Estradiol 10mcg Vaginal Tabs 8s
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
- Estradiol 0.05mg Patch (once Wk)
- Estradiol 0.1mg Patch (once Wk)
- Estradiol 1mg Tablets
- Estradiol 2mg Tablets
- Estradiol 0.5mg Tablets
- Estradiol 0.025mg Patch (once Wk)
- Estradiol 0.075mg Patch (once Wk)
- Estradiol Tds 0.0375mg Patches 4s
- Estradiol Tds 0.06mg Patch 4s
- Estradiol 0.025mg Patch (twice Wk)
- Estradiol 0.075mg Patch (twice Wk)
- Estradiol 0.0375mg Patch (twice Wk)
- Estradiol 0.1mg Patch (twice Wk)
- Estradiol 0.05mg Patch (twice Wk)
- Estradiol 0.0375mg Patch (twice Wk
- Estradiol 10mcg Vaginal Tabs 8s
- Estradiol 10mcg Vaginal Tabs 18s
- Estradiol 0.01% Vag Cream 42.5gm
- Estradiol Val 20mg/ml Inj, 5ml
- Estradiol Valerate 40mg/ml Inj, 5ml
- Estradiol Valerate 40mg/ml Inj, 5ml
- Estradiol 0.5mg/day Top Gel Pk
- Estradiol 0.5mg/day Top Gel Pk
- Estradiol 1mg/day Top Gel Pk
- Estradiol 1mg/day Top Gel Pk
- Estradiol 0.75mg/day Top Gel Pk
- Estradiol 0.75mg/day Top Gel Pk
- Estradiol 0.25mg/day Top Gel Pk
- Estradiol 0.25mg/day Top Gel Pk
- Estradiol 1.25mg/day Top Gel Pk
- Estradiol 1.25mg/day Top Gel Pk
- Estradiol Valerate 10mg/ml Inj, 5ml
- Estradiol Val 20mg/ml Inj, 5ml
- Estradiol Valerate 10mg/ml Inj, 5ml
- Estradiol 1.25mg/day Top Gel Pk
- Estradiol 0.75mg/day Top Gel Pk
- Estradiol 1mg/day Top Gel Pk
- Estradiol 0.5mg/day Top Gel Pk
- Estradiol 0.25mg/day Top Gel Pk
- Estradiol 0.06% Gel 37.5gm(pumps)
- Estradiol 0.06% Gel 37.5gm(pumps)
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Baseline Monitoring
Rationale: To assess overall health status and identify contraindications or risk factors for estrogen therapy.
Timing: Prior to initiation of therapy
Rationale: To establish baseline and monitor for potential cardiovascular effects.
Timing: Prior to initiation of therapy
Rationale: To assess gynecological health and rule out underlying conditions.
Timing: Prior to initiation of therapy
Rationale: To establish baseline and screen for breast abnormalities.
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: Annually
Target: Normal
Action Threshold: Any significant changes or new symptoms
Frequency: Annually
Target: Normal
Action Threshold: Any new lumps, pain, or changes
Frequency: Annually
Target: Normal
Action Threshold: Any abnormal findings or symptoms
Frequency: Annually or as clinically indicated
Target: Normal
Action Threshold: Sustained elevation
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
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:
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.
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established.
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
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.
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)