Brand Name

Demulen { Pfizer}

Generic Name

ethinyl estradiol and ethynodiol, pronounced ETH-in-il ess-trah-DYE-ole and e-thye-noe-DYE-ole

What is Demulen?

Demulen is a birth control medication containing estrogen and progestin that is used to prevent pregnancy.

Demulen may also be used for purposes not described in this medication guide.

Key Facts About Demulen

Some drugs may make Demulen less effective in preventing a pregnancy, including antibiotics, hepatitis C medications, HIV/AIDS medications, seizure medications, or barbiturate sedatives. You should tell your doctor about all of the other medications you take.

Demulen does not protect you from sexually transmitted diseases, including HIV and AIDS. The only way to prevent these diseases is to use a condom. If your sexual partner develops HIV or a sexually transmitted disease while you are using Demulen, or if you have any change in sexual relationships you should tell your doctor right away.

You may need to use back up birth control, like a condom, when you first start using Demulen or if you miss a dose.

Demulen is in Pregnancy category X. If you are pregnant, think you may be pregnant, or are breastfeeding you should not use Demulen. We do not know if Demulen may harm your baby in utero. Demulen can pass into breast milk and may harm a nursing baby, and it may also slow breast milk production. You should not use Demulen if you are breast feeding a baby.

Before You Take Demulen

If you are allergic to ethinyl estradiol or ethynodiol you should not use Demulen.

If you have a history of uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems or a previous heart attack, stroke or blood clot caused by a birth control pill you should not use Demulen.

Do not use Demulen if you are pregnant or if you have recently had a baby.

If you have had diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches or if you have ever had breast or uterine cancer you may not be a candidate for a Demulen.

Tell your doctor if you have severe migraine headaches (with aura, numbness, weakness, or vision changes), jaundice caused by pregnancy or birth control pills, diabetes, an underactive thyroid or gallbladder disease before using Demulen.

Tell your doctor before starting treatment with Demulen if you have depression, seizures or epilepsy, tuberculosis, a history of irregular menstrual cycles, toxic shock syndrome, or easy vaginal irritation.

If you are a heavy smoker and smoke 15 or more cigarettes a day you should not use Demulen.

If you smoke and are over age 35 you should tell your doctor, as Demulen may not be safe for you to take.

Let your doctor know if you have a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram before using Demulen.

If you have varicose veins, high cholesterol or triglycerides or if you are overweight inform your doctor before beginning treatment with Demulen.

Demulen Drug Interactions

You should inform your doctor if you are taking any of the following:

• AIDS or HIV drugs
• antibiotics
• antifungal medications
• beta-blockers (Atenolol)
• lamotrigine
• phenobarbital and other barbiturates
• seizure medications
• St. John’s wart
• topiramate
• tuberculosis medication

Other drugs you take that are not listed may interact with Demulen. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Using Demulen

Use Demulen exactly as your doctor has prescribed you to. Do not use it in larger or smaller amounts or for shorter or longer than recommended. Demulen comes with patient instructions for you so you can use this medication safely and effectively. Be sure to follow these instructions carefully.

You will take your first Demulen pill on the first day of your period, or on the first Sunday after your period begins. You may need to use back-up birth control, like a condom, when you first start using Demulen.

You should take one Demulen pill every day, but no more than 24 hours apart. Be sure to get your prescription refilled before you run out of Demulen.

If you miss 1 dose of Demulen you should take it as soon as you remember and then take your next dose at the regular time. This means you may take 2 doses on the same day. If you only miss 1 pill you do not need to use backup birth control, like a condom. If you miss more than 1 active dose of Demulen you should read the extra patient leaflet that comes with your prescription or contact your doctor for instructions. You will need to use a backup method of birth control if you miss more than 1 active dose of Demulen.

The Demulen 28 day birth control pack will contain 7 “reminder” pills to keep you on your regular cycle. Your menstrual cycle will normally begin while you are using these “reminder” pills. You will begin taking your next pack of Demulen pills the day after you have finished your last “reminder” pill, regardless of whether your menstrual cycle has stopped or not.

If you miss one of the 7 “reminder” pills, it is fine. Continue taking one pill a day on your schedule, but throw out the “reminder” pill that you missed to avoid confusion. You do not have to use back-up birth control if you miss a reminder pill.

It is normal to experience breakthrough bleeding, especially during the first 3 months of treatment with Demulen. Tell your doctor if you have bleeding that is heavy or continues daily throughout the month.

If you become ill with severe vomiting or diarrhea you should use back-up birth control.

Store Demulen at room temperature and away from both moisture and heat.

Demulen Side Effects

Contact your doctor at once if you have a serious side effect such as:

• allergic reaction including breathing difficulties, hives and swelling of your face, lips, throat or tongue
• breast lump
• chest pain or a heavy feeling with pain spreading to your arm or shoulder, nausea, sweating and a general ill feeling
• depression symptoms
• headache that is severe or sudden
• jaundice or a yellowing of your skin or eyes
• nausea and upper stomach pain
• numbness and weakness that is sudden, or on one side of your body
• pain and swelling, warmth, or redness in one or both legs
• pattern or severity change in migraine headaches
• swelling in your hands, ankles or feet
• urine which is very dark
• wheezing and cough along with rapid breathing and coughing up blood

Less serious side Demulen effects may include:

• appetite and weight changes
• bloating
• breast pain, tenderness and swelling, possibly nipple discharge
• contact lens problems
• darkening of facial skin
• decreased libido
• dizziness
• freckles
• hair growth that is increased
• mild headache
• loss of scalp hair
• mild nausea
• nervousness
• stomach cramps
• feeling tired
• vaginal discharge or itching
• vomiting

It should be noted that this is not a complete list of possible side effects of Demulen. You should contact your physician for a complete list and medical advice regarding these effects.

Demulen Description and Dosing

Demulen 30 is available in blister packs of either 21 film-coated tablets or 28 film-coated tablets, which are white, circular, biconvex and impressed with “SEARLE” over “930”on one side. The 28 day blister pack contains 7 inert pills which are peach-colored and impressed with “SEARLE” on one side and “P” on the other side.

If you believe that you have overdosed on Demulen you should seek emergency medical help immediately.

Ingredients in Demulen

Demulen is comprised of the main ingredients ethynodiol diacetate 2 mg and ethinyl estradiol 0.03 mg. Other inactive ingredients are cornstarch, ethylcellulose, hydroxypropyl cellulose, lactose, magnesium stearate, polyvidone, sodium acid phosphate, sodium phosphate dibasic anhydrous, and titanium dioxide. The 28 day pack may include the following inactive ingredients in the placebo or inert pills: FD&C Yellow No. 6 Lake, lactose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

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