Norgestrel + Ethinyl Estradiol

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Generic Name: Norgestrel + Ethinyl Estradiol Brand Name(s): Generics only. No brands available.

Uses

What is Norgestrel + Ethinyl Estradiol used for?

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin and an estrogen. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body.

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 should I take Norgestrel + Ethinyl Estradiol?

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. With certain brands of birth control pills, the amount of estrogen and progestin in each active tablet will vary at different times in the cycle. Therefore, it is very important that you 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).

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.

Your pill pack contains 21 pills with active medication. It may also contain 7 reminder pills with no medication. Take one active pill (with hormones) once daily for 21 days in a row. If you are using a product with 28 tablets, take an inactive pill once daily for 7 days in a row after you have taken the last active pill unless otherwise directed by your doctor. If you are using a product with 21 tablets, do not take any tablets for 7 days unless otherwise directed by your doctor. You should have your period during the fourth week of the cycle. After you have taken the last inactive tablet in the pack or gone 7 days without taking an active tablet, start a new pack the next day 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 and you are not switching from another form of hormonal birth control (such as patch, other birth control pills), take the first tablet in the pack on the first Sunday following the beginning of your menstrual period or on the first day of your period. If your period begins on a Sunday, begin taking this medication on that day. For the first cycle of use only, 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.

How do I store Norgestrel + Ethinyl Estradiol?

Norgestrel + Ethinyl Estradiol is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Norgestrel + Ethinyl Estradiol in the bathroom or the freezer. There may be different brands of Norgestrel + Ethinyl Estradiol that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Norgestrel + Ethinyl Estradiol down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Norgestrel + Ethinyl Estradiol?

Before using this medication, tell your doctor or pharmacist if you are allergic to any estrogens (such as ethinyl estradiol, mestranol) or any progestins (such as norethindrone, desogestrel); 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 medical history (especially 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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Norgestrel + Ethinyl Estradiol during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Norgestrel + Ethinyl Estradiol. Norgestrel + Ethinyl Estradiol is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Norgestrel + Ethinyl Estradiol?

Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Norgestrel + Ethinyl Estradiol?

Some products that may interact with this drug include: aromatase inhibitors (such as anastrozole, exemestane), ospemifene, tamoxifen, tizanidine, tranexamic acid, certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir).

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John’s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.

Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain laboratory tests (such as blood clotting factors, thyroid), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.

Norgestrel + Ethinyl Estradiol may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Norgestrel + Ethinyl Estradiol?

Norgestrel + Ethinyl Estradiol may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Norgestrel + Ethinyl Estradiol?

Norgestrel + Ethinyl Estradiol may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Norgestrel + Ethinyl Estradiol.

What is the dose of Norgestrel + Ethinyl Estradiol for an adult?

Usual Adult Dose for Contraception

1 tablet orally once a day

Comments:

-To be taken at the same time each day.

-Correct and consistent use can result in low failure rates.

-Withdrawal bleeding usually occurs within 3 days after discontinuing active tablets.

Use: For the prevention of pregnancy in women who elect to use this product as a method of contraception

Renal Dose Adjustments

Use with caution; other methods of contraception should be considered in patients with renal disease.

Liver Dose Adjustments

Active liver disease: Contraindicated

Other Comments

Administration advice:

-For maximum effectiveness, this drug must be taken exactly as directed and at intervals not exceeding 24 hours.

-Tablets should be taken at the same time each day.

-The active tablets are to be taken consistently once a day for 21 days, followed by the inert tablets once a day for 7 days.

-Backup birth control should be used until the active tablets have been taken consistently for 7 days; some manufacturers recommend using a backup method for the first 7 days in either administration course (i.e. day 1 start or Sunday start).

-Spotting or breakthrough bleeding may occur, however the same regimen should be continued as this type of bleeding is usually transient; however, if the bleeding is persistent or prolonged, a physician should be consulted.

-Pregnancy should be considered at the first missed period and ruled out before continuing use in any patient that has missed 2 consecutive periods.

-Some manufacturers recommend a Sunday start upon starting the first pack of oral contraceptives; the manufacturer product information should be consulted.

-Whichever method of administration is chosen (i.e. day 1 start or Sunday start), the patient should continue to start each subsequent pack on the same day of the week.

Sunday Start:

-Take the first active pill on the Sunday after the period starts, even if the patient is still bleeding; if the period begins on a Sunday, start the pack the same day.

-A backup form of birth control (e.g., condoms) should be used from the Sunday the pills are started to the next Sunday (7 days)

Day 1 Start:

-Take the first active pill during the first 24 hours of starting the period.

-A backup method of birth control will not be necessary with the Day 1 start.

Missed Pills:

-If 1 active pill is missed, take it as soon as it is remembered and the next pill at the regular time (2 pills in 1 day); a backup birth control method is not necessary

-If 2 active pills are missed in a row on week 1 or week 2 of the pack, take 2 pills on the day they are remembered and 2 pills the next day, then 1 pill each day until the pack is finished; a form of back-up birth control is necessary for the next 7 days

-If 2 active pills are missed in a row on Week 3, or 3 or more pills are missed in a row, the rest of the pill pack should be thrown out and a new pack started the same day for Day 1 starters; for Sunday starters, keep taking 1 pill every day until Sunday, then on Sunday, throw out the rest of the pack and start a new pack of pills the same day; back-up birth control is necessary for the next 7 days

General:

-The use of oral contraceptives is associated with increased risks of serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, and hypertension; although risk of serious morbidity or mortality is low in healthy women without underlying risk factors.

-The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes.

-Noncontraceptive health benefits related to oral contraceptives include: increased menstrual cycle regularity, decreased blood loss, decreased incidence of iron-deficiency anemia, decreased incidence of dysmenorrhea, decreased incidence of functional ovarian cysts, decreased incidence of ectopic pregnancies, decreased incidence of fibroadenomas and fibrocystic disease of the breast, decreased incidence of acute pelvic inflammatory disease, decreased incidence of endometrial cancer, and decreased incidence of ovarian cancer.

Patient advice:

-This drug does not protect against HIV infection, AIDS, and other sexually transmitted diseases.

-Smoking while using this drug is not recommended as it increases the risk of thromboembolism.

-Consult your physician if you are breastfeeding; some authorities recommend to not initiate this medication until 4 to 6 weeks after a full-term delivery.

-If pregnancy is terminated in the first 12 weeks, oral contraceptives should be initiated immediately or within 7 days.

-If pregnancy is terminated after 12 weeks, oral contraceptives should be initiated after 2 weeks.

-The patient information leaflet should be consulted for further information.

What is the dose of Norgestrel + Ethinyl Estradiol for a child?

Usual Pediatric Dose for Contraception

1 tablet orally once a day

Comments:

-To be taken at the same time each day.

-Correct and consistent use can result in low failure rates.

-Withdrawal bleeding usually occurs within 3 days after discontinuing active tablets.

Use: For the prevention of pregnancy in women who elect to use this product as a method of contraception

Precautions

Safety and efficacy have been established in female patients of reproductive age; use prior to menarche is not indicated.

How is Norgestrel + Ethinyl Estradiol available?

Norgestrel + Ethinyl Estradiol is available in the following dosage forms and strengths:

  • Oral tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Norgestrel + Ethinyl Estradiol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 5, 2018 | Last Modified: April 5, 2018

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