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Natazia

"Nov. 20, 2012 -- Oral contraceptives should be made available without a prescription to reduce unintended pregnancies, according to a newly published opinion by the American College of Obstetricians and Gynecologists (ACOG).

Whether t"...

Natazia

NATAZIA
(estradiol valerate and estradiol valerate/dienogest)

WARNING

CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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 should not be used by women who are over 35 years of age and smoke. [See CONTRAINDICATIONS]

DRUG DESCRIPTION

Natazia (estradiol valerate and estradiol valerate/dienogest) tablets provide an oral contraceptive regimen consisting of 26 active film-coated tablets that contain the active ingredients specified for each tablet below, followed by two inert film-coated tablets:

  • 2 dark yellow tablets each containing 3 mg estradiol valerate
  • 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest
  • 17 light yellow tablets each containing 2 mg estradiol valer ate and 3 mg dienogest
  • 2 dark red tablets each containing 1 mg estradiol valerate
  • 2 white tablets (inert)

Natazia also contains the excipients lactose monohydrate, maize starch, maize starch pre-gelatinized, povidone 25, magnesium stearate, h ypromellose, macrogol 6000, talc, titanium dioxide, and ferric oxide pigment, yellow, or ferric oxide pigment, red. The empirical formula of estradiol valerate is C23H32O3 and the chemical structure is:

Estradiol Valerate

Estradiol valerate Structural Formula Illustration

The chemical name of estradiol valerate is Estra-1,3,5(10)-triene-3,17-diol(17β)-,17-pentanoate.

The empirical formula of dienogest is C20H25NO2 and the chemical structure is:

Dienogest

Dienogest Structural Formula Illustration

The chemical name of dienogest is (17α)-17-Hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile.

What are the possible side effects of dienogest and estradiol (Natazia)?

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 dienogest and estradiol 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,...

Read All Potential Side Effects and See Pictures of Natazia »

What are the precautions when taking estradiol valerate and estradiol valerate dienogest tablets (Natazia)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to estradiol or dienogest; or to any other estrogen or progestin; 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.

Before using this product, tell your doctor or pharmacist your medical history, especially of: personal or family history of stroke or other blood clots (such as in the legs, eyes, lungs), high blood pressure, cancer (especially endometrial or breast cancer), blood clotting disorders (such as protein C or protein S deficiency), history of heart disease (such as heart attack, chest pain, irregular heartbeat), heart valve...

Read All Potential Precautions of Natazia »

Last reviewed on RxList: 9/5/2013
This monograph has been modified to include the generic and brand name in many instances.

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Natazia - User Reviews

Natazia 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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