Brand Name

Ortho Tri-Cyclen {Janssen}

Generic Name

ethinyl estradiol and norgestimate, pronounced ETH in ill ess tra DYE ol and nor JESS ti mate

What is Ortho Tri-Cyclen?

Ortho Tri-Cyclen is a birth control medication, used to prevent pregnancy. Ortho Tri-Cyclen is a combination medication which has female hormones that prevent ovulation and cause changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and also harder for a fertilized egg to attach to the uterus.

Ortho Tri-Cyclen may also be used for purposes not described in this medication guide.

Key Facts About Ortho Tri Cyclen

Some drugs may make Ortho Tri-Cyclen 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.

Ortho Tri-Cyclen 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 Ortho Tri Cyclen, 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 Ortho Tri-Cyclen or if you miss a dose.

Ortho Tri-Cyclen can pass into breast milk and may harm a nursing baby, and it may also slow breast milk production. You should not use Ortho Tri-Cyclen if you are breast feeding a baby.

If you are pregnant, think you may be pregnant, or are breast-feeding you should not use Ortho Tri Cyclen. The hormones in Ortho Tri-Cyclen can pass into breast milk and may harm a nursing baby. Ortho Tri-Cyclen may also slow down your breast milk production. Do not use Ortho Tri-Cyclen if you are breast-feeding.

Before You Take OrthoTri-Cyclen

If you are allergic to ethinyl estradiol or norgestimate you should not use Ortho Tri Cyclen.

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 Ortho Tri Cyclen.

Do not use Ortho Tri-Cyclen 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, if you smoke and are over 35, or if you have ever had breast or uterine cancer you may not be a candidate for Ortho Tri-Cyclen.

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 Ortho Tri-Cyclen.

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

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

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

Ortho Tri-Cyclen Drug Interactions

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

• AIDS or HIV drugs
• antibiotics
• barbiturates like phenobarbital (Solfoton)
• bosentan (Tracleer)
• dantrolene (Dantrium)
• hepatitis C drugs
• seizure medications
• St. John’s wort
• tizanidine (Zanaflex)
• tranexamic acid (Cyklokapron, Lysteda)
• tuberculosis medication

Other drugs you take that are not listed may interact with Ortho Tri Cyclen. 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 Ortho Tri-Cyclen

Use Ortho Tri-Cyclen exactly as your doctor has prescribed you to. Do not use it in larger or smaller amounts or for shorter or longer than recommended. Ortho Tri-Cyclen 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 Ortho Tri-Cyclen 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 Ortho Tri-Cyclen.

You should take one Ortho Tri-Cyclen pill every day, but no more than 24 hours apart. When the pills run out you should start a new pack the following day. You may get pregnant if you do not take one pill each day. Be sure to get your prescription refilled before you run out of Ortho Tri-Cyclen.

The 28 day birth control pack will contain 7 “reminder” pills. Your menstrual cycle will normally begin while you are using these “reminder” pills, which will help you stay on schedule.

It is normal to experience breakthrough bleeding, especially during the first 3 months of treatment with Ortho Tri-Cyclen. 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.

You should store Ortho Tri-Cyclen at room temperature away from moisture and heat.

If you miss one active Ortho Tri-Cyclen pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two active pills in a row in Week 1 or 2, you should take two pills per day, for two days in a row. Then you will take one pill per day for the rest of the pack. If this occurs you should use back-up birth control for at least 7 days following the missed pills.

If you miss two active pills in a row, in Week 3 you should throw out the rest of your current pack of Ortho Tri-Cyclen and start a new pack the same day, if you are a day 1 starter. If you normally start on a Sunday you should continue taking the pills until Sunday, and then throw out your old pack and begin a new one. Be sure to use back-up birth control during this time. You may not have a period during this month. However, if you miss a period for two months in a row you should call your doctor as that might be a sign that you are pregnant.

If you miss three active pills in a row in Week 1, 2, or 3, you should throw out the rest of your current pack of Ortho Tri-Cyclen and start a new pack the same day, if you are a day 1 starter. If you normally start on a Sunday you should continue taking the pills until Sunday, and then throw out your old pack and begin a new one. Be sure to use back-up birth control during this time. You may not have a period during this month. However, if you miss a period for two months in a row you should call your doctor as that might be a sign that you are pregnant.

If you miss any of the “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.

Ortho Tri-Cyclen 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
• clay colored stools
• 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 Ortho Tri-Cyclen 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
• headache (mild)
• loss of scalp hair
• nausea (mild)
• nervousness
• stomach cramps
• tired feeling
• vaginal discharge or itching
• vomiting

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

Ortho Tri-Cyclen Description and Dosing

Ortho Tri-Cyclen is available in a DIALPAK Tablet Dispenser containing 28 tablets.

The white tablets are round, biconvex, coated and imprinted with “O 180” on one side and “35” on the other side of the tablet. The light blue tablets are round, biconvex, coated and imprinted with “O 215” on one side and “35” on the other side of the tablet. The blue tablets are round, biconvex, coated and imprinted with “O 250” on one side and “35” on the other side of the tablet. Each dark green “reminder” pill is a round, biconvex, coated tablet, imprinted with “O-M” on one side and “P” on the other side.

Take Ortho Tri-Cyclen exactly as directed. If you believe that you have overdosed on Ortho Tri-Cyclen you should seek emergency medical help immediately.

Ingredients in OrthoTri-Cyclen

Ortho Tri-Cyclen contains the active ingredients ethinyl estradiol and norgestimate. Each white tablet also contains carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, purified water and titanium dioxide. Each light blue tablet contains the following inactive ingredients: FD & C Blue No. 2 Aluminum Lake, carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, purified water and titanium dioxide. Each blue tablet also contains FD & C Blue No. 2 Aluminum Lake, carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water and titanium dioxide. The dark green tablets contain only inert ingredients, as follows: FD & C Blue No. 2 Aluminum Lake, ferric oxide, hypromellose, lactose, magnesium stearate, polyethylene glycol, pregelatinized corn starch, purified water, talc and titanium dioxide.

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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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