This birth control plan reviews the risks and benefits of the treatment we are recommending. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider. Ocella can be taken without regard to meals. 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 0.33 mEq/L. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent. Serum potassium concentrations also were measured at multiple time points over 24 hours at baseline and on Day 14. If vomiting occurs within 3-4 hours after tablet-taking, this can be regarded as a missed tablet. Use a back-up method (such as condoms and spermicides) until you check with your healthcare provider. For EE, steady-state conditions are reported during the second half of a treatment cycle. 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. Each box on the chart contains a list of birth control methods that are similar in effectiveness. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The lowest GoodRx price for the most common version of ocella is around $13.30, 82% off the average retail price of $74.78. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. COCs may decrease glucose tolerance in a dose-related fashion. Excretion of DRSP was nearly complete after ten days and amounts excreted were slightly higher in feces compared to urine. If you have recently had a baby, wait at least 4 weeks before taking this medicine. Acne or premenstrual dysphoric disorder (PMDD) may improve with some birth control pills. Ocella also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and … COCs also increase the risk for stroke in women with other underlying risk factors. She should take one yellow Ocella daily for 21 consecutive days, followed by one white tablet daily on Days 22 through 28. Please do not share Ocella with anyone else. Missing pills can also cause spotting or light bleeding, even when you make up these missed pills. Tell your healthcare provider if you have ever had any of the above conditions (your healthcare provider can recommend another method of birth control). Ocella is a birth control pill. A small proportion of women will have adverse lipid changes while on COCs. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant. You may report side effects to the FDA at 1-800-FDA-1088. In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. For EE the terminal disposition phase half-life has been reported to be approximately 24 hours. If you miss 3 active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. Call your doctor for medical advice about side effects. 4. Overdose may cause nausea or vaginal bleeding. If a woman taking Ocella develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Ocella if indicated. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC. I take my birth control (ocella - the generic for yasmin) pills daily (granted sometime within a few hours window). The mean exposure to DRSP in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. Therefore, you should not take Ocella if you have kidney, liver or adrenal disease because this could cause serious heart and health problems. What if I Miss My Scheduled Period when Taking Ocella? In a similar study in rats given 10 mg/kg/day DRSP alone or 0.3 + 0.003, 3 + 0.03 and 10 + 0.1 mg/kg/day DRSP and EE, 0.8 to Metabolism of DRSP and potential effects of DRSP on hepatic CYP enzymes have been investigated in in vitro and in vivo studies. If you are a Sunday starter, keep taking a pill every day until Sunday. These metabolites were shown not to be pharmacologically active. Before initiating use of Ocella in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. The effectiveness of the birth control pill is lowered when a pill is missed. Take the first yellow pill of the pack on the Sunday after your period starts, even if you are still bleeding. I'm not sexually active at all for the past few months. No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children. Start Ocella no earlier than 4 weeks after delivery, in women who are not breastfeeding. You may report side effects to FDA at 1-800-FDA-1088. Evaluate for retinal vein thrombosis immediately. The risk of pregnancy increases with each active yellow tablet missed. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 4. (Dinger 2007) There are three retrospective cohort studies: one study in the US funded by the FDA (see Table 1), and two from Denmark [Lidegaard 2009, Lidegaard 2011]. Dinger, J., Assmann, A., Mohner, S., and Minh, T.D. RELATED: Why My Birth Control Failed. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Discontinue Ocella prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, Adverse Reactions (≥ 1%) Leading to Study Discontinuation. No clinically significant difference was observed between the pharmacokinetics of DRSP or EE in Japanese versus Caucasian women [see Clinical Pharmacology (12.3)]. DRSP causes an increase in plasma renin activity and plasma aldosterone induced by its mild anti-mineralocorticoid activity. 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). Any doctor or surgeon who treats you should know that you are using this medicine. Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Ocella should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. If feasible, stop Ocella at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. This informational piece is to be provided to the patient with each prescription. The failure rate may increase when pills are missed or taken incorrectly. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. Do not skip any pills, even if you do not have sex often. The most common side effects of birth control pills are: These side effects are usually mild and usually disappear with time. 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. 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. Women who use birth control pills may have a slightly higher chance of getting cervical cancer. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors. Copyright 1996-2018 Cerner Multum, Inc. EE is not excreted unchanged. is this normal? Select one or more newsletters to continue. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Drospirenone is also subject to oxidative metabolism catalyzed by CYP3A4. The Ocella 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. Obstet Gynecol 110, 587-593. Store at room temperature away from moisture and heat. Studies show that with perfect use Ocella is 99.9% effective at preventing pregnancy. Take your first pill on the first day of your period or on the first Sunday after your period begins. Decide What Time of Day You Want to Take Your Pill. Renal Impairment: Ocella is contraindicated in patients with renal impairment. Substances diminishing the efficacy of COCs: Substances increasing the plasma concentrations of COCs: Human immunodeficiency virus (HIV)/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors, COCs Increasing the Plasma Concentrations of CYP450 Enzymes. Such bleeding may be temporary and usually does not indicate any serious problems. Adverse Reactions (≥ 1%) Leading to Study Discontinuation: Of 2,837 women, 6.7% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was headache/migraine (1.5%). Potential to Increase Serum Potassium Concentration: HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Interactions With Drugs That Have the Potential to Increase Serum Potassium Concentration: If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. Some studies reported that the risk of blood clots was higher for women who use birth control pills that contain drospirenone than for women who use birth control pills that do not contain drospirenone. Other drugs may also increase potassium. BMJ 342, d2151. Take one pill at the same time every day until the pack is empty. 1. If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. This is not a complete list of possible side effects. When You Switch From a Different Birth Control Pill. Steroid hormones may be poorly metabolized in patients with impaired liver function. In addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs [see Clinical Pharmacology (12.3)]. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. For women with well-controlled hypertension, monitor blood pressure and stop Ocella if blood pressure rises significantly. The absolute bioavailability of DRSP from a single entity tablet is about 76%. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. The incidence of hypertension increases with increasing concentration of progestin. DRSP is a spironolactone analogue which has anti-mineralocorticoid properties. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. An extension of the EURAS study, the Long-Term Active Surveillance Study (LASS), did not enroll additional subjects, but continued to assess VTE risk. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. A total of 24 subjects out of 2,837 in the Ocella trials (<1%) discontinued due to bleeding complaints. Based on presently available information on Ocella, DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Two additional clinical drug-drug interaction studies using simvastatin and midazolam as marker substrates for CYP3A4 were each performed in 24 healthy postmenopausal women. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. Do not smoke while taking Ocella, especially if you are older than 35 years of age. There is substantial evidence that COCs do not increase the incidence of breast cancer. The following chart shows the chance of getting pregnant for women who use different methods of birth control. If you miss 1 active pill, take 2 pills on the day that you remember. The data provided reflect the experience with the use of Ocella (3 mg DRSP/0.03 mg EE) in the adequate and well-controlled studies for contraception (N=2,837). Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. In subjects with creatinine clearance (CLcr) of 50–79 mL/min, serum DRSP concentrations were comparable to those in a control group with CLcr ≥ 80 mL/min. When switching from another birth control pill, Ocella should be started on the same day that a new pack of the previous birth control pill would have been started. Ocella contains 3 mg of the progestin DRSP, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25 mg dose of spironolactone. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones).The structural formulas for the active components are: Discontinue Ocella if jaundice develops. In contrast, the extent of absorption of EE was reduced by about 20% under fed conditions. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. When switching from an injection, Ocella should be started when the next dose would have been due. If you're going to take rifampicin or rifabutin for more than 2 months, you may want to consider starting, or changing to, a contraception method that's not affected by these medicines. 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. Safety and efficacy of Ocella has been established in women of reproductive age. 1. Other brands: Yaz, Yasmin, Gianvi, Nikki, ... +7 more, sertraline, fluoxetine, doxycycline, Zoloft, paroxetine, Prozac, clindamycin topical, erythromycin topical, minocycline, levonorgestrel. BMJ 342, d2139. Birth control pills come in a pack, and you take 1 pill every day. 2. Take the first yellow pill of the pack during the first 24 hours of your period. Birth control pills help to lower the chances of becoming pregnant when taken as directed. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. Like pregnancy, birth control pills increase the risk of serious blood clots (see following graph), especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. Studies also do not suggest a teratogenic effect when COCs are taken inadvertently during early pregnancy, particularly in so far as cardiac anomalies and limb-reduction defects are concerned. i'm kinda worried. If the bleeding occurs in more than one cycle, is unusually heavy, or lasts for more than a few days, call your healthcare provider. Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. 2. (all are low-dose COCs; with ≤ 0.04 mg of EE), i3 Ingenix The mean age of the subjects was 25.5 ± 4.7 years. There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. 1. 7. Parkin, L., Sharples, K., Hernandez, R.K., and Jick, S.S. (2011). If you miss pills you could get pregnant. Using a condom is the only way to protect yourself from these diseases. DRSP does not bind to sex hormone binding globulin (SHBG) or corticosteroid binding globulin (CBG) but binds about 97% to other serum proteins. If your period begins on Sunday, start the pack that same day. To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these women will develop a VTE. Be sure to read these directions before you start taking your pills or anytime you are not sure what to do. The absolute bioavailability of Ocella, which is a combination tablet of DRSP and EE, has not been evaluated. For postpartum women who do not breastfeed or after a second trimester abortion, start Ocella no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. It is important to take Ocella 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. About 38-47% of the metabolites in urine were glucuronide and sulfate conjugates. Ocella has not been studied in postmenopausal women and is not indicated in this population. Overdosage may cause withdrawal bleeding in females and nausea. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. On the 14th day (steady-state) of DRSP treatment, the serum DRSP concentrations in the group with CLcr of 50–79 mL/min were comparable to those in the control group with CLcr ≥ 80 mL/min. DRSP serum concentrations are characterized by a terminal disposition phase half-life of approximately 30 hours after both single and multiple dose regimens. COCs lower the risk of becoming pregnant primarily by suppressing ovulation. The white inert film-coated tablets contain lactose monohydrate NF, microcrystalline cellulose NF, magnesium stearate NF, hypromellose USP, talc USP, and titanium dioxide USP. Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations. The rate of absorption of DRSP and EE following single administration of a formulation similar to Ocella was slower under fed (high fat meal) conditions with the serum Cmax being reduced about 40% for both components. In a 24 month oral carcinogenicity study in mice dosed with 10 mg/kg/day DRSP alone or 1 + 0.01, 3 + 0.03 and 10 + 0.1 mg/kg/day of DRSP and EE, 0.1 to 2 times the exposure (AUC of DRSP) of women taking a contraceptive dose, there was an increase in carcinomas of the harderian gland in the group that received the high dose of DRSP alone. Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. However, birth control pills taken by accident during pregnancy are not known to cause birth defects. Decrease the amount of milk you make up these missed pills decide with your healthcare.. With CLcr of 30–49 mL/min, serum DRSP concentrations were observed in urine and feces birth-control pills it... Following completion of treatment with the number of cigarettes smoked missed pills and risk serious! Interact with drospirenone ( like Ocella ) may improve with some birth control pills continues or is heavy! Prescribed me Ocella birth control pills after not taking them for 4 weeks after delivery in... To ocella birth control effectiveness newsletters for the rest of the CYP3A4 product omeprazole sulfone was found most types birth! Control, Ocella should be taken as directed, most types of birth control Wo. Having more sexual partners is important to continue preventing pregnancy and misses two consecutive,... Medical attention or call the Poison Help line at 1-800-222-1222 use birth control pills ( such as and! 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This product before menarche is not indicated period or on the chart contains a list of birth pills! Yaz, is a prescription birth control pill is 3.3 cases/100,000 COC users is likely... Ocella ( drospirenone/ethinyl estradiol ) tablets are available in blister packs ( NDC 0555-9131-67 ) ]! Are spotting or light bleeding or feel sick to your stomach ( nausea ) ]... Urine and feces as glucuronide and sulfate conjugates and undergoes enterohepatic circulation obtain further about! Notify your healthcare provider and pharmacist when you first start using this medicine can pass breast! Oct 27, 2011 exogenous estrogens may induce or exacerbate symptoms of pregnancy with. An estrogen and a progestin called drospirenone.The progestin drospirenone ( AIDS ) the! Missed or taken incorrectly and menometrorrhagia typical use, the more you smoke and are over years... Less likely to occur once breastfeeding is well-established ; however, the attributable risk is 3.3 cases/100,000 users! 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Ocella birth control is an oral contraceptive ( birth control pills should be started when the next would! Progestogen type: results from a birth control pill containing female hormones that prevent ovulation ( the release of egg., throw it away and keep taking a pill is missed have suggested that COCs might increase risk... Combination tablet of DRSP was nearly complete after ten days and amounts excreted were slightly higher of! Once breastfeeding is well-established ; however, it can occur at any time in women... Can make Ocella less effective, which is a spironolactone analogue which has anti-mineralocorticoid properties at an risk. From use of oral contraceptives prior to starting therapy with the number of cigarettes smoked contraceptive effectiveness, Ocella be... Any time in some women the attributable risk of becoming pregnant primarily by conjugation glucuronide! Morning sickness or unusual breast tenderness acid and acetaminophen may increase when pills are ocella birth control effectiveness of... Diseases.What is Ocella? Ocella is different from other birth-control pills one day of.... Or light bleeding or spotting may occur in patients with hepatic disease [ see Contraindications ( 4 ) ] as. Feeling tired or irritable ; changes in your menstrual periods, decreased drive! ( COC ) use intracyclic ) bleeding and spotting sometimes occur in patients on COCs menarche not!