Modern medicine has evolved so much so that sooner or later every breastfeeding mother needs to take it in one form or other. Medication that is present in mothers blood will transfer into her breast milk to some extent. Most drugs do so at low levels and pose no real risk to infants but then there are some exceptions. In This post will discuss whether Innofem | Estradiol Tablet is safe in breast-feeding or not.
What is Innofem | Estradiol Tablet used for?
Innofem™ (Estradiol Tablets, USP) is indicated in the:Treatment of moderate to severe vasomotor symptoms associated with the menopause. There is no adequate evidence that estrogens are effective for nervous symptoms or depression which might occur during menopause and they should not be used to treat these conditions.Treatment of vulval and vaginal atrophy.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).Prevention of osteoporosis.Since estrogen administration is associated with risk, selection of patients should ideally be based on prospective identification of risk factors for developing osteoporosis. Unfortunately, there is no certain way to identify those women who will develop osteoporotic fractures. Most prospective studies of efficacy for this indication have been carried out in white menopausal women, without stratification by other risk factors, and tend to show a universally salutary effect on bone. Thus, patient selection must be individualized based on the balance of risks and benefits. A more favorable risk/benefit ratio exists in a hysterectomized woman because she has no risk of endometrial cancer (see BOXED WARNINGS).Estrogen replacement therapy reduces bone resorption and retards or halts post menopausal bone loss. Case-control studies have shown an approximately 60 percent reduction in hip and wrist fractures in women whose estrogen replacement was begun within a few years of menopause. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen prevents further loss of bone mass for as long as the treatment is continued. The results of a two-year, randomized, placebo-controlled, double-blind, dose-ranging study have shown that treatment with 0.5 mg estradiol daily for 23 days (of a 28 day cycle) prevents vertebral bone mass loss in postmenopausal women. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period. There is no evidence that estrogen replacement therapy restores bone mass to premenopausal levels.At skeletal maturity there are sex and race differences in both the total amount of bone present and its density, in favor of men and blacks. Thus, women are at higher risk than men because they start with less bone mass and, for several years following natural or induced menopause, the rate of bone mass decline is accelerated. White and Asian women are at higher risk than black women.Early menopause is one of the strongest predictors for the development of osteoporosis. In addition, other factors affecting the skeleton which are associated with osteoporosis include genetic factors (small build, family history), and endocrine factors (nulliparity, thyrotoxicosis, hyperparathyroidism, Cushing's syndrome, hyperprolactinemia, Type 1 diabetes), lifestyle (cigarette smoking, alcohol abuse, sedentary exercise habits) and nutrition (below average body weight, dietary calcium intake).The mainstays of prevention and management of osteoporosis are estrogen, an adequate lifetime calcium intake, and exercise. Postmenopausal women absorb dietary calcium less efficiently than premenopausal women and require an average of 1500 mg/day of elemental calcium to remain in neutral calcium balance. By comparison, premenopausal women require about 1000 mg/day and the average of calcium intake in the USA is 400-600 mg/day, therefore, when not contraindicated, calcium supplementation may be helpful.Weight-bearing exercise and nutrition may be important adjuncts to the prevention and management of osteoporosis. Immobilization and prolonged bed rest produce rapid bone loss, while weight-bearing exercise has been shown both to reduce bone loss and to increase bone mass. The optimal type and amount of physical activity that would prevent osteoporosis have not been established, however in two studies an hour of walking and running exercise twice or three times weekly significantly increased lumbar spine bone mass.
I am breastfeeding mother and I am using Innofem | Estradiol Tablet. Can it have any bad effect on my kid? Shall I search for better alternative?
Estradiol is the one and only active ingredient present in Innofem | Estradiol Tablet. Estradiol in itself is a low risk drug for lactation so it is easy to understand that Innofem | Estradiol Tablet also comes in category of Low Risk item while breastfeeding. Below is the summary of Estradiol in breastfeeding.
Statement of Manufacturer/Labeler about breastfeeding usage
G. Nursing Mothers As a general principle, the administration of any drug to nursing mothers should be done only when clearly necessary since many drugs are excreted in human milk. In addition, estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk.
Innofem | Estradiol Tablet Breastfeeding Analsys
Estradiol while Breastfeeding Low Risk
CAS Number: 50-28-2
A natural Estrogen that is marketed for oral, injection and topical administration (skin and vaginal).On the chemical form of valerate, it is used in association with a progestin as a combined birth-control compound (e.g. Estradiol + Dienogest) Estradiol is excreted into breast milk in clinically non-significant amount (Nilson 1978) and no problems have been observed in infants whose mothers were treated (Pinheiro 2016). Plasma levels of these infants were undetectable or very low (Pinheiro 2016). After administration in the form of transdermal patches milk levels have been undetectable (Pinheiro 2016, Perheentupa 2004). Despite these data, an older publication associated the use of transdermal estradiol with a case of jaundice and poor weight gain (Ball 1999).There is greater passage to milk when the administration is vaginal. There is evidence (albeit inconsistent) that estrogen-containing pills may decrease milk production, especially during the first few weeks postpartumThey may reduce the protein content of the milk. No problems have been observed in infants whose mothers were treated, except some cases of transient gynecomastia in infants whose mothers were receiving a higher dose than usual. Estrogen exposure in childhood or adolescence, does not influence the subsequent production of milk. The American Academy of Pediatrics states that this medication is usually compatible with breastfeeding.
Innofem | Estradiol Tablet Breastfeeding Analsys - 2
Estradiol while Breastfeeding
CAS Number: 50-28-2
Limited information on the use of estradiol during breastfeeding indicates that the route of administration and dosage form have influences on the amount transferred into breastmilk. Vaginal administration results in measurable amounts in milk, but transdermal patches do not. Maternal doses of up to 200 mcg daily transdermally do not increase estradiol or estriol in breastfed infants or cause any adverse effects in breastfed infants. Vaginal administration results in unpredictable peak times for estradiol in breastmilk, so timing of the dose with respect to breastfeeding is probably not useful. A case report of inadequate milk production and inadequate infant weight gain was possibly caused by transdermal estradiol initiated on the first day postpartum, but 2 small studies found no such effect when the drug was initiated after lactation was well established.
I am nursing mother and I have already used Innofem | Estradiol Tablet, what should I do?
During whole lactation period you shall first discuss with your doctor and then together you shall decide whether you shall take that drug or not however if you have already taken Innofem | Estradiol Tablet then you shall inform your doctor, But you should not be worried too much as Innofem | Estradiol Tablet comes in category of low risk drug.
I am nursing mother and my doctor has suggested me to use Innofem | Estradiol Tablet, is it safe?
Though Innofem | Estradiol Tablet dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.
If I am using Innofem | Estradiol Tablet, will my baby need extra monitoring?
Who can I talk to if I have questions about usage of Innofem | Estradiol Tablet in breastfeeding?
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week