Estradiol 10mcg Vaginal Tabs 8s

Manufacturer TEVA PHARMACEUTICALS USA Active Ingredient Estradiol Vaginal Tablets(es tra DYE ole) Pronunciation es-tra-DYE-ole
WARNING: Do not use this drug to prevent heart disease or dementia. A study of women taking an estrogen with a progestin showed a raised chance of heart attack, stroke, blood clot, breast cancer, and dementia. The chance of stroke, blood clot, and dementia was also raised when the estrogen was taken alone. Not all products and doses were studied. It is not known if the same effects may happen with this drug.The chance of endometrial cancer may be raised with the use of estrogen alone in patients with a uterus. Use of a progestin along with estrogen may lower the risk. Call your doctor right away if you have unexplained or long-lasting vaginal bleeding.Use this drug for the shortest time needed at the lowest useful dose. Your doctor will talk with you on a regular basis to see if you need to keep taking this drug. @ COMMON USES: It is used to treat vaginal irritation and dryness caused by menopause.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Estrogen
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Pharmacologic Class
Estrogen receptor agonist
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Pregnancy Category
Category X
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FDA Approved
Mar 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Estradiol vaginal tablets are a small tablet inserted into the vagina to treat symptoms like dryness, itching, and burning caused by menopause. It works by replacing the natural estrogen that your body no longer makes enough of, helping to restore the health of the vaginal tissues. It is primarily for local relief and has minimal absorption into the bloodstream.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Before each use, wash your hands thoroughly. Insert the medication into your vagina using the provided applicator, and then wash the applicator after use. Establish a routine by taking this medication at the same time every day. Note that there may be days when you are not scheduled to take this medication.

Storing and Disposing of Your Medication

Store this medication in its original container at room temperature, protecting it from heat sources. Keep all medications in a secure location, out of the reach of children and pets, to ensure safety.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to compensate for a missed dose.
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Lifestyle & Tips

  • Continue regular gynecological examinations, including breast exams and mammograms, as recommended by your doctor.
  • Report any unusual vaginal bleeding or spotting to your doctor immediately.
  • Discuss any concerns about long-term use with your healthcare provider.
  • Maintain a healthy lifestyle, including regular exercise and a balanced diet.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mcg vaginally once daily for 2 weeks, then 10 mcg vaginally twice weekly

Condition-Specific Dosing:

vulvarAndVaginalAtrophy: 10 mcg vaginally once daily for 2 weeks, then 10 mcg vaginally twice weekly
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption
Moderate: No specific adjustment needed due to minimal systemic absorption
Severe: No specific adjustment needed due to minimal systemic absorption, but caution in severe renal disease is prudent
Dialysis: No specific adjustment needed due to minimal systemic absorption

Hepatic Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption
Moderate: No specific adjustment needed due to minimal systemic absorption
Severe: No specific adjustment needed due to minimal systemic absorption, but caution in severe hepatic disease is prudent

Pharmacology

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Mechanism of Action

Estradiol is an estrogen that binds to estrogen receptors in the vaginal mucosa. This binding promotes proliferation and maturation of vaginal epithelial cells, increases the number of superficial cells, and decreases parabasal cells. It also helps restore vaginal pH to normal levels, leading to improved vaginal lubrication, elasticity, and reduced symptoms of vulvar and vaginal atrophy.
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Pharmacokinetics

Absorption:

Bioavailability: Not clinically quantifiable for local action; minimal systemic absorption
Tmax: Not clinically relevant for local action; systemic peak concentrations are very low and typically within postmenopausal range
FoodEffect: Not applicable for vaginal administration

Distribution:

Vd: Not clinically relevant for local action
ProteinBinding: Not clinically relevant for local action
CnssPenetration: No

Elimination:

HalfLife: Not clinically relevant for local action
Clearance: Not clinically relevant for local action
ExcretionRoute: Not clinically relevant for local action
Unchanged: Not clinically relevant for local action
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Pharmacodynamics

OnsetOfAction: Symptomatic relief may begin within weeks
PeakEffect: Optimal cellular changes and symptom relief may take 8-12 weeks
DurationOfAction: Sustained with twice-weekly dosing regimen

Safety & Warnings

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BLACK BOX WARNING

Estrogens increase the risk of endometrial cancer. Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) study reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI) in postmenopausal women receiving estrogen-alone therapy. The WHI study also reported an increased risk of probable dementia in postmenopausal women 65 years of age or older receiving estrogen-alone therapy. The WHI study reported an increased risk of invasive breast cancer in postmenopausal women receiving estrogen plus progestin therapy. The WHI study also reported an increased risk of probable dementia in postmenopausal women 65 years of age or older receiving estrogen plus progestin therapy. Although systemic absorption of estradiol from vaginal tablets is minimal, the warnings associated with oral estrogen-alone therapy should be considered.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, change in stools, dark urine, yellow skin or eyes, or fever with chills.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or throwing up.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Pelvic pain or pressure, vaginal irritation, vaginal itching or discharge, or abnormal vaginal bleeding.
Breast changes: lump, pain, soreness, or nipple discharge.
Depression or other mood changes, memory problems or loss, eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Fluid retention: swelling, weight gain, or trouble breathing.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm, or trouble speaking or swallowing.
High calcium levels: weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

* Headache, hair loss, tender breasts, diarrhea, upset stomach, throwing up, stomach pain or cramps, bloating, or back pain.

Reporting Side Effects

These are not all the possible side effects that may occur. If you have questions about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Abnormal vaginal bleeding or spotting
  • New breast lumps or changes
  • Severe headache or migraine
  • Sudden vision changes
  • Chest pain, shortness of breath, or coughing up blood
  • Pain, swelling, or redness in one or both legs (signs of a blood clot)
  • Yellowing of the skin or eyes (jaundice)
  • Severe abdominal pain
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication should not be taken during pregnancy.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and if so, they will instruct you on when to resume taking it after the surgery or procedure.

If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels. Additionally, have your blood work and other laboratory tests checked as directed by your doctor.

Regular breast exams and gynecology check-ups are vital, and you should also perform breast self-exams as instructed by your doctor.

Be aware that this medication can cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.

Elevated triglyceride levels have been associated with this drug. If you have a history of high triglyceride levels, inform your doctor.

This medication may interfere with certain laboratory tests. Notify all your healthcare providers and laboratory personnel that you are taking this drug.

Smoking can increase the risk of heart disease. Avoid smoking and discuss any concerns with your doctor.

If you consume grapefruit juice or eat grapefruit frequently, consult with your doctor.

If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor. Prolonged immobility may increase the risk of blood clots.

The risk of certain side effects, including heart attack, stroke, breast cancer, ovarian cancer, and others, may vary depending on factors such as the duration of estrogen use, whether it is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are breastfeeding, inform your doctor, as they will need to discuss potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Breast tenderness
  • Abdominal pain
  • Drowsiness/fatigue
  • Withdrawal bleeding in women

What to Do:

Overdose with vaginal tablets is unlikely due to minimal systemic absorption. If suspected, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.

Drug Interactions

Monitoring

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Baseline Monitoring

Complete medical history and physical examination

Rationale: To assess overall health status and identify contraindications or risk factors for estrogen therapy.

Timing: Prior to initiation of therapy

Blood pressure

Rationale: To establish baseline and monitor for potential cardiovascular effects.

Timing: Prior to initiation of therapy

Pelvic examination (including Pap test if indicated)

Rationale: To assess gynecological health and rule out underlying conditions.

Timing: Prior to initiation of therapy

Breast examination

Rationale: To establish baseline and screen for breast abnormalities.

Timing: Prior to initiation of therapy

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Routine Monitoring

Annual physical examination

Frequency: Annually

Target: Normal

Action Threshold: Any significant changes or new symptoms

Annual breast examination and mammogram (as per age/risk guidelines)

Frequency: Annually

Target: Normal

Action Threshold: Any new lumps, pain, or changes

Annual pelvic examination

Frequency: Annually

Target: Normal

Action Threshold: Any abnormal findings or symptoms

Blood pressure

Frequency: Annually or as clinically indicated

Target: Normal

Action Threshold: Sustained elevation

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Symptom Monitoring

  • Abnormal vaginal bleeding or spotting
  • Breast lumps or pain
  • Changes in vision or speech
  • Severe headache
  • Chest pain or shortness of breath
  • Pain, swelling, or redness in legs (signs of DVT)
  • Yellowing of skin or eyes (jaundice)
  • Abdominal pain or swelling

Special Patient Groups

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Pregnancy

Contraindicated during pregnancy (Category X). There is no indication for estrogen therapy in pregnancy, and there is evidence of fetal harm.

Trimester-Specific Risks:

First Trimester: Potential for adverse effects on the fetus, including genital abnormalities.
Second Trimester: Potential for adverse effects on the fetus.
Third Trimester: Potential for adverse effects on the fetus.
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Lactation

Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant.

Infant Risk: L4 (Possibly Hazardous) - Potential for decreased milk production and possible adverse effects on the infant (e.g., feminization).
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Pediatric Use

Not indicated for use in pediatric patients. Safety and efficacy have not been established.

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Geriatric Use

Generally considered safe and effective for vulvar and vaginal atrophy in postmenopausal women, including geriatric patients. Use the lowest effective dose for the shortest duration consistent with treatment goals. No specific dose adjustment is typically needed based on age alone, but monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Estradiol 10mcg vaginal tablets are specifically designed for local treatment of vulvar and vaginal atrophy, with minimal systemic absorption, which differentiates them from oral or transdermal estrogen therapies.
  • Despite minimal systemic absorption, the product labeling includes the Black Box Warning for systemic estrogen risks (endometrial cancer, cardiovascular events, dementia, breast cancer) due to the class effect of estrogens.
  • Patients should be instructed on the correct insertion technique to ensure optimal local delivery and efficacy.
  • This formulation is not intended for the treatment of hot flashes or other systemic menopausal symptoms.
  • Regular follow-up appointments are crucial to assess the continued need for therapy and to monitor for any adverse effects, particularly abnormal vaginal bleeding.
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Alternative Therapies

  • Non-hormonal vaginal lubricants and moisturizers (e.g., Replens, K-Y Jelly)
  • Ospemifene (oral selective estrogen receptor modulator for dyspareunia)
  • Laser therapy (e.g., CO2 laser) for vaginal rejuvenation (off-label for VVA)
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Cost & Coverage

Average Cost: $200 - $600 per 8 tablets (1 month supply)
Generic Available: Yes
Insurance Coverage: Tier 1 (generic) or Tier 2/3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.