|monitoring======Carbohydrate and Lipid Metabolic Effects=====
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Carefully monitor prediabetic and diabetic women who are taking Estradiol valerate and estradiol valerate/dienogest. COCs may decrease glucose tolerance in a dose-related fashion.
* Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
* Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
=====High Blood Pressure=====
* For women with well-controlled hypertension, monitor blood pressure and stop Estradiol valerate and estradiol valerate/dienogest if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.
* A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
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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 Acne, Weight increased, Nausea, Vomiting, Headache, Mood disorder, Bleeding between periods, Breast tenderness, Disorder of menstruation, Pain of breast..
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.
Instruct 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
There is limited information regarding Off-Label Guideline-Supported Use of Estradiol Valerate and Estradiol Valerate/Dienogest in adult patients.
Non–Guideline-Supported Use
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)
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
There is limited information regarding Off-Label Guideline-Supported Use of Estradiol Valerate and Estradiol Valerate/Dienogest in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Estradiol Valerate and Estradiol Valerate/Dienogest in pediatric patients.
Contraindications
Do not prescribe Estradiol Valerate and Estradiol Valerate/Dienogest to women who are known to have the following:
A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
Smoke, if over age 35.
Have deep vein thrombosis or pulmonary embolism, now or in the past.
Have cerebrovascular disease.
Have coronary artery disease.
Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation).
Have inherited or acquired hypercoagulopathies.
Have uncontrolled hypertension.
Have diabetes mellitus with vascular disease.
Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35.
Undiagnosed abnormal uterine bleeding.
Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.
Liver tumors, benign or malignant, or liver disease.
Pregnancy, because there is no reason to use COCs during pregnancy.
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.
Thromboembolic Disorders and Other Vascular Problems
Stop Estradiol Valerate and Estradiol Valerate/Dienogest if an arterial or venous thrombotic event (VTE) occurs.
The use of COCs increases the risk of venous thromboembolism. However, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.
Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.
The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.
If feasible, stop Estradiol Valerate and Estradiol Valerate/Dienogest at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.
Start Estradiol Valerate and Estradiol Valerate/Dienogest no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.
Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
Stop Estradiol Valerate and Estradiol Valerate/Dienogest if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
Carcinoma of the Breasts and Reproductive Organs
Women who currently have or have had breast cancer should not use Estradiol Valerate and Estradiol Valerate/Dienogest because breast cancer is a hormonally-sensitive tumor.
There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.
Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.
Endometrial biopsies performed in a subset of subjects in a Phase 3 Estradiol Valerate and Estradiol Valerate/Dienogest clinical trial did not reveal any unexpected or concerning findings for subjects taking COCs.
Liver Disease
Discontinue Estradiol Valerate and Estradiol Valerate/Dienogest if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded.
Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.
Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use.
High Blood Pressure
For women with well-controlled hypertension, monitor blood pressure and stop Estradiol Valerate and Estradiol Valerate/Dienogest if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.
Gallbladder Disease
Studies suggest a small increased relative risk of developing gallbladder disease among COC users.
Carbohydrate and Lipid Metabolic Effects
Carefully monitor prediabetic and diabetic women who are taking Estradiol Valerate and Estradiol Valerate/Dienogest. COCs may decrease glucose tolerance in a dose-related fashion.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
Headache
If a woman taking Estradiol Valerate and Estradiol Valerate/Dienogest develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Estradiol Valerate and Estradiol Valerate/Dienogest if indicated.
An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.
Bleeding Irregularities
Breakthrough bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC.
Women who are not pregnant and use Estradiol Valerate and Estradiol Valerate/Dienogest, may experience amenorrhea. Based on patient diaries, amenorrhea occurs in approximately 16% of cycles in women using Estradiol Valerate and Estradiol Valerate/Dienogest. Pregnancy should be ruled out in the event of amenorrhea occurring in two or more consecutive cycles. Some women may encounter amenorrhea or oligomenorrhea after stopping COCs, especially when such a condition was pre-existent.
Based on patient diaries from three clinical trials evaluating the safety and efficacy of Estradiol Valerate and Estradiol Valerate/Dienogest for contraception, 10-23% of women experienced intracyclic bleeding per cycle.
COC Use Before or During Early Pregnancy
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy. Oral contraceptive use should be discontinued if pregnancy is confirmed.
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy.
Depression
Women with a history of depression should be carefully observed and Estradiol Valerate and Estradiol Valerate/Dienogest discontinued if depression recurs to a serious degree.
Interference with Laboratory Tests
The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increase with use of COCs.
Monitoring
A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
Drug Interactions
Women who take medications that are strong cytochrome P450 3A4 (CYP3A4) inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not choose Estradiol Valerate and Estradiol Valerate/Dienogest as their oral contraceptive while using these inducers and for at least 28 days after discontinuation of these inducers due to the possibility of decreased contraceptive efficacy.
Other Conditions
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet
Adverse Reactions
Clinical Trials Experience
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Contraception and Heavy Menstrual Bleeding Studies
A total of 2,131 women, 18 to 54 years of age, who took at least one dose of Natazia were enrolled in four clinical phase 3 trials. A total of 1,867 subjects were included in two clinical phase 3 studies with a treatment duration up to 28 cycles with Natazia as an oral contraceptive and 264 subjects in the two phase 3 clinical trials with a treatment duration of 7 cycles evaluating Natazia in the treatment of heavy, prolonged, and/or frequent menstrual bleeding in women without organic pathology. [See Clinical Studies (14.1, 14.2.)]
Adverse Reactions Leading to Study Discontinuation: 11.4% of the women discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were menstrual disorder (metrorrhagia, menorrhagia, menstruation irregular, genital hemorrhage, vaginal hemorrhage, dysfunctional uterine bleeding) (2.3%); mood changes (depression, mood swings, mood altered, depressed mood, dysthymic disorder, crying) (1.2%); acne (1.1%), headache (including migraines) (1.1%), and weight increased (0.7 %).
Serious Adverse Reactions: myocardial infarction (2 cases), ruptured ovarian cyst (2 cases), deep vein thrombosis, focal nodular hyperplasia of the liver, uterine leiomyoma, acute cholecystitis, and chronic acalculous cholecystitis.
The following serious adverse reactions with the use of COCs:
Serious cardiovascular events and stroke [see Boxed Warning and Warnings]
Vascular events [see Warnings]
Liver disease [see Warnings ]
Adverse reactions commonly reported by COC users are:
Irregular uterine bleeding
Nausea
Breast tenderness
Headache
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Estradiol Valerate and Estradiol Valerate/Dienogest. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Vascular disorders
Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, myocardial infarction and stroke), hypertension
Hepatobiliary disorders
Gallbladder disease
Hepatitis
Immune system disorders
Hypersensitivity
Metabolism and nutrition disorders
Fluid retention
Hypertriglyceridemia
Nervous system disorders
Dizziness
Skin and subcutaneous tissue disorders
Chloasma
Angioedema
Erythema nodosum
Erythema multiforme
Gastrointestinal disorders
Gastrointestinal symptoms (for example, abdominal pain)
Infections and infestations
Vulvovaginal candidiasis
Drug Interactions
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Effects of Other Drugs on Combined Oral Contraceptives
Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in the literature for COCs in general or were studied in clinical trials with Estradiol Valerate and Estradiol Valerate/Dienogest.
CYP3A4 Inducers: Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include barbiturates, bosentan, felbamate, griseofulvin, oxcarbazepine, and topiramate. Counsel women to use an alternative method of contraception or a back-up method when moderate or weak enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Dienogest is a substrate of CYP3A4. Women who take medications that are strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not choose Estradiol Valerate and Estradiol Valerate/Dienoges as their oral contraceptive while using these inducers and for at least 28 days after discontinuation of these inducers due to the possibility of decreased contraceptive efficacy.
The effect of the CYP3A4 inducer rifampicin was studied in healthy postmenopausal women. Co-administration of rifampicin with estradiol valerate/dienogest tablets led to a 52 % and 83% decrease in the mean Cmax and AUC (0–24hr), respectively, for dienogest and a 25% and 44% decrease in Cmax and AUC (0–24hr), respectively, for estradiol at steady state.
Strong CYP3A4 Inhibitors: Strong CYP3A4 inhibitors such as ketoconazole increased hormone serum concentrations. In a study investigating the effect of ketoconazole on dienogest and estradiol pharmacokinetics, co-administration with the strong CYP3A4 inhibitor ketoconazole resulted in a 186% increase of AUC (0–24hr) at steady state for dienogest and a 57% increase for estradiol. There was also a 94% and 65% increase of Cmax at steady state for dienogest and estradiol when co-administered with ketoconazole.
Moderate CYP3A4 Inhibitors: The AUC (0–24hr) of dienogest and estradiol at steady state were increased by 62% and 33%, respectively, when co-administered with a moderate CYP3A4 inhibitor, erythromycin. There was also a 33% and 51% increase of Cmax at steady state for dienogest and estradiol, respectively, when co-administered with erythromycin.
Other known CYP3A4 inhibitors like azole antifungals, cimetidine, verapamil, macrolides, diltiazem, antidepressants, and grapefruit juice may increase plasma concentrations of dienogest.
Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors: Significant changes (increase and decrease) in plasma concentrations of estrogen and progestin have been noted in some cases of co-administration of HIV/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.
Effects of Combined Oral Contraceptives on Other Drugs
COCs containing ethinyl estradiol may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations.
In vitro studies with human CYP enzymes did not indicate an inhibitory potential of dienogest at clinically relevant concentrations.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increase with use of COCs.
Interference with Laboratory Tests
The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
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 withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion.
Women who do not breastfeed may start COCs no earlier than four weeks postpartum.
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
When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen-containing COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.
Pediatric Use
Safety and efficacy of Estradiol Valerate and Estradiol Valerate/Dienogest have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.
Geriatic Use
There is no FDA guidance on the use of Estradiol Valerate and Estradiol Valerate/Dienogest with respect to geriatric patients.
Estradiol Valerate and Estradiol Valerate/Dienogest has not been studied in postmenopausal women and is not indicated in this population.
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
The pharmacokinetics of Estradiol Valerate and Estradiol Valerate/Dienoget has not been studied in subjects with hepatic impairment. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Estradiol Valerate and Estradiol Valerate/Dienoget in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Estradiol Valerate and Estradiol Valerate/Dienoget in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Monitoring
Carbohydrate and Lipid Metabolic Effects
Carefully monitor prediabetic and diabetic women who are taking Estradiol valerate and estradiol valerate/dienogest. COCs may decrease glucose tolerance in a dose-related fashion.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
High Blood Pressure
For women with well-controlled hypertension, monitor blood pressure and stop Estradiol valerate and estradiol valerate/dienogest if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.
A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
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.
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.
