FDA records indicate that there are no current recalls for this drug.
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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
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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 BleedingEstradiol 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:
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- 2 dark yellow tablets each containing 3 mg estradiol valerate
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- 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest
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- 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest
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- 2 dark red tablets each containing 1 mg estradiol valerate
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- 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:
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:
Dienogest
Dienogest
The chemical name of dienogest is (17α)-17-Hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile.
Sources
Estradiol Valerate And Estradiol Valerate/dienogest Kit Manufacturers
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Sandoz Inc
Estradiol Valerate And Estradiol Valerate/dienogest Kit | Jw Holdings
■ Do not take more than directed (see overdose warning)
■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day
■ do not take night time capsule in less than 6 hours after taking day time capsule
■ children under 15 years: do not use and ask a doctor.
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