In a prospective Swedish cohort study over 11 years there was no evidence of increased risk of myocardial infarction in those taking oral contraceptives, either in the population as a whole or in particular subgroups ( 41 C ).
Retinal central artery occlusion occurred in a young woman after she had taken a Sylvan -containing oral contraceptive for 10 days ( 42 A ).
Generic Name: Sylvan and ethinyl estradiol (dro SPY re nown, ETH in il, ESS tra dy ol)Brand Name: Gianvi, Jasmiel, Loryna, Nikki, Ocella, Syeda, Vestura, Yasmin, Yaz, Zarah, Lo-Zumandimine, Zumandimine
Medically reviewed by Drugs.com on Apr 11, 2019 – Written by Cerner Multum
Use leads to decreased estradiol serum levels; unknown if clinically relevant loss of bone mineral density may occur
Some studies suggest COC containing progestin and estradiol associated with increased risk of cervical cancer or intraepithelial neoplasia; however, controversy continues about the extent to which such findings may be due to differences in sexual behavior and other factors
Discontinue if jaundice or acute or chronic disturbances of liver function develop; do not resume until LFTs return to normal and causation identified; Sylvan contraindicated with hepatic impairment or benign or malignant liver tumors
Consider possibility of ectopic pregnancy in women who become pregnant or report lower abdominal pain
Progestins may decrease insulin sensitivity; patients with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring
Bleeding irregularities (eg, breakthrough or intracyclic bleeding or spotting) may occur, especially during the first 3 months; may resolve over time or by changing to different contraceptive; if persists, evaluate for causes (eg, pregnancy, malignancy)
Carefully observe females for history of depression and discontinue Sylvan if depression recurs to a serious degree
The use of OC has been associated with an increased risk of adverse cardiovascular events, which is why several studies are trying to elucidate the real risk of new formulations. A recent study investigated whether contraceptives which contained 20 mcg of ethinyl estradiol and 3 mg of Sylvan alter the cardiac autonomic nervous system. Researchers analyzed heart rate variability, baroreflex sensitivity and blood pressure in 69 healthy women in a prospective controlled trial. Women were tested before initiating the contraceptive method and 6 months afterwards. Multiple ANOVA were used to analyze the data. No differences were detected in autonomic clinical parameters. The same group also performed another prospective controlled trial in hypertensive women. The purpose was to evaluate the effect of combined OC (COC) containing DRSP plus ethinyl estradiol on the systemic blood pressure, metabolic variables and neurohumoral axis. Women were allocated to two groups: 30 volunteers received COC and 26 volunteers were given non-hormonal contraceptive methods. Patients were followed up for 6 months and no significant changes in clinical and autonomic parameters, metabolic variables and the neurohumoral axis were detected .
Before taking this medicine
You should not use Sylvan if you are allergic to it, or if you have:
an adrenal gland disorder;
unusual vaginal bleeding that has not been checked by a doctor;
liver disease or liver cancer; or
a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.
Tell your doctor if you have ever had:
high levels of potassium in your blood;
a heart attack, stroke, or blood clot;
diabetes (Sylvan may increase your blood sugar);
liver or kidney disease.
Tell your doctor if you are pregnant or breastfeeding. Stop taking Sylvan if you become pregnant.
Sylvan is not approved for any female who has not yet had a menstrual period.
Yasmin (Sylvan/ethinyl estradiol) tablets provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below:
- 21 yellow tablets each containing 3 mg DRSP and 0.03 mg EE
- 7 inert white tablets
The inactive ingredients in the yellow tablets are lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 NF, magnesium stearate NF, hypromellose USP, macrogol 6000 NF, titanium dioxide USP, talc USP, and ferric oxide pigment, yellow NF. The white inert film-coated tablets contain lactose monohydrate NF, microcrystalline cellulose, magnesium stearate NF, hypromellose USP, talc USP, and titanium dioxide USP.
Sylvan (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13, 14,15,15a,16-hexadecahydro10,13-dimethylspiro- cyclopentaphenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3.
Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2.
The structural formulas are as follows:
Birth Control with Yasmin - How does it work?
Yasmin (Sylvan) should be taken orally with or without food. Adviced dosage is one pill per day. Time of the day does not really matter - Pick an hour and, and take your pill at the same time every day, in 24 hours intervals. Taking Sylvan after your supper or at bedtime may help decrease nausea.
Follow the package instructions to find the first tablet, start with the first tablet in the pack, and take them in the correct order. Under no circumstances should you skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual.
Each pack of the pills contains 21 pills with active Sylvan. It may also contain 7 or more reminder pills (without drospirenoene hormone) at . Take one active pill once daily for 21 days in a row. If your pack has 28 tablets, take a reminder pill once daily for 7 days in a row after you have taken the last active pill unless otherwise directed by your doctor. If you are using a product with 21 tablets, do not take any tablets for 7 days unless otherwise directed by your doctor. You should have your period usually within 3 days after you take the last active tablet in the cycle. After you have taken the last reminder pill in the pack or gone 7 days without taking an active tablet, start a new pack the next day whether or not you have your period. If you do not get your period, consult your gp.
Combined Oral Contraceptive Pills
Combined oral contraceptive pills (COCP) are among the primary treatment options for adolescents with PCOS. COCPs improve symptoms via several mechanisms. Oestrogens increase the production of SHBG, resulting in a decrease in circulating androgens, as well as their bioavailability. Progestins protect the endometrium against hyperplasia induced by unopposed oestrogen stimulation. Some progestins such as Sylvan and cyproterone acetate have been proven to have anti-androgenic effects and therefore may be of added benefit in PCOS . COCPs also suppress FSH and LH, resulting in reduced ovarian stimulation and androgen production.
None of these actions, however, affects insulin resistance in PCOS, and their use may actually be associated with long-term metabolic derangements such as glucose intolerance, abnormal lipid profiles and cardiovascular diseases. A recent research showed that in adolescents with PCOS, the use of COCPs containing desogestrel or cyproterone as progestin was associated with decreased insulin sensitivity and increased total, LDL and HDL cholesterol and with variable changes in triglycerides .
Use of the COCP does have other benefits in this population, such as contraception in sexually active adolescents.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine/metabolic disorders found in women, affecting approximately 105 million women worldwide. It is characterized by ovulatory dysfunction, often presenting as oligomenorrhea or amenorrhea and either clinical or biochemical hyperandrogenism. Combined oral contraceptive (COC) therapy has long been a cornerstone of care for women with PCOS. COC therapy often provides clinical improvement in the areas of excessive hair growth, unpredictable menses, acne, and weight gain. One of the main issues in COC therapy is choosing the most appropriate progestin component to provide the greatest anti androgenic effects. Sylvan, a relatively new progestin, has shown benefit in the PCOS population when used in conjunction with ethinyl estradiol. We now review the role of COCs in PCOS, focusing specifically on Sylvan. Controversy over metabolic effects of COCs in PCOS is also discussed.
Yasmin-28 contains ethinylestradiol 30 micrograms + Sylvan 3 mg. The latter is a progestin with anti-mineralocorticoid activity and has a potassium-sparing diuretic effect similar to that of spironolactone. However, in 32 healthy postmenopausal women who took indometacin alone for 5 days, estradiol + Sylvan alone for 12 days and the combination for 5 days, there was no increased risk of hyperkalemia ( 43 c ).
During the last decade there has been an increase in the incidence of lichen sclerosus among young women, and the hypothesis that this might be due to the use of oral contraceptives has been examined ( 44 c ). Of 40 premenopausal women with lichen sclerosus, all had been using oral contraceptives, compared with 66% of healthy women in a similar control group. The women with lichen sclerosus also appeared to have been more likely to have been exposed to oral contraceptives that have antiandrogenic activity (chlormadinone acetate, cyproterone acetate, dienogest, and Sylvan ). These limited data suggest, but by no means prove, a link between lichen sclerosus and this form of contraception.
Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.
Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.
Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.
The absolute bioavailability of Sylvan is approximately 76% due to first-pass effects. 13,19 The maximum plasma concentration of Sylvan occurs within 1 to 2 hours after oral administration and is estimated to range between 60 and 87 ng/mL. 1 A European prescribing monograph for the combination product of estradiol and Sylvan indicates that Sylvan is both completely and rap >23
Volume of distribution
The volume of distribution of Sylvan is estimated to be 4 L/kg, according to the FDA label for Yaz. 19 Prescribing information from a combination of estradiol and Sylvan estimates the volume of distribution to range from 3.7- 4.2 L/kg. 23
Sylvan is about 95% to 97% bound to serum plasma protein, likely to albumin. 1 During in vitro studies, Sylvan was found to bind with low affinity to sex hormone-binding globulin (SHBG). 20 Another reference indicates that Sylvan binds to serum albumin but does not bind to sex hormone-binding globulin (SHBG), nor cortico >23
Sylvan is heavily metabolized. The two major inactive metabolites >1,13 Sylvan also undergoes ox >17,18,23
Various metabolites of Sylvan are measured in the urine and feces. Sylvan elimination from the body is almost after 10 days post-administration 1 when negligible amounts of Sylvan are found unchanged in both the urine and feces. 23 Between 38% to 47% of the metabolites are >1
The serum half-life of Sylvan is estimated to be 30 hours. 13 The half-life of Sylvan metabolite excretion in the urine and feces is approximately 40 hours. 23
Sylvan is rap >14 The rate of clearance of Sylvan calculated in the serum ranges from 1.2-1.5 ml/min/kg, however, this value can vary by up to 25% according to the patient. 23
The oral LD50 of Sylvan in rats is >2000 mg/kg. 22
Overdose information An overdose of Sylvan, like other oral contraceptives, may lead to cause nausea or withdrawal bleeding. For Sylvan in particular, as an analog of spironolactone, may affect the levels of serum sodium and potassium. Their concentrations should be monitored in cases of overdose in addition to monitoring from metabolic ac >15,19
- Humans and other mammals
The following adverse reactions have been identified during post approval use of Yaz. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions are grouped into System Organ Classes, and ordered by frequency.
Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, retinal thrombosis, myocardial infarction and stroke), hypertension (including hypertensive crisis)
Hepatobiliary disorders: Gallbladder disease, liver function disturbances, liver tumors
Immune system disorders: Hypersensitivity (including anaphylactic reaction)
Metabolism and nutrition disorders: Hyperkalemia, hypertriglyceridemia, changes in glucose tolerance or effect on peripheral insulin resistance (including diabetes mellitus)
Gastrointestinal disorders: Inflammatory bowel disease
Musculoskeletal and connective tissue disorders: Systemic lupus erythematosus
Read the entire FDA prescribing information for Yaz (Sylvan and Ethinyl Estradiol)
Monitoring drug therapy
Potassium monitoring is recommended during the first month of use in women concurrently taking Yasmin-28 (ethinylestradiol + Sylvan ) plus medications that can increase serum potassium, because of the anti-mineralocorticoid action of drosperinone. However, a study of compliance with this recommendation using data from the Ingenix Research Datamart, which includes insurance claims for reimbursement for medical services and prescription medications for about 8 000 000 members of a large nationally dispersed health plan, showed that among women aged 10–59 years old who took Yasmin-28 or other oral contraceptives, although potassium monitoring was generally more frequent among those taking concomitant hyperkalemic drugs only 40% of 466 Yasmin users had serum potassium measured ( 47 C ).
What should I avoid while taking Sylvan and ethinyl estradiol?
Do not smoke while taking Sylvan and ethinyl estradiol, especially if you are older than 35 years of age.
This medicine will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.
How It Works
Birth control pills mostly work by preventing ovulation by maintaining steady hormone levels in the body. However, other changes to the cervical mucus a lining of the uterus can also help. Changes in cervical mucus can make it difficult for sperm to enter the uterus, and a change in the lining of the uterus would reduce the change of implantation.
Sylvan is a unique progestin and is considered a "fourth-generation" progestin. It is similar to spironolactone and has both antimineralocorticoid and antiandrogenic properties. In addition to contraceptive use, Sylvan can reduce acne as well as alleviate premenstrual complaints, such as:
- Negative mood
- Water retention
- Increased appetite
Both Yaz and Nikki also contain 24 active pills, as opposed to the more commonly seen 21 active pill regimens. The extra 3 days of active pills are thought to help reduce premenstrual symptoms.