Noreth/ethin EST 0.5-2.5mcg Tablets
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 prevent soft, brittle bones (osteoporosis) after menopause.It is used to treat signs caused by menopause.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Hormone Replacement Therapy (HRT)
Pharmacologic Class
Estrogen and Progestin Combination
Pregnancy Category
Category X
FDA Approved
Aug 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication contains two female hormones, estrogen and progestin. It's used by women after menopause to help relieve symptoms like hot flashes and night sweats. The progestin is included to protect the uterus from certain risks associated with estrogen alone.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day. You can take it with or without food, but if it causes stomach upset, take it with food.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets.
When you no longer need your medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss 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 dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses. If you miss taking your medication for several days in a row, contact your doctor before starting to take it again.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day. You can take it with or without food, but if it causes stomach upset, take it with food.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets.
When you no longer need your medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss 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 dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses. If you miss taking your medication for several days in a row, contact your doctor before starting to take it again.
Lifestyle & Tips
- Do not smoke, as smoking significantly increases the risk of serious cardiovascular events (blood clots, stroke, heart attack) when taking this medication.
- Maintain a healthy diet and engage in regular physical activity to support overall cardiovascular health.
- Discuss any personal or family history of blood clots, heart disease, stroke, or cancer with your doctor.
- Attend all scheduled doctor appointments and screenings (e.g., mammograms, pelvic exams).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally once daily
Dose Range:
0.5 - 2.5 mg
Condition-Specific Dosing:
menopausalSymptoms:
One tablet (0.5 mg norethindrone acetate / 2.5 mcg ethinyl estradiol) orally once daily for the treatment of moderate to severe vasomotor symptoms associated with menopause.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dosage adjustment recommended, but use with caution.
Moderate:
No specific dosage adjustment recommended, but use with caution.
Severe:
No specific dosage adjustment recommended, but use with caution. Monitor for fluid retention.
Dialysis:
Not available. Use with caution and monitor for fluid retention.
Hepatic Impairment:
Mild:
Use with caution. Monitor for adverse effects.
Moderate:
Use with caution. Monitor for adverse effects.
Severe:
Contraindicated in patients with severe liver disease or liver tumors.
Pharmacology
Mechanism of Action
Norethindrone acetate and ethinyl estradiol tablets provide exogenous estrogen and progestin to replace declining endogenous hormone levels in postmenopausal women. Estrogen acts by binding to estrogen receptors in target tissues, leading to gene transcription and protein synthesis, alleviating menopausal symptoms. Progestin (norethindrone acetate) is added to reduce the risk of endometrial hyperplasia and carcinoma associated with unopposed estrogen therapy in women with an intact uterus.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: Approximately 40-45% (due to significant first-pass metabolism); Norethindrone Acetate: Approximately 60% (after deacetylation to norethindrone)
Tmax:
Ethinyl Estradiol: Approximately 2 hours; Norethindrone: Approximately 1-2 hours
FoodEffect:
Food may slightly decrease the rate but not the extent of absorption.
Distribution:
Vd:
Ethinyl Estradiol: Approximately 4-13 L/kg; Norethindrone: Approximately 4 L/kg
ProteinBinding:
Ethinyl Estradiol: Approximately 98% (to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: Approximately 80% (to albumin and SHBG)
CnssPenetration:
Limited, but hormones can cross the blood-brain barrier.
Elimination:
HalfLife:
Ethinyl Estradiol: Approximately 13-27 hours; Norethindrone: Approximately 5-14 hours
Clearance:
Not readily available for combination, but high hepatic clearance for both components.
ExcretionRoute:
Primarily renal (urine) and fecal (bile) as glucuronide and sulfate conjugates.
Unchanged:
Very little unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Symptomatic relief may begin within weeks, with full effect often seen after 2-4 weeks.
PeakEffect:
Peak therapeutic effects for vasomotor symptoms are typically observed within 4-8 weeks of consistent use.
DurationOfAction:
Effects persist as long as therapy is continued; hormone levels return to baseline upon discontinuation.
Safety & Warnings
BLACK BOX WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. These risks apply to other estrogen/progestin combinations as well. Estrogen-alone therapy also carries risks, including increased risk of endometrial cancer in women with an intact uterus.
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 liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting
Signs of low calcium levels: muscle cramps or spasms, numbness and tingling, or seizures
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
Additional Serious Side Effects
Blood clots: 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 (more common in people with cancer): weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain
Other Possible Side Effects
Not everyone experiences side effects, and many people have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
Diarrhea
Vaginal bleeding or spotting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 online at https://www.fda.gov/medwatch.
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 liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting
Signs of low calcium levels: muscle cramps or spasms, numbness and tingling, or seizures
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
Additional Serious Side Effects
Blood clots: 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 (more common in people with cancer): weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain
Other Possible Side Effects
Not everyone experiences side effects, and many people have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
Diarrhea
Vaginal bleeding or spotting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache or migraine
- Sudden vision changes (e.g., partial or complete loss of vision)
- Numbness or weakness in your face, arm, or leg, especially on one side of the body
- Sudden chest pain, shortness of breath, or coughing up blood
- Pain, swelling, or warmth in your leg (especially calf or thigh)
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
- New breast lump or changes in breast tissue
- Unusual vaginal bleeding or spotting after menopause
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 conditions or situations to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain) or a history of heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Previous removal of the uterus (hysterectomy).
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy, as this medication should not be taken during pregnancy.
Breastfeeding or plans to breastfeed.
* A history of jaundice (yellowing of the skin and eyes) during pregnancy or with estrogen use, such as hormonal birth control.
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 to ensure safe use of this medication. Do not initiate, stop, or modify any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions or situations to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain) or a history of heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Previous removal of the uterus (hysterectomy).
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy, as this medication should not be taken during pregnancy.
Breastfeeding or plans to breastfeed.
* A history of jaundice (yellowing of the skin and eyes) during pregnancy or with estrogen use, such as hormonal birth control.
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 to ensure safe use of this medication. Do not initiate, stop, or modify any medication without consulting your doctor.
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 will provide guidance on when to resume taking it after the surgery or procedure.
If you anticipate being inactive for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged inactivity may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
This medication may cause high blood pressure. Ensure that your blood pressure is checked regularly, as advised by your doctor.
Additionally, this drug may lead to increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly undergo blood work and other lab tests as recommended by your doctor.
It is crucial to maintain regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you frequently consume grapefruit juice or eat grapefruit, consult with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this drug.
For optimal effectiveness, this medication should be used 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, limit your alcohol consumption, and avoid smoking, as it increases the risk of heart disease. Discuss this with 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. Consult with your doctor to understand the benefits and risks associated with this medication.
This medication is not intended for use in children. Consult with your doctor if you have any questions or concerns.
If you anticipate being inactive for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged inactivity may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
This medication may cause high blood pressure. Ensure that your blood pressure is checked regularly, as advised by your doctor.
Additionally, this drug may lead to increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly undergo blood work and other lab tests as recommended by your doctor.
It is crucial to maintain regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you frequently consume grapefruit juice or eat grapefruit, consult with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this drug.
For optimal effectiveness, this medication should be used 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, limit your alcohol consumption, and avoid smoking, as it increases the risk of heart disease. Discuss this with 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. Consult with your doctor to understand the benefits and risks associated with this medication.
This medication is not intended for use in children. Consult with your doctor if you have any questions or concerns.
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. In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - theoretical antagonism of effects.
Major Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, phenytoin, St. John's Wort) - may decrease estrogen/progestin levels, leading to reduced efficacy and increased risk of breakthrough bleeding.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) - may increase estrogen/progestin levels, potentially increasing adverse effects.
- Thyroid hormone replacement (e.g., levothyroxine) - estrogens can increase thyroid-binding globulin (TBG), requiring increased thyroid hormone dose.
- Anticoagulants (e.g., warfarin) - estrogens may decrease the anticoagulant effect; monitor INR.
Moderate Interactions
- Corticosteroids (e.g., prednisone) - estrogens may increase corticosteroid levels due to reduced clearance.
- Cyclosporine - estrogens may increase cyclosporine levels.
- Lamotrigine - estrogens may decrease lamotrigine levels, potentially leading to loss of seizure control.
- Ursodiol - theoretical interaction, may reduce ursodiol efficacy.
Minor Interactions
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
- Acetaminophen - may increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Complete medical history and physical examination
Rationale: To identify contraindications, risk factors (e.g., cardiovascular disease, breast cancer), and establish baseline health status.
Timing: Prior to initiation of therapy
Blood pressure
Rationale: Estrogens can cause fluid retention and may affect blood pressure.
Timing: Prior to initiation of therapy
Lipid profile (total cholesterol, HDL, LDL, triglycerides)
Rationale: Estrogens can affect lipid metabolism; assess cardiovascular risk.
Timing: Prior to initiation of therapy
Liver function tests (LFTs)
Rationale: To assess hepatic function, as hormones are metabolized in the liver; contraindicated in severe liver disease.
Timing: Prior to initiation of therapy
Breast examination and mammography
Rationale: To screen for breast cancer, as HRT may increase risk.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Pelvic examination and Pap test
Rationale: To screen for gynecological conditions, including endometrial cancer (though progestin mitigates this risk).
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Routine Monitoring
Annual physical examination, including blood pressure
Frequency: Annually
Target: Individualized, aiming for healthy ranges
Action Threshold: Significant changes or values outside normal range warrant investigation.
Annual breast examination and mammography
Frequency: Annually (or as per national guidelines)
Target: No suspicious findings
Action Threshold: New lumps, pain, or abnormal mammogram findings require immediate investigation.
Annual pelvic examination and Pap test
Frequency: Annually (or as per national guidelines)
Target: No suspicious findings
Action Threshold: Abnormal bleeding, pain, or abnormal Pap test results require investigation.
Lipid profile
Frequency: Periodically, based on individual risk factors and clinical judgment
Target: Individualized, aiming for healthy ranges
Action Threshold: Significant changes or values outside normal range warrant investigation.
Symptom Monitoring
- Signs and symptoms of thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction): sudden chest pain, shortness of breath, sudden severe headache, sudden vision changes, numbness/weakness in face/arm/leg, swelling/pain in leg.
- Signs of breast cancer: new breast lump, skin changes, nipple discharge.
- Abnormal vaginal bleeding or spotting (especially after menopause).
- Signs of liver dysfunction: jaundice, severe abdominal pain, dark urine, pale stools.
- Severe headache or migraine onset/worsening.
- Changes in mood or signs of depression.
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for use in pregnancy, and there is evidence of fetal harm.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including genital abnormalities.
Second Trimester:
Not indicated; continued exposure carries risks.
Third Trimester:
Not indicated; continued exposure carries risks.
Lactation
Not recommended during lactation. Estrogens and progestins are excreted in breast milk and may reduce the quantity and quality of breast milk. Potential adverse effects on the breastfed infant are unknown but possible.
Infant Risk:
L4 (Potentially Hazardous) - Risk of decreased milk production and potential transfer of hormones to the infant.
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established in this population.
Geriatric Use
Use with caution in women 65 years of age or older. The WHIMS study showed an increased risk of probable dementia in women 65 years of age or older treated with conjugated estrogens plus medroxyprogesterone acetate. Increased risk of stroke and deep vein thrombosis has also been observed in this age group. Consider the lowest effective dose for the shortest duration consistent with treatment goals and risks.
Clinical Information
Clinical Pearls
- This combination HRT is specifically for women with an intact uterus to mitigate the risk of endometrial hyperplasia/cancer associated with unopposed estrogen.
- Always use the lowest effective dose for the shortest duration consistent with treatment goals and risks.
- Thoroughly assess patient's cardiovascular risk factors, history of breast cancer, and thromboembolic events before initiating and periodically during therapy.
- Educate patients on the signs and symptoms of serious adverse events (e.g., blood clots, stroke, heart attack, breast cancer) and when to seek immediate medical attention.
- Regular follow-up, including breast exams and mammograms, is crucial due to the increased risk of breast cancer with long-term HRT use.
- Consider non-hormonal alternatives for menopausal symptoms if HRT risks outweigh benefits for the individual patient.
Alternative Therapies
- Estrogen-only therapy (for women without a uterus)
- Selective Estrogen Receptor Modulators (SERMs) (e.g., bazedoxifene/conjugated estrogens, ospemifene, tamoxifen, raloxifene - for specific indications)
- Non-hormonal options for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Lifestyle modifications (e.g., diet, exercise, stress reduction, avoiding triggers for hot flashes)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$150+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 or higher (for brand)
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.