Ethinyl Estradiol and Norethindrone (Oral)

Overview

Ethinyl estradiol and norethindrone is a combination hormonal medication that is used to prevent pregnancy. It is comprised of two hormones: ethinyl estradiol (a form of estrogen) and norethindrone (a form of progestin). This medication renders a human egg unable to fertilise by accepting sperm, and does so by stopping its development. To stop sperm from reaching the egg, ethinyl estradiol and norethindrone thickens the fluid of the vagina. It also affects uterine lining so that it is more difficult for an egg to attach to the wall of the womb and to start developing into an embryo.

This medication is reliant on timing - it is highly recommended that patients take it every 24 hours and as close to the scheduled time as possible, as that is when oral contraceptives are most effective. If patients miss a dose or take this medication at irregular timings, there is a possibility that it may not work and that pregnancy may result.

Ethinyl estradiol and norethindrone also may interact with or lead to higher risks of certain medical conditions, such as cancer, kidney problems, thrombosis or high blood pressure, although the chances are low, and not all patients who take this medicine will encounter these effects, if any at all.

Oral contraceptives are one form of birth control among several, and patients should discuss the matter with their doctor to determine which is the best method for them. While more permanent methods of contraception exist, such as surgical sterilization, birth control pills are a convenient way to help with pregnancy planning, provided they are used properly. Patients should take note however, that they do not help to prevent sexually transmitted diseases, nor should they be used as emergency birth control after unprotected sex.

Conditions Treated

  • Birth control

Type Of Medicine

  • Female hormones

Side Effects

While taking ethinyl estradiol and norethindrone, patients may encounter some side effects, ranging from mild to serious. Not all patients who take this medicine will experience these effects. However, patients should still keep an eye out for any unusual signs and symptoms that develop and report them to their doctor as soon as possible. These symptoms may not be covered in the following lists, which are incomplete descriptions of such side effects.

Ethinyl estradiol and norethindrone may cause some milder side effects which should go away on their own. However, if they persist or become worse, patients should talk to their doctor about them, or about any questions they have on these side effects. These include:

  • Nausea

If the patient misses two periods in a row, they should contact their doctor in order to take a pregnancy test. They should also do the same if the medicine has not been taken properly, and if it results in missing 1 period.

More serious side effects may also occur while the patient is taking ethiny estradiol and norethindrone:

  • Mental or mood changes (such as depression, which can present as irritability or loss of interest in daily activities)

Use of this medicine may lead to serious (and possibly fatal) problems from blood clotting, although these problems are rare. These conditions can include strokes, heart attacks, pulmonary embolisms and deep vein thrombosis. Patients should look out for the following signs of these conditions:

  • Confusion

As ethinyl estradiol and norethindrone may raise blood pressure, patients should have their blood pressure checked regularly, and if the results turn out to be high, they should contact their doctor for further advice.

It is unusual for an allergic reaction to occur to ethinyl estradiol and norethindrone. Still, patients should look out for the following signs of a serious allergic reaction and seek immediate treatment if they notice them:

  • Rashes

Dosage

When starting the use of ethinyl estradiol and norethindrone, it will take at least 7 days for the body to adjust to the medicine, and for it to prevent pregnancy. During this period, patients should use other forms of contraception as well, such as condoms or diaphragms.

In order to help the patient remember to take their pills, it is recommended that they take the medicine at the same time each day. Other ways of remembering to take the medicine can include placing the pills at the patient's bedside to be taken either in the morning or evening, or utilising segmented pillboxes. Oral contraceptives work optimally when there is no more than 24 hours between doses. There is a possibility of pregnancy if the patient misses a dose or if they are irregular with their dosage timing. If the patient has missed a dose or more, they should contact their doctor for advice.

During the first few months of using ethinyl estradiol and norethindrone, patients may feel nausea. If the nausea persists, the patient should seek further medical advice.

Dosage for each patient may vary depending on their needs, which the doctor will be able to determine. Patients should follow their doctor's instructions closely when using ethinyl estradiol and norethindrone.

It is usual for patients taking ethinyl estradiol and norethindrone to start taking this medication on either the first day of their menstrual period, or the first Sunday after their period starts. Whichever day the patient starts on, it is important that they follow their dosage schedule closely. It is especially essential that patients use a secondary form of birth control such as condoms if they start on a Sunday, for the first 7 days of using the medication.

Ethinyl estradiol and norethindrone come in blister packs of 28, which is a full four-week cycle of the medicine. After one pack has been finished, the next pack should be started on the very next day. Menstrual periods usually occur on the fourth week of taking the medication.

Patients should not start, stop or change their dose without first discussing it with their doctor. If the dosage schedule is inconvenient for the patient, they should talk to their doctor about ways to change it.

The average oral dose (in tablet form) is as follows:

For contraceptive purposes (adults and teenagers):

  • ModiconĀ®: Take one white tablet at the same time each day for 21 days consecutively. Take a green pill (inert) for the next 7 consecutive days.

For children: Use and dosage will be determined by the doctor.

Different brands of oral contraceptives may contain differing amounts of estrogen and progestin for different times of the cycle. Therefore, patients should be careful to closely follow the instructions given by either their doctor or the package. They should start with the correct tablet and take them in the correct order, as certain tablets may be inactive or inert and do not contain the necessary hormones.

If the patient vomits or has diarrhea, it may affect the use of the contraceptive. In such cases, the patient should use a secondary form of birth control if they require it. If they have any questions at all, they should call their doctor for advice.

Consuming the medicine after dinner or supper, or before sleep may help with symptoms of nausea or stomach upsets.

Bleeding and spotting may occur if the patient is not regular with taking this medication.

Interactions

When using any drug, there is a possibility that it may interact with other drugs, supplements or herbal products. These interactions may cause an elevated risk of unwanted side effects, or even affect the effectiveness of the medication.

Prior to starting their medication, patients should keep a list of any drugs, supplements (such as vitamins) and herbal products that they are currently or have recently consumed, so that they can share the list with their doctor. This is to help prevent any unwanted interactions and effects.

The doctor may prescribe certain medications together with ethinyl estradiol and norethinedrone even if they could interact together. It may be to increase the effectiveness of the medication, or it may be because the doctor has judged the benefits of the prescription to outweigh the negative effects of the interaction. Patients who have any doubts or questions about their medicines and prescriptions should discuss them with their doctor before starting any medication.

Some drugs decrease the amount of birth control hormones in the body, and thus may prevent ethinyl estradiol and norethindrone from working properly, which can result in pregnancy. Drugs used to treat HIV or seizures are some examples. These drugs and herbal products include but are not limited to:

  • Barbiturates

The following is a non-exhaustive list of drugs that may interact with ethinyl estradiol and norethindrone:

  • Acetaminophen

If the patient wishes to start any new drug, they should discuss it beforehand with their doctor, and whether they should use supplementary and reliable forms of birth control.

Patients should also let their doctor know if they experience unusual spotting or breakthrough bleeding, as this may indicate that the birth control is not working as intended.

Certain medical conditions may also affect the use of ethinyl estradiol and norethindrone. In some cases, they may become dangerous if they interact with the medication. Therefore, patients should share their medical history with their doctor, especially if they have, or have had:

  • Abnormal bleeding (especially of the genitals)

Some foods and consumables may cause interactions with ethinyl estradiol and norethindrone. Alcohol and tobacco are especially likely to cause interactions with most medicines. If the patient wishes to continue using them, they should ask their doctor about their dose schedule and how they can minimise chances of interactions. Some other foods that have a higher chance of interacting with this medication are as follows:

  • Caffeine

The above is not a complete list of possible interactions. Patients can ask their doctors if they have any queries.

If the patient is scheduled for any laboratory test or surgery, they should let their doctors, surgeons or laboratory personnel know that they are taking this medication. This is because ethinyl estradiol and norethindrone may interfere with the results of the tests or surgery.

Warnings

Prior to starting ethinyl estradiol and norethindrone, patients should inform their doctors about any allergies they have, especially if they are allergic to estrogens (such as ethinyl estradiol or mestranol) or progestins (such as norethindrone or desogestrel). They should also mention if they have allergies to any food, dyes, medications or preservatives, as the medication may contain inactive ingredients which can cause allergic reactions.

Patients should also tell their doctors about their medical history, especially if they involve problems with blood clotting, cancers of the breast or cervix, high blood cholesterol, depression, diabetes, strokes, heart attacks, thyroid problems or unusual vaginal bleeding.

While on ethinyl estradiol and norethindrone, the doctor should check on the patient regularly to ensure that the medication is working as intended and that side effects are not developing. These visits will likely take place every 6 to 12 months, although the doctor may schedule more frequent check-ups if they feel it is necessary. During these visits, the patient may also expect to have their blood pressure taken.

This medication is taken to prevent pregnancy. If the patient is pregnant while using this medicine, it could harm the unborn baby. Therefore patients who think they may have become pregnant while on ethinyl estradiol and norethindrone should tell their doctor immediately. They should also let their doctor know if they intend to become pregnant so that the doctor can start tapering or stopping the medication safely.

Patients who decide to start on this medication within 4 weeks of having a baby should discuss their condition and issues with their doctor.

During the first three months of usage, light bleeding from the vagina may occur. Lighter bleeding is called spotting, whereas if it becomes heavier, it is known as breakthrough bleeding. Patients experiencing spotting or bleeding should continue with their regular dosing schedule as the bleeding should stop within a week. If the bleeding continues beyond a week, or even after the patient has been taking hormonal contraceptives on schedule for more than 3 months, they should seek medical advice from their doctor.

Patients should check in with their doctor as quickly as possible if they have missed a period. This may happen if the patients are irregular with their medicine doses. If more than two periods have been missed, the patient may require a pregnancy test.

Ethinyl estradiol and norethindrone may increase the chances of problems with blood clotting. Patients should be alert for symptoms of blood clots while on this medicine, such as pain in the chest, groin or legs, trouble with breathing, sudden and severe headaches, slurred speech, sudden loss of bodily coordination, and changes with their vision.

This medicine can also increase risks of certain other medical conditions. These include breast, endometrial or cervical cancer, liver problems, gallbladder surgery and difficulties with vision. Patients with vision problems may be required to visit a separate opthalmologist (or eye doctor) to check on their eyes.

It is recommended that patients do not use ethinyl estradiol and norethindrone if they smoke or are older than 35 years of age. Smoking while using oral contraceptives can lead to higher risks of blood clots, heart attacks or strokes, and this risk is compounded if the patient is over 35 years old, if they have diabetes, high blood pressure, high cholesterol or if they are overweight. Should the patient still wish to continue with using this medication, they should discuss their conditions and diet with the doctor, and how they can best proceed.

Refilling an old prescription without first checking in with a doctor is not advised. The patient will require a new physical examination, and the doctor may feel it is necessary to change the prescription.

Ethinyl estradiol and norethindrone may affect the results of certain lab tests. Patients should ensure that their doctors, dentists or other healthcare givers are aware that they are currently using this medication. As this medicine affects blood clotting, patients may also be required to stop use of it for at least 4 weeks before major surgery, and 2 weeks after it.

Grapefruit and its products such as grapefruit juice may change how the body absorbs ethinyl estradiol and norethindrone. Patients should refrain from them while using this medication.

Patients should not take other medicines, supplements or herbal products while on this medication unless they have already discussed it with their doctor. These include both prescription and non-prescription drugs, and herbal products like St. John's wort.

Storage

Ethinyl estradiol and norethindrone should be stored in a closed container, in a cool and dry place, and kept away from direct sunlight. This medicine should not be kept in the bathroom as it may be too humid. It should also not be exposed to freezing temperatures.

The tablets should be kept in a place that is out of the reach of children and animals.

If the medicine is expired or unwanted, it should be disposed of properly. If the patient does not know how to handle medical waste, they should contact their doctor or local waste management center for advice on the proper ways to discard their medicine.

Summary

Ethinyl estradiol and norethindrone are two hormones (estrogen and progestin respectively) that are used together as an oral contraceptive, or a birth control pill. They work by stopping the development of a human egg each month, so that the egg is unable to accept sperm, and therefore preventing fertilisation of the egg.

Unlike physical forms of contraception, this medicine is unable to prevent transmission of any sexually transmitted disease such as HIV or chlamydia. It is also ineffective as emergency contraception, which is typically used after unprotected sex.

This medicine is primarily available through a doctor's prescription and usually comes in the form of a tablet (both swallowed and chewable) as well as in the form of a liquid-filled capsule.

While ethinyl estradiol and norethindrone is a useful form of contraceptive, it has some drawbacks. These include elevated risks of certain health conditions, such as blood clotting problems, breast cancer, cervical cancer, liver disease, kidney disease and strokes or heart attacks. Patients who are over 35 years old or smoke should be careful as these may increase the risks as well.

It is especially important for patients to take this medication every day, spaced equally across 24 hours as this may affect how effective the medicine is. Failure to take the medication as prescribed, or irregularity with taking it, may lead to pregnancy. If the patient finds it difficult to remember to take their medication, they can talk to their doctor about ways to remember, such as utilising segmented pill boxes, or placing it beside their bed so that they remember to take it either when waking up or going to sleep. Alternatively, they may also discuss other methods of contraception with their doctor to see which is the best fit for them.

Patients should be aware that vomiting and diarrhea may cause the medicine to pass out of their bodies and thus be rendered ineffective. In such cases, they should refer to their doctor for further advice, as well as be prepared to use back-up contraceptive methods such as condoms.

If used properly, birth control pills can be effective as contraceptives, although if the patient wishes to have fully effective birth control, they may wish to turn to alternatives such as surgical sterilisation.

The combination of ethinyl estradiol and norethindrone should be taken properly in order to be effective as birth control, and is usually available only through a doctor's prescription.

  • Menstruation regulation
  • Acne
  • Headaches
  • Vomiting
  • Bloatedness
  • Weight gain
  • Tenderness in the breast
  • Enlargement of the breast
  • Fluid retention (such as swelling in the feet or ankles)
  • Thick, white and curd-like vaginal discharge
  • Unusual bleeding from the vagina between periods (such as spotting)
  • Irregular or missing menstrual periods
  • Blotchy spots on skin
  • Insomnia
  • Yellowing eyes or skin
  • Unusual changes in bleeding from the vagina (such as missed periods, abrupt heavy bleeding or continuous spotting)
  • Dark urine
  • Clay colored stools
  • Diarrhea
  • Constipation
  • Severe pain in the stomach or abdominal area
  • Lumps or unusual changes to the breast
  • Hives or welts
  • Slurred speech
  • Sudden trouble with breathing
  • Quickened breathing
  • Unusual or severe headaches (such as headaches with a lack of coordination or worsening migraines)
  • Sudden dizziness or fainting
  • Unusual sweating
  • Weakness on one side of the body
  • Changes in vision (such as double vision, or blindness, either partial or complete)
  • Pain in the chest, jaw or left arm
  • Pain, swelling or warmth in the groin or calf
  • Itching and swelling, especially in the face, tongue and throat
  • Severe dizziness
  • Trouble with breathing
  • Ortho-novumĀ®: Take one white or peach tablet at the same time each day for 21 days consecutively. Take a green pill (inert) for the next 7 consecutive days.
  • Carbamazepine
  • Felbamate
  • Griseofulvin
  • Modafinil
  • Nelfinavir
  • Nevirapine
  • Phenytoin
  • Primidone
  • Rifamycins
  • Ritonavir
  • St. John's Wort
  • Topiramate
  • Albuterol
  • Alprazolam
  • Amphetamine / dextroamphetamine
  • Anastrozole
  • Ascorbic acid (vitamin C)
  • Cholecalciferol
  • Cyanocobalamin (vitamin B12)
  • Diazepam
  • Duloxetine
  • Ergocalciferol (vitamin D2)
  • Exemestane
  • Golimumab
  • Hydroxychloroquine
  • Lactobacillus acidophilus
  • Omega-3 polyunsaturated fatty acids (fish oil)
  • Ospemifene
  • Quetiapine
  • Sertraline
  • Simethicone
  • Tamoxifen
  • Tizanidine
  • Tranexamic acid
  • Venlafaxine
  • Warfarin
  • Angioedema
  • Problems with blood clotting
  • Cancer (especially endometrial, cervical or breast)
  • Depression
  • Epilepsy
  • Estrogenic carcinomas
  • Fluid retention
  • Gallbladder disease
  • Glucose intolerance
  • Heart attacks
  • Hepatic neoplasms
  • Hypercalcemia
  • Hyperlipidemia
  • Hypertension
  • Jaundice (from pregnancy or hormone therapy)
  • Kidney disease
  • Liver disease
  • Malignancy in the breast
  • Major surgery with long periods of immobility
  • Melasma
  • Migraines
  • Obesity
  • Retinal thrombosis
  • Strokes
  • Thyroid problems
  • Weight gain
  • Ginseng
  • Grapefruit
  • Licorice