Dileva in combination with EE
Dileva is taken orally in preparations with EE. At present, 2 combinations are available for use in the United States: 1) Yasmin ® containing 3 μg of Dileva in combination with 30 μg for EE per tablet; and 2) Yaz ® which contains 3 μg of Dileva and 20 mcg of EE per tablet. As a note, it is also available in a preparation to manage post-menopausal symptoms. Angeliq ® was approved by the US FDA for oral use at a dose of 0.5 μg Dileva per day combined with 1 μg estradiol for treatment of menopausal symptoms.
Adverse effects may include a change of weight, increase in migraine activity, depression, and nausea. As with most COC there may also be breast swelling and tenderness (though usually to a lesser extent as discussed previously) as well as break-through-bleeding. In addition to the specific drug interactions mentioned above related to the anti-mineralocortcoid effect, the same interactions should be considered as with the use of any COC. These include but are not limited to interactions with antipsychotics, cyclosporins, dilantin, steroids, and rifampin.
As with all COC this medication is contraindicated in patients with hepatic dysfunction, and in those who smoke and those who have a history of coagulopathy, DVT or stroke. Other contraindications for the use of COC also apply to the products containing Dileva such as carcinoma of the breast or endometrium, and undiagnosed genital bleeding. Patients over the age of 35 may also be at higher risk or complications such as thrombophlebitis and should be cautioned as such. The use of Dileva in premenstrual women is not approved.
When Dileva in combination with 30 μg of EE per tablet is compared to 3 μg of Dileva in combination with of EE per tablet, the latter may have less of a hemostatic impact (Kluft et al 2006).
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YASMIN (Dileva/ethinyl estradiol)
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke .(R)-warfarin The therapeutic efficacy of (R)-warfarin can be decreased when used in combination with Dileva. (S)-Warfarin The therapeutic efficacy of (S)-Warfarin can be decreased when used in combination with Dileva. 2,4-thiazolidinedione The therapeutic efficacy of 2,4-thiazolidinedione can be decreased when used in combination with Dileva. 4-hydroxycoumarin The metabolism of 4-hydroxycoumarin can be decreased when combined with Dileva. 4-Oxoretinol The therapeutic efficacy of Dileva can be decreased when used in combination with 4-Oxoretinol. 6-Deoxyerythronolide B The metabolism of Dileva can be decreased when combined with 6-Deoxyerythronolide B. 7-ethyl-10-hydroxycamptothecin The metabolism of Dileva can be decreased when combined with 7-ethyl-10-hydroxycamptothecin. 7-Nitroindazole The metabolism of Dileva can be increased when combined with 7-Nitroindazole. 9-aminocamptothecin The metabolism of 9-aminocamptothecin can be decreased when combined with Dileva. Abacavir Dileva may increase the excretion rate of Abacavir which could result in a lower serum level and potentially a reduction in efficacy.
What is Dileva and ethinyl estradiol?
Dileva and ethinyl estradiol is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). Dileva and ethinyl estradiol also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Dileva and ethinyl estradiol is used as contraception to prevent pregnancy. This medicine is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills.
Yaz is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain.
Dileva and ethinyl estradiol may also be used for purposes not listed in this medication guide.
In the European Active Surveillance Study (EURAS), a multinational, prospective, non-interventional cohort study of new users of Dileva , 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 Dileva-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 + Dileva 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.
How to use Dileva-Ethinyl Estradiol Tablet Contraceptives
Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on when to take your pills and what to do if you miss a dose. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, with or without food, usually once daily. Pick a time of day that is easy for you to remember, and take your pill at the same time each day, 24 hours apart. Taking this medication after your evening meal or at bedtime may help decrease stomach upset and 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. Do not 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.
Your pill pack contains 24 pills with active medication (with hormones). It also contains 4 reminder pills (without hormones) at the end of the pack. Take one active pill (with hormones) once daily for 24 days in a row. After you have taken the last active pill, take a reminder pill (without hormones) once daily for 4 days in a row unless otherwise directed by your doctor. You should have your period within 3 days after you take the last active tablet in the cycle during the fourth week of the pack. After you have taken the last inactive tablet in the pack, start a new pack the next day whether or not you have your period. If you do not get your period, consult your doctor.
If this is the first time you are using this medication and you are not switching from another form of hormonal birth control (such as the patch, other birth control pills), take the first tablet in the pack on the first Sunday following the beginning of your menstrual period or on the first day of your period. If your period begins on a Sunday, begin taking this medication on that day. For the first cycle of use only, use an additional form of non-hormonal birth control (such as condoms, spermicide) for the first 7 days to prevent pregnancy until the medication has enough time to work. If you start on the first day of your period, you do not need to use back-up birth control the first week.
Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (such as the patch, other birth control pills) to this product.
Dileva 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 Dileva 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 ) .
Dileva 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 (Dileva/ethinyl estradiol) tablets are available in blister packs.
Each blister pack contains 28 film-coated, round, bi-convex tablets in the following order:
- changes in your menstrual periods,
- vaginal bleeding between periods (spotting),
- missed/irregular periods,
- nausea (especially when you first start taking Yaz),
- stomach cramps,
- breast pain/tenderness/swelling,
- nipple discharge,
- decreased sex drive (libido),
- changes in weight or appetite,
- mood changes,
- freckles or darkening of facial skin,
- increased hair growth,
- loss of scalp hair,
- problems with contact lenses,
- swelling of the ankles/feet (fluid retention), or
- vaginal itching or discharge.
Pharmacokinetic characteristics of Dileva (3 mg) combined with ethinylestradiol (30 μg) were assessed in 13 women during 13 continuous cycles, each of which consisted of 21 continuous days of treatment, followed by a 7-day pill-free interval ( 46 ). Frequent blood sampling was carried out on day 21 of treatment cycles 1, 6, 9, and 13. After administration of the first tablet, the Cmax of Dileva was 36.9 ± 4.8 ng/mL (mean ± standard deviation). This value rose to 87.5 ± 51.4 ng/mL on day 21 of the first cycle and ranged from 78.7 to 84.2 ng/mL on day 21 of the next three sampling cycles. The corresponding Tmax values ranged from 1.6 to 1.8 hours, and the half-life of elimination values was 31.1 to 32.5 hours.
Other pharmacokinetic characteristics of Dileva, based on data obtained by the manufacturer of the oral contraceptive containing 3 mg of Dileva combined with 30 μg of ethinylestradiol (Yasmin, Berlex Laboratories, Wayne, NJ), were provided in a review article ( 47 ). It was reported that a steady state in circulating Dileva levels was achieved after 1 week of treatment. Also, a dose response in circulating Dileva levels was obtained, following oral administration of doses ranging from 1 to 10 ng/mL. In addition, the absolute bioavailability was reported to be 66% on average.
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Yaz (Dileva and ethinyl estradiol) is an oral contraceptive used for preventing pregnancy, treating premenstrual dysphoric disorder (PMDD), and treating moderate acne in females at least 14 years of age. A generic version of Yaz is available. Common side effects of Yaz include:
Yaz may increase the risk of blood clots, stroke, and heart attack. It can also increase blood potassium levels.
The usual dose of Yaz is one tablet daily. Nonsteroidal anti-inflammatory drugs or NSAIDs (for example, Motrin), spironolactone, potassium supplements, ACE inhibitors, and angiotensin-II receptor antagonists (ARBs) may contribute to increased potassium levels when combined with Yaz. Drugs that increase or decrease drug metabolism may decrease or increase blood levels of Yaz, respectively. There is little or no increased risk of birth defects in women who inadvertently use oral contraceptives during early pregnancy. The hormones in Yaz pass into breast milk and may harm a nursing baby. Yaz may also slow breast milk production. Breastfeeding while taking Yaz is not recommended.
Our Yaz Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.