Seasonique

DRUG DESCRIPTION

Seasonique (levonorgestrel, ethinyl estradiol) (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol.

The structural formulas for the active components are:

Levonorgestrel structural illustration

Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-, (-)-.

Ethinyl Estradiol structural illustration

Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17a)-.

Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.

Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.

What are the possible side effects of ethinyl estradiol and levonorgestrel (EC) (Preven EC, Seasonique)?

If you experience any of the following serious side effects, stop taking ethinyl estradiol and levonorgestrel (EC) and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • sudden shortness of breath, sudden pain or heaviness in the chest, or coughing up blood (possible heart attack or blood clot in the lung);
  • pain, redness, swelling, or numbness of an arm or leg...

Read All Potential Side Effects and See Pictures of Seasonique

What are the precautions when taking levonorgestrel, ethinyl estradiol (Seasonique)?

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.

This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, cancer (especially endometrial and breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of...

Read All Potential Precautions of Seasonique


Seasonique Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort/irritation, increased vaginal fluids, or breast tenderness/enlargement may occur. Acne may improve or get worse. Vaginal bleeding between periods (spotting) may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor promptly.

You should not have your period during the 3 months that you are taking the combination pills. Instead, you will have your period once every 3 months during the week that you are taking the estrogen-only pills. This effect is normal with this product. However, if you do not have your period while taking the estrogen-only pills, 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods while taking the estrogen-only pills), problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling of the ankles/feet/hands, weight changes (gain or loss).

This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), unusual tiredness, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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.

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.

This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, cancer (especially endometrial and breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart disease (e.g., heart attack, chest pain), heart valve disease, liver problems (e.g., liver tumor, active liver disease), current or suspected pregnancy, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, unexplained vaginal bleeding, heavy tobacco use (especially if 35 or over).

Before using this product, tell your doctor your medical history, especially of: high blood pressure, high cholesterol or triglyceride (blood fat) levels, depression, diabetes, swelling (edema), gallbladder problems, kidney disease, migraine, obesity, irregular/missed/very light periods, recent pregnancy, thyroid problems.

Do not smoke cigarettes or use tobacco. Hormonal birth control (e.g., pills, injections, devices) combined with smoking significantly increases your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. For more details, ask your doctor or pharmacist, or consult the Patient Information Leaflet that comes with this product.

If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and of any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions.

This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a 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 have regular periods or become pregnant after you stop taking birth control pills. Consult your doctor.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. 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 passes into breast milk. This may affect how much milk you make and may also have undesirable effects on the nursing infant. Consult your doctor before breast-feeding.


Seasonique Patient Information Including Side Effects

Brand Names: Preven EC, Seasonique

Generic Name: ethinyl estradiol and levonorgestrel (EC) (Pronunciation: ETH ih nill ess tra DYE all and lee voe nor JESS trell)

  • What is ethinyl estradiol and levonorgestrel (EC) (Seasonique)?
  • What are the possible side effects of ethinyl estradiol and levonorgestrel (EC) (Seasonique)?
  • What is the most important information I should know about ethinyl estradiol and levonorgestrel (EC) (Seasonique)?
  • What should I discuss with my healthcare provider before using ethinyl estradiol and levonorgestrel (EC) (Seasonique)?
  • How should I take ethinyl estradiol and levonorgestrel (EC) (Seasonique)?
  • What happens if I miss a dose (Seasonique)?
  • What happens if I overdose (Seasonique)?
  • What should I avoid while taking ethinyl estradiol and levonorgestrel (EC) (Seasonique)?
  • What other drugs will affect ethinyl estradiol and levonorgestrel (EC) (Seasonique)?
  • Where can I get more information?

What is ethinyl estradiol and levonorgestrel (EC) (Seasonique)?

Ethinyl estradiol and levonorgestrel are forms of estrogen and progesterone, which are both female hormones involved in conception.

Ethinyl estradiol and levonorgestrel are used together in this product as an emergency contraceptive (EC) to prevent pregnancy after contraceptive failure or unprotected intercourse. Ethinyl estradiol and levonorgestrel prevent ovulation (the release of an egg from an ovary), disrupt fertilization (joining of the egg and sperm), and inhibit implantation (attachment of a fertilized egg to the uterus).

Ethinyl estradiol and levonorgestrel (EC) may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ethinyl estradiol and levonorgestrel (EC) (Seasonique)?

If you experience any of the following serious side effects, stop taking ethinyl estradiol and levonorgestrel (EC) and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • sudden shortness of breath, sudden pain or heaviness in the chest, or coughing up blood (possible heart attack or blood clot in the lung);
  • pain, redness, swelling, or numbness of an arm or leg (possible blood clot in an arm or leg);
  • severe headache, sudden difficulty seeing or speaking, dizziness, weakness, numbness, or fainting;
  • severe pain or tenderness in the stomach area; or
  • liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).

Other, less serious side effects may be more likely to occur. Continue to take ethinyl estradiol and levonorgestrel (EC) and talk to your doctor if you experience

  • headache or mild dizziness;
  • nausea or vomiting;
  • changes in menstrual bleeding (spotting, earlier or later menstrual period, heavier or lighter menstrual bleeding, longer or shorter menstrual period); or
  • breast tenderness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What is the most important information I should know about ethinyl estradiol and levonorgestrel (EC) (Seasonique)?

The first dose of ethinyl estradiol and levonorgestrel (EC) must be taken as soon as possible and within 72 hours of having unprotected sex, and the second dose 12 hours following the first, to be effective.

Ethinyl estradiol and levonorgestrel (EC) does not protect you from sexually transmitted diseases--including HIV and AIDS.

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