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Ethinyl estradiol and norgestrel (Oral route)

Pronunciation:

ETH-i-nil es-tra-DYE-ol, nor-JES-trel

Brand Names:

  • Cryselle
  • Lo/Ovral
  • Low-Ogestrel
  • Ogestrel
  • Ovral

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

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 .

Classifications:

Therapeutic—

Contraceptive

Pharmacologic—

Estrogen

Uses of This Medicine:

Ethinyl estradiol and norgestrel combination is used to prevent 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 will 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:

Allergies—

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.

Children—

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norgestrel combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine 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.

Older adults—

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norgestrel combination have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersXStudies 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.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

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.

  • Dasabuvir
  • Ombitasvir
  • Paritaprevir
  • Ritonavir
  • 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.

  • Anagrelide
  • Aprepitant
  • Boceprevir
  • Bosentan
  • Bupropion
  • Carbamazepine
  • Ceritinib
  • Dabrafenib
  • Darunavir
  • Dexamethasone
  • Donepezil
  • Eliglustat
  • Enzalutamide
  • Fosphenytoin
  • Glecaprevir
  • Griseofulvin
  • Idelalisib
  • Isotretinoin
  • Lesinurad
  • Lixisenatide
  • Lumacaftor
  • Mitotane
  • Modafinil
  • Oxcarbazepine
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Phenytoin
  • Pibrentasvir
  • Piperaquine
  • Pitolisant
  • Prednisone
  • Rifabutin
  • Rifampin
  • St John's Wort
  • Sugammadex
  • Theophylline
  • Tizanidine
  • Topiramate
  • Ulipristal
  • 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.

  • Alprazolam
  • Amprenavir
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Clarithromycin
  • Colesevelam
  • Cyclosporine
  • Delavirdine
  • Efavirenz
  • Eslicarbazepine Acetate
  • Etoricoxib
  • Fosamprenavir
  • Fosaprepitant
  • Ginseng
  • Lamotrigine
  • Licorice
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Parecoxib
  • Prednisolone
  • Rifapentine
  • Ritonavir
  • Roflumilast
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • Telaprevir
  • Tipranavir
  • Troglitazone
  • Troleandomycin
  • Valdecoxib
  • Voriconazole
  • Warfarin

Other interactions—

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.

  • Caffeine
  • Grapefruit Juice

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, or history of or
  • Diabetes with kidney, eye, nerve, or blood vessel damage 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), uncontrolled or
  • Jaundice during pregnancy or from using hormonal therapy in the past or
  • Liver disease, including tumors or cancer or
  • Major surgery in near future, 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.
  • Depression, history of or
  • Epilepsy, history of or
  • Gallbladder disease, history of or
  • Hyperlipidemia (high cholesterol or fats in the blood) or
  • Kidney disease—May make these conditions worse.
  • Diarrhea or
  • Vomiting—May decrease the absorption of ethinyl estradiol and norgestrel combination in the body.

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.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may begin taking the pills on the first day of your menstrual period, or on the first Sunday after your period begins.

You should use a second form of birth control (eg, condoms, diaphragms, or contraceptive foams and jellies) when you first start using this medicine.

It is very important that you take this medicine on time every day. Birth control pills work best when there is no more than 24 hours between doses.

You could have light bleeding or spotting 3 days after you stop taking a white tablet, or when you switch to ethinyl estradiol and norgestrel combination from another birth control pill or implant, or injection.

Dosing—

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.

  • For prevention of pregnancy:
    • For oral dosage form (tablets):
      • Adults—One white tablet each day for 21 days. Then one peach tablet per day for 7 days.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss one white pill, take it as soon as you can. Then take your next pill at the regular time. This means, you may take two pills in one day. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you miss two white pills in a row during Week 1 or 2, take two pills as soon as you can. Take two more pills on the next day. Then go back to your regular schedule of taking one pill every day. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you started this medicine on Day 1 of your period and you miss two white pills in a row during Week 3, throw out the rest of your pills and start a new pack the same day. If you miss three or more white pills in a row during any week, throw out the rest of your pills and start a new pack the same day. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you started this medicine on the Sunday after your period started and you miss two white pills in a row during Week 3, keep taking one pill every day until the next Sunday. Then throw away the rest of your pills and start a new pack on that same Sunday. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you started this medicine on the Sunday after your period started and you miss three or more white pills in a row during any week, keep taking one pill every day until the next Sunday. Then throw away the rest of your pills and start a new pack on that same Sunday. Use a second form of birth control until you have been taking white pills for seven days in a row.

If you miss your pills and change your schedule, you may not have a period for that month. Make sure your doctor knows if you miss your period two months in a row, because you may be pregnant.

You could have light bleeding or spotting any time you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Storage—

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 this medicine is working properly and does not cause unwanted effects. Your doctor may also want to check your blood pressure while using this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

You may be pregnant if:

  • You do not take the pills regularly and missed a menstrual period.
  • You missed 2 menstrual periods.

If you suspect that you may be pregnant, stop using this medicine and check with your doctor right away. You may have a higher risk of an ectopic pregnancy if you get pregnant while using this medicine. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

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®).

This medicine will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begin to have sexual intercourse with other people, or you or your partner tests positive for a sexually transmitted disease. If this is a concern for you, talk with your doctor.

You might have some light bleeding or spotting when you first start using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than a few days in a row, call your doctor.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using ethinyl estradiol and norgestrel 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 you experience abnormal vaginal bleeding.

Check with your doctor right away if you have pain or tenderness in the stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately 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.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

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.

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:

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:

Incidence not known
Absent, missed, or irregular menstrual periods
backache
belching
bleeding between periods
blurred vision
breast tenderness, pain, enlargement, or secretion
change in the amount of bleeding during periods
change in the pattern of monthly periods
changes in skin color, pain, tenderness, swelling of the foot or leg
chest pain or discomfort
chills
clay-colored stools
clear or bloody discharge from the nipple
cough
dark urine
diarrhea
difficulty swallowing
dimpling of the breast skin
dizziness
dull ache or feeling of pressure or heaviness in the legs
fast heartbeat
fever
full or bloated feeling or pressure in the stomach
headache
headache, severe and throbbing
heartburn
hives
inability to speak
indigestion
inverted nipple
itching of the vagina or genital area
itching skin near damaged veins
light vaginal bleeding between periods and after intercourse
loss of appetite
lump in the breast or under the arm
nausea and vomiting
nervousness
pain during sexual intercourse
pain or discomfort in the arms, jaw, back or neck
persistent crusting or scaling of the nipple
pounding in the ears puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness or swelling of the breast
seizures
severe or sudden headache
slow or fast heartbeat
slurred speech
sore on the skin of the breast that does not heal
stomach discomfort, upset, or pain
stopping of menstrual bleeding
sweating
swelling, pain, or tenderness in the upper abdominal area
swollen feet and ankles
temporary blindness
thick, white vaginal discharge with no odor or with a mild odor
tightness in the chest
twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
unpleasant breath odor
unusual stopping of menstrual bleeding
unusual tiredness or weakness
vomiting of blood
weakness in the arm or leg on one side of the body, sudden and severe
yellow eyes or skin

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:

Incidence not known
Acne
changes in weight or appetite
decreased interest in sexual intercourse
inability to have or keep an erection
increased hair growth, especially on the face
intolerance to contact lenses
loss in sexual ability, desire, drive, or performance
loss of hair on the scalp

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: 9/4/2017
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