Estradiol valerate and estradiol valerate/dienogest

Estradiol valerate and estradiol valerate/dienogest
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Black Box Warning

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete Boxed Warning. * 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.

Overview

Estradiol valerate and estradiol valerate/dienogest is a Contraceptive, Estrogen, Hormonal Contraceptive that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include * Headaches, irregular uterine bleeding,headache (including migraines), breast tenderness, pain, menstrual disorders, nausea/ or vomiting,, acne, mood changes and increased weight..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Oral Contraception

• Estradiol valerate is indicated for use by women to prevent pregnancy.
• The efficacy of Estradiol valerate in women with a body mass index (BMI) of > 30 kg/m2 has not been evaluated.

Heavy Menstrual Bleeding

• Estradiol valerate 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.

How to Take Estradiol valerate

• To achieve maximum contraceptive effectiveness Estradiol valerate must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or intake delayed by more than 12 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling.

How to Start Estradiol valerate

• Instruct the patient to begin taking Estradiol valerate on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). See FDA-Approved Patient Labeling. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 9 days.

• For postpartum women who do not breastfeed or after a second trimester abortion, start Estradiol valerate no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Estradiol valerate postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Estradiol valerate for 9 consecutive days. The possibility of ovulation and conception prior to initiation of medication should also be considered.

• If the patient is switching from a combination hormonal method such as:

• Another pill
• Vaginal ring
• Patch

• Instruct her to take the first dark yellow pill on the first day of her withdrawal bleed. She should not continue taking the pills from her previous birth control pack. If she does not have a withdrawal bleed, rule out pregnancy before starting Estradiol valerate.
• If she previously used a vaginal ring or transdermal patch, she should start using Estradiol valerate on the day the ring or patch is removed.
• Instruct the patient to use a non-hormonal back-up method such as a condom or spermicide for the first 9 days.
• If the patient is switching from a progestin-only method such as a:

• Progestin-only pill
• Implant
• Intrauterine system
• Injection

• Instruct her to take the first dark yellow pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection.

I* nstruct the patient to use a non-hormonal back-up method such as a condom or spermicide for the first 9 days.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Estradiol valerate and estradiol valerate/dienogest in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Estradiol valerate and estradiol valerate/dienogest in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Estradiol valerate and estradiol valerate/dienogest in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Estradiol valerate and estradiol valerate/dienogest in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Estradiol valerate and estradiol valerate/dienogest in pediatric patients.

Contraindications

• Condition1

Warnings

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete Boxed Warning. * 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.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Estradiol valerate and estradiol valerate/dienogest in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Estradiol valerate and estradiol valerate/dienogest in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Estradiol valerate and estradiol valerate/dienogest in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Estradiol valerate and estradiol valerate/dienogest during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to specific gender populations.

Race

There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Estradiol valerate and estradiol valerate/dienogest in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Estradiol valerate and estradiol valerate/dienogest in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Estradiol valerate and estradiol valerate/dienogest in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Estradiol valerate and estradiol valerate/dienogest in the drug label.

Pharmacology

There is limited information regarding Estradiol valerate and estradiol valerate/dienogest Pharmacology in the drug label.

Mechanism of Action

Structure

File:Estradiol valerate and estradiol valerate/dienogest01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Estradiol valerate and estradiol valerate/dienogest in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Estradiol valerate and estradiol valerate/dienogest in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Estradiol valerate and estradiol valerate/dienogest in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Estradiol valerate and estradiol valerate/dienogest in the drug label.

How Supplied

Storage

There is limited information regarding Estradiol valerate and estradiol valerate/dienogest Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Estradiol valerate and estradiol valerate/dienogest in the drug label.

Precautions with Alcohol

• Alcohol-Estradiol valerate and estradiol valerate/dienogest interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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