Ethinyl estradiol and norgestimate

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop taking this medicine and tell your doctor if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure;

• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);

• chest pain;

• unusual vaginal bleeding that has not been checked by a doctor;

• problems with your eyes, kidneys or circulation caused by diabetes;

• a history of hormone-related cancer such as breast or uterine cancer;

• liver cancer;

• a history of jaundice caused by pregnancy or birth control pills; or

• severe migraine headaches (with aura, numbness, weakness, or vision changes).

To make sure birth control pills are safe for you, tell your doctor if you have:

• heart disease, high blood pressure;

• high cholesterol or triglycerides;

• a history of depression;

• gallbladder disease;

• liver or kidney disease;

• diabetes;

• seizures or epilepsy;

• a history of irregular menstrual cycles; or

• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast feeding a baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Coughing up blood.
• Shortness of breath.
• Chest pain or pressure.
• Very bad dizziness or passing out.
• Very upset stomach or throwing up.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Low mood (depression).
• Mood changes.
• Feeling very tired or weak.
• Very bad belly pain.
• Swelling.
• Not able to pass urine or change in how much urine is passed.
• A lump in the breast, breast soreness, or nipple discharge.
• Vaginal itching or discharge.
• Spotting or vaginal bleeding that is very bad or does not go away.
• Bulging eyes.
• Change in eyesight.
• Change in how contact lenses feel in the eyes.

• Ethinyl Estradiol and NGM
• Norgestimate and Ethinyl Estradiol
• Ortho Cyclen
• Ortho Tri Cyclen

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, oral [monophasic formulation]:

Estarylla: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [21 blue tablets and 7 green inactive tablets] (28s)

Femynor: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [21 red tablets and 7 white inactive tablets] (28s)

MonoNessa, Ortho-Cyclen: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [21 blue tablets and 7 dark green inactive tablets] (28s)

Previfem: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [21 blue tablets and 7 light green inactive tablets] (28s)

Mono-Linya, Sprintec: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [21 blue tablets and 7 white inactive tablets] (28s)

Tablet, oral [triphasic formulation]:

Ortho Tri-Cyclen:

Day 1 to 7: Ethinyl estradiol 0.035 mg and norgestimate 0.18 mg [7 white tablets]

Day 8 to 14: Ethinyl estradiol 0.035 mg and norgestimate 0.215 mg [7 light blue tablets]

Day 15 to 21: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [7 blue tablets]

Day 22 to 28: 7 dark green inactive tablets (28s)

Ortho Tri-Cyclen Lo:

Day 1 to 7: Ethinyl estradiol 0.025 mg and norgestimate 0.18 mg [7 white tablets]

Day 8 to 14: Ethinyl estradiol 0.025 mg and norgestimate 0.215 mg [7 light blue tablets]

Day 15 to 21: Ethinyl estradiol 0.025 mg and norgestimate 0.25 mg [7 dark blue tablets]

Day 22 to 28: 7 dark green inactive tablets (28s)

Tri-Estarylla:

Day 1 to 7: Ethinyl estradiol 0.035 mg and norgestimate 0.18 mg [7 white tablets]

Day 8 to 14: Ethinyl estradiol 0.035 mg and norgestimate 0.215 mg [7 light blue tablets]

Day 15 to 21: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [7 blue tablets]

Day 22 to 28: 7 green inactive tablets (28s)

Tri Femynor:

Day 1 to 7: Ethinyl estradiol 0.035 mg and norgestimate 0.18 mg [7 light pink tablets]

Day 8 to 14: Ethinyl estradiol 0.035 mg and norgestimate 0.215 mg [7 light red tablets]

Day 15 to 21: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [7 red tablets]

Day 22 to 28: 7 white inactive tablets (28s)

Tri-Linyah:

Day 1 to 7: Ethinyl estradiol 0.035 mg and norgestimate 0.18 mg [7 green tablets]

Day 8 to 14: Ethinyl estradiol 0.035 mg and norgestimate 0.215 mg [7 light blue tablets]

Day 15 to 21: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [7 blue tablets]

Day 22 to 28: 7 white inactive tablets (28s)

Tri-Lo-Estarylla:

Day 1 to 7: Ethinyl estradiol 0.025 mg and norgestimate 0.18 mg [7 white tablets]

Day 8 to 14: Ethinyl estradiol 0.025 mg and norgestimate 0.215 mg [7 light blue tablets]

Day 15 to 21: Ethinyl estradiol 0.025 mg and norgestimate 0.25 mg [7 blue tablets]

Day 22 to 28: 7 green inactive tablets (28s)

Tri-Lo-Marzia:

Day 1 to 7: Ethinyl estradiol 0.025 mg and norgestimate 0.18 mg [7 white tablets]

Day 8 to 14: Ethinyl estradiol 0.025 mg and norgestimate 0.215 mg [7 light yellow tablets]

Day 15 to 21: Ethinyl estradiol 0.025 mg and norgestimate 0.25 mg [7 yellow tablets]

Day 22 to 28: 7 green inactive tablets (28s)

Tri-Lo-Sprintec:

Day 1 to 7: Ethinyl estradiol 0.025 mg and norgestimate 0.18 mg [7 gray tablets]

Day 8 to 14: Ethinyl estradiol 0.025 mg and norgestimate 0.215 mg [7 light blue tablets]

Day 15 to 21: Ethinyl estradiol 0.025 mg and norgestimate 0.25 mg [7 blue tablets]

Day 22 to 28: 7 white inactive tablets (28s)

Tri-Previfem:

Day 1 to 7: Ethinyl estradiol 0.035 mg and norgestimate 0.18 mg [7 white tablets]

Day 8 to 14: Ethinyl estradiol 0.035 mg and norgestimate 0.215 mg [7 light blue tablets]

Day 15 to 21: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [7 blue tablets]

Day 22 to 28: 7 light green inactive tablets (28s)

Tri-Sprintec:

Day 1 to 7: Ethinyl estradiol 0.035 mg and norgestimate 0.18 mg [7 gray tablets]

Day 8 to 14: Ethinyl estradiol 0.035 mg and norgestimate 0.215 mg [7 light blue tablets]

Day 15 to 21: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [7 blue tablets]

Day 22 to 28: 7 white inactive tablets (28s)

TriNessa:

Day 1 to 7: Ethinyl estradiol 0.035 mg and norgestimate 0.18 mg [7 white tablets]

Day 8 to 14: Ethinyl estradiol 0.035 mg and norgestimate 0.215 mg [7 light blue tablets]

Day 15 to 21: Ethinyl estradiol 0.035 mg and norgestimate 0.25 mg [7 blue tablets]

Day 22 to 28: 7 dark green inactive tablets (28s)

TriNessa Lo:

Day 1 to 7: Ethinyl estradiol 0.025 mg and norgestimate 0.18 mg [7 white tablets]

Day 8 to 14: Ethinyl estradiol 0.025 mg and norgestimate 0.215 mg [7 light blue tablets]

Day 15 to 21: Ethinyl estradiol 0.025 mg and norgestimate 0.25 mg [7 blue tablets]

Day 22 to 28: 7 dark green inactive tablets (28s)

Acne vulgaris: Treatment of moderate acne vulgaris in females at least 15 years of age

Limitations of use: When used for acne, use only in females ≥15 years of age who achieved menarche, who also desire combination hormonal contraceptive therapy, and have no contraindications to combination hormonal contraceptive use

Contraception: Prevention of pregnancy.

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution and monitor blood pressure closely.

Applies to ethinyl estradiol / norgestimate: oral tablet

Along with its needed effects, ethinyl estradiol / norgestimate 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 while taking ethinyl estradiol / norgestimate:

• Abdominal or stomach pain
• absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fever
• headache
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• nausea and vomiting
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• sudden loss of coordination or slurred speech
• sudden onset of shortness of breath for no apparent reason
• sudden shortness of breath or troubled breathing
• sweating
• unusual tiredness or weakness
• vomiting of blood

Some side effects of ethinyl estradiol / norgestimate 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:

• Abdominal or stomach cramps
• bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside the genitals
• loss of interest or pleasure
• pain during sexual intercourse
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

Ethinyl estradiol-norgestimate products are packaged in 21 or 28 day dosage preparations. The last seven tablets in 28 day dosage preparations are hormonally inert.

Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1.)

Initiation of Oral Contraceptive Therapy

This product can be administered in two ways.

When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.

When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.

Many clinicians recommend that additional contraceptive methods be used during the first cycle of hormonal therapy in order to reduce the risk of unintended pregnancy.

Missed Doses

If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed.

If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed. (Additional contraceptive methods should be used for 7 days.)

If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun. (Additional contraceptive methods should be used until the woman has taken at least 7 days of hormonal therapy from the new package.)

Ethinyl estradiol-norgestimate products are packaged in 21 or 28 day dosage preparations. The last seven tablets in 28 day dosage preparations are hormonally inert.

Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1.)

This product can be administered in two ways.

When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.

When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.

Missed Doses

If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed.

If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed.

If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun.