Norgestimate/ethinyl estradiol

Oral Contraception

ORTHO TRI-CYCLEN Lo Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies].

Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Your pharmacist can provide more information about ethinyl estradiol and norgestimate.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Norgestimate & Ethinyl Estradiol may be found in some form under the following brand names:

• Estarylla

• MonoNessa

• Ortho Tri-Cyclen

• Ortho Tri-Cyclen Lo

• Ortho-Cyclen

• Previfem

• Sprintec

• Tri-Estarylla

• Tri-Previfem

• Tri-Sprintec

• TriNessa

Norgestimate & Ethinyl Estradiol is part of the drug class:

• Combination Progesterone and Estrogen Contraceptives

Serious side effects have been reported with norgestimate/ethinyl estradiol. See the "Norgestimate & Ethinyl Estradiol Precautions" section.

Common side effects of norgestimate/ethinyl estradiol include:

• nausea
• vomiting
• diarrhea
• constipation
• gingivitis
• changes in appetite
• brown or black patches on skin
• acne
• unusual hair growth
• spotting or bleeding between menstrual periods
• changes in menstrual flow
• painful or missed periods
• swelling of the fingers or ankles
• breast tenderness, enlargement, or discharge
• vaginal discharge
• swelling or irritation of the vagina
• weight changes
• difficulty wearing contact lenses

​This is not a complete list of norgestimate/ethinyl estradiol side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Norgestimate/ethinyl estradiol falls into category X. This medication should not be used during pregnancy as it has the potential to cause miscarriage.

Take norgestimate/ethinyl estradiol exactly as prescribed.

Norgestimate/ethinyl estradiol comes in a blister card and tablet dispenser containing 28 tablets: 21 "active" tablets (white, light blue, and blue) and 7 "reminder" tablets (green). One tablet should be taken by mouth at the same time daily. It can be taken with or without food. The tablets are taken in the order shown on the packaging, starting with the first white pill on the first day of menstruation. When all 28 tablets have been taken, a new package should be started the following day.

When starting norgestimate/ethinyl estradiol, use another method of birth control for at least the first 7 days of using norgestimate/ethinyl estradiol.

If you miss an active tablet during weeks 1, 2, or 3, the tablet should be taken as soon as you remember. If you miss 2 active tablets in a row during week 1 or week 2, you should take 2 tablets the day you remember and 2 tablets the next day, and then continue taking one tablet daily. If you miss 2 active tablets in a row during week 3 or miss 3 or more active tablets in a row, you should throw away the rest of the pack and start a new pack that same day. You should use a back-up method of birth control if you have sex in the 7 days after missing a dose.

If you miss any of the 7 reminder tablets during week 4, throw away the pill you missed and continue taking 1 pill each day until the pack is empty.

Take norgestimate/ethinyl estradiol exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Norgestimate/ethinyl estradiol comes in a blister card containing 28 tablets:

• 7 white tablets containing 0.180 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 light blue tablets containing 0.215 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 blue tablets containing 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 green tablets containing no active drug

Norgestimate/ethinyl estradiol also comes in a blister card containing 28 tablets:

• 21 blue tablets containing 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 green tablets containing no active drug

One tablet should be taken by mouth at the same time each day in the order indicated on the packaging.