Desogen

DRUG DESCRIPTION

Desogen® (desogestrel and ethinyl estradiol tablets) (desogestrel and ethinyl estradiol) Tablets provide an oral contraceptive
regimen of 21 white round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17
alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5
(10)-trien-20-yne-3,17-diol). Inactive ingredients include vitamin E, corn starch,
povidone, stearic acid, colloidal silicon dioxide, lactose, hydroxypropyl methyl-cellulose,
polyethylene glycol, titanium dioxide, and talc. Desogen® (desogestrel and ethinyl estradiol tablets) also contains
7 green round tablets containing the following inactive ingredients: lactose,
corn starch, magnesium stearate, FD&C Blue No. 2 aluminum lake, ferric oxide,
hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, and talc.
The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.41,
respectively. The structural formulas are as follows:

What are the possible side effects of ethinyl estradiol and desogestrel?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;


• sudden headache, confusion, problems with vision, speech, or balance;


• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill...

Read All Potential Side Effects and See Pictures of Desogen »

What are the precautions when taking desogestrel and ethinyl estradiol tablets (Desogen)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or desogestrel; or to any other estrogen or progestin; 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 or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart...

Read All Potential Precautions of Desogen »

Desogen 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) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, notify your doctor 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.

Tell your doctor immediately if any of these serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods), problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling of the ankles/feet, 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 desogestrel; or to any other estrogen or progestin; 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 or 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 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 milk production and may have harmful effects on a nursing infant. Consult your doctor before breast-feeding.

Desogen Patient Information Including Side Effects

Brand Names: Apri, Cesia, Cyclessa, Desogen, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet

Generic Name: ethinyl estradiol and desogestrel (Pronunciation: EH thih nill ess tra DYE ole and des oh JESS trel)

• What is ethinyl estradiol and desogestrel (Desogen)?


• What are the possible side effects of ethinyl estradiol and desogestrel?


• What is the most important information I should know about ethinyl estradiol and desogestrel?


• What should I discuss with my healthcare provider before taking ethinyl estradiol and desogestrel?


• How should I take ethinyl estradiol and desogestrel?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while taking ethinyl estradiol and desogestrel?


• What other drugs will affect ethinyl estradiol and desogestrel?


• Where can I get more information?

What is ethinyl estradiol and desogestrel (Desogen)?

Ethinyl estradiol and desogestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and desogestrel are used as contraception to prevent pregnancy.

Ethinyl estradiol and desogestrel may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ethinyl estradiol and desogestrel?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;


• sudden headache, confusion, problems with vision, speech, or balance;


• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;


• a change in the pattern or severity of migraine headaches;


• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);


• swelling in your hands, ankles, or feet;


• a breast lump; or


• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;


• breast pain, tenderness, or swelling;


• freckles or darkening of facial skin;


• increased hair growth, loss of scalp hair;


• changes in weight or appetite;


• problems with contact lenses;


• vaginal itching or discharge;


• changes in your menstrual periods, decreased sex drive; or


• headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ethinyl estradiol and desogestrel?

Do not use birth control pills if you are pregnant or if you have recently had a baby.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

Related Drug Centers

• Kariva


• Desogen


• Apri


• Cyclessa


• Mircette