Yasminelle tablets

Yasminelle

  • Active Ingredient: Drospirenone
  • 3.03 mg
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What is Yasminelle?

The active ingredient of Yasminelle brand is drospirenone.

Used for

Yasminelle is used to treat diseases such as: Postmenopausal Symptoms.

Side Effect

Possible side effects of Yasminelle include: ; ; ; ; ; ; .

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Observational studies

In the European Active Surveillance Study (EURAS), a multinational, prospective, non-interventional cohort study of new users of Yasminelle , levonorgestrel and other progestin-containing oral contraceptives, 58 674 women were followed for 142 475 women-years ( 39 C ). Loss to follow-up was 2.4%. Serious adverse and fatal events were rare, and rate ratios were close to unity. Cox regression analysis of cardiovascular outcomes yielded hazard ratios for Yasminelle-containing versus levonorgestrel-containing and other oral contraceptives of 1.0 and 0.8 (upper 95% conf >

Similar results have been observed in a study of 22 429 women who took ethinylestradiol + Yasminelle initiators and 44 858 other oral contraceptive users, who were followed for an average of 7.6 months ( 40 C ). Although those who used the latter had a slightly higher risk of thromboembolism it was not significant (RR = 0.9; 95% CI = 0.5, 1.6), and more than 9000 women would have to be studied to observe a difference of one case.

Yasminelle

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Metabolic concerns

More recently, controversy has arisen over the use of COC in patients with PCOS (Nader and Diamanti-Kandarakis 2007) specifically regarding the effects of COCs on carbohydrate metabolism and metabolic parameters such as insulin resistance and glucose tolerance (Korytkowski et al 1995; Nader and Diamanti-Kandarakis 2007). The most significant change found is a deterioration of insulin sensitivity with the administration of COCs (Korytkowski et al 1995; Dahlgren et al 1998). Two studies conducted in obese women with PCOS also showed a decrease in glucose tolerance demonstrated by the results of an oral glucose tolerance test (Nader et al 1997; Morin-Papunen et al 2000). Plasma insulin concentrations were constant in both of these studies indicating that the decrease in glucose tolerance was again due to a decrease in insulin sensitivity rather than a change in insulin levels/production. However, other studies performed in non-obese women showed no change in glucose tolerance and insulin sensitivity (Armstrong et al 2001; Cibula et al 2002; Elter et al 2002; Morin-Papunen et al 2003). This variation in results may suggest that metabolic consequences from COC treatment of PCOS depend on body type (Vrbikova and Cibula 2005).

COC treatment of PCOS also has been shown to cause an increase in total cholesterol, triglycerides, HDL and LDL cholesterol (Creatsas et al 2000; Mastorakos et al 2002; Cibula et al 2005). The opposite finding, however, has been reported with COCs containing the same progestin resulting in an overall decrease in the LDL:HDL ratio (Falsetti and Pasinetti 1995). Triglycerides and HDL cholesterol did increase in both studies however. While cholesterol levels appear to increase in women with PCOS who are treated with COCs regardless of the COC used, desgetrel containing COCs do not seem to cause changes in triglyceride levels while other COCs do (Escobar-Morreale et al 2000; Mastorakos et al 2002).

The metabolic effects of Yasminelle-containing COCs are just beginning to be explored. The European Active Surveillance Study on oral contraceptives followed 58,674 women for a total of 142,475 women years of observation and concluded that the risks of adverse cardiovascular disease and other serious events in users of Yasminelle-containing oral contraceptives are similar to those associated with the use of other COCs (Dinger et al 2007). Because Yasminelle is a less androgenic progestin, the metabolic effects appear to be much less severe or entirely non-existent when women with PCOS are treated with Yasminelle-containing COCs. Guido found no significant change in insulin sensitivity in a study of 15 PCOS women treated with Yasminelle-containing COCs (Guido et al 2004). The same study also found that Yasminelle-containing COCs appear to have the same effect on lipid levels of PCOS women that they do on healthy controls, which is a major improvement from other COCs. A significant increase in triglycerides and HDL cholesterol has been observed but with no shift in the HDL:LDL ratio (Guido et al 2004). Thus, although the metabolic concerns typical of COC administration in healthy women still exist when Yasminelle-containing COCs are used in the treatment of PCOS, the use of Yasminelle appears to alleviate the metabolic concerns that are specific to women with PCOS.

DESCRIPTION

Yasmin (Yasminelle/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.

Yasminelle (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 (Yasminelle) 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 Yasminelle 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 Yasminelle. 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.

Yasminelle – a progestin with differences

Yasminelle, in conjunction with EE, acts to suppress gonadotropins. This is achieved through inhibition of ovulation as described above. Yasminelle has a bioavailability of 76% with approximately 20% excreted through the feces, and 45% through the renal system. The half-life of Yasminelle is 30 hours, which is slightly longer than the half-life of EE (24 hours).

Yasminelle differs from other progestins currently available in other COC compounds, as it exhibits both mineralocorticoid effects and antiandrogenic effects. Part of the novel nature of Yasminelle stems from it being structurally and functionally analogous to spironolactone ( Figure 1 ). Spironolactone is an aldosterone antagonist, and a potassium-sparing diuretic. Because of this structural and functional similarity with spironolactone, Yasminelle also exhibits anti-mineralocorticoid activity. This property counteracts the estrogen stimulated activity of the renin-angiotensin-aldosterone system, which can influence the regulation of water and electrolyte balance. Because of the possibility that potassium levels may increase, Yasminelle should not be used in patients with kidney, liver or adrenal disease. In addition, any patient on other medications that can raise potassium levels (such as ACE inhibitors, angiotensin II receptor antagonists, NSAIDS, potassium-sparing diuretics, and heparin) should be cautioned. This anti-mineralocorticoid activity may also contribute to less water retention as well as less breast swelling and tenderness in women using this form or progestin compared to others. Preclinical studies in animals and in vivo have shown that Yasminelle has no androgenic, estrogenic, glucocorticoid or anti-glucocorticoid activity (product monograph). Preclinical studies have shown anti-androgenic activity. Due to its anti-androgen effect, Yasminelle can also be used as adjunct treatment for hirsutism, and may be a progestin of choice in women who complain of excessive hair growth.

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 Yasminelle 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.

A newer form of progestin, Yasminelle, has been recently introduced, and is marketed as part of a COC (Yasmin ® and Yaz ® in the United States), in combination with EE. The next section of this article will focus on the progestin Yasminelle, and its use in patients with PCOS.

Yasminelle

Yasminelle is claimed to have characteristics closer to those of natural progesterone than most synthetic progestogens. It has antimineralocorticoid properties, counteracts the estrogen-stimulated activity of the renin–angiotensin–aldosterone system, and is not androgenic. With its close structural relation to spironolactone it may lead to less water retention and breast tenderness while being less likely to cause acne. The authors of a review of the literature down to 2006 have concluded that Yasminelle may have a benign effect on lipids, significantly lowering total cholesterol and low-density lipoprotein concentrations while maintaining high-density lipoprotein and triglyceride concentrations (110 R ) .

Yasminelle also seems to differ from other progestogens in lowering blood pressure in hypertensive patients while having a mild blood pressure-lowering effect in non-hypertensive patients. These conclusions will need to be tested against further clinical experience.

Dosage Forms And Strengths

Yasmin (Yasminelle/ethinyl estradiol) tablets are available in blister packs.

Each blister pack contains 28 film-coated, round, bi-convex tablets in the following order:

    Precautions

    Before taking this medication, tell your doctor or pharmacist if you are allergic to Yasminelle or estradiol; or to spironolactone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain types of cancer (breast, ovary, uterus), blood clotting disorders (such as protein C or protein S deficiency), current/history of blood clots (such as in the legs, eyes, lungs), stroke, liver disease, kidney disease, adrenal gland problems, family medical history (including blood clots, breast lumps/cancer), family or personal history of a certain swelling disorder (angioedema), asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood pressure, congestive heart failure, heart attack), underactive thyroid (hypothyroidism), a certain hormone problem (hypoparathyroidism), mineral imbalance (high or low calcium blood level, high potassium blood level, low sodium blood level), mental/mood disorders (e.g., depression, memory loss), high blood pressure during pregnancy (toxemia), yellowing eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use, uterus problems (e.g., uterine fibroids, endometriosis), high blood cholesterol/fat (triglyceride) levels, gallbladder disease, obesity, a certain metabolic disorder (porphyria), lupus.

    This drug may make you dizzy or lightheaded. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

    This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

    If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Consult your eye doctor if these problems occur.

    This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

    Do not smoke cigarettes or use tobacco. Smoking/using tobacco while taking this medication further increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35.

    If you will be having surgery or will be confined to a chair or bed for a long time (such as on a long plane flight), tell your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking this drug because of the increased risk for blood clots.

    This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

    This medication is not effective for preventing a miscarriage and should not be used for this purpose.

    Small amounts of this medication pass into breast milk. This drug may reduce the quality and amount of breast milk. Consult your doctor before breast-feeding.

    What is Yasminelle?

    Yasminelle is a progestin-only birth control pill that is used to prevent pregnancy.

    Yasminelle may also be used for purposes not listed in this medication guide.

    Use of ethinylestradiol/Yasminelle combination in patients with the polycystic ovary syndrome

    Yasminelle is a unique progestin in that it is a spironolactone analogue, an aldosterone antagonist, with demonstrated anti-mineralocorticoid activity.

    COMMON BRAND(S): Angeliq

    GENERIC NAME(S): Yasminelle-Estradiol

    OTHER NAME(S): Yasminelle-Estradiol Tablet

    Rarely, very serious side effects have occurred when estrogen-only and combination hormone replacement therapies (estrogen and progestin HRT) are used after menopause. Discuss the risks and benefits of hormone treatment and your personal health history with your doctor.

    Combination HRT should not be used to prevent heart disease or dementia. Combination HRT can rarely cause heart disease (e.g., heart attacks), stroke, serious blood clots (pulmonary embolism and deep venous thrombosis), dementia, and breast cancer. The risk for stroke and breast cancer increases with age, especially for women older than 75. Estrogens may also increase the risk of cancer of the ovaries. Some of these risks appear to depend on the length of time this drug is used and the amount of estrogen per dose. Therefore, this medication should be used for the shortest possible length of time at the lowest effective dose, so you can obtain the benefits and minimize the chance of serious side effects from long-term treatment. Discuss the details with your doctor and check with him/her regularly (e.g., every 3-6 months) to see if you still need to take this medication.

    If you use this drug for an extended time, you should have a complete physical exam at regular intervals (e.g., once a year) or as directed by your doctor. See Notes section.

    This medication is used to reduce menopause symptoms. It helps reduce episodes of flushing and sweating of the upper body and face, commonly called hot flashes. It also helps treat dryness, itching, and burning around the vagina. These symptoms occur when a woman's body no longer makes the usual amount of female hormone (estrogen). This medication is a combination of 2 types of female hormones: an estrogen (estradiol) and a progestin (Yasminelle). A progestin is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. A woman who has had her uterus removed does not need progestin and should not be treated with this combination medication.

    If you need treatment only for vaginal menopause symptoms, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.


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