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Ortho-Novum

What are birth control pills and how do they work?

Birth control pills are also known as oral contraceptives (OCs) or, simply, “the pill.” They offer protection against pregnancy by blocking the union of sperm and egg, thereby preventing conception.

Oral contraceptives or birth control pills contain synthetic female hormones. They work largely by preventing the release of an egg from an ovary, or ovulation. If no egg is released, there can be no pregnancy.

Stopping ovulation is not the only way birth control pills can work. The progestin or synthetic progesterone in birth control pills also changes the physical and chemical environment of the female reproductive tract, making it hostile for sperm.

What are the different types of birth control pills?

The active ingredients in birth control pills are synthetic versions of the female hormones estrogen and progesterone. Combination oral contraceptives are birth control...

Ortho-Novum

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ORTHO-NOVUM®
(norethindrone/ethinyl estradiol) Tablets
and
MODICON®
(norethindrone/ethinyl estradiol) Tablets

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

DRUG DESCRIPTION

COMBINATION ORAL CONTRACEPTIVES

Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol.

ORTHO-NOVUM® (norethindrone and ethinyl estradiol) 7/7/7 Tablets: Each white tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include lactose, magnesium stearate and pregelatinized corn starch. Each light peach tablet contains 0.75 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Yellow No. 6, lactose, magnesium stearate and pregelatinized corn starch. Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Yellow No. 6, lactose, magnesium stearate and pregelatinized corn starch. Each green tablet contains only inert ingredients, as follows: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch.

ORTHO-NOVUM® (norethindrone and ethinyl estradiol) 1/35 Tablets: Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Yellow No. 6, lactose, magnesium stearate and pregelatinized corn starch. Each green tablet contains only inert ingredients, as listed under green tablets in ORTHO-NOVUM (norethindrone and ethinyl estradiol) 7/7/7.

MODICON®Tablets: Each white tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include lactose, magnesium stearate and pregelatinized corn starch. Each green tablet contains only inert ingredients, as listed under green tablets in ORTHO-NOVUM (norethindrone and ethinyl estradiol) 7/7/7.

The chemical name for norethindrone is 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, for ethinyl estradiol is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulas are as follows:

Norethindrone structural formula illustration Ethinyl estradiol structural formula illustration

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

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, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder,...

Read All Potential Side Effects and See Pictures of Ortho-Novum »

What are the precautions when taking norethindrone and ethinyl estradiol (Ortho-Novum)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to any estrogens (e.g., ethinyl estradiol, mestranol) or any progestins (e.g., norethindrone, desogestrel); 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,...

Read All Potential Precautions of Ortho-Novum »

Last reviewed on RxList: 12/28/2007
This monograph has been modified to include the generic and brand name in many instances.

Ortho-Novum - User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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