Estradiol Valerate And Estradiol Valerate/dienogest Kit

Estradiol Valerate And Estradiol Valerate/dienogest Kit

Estradiol Valerate And Estradiol Valerate/dienogest Kit Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Oral Contraception

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.

1.2 Heavy Menstrual Bleeding

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)].

History

There is currently no drug history available for this drug.

Other Information

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 valerate and 3 mg dienogest
2 dark red tablets each containing 1 mg estradiol valerate
2 white tablets (inert)

Estradiol Valerate and Estradiol Valerate/Dienogest also contains the excipients lactose monohydrate, maize starch, maize starch pre-gelatinized, povidone 25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide, and ferric oxide pigment, yellow, or ferric oxide pigment, red.

The empirical formula of estradiol valerate is C23 H32 O3 and the chemical structure is:

EV Chem Struc

Estradiol Valerate

Estradiol Valerate

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

The empirical formula of dienogest is C20 H25 NO2 and the chemical structure is:

Dien Chem Struc

Dienogest

Dienogest

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

Estradiol Valerate And Estradiol Valerate/dienogest Kit Manufacturers


  • Sandoz Inc
    Estradiol Valerate And Estradiol Valerate/dienogest Kit [Sandoz Inc]

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