July 27, 2015
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Ortho Tri-Cyclen

"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...

Ortho Tri-Cyclen / Ortho-Cyclen

ORTHO-CYCLEN® and ORTHO TRI-CYCLEN®
(norgestimate/ethinyl estradiol)




WARNING

CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS].

DRUG DESCRIPTION

Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol).

ORTHO-CYCLEN

  • Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include carnauba wax, croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water, and titanium dioxide.
  • Each dark green placebo tablet containing only inert ingredients, as follows: FD & C Blue No. 2 Aluminum Lake, ferric oxide, lactose, magnesium stearate, polyethylene glycol, pregelatinized corn starch, purified water, polyvinyl alcohol, talc, and titanium dioxide.

ORTHO TRI-CYCLEN

  • Each active white tablet contains 0.180 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, purified water, and titanium dioxide.
  • Each active light blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include carnauba wax, croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, purified water, and titanium dioxide.
  • Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include carnauba wax, croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water, and titanium dioxide.
  • Each dark green placebo tablet contains only inert ingredients, as follows: FD & C Blue No. 2 Aluminum Lake, ferric oxide, lactose, magnesium stearate, polyethylene glycol, pregelatinized corn starch, purified water, polyvinyl alcohol, talc, and titanium dioxide.

ORTHO-CYCLEN® and ORTHO TRI-CYCLEN® (norgestimate/ethinyl estradiol) Structural Formula Illustration

What are the possible side effects of birth control pills?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden and severe headache, confusion, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden cough, wheezing, rapid...

Read All Potential Side Effects and See Pictures of Ortho Tri-Cyclen / Ortho-Cyclen »

Last reviewed on RxList: 5/15/2015
This monograph has been modified to include the generic and brand name in many instances.

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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