What are the main side effects of Levonorgestrel and Ethinyl Estradiol. How does this medication work to prevent pregnancy. What are the proper usage instructions for this oral contraceptive. When should you seek medical attention while taking this medication.

Understanding Levonorgestrel and Ethinyl Estradiol: A Powerful Combination for Birth Control

Levonorgestrel and Ethinyl Estradiol is a combination hormone medication primarily used for preventing pregnancy. This oral contraceptive contains two key hormones: levonorgestrel (a progestin) and ethinyl estradiol (an estrogen). Together, these hormones work synergistically to provide effective birth control.

Beyond its primary function, this medication offers several additional benefits. These include:

• Regulating menstrual cycles
• Reducing blood loss during periods
• Alleviating menstrual pain
• Decreasing the risk of ovarian cysts
• Treating acne

It’s crucial to note that while this medication is highly effective at preventing pregnancy, it does not protect against sexually transmitted diseases (STDs) such as HIV, gonorrhea, or chlamydia. Additional protective measures should be taken to prevent the transmission of these infections.

Proper Usage and Administration of Levonorgestrel-Ethinyl Estradiol

Correct usage of Levonorgestrel-Ethinyl Estradiol is essential for its effectiveness. Here are the key points to remember:

1. Take the medication orally, once daily, at the same time each day.
2. Choose a convenient time that you can easily remember.
3. Follow the package instructions carefully, starting with the first tablet in the pack.
4. Take the pills in the correct order without skipping any doses.

Are you experiencing stomach upset or nausea with the medication? Taking it after your evening meal or at bedtime may help alleviate these symptoms. However, consistency in timing is crucial – ensure you take the pill at the same time every day, 24 hours apart, regardless of when you choose to take it.

Starting Your First Pack

For those new to this medication, follow these guidelines:

• Begin taking the medication on the first Sunday following the start of your menstrual period.
• If your period begins on a Sunday, start the medication on that day.
• Use additional non-hormonal birth control (e.g., condoms, spermicide) for the first 7 days to ensure protection.
• If you start on the first day of your period, additional birth control is not necessary for the first week.

Understanding Your Pill Pack

The typical pill pack contains:

• 84 active pills (with hormones)
• 7 inactive pills (without hormones)

Take one active pill daily for 84 consecutive days, followed by one inactive pill daily for 7 days. You should expect your period during the week you’re taking the inactive pills. After completing the inactive pills, start a new pack immediately, regardless of whether your period has ended.

Common Side Effects and What to Expect

While Levonorgestrel-Ethinyl Estradiol is generally well-tolerated, some users may experience side effects. Common side effects include:

• Nausea
• Vomiting
• Headache
• Bloating
• Breast tenderness
• Swelling of ankles/feet (fluid retention)
• Weight changes
• Vaginal bleeding between periods (spotting), especially in the first few months

Is spotting normal while taking this medication? Yes, some vaginal bleeding or spotting between periods is common, particularly during the initial months of use. However, if these effects persist or worsen, it’s important to consult your healthcare provider promptly.

Serious Side Effects: When to Seek Medical Attention

While rare, some users may experience more serious side effects that require immediate medical attention. These include:

• Lumps in the breast
• Mental/mood changes (such as new or worsening depression)
• Severe stomach or abdominal pain
• Unusual changes in vaginal bleeding (continuous spotting, sudden heavy bleeding, missed periods)
• Dark urine
• Yellowing of eyes/skin
• Signs of a blood clot (such as sudden severe headache, chest pain, trouble breathing, calf pain/swelling, sudden vision changes)

Can this medication affect blood pressure? Yes, Levonorgestrel-Ethinyl Estradiol may raise blood pressure in some users. Regular blood pressure monitoring is recommended, and any high readings should be reported to your doctor.

Special Considerations and Precautions

Certain factors may affect the use of Levonorgestrel-Ethinyl Estradiol or require special precautions:

• Smoking, especially if over 35 years old
• History of blood clots or certain cancers
• Liver disease
• Uncontrolled high blood pressure
• Certain heart problems
• Diabetes with complications
• Severe migraines with aura

Should you disclose your full medical history to your doctor before starting this medication? Absolutely. A comprehensive discussion of your medical history, current medications, and any existing health conditions is crucial for determining if Levonorgestrel-Ethinyl Estradiol is the right choice for you.

Interactions with Other Medications and Substances

Levonorgestrel-Ethinyl Estradiol can interact with various medications and substances, potentially affecting its effectiveness or increasing the risk of side effects. Some notable interactions include:

• Certain antibiotics (e.g., rifampin)
• Antifungal medications (e.g., griseofulvin)
• HIV medications
• Anti-seizure drugs
• St. John’s Wort
• Some medications used to treat chronic hepatitis C

Do over-the-counter medications interact with this birth control? While most OTC medications are safe to use with Levonorgestrel-Ethinyl Estradiol, it’s always best to consult with your healthcare provider or pharmacist before combining medications.

Managing Missed Doses and Ensuring Continued Protection

Missing doses of Levonorgestrel-Ethinyl Estradiol can significantly reduce its effectiveness as a contraceptive. Here’s what to do if you miss a dose:

• If you’re less than 24 hours late: Take the missed pill as soon as you remember, then continue with your regular schedule.
• If you’re more than 24 hours late: Refer to the Patient Information Leaflet for specific instructions, as they may vary depending on which week of the pill pack you’re in.
• If you miss two or more pills: Additional contraceptive measures may be necessary, and you should consult the leaflet or your healthcare provider for guidance.

Is it necessary to use backup contraception after missing a pill? In many cases, yes. Especially if you’ve missed more than one pill or are in the first or third week of your pill pack, using a backup method like condoms for 7 days is recommended.

Vomiting and Diarrhea: Impact on Effectiveness

Severe vomiting or diarrhea can potentially reduce the effectiveness of oral contraceptives. If you experience these symptoms:

1. Continue taking your pills as scheduled if possible.
2. Use a backup method of birth control (e.g., condoms) until you’ve taken active pills for 7 consecutive days after recovering from the illness.
3. If your illness occurs in the last week of active pills (days 78-84), skip the inactive pills and start a new pack immediately.

Should you consult your healthcare provider if you experience prolonged vomiting or diarrhea while on this medication? Yes, especially if the symptoms persist for more than 24 hours, as they may advise additional contraceptive measures or alternative treatments.

Long-Term Use and Health Considerations

While Levonorgestrel-Ethinyl Estradiol is generally safe for long-term use, regular check-ups with your healthcare provider are essential. These visits allow for:

• Monitoring of blood pressure and other vital signs
• Discussion of any side effects or concerns
• Evaluation of overall health and any changes in medical history
• Consideration of alternative contraceptive methods if necessary

Does long-term use of this medication increase cancer risk? The relationship between oral contraceptives and cancer is complex. While some studies suggest a slight increase in breast cancer risk, others indicate a decreased risk of ovarian and endometrial cancers. Your healthcare provider can help you weigh the risks and benefits based on your individual health profile.

Fertility After Discontinuation

Many women wonder about their fertility after stopping Levonorgestrel-Ethinyl Estradiol. Here are some key points:

• Fertility typically returns quickly after discontinuing the medication.
• Some women may experience a temporary delay in ovulation.
• If you don’t wish to become pregnant immediately after stopping, use an alternative form of contraception.

How long should you wait before trying to conceive after stopping this medication? While it’s possible to conceive immediately after discontinuation, some healthcare providers recommend waiting for one normal menstrual cycle before trying to get pregnant. This can help with more accurate dating of the pregnancy.

Alternatives to Levonorgestrel-Ethinyl Estradiol

While Levonorgestrel-Ethinyl Estradiol is an effective and popular choice for contraception, it’s not suitable for everyone. Alternative options include:

• Other oral contraceptives with different hormone combinations
• Progestin-only pills (“mini-pills”)
• Intrauterine devices (IUDs)
• Contraceptive implants
• Contraceptive injections
• Barrier methods (condoms, diaphragms)
• Natural family planning methods

How do you determine which contraceptive method is best for you? The choice of contraception is highly individual and depends on factors such as medical history, lifestyle, personal preferences, and future pregnancy plans. A thorough discussion with your healthcare provider can help you make an informed decision.

Non-Contraceptive Uses

Beyond contraception, Levonorgestrel-Ethinyl Estradiol may be prescribed for other medical reasons, including:

• Management of heavy or painful periods
• Treatment of endometriosis
• Regulation of irregular menstrual cycles
• Management of polycystic ovary syndrome (PCOS) symptoms
• Reduction of acne

Can this medication be used for emergency contraception? While Levonorgestrel-Ethinyl Estradiol is not typically used for emergency contraception, other formulations containing levonorgestrel alone are available for this purpose. It’s important to consult a healthcare provider or pharmacist for appropriate emergency contraception options.

Levonorgestrel-Ethinyl Estradiol Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin (levonorgestrel) and an estrogen (ethinyl estradiol).Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne.Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How to use levonorgestrel-ethinyl estradiol oral

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, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, 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.

It is very important to continue taking this medication exactly as prescribed by your doctor. 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.

Vomiting or diarrhea can prevent your birth control pills from working well. If you have vomiting or diarrhea, you may need to use a back-up birth control method (such as condoms, spermicide). Follow the directions in the Patient Information Leaflet and check with your doctor or pharmacist for more details.

Taking this medication after your evening meal or at bedtime may help if you have stomach upset or nausea with the medication. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart. Ask your doctor or pharmacist if you have any questions.

Begin taking this medication on the first Sunday following the beginning of your menstrual period. If your period begins on a Sunday, begin taking this medication on that day. Your pill pack contains 84 active pills (with hormones) and 7 inactive pills (without hormones). Take one active pill daily for 84 days in a row. The day after you finish all the active pills, start taking one inactive pill daily for 7 days in a row. You should have your period during the week you are taking the inactive pills. The day after you take the last inactive tablet in the pack, start a new pack 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, 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 about how to switch from other forms of hormonal birth control (such as patch, other birth control pills) to this product. If any information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

Side Effects

Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) may occur, especially during the first few months of use. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

You should not have your period during the 3 months that you are taking the active pills. Instead, you will have your period once every 3 months, during the week that you are taking the inactive pills. This effect is normal with this product. However, if you do not have your period while taking the inactive pills, contact your doctor for a pregnancy test.

Remember that this medication has been prescribed because your doctor 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, trouble speaking, 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.

Precautions

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or levonorgestrel; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels, depression, diabetes, family or personal history of a certain swelling disorder (angioedema), gallbladder problems, severe headaches/migraines, heart problems (such as heart valve disease, irregular heartbeat, previous heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch), kidney disease, liver disease (including tumors), stroke, swelling (edema), thyroid problems, unexplained vaginal bleeding.

If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormonal birth control. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

This medication may decrease breast milk production. A small amount passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

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), fezolinetant, 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), ritonavir, St. John’s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), 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 lab tests (such as blood clotting factors, thyroid), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Does levonorgestrel-ethinyl estradiol oral interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe nausea and vomiting, sudden/unusual vaginal bleeding.

Do not share this medication with others.

Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam, pelvic exam, Pap smear) should be done while you are taking this medication. Follow your doctor’s instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Refer to the product package information for advice on missed doses. You may need to use back-up birth control (such as condoms, spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.

If you often forget to take your pills as directed, contact your doctor to discuss switching to another form of birth control.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

levonorgestrel 0.15 mg-ethinyl estradiol 30 mcg tablets,3 mos pack(91)

Color: multi-color (2)Shape: roundImprint: E1 or E2

This medicine is a multi-color (2), round, dose pack imprinted with “E1 or E2”.

levonorgestrel 0.15 mg-ethinyl estradiol 30 mcg tablets,3 mos pack(91)

Color: multi-color (2)Shape: roundImprint: LU U21 or U22

This medicine is a multi-color (2), round, dose pack imprinted with “E1 or E2”.

levonorgestrel 0.15 mg-ethinyl estradiol 30 mcg tablets,3 mos pack(91)

Color: multi-color (2)Shape: roundImprint: E1 or E2

This medicine is a multi-color (2), round, dose pack imprinted with “E1 or E2”.

levonorgestrel 0.15 mg-ethinyl estradiol 30 mcg tablets,3 mos pack(91)

Color: multi-color (2)Shape: roundImprint: LU U21 or U22

This medicine is a multi-color (2), round, dose pack imprinted with “E1 or E2”.

levonorgestrel 0.15 mg-ethinyl estradiol 30 mcg tablets,3 mos pack(91)

Color: multi-color (2)Shape: roundImprint: 212 or 279

This medicine is a multi-color (2), round, dose pack imprinted with “E1 or E2”.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Teva-cyproterone/ethinyl estradiol – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

This medication contains a combination of two ingredients: cyproterone and ethinyl estradiol. Cyproterone belongs to a group of medications known as antiandrogens. Ethinyl estradiol belongs to a group of medications known as estrogens. Together, they are used to treat certain severe types of acne for women for whom antibiotics and other treatments have not been successful.  This medication works by regulating hormones that affect the skin.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. 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.

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What form(s) does this medication come in?

Each yellow, round, sugar-coated tablet contains cyproterone acetate 2 mg and ethinyl estradiol 0. 035 mg. Nonmedicinal ingredients: corn starch, lactose, magnesium stearate, povidone, and talc; tablet coating: calcium carbonate, glycerol, iron oxide pigment, polyethylene glycol, povidone, sucrose, talc, titanium dioxide, and wax.

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How should I use this medication?

This medication is taken in 28-day cycles consisting of 1 tablet daily for 21 days, followed by a 7-day interval without medication (i.e., 3 weeks on, 1 week off). Tablets should be taken at the same time each day. Treatment is usually started on the first day of menstrual bleeding. Often, several months of treatment are needed before improvement is seen. Once the acne has completely resolved, this medication is usually continued for another 3 or 4 cycles and then stopped. This medication may be restarted if your acne returns.

If spotting or breakthrough bleeding occurs during the 3 weeks during which this medication is being taken, continue taking this medication. The spotting or breakthrough bleeding is usually temporary. If bleeding is persistent or lasts a long time, contact your doctor.

If your menstrual period fails to occur during the 7-day tablet-free interval, do not start the next medication cycle and contact your doctor.

Many things can affect the dose of 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 using the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. The medication will be less effective if you miss doses. If you miss a dose of this medication, and you remember within 12 hours, take the missed dose. If more than 12 hours have passed, discard the missed tablet and continue to take the remaining tablets in the pack at the usual time. An additional non-hormonal method of birth control (e. g., condoms) should be used until the pack is empty. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

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Who should NOT take this medication?

Do not take cyproterone – ethinyl estradiol if you:

• are allergic to cyproterone, estradiol, or any ingredients of the medication
• are or may be pregnant
• have a history of cholestatic jaundice (yellowing of the skin, whites of the eyes caused by problems with bile flow)
• have active liver disease
• have any eye problems caused by blood vessel disease in the eye (such as partial or complete loss of vision or other vision changes)
• have or have had a blood vessel or blood clotting disorder (including deep vein thrombosis, pulmonary embolism, thrombophlebitis, and cerebrovascular disease such as stroke, heart attack, and coronary artery disease)
• have had otosclerosis (abnormal bone growth in the ear) that worsened during pregnancy
• have known or suspected breast cancer
• have known or suspected tumours dependent on estrogen
• have or have had liver tumours
• have severe diabetes with blood vessel changes
• have undiagnosed abnormal vaginal bleeding
• are taking another estrogen/progestogen combination or estrogens or progestogens alone

What side effects are possible with this medication?

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. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal cramps and bloating
• appetite changes
• breast pain, tenderness, or swelling
• brown, blotchy spots on exposed skin
• discomfort wearing contact lenses
• dizziness
• excess hair growth on face, chest, legs
• hair loss
• headache
• increased or decreased interest in sexual intercourse
• irritability
• menstrual pain
• mood changes
• nausea
• nervousness
• rash or reddish lumps under the skin
• red or purple spots or patches under the skin
• runny or stuffy nose
• swelling of ankles and feet
• unusual tiredness or weakness
• vomiting
• weight gain or loss

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal, uncontrollable movements of the arms or legs
• changes in the uterine bleeding pattern during or between menstrual periods (such as decreased bleeding, breakthrough bleeding or spotting between periods, prolonged bleeding, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes)
• decreased blood flow to the extremities (Raynaud’s syndrome)
• decreased milk supply if breast-feeding
• difficulty becoming pregnant after stopping the medication
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• for women with diabetes: mild increase of blood sugar, faintness, nausea, pale skin, or sweating
• for women with a history of breast disease: lumps in breast
• headaches or migraines (although headaches may lessen for many users, they may increase in number or become worse for others)
• hearing changes
• increased blood pressure (e. g., headache, nausea, vomiting, vision change)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, confusion, fatigue, fluid retention)
• symptoms of bladder infection (e.g., frequent or urgent need to urinate; pain or burning with urination; foul-smelling, cloudy, or bloody urine)
• symptoms of gall stones (e.g., pain in the upper abdomen, nausea, vomiting)
• symptoms of liver problems (e.g., swelling, pain, or tenderness or lump in upper abdominal area, yellowing of eyes or skin, skin itching)
• symptoms of porphyria (disease affecting how blood functions; e.g., severe abdominal pain, pounding heartbeat, trouble breathing, red or brown urine)
• vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• abdominal or stomach pain (sudden, severe, or continuing)
• signs of a serious allergic reaction (e. g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of blood clots (e.g., coughing up blood; pains in chest, groin, or leg – especially in calf of leg)
• signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• shortness of breath
• sudden, partial, or complete loss of vision
• swelling of the face, hands, feet, or airways

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Birth control: This medication should not be used only for the purpose of birth control. Women should use a non-hormonal method of birth control (such as condoms) while taking this medication. Birth control pills should not be taken at the same time as cyproterone – ethinyl estradiol.

Blood clots: This medication appears to increase the risk of developing blood clots. This risk may be greater than that which occurs with birth control pills. These blood clots may form anywhere in the body, but are more noticeable when they occur in the large muscles, lung, brain (stroke), or heart (heart attack). This risk of developing blood clots is increased for women over 35 years of age. If you experience pain in the chest or leg, unexplained shortness of breath, fast and irregular heartbeat, severe headache, blurred vision, or slurred speech, get immediate medical attention. 

Breast cancer: All women who take this medication should practice breast self-examination. Ask your doctor to teach you how to do this. If you have a family history of breast cancer, you should be closely monitored by your doctor while taking this medication.

Diabetes: This medication can cause changes in blood sugars. If you have diabetes or a family history of diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Depression: Hormones, such as cyproterone – ethinyl estradiol have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Blood pressure: You should not take this medication if you have high blood pressure that is not controlled by medication. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Like other hormones, cyproterone – ethinyl estradiol can cause decreased liver function and liver disease. If you have decreased liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication should not be taken by women with severe liver disease.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Medical conditions: The combination of obesity, high blood pressure, and diabetes greatly increases the risk of side effects from this medication. If you have this combination of medical conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This medication can cause fluid retention, which may worsen conditions such as high blood pressure, heart disease, or kidney disease.

Migraine: This medication may cause migraine headaches to occur. If you experience a new pattern of headaches that is severe, persistent, or recurrent, contact your doctor as soon as possible. Cyproterone – ethinyl estradiol is not recommended for people who experience migraine headaches with aura.

Smoking: Smoking increases the risk of serious side effects on the heart and blood vessels. This risk increases with age and heavy smoking (15 or more cigarettes per day) and is even more serious for women over 35 years of age. Women who use this medication should not smoke.

Surgery: Certain situations such as long-term bed confinement may make blood clots more likely. Discuss with your doctor the risks and benefits of temporarily stopping this medication. If you are scheduled for surgery, let all doctors involved in your care know that you are taking this medication.

Vaginal bleeding: Report any unusual vaginal bleeding to your doctor.

Vision and contact lenses: Like other hormones, cyproterone – ethinyl estradiol may cause changes to the shape of the eye. If your contact lenses do not seem to fit as well as they used to, consult your doctor or eye care professional. You may need to stop wearing them or be fitted for a different pair. If you experience any vision changes while taking this medication, contact your doctor.

Pregnancy: This medication should not be taken by pregnant women as it can cause harm to the developing baby. If you become pregnant or suspect that you may be pregnant while taking this medication, contact your doctor immediately. After stopping treatment, you should wait until at least one normal menstrual cycle has occurred before trying to get pregnant.

Breast-feeding: This medication passes into breast milk and can reduce the amount and quality of breast-milk produced. This medication is not recommended for women who are breast-feeding.

What other drugs could interact with this medication?

There may be an interaction between cyproterone – ethinyl estradiol and any of the following:

• ampicillin
• anastrozole
• antiseizure medications (e.g., carbamazepine, clobazam, eslicarbazepine, lamotrigine, phenobarbital, phenytoin, primidone, rufinamide, topiramate)
• “azole” antifungals (e. g., fluconazole, ketoconazole, voriconazole)
• barbiturates (e.g., pentobarbital, secobarbital)
• bosentan
• celecoxib
• cholestyramine
• clozapine
• cobicistat
• colesevelam
• corticosteroids (e.g., dexamethasone, prednisone)
• cotrimoxazole
• cyclosporine
• deferasirox
• dehydroepiandrosterone
• diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, linagliptin, lixisenatide, metformin, rosiglitazone)
• echinacea
• elagolix
• elexacaftor, tezacaftor, and ivacaftor
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• exemestane
• glecaprevir and pibrentasvir
• grapefruit juice
• heparin
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine, rilpivirine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• lenalidomide
• lomitapide
• low-molecular-weight heparins (e. g., dalteparin, enoxaparin, tinzaparin)
• lumacaftor and ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• melatonin
• mifepristone
• modafinil
• nitrofurantoin
• ospemifene
• penicillin
• pomalidomide
• protein kinase inhibitors (e.g., bosutinib, ceritinib, dasatinib, imatinib, nilotinib)
• rifabutin
• rifampin
• roflumilast
• ropinirole
• St. John’s wort
• selegiline
• somatostatin analogues (e.g., lanreotide, octreotide, pasireotide)
• somatropin
• “statins” (e.g., atorvastatin, pravastatin, simvastatin)
• tacrolimus
• tetracycline
• thalidomide
• theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
• thyroid medications (e.g., levothyroxine, desiccated thyroid)
• tizanidine
• tobacco (smoked)
• tranexamic acid
• ursodiol
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist.  Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2023. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Teva-cyproteroneethinyl-estradiol

Description of ETHINYLESTRADIOL indications, dosages, contraindications of the active substance ETHINYLESTRADIOL

Rec.INN WHO registered drug interaction Included in preparations: list Pharmacological action Synthetic estrogen. Just like endogenous estrogens, it stimulates the development of the uterus, fallopian tubes, secondary sexual characteristics, causes proliferative changes in the endometrium, and increases the excitability of the uterus. Regulates nitrogen metabolism, reduces the level of lipids and cholesterol in the blood, has a weak anabolic effect. Increases the absorption of calcium and the formation of calcium depots in the bones. In high doses, it causes sodium and water retention. Pharmacokinetics Binds predominantly to plasma albumin. Metabolized in the liver to form hydroxylated and methylated metabolites. Excreted as metabolites by the kidneys – 40% and through the intestines – 60%. Indications of the active substance ETINILESTRADIOL Contraception (mainly in combined preparations). Manifestations of climacteric syndrome associated with estrogen deficiency; female hypogonadism, dysmenorrhea. Palliative treatment of malignant tumors of the mammary gland in the postmenopausal period. Palliative treatment of malignant tumors of the prostate. Open list of ICD-10 codes C50 Malignant neoplasm of the mammary gland C61 Malignant neoplasm of the prostate E23. 0 Hypopituitarism N94.4 Primary dysmenorrhea N94.5 Secondary dysmenorrhea N95.1 Menopause and climacteric conditions in women N95.3 Conditions associated with induced menopause Z30.0 General advice and advice on contraception Z51.5 Palliative care Dosing regimen Set individually, depending on the indication. The daily dose for oral administration varies from 10 mcg to 3 mg. Side effects On the part of the digestive system: nausea, vomiting, gastrointestinal dysfunction, liver dysfunction, jaundice, formation of gallstones are possible. From the endocrine system: possible soreness and enlargement of the mammary glands, changes in libido, menstrual irregularities and bleeding after withdrawal, decreased glucose tolerance. From the side of metabolism: possible swelling, weight gain. From the nervous system: possible depression, headache, migraine, dizziness. Dermatological reactions: possible skin hyperpigmentation. On the part of the blood coagulation system: may increase the tendency to thrombosis and increase the risk of thromboembolism. Contraindications for use Breast cancer and other estrogen-dependent neoplasms, vaginal bleeding of unknown origin, endometriosis, thrombosis and thromboembolism (including in history), severe cardiovascular disease, liver failure, sickle cell anemia, herpes of pregnant women in history; pregnancy, lactation (breastfeeding). Use in pregnancy and lactation Contraindicated in pregnancy and lactation (breastfeeding). Use in hepatic impairment Contraindicated in hepatic impairment. Use in impaired renal function Use with caution in kidney disease. Special instructions Use with caution in bronchial asthma, epilepsy, migraine, heart and kidney diseases, as well as arterial hypertension, hypercalcemia, multiple sclerosis, systemic lupus erythematosus, otosclerosis. Can be used in combination with gestagens (including gestodene, dienogest, drospirenone, desogestrel, levonorgestrel) and cyproterone. Drug interactions Estrogens may reduce the effects of anticoagulants, antihypertensives and hypoglycemic agents. With the simultaneous use of ethinylestradiol and drugs that induce hepatic enzymes (barbiturates, carbamazepine, griseofulvin and rifampicin), a decrease in the level of ethinylestradiol in blood plasma is possible.

Ethinylestradiol – description of the substance, pharmacology, use, contraindications, formula

Contents

• Structural formula

• Russian name

• English name

• Latin name

• chemical name

• Gross formula

• Pharmacological group of the substance Ethinylestradiol

• Nosological classification

• CAS code

• pharmachologic effect

• Characteristic

• Pharmacology

• Application of the substance Ethinylestradiol

• Contraindications

• Use during pregnancy and lactation

• side effects of ethinylestradiol

• Interaction

• Dosage and administration

• Trade names with the active substance Ethinylestradiol

Structural formula

Russian name

Ethinylestradiol

English name

Ethinylestradiol

Latin name

Aethinyloestradiolum ( genus Aethinyloestradioli)

Chemical name

(17 alpha)-19-Norpregna-1,3 ,5(10)-triene-20-yn-3,17-diol

Gross formula

C ₂₀ H ₂₄ O ₂

Pharmacological group of the substance Ethinylestradiol

Estrogens, gestagens; their homologues and antagonists

Anticancer hormonal agents and hormone antagonists

Nosological classification

ICD-10 code list

CAS code

57-63-6

Pharmacological action

Pharmacological action –

anabolic , hypolipidemic , estrogenic .

Characteristics

White or off-white fine crystalline powder. Practically insoluble in water, soluble in alcohols and vegetable oils.

Pharmacology

Interacts with specialized estrogen receptors in target cells. Rapidly absorbed through mucous membranes and skin. It undergoes hepatoenteric recirculation, accompanied by the effect of “first pass” through the liver, where it undergoes oxidation with the formation of 2-OH-ethinylestradiol and 2-methoxyethinylestradiol and subsequent glucuronidation and sulfonation. Metabolites are inactive, excreted in the urine and bile. Depending on the physiological state (pregnancy, individual phases of the ovarian-menstrual cycle, age, and other conditions), the excretion rate varies greatly. In the fallopian tubes, cervix, vagina, external genital organs, excretory ducts of the mammary glands, it increases the proliferation of the epithelium. Increases the sensitivity of the muscles of the uterus and tubes to substances that excite their motility. It has a hypocholesterolemic effect, increases blood levels of beta-lipoproteins, insulin sensitivity, improves glucose utilization. In high doses, it retains water and sodium in the body, inhibits erythropoiesis. In large doses, it reduces, and in small doses, it activates the secretion of FSH from the pituitary gland. In men, it inhibits spermatogenesis (atrophic changes may develop in the testicles) and suppresses the secretion of androgens. It has a weak anabolic effect. Under certain conditions, it exhibits contraceptive properties (it is an integral part of a number of oral contraceptives).

Use of the substance Ethinylestradiol

Some forms of endocrine infertility, severe pathological menopause, dysfunctional uterine bleeding, androgen-dependent prostate cancer, some forms of breast cancer.

Contraindications

Hypersensitivity, thrombophlebitis, active hepatitis, liver cirrhosis, arterial hypertension, breast and endometrial cancer, porphyria, pregnancy.

Pregnancy and lactation

Category of effect on the fetus according to FDA – X.

Side effects of the substance Ethinylestradiol

Violation of calcium metabolism, edematous syndrome, nausea, headache, thromboembolic syndrome, arterial hypertension; men have gynecomastia.

Interactions

Efficiency is reduced by barbiturates (accelerate oxidation).

Method of administration and doses

IM, for amenorrhea and oligomenorrhea — 0.02–0.1 mg/day for 20 days, then progesterone is administered intramuscularly for 5 days — 5 mg/day . With dysmenorrhea, treatment begins on the 4-5th day of the menstrual cycle – 0.01-0.03 mg / day (in 3 doses) for 20 days, the course of treatment is repeated every 2-3 months. To stop lactation, it is prescribed in the first three days after childbirth, 0.02 mg 3 times a day, then in the next three days – 0.01 mg 3 times a day, then – 0.01 mg / day once for 3 days . In the treatment of acne vulgaris – 0.