however, failed to support an association between female sex hormones and cardiac malformations (7). An earlier study also failed to find any relationship with nongenital malformations (3). One investigator observed two infants with malformations who were exposed to norethindrone (8). The congenital defects included spina bifida and hydrocephalus. The relationship between norethindrone and the anomalies is unknown.
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 238 newborns had been exposed to norethindrone (see also Oral Contraceptives) shortly before or after conception (F. Rosa, personal communication, FDA, 1993). A total of 20 (8.4%) major birth defects were observed (10 expected). Specific data were available for six defect categories, including (observed/expected) 2/2 cardiovascular defects, 1/0.5 oral clefts, 0/0 spina bifida, 0/1 polydactyly, 0/0.5 limb reduction defects, and 1/1 hypospadias. The total number of congenital malformations suggests a moderate association between the drug and the incidence of congenital defects, but the study could not determine the percentage of women who presumably stopped the hormone before conception or the number of anomalies as a result of prematurity (F. Rosa, personal communication, FDA, 1993).
Breast Feeding Summary
Norethindrone exhibits a dose-dependent suppression of lactation (9). Lower infant weight gain, decreased milk production, and decreased composition of nitrogen and protein content of human milk have been associated with norethindrone and estrogenic agents (10,11,12 and 13). The magnitude of these changes is low. However, the changes in milk production and composition may be of nutritional importance in malnourished mothers. If breast feeding is desired, the lowest dose of oral contraceptives should be chosen. Monitoring of infant weight gain and the possible need for nutritional supplementation should be considered. The American Academy of Pediatrics considers norethindrone to be compatible with breast feeding (14).
"Official medicines" is the best online drugstore.World’s leading meds delivered to your door – and you don’t even need a prescription! Only certified, first class drugs on offer! Buy more and spend less with our great discount system. |
References
- Hagler S, Schultz A, Hankin H, Kunstadter RN. Fetal effects of steroid therapy during pregnancy. Am J Dis Child 1963;106:586–90.
- Jacobson BD. Hazards of norethindrone therapy during pregnancy. Am J Obstet Gynecol 1962;84:962–8.
- Wilson JG, Brent RL. Are female sex hormones teratogenic? Am J Obstet Gynecol 1981;141:567–80.
- Bongiovanni AM, McFadden AJ. Steroids during pregnancy and possible fetal consequences. Fertil Steril 1960;11:181–4.
- Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977.
- Heinonen OP, Slone D, Monson RR, Hook EB, Shapiro S. Cardiovascular birth defects and antenatal exposure to female sex hormones. N Engl J Med 1977;296:67–70.
- Wiseman RA, Dodds-Smith IC. Cardiovascular birth defects and antenatal exposure to female sex hormones: a reevaluation of some base data. Teratology 1984;30:359–70.
- Dillon S. Congenital malformations and hormones in pregnancy. Br Med J 1976;2:1446.
- Guiloff E, Ibarra-Polo A, Zanartu J, Toscanini C, Mischler TW, Gomez-Rogers C. Effect of contraception on lactation. Am J Obstet Gynecol 1974;118:42–5.
- Karim M, Ammarr R, El-Mahgoubh S, El-Ganzoury B, Fikri F, Abdou I. Injected progestogen and lactation. Br Med J 1971;1:200–3.
- Kora SJ. Effect of oral contraceptives on lactation. Fertil Steril 1969;20:419–23.
- Miller GH, Hughes LR. Lactation and genital involution effects of a new low-dose oral contraceptive on breast-feeding mothers and their infants. Obstet Gynecol 1970;35:44–50.
- Lonnerdal B, Forsum E, Hambraeus L. Effect of oral contraceptives on composition and volume of breast milk. Am J Clin Nutr 1980;33:816–24.
- Committee on Drugs, American Academy of Pediatrics. Transfer of drugs and other chemicals into human milk. Pediatrics 1989;84:924–36.
Q&A about Norethindrone
will norethindrone increase my chances of a blood clots if I have a stent?
I have been perscribed norethindrone for severe menstal bleeding and pain. However,I am also taking plavix and aspirin because I have a medicated stent.
I have been perscribed norethindrone for severe menstal bleeding and pain. However,I am also taking plavix and aspirin because I have a medicated stent.
Connie - You ask a great question. As you know, the results of the Women's Health Initiative in 2003 suggested that there could be an increase in heart attacks in women using combination estrogen-progestin pills. More striking, however, was the finding that women taking estrogen-progestin had a significantly higher risk of developing blood clots in the legs that could come loose and lodge in the lungs. It was based on these findings that doctors stopped recommending hormone replacement for post-menopausal women (which many had thought could protect AGAINST heart attacks).
Norethindrone is a progestogen that is used in progestin-only pills (pills without estrogen). At this time, the best studies we have show that progestin-only pills DO NOT increase a woman's risk for heart attack, stroke or blood clots. Therefore, based on this, it is reasonable to take norethindrone even with your medicated stent. It is important to keep taking the Plavix and aspirin, however, until your cardiologist tells you to stop! It is also important to avoid smoking, if you do so, since this will increase your risk of blood clots as well!
If you are still worried about the risks of blood clots, you may want to ask your gynecologist about Mirena, a medicated IUD containing progestin. This can control severe menstrual bleeding and cramping with fewer side effects because less of the progestin enters your bloodstream. It is not associated with increased risk of pelvic inflammatory disease (pelvic infections) and is an effective contraceptive.
I hope that helps! Good luck to you!
Norethindrone is a progestogen that is used in progestin-only pills (pills without estrogen). At this time, the best studies we have show that progestin-only pills DO NOT increase a woman's risk for heart attack, stroke or blood clots. Therefore, based on this, it is reasonable to take norethindrone even with your medicated stent. It is important to keep taking the Plavix and aspirin, however, until your cardiologist tells you to stop! It is also important to avoid smoking, if you do so, since this will increase your risk of blood clots as well!
If you are still worried about the risks of blood clots, you may want to ask your gynecologist about Mirena, a medicated IUD containing progestin. This can control severe menstrual bleeding and cramping with fewer side effects because less of the progestin enters your bloodstream. It is not associated with increased risk of pelvic inflammatory disease (pelvic infections) and is an effective contraceptive.
I hope that helps! Good luck to you!
Is there a website for prescription assistance for Aygestin/Norethindrone?
www.PPAP.org
I was perscribed norethindrone to take once a day for ten days to bring on my period. I am TTC and not?
ovulating=(......Will this RX help regulate periods in the future? Will it effect me getting pregnant if I end up ovulating next month with the Maca Root I just started taking?
ovulating=(......Will this RX help regulate periods in the future? Will it effect me getting pregnant if I end up ovulating next month with the Maca Root I just started taking?
It will bring on your period but will most likely not effect your next cycle. Talk to your doc. about Clomid to induce ovulation.
is norethindrone good for irregular periods and will i see a change in my body?
april 5 my doctor put me on norethindrone for about three mths cause i have irregular cycle and he said when i come back june the 19 hes gonna put me on clomid so how long do u think this will work to concieve pray for me
april 5 my doctor put me on norethindrone for about three mths cause i have irregular cycle and he said when i come back june the 19 hes gonna put me on clomid so how long do u think this will work to concieve pray for me
No prediction is possible. Also your detailed medical, gynaecological history is unknown to me. Apologies but no useful or meaningful medical answer is possible.
Good luck however!
Good luck however!
if pregnant does taking norethindrone tablets cause miscarriage?
taking ANYTHING could be detrimental. are you trying to miscarry?
Does Norethindrone/Errin affect breast feeding?
I'm a first time mom and have chosen to breast feed my baby girl. I recently got a perscription for Errin for birth control. My question is, will this pill effect my 7 week old daughter in anyway?
I'm a first time mom and have chosen to breast feed my baby girl. I recently got a perscription for Errin for birth control. My question is, will this pill effect my 7 week old daughter in anyway?
http://toxnet.nlm.nih.gov/cgi-bin/sis/se...
Drug Levels and Effects:
Summary of Use during Lactation:
This record contains information specific to norethindrone used alone. Users with an interest in a combination oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined."
Although nonhormonal methods are preferred during breastfeeding, progestin-only contraceptives such as norethindrone are considered the hormonal contraceptives of choice during all stages of lactation.[1][2][3][4] Three small studies on the effect of norethindrone on milk supply and quality have found conflicting results, but fair quality evidence on another progestin-only contraceptive (levonorgestrel) indicates that progestin-only contraceptives do not adversely affect the composition of milk, the growth and development of the infant or the milk supply.[1][2][3]
The timing of initiation of postpartum contraception with norethindrone is controversial. The product labeling states that it should be started no sooner than 6 weeks postpartum, based on data submitted for product approval. Starting sooner theoretically could affect the newborn infant adversely because of slower metabolism of the drug than older infants. Of concern is that no data exist on the effects of exogenous progestins on brain and liver development at this age.[4] Administration sooner than 3 days postpartum could inhibit lactogenesis and interfere with the establishment of lactation.
With the current state of knowledge expert opinion holds that it is preferable to initiate norethindrone contraception at 6 weeks postpartum, especially if the mother is exclusively breastfeeding. In certain cases, the physician and patient may elect to give the drug sooner, but is prudent to give it no sooner than 3 days postpartum after lactation is established.[2][3][4]
http://www.kellymom.com/health/meds/birt...
Progestin-only contraceptives
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.
[...]
Side effects related to lactation
Milk supply: As noted above, hormonal birth control pills (particularly those containing estrogen) have the potential to decrease milk supply, sometimes dramatically.
Effects on baby: There have been no adverse reports of side effects to the baby. Both progestin and estrogen are approved by the AAP for use by nursing moms. Children whose mothers used hormonal birth control while nursing have been followed as late as 17 years of age. The exception to this is the very young baby - less than 6 weeks old. There may be some concern about the baby's immature liver being able to metabolize the hormones passed through the milk well enough.
Any hormonal birth control may cause fussiness in the baby (not reported in the literature but often anecdotally by mothers). This may be due to the hormones causing a minimal decrease in the protein/nitrogen/lactose content of the milk. Some mothers have reported marked improvement in their baby's degree of fussiness once they come off hormonal birth control.
Effects on mother: If you had gestational diabetes during pregnancy, talk to your doctor about the safety of using the mini-pill while breastfeeding. A 1998 study conducted at the University of Southern California School of Medicine in Los Angeles (Kjos SL, et al. Contraception and the risk of type 2 diabetes mellitus in Latina women with prior gestational diabetes mellitus. JAMA. 1998 Aug 12;280(6):533-8.) indicated that for certain women, taking the mini-pill while breastfeeding may increase the risk of chronic, non-insulin-dependent diabetes. This study of more than 900 Latinas found that those who had been diagnosed with gestational diabetes and then took mini-pills while breastfeeding had an almost threefold risk of developing type II diabetes within a year, compared with those who used different contraception. This study concentrated on Hispanic women, and thus it is not clear whether the results can be applied to all ethnic groups. Other, smaller studies on the mini-pill did not show any increased rates of diabetes, so more research in needed on this subject.
Here's the bottom line...
* Use any hormonal type of birth control with caution (particularly the forms that contain estrogen).
* Use as low a dose as possible.
* If you experience supply problems (or if baby's weight gain slows more than expected or stops) and are using any type of hormonal birth control, it's a good idea to discontinue using it for a time and see if your supply rebounds as a result.
Drug Levels and Effects:
Summary of Use during Lactation:
This record contains information specific to norethindrone used alone. Users with an interest in a combination oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined."
Although nonhormonal methods are preferred during breastfeeding, progestin-only contraceptives such as norethindrone are considered the hormonal contraceptives of choice during all stages of lactation.[1][2][3][4] Three small studies on the effect of norethindrone on milk supply and quality have found conflicting results, but fair quality evidence on another progestin-only contraceptive (levonorgestrel) indicates that progestin-only contraceptives do not adversely affect the composition of milk, the growth and development of the infant or the milk supply.[1][2][3]
The timing of initiation of postpartum contraception with norethindrone is controversial. The product labeling states that it should be started no sooner than 6 weeks postpartum, based on data submitted for product approval. Starting sooner theoretically could affect the newborn infant adversely because of slower metabolism of the drug than older infants. Of concern is that no data exist on the effects of exogenous progestins on brain and liver development at this age.[4] Administration sooner than 3 days postpartum could inhibit lactogenesis and interfere with the establishment of lactation.
With the current state of knowledge expert opinion holds that it is preferable to initiate norethindrone contraception at 6 weeks postpartum, especially if the mother is exclusively breastfeeding. In certain cases, the physician and patient may elect to give the drug sooner, but is prudent to give it no sooner than 3 days postpartum after lactation is established.[2][3][4]
http://www.kellymom.com/health/meds/birt...
Progestin-only contraceptives
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.
[...]
Side effects related to lactation
Milk supply: As noted above, hormonal birth control pills (particularly those containing estrogen) have the potential to decrease milk supply, sometimes dramatically.
Effects on baby: There have been no adverse reports of side effects to the baby. Both progestin and estrogen are approved by the AAP for use by nursing moms. Children whose mothers used hormonal birth control while nursing have been followed as late as 17 years of age. The exception to this is the very young baby - less than 6 weeks old. There may be some concern about the baby's immature liver being able to metabolize the hormones passed through the milk well enough.
Any hormonal birth control may cause fussiness in the baby (not reported in the literature but often anecdotally by mothers). This may be due to the hormones causing a minimal decrease in the protein/nitrogen/lactose content of the milk. Some mothers have reported marked improvement in their baby's degree of fussiness once they come off hormonal birth control.
Effects on mother: If you had gestational diabetes during pregnancy, talk to your doctor about the safety of using the mini-pill while breastfeeding. A 1998 study conducted at the University of Southern California School of Medicine in Los Angeles (Kjos SL, et al. Contraception and the risk of type 2 diabetes mellitus in Latina women with prior gestational diabetes mellitus. JAMA. 1998 Aug 12;280(6):533-8.) indicated that for certain women, taking the mini-pill while breastfeeding may increase the risk of chronic, non-insulin-dependent diabetes. This study of more than 900 Latinas found that those who had been diagnosed with gestational diabetes and then took mini-pills while breastfeeding had an almost threefold risk of developing type II diabetes within a year, compared with those who used different contraception. This study concentrated on Hispanic women, and thus it is not clear whether the results can be applied to all ethnic groups. Other, smaller studies on the mini-pill did not show any increased rates of diabetes, so more research in needed on this subject.
Here's the bottom line...
* Use any hormonal type of birth control with caution (particularly the forms that contain estrogen).
* Use as low a dose as possible.
* If you experience supply problems (or if baby's weight gain slows more than expected or stops) and are using any type of hormonal birth control, it's a good idea to discontinue using it for a time and see if your supply rebounds as a result.
Women who have taken Aygestin/Norethindrone Please Help!?
I was recently put on Aygestin (Norethindrone). I was prescribed five 5mg tablets (once a day for five days). I stoped taking it yesterday. While taking it I noticed I was much more emotional and since I have stopped taking it I feel I am having emotional outbursts (crying, anxiety etc.). Is this normal? When can I expect these unpleasant feelings to stop? They are horrible! Please Help!
I was recently put on Aygestin (Norethindrone). I was prescribed five 5mg tablets (once a day for five days). I stoped taking it yesterday. While taking it I noticed I was much more emotional and since I have stopped taking it I feel I am having emotional outbursts (crying, anxiety etc.). Is this normal? When can I expect these unpleasant feelings to stop? They are horrible! Please Help!
Yeah, that's typical. This is an artificial progesterone, and they all have the possible side-effect of making you depressed. It will take a few days to get it out of your system, so the emotional lows will last for a few days following you stopping the drug. But it should go away shortly. I just answered a similar question here, about a different artificial progesterone: http://answers.yahoo.com/question/index;...
Has anyone had major side effects of Norethindrone (Birth Control Pill)?
I am currently switching my birth control method to the Norethindrone Pill. I am switching from depro. (The 3 month shot) I had really bad side effects from that. I gained an enormous amount of weight, joint pains, just didn't like it at all. I am currenlty breast feeding so that is why my Dr. suggested this one. So is anyone currently taking this pill? If so were there any major side effects? (I know each person is different but I was just curious) I also am aware that it passes through to the breast milk, does that have any effects on the baby? Thank you in advance for responses.
I am currently switching my birth control method to the Norethindrone Pill. I am switching from depro. (The 3 month shot) I had really bad side effects from that. I gained an enormous amount of weight, joint pains, just didn't like it at all. I am currenlty breast feeding so that is why my Dr. suggested this one. So is anyone currently taking this pill? If so were there any major side effects? (I know each person is different but I was just curious) I also am aware that it passes through to the breast milk, does that have any effects on the baby? Thank you in advance for responses.
I am not sure if you read any of these sites, that deal with Norethindrone side effects:
http://www.medicinenet.com/norethindrone...
http://www.nlm.nih.gov/medlineplus/drugi...
http://www.pdrhealth.com/drug_info/rxdru...
http://www.rxlist.com/cgi/generic/noreth...
I think these 4 sites are enough, though there are many more. After reading you can decide if you want to continue using it or not.
http://www.medicinenet.com/norethindrone...
http://www.nlm.nih.gov/medlineplus/drugi...
http://www.pdrhealth.com/drug_info/rxdru...
http://www.rxlist.com/cgi/generic/noreth...
I think these 4 sites are enough, though there are many more. After reading you can decide if you want to continue using it or not.
Can Norethindrone cause Hair Shedding?
My hair has been shedding excessively for months now. I've been switching birth control pills and this is the cause for my shedding. But four months ago, I stopped Birth Control pills altogether, but my hair still was shedding. Now I decided to take birth control called Ovcon (Estrogen and Norethidrone) My hair is now coming out by the handfull, but my acne is clearing. If Norethidrone is androgenic, shouldn't I be breaking out even more? Can Norethidrone be the cause of this and is it high or low in androgenity?
My hair has been shedding excessively for months now. I've been switching birth control pills and this is the cause for my shedding. But four months ago, I stopped Birth Control pills altogether, but my hair still was shedding. Now I decided to take birth control called Ovcon (Estrogen and Norethidrone) My hair is now coming out by the handfull, but my acne is clearing. If Norethidrone is androgenic, shouldn't I be breaking out even more? Can Norethidrone be the cause of this and is it high or low in androgenity?
One of the side effects of Norethindrone is hair loss. It is actually a female hormone: progestrin which is similar to the progesterone that a female body produces naturally. It actually has some anabolic, estrogenic, and androgenic properties so it is probably low since it has "some".
You might want to notify your doctor about the hair loss expecially if you seem to be losing an unusual amount of hair or developing bald spots.
You might want to notify your doctor about the hair loss expecially if you seem to be losing an unusual amount of hair or developing bald spots.
