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 - UNII:4TI98Z838E)

Available from:

Sandoz Inc

INN (International Name):

ESTRADIOL VALERATE

Composition:

ESTRADIOL VALERATE 3 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol Valerate and Estradiol Valerate/Dienogest is indicated for use by women to prevent pregnancy. The efficacy of Estradiol Valerate and Estradiol Valerate/Dienogest in women with a body mass index (BMI) of > 30 kg/m2 has not been evaluated. Estradiol Valerate and Estradiol Valerate/Dienogest is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see Clinical Studies (14.2)]. Do not prescribe Estradiol Valerate and Estradiol Valerate/Dienogest to women who are known to have the following: There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce w

Product summary:

Estradiol Valerate and Estradiol Valerate/Dienogest tablets are available in packages of three blister packs (NDC 50419-409-03). 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: 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 Authorized Generic

Summary of Product characteristics

ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST- ESTRADIOL
VALERATE
AND ESTRADIOL VALERATE/DIENOGEST
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL VALERATE AND ESTRADIOL
VALERATE/DIENOGEST TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ESTRADIOL
VALERATE AND ESTRADIOL VALERATE/DIENOGEST.
ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTTABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 2010
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Estradiol Valerate and Estradiol Valerate/Dienogest consists of 28
film-coated, unscored tablets in the following order (3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE ESTRADIOL VALERATE
AND ESTRADIOL
VALERATE/DIENOGEST . (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE. (4)
Estradiol Valerate and Estradiol Valerate/Dienogest is an
estrogen/progestin COC indicated for use by women to
prevent pregnancy. (1)
Treatment of heavy menstrual bleeding in women without organic
pathology who choose to use an oral contraceptive
as their method of contraception. (1.2)
The efficacy of Estradiol Valerate and Estradiol Valerate/Dienogest in
women with a body mass index (BMI) of
>30 kg/m has not been evaluated. (1, 8.8)
2
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)
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 ta