Noreth/ethin 1mg-5mcg Tablets 28s
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
Contraceptive; Menopausal Hormone Therapy (MHT)
Pharmacologic Class
Estrogen and Progestin Combination
Pregnancy Category
Category X
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication contains two female hormones, an estrogen (ethinyl estradiol) and a progestin (norethindrone). It is primarily used to prevent pregnancy by stopping ovulation and changing the uterine lining and cervical mucus. It is also used as hormone replacement therapy to relieve symptoms of menopause, such as hot flashes and vaginal dryness, and to prevent bone loss (osteoporosis) after menopause. For menopausal hormone therapy, the progestin helps protect the uterus from certain cancers 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 to help minimize this side effect. 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
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or inquire about 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 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. If you miss taking your medication for several days in a row, contact your doctor before restarting your medication regimen.
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 to help minimize this side effect. 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
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or inquire about 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 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. If you miss taking your medication for several days in a row, contact your doctor before restarting your medication regimen.
Lifestyle & Tips
- Do not smoke, especially if you are over 35 years old, as smoking significantly increases the risk of serious side effects like blood clots, heart attack, and stroke.
- Maintain regular physical activity and a healthy diet.
- Attend all scheduled doctor's appointments and routine screenings (e.g., blood pressure checks, breast exams, Pap tests).
- Inform your doctor about all medications, supplements, and herbal products you are taking, as they can interact with this medication.
- If using for contraception, use a backup birth control method (e.g., condoms) for the first 7 days of the first cycle, or if you miss pills.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally once daily at the same time each day.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
Contraception:
Start on the first day of menstruation or the first Sunday after menstruation begins. Take continuously.
Menopausal Hormone Therapy (MHT):
Take continuously, without interruption.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Contraception: Not indicated before menarche; MHT: Not indicated)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required, but monitor for fluid retention.
Moderate:
No specific dose adjustment generally required, but monitor for fluid retention.
Severe:
Use with caution; monitor for fluid retention. Not extensively studied.
Dialysis:
Considerations: Not extensively studied. Use with caution and monitor closely.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Use with caution; monitor liver function. May require dose adjustment or discontinuation if liver function deteriorates.
Severe:
Contraindicated due to impaired metabolism of steroid hormones.
Pharmacology
Mechanism of Action
As a contraceptive, it primarily acts by suppressing gonadotropins (LH and FSH), thereby inhibiting ovulation. It also alters cervical mucus to impede sperm penetration and changes the endometrium to make it unsuitable for implantation. As Menopausal Hormone Therapy (MHT), Ethinyl Estradiol replaces declining endogenous estrogen levels, alleviating menopausal symptoms (e.g., hot flashes, vaginal atrophy) and preventing osteoporosis. Norethindrone is added to reduce the risk of endometrial hyperplasia and cancer associated with unopposed estrogen.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol (EE): ~40-45% (due to first-pass metabolism); Norethindrone (NE): ~60-100%
Tmax:
EE: ~1-2 hours; NE: ~0.5-4 hours
FoodEffect:
Food may slightly decrease Cmax for EE but does not significantly affect bioavailability. No clinically significant food effect for NE.
Distribution:
Vd:
EE: ~5-18 L/kg; NE: ~2-4 L/kg
ProteinBinding:
EE: >95% (to albumin and SHBG); NE: ~60-90% (to albumin and SHBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
EE: ~10-20 hours (terminal); NE: ~5-14 hours
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal and fecal (via enterohepatic recirculation for EE)
Unchanged:
Less than 10% for both
Pharmacodynamics
OnsetOfAction:
Contraceptive effect: Typically within 7 days of consistent use (if started correctly); MHT symptom relief: Days to weeks.
PeakEffect:
Contraceptive effect: Continuous with daily dosing; MHT symptom relief: Weeks to months.
DurationOfAction:
Continuous with daily dosing.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combined oral contraceptives should not be used by women who are over 35 years of age and smoke.
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) and 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 and medroxyprogesterone acetate, relative to placebo.
Increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Appropriate progestin should be added to decrease this risk.
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) and 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 and medroxyprogesterone acetate, relative to placebo.
Increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Appropriate progestin should be added to decrease this risk.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdominal area, right shoulder, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Signs of low calcium levels: muscle cramps or spasms, numbness and tingling, or seizures.
Weakness on one side of the body, difficulty speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge.
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel.
Severe or persistent vaginal bleeding or spotting.
Fluid Retention and Swelling
This medication may cause fluid retention and swelling in the body. If you experience swelling, weight gain, or difficulty breathing, inform your doctor.
Blood Clots
Seek medical attention immediately if you notice signs of a blood clot, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Difficulty speaking or swallowing
High Calcium Levels
In some people with cancer, high calcium levels have occurred while taking this medication. If you experience any of the following symptoms, contact your doctor right away:
Weakness
Confusion
Fatigue
Headache
Stomach upset or vomiting
Constipation
Bone pain
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Changes in appetite
Weight gain or loss
Dizziness or headache
Stomach upset or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Diarrhea
Vaginal bleeding or spotting
Skin Darkening
This medication may cause dark patches on the skin, particularly on the face. To minimize this risk, avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when outdoors.
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 right away:
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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdominal area, right shoulder, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Signs of low calcium levels: muscle cramps or spasms, numbness and tingling, or seizures.
Weakness on one side of the body, difficulty speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge.
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel.
Severe or persistent vaginal bleeding or spotting.
Fluid Retention and Swelling
This medication may cause fluid retention and swelling in the body. If you experience swelling, weight gain, or difficulty breathing, inform your doctor.
Blood Clots
Seek medical attention immediately if you notice signs of a blood clot, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Difficulty speaking or swallowing
High Calcium Levels
In some people with cancer, high calcium levels have occurred while taking this medication. If you experience any of the following symptoms, contact your doctor right away:
Weakness
Confusion
Fatigue
Headache
Stomach upset or vomiting
Constipation
Bone pain
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Changes in appetite
Weight gain or loss
Dizziness or headache
Stomach upset or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Diarrhea
Vaginal bleeding or spotting
Skin Darkening
This medication may cause dark patches on the skin, particularly on the face. To minimize this risk, avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when outdoors.
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:
- **A**bdominal pain (severe)
- **C**hest pain (severe), cough, shortness of breath
- **H**eadaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
- **E**ye problems (sudden partial or complete loss of vision, blurred vision)
- **S**evere leg pain (calf or thigh), swelling, redness, warmth
- Yellowing of skin or eyes (jaundice)
- Unusual vaginal bleeding or spotting (especially if heavy or persistent)
- Lump in the breast
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 to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, 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 heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, or vaginal cancer
+ Unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
Previous experiences with:
+ Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation
+ Hysterectomy (removal of the uterus)
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed
History of jaundice (yellowing of the skin) during pregnancy or with estrogen use, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. Verify that it is safe to take this medication with your other medications and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your medication regimen.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, 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 heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, or vaginal cancer
+ Unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
Previous experiences with:
+ Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation
+ Hysterectomy (removal of the uterus)
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed
History of jaundice (yellowing of the skin) during pregnancy or with estrogen use, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. Verify that it is safe to take this medication with your other medications and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your medication regimen.
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 inactivity 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 instructed 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, gynecology check-ups, and breast self-exams, as instructed by your doctor, are crucial while taking this medication.
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.
Be aware that this medication may affect certain lab test results. 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, vitamin D, and weight-bearing exercises, such as 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.
It is essential 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. 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 inactivity 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 instructed 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, gynecology check-ups, and breast self-exams, as instructed by your doctor, are crucial while taking this medication.
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.
Be aware that this medication may affect certain lab test results. 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, vitamin D, and weight-bearing exercises, such as 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.
It is essential 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. Consult with your doctor if you have any questions or concerns.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Withdrawal bleeding (in females)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive; there is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Drugs that are strong inducers of CYP3A4 (e.g., Rifampin, Carbamazepine, Phenytoin, Barbiturates, St. John's Wort) due to potential loss of contraceptive efficacy or MHT effect.
- Certain Hepatitis C virus (HCV) drug combinations (e.g., Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir) due to risk of elevated ALT levels.
Major Interactions
- Anticonvulsants (e.g., Topiramate, Oxcarbazepine, Felbamate): May reduce efficacy of hormonal contraceptives/MHT.
- Griseofulvin: May reduce efficacy.
- Lamotrigine: Estrogens can decrease lamotrigine plasma concentrations, requiring dose adjustments of lamotrigine.
- Thyroid hormones: May increase thyroid-binding globulin, leading to increased thyroid hormone requirements.
Moderate Interactions
- Antibiotics (e.g., Ampicillin, Tetracycline): Theoretical risk of reduced efficacy due to interference with enterohepatic recirculation (clinical significance debated).
- Azole antifungals (e.g., Ketoconazole, Itraconazole, Voriconazole): May increase estrogen/progestin levels.
- Grapefruit juice: May increase estrogen levels.
- Atorvastatin/Rosuvastatin: May increase estrogen levels.
Minor Interactions
- Acetaminophen: May increase estrogen levels.
- Ascorbic acid (Vitamin C): May increase estrogen levels.
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: To establish baseline and identify hypertension, a risk factor for cardiovascular events.
Timing: Prior to initiation
Physical Examination (including breast and pelvic exam)
Rationale: To assess overall health, rule out contraindications, and establish baseline for future comparisons.
Timing: Prior to initiation
Lipid Profile
Rationale: To assess cardiovascular risk, especially if patient has pre-existing dyslipidemia or risk factors.
Timing: Prior to initiation (if indicated)
Liver Function Tests (LFTs)
Rationale: To rule out pre-existing liver disease, a contraindication.
Timing: Prior to initiation (if history of liver disease or symptoms)
Routine Monitoring
Blood Pressure
Frequency: Annually or more frequently if concerns arise
Target: <140/90 mmHg (or individualized)
Action Threshold: Sustained elevation requiring intervention or discontinuation.
Annual Physical Examination
Frequency: Annually
Target: Not applicable
Action Threshold: Detection of new or worsening conditions, or signs of adverse effects.
Weight
Frequency: Annually or as needed
Target: Maintain healthy weight
Action Threshold: Significant, unexplained weight gain or loss.
Symptom Monitoring
- Signs and symptoms of venous thromboembolism (VTE) such as severe leg pain, swelling, warmth, redness (DVT), or sudden shortness of breath, chest pain, coughing up blood (PE).
- Signs and symptoms of stroke (e.g., sudden severe headache, weakness or numbness on one side of the body, speech changes, vision changes).
- Signs and symptoms of myocardial infarction (e.g., chest pain, discomfort, shortness of breath, pain radiating to arm/jaw).
- Signs and symptoms of liver dysfunction (e.g., jaundice, dark urine, light-colored stools, severe abdominal pain).
- Signs and symptoms of depression or mood changes.
- Unusual vaginal bleeding or spotting (especially for MHT, to rule out endometrial issues).
- Breast lumps or changes.
Special Patient Groups
Pregnancy
Contraindicated during pregnancy. There is no indication for use in pregnancy, and there is evidence of fetal risk. If pregnancy occurs during use, discontinue immediately.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on the fetus, including cardiovascular defects and limb reduction defects, if exposure occurs during early pregnancy. However, data are conflicting and the overall risk is considered low.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Use is generally not recommended during breastfeeding. Estrogens and progestins can be excreted in breast milk and may decrease the quantity and quality of breast milk. Small amounts of steroids have been identified in the milk of mothers receiving oral contraceptives.
Infant Risk:
Potential for adverse effects on the infant, including jaundice and breast enlargement. Long-term effects on breastfed infants are not fully established. Consider non-hormonal methods or progestin-only methods if breastfeeding.
Pediatric Use
Not indicated for contraception before menarche. Not indicated for menopausal hormone therapy in pediatric patients. Safety and efficacy have not been established in pediatric patients.
Geriatric Use
Not indicated for contraception in geriatric patients. For menopausal hormone therapy, use in women aged 65 years and older should be carefully considered due to increased risks of stroke and probable dementia, as observed in the WHI and WHIMS studies. Use the lowest effective dose for the shortest duration consistent with treatment goals.
Clinical Information
Clinical Pearls
- This specific low-dose combination (1mg Norethindrone / 5mcg Ethinyl Estradiol) is commonly used for Menopausal Hormone Therapy (MHT) to manage menopausal symptoms and prevent osteoporosis, with the progestin component protecting the endometrium.
- While it can provide contraception, the very low estrogen dose (5mcg EE) might be associated with more breakthrough bleeding compared to higher-dose contraceptive pills.
- Missed doses: If one pill is missed, take it as soon as remembered and the next pill at the regular time. If two or more pills are missed, refer to the package insert for specific instructions, as contraceptive efficacy may be reduced, and a backup method may be needed.
- Non-contraceptive benefits (when used for contraception) include regulation of menstrual cycles, reduction of menstrual pain and blood loss, and improvement of acne.
- Patients should be advised to report any signs of blood clots (e.g., severe leg pain, chest pain, sudden shortness of breath) immediately.
Alternative Therapies
- For Contraception: Progestin-only pills, contraceptive patch, vaginal ring, injectable contraceptives (Depo-Provera), contraceptive implant (Nexplanon), intrauterine devices (IUDs), barrier methods (condoms, diaphragm), permanent sterilization.
- For Menopausal Hormone Therapy: Non-hormonal therapies for hot flashes (e.g., SSRIs/SNRIs, gabapentin, clonidine), vaginal moisturizers/lubricants for vaginal atrophy, bisphosphonates or other anti-resorptive agents for osteoporosis.
Cost & Coverage
Average Cost:
$20 - $60 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generics)
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.