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Tri-Sprintec

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Tri-Sprintec

Tri-Sprintec™
(norgestimate and ethinyl estradiol) Tablets-Triphasic Regimen

PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.

Tri-Sprintec

DRUG DESCRIPTION

Tri-Sprintec™ (norgestimate and ethinyl estradiol tablets-triphasic regimen) Tablets are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.

Each gray tablet contains 0.18 mg of the progestational compound, norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized starch

Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch.

Each blue tablet contains 0.25 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.

The structural formula is as follows:

Tri-Sprintec™
  (norgestimate and ethinyl estradiol)  Structural Formula Illustration

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

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 taking this medicine 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 severe headache, confusion, problems with vision, speech, or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • chest pain or...

Read All Potential Side Effects and See Pictures of Tri-Sprintec »

Last reviewed on RxList: 12/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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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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