Ethinyl estradiol and norgestimate is a combination contraceptive used for pregnancy prevention. Produced under the brand name Estarylla, this birth control pill contains two hormones, norgestimate and ethinyl estradiol. The combination is also used for acne treatment in females (at least 14 years of age) who are already having menstrual periods and also wish to take this medicine for birth control purposes.
Ethinyl estradiol and norgestimate is available in tablet form. It is administered orally and works by preventing ovulation during the woman's menstrual cycle. It also makes the vaginal secretion thicker to prevent fertilization by stopping sperm from getting into contact with the egg. Should fertilization occur, the drug causes changes in the uterine lining to prevent the fertilized egg from attaching onto the womb.
Besides preventing fertilization, this birth control pill can also make a woman's periods more regular and reduce both painful periods and excessive blood loss. It also reduces the woman's risk of contracting ovarian cysts.
Even though it may be rare, some women may experience severe side effects when taking this contraceptive. Talk to your healthcare provider or seek help when you experience any of the following side effects after taking this contraceptive:
There are some other ethinyl estradiol and norgestimate side effects, too. Call your healthcare provider if any of these side effects bother you:
This contraceptive may cause dark patches on your skin. Avoid exposure to direct sunlight or UV radiation and use sunscreen and protective clothing when outdoors during sunny days.
Not all these side effects may occur. Call your healthcare provider if you have questions about these side effects. You may also report the side effect to the FDA at 1-800-FDA-1088.
Read and understand the Patient Information Leaflet provided by your pharmacist before you start using this contraceptive and each time you go for a refill. The leaflet contains vital information on when to take your contraceptive and what you should do in an event of a missed dose. Ask your healthcare or pharmacist any questions you might be having.
Take Estarylla orally as directed by your healthcare provider, usually once per day. It helps to pick a time of the day that is easy for you to remember, and take your contraceptive at the same time of the day.
It is imperative that you continue taking this pill exactly as directed by your healthcare provider. As with most brands of birth control pills, the levels of progestin and estrogen hormones in each active pill varies based on the time of the cycle. Thus, it is crucial that you follow your package's instructions to identify and start with the first pill in the pack, and take them in the right order. Avoid skipping doses. Pregnancy is more likely if you skip a dose, start your new pack late in the cycle or take your contraceptive at irregular times of the day.
Diarrhea and vomiting can prevent your contraceptive from working well. If you are prone to vomiting or diarrhea, especially after taking your pill, you should consider using a back-up birth control method, such as condoms. Check with your healthcare provider or follow the information in your pack's Patient Information Leaflet for more details.
Taking your contraceptive after dinner or just before bedtime may help if your nausea or stomach upset are associated with the medication. That said, you are free to schedule your contraceptive at a time of day that is convenient for you. No matter what your dosing schedule is, be sure to take your contraceptive at the same time each day, 24 hours apart. Consult your healthcare provider if you have any questions.
Your Estarylla pack contains 21 active pills. It may also come with seven non-medication reminder pills. Take one active pill (with hormones) once daily in a row for 21 days. If you are using a pack with 28 pills, take the inactive pill once per day for seven consecutive days after taking the last active pill, unless directed otherwise by your healthcare provider. If you are using the pack with 21 pills, do not take any pill for seven days, unless otherwise directed by your healthcare provider. You should have your menses during the fourth week of your cycle. After taking the last inactive pill in your pack or when you've gone seven days without taking an active pill, start a new pack the following day, whether or not you get your period. It is important that you consult your healthcare provider in an event of a missed period.
If you are using this contraceptive for the first time and you are not making the switch from another hormone-based birth control method, such as a patch, take the first pill in the pack on the first Sunday after the onset of your menses or on day one of your cycle. If your first day of the period falls on a Sunday, start taking your contraceptive on that day. For your first cycle of use, it is important that you use a back-up form of non-hormonal birth control, such as a condom or spermicide, for the first seven days, to prevent conception and give Estarylla enough time to work. However, you do not need to use back-up birth control method if you are starting your medication on the first day of your period.
If you are switching from other forms of hormonal birth control, like a patch or other oral contraceptives, to Estarylla, be sure to ask your healthcare provider for direction on how to best make the switch.
How to best take ethinyl estradiol norgestimate
As already mentioned, use this contraceptive as directed by your healthcare provider. Read the information provided in the pack's Patient Information Leaflet and follow the instructions therein to the letter.
In case of a missed dose
Skipping a day without taking your medication can increase your chances of conceiving. If you skip one active tablet, take two tablets on the day that you remember before resuming your regular daily tablet for the remaining days of the cycle.
If you skip two active tablets consecutively in the first or second week, take two tablets daily for two consecutive days. Then resume your regular dosage for the rest of the pack. Consider using a non-hormonal back-up birth control for at least seven days following the missed tablets.
If you missed two active tablets in a row in week three, dispose of the rest of the pack and start a new pack the same way you would if you are a Day 1 starter. If you are a Sunday starter, keep taking a tablet daily until Sunday, before discarding the rest of the pack to open a new pack that Sunday.
You may miss your period if you skip two or more pills in a row. If you miss your period for two consecutive months, contact your healthcare provider for a pregnancy test.
If you skip a reminder pill, dispose of it and keep taking one reminder pill daily until you empty the pack.
Call the Poison Control center or get medical care immediately if you overdose this contraceptive.
Starting Estarylla after a miscarriage or abortion
First trimester miscarriage or abortion
You may start Estarylla immediately after the first-trimester miscarriage or abortion. You do not need an additional birth-control method if you start Estarylla immediately. If you do not start Estarylla within five days after termination of the pregnancy, you should use additional non-hormonal birth-control, such as condoms, for the first seven days of your first cycle pack.
Second-trimester miscarriage or abortion
Wait for up to four weeks before starting Estarylla following a second-trimester abortion or miscarriage. Starting this contraceptive immediately can increase your risk of thromboembolic disease. Start Estarylla in table for Day 1 or Sunday start, as you please. If you are starting on Sunday, be sure to use a back-up birth control method (e.g spermicide or condom) for the first seven days of the first cycle pack.
Starting Estarylla after childbirth
Wait for up to four weeks after delivery before starting Estarylla, to avoid the risk of contracting thromboembolic disease. Start using the contraceptive by following instructions given above.
Estarylla is not recommended for use by breastfeeding mothers
If you are yet to have a period postpartum, consider the possibility of ovulating and conceiving prior to using the contraceptive.
Three ways to remember the order in which you should take Estarylla
Effects of other medications on combined oral contraceptives (COCs)
Substances that lower the plasma levels in combined oral contraceptives
Drugs, vitamins or herbal supplements that affect activities of certain enzymes, like cytochrome P450 3A4, may lower the plasma levels of the contraceptive and significantly reduce its efficacy, while increasing breakthrough bleeding. Such medications and herbal products include barbiturates, phenytoin, carbamazepine, oxcarbazepine, bosentan, griseofulvin, drugs that contain St. John's wort, and rifabutin.
Interactions between COCs and these drugs may trigger breakthrough bleeding or failure of the contraceptive to prevent conception. It is thus advisable that back-up birth control methods are used when enzyme inducers are used alongside COCs. Such back-up birth control methods should be used for 28 days after discontinuing the enzyme inducer, to give the contraceptive adequate time to be effective.
This is a bile acid sequestrant that is administered together with a COC. It is known to lower the contraceptive's efficiency if they are administered within three hours of each other.
Substances that increase the plasma concentration of COCs.
Administering atorvastatin or rosuvastatin together with Estarylla may increase the AUC for ethinyl estradiol (EE) by up to 25%. Acetaminophen and ascorbic acid are also known to increase plasma EE concentrations by inhibiting conjugations. Additionally, cytochrome P450 3A4 inhibitors like voriconazole, itraconazole, grapefruit juice, ketoconazole and fluconazole may increase plasma hormone concentrations.
How Estarylla affects other medications
The use of Estarylla may influence the outcome of certain laboratory tests, such as lipids, coagulation factors, binding proteins and glucose tolerance.
Ethinyl estradiol norgestimate
It is important that you inform your doctor of whether or not you have any of the following conditions before taking this medication:
Thromboembolic disorders and other vascular problems associated with Estarylla:
Do not use Estarylla if you have a liver disease, such as severe cirrhosis of liver or acute viral hepatitis. Discontinue this contraceptive if you develop jaundice. Estarylla is contraindicated in patients with a tumor in the liver. Hepatic adenomas have been linked to combined oral contraceptives like Estarylla. Studies have shown that long term use of this and other COCs increases the risk of developing hepatocellular carcinoma.
Estarylla is contraindicated in women with vascular disease or uncontrolled hypertension. Women with controlled hypertension should be closely monitored while on this contraceptive and its use should be terminated if blood pressure rises significantly.
Hypertension has been reported in women taking this contraceptive and this is more likely in older women who use Estarylla for extended periods. Incidence of hypertension increases with rising levels of progestin.
Studies suggest an increased risk for gallbladder disease among women on COCs. Use of these contraceptives may worsen existing gallbladder conditions.
Diabetic and prediabetic women who take Estarylla should be closely monitored, as Estarylla is known to decrease glucose tolerance. Alternative contraceptive should be considered for women with uncontrolled dyslipidemia. Women with hypertriglyceridemia, or a family history of the condition, may be at an increased risk of pancreatitis when on Estarylla.
Estarylla should be discontinued if the woman develops persistent, severe or recurrent headache. The contraceptive should also be discontinued in the case of severe or frequent migraine.
Bleeding irregularities and amenorrhea
Women with a history of depression should be closely monitored and Estarylla discontinued if the depression is persistent or becomes severe.
Exogenous estrogen found in Estarylla may induce or exacerbate symptoms of angioedema in women with hereditary angioedema.
Chloasma may occur in women with a history of chloasma gravidarum during Estarylla. Women with tendency towards chloasma should avoid exposure to UV radiation or the sun while taking Estarylla.
Estarylla should be stored at room temperature (20 degrees C to 25 degrees C). The drug should be stored in a dry place, away from moisture and direct sunlight. All medications should be safely kept out of reach of pets and children. Check with your healthcare provider or pharmacist on how to get rid of unused medication. Do not flush down the toilet or kitchen sink.
Ethinyl estradiol and norgestimate is a combination oral contraceptive (COC) medication that contains synthetic versions of ethinyl estradiol and norgestimate hormones. It is taken orally to prevent ovulation and pregnancy. The contraceptive works by causing changes to the cervical mucus, as well as the uterine lining. These changes make it impossible for the sperm get into contact with and fertilize the egg released in the uterus. Should fertilization occur, it makes it difficult for the fertilized egg to attach to the uterus to complete conception.
Ethinyl estradiol and norgestimate can also be used for treating acne in women who are at least 14 years old and have already started menstruating.
This contraceptive should not be used by pregnant women or those who are breastfeeding. In addition, you should not use Estarylla if you have an uncontrolled hypertension, coronary artery disease, heart disease, circulatory problems (especially due to diabetes), undiagnosed bleeding through the vagina, liver cancer or liver disease, if you are taking certain hepatitis C medications, experience severe headache and migraine, if you smoke and are over 35 years of age, if you have major surgery, or if you have a history of stroke, heart attack, jaundice caused by birth control medication or pregnancy, blood clots, or cancer of the cervix, vagina, uterus or breast.
Smoking while on this contraceptive can greatly increase a woman's risk of stroke, blood clots and heart attacks. The risk increases when the woman is 35 years or older.
Like with other birth control pills, taking Estarylla can increase your risk of stroke and heart attack if you are overweight, have high blood pressure, high cholesterol, diabetes, or if you are obese or overweight. The risk of stroke is highest during the first year of using this contraceptive. Your risk of stroke and blood clot is also high when you resume taking this contraceptive after a break of four weeks or longer.
Before using this contraceptive, tell your healthcare of your provider if you:
Inform your healthcare provider about all the medications you are taking, including over the counter medications, herbal medications, supplements and vitamins. Estarylla may affect the efficiency of other medications, and other medications may also affect how well this contraceptive works.
Women using Estarylla and other hormonal birth control medications should be counselled about the following information: