- Chateal EQ®
- Ethinyl Estradiol and Levonorgestrel
- Brands: US
- Brands: Canada
- What is this drug used for?
- What do I need to tell my doctor BEFORE I take this drug?
- What are some things I need to know or do while I take this drug?
- What are some other side effects of this drug?
- How is this drug best taken?
- How do I store and/or throw out this drug?
- General drug facts
- Chateal Dosage
Ethinyl estradiol and levonorgestrel is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). This medicine 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.
Ethinyl estradiol and levonorgestrel is used as contraception to prevent pregnancy. There are many brands and forms of this medicine available. Not all brands are listed on this leaflet.
Ethinyl estradiol and levonorgestrel may also be used for purposes not listed in this medication guide.
Do not use birth control pills if you are pregnant or if you have recently had a baby.
You should not use birth control pills if you have: uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.
Taking birth control pills can increase your risk of blood clots, stroke, or heart attack.
Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take this medicine if you smoke and are over 35 years old.
Taking this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart this medicine after not taking it for 4 weeks or longer.
Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.
Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.
You should not take birth control pills if you have:
- untreated or uncontrolled high blood pressure;
- heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);
- an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
- circulation problems (especially if caused by diabetes);
- a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
- unusual vaginal bleeding that has not been checked by a doctor;
- liver disease or liver cancer;
- severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
- a history of jaundice caused by pregnancy or birth control pills; or
- if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).
Tell your doctor if you have ever had:
- heart disease, high blood pressure, or if you are prone having blood clots;
- high cholesterol or triglycerides, or if you are overweight;
- a seizure or migraine headache;
- diabetes, gallbladder disease;
- liver or kidney disease;
- irregular menstrual cycles; or
- fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.
Ethinyl estradiol and levonorgestrel can slow breast milk production. You should not breast-feed while using this medicine.
IMPORTANT SAFETY INFORMATION
Combination oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
Consult the Package Insert for Complete Prescribing Information
Combination oral contraceptives should not be used in women with any of the following conditions:
- Thrombophlebitis or thromboembolic disorders
- A history of deep-vein thrombophlebitis or thromboembolic disorders
- Cerebrovascular or coronary artery disease (current or past history)
- Valvular heart disease with thrombogenic complications
- Thrombogenic rhythm disorders
- Hereditary or acquired thrombophilias
- Major surgery with prolonged immobilization
- Diabetes with vascular involvement
- Headaches with focal neurological symptoms
- Uncontrolled hypertension
- Known or suspected carcinoma of the breast or personal history of breast cancer
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- Hepatic adenomas or carcinomas, or active liver disease
- Known or suspected pregnancy
- Hypersensitivity to any of the components of levonorgestrel and ethinyl estradiol tablets
- Are receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis.
Practitioners prescribing oral contraceptives should be familiar with information relating to these risks.
The most serious reactions are discussed in detail in the full product labeling and include serious cardiovascular events and smoking, vascular events, and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness, and headache.
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
Chateal EQ® . Charleston, SC: Afaxys Pharma, LLC; May 2018.
Please see full Prescribing Information here.
To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.
The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/ or 1-800-555-DRUG. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Ethinyl Estradiol and Levonorgestrel
WARNING TO WOMEN WHO SMOKE
Do not use Ethinyl Estradiol and Levonorgestrel if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
- Smoking cigarettes while using this drug raises the chance of very bad heart and blood-related side effects. This chance is raised with age (mainly in women older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age.
What is this drug used for?
- It is used to prevent pregnancy.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
- If you have an allergy to ethinyl estradiol, levonorgestrel, or any other part of this drug.
- If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer or other cancer where hormones make it grow, diseased blood vessels in the brain or heart, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, liver disease, liver tumor, very bad headache or migraine, or diabetes that affects blood flow.
- If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.
- If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
- If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
- If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
- If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
- Tell all of your healthcare providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. This drug may need to be stopped before certain types of surgery as your doctor has told you. If this drug is stopped, your doctor will tell you when to start taking this drug again after your surgery or procedure.
- This drug may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
- Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
- If you have high blood sugar (diabetes), talk with your doctor. This drug may raise blood sugar.
- Check your blood sugar as you have been told by your doctor.
- High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
- This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
- Certain drugs, herbal products, or health problems could cause this drug to not work as well. Be sure your doctor knows about all of your drugs and health problems.
- If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
- This drug may cause high cholesterol and triglyceride levels. Talk with the doctor.
- This drug does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Do not have any kind of sex without using a latex or polyurethane condom. If you have questions, talk with your doctor.
- Do not use in children who have not had their first menstrual period.
- If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away. What are some side effects that I need to call my doctor about right away?
Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; change in stools; dark urine or yellow skin or eyes; or fever with chills.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Depression or other mood changes.
- A lump in the breast, breast pain or soreness, or nipple discharge.
- Vaginal itching or discharge.
- Spotting or vaginal bleeding that is very bad or does not go away.
- Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
- Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling more or less hungry.
- Weight gain or loss.
- Upset stomach or throwing up.
- Stomach cramps.
- Enlarged breasts.
- Tender breasts.
- Period (menstrual) changes. These include spotting or bleeding between cycles.
- This drug may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.
How is this drug best taken?
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take this drug at the same time of day.
- Take with or without food. Take with food if it causes an upset stomach.
- Do not skip doses, even if you do not have sex very often.
- If you also take colesevelam, take it at least 4 hours before or after you take this drug.
- After starting this drug, you may need to use a non-hormone type of birth control like condoms to prevent pregnancy for some time. Follow what your doctor has told you to do about using a non-hormone type of birth control.
- If you throw up or have diarrhea, this drug may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
- If your monthly cycle is 28 days and you miss 2 periods in a row, take a pregnancy test before starting a new dosing cycle.
- If you have a cycle longer than 91 days and you miss one period, take a pregnancy test before starting a new dosing cycle.
What do I do if I miss a dose?
- If a dose is missed, check the package insert or call the doctor to find out what to do. If using this drug to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.
How do I store and/or throw out this drug?
- Store at room temperature.
- Store in a dry place. Do not store in the bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin. This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
- vulvovaginal candidiasis
- benign hepatic cell adenoma
- neoplasm of breast
- folate deficiency
- body fluid retention
- hemolytic uremic syndrome
- mood changes
- libido changes
- retinal thrombosis
- optic neuritis
- acute myocardial infarction
- pulmonary thromboembolism
- cerebrovascular accident
- thromboembolic disorder
- arterial thrombosis
- hepatic vein thrombosis
- thrombotic disorder
- deep venous thrombosis
- biliary calculus
- gallbladder disease
- obstructive hyperbilirubinemia
- kidney disease with reduction in glomerular filtration rate (GFR)
- galactorrhea not associated with childbirth
- vaginal dryness
- premenstrual syndrome
- irregular menstrual periods
- abnormal vaginal bleeding
- skin photosensitivity
- Erythema Multiforme
- erythema nodosum
- pruritus of skin
- acne vulgaris
- back pain
- muscle spasm
- change in corneal curvature
- skin rash
- peripheral edema
- weight gain
- weight loss
- appetite changes
- headache disorder
- abdominal pain with cramps
- abdominal distension
- pelvic pain
- abnormal glucose tolerance
- hypersensitivity drug reaction
- general weakness
- Acute Abdominal Pain
- Dysplasia of Cervix
- neoplasm of liver
- Erosion of Cervix
- Cervical Discharge
- Liver Cell Carcinoma
- Focal Nodular Hyperplasia of Liver
- symptoms of anxiety
- acute occlusion of mesenteric vein
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Some products that may interact with this drug include: aromatase inhibitors (such as anastrozole, exemestane), ospemifene, tamoxifen, tizanidine, tranexamic acid, certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir). Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John’s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others. Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. This medication may interfere with certain laboratory tests (such as blood clotting factors, thyroid), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.
To achieve maximum contraceptive effectiveness, Chateal (levonorgestrel and ethinyl estradiol tablets, 0.15 mg/0.03 mg) must be taken exactly as directed and at intervals not exceeding 24 hours.
The dosage of Chateal is one white to off-white tablet daily for 21 consecutive days, followed by one green inert tablet daily for 7 consecutive days, according to prescribed schedule.
It is recommended that tablets be taken at the same time each day, preferably after the evening meal or at bedtime.
During the first cycle of medication, the patient is instructed to begin taking Chateal on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white to off-white) is taken that day. One white to off-white tablet should be taken daily for 21 consecutive days, followed by one green inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white to off-white tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Chateal until a white to off-white tablet has been taken daily for 7 consecutive days and a nonhormonal back-up method of birth control should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on white to off-white tablets 7 days on green inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a white to off-white tablet daily for 7 consecutive days.
When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Chateal. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Chateal on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Chateal the next day. If switching from an implant or injection, the patient should start Chateal on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.
If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.
Although the occurrence of pregnancy is highly unlikely if Chateal is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING below.
Any time the patient misses two or more white to off-white tablets, she should also use another method of contraception until she has taken a white to off-white tablet daily for seven consecutive days. If the patient misses one or more green tablets, she is still protected against pregnancy provided she begins taking white to off-white tablets again on the proper day.
If breakthrough bleeding occurs following missed white to off-white tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two white to off-white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white to off-white tablets are missed.
Chateal may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS) concerning thromboembolic disease. The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.
In the case of first-trimester abortion, if the patient starts Chateal immediately, additional contraceptive measures are not needed. It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.