NATAZIA- estradiol valerate and estradiol valerate/dienogest kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTRADIOL VALERATE (UNII: OKG364O896) (ESTRADIOL VALERATE - UNII:OKG364O896)

Available from:

Physicians Total Care, Inc.

INN (International Name):

ESTRADIOL VALERATE

Composition:

ESTRADIOL VALERATE 3 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Natazia™ is indicated for use by women to prevent pregnancy. The efficacy of Natazia in women with a body mass index (BMI) of > 30 kg/m2 has not been evaluated. Do not prescribe Natazia to women who are known to have the following: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1 )] Have cerebrovascular disease [see Warnings and Precautions (5.1 )] Have coronary artery disease [see Warnings and Precautions (5.1 )] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1 )] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1 )] Have uncontrolled hypertension [see Warnings and Precautions (5.

Product summary:

Enter section text here Natazia (estradiol valerate and estradiol valerate/dienogest) tablets are available in 28 tablets per blister packs (NDC 54868-6183-0). The active and inert film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with the letters DD or DJ or DH or DN or DT. Each blister pack (28 film-coated tablets) contains in the following order: Keep out of reach of children. Store at 25º C (77º F); excursions permitted to 15–30o C (59–86o F) [see USP Controlled Room Temperature] .

Authorization status:

New Drug Application

Summary of Product characteristics

NATAZIA - ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NATAZIA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NATAZIA. NATAZIA (ESTRADIOL VALERATE AND
ESTRADIOL VALERATE/DIENOGEST) TABLETS FOR
ORAL USE INITIAL U.S. APPROVAL: 2010
WARNING: CIGARETTE SMOKING AND
SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
Women who are over 35 years old and smoke should not use Natazia.
Cigarette smoking increases the risk of serious cardiovascular events
from combination oral contraceptive (COC)
use .
INDICATIONS AND USAGE
Natazia is an estrogen/progestin COC indicated for use by women to
prevent pregnancy. (1)
The efficacy of Natazia in women with a body mass index (BMI) of
>30 kg/m has not been evaluated. (1, 8.8)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.1)
Tablets must be taken in the order directed on the blister pack. (2.1)
Do not skip or delay intake by more than 12 hours. (2.1)
DOSAGE FORMS AND STRENGTHS
Natazia consists of 28 film-coated, unscored tablets in the following
order:
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 valerate and 3
mg dienogest
2 dark red tablets each containing 1 mg estradiol valerate
2 white tablets (inert) (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal genital bleeding (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Pregnancy (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop Natazia if a thrombotic event occurs. Stop
Natazia at least 4 weeks before and through 2 weeks
after major surgery. Start Natazia no earlier than 4 weeks after
delivery, in women who are not breastfeeding. (5.1)
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