Estrace 2mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day. Note that there may be days when you are not scheduled to take this medication. You can take it with or without food, but if it causes stomach upset, take it with food.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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 make up for the missed one.
Lifestyle & Tips
- Maintain a healthy lifestyle: regular exercise, balanced diet.
- Quit smoking: Smoking increases the risk of serious cardiovascular events with estrogen use.
- Limit alcohol intake.
- Discuss any new or worsening symptoms with your doctor immediately.
- Attend all scheduled follow-up appointments and screenings (e.g., mammograms, pelvic exams).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of pancreatitis (pancreas problem), including:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
Breast lump, pain, or soreness
Nipple discharge
Vaginal itching or discharge
Abnormal vaginal bleeding
Depression or other mood changes
Memory problems or loss
Fever
Difficulty urinating or changes in urine output
Pain while urinating
This medication may cause fluid retention, leading to swelling or weight gain. If you experience any of these symptoms, inform your doctor.
Blood Clots and High Calcium Levels
Seek immediate medical attention if you experience signs of a blood clot, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
High calcium levels can occur in some people with cancer. Contact your doctor right away if you experience signs of high calcium levels, including:
Weakness
Confusion
Fatigue
Headache
Upset stomach or vomiting
Constipation
Bone pain
Other Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness or headache
Hair loss
Upset stomach or vomiting
Constipation
Stomach pain or cramps
Bloating
Enlarged or tender breasts
Vaginal bleeding or spotting
Painful periods
Signs of a common cold
Nose or throat irritation
Weight gain or loss
Joint pain
Leg cramps
* Changes in sex interest
This list is not exhaustive. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache, dizziness, or fainting.
- Sudden vision changes (e.g., partial or complete loss of vision).
- Sudden chest pain, shortness of breath, or coughing up blood.
- Pain, swelling, or tenderness in one or both legs.
- New breast lump or nipple discharge.
- Unusual vaginal bleeding (e.g., bleeding after menopause, very heavy or prolonged bleeding).
- Yellowing of the skin or eyes (jaundice), dark urine, or severe abdominal pain (signs of liver problems).
- Memory loss or confusion (especially in older women).
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 suspected 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
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. Your doctor may advise you to stop taking this medication before certain surgical procedures. If you need to stop taking this drug, your doctor will provide guidance on when to resume taking it after your surgery or procedure.
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 your risk of developing blood clots.
If you have a known allergy to tartrazine (FD&C Yellow No. 5), consult your doctor before taking this medication, as some products may contain this ingredient.
If you have diabetes, closely monitor your blood sugar levels, as this medication may affect them. Additionally, this medication has been associated with increased blood pressure in some individuals. Regularly check your blood pressure as advised by your doctor.
Follow your doctor's recommendations for regular blood tests and bone density checks. It is also essential to undergo regular breast exams and gynecology check-ups, as well as perform breast self-exams as instructed by your doctor.
The risk of certain side effects, such as heart attack, stroke, breast cancer, ovarian cancer, and others, may vary depending on factors like 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.
Be aware that this medication has been linked to high triglyceride levels. If you have a history of elevated triglycerides, inform your doctor.
This medication may cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize sun exposure.
As this medication may affect certain laboratory tests, inform all your healthcare providers and lab personnel that you are taking this drug.
To minimize the risk of heart disease, avoid smoking. If you smoke, discuss quitting strategies with your doctor. Limit your alcohol consumption, and if you regularly drink grapefruit juice or eat grapefruit, consult your doctor.
For optimal effectiveness, use this medication in conjunction with calcium and vitamin D supplements, as well as weight-bearing exercises like walking or physical therapy. Adhere to the diet and exercise plan recommended by your doctor.
In rare cases, this medication may affect growth in children and teenagers. If you are a parent or guardian of a child or teenager taking this medication, discuss the need for regular growth checks with their 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, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in females)
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Contact a poison control center (1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use would counteract their mechanism of action.
Major Interactions
- CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, St. John's Wort) - may significantly decrease estradiol levels, reducing efficacy.
- CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin, Erythromycin, Grapefruit juice) - may increase estradiol levels, increasing risk of adverse effects.
- Thyroid hormone replacement (e.g., Levothyroxine) - Estrogens can increase thyroid-binding globulin (TBG), leading to increased bound thyroid hormone and potentially requiring an increased dose of thyroid hormone.
Moderate Interactions
- Corticosteroids (e.g., Prednisone) - Estrogens may decrease the clearance of corticosteroids, leading to increased corticosteroid effects and toxicity.
- Oral anticoagulants (e.g., Warfarin) - Estrogens may decrease the anticoagulant effect of warfarin, requiring dose adjustments.
- Fluvoxamine - May increase estradiol levels.
- Lamotrigine - Estrogens may decrease lamotrigine levels, potentially leading to loss of seizure control.
Minor Interactions
- Not specifically identified as clinically significant minor interactions for oral estradiol.
Monitoring
Baseline Monitoring
Rationale: To identify contraindications, risk factors (e.g., cardiovascular disease, breast cancer), and establish baseline health status.
Timing: Prior to initiation of therapy
Rationale: Estrogens can affect blood pressure.
Timing: Prior to initiation of therapy
Rationale: To screen for pre-existing breast conditions and establish baseline for breast cancer surveillance.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Rationale: To screen for pre-existing gynecological conditions and establish baseline for endometrial cancer surveillance.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: Annually
Target: Normal for age
Action Threshold: Significant changes or hypertension development
Frequency: Annually (or as per national guidelines)
Target: No suspicious findings
Action Threshold: New lumps, pain, or suspicious mammogram findings
Frequency: Annually (or as per national guidelines)
Target: No suspicious findings
Action Threshold: Abnormal bleeding, pain, or suspicious Pap test findings
Frequency: Periodically, as clinically indicated
Target: Optimal levels
Action Threshold: Significant adverse changes
Symptom Monitoring
- Signs and symptoms of venous thromboembolism (VTE) such as leg pain, swelling, sudden chest pain, shortness of breath.
- Signs and symptoms of stroke (e.g., sudden severe headache, vision changes, weakness/numbness on one side of body, speech difficulty).
- Signs and symptoms of myocardial infarction (e.g., chest pain, discomfort, shortness of breath, pain in arm/back/neck/jaw).
- New breast lumps or changes, nipple discharge.
- Abnormal vaginal bleeding (e.g., postmenopausal bleeding, prolonged or heavy bleeding).
- Signs of liver dysfunction (e.g., jaundice, dark urine, abdominal pain).
- Changes in vision (e.g., sudden partial or complete loss of vision, proptosis, diplopia).
Special Patient Groups
Pregnancy
Contraindicated during pregnancy (Pregnancy Category X). Estrogen use during pregnancy is associated with an increased risk of birth defects and should not be used.
Trimester-Specific Risks:
Lactation
Not recommended during lactation (Lactation Risk L4). Estrogens can decrease the quantity and quality of breast milk and are excreted into breast milk, potentially affecting the infant.
Pediatric Use
Generally not indicated for pediatric use, except for specific conditions like hypogonadism in adolescent girls. Safety and efficacy in pre-pubertal children have not been established. Use in children should be under the guidance of a specialist.
Geriatric Use
Increased risk of stroke, deep vein thrombosis, and probable dementia in women 65 years of age or older. Use the lowest effective dose for the shortest duration consistent with treatment goals. Careful risk-benefit assessment is crucial.
Clinical Information
Clinical Pearls
- Estradiol is the most potent natural estrogen. Oral administration undergoes significant first-pass metabolism, leading to lower bioavailability compared to transdermal forms.
- Always use the lowest effective dose for the shortest duration consistent with treatment goals, especially for menopausal hormone therapy, due to associated risks.
- For women with an intact uterus, a progestin must be co-administered with estradiol to reduce the risk of endometrial hyperplasia and cancer.
- Patients should be educated on the signs and symptoms of serious adverse events (e.g., VTE, stroke, MI, breast cancer) and instructed to seek immediate medical attention if they occur.
- Regular follow-up, including physical exams and appropriate screenings (mammograms, pelvic exams), is crucial during estrogen therapy.
- Consider non-hormonal alternatives for menopausal symptoms or osteoporosis prevention, especially in patients with contraindications or high-risk profiles.
Alternative Therapies
- For vasomotor symptoms: SSRIs/SNRIs (e.g., paroxetine, venlafaxine), gabapentin, clonidine, fezolinetant (Veozah).
- For vulvar/vaginal atrophy: Vaginal moisturizers and lubricants, ospemifene (Osphena), prasterone (Intrarosa).
- For osteoporosis prevention: Bisphosphonates (e.g., alendronate), denosumab, teriparatide, raloxifene.