Ethinyl estradiol and norethindrone (Oral route)
ETH-i-nil es-tra-DYE-ol, nor-ETH-in-drone AS-e-tate
- Femhrt 1/5
- Femhrt Lo
- Gildess 1.5/30
- Junel 1/20
- Junel 1.5/30
- Larin 1/20
- Loestrin 1/20
- Loestrin 1.5/30
- Microgestin 1/20
- Microgestin 1.5/30
- Tablet, Chewable
- Capsule, Liquid Filled
Junel(R), Loestrin(R), Microgestin(R), Tri-Legest(R): Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke .Femhrt(R): Estrogen alone or with a progestin should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke, DVT, pulmonary embolism, myocardial infarction, and invasive breast cancer have been reported with estrogen plus progestin therapy. Increased risks of stroke and DVT have been reported with estrogen-alone therapy, along with increased risk for endometrial cancer in a woman with a uterus who uses unopposed estrogens. An increased risk of probable dementia in postmenopausal women aged 65 and older has been reported with estrogen alone and with estrogen plus progestin therapy. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration possible .
Uses of This Medicine:
Ethinyl estradiol and norethindrone combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norethindrone, and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.
No contraceptive method is 100 percent effective. Birth control methods, such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.
This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norethindrone combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.
No information is available on the relationship of age to the effects of ethinyl estradiol and norethindrone combination in the geriatric patients.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Tranexamic Acid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Paclitaxel Protein-Bound
- St John's Wort
- Valproic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Eslicarbazepine Acetate
- Mycophenolate Mofetil
- Mycophenolic Acid
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
- Breast cancer, known or suspected or
- Diabetes with kidney, eye, nerve, or blood vessel damage or
- Endometrial cancer or
- Heart attack, history of or
- Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
- Hypertension (high blood pressure) that is not under good control, or
- Jaundice during pregnancy or from using hormonal therapy in the past or
- Liver disease, including tumors or cancer or
- Major surgery with prolonged periods of immobilization or
- Migraine headache or
- Stroke, history of or
- Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.
- Breast cancer, family history of or
- Cervical cancer or
- Depression, history of or
- Edema (fluid retention or body swelling) or
- Epilepsy (seizures) or
- Gallbladder disease or
- Hypertension (high blood pressure)—Use with caution. May make these conditions worse.
- Diabetes or
- Hyperlipidemia (high cholesterol or fats in the blood) or
- Kidney disease or
- Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.
Proper Use of This Medicine:
It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.
This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
This medicine is available in blister packs with a Dialpak® tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.
When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.
Take this medicine at the same time each day (with meals or at bedtime). Birth control pills work best when no more than 24 hours pass between doses.
Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.
You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.
You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.
- For oral dosage form (tablets):
- For contraception (to prevent pregnancy):
- Adults and teenagers—
- Loestrin® 21: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one week without the tablets.
- Loestrin® Fe: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one brown (inert) tablet daily for 7 days per menstrual cycle.
- Modicon®: One white tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
- Ortho-novum®: One white or peach tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
- Children—Use and dose must be determined by your doctor.
- Adults and teenagers—
- For contraception (to prevent pregnancy):
Call your doctor or pharmacist for instructions.
This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.
- If you miss one active pill: Take it as soon as you can, then take your next pill at your regular schedule.
- If you miss two active pills in week 1 or 2: Take two pills as soon as you can and two more pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
- If you miss two active pills in week 3, or you miss three or more active pills in a row in weeks 1, 2, or 3:
- Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
- Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.
You may not have a period for that month if you miss more than one dose or change your schedule.
You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.
Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.
Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.
Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.
- If this should occur, continue with your regular dosing schedule.
- The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
- If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.
Check with your doctor right away if you missed a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
If you suspect that you may be pregnant, check with your doctor right away.
Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using norethindrone and ethinyl estradiol combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.
Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.
Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.
Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.
Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.
Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- Incidence not known
- Absent, missed, or irregular menstrual periods
- change in vision
- changes in skin color
- chest pain or discomfort
- clay-colored stools
- dark urine
- dizziness or lightheadedness
- fast heartbeat
- hives or welts
- itching skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
- pain or discomfort in the arms, jaw, back, or neck
- pain, tenderness, or swelling of the foot or leg
- pains in the chest, groin, or legs, especially in the calves of the legs
- pounding in the ears
- redness of the skin
- severe headaches of sudden onset
- slow or fast heartbeat
- stomach pain
- sudden loss of coordination or slurred speech
- troubled breathing
- unusual tiredness or weakness
- vomiting of blood
- Incidence not known
- blotchy spots on the exposed skin
- breast enlargement or tenderness
- feeling sad or empty
- itching of the vagina or outside genitals
- loss of interest or pleasure
- pain during sexual intercourse
- stomach cramps
- thick, white curd-like vaginal discharge without odor or with mild odor
- trouble concentrating
- trouble sleeping
- trouble wearing contact lenses
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 6/18/2019