May need barrier contraception with Sunday starts or postpartum use see full labeling. Nursing mothers: not recommended. See Contraindications. May be antagonized by CYP3A4 or other enzyme inducers eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St.
John's wort, topiramate use backup contraception. May antagonize lamotrigine. May affect laboratory tests eg, coagulation factors, lipids, glucose tolerance, binding proteins. May need dose adjustment of thyroid hormones. Adult Dosage: 1 tab daily for 28 days; repeat. Drospirenone 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,hexadecahydro,dimethylspiro-[17H-dicyclopropa-[6,,16] cyclopenta[a]phenanthrene,2' 5H -furan]-3,5' 2H -dione is a synthetic progestational compound and has a molecular weight of COCs lower the risk of becoming pregnant primarily by suppressing ovulation.
Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation. Drospirenone is a spironolactone analogue with anti-mineralocorticoid activity. The estrogen in Yasmin is ethinyl estradiol EE. The pharmacokinetics of DRSP are dose proportional following single doses ranging from mg.
For EE, steady-state conditions are reported during the second half of a treatment cycle. T max h. The extent of absorption of DRSP, however, remained unchanged. Multiple dosing over 3 cycles resulted in no change in the free fraction as measured at trough concentrations. EE is reported to be highly but non-specifically bound to serum albumin approximately The two main metabolites of DRSP found in human plasma were identified to be the acid form of DRSP generated by opening of the lactone ring and the 4,5-dihydrodrospirenonesulfate, formed by reduction and subsequent sulfation.
These metabolites were shown not to be pharmacologically active. Drospirenone is also subject to oxidative metabolism catalyzed by CYP3A4. EE has been reported to be subject to significant gut and hepatic first-pass metabolism. Metabolism of EE and its oxidative metabolites occur primarily by conjugation with glucuronide or sulfate. CYP3A4 in the liver is responsible for the 2-hydroxylation which is the major oxidative reaction.
The 2-hydroxy metabolite is further transformed by methylation and glucuronidation prior to urinary and fecal excretion. DRSP serum concentrations are characterized by a terminal disposition phase half-life of approximately 30 hours after both single and multiple dose regimens. Excretion of DRSP was nearly complete after ten days and amounts excreted were slightly higher in feces compared to urine.
At least 20 different metabolites were observed in urine and feces. For EE the terminal disposition phase half-life has been reported to be approximately 24 hours. EE is not excreted unchanged. EE is excreted in the urine and feces as glucuronide and sulfate conjugates and undergoes enterohepatic circulation.
Pediatric Use: Safety and efficacy of Yasmin has been established in women of reproductive age. Geriatric Use: Yasmin has not been studied in postmenopausal women and is not indicated in this population. Other ethnic groups have not been specifically studied. Renal Impairment: Yasmin is contraindicated in patients with renal impairment. All subjects were on a low potassium diet.
During the study, 7 subjects continued the use of potassium-sparing drugs for the treatment of their underlying illness. DRSP treatment did not show any clinically significant effect on serum potassium concentration.
Although hyperkalemia was not observed in the study, in five of the seven subjects who continued use of potassium sparing drugs during the study, mean serum potassium concentrations increased by up to 0. Hepatic Impairment: Yasmin is contraindicated in patients with hepatic disease. Consult the labeling of all concurrently used drugs to obtain further information about interactions with oral contraceptives or the potential for enzyme alterations.
The increases in C max were 1. Although no clinically relevant effects on safety or laboratory parameters including serum potassium were observed, this study only assessed subjects for 10 days. Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.
In the study with 24 postmenopausal women [including 12 women with homozygous wild type CYP2C19 genotype and 12 women with heterozygous CYP2C19 genotype] the daily oral administration of 3 mg DRSP for 14 days did not affect the oral clearance of omeprazole 40 mg, single oral dose and the CYP2C19 product 5-hydroxy omeprazole.
Two additional clinical drug-drug interaction studies using simvastatin and midazolam as marker substrates for CYP3A4 were each performed in 24 healthy postmenopausal women. Interactions With Drugs That Have the Potential to Increase Serum Potassium Concentration: There is a potential for an increase in serum potassium concentration in women taking Yasmin with other drugs that may increase serum potassium concentration [see Warnings and Precautions 5.
Potassium concentrations were obtained every other day for a total of 2 weeks in all subjects. Serum potassium concentrations also were measured at multiple time points over 24 hours at baseline and on Day Mutagenesis studies for DRSP were conducted in vivo and in vitro and no evidence of mutagenic activity was observed. In the clinical efficacy studies of up to 2 years duration, 2, subjects completed 33, cycles of use without any other contraception.
The mean age of the subjects was The age range was 16 to 37 years. Pregnancy rates in the clinical trials were less than one per woman-years of use. Seeger, J. Obstet Gynecol , Dinger, J.
The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on , women-years of observation. Contraception 75 , Combined hormonal contraceptives CHCs and the risk of cardiovascular endpoints. Sidney, S. Lidegaard, O. Hormonal contraception and risk of venous thromboembolism: national follow-up study.
BMJ , b Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, BMJ , d The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. Risk of venous thromboembolism and the use of dienogest- and drospirenone-containing oral contraceptives: results from a German case-control study. Jick, S. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data.
Parkin, L. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with DO or DP. Birth control pills help to lower the chances of becoming pregnant when taken as directed. Yasmin is a birth control pill.
It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone. The progestin drospirenone may increase potassium. Therefore, you should not take Yasmin if you have kidney, liver or adrenal disease because this could cause serious heart and health problems.
Other drugs may also increase potassium. If you are currently on daily, long-term treatment for a chronic condition with any of the medications below, you should consult your healthcare provider about whether Yasmin is right for you, and during the first month that you take Yasmin, you should have a blood test to check your potassium level.
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant. Based on the results of two clinical studies, about 1 woman out of women may get pregnant during the first year they use Yasmin. The following chart shows the chance of getting pregnant for women who use different methods of birth control.
Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
Be sure to read these directions before you start taking your pills or anytime you are not sure what to do. The right way to take the pill is to take one pill every day at the same time in the order directed on the package. Preferably, take the pill after the evening meal or at bedtime, with some liquid, as needed. If you miss pills you could get pregnant.
This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. Many women have spotting or light bleeding at unexpected times, or may feel sick to their stomach during the first packs of pills. If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill.
The problem will usually go away. If it does not go away, check with your healthcare provider. Missing pills can also cause spotting or light bleeding, even when you make up these missed pills. On the days you take two pills, to make up for missed pills, you could also feel a little sick to your stomach.
John's Wort, your pills may not work as well. Use a back-up method such as condoms and spermicides until you check with your healthcare provider.
If you have trouble remembering to take the pill, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control. If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.
It is important to take Yasmin in the order directed on the package at the same time every day, preferably after the evening meal or at bedtime, with some liquid, as needed. The Yasmin pill pack has 21 yellow pills with hormones to be taken for three weeks, followed by 7 white pills without hormones to be taken for one week. Be sure you have ready at all times a another kind of birth control such as condoms and spermicides to use as a back-up in case you miss pills, and b an extra, full pill pack.
You have a choice for which day to start taking your first pack of pills. Decide with your healthcare provider which is the best day for you. Pick a time of day which will be easy to remember. You will not need to use a back-up method of birth control, because you are starting the Pill at the beginning of your period. However, if you start Yasmin later than the first day of your period, you should use another method of birth control such as a condom and spermicide as a back-up method until you have taken 7 yellow pills.
Take the first yellow pill of the pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day. Use another method of birth control such as a condom and spermicide as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday 7 days. This also applies if you start Yasmin after having been pregnant and you have not had a period since your pregnancy.
When switching from another birth control pill, Yasmin should be started on the same day that a new pack of the previous birth control pill would have been started.
Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach nausea. When you finish a pack of pills, start the next pack on the day after your last white pill. Do not wait any days between packs. Finally, if you are still not sure what to do about the pills you have missed:. Birth control pills may not be a good choice for you if you have ever had jaundice yellowing of the skin or eyes caused by pregnancy also called cholestasis of pregnancy.
Tell your healthcare provider if you have ever had any of the above conditions your healthcare provider can recommend another method of birth control. Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.
Due to an increased risk of blood clots, you should stop Yasmin at least four weeks before you have major surgery and not restart it until at least two weeks after the surgery. If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Yasmin, may decrease the amount of milk you make.
A small amount of the pill's hormones pass into breast milk. If you have vomiting or diarrhea, your birth control pills may not work as well. Take another pill if you vomit within hours after taking your pill, or use another birth control method, like condoms and a spermicide, until you check with your healthcare provider. If you are scheduled for any laboratory tests, tell your doctor you are taking birth-control pills.
As well, some forms of this medication may not be used for all of the conditions discussed here. Your doctor may have suggested this medication for conditions other than those listed in these drug information articles.
If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor. Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
Record your current acne treatment and concerns to help your doctor find the best management strategies. Each hormone-containing yellow, round, film-coated tablet contains 3. Nonmedicinal ingredients: cornstarch, hydroxypropylmethyl cellulose, lactose monohydrate, magnesium stearate, modified starch, polyethylene glycol, povidone, talc, titanium dioxide, and yellow ferric oxide.
Nonmedicinal ingredients: cornstarch, hydroxypropylmethyl cellulose, lactose monohydrate, magnesium stearate, modified starch, polyethylene glycol, povidone, talc, titanium dioxide and yellow ferric oxide. The white tablets are hormone-free. Nonmedicinal ingredients for hormone-free tablets: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide;.
Take no tablets for 7 days, and then begin the next pack. Talk with your doctor about the best time to start your pills. The first day of your menstrual period bleeding is known as "Day 1. The pills should be taken approximately the same time every day, e. It is a good idea to use a second method of birth control e.
Many women experience spotting or light bleeding or may feel sick to their stomach during the first 3 months of taking the pill. If you do feel sick, do not stop taking the pill. The problem will usually go away.
If it does not go away, check with your doctor or clinic. If you have vomiting or diarrhea, or if you take certain medications such as antibiotics , your pills may not work as well. If you start a new medication while taking birth control pills, check with your doctor or pharmacist to make sure that it will not reduce the effectiveness of the pills.
Use a backup method of birth control, such as latex condoms and permicidal foam or gel, until you can check with your doctor or pharmacist. Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that you take this medication exactly as prescribed by your doctor. If you miss pills at any time, the risk of becoming pregnant increases.
If you miss one pill, take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day. If you miss 2 pills in a row during the first 2 weeks of your cycle, take 2 pills on the day you remember and 2 pills the next day. Then take one pill a day until you finish the pack. Use a second method of birth control if you have sex in the 7 days after you miss the pills.
If you start your pills on Sunday and you miss 2 pills in a row during the third week of your cycle or 3 or more pills in a row anytime in your cycle, keep taking one pill a day until Sunday.
On Sunday, safely discard the rest of the pack and start a new pack that day. Use another method of birth control if you have sex in the 7 days after you miss the pills.
You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic. If you start your pills on a day other than a Sunday and you miss 2 pills in a row during the third week of your cycle or 3 or more pills at anytime during your cycle, safely dispose of the rest of the pill pack and start a new pack that same day.
If you are taking the day pack and miss any of the white pills in week 4, safely dispose of the pills you missed and keep taking one pill each day until the pack is empty. Begin a new pack as you would normally. See the package insert for additional information on where to start and what to do if you forget to take a pill.
Store this medication at room temperature in its original packaging and keep it out of the reach of children. Do not dispose of medications in wastewater e. Ask your pharmacist how to dispose of medications that are no longer needed or have expired. Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses.
Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication.
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