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(estradiol valerate and estradiol valerate/dienogest)
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]
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:
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:
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,...
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 estrogens (such as mestranol) or any progestins (such as 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.
Before using this product, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels,...
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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