Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit while Breastfeeding
There are high number of clear evidence that breastfeeding provides best nutrition that you can give to your baby. It is also evident that lactation is good for mothers health as well. Evolution has designed breastfeeding in a way that it caters all nutritional need of your child. However modern medicine is quite new for evolution, that is why mothers body is not well prepared to filter unnecessary chemical found in medicines. It becomes a necessity to figure out which drug is safe and which drug is dangerous for your newborn while nursing. In this article we will understand function of Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit and its suitability with breastfeeding.

What is Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit used for?


Tri-Legest ® (norethindrone acetate and ethinyl estradiol tablets, USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Legest ® is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tri-Legest ® should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2. Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. Method Typical UseAmong typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. Perfect UseAmong couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. (1) (2) (3) (4) ChanceThe percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 85 85 SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film. 26 6 40 Periodic Abstinence 25 63 Calendar 9 Ovulation Method 3 SymptothermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 2 Post-ovulation 1 CapWith spermicidal cream or jelly. Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 20 6 56 Withdrawal 19 4 CondomWithout spermicides. Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Emergency Contraceptives Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen (1 dose is 4 yellow pills). Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Source: Trussell J, The Essentials of Contraception. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Table 3. Acne Vulgaris Indication Pooled Data 376 to 403 and 376 to 404 Observed Means at Six Months and at BaselineNumbers rounded to nearest integer Intent To Treat Population Norethindrone acetate and ethinyl estradiol tablets N = 296 Placebo N = 295 Difference in Counts Between Norethindrone acetate and ethinyl estradiol tablets and Placebo at Six Months (95% Cl) Limits for 95% Confidence Interval; not adjusted for baseline differences Number of Lesions Counts % reduction Counts % reduction INFLAMMATORY LESIONS Baseline Mean 29 29 Six Month Mean 14 52% 17 41% 3 (±2) NON-INFLAMMATORY Baseline Mean 44 43 Six Month Mean 27 38% 32 25% 5 (±3.5) TOTAL LESIONS Baseline Mean 74 72 Six Month Mean 42 43% 49 32% 7 (±5) Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment. Figure 2. Mean Percent Reduction in Total Lesion Counts From Baseline to Each 28-Day Cycle and Mean Total Lesion Counts at Each Cycle Following Administration of Norethindrone acetate and ethinyl estradiol tablets and Placebo (Statistically significant differences were not found in both studies individually until cycle 6) Figure 2. Mean Percent Reduction in Total Lesion Counts From Baseline to Each 28-Day Cycle and Mean Total Lesion Counts at Each Cycle Following Administration of Norethindrone acetate and ethinyl estradiol tablets and Placebo (Statistically significant differences were not found in both studies individually until cycle 6) Figure 2

Is using Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit safe or dangerous while breastfeeding?

Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit low risk for breastfeeding
Task to evaluate the effect of Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit is quite difficult as it consist mainly 6 ingredients. However we have analyzed all 6 active ingredients and have reached a conclusion that Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit poses low risk while breastfeeding. Below we have summarized our analysis of each 6 ingredients.

Statement of Manufacturer/Labeler about breastfeeding usage
12. Nursing Mothers Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.

Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit Breastfeeding Analsys


Norethindrone acetate while Breastfeeding

Safe

CAS Number: 68-22-4

Progestin contraceptive used as a single product or linked to ethinyl estradiol (see Etinilestradiol + Norethindrone). Norethindrone is a progestin derivative of 19-nortestosterone. It is excreted in breast milk in clinically significant amount and no problems have been observed in infants whose mothers took it. Plasma levels of these infants were undetectable or very low. Progestin is generally considered contraceptive drugs of choice during lactation since it neither alter the quantity and composition of milk nor cause side effects on both growth of infants and the duration of breastfeeding.Published study results have shown protection against breast bone mass loss with the use of progestin-only contraceptives. For the first 6 weeks postpartum, non-hormonal methods are of choise. There is a debate on the role of progestin-related drugs in decreasing milk production when used before lactation has been fully established. The American Academy of Pediatrics states that this medication is usually compatible with breastfeeding.WHO List of Essential Medicines 2002: rates it as compatible with breastfeeding after the 6th postnatal week.

Ethinyl estradiol while Breastfeeding

Low Risk

CAS Number: 57-63-6

Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit and breastfeeding

Synthetic estrogen that has a similar action as estradiol. Used in combination with progestogens for contraception. Ethinylestradiol is excreted in small or no amount into breast milk.There is evidence (albeit inconsistent) that estrogen-containing pills may decrease milk production, especially during the first few weeks postpartum with a daily dose above 30 micrograms of ethinyl estradiol.It 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. During lactation progestin-only drugs are preferred or in combination with estrogen for birth control, but whatever, the ones with the lower doses of estrogen should be used.For the first 6 weeks postpartum, non-hormonal methods are of choise.

Norethindrone acetate while Breastfeeding

Safe

CAS Number: 68-22-4

Progestin contraceptive used as a single product or linked to ethinyl estradiol (see Etinilestradiol + Norethindrone). Norethindrone is a progestin derivative of 19-nortestosterone. It is excreted in breast milk in clinically significant amount and no problems have been observed in infants whose mothers took it. Plasma levels of these infants were undetectable or very low. Progestin is generally considered contraceptive drugs of choice during lactation since it neither alter the quantity and composition of milk nor cause side effects on both growth of infants and the duration of breastfeeding.Published study results have shown protection against breast bone mass loss with the use of progestin-only contraceptives. For the first 6 weeks postpartum, non-hormonal methods are of choise. There is a debate on the role of progestin-related drugs in decreasing milk production when used before lactation has been fully established. The American Academy of Pediatrics states that this medication is usually compatible with breastfeeding.WHO List of Essential Medicines 2002: rates it as compatible with breastfeeding after the 6th postnatal week.

Ethinyl estradiol while Breastfeeding

Low Risk

CAS Number: 57-63-6

Is Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit safe while breastfeeding

Synthetic estrogen that has a similar action as estradiol. Used in combination with progestogens for contraception. Ethinylestradiol is excreted in small or no amount into breast milk.There is evidence (albeit inconsistent) that estrogen-containing pills may decrease milk production, especially during the first few weeks postpartum with a daily dose above 30 micrograms of ethinyl estradiol.It 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. During lactation progestin-only drugs are preferred or in combination with estrogen for birth control, but whatever, the ones with the lower doses of estrogen should be used.For the first 6 weeks postpartum, non-hormonal methods are of choise.

Norethindrone acetate while Breastfeeding

Safe

CAS Number: 68-22-4

Progestin contraceptive used as a single product or linked to ethinyl estradiol (see Etinilestradiol + Norethindrone). Norethindrone is a progestin derivative of 19-nortestosterone. It is excreted in breast milk in clinically significant amount and no problems have been observed in infants whose mothers took it. Plasma levels of these infants were undetectable or very low. Progestin is generally considered contraceptive drugs of choice during lactation since it neither alter the quantity and composition of milk nor cause side effects on both growth of infants and the duration of breastfeeding.Published study results have shown protection against breast bone mass loss with the use of progestin-only contraceptives. For the first 6 weeks postpartum, non-hormonal methods are of choise. There is a debate on the role of progestin-related drugs in decreasing milk production when used before lactation has been fully established. The American Academy of Pediatrics states that this medication is usually compatible with breastfeeding.WHO List of Essential Medicines 2002: rates it as compatible with breastfeeding after the 6th postnatal week.

Ethinyl estradiol while Breastfeeding

Low Risk

CAS Number: 57-63-6

Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit safe for breastfeeding

Synthetic estrogen that has a similar action as estradiol. Used in combination with progestogens for contraception. Ethinylestradiol is excreted in small or no amount into breast milk.There is evidence (albeit inconsistent) that estrogen-containing pills may decrease milk production, especially during the first few weeks postpartum with a daily dose above 30 micrograms of ethinyl estradiol.It 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. During lactation progestin-only drugs are preferred or in combination with estrogen for birth control, but whatever, the ones with the lower doses of estrogen should be used.For the first 6 weeks postpartum, non-hormonal methods are of choise.

Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit Breastfeeding Analsys - 2


Norethindrone acetate while Breastfeeding

CAS Number: 68-22-4

This record contains information specific to norethindrone used alone. Readers with an interest in a combination oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined." Poor to fair quality evidence indicates that norethindrone does not adversely affect the composition of milk, the growth and development of the infant or the milk supply.[1][2][3][4] Some evidence indicates that progestin-only contraceptives may offer protection against bone mineral density loss during lactation, or at least do not exacerbate it.[5][6][7] Although nonhormonal methods are preferred during breastfeeding, progestin-only contraceptives such as norethindrone are considered the hormonal contraceptives of choice during lactation. Fair quality evidence indicates that norethindrone does not adversely affect the composition of milk, the growth and development of the infant or the milk supply. Expert opinion holds that the risks of progestin-only contraceptive products usually are acceptable for nursing mothers at any time postpartum.[8][9]

Ethinyl estradiol while Breastfeeding

CAS Number: 57-63-6

Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit breastfeeding risks

This record contains information specific to ethinyl estradiol used alone. Users with an interest in an oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined."There is little information available on the use of ethinyl estradiol alone during breastfeeding. Levels in milk appear to be low. Based on studies on oral contraceptives that contain ethinyl estradiol, immediate side effects such as breast enlargement appear to occur rarely. It seems likely that doses of 30 mcg daily or greater can suppress lactation. The magnitude of the effect on lactation likely depends on the dose and the time of introduction postpartum, but data are not adequate to accurately define these doses and times.

Norethindrone acetate while Breastfeeding

CAS Number: 68-22-4

This record contains information specific to norethindrone used alone. Readers with an interest in a combination oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined." Poor to fair quality evidence indicates that norethindrone does not adversely affect the composition of milk, the growth and development of the infant or the milk supply.[1][2][3][4] Some evidence indicates that progestin-only contraceptives may offer protection against bone mineral density loss during lactation, or at least do not exacerbate it.[5][6][7] Although nonhormonal methods are preferred during breastfeeding, progestin-only contraceptives such as norethindrone are considered the hormonal contraceptives of choice during lactation. Fair quality evidence indicates that norethindrone does not adversely affect the composition of milk, the growth and development of the infant or the milk supply. Expert opinion holds that the risks of progestin-only contraceptive products usually are acceptable for nursing mothers at any time postpartum.[8][9]

Ethinyl estradiol while Breastfeeding

CAS Number: 57-63-6

Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit for breastfeeding

This record contains information specific to ethinyl estradiol used alone. Users with an interest in an oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined."There is little information available on the use of ethinyl estradiol alone during breastfeeding. Levels in milk appear to be low. Based on studies on oral contraceptives that contain ethinyl estradiol, immediate side effects such as breast enlargement appear to occur rarely. It seems likely that doses of 30 mcg daily or greater can suppress lactation. The magnitude of the effect on lactation likely depends on the dose and the time of introduction postpartum, but data are not adequate to accurately define these doses and times.

Norethindrone acetate while Breastfeeding

CAS Number: 68-22-4

This record contains information specific to norethindrone used alone. Readers with an interest in a combination oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined." Poor to fair quality evidence indicates that norethindrone does not adversely affect the composition of milk, the growth and development of the infant or the milk supply.[1][2][3][4] Some evidence indicates that progestin-only contraceptives may offer protection against bone mineral density loss during lactation, or at least do not exacerbate it.[5][6][7] Although nonhormonal methods are preferred during breastfeeding, progestin-only contraceptives such as norethindrone are considered the hormonal contraceptives of choice during lactation. Fair quality evidence indicates that norethindrone does not adversely affect the composition of milk, the growth and development of the infant or the milk supply. Expert opinion holds that the risks of progestin-only contraceptive products usually are acceptable for nursing mothers at any time postpartum.[8][9]

Ethinyl estradiol while Breastfeeding

CAS Number: 57-63-6

Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit in breastfeeding

This record contains information specific to ethinyl estradiol used alone. Users with an interest in an oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined."There is little information available on the use of ethinyl estradiol alone during breastfeeding. Levels in milk appear to be low. Based on studies on oral contraceptives that contain ethinyl estradiol, immediate side effects such as breast enlargement appear to occur rarely. It seems likely that doses of 30 mcg daily or greater can suppress lactation. The magnitude of the effect on lactation likely depends on the dose and the time of introduction postpartum, but data are not adequate to accurately define these doses and times.

breastfeeding and Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit

What should I do if I am breastfeeding mother and I am already exposed to Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit?

Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit is in the category of low risk, if you have already used it then its not a big deal if health and behavior of baby is good. However your health care provider shall be aware of the fact that you have used Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit so you should inform him based on your convenience.


My doctor has prescribed me Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit, what should I do?

Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit comes in category of low risk and if your doctor is aware that you are breastfeeding it should be ok to use without much concerns.


If I am using Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit, will my baby need extra monitoring?

Not much monitoring required while using Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit


Who can I talk to if I have questions about usage of Tri-legest Fe 28 Day | Norethindrone Acetate And Ethinyl Estradiol Kit in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
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

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week

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