Estradiol valerate and estradiol valerate/dienogest

{{DrugProjectFormSinglePage |authorTag=Adeel Jamil, M.D. [1] |genericName=Estradiol Valerate and Estradiol Valerate/Dienogest |aOrAn=a |drugClass=Contraceptive, Estrogen, Hormonal Contraceptive |indicationType=treatment |hasBlackBoxWarning=Yes |adverseReactions=* Headaches, irregular uterine bleeding,headache (including migraines), breast tenderness, pain, menstrual disorders, nausea/ or vomiting,, acne, mood changes and increased weight. |blackBoxWarningTitle=WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS |blackBoxWarningBody=* 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.

|fdaLIADAdult======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.

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

|offLabelAdultGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of {{Estradiol Valerate and Estradiol Valerate/Dienogest} in adult patients.

|offLabelAdultNoGuideSupport=There is limited information regarding Off-Label Non–Guideline-Supported Use of Template:Estradiol Valerate and Estradiol Valerate/Dienogest in adult patients.

|fdaLIADPed======Condition1=====

• Dosing Information

• Dosage

Condition2

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

|offLabelPedGuideSupport======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.

|offLabelPedNoGuideSupport======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=* Description

Precautions

• Description

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

Miscellaneous

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

Miscellaneous

|drugInteractions=* Drug

• Description

|useInPregnancyFDA=* Pregnancy Category |useInPregnancyAUS=* 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. |useInLaborDelivery=There is no FDA guidance on use of Estradiol valerate and estradiol valerate/dienogest during labor and delivery. |useInNursing=There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to nursing mothers. |useInPed=There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to pediatric patients. |useInGeri=There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to geriatric patients. |useInGender=There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to specific gender populations. |useInRace=There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to specific racial populations. |useInRenalImpair=There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest in patients with renal impairment. |useInHepaticImpair=There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest in patients with hepatic impairment. |useInReproPotential=There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest in women of reproductive potentials and males. |useInImmunocomp=There is no FDA guidance one the use of Estradiol valerate and estradiol valerate/dienogest in patients who are immunocompromised.

|administration=* Oral

• Intravenous

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

• Description

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

|overdose====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.

|drugBox= |mechAction=*

|structure=*

File:Estradiol valerate and estradiol valerate/dienogest01.png

This image is provided by the National Library of Medicine.

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

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

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

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

|howSupplied=*

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

|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.

|brandNames=* ®

|lookAlike=* A® — B®

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