Do you know that important immune protective proteins are present in breast milk? Breast milk also contains required vitamins, minerals, saturated and un saturated fats. These things are extremely important for development of healthy brain. If you are taking any medicine for short term or for the chronic reason then that passes in breast milk as well, that is why you should always check the drug with your health care provider. Here at DrLact we try to analyze drugs based on available researches and in this sheet we will present our analysis for Gianvi | Drospirenone And Ethinyl Estradiol Kit.
What is Gianvi | Drospirenone And Ethinyl Estradiol Kit used for?
Gianvi is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. Oral contraceptives are highly effective. Table II lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and contraceptive implants and IUDs, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Gianvi is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Gianvi for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders. Gianvi has not been evaluated for the treatment of premenstrual syndrome (PMS). Gianvi is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Gianvi should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and first year of perfect use of contraception and the percentage continuing use at the end of the first year: United States. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Guest F, Kowal D, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. % of Women Experiencing an Unintended Pregnancy Within the First Year of Use % of WomenContinuing Use at One YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. Method (1) 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. (2) 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 reason. (3) (4) ChanceThe percents 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 percentage 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 Sympto-thermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 2 Post-ovulation 1 Withdrawal 19 4 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 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 1.5 81 Copper T 380A 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 0.1 100 Emergency Contraceptive 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 2 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 six months of age. Oral Contraceptive Clinical Trial In the primary contraceptive efficacy study of Gianvi (3 mg DRSP/0.02 mg EE) of up to 1 year duration, 1,027 subjects were enrolled and completed 11,480 28-day cycles of use. The age range was 17 to 36 years. The racial demographic was: 87.8% Caucasian, 4.6% Hispanic, 4.3% Black, 1.2% Asian, and 2.1% other. Women with a BMI greater than 35 were excluded from the trial. The pregnancy rate (Pearl Index) was 1.41 per 100 woman-years of use based on 12 pregnancies that occurred after the onset of treatment and within 14 days after the last dose of Gianvi in women 35 years of age or younger during cycles in which no other form of contraception was used. Premenstrual Dysphoric Disorder Clinical Trials Two multicenter, double-blind, randomized, placebo-controlled studies were conducted to evaluate the effectiveness of Gianvi in treating the symptoms of PMDD. Women aged 18-42 who met DSM-IV criteria for PMDD, confirmed by prospective daily ratings of their symptoms, were enrolled. Both studies measured the treatment effect of Gianvi using the Daily Record of Severity of Problems scale, a patient-rated instrument that assesses the symptoms that constitute the DSM-IV diagnostic criteria. The primary study was a parallel group design that included 384 evaluable reproductive-aged women with PMDD who were randomly assigned to receive Gianvi or placebo treatment for 3 menstrual cycles. The supportive study, a crossover design, was terminated prematurely prior to achieving recruitment goals due to enrollment difficulties. A total of 64 women of reproductive age with PMDD were treated initially with Gianvi or placebo for up to 3 cycles followed by a washout cycle and then crossed over to the alternate medication for 3 cycles. Efficacy was assessed in both studies by the change from baseline during treatment using a scoring system based on the first 21 items of the Daily Record of Severity of Problems. Each of the 21 items was rated on a scale from 1 (not at all) to 6 (extreme); thus a maximum score of 126 was possible. In both trials, women who received Gianvi had statistically significantly greater improvement in their Daily Record of Severity of Problems scores. In the primary study, the average decrease (improvement) from baseline was 37.5 points in women taking Gianvi, compared to 30 points in women taking placebo. Acne Clinical Trials In two multicenter, double blind, randomized, placebo-controlled studies, 889 subjects, ages 14 to 45 years, with moderate acne received Gianvi or placebo for six 28 day cycles. The primary efficacy endpoints were the percent change in inflammatory lesions, non-inflammatory lesions, total lesions, and the percentage of subjects with a "clear" or "almost clear" rating on the Investigator's Static Global Assessment (ISGA) scale on day 15 of cycle 6, as presented in Table III: Table III: Efficacy Results for Acne TrialsEvaluated at day 15 of cycle 6, last observation carried forward for the Intent to treat population Study 1 Study 2 Gianvi Placebo Gianvi Placebo N=228 N=230 N=218 N=213 ISGA Success Rate 35 (15%) 10 (4%) 46 (21%) 19 (9%) Inflammatory Lesions Mean Baseline Count Mean Absolute (%) Reduction 3315 (48%) 3311 (32%) 3216 (51%) 3211 (34%) Non-inflammatory Lesions Mean Baseline Count Mean Absolute (%) Reduction 4718 (39%) 4710 (18%) 4417 (42%) 4411 (26%) Total lesions Mean Baseline Count Mean Absolute (%) reduction 8033 (42%) 8021 (25%) 7633 (46%) 7622 (31%)
Is using Gianvi | Drospirenone And Ethinyl Estradiol Kit unsafe in breastfeeding? Can there be bad consequences for baby if I use it while breastfeeding?
Drospirenone and Ethinyl estradiol are the two main ingredients of Gianvi | Drospirenone And Ethinyl Estradiol Kit. Based on our individual analysis of Drospirenone and Ethinyl estradiol we can safely say that Gianvi | Drospirenone And Ethinyl Estradiol Kit has low risk while breastfeeding. Below we have summarized the usage of Drospirenone and Ethinyl estradiol while breastfeeding, we recommend you to go through it for better understanding of your usage.
Gianvi | Drospirenone And Ethinyl Estradiol Kit Breastfeeding Analsys
Low RiskBirth control pill that contains the combination of an estrogen (Ethinyl estradiol) and a progestin (Drospirenone) for oral use. Ethinylestradiol is a synthetic estrogen with similar action than estradiol. Used in combination with progestogens for contraception.Ethinylestradiol is excreted into the breast milk in no or small amount.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. Drospirenone is an analogue of spironolactone which has the effects of progesterone. It is excreted into breast milk in clinically non-significant amount. With other similar combined contraceptives no differences have been observed in the frequency of breastfeeding or the amount of milk produced or weight gain of breastfed infants compared to other contraceptive methods (intrauterine devices, isolated progestogens). However, it would be advisable to avoid them until breastfeeding is well established (4-6 weeks). During lactation, progestin-only contraceptive pills are preferred to Estrogen containing ones, otherwise, the lowest estrogen dose should be used.During the first 6 postpartum weeks, non-hormonal methods are in the first line of choice. Hormone containing contraceptives do not affect the composition of milk, minerals (Mg, Fe, Cu, Ca, P) fat, lactose and calories but only a few the proteins.
Low RiskCAS Number: 57-63-6
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.
Gianvi | Drospirenone And Ethinyl Estradiol Kit Breastfeeding Analsys - 2
CAS Number: 67392-87-4
Drospirenone is a progestin that is an analogue of spironolactone. It has antimineralocorticoid and antiandrogenic activities and is available in the U.S. only in combination with ethinyl estradiol as an oral contraceptive agent. Based on the available evidence, expert opinion holds that nonhormonal methods are preferred during breastfeeding and progestin-only contraceptive are preferred over combined oral contraceptives in breastfeeding women, especially during the first 4 weeks postpartum. For further information, consult the record entitled, "Contraceptives, Oral, Combined."
CAS Number: 57-63-6
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.
I already used Gianvi | Drospirenone And Ethinyl Estradiol Kit and meanwhile I breastfed my baby should I be concerned?
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 Gianvi | Drospirenone And Ethinyl Estradiol Kit then you shall inform your doctor, But you should not be worried too much as Gianvi | Drospirenone And Ethinyl Estradiol Kit comes in category of low risk drug.
My health care provider has asked me to use Gianvi | Drospirenone And Ethinyl Estradiol Kit, what to do?
Gianvi | Drospirenone 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 Gianvi | Drospirenone And Ethinyl Estradiol Kit, will my baby need extra monitoring?
Not much
Who can I talk to if I have questions about usage of Gianvi | Drospirenone 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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