Noreth/ethin 1mg-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
Menopausal Hormone Therapy (MHT)
Pharmacologic Class
Estrogen-progestin combination
Pregnancy Category
Not applicable (contraindicated in women who are or may become pregnant)
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a hormone therapy that contains two female hormones, an estrogen (ethinyl estradiol) and a progestin (norethindrone). It is used by women after menopause to help relieve symptoms like hot flashes and to help prevent bone thinning (osteoporosis). The progestin is included to protect the lining of the uterus from changes that can be caused by 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're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. 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's close to the time for your next dose, skip the missed dose and go back 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're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. 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's close to the time for your next dose, skip the missed dose and go back 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
- Take the tablet at the same time each day.
- Do not smoke, especially if you are over 35, as smoking significantly increases the risk of serious cardiovascular side effects.
- Maintain a healthy diet and engage in regular weight-bearing exercise to support bone health.
- Attend all scheduled doctor's appointments and screenings (e.g., mammograms, blood pressure checks).
- Report any unusual vaginal bleeding immediately to your doctor.
- Discuss all other medications, supplements, and herbal products you are taking with your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (1 mg norethindrone acetate / 5 mcg ethinyl estradiol) orally once daily.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
menopausal_symptoms:
Continuous combined regimen for relief of moderate to severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis.
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:
Use with caution; monitor for fluid retention and other adverse effects.
Dialysis:
Not specifically studied; use with caution.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Use with caution; monitor for adverse effects.
Severe:
Contraindicated in severe hepatic dysfunction or disease.
Pharmacology
Mechanism of Action
Ethinyl estradiol is a synthetic estrogen that replaces the declining endogenous estrogen levels in postmenopausal women, alleviating symptoms such as hot flashes and vaginal atrophy. It also helps prevent bone loss. Norethindrone acetate is a synthetic progestin that is added to reduce the risk of endometrial hyperplasia and endometrial cancer, which is associated with unopposed estrogen therapy in women with an intact uterus.
Pharmacokinetics
Absorption:
Bioavailability:
High oral bioavailability for both components, though subject to first-pass metabolism.
Tmax:
Ethinyl Estradiol: ~1.5-2 hours; Norethindrone: ~1-2 hours
FoodEffect:
Food may slightly delay absorption but does not significantly affect bioavailability.
Distribution:
Vd:
Ethinyl Estradiol: ~4.3 L/kg; Norethindrone: ~4 L/kg
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin); Norethindrone: ~96% (to albumin and sex hormone-binding globulin)
CnssPenetration:
Limited, but can cross the blood-brain barrier to exert central effects.
Elimination:
HalfLife:
Ethinyl Estradiol: ~13-27 hours; Norethindrone: ~8-11 hours
Clearance:
Ethinyl Estradiol: ~10-20 L/hr; Norethindrone: ~600 L/hr
ExcretionRoute:
Primarily renal (urine) and fecal (bile).
Unchanged:
Very little unchanged drug is excreted.
Pharmacodynamics
OnsetOfAction:
Symptomatic relief (e.g., hot flashes) may begin within a few weeks, but full effect may take several months.
PeakEffect:
Not directly applicable for chronic MHT; refers to sustained therapeutic effect.
DurationOfAction:
Maintained with daily dosing.
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 (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. These risks apply to other estrogen-progestin combinations as well. Estrogen-alone therapy in women with a uterus increases the risk of endometrial cancer.
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.
Changes in eyesight or loss of eyesight, 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.
Common Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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
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.
Changes in eyesight or loss of eyesight, 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.
Common Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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
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, dizziness, or fainting.
- Sudden vision changes (e.g., partial or complete loss of vision, double vision).
- Sudden chest pain, shortness of breath, or coughing up blood.
- Pain, swelling, or warmth in the leg (especially calf or thigh).
- Weakness or numbness in an arm or leg, or one side of the body.
- Trouble speaking or understanding speech.
- Yellowing of the skin or eyes (jaundice).
- Severe abdominal pain.
- New breast lump or changes in existing breast lumps.
- Unusual or abnormal vaginal bleeding 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 and situations to ensure safe treatment:
Any allergies you have, including allergies to this medication, 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
+ Chest pain caused by angina
+ Heart attack or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical cancer, 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 is contraindicated during pregnancy.
Breastfeeding or plans to breastfeed, as the medication may pass into breast milk.
* A history of jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
Any allergies you have, including allergies to this medication, 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
+ Chest pain caused by angina
+ Heart attack or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical cancer, 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 is contraindicated during pregnancy.
Breastfeeding or plans to breastfeed, as the medication may pass into breast milk.
* A history of jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of 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 immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged immobility may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult with your doctor, as this medication may cause an increase in blood sugar levels. Monitor your blood sugar levels as directed by your doctor.
This medication may also cause high blood pressure. Have your blood pressure 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 and have your blood work and other lab tests checked as recommended.
Regular breast exams and gynecology check-ups are crucial, and you should also 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. Furthermore, if you consume grapefruit juice or eat grapefruit frequently, consult with your doctor.
This medication may affect certain lab test results, so it is essential to inform all your healthcare providers and lab workers that you are taking this drug.
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements, and engage in weight-bearing exercises, such as walking or physical therapy, as recommended by your doctor. Adhere to the diet and exercise plan outlined by your doctor, limit your alcohol consumption, and avoid smoking, as it increases the risk of heart disease.
It is crucial to discuss the benefits and risks of using this medication with your doctor, as 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.
This medication is not intended for use in children, so do not give it to a child. Consult with your doctor if you have any questions or concerns.
If you anticipate being immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged immobility may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult with your doctor, as this medication may cause an increase in blood sugar levels. Monitor your blood sugar levels as directed by your doctor.
This medication may also cause high blood pressure. Have your blood pressure 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 and have your blood work and other lab tests checked as recommended.
Regular breast exams and gynecology check-ups are crucial, and you should also 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. Furthermore, if you consume grapefruit juice or eat grapefruit frequently, consult with your doctor.
This medication may affect certain lab test results, so it is essential to inform all your healthcare providers and lab workers that you are taking this drug.
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements, and engage in weight-bearing exercises, such as walking or physical therapy, as recommended by your doctor. Adhere to the diet and exercise plan outlined by your doctor, limit your alcohol consumption, and avoid smoking, as it increases the risk of heart disease.
It is crucial to discuss the benefits and risks of using this medication with your doctor, as 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.
This medication is not intended for use in children, so do not give it to a child. 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 or emergency medical services immediately. Call 1-800-222-1222 for poison control.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - theoretical antagonism of effects.
- Ombitasvir/paritaprevir/ritonavir with or without dasabuvir - risk of ALT elevations.
Major Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, phenytoin, St. John's Wort) - may decrease estrogen/progestin levels, reducing efficacy and increasing risk of breakthrough bleeding.
- Thyroid hormone replacement (e.g., levothyroxine) - estrogen can increase thyroid-binding globulin, potentially increasing thyroid hormone requirements.
- Warfarin - estrogens can affect coagulation factors, potentially altering anticoagulant effects (monitor INR).
Moderate Interactions
- CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, grapefruit juice, clarithromycin, erythromycin) - may increase estrogen/progestin levels, increasing risk of adverse effects.
- Corticosteroids (e.g., prednisone) - estrogens may decrease corticosteroid clearance, increasing their effects.
- Cyclosporine - estrogens may inhibit cyclosporine metabolism, increasing cyclosporine levels and toxicity.
- Lamotrigine - estrogens may decrease lamotrigine levels, reducing seizure control.
Minor Interactions
- Acetaminophen - may increase ethinyl estradiol levels.
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Complete medical history and physical examination
Rationale: To identify contraindications, risk factors, and establish baseline health status.
Timing: Prior to initiation of therapy.
Blood pressure
Rationale: Estrogens can affect blood pressure; baseline assessment is crucial.
Timing: Prior to initiation of therapy.
Breast examination and mammography
Rationale: To screen for breast cancer and establish baseline for future comparisons.
Timing: Prior to initiation of therapy, as appropriate for age and risk.
Lipid profile
Rationale: Estrogens can affect lipid metabolism; baseline assessment is important.
Timing: Prior to initiation of therapy.
Liver function tests
Rationale: To assess hepatic function, as hormones are metabolized in the liver.
Timing: Prior to initiation of therapy, especially if hepatic concerns.
Routine Monitoring
Annual physical examination
Frequency: Annually
Target: Normal for age and health status
Action Threshold: Any significant change or new finding requires investigation.
Blood pressure
Frequency: Annually, or more frequently if indicated
Target: <130/80 mmHg (general guideline)
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) requires intervention.
Breast examination and mammography
Frequency: Annually (breast exam), mammography per screening guidelines
Target: No new masses or suspicious findings
Action Threshold: Any new lump, discharge, or suspicious mammogram finding requires immediate investigation.
Assessment of vaginal bleeding
Frequency: Regularly, patient self-monitoring
Target: Absence of unscheduled or abnormal bleeding after initial adjustment period
Action Threshold: Persistent, recurrent, or new onset of abnormal vaginal bleeding requires investigation to rule out endometrial pathology.
Symptom Monitoring
- Signs and symptoms of thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction): sudden severe headache, sudden vision changes, chest pain, shortness of breath, pain/swelling/redness in leg.
- Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe stomach pain, nausea/vomiting.
- Signs of allergic reaction: rash, itching, swelling (especially face/tongue/throat), severe dizziness, trouble breathing.
- Changes in breast tissue (lumps, pain, discharge).
- Mood changes, depression.
- Fluid retention (swelling of ankles/feet).
Special Patient Groups
Pregnancy
Contraindicated. This medication is not indicated for use in pregnant women and should not be used during pregnancy. If pregnancy occurs during therapy, discontinue immediately.
Trimester-Specific Risks:
First Trimester:
Not applicable; contraindicated.
Second Trimester:
Not applicable; contraindicated.
Third Trimester:
Not applicable; contraindicated.
Lactation
Contraindicated. This medication is not indicated for use in lactating women. Estrogens and progestins are excreted in human milk and may decrease milk production and alter the composition of breast milk.
Infant Risk:
Potential for adverse effects on the infant (e.g., feminization, decreased milk supply).
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established.
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. Consider the lowest effective dose for the shortest duration consistent with treatment goals and risks.
Clinical Information
Clinical Pearls
- This specific low-dose combination (1mg norethindrone acetate / 5mcg ethinyl estradiol) is primarily used for menopausal hormone therapy (MHT), not contraception.
- Always assess for contraindications (e.g., history of VTE, breast cancer, liver disease, undiagnosed abnormal genital bleeding) before initiating MHT.
- Emphasize the importance of the Black Box Warning regarding cardiovascular events, stroke, breast cancer, and dementia, especially for women over 60 or those with risk factors.
- The goal of MHT is to use the lowest effective dose for the shortest duration to manage symptoms.
- Regular follow-up, including blood pressure checks, breast exams, and mammograms, is crucial.
- Counsel patients on the importance of reporting any unscheduled or abnormal vaginal bleeding immediately, as it may indicate endometrial pathology.
- Inform patients that while MHT can help with bone density, it is not the primary indication for this specific formulation if other osteoporosis treatments are available and preferred.
Alternative Therapies
- SSRIs/SNRIs (e.g., paroxetine, venlafaxine) for vasomotor symptoms.
- Gabapentin for vasomotor symptoms.
- Clonidine for vasomotor symptoms.
- Non-hormonal vaginal moisturizers/lubricants for vaginal atrophy.
- Bisphosphonates, denosumab, teriparatide for osteoporosis prevention/treatment.
- Lifestyle modifications (e.g., diet, exercise, avoiding triggers for hot flashes).
Cost & Coverage
Average Cost:
$30 - $150 per 28 or 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generics), Tier 3 (for brands)
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 details. 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 information about the medication taken, the amount, and the time it happened.