Jinteli 1mg/5mcg Tablets28s
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
Category X
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication contains two female hormones, estrogen (Ethinyl Estradiol) and progestin (Norethindrone). It is used to help women who are going through menopause by reducing symptoms like hot flashes and vaginal dryness. It also helps prevent bone thinning (osteoporosis) that can happen after menopause. The progestin is included to protect the lining of the uterus if you still have your uterus.
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 to establish a routine. You can take it with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication to avoid any potential interactions.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom, and out of reach of children and pets. Properly dispose of any 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. Check with your pharmacist for guidance on the best way to dispose of your medication, as there may be drug take-back programs available 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 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, consult your doctor before restarting your medication to ensure your safety and the effectiveness of the treatment.
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 to establish a routine. You can take it with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication to avoid any potential interactions.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom, and out of reach of children and pets. Properly dispose of any 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. Check with your pharmacist for guidance on the best way to dispose of your medication, as there may be drug take-back programs available 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 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, consult your doctor before restarting your medication to ensure your safety and the effectiveness of the treatment.
Lifestyle & Tips
- Maintain a healthy diet rich in calcium and Vitamin D.
- Engage in regular weight-bearing exercise to support bone health.
- Avoid smoking, as it increases the risk of blood clots and other cardiovascular issues.
- Limit alcohol consumption.
- Attend all scheduled doctor appointments and screenings (e.g., mammograms).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (1 mg norethindrone / 5 mcg ethinyl estradiol) orally once daily.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
vasomotorSymptoms:
One tablet orally once daily.
osteoporosisPrevention:
One tablet orally once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
Dialysis:
Not available, use with caution.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution.
Severe:
Contraindicated due to impaired estrogen metabolism.
Pharmacology
Mechanism of Action
Ethinyl Estradiol (estrogen component) replaces declining endogenous estrogen levels, alleviating menopausal symptoms such as vasomotor symptoms (hot flashes) and vulvar and vaginal atrophy. It also helps prevent postmenopausal osteoporosis. Norethindrone (progestin component) 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: ~40-50% (due to first-pass metabolism); Norethindrone: ~60-100%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours
FoodEffect:
Minimal or variable effect on absorption.
Distribution:
Vd:
Ethinyl Estradiol: 4-15 L/kg; Norethindrone: 2-4 L/kg
ProteinBinding:
Ethinyl Estradiol: >95% (to albumin and sex hormone-binding globulin); Norethindrone: >95% (to albumin and sex hormone-binding globulin)
CnssPenetration:
Yes
Elimination:
HalfLife:
Ethinyl Estradiol: 13-27 hours; Norethindrone: 5-14 hours
Clearance:
Not readily available as a single value for combination.
ExcretionRoute:
Primarily renal (as metabolites), some biliary/fecal excretion.
Unchanged:
<10% (both components)
Pharmacodynamics
OnsetOfAction:
Symptomatic relief may begin within weeks.
PeakEffect:
Full therapeutic effect for symptom relief may take several weeks to months.
DurationOfAction:
Daily dosing maintains therapeutic levels.
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 conjugated estrogens (CE) plus medroxyprogesterone acetate (MPA) relative to placebo. The WHI study also reported an increased risk of stroke and deep vein thrombosis in postmenopausal women (50-79 years of age) during 7.1 years of treatment with CE alone relative to placebo. The WHI Memory Study (WHIMS), an ancillary study of WHI, reported an increased risk of probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with CE plus MPA and during 5.2 years of treatment with CE alone relative to placebo. These risks apply to other estrogen and progestin products for MHT. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks.
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 experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of low calcium levels, such as:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Depression or other mood changes
Breast changes, including:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal itching or discharge
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
Severe or persistent vaginal bleeding or spotting
Fluid retention, which may cause swelling, weight gain, or trouble breathing
Blood Clots and High Calcium Levels
If you experience any of the following symptoms, seek medical attention immediately:
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach or vomiting
+ Constipation
+ Bone pain
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Appetite changes
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged breasts
Tender breasts
Dark patches of skin on the face (avoid sun exposure and use sunscreen)
Diarrhea
* Vaginal bleeding or spotting
Reporting Side Effects
If you have questions about side effects or experience any side effects not listed here, 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 experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of low calcium levels, such as:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Depression or other mood changes
Breast changes, including:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal itching or discharge
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
Severe or persistent vaginal bleeding or spotting
Fluid retention, which may cause swelling, weight gain, or trouble breathing
Blood Clots and High Calcium Levels
If you experience any of the following symptoms, seek medical attention immediately:
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach or vomiting
+ Constipation
+ Bone pain
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Appetite changes
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged breasts
Tender breasts
Dark patches of skin on the face (avoid sun exposure and use sunscreen)
Diarrhea
* Vaginal bleeding or spotting
Reporting Side Effects
If you have questions about side effects or experience any side effects not listed here, 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 on one side of the body
- Slurred speech or difficulty speaking
- Sudden chest pain, shortness of breath, or coughing up blood
- Pain, swelling, or redness in one leg
- New breast lumps or changes
- Unusual vaginal bleeding (e.g., heavy bleeding, bleeding between periods, or bleeding after menopause has stopped)
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
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, 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, heart disease, or abnormal heart rhythms like 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 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 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 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 regimen without consulting 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, 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, heart disease, or abnormal heart rhythms like 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 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 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 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 regimen 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 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. 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 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 consume grapefruit juice or eat grapefruit frequently, consult with your doctor.
This medication may affect the results of certain lab tests. Inform all your healthcare providers and lab workers 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. 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 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 consume grapefruit juice or eat grapefruit frequently, consult with your doctor.
This medication may affect the results of certain lab tests. Inform all your healthcare providers and lab workers 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
- 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 in the US) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - due to antagonism of effect.
- Certain anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital) - may decrease efficacy of HRT.
- Rifampin - may decrease efficacy of HRT.
- St. John's Wort - may decrease efficacy of HRT.
Major Interactions
- CYP3A4 inducers (e.g., bosentan, efavirenz, nevirapine) - may decrease estrogen/progestin levels and efficacy.
- CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) - may increase estrogen/progestin levels and adverse effects.
- Thyroid hormones (e.g., levothyroxine) - HRT may increase thyroid-binding globulin, requiring increased thyroid hormone dose.
Moderate Interactions
- Corticosteroids (e.g., prednisone) - HRT may decrease corticosteroid clearance, increasing their effects.
- Cyclosporine - HRT may inhibit cyclosporine metabolism, increasing its levels and toxicity.
- Lamotrigine - HRT may decrease lamotrigine levels, potentially leading to loss of seizure control.
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 assess overall health, identify contraindications, and establish baseline for future comparisons.
Timing: Prior to initiation of therapy.
Blood pressure
Rationale: To establish baseline and monitor for hypertension, a potential risk factor.
Timing: Prior to initiation.
Breast examination and mammography
Rationale: To screen for breast cancer and establish baseline for breast health.
Timing: Prior to initiation, as per screening guidelines.
Pelvic examination and Pap test
Rationale: To screen for gynecological conditions and cervical cancer.
Timing: Prior to initiation, as per screening guidelines.
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if clinically indicated.
Target: <130/80 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require intervention or re-evaluation of HRT.
Breast examination
Frequency: Annually.
Target: Normal findings.
Action Threshold: New lumps, pain, or other abnormalities should prompt further investigation.
Mammography
Frequency: As per national screening guidelines (e.g., every 1-2 years).
Target: Normal findings.
Action Threshold: Abnormal findings require further diagnostic workup.
Assessment of symptoms and treatment goals
Frequency: Annually.
Target: Symptom control with minimal side effects.
Action Threshold: Persistent symptoms, intolerable side effects, or changes in risk profile may warrant dose adjustment or discontinuation.
Symptom Monitoring
- Abnormal vaginal bleeding (spotting, breakthrough bleeding, or persistent bleeding)
- New breast lumps or pain
- Severe headache or migraine
- Sudden vision changes
- Leg pain, swelling, or tenderness (signs of deep vein thrombosis)
- Chest pain, shortness of breath, or coughing up blood (signs of pulmonary embolism)
- Yellowing of skin or eyes (jaundice)
- Abdominal pain or swelling
- Changes in mood or memory
Special Patient Groups
Pregnancy
Contraindicated. This medication is not indicated for use during pregnancy and there is no benefit to its use in pregnant women. There is evidence of increased risk of birth defects associated with the use of sex hormones during pregnancy.
Trimester-Specific Risks:
First Trimester:
Known teratogen risk for sex hormones, though specific risks with this low dose for MHT are not fully established, it is not indicated for use in pregnancy.
Second Trimester:
Not applicable, contraindicated.
Third Trimester:
Not applicable, contraindicated.
Lactation
Not recommended. Estrogens and progestins are excreted in breast milk and may decrease the quantity and quality of breast milk. Potential adverse effects on the infant have been reported.
Infant Risk:
Possible adverse effects on the infant, including feminization or other hormonal effects. Decreased milk production.
Pediatric Use
Not indicated for pediatric use. Safety and efficacy have not been established in pediatric patients.
Geriatric Use
Use with caution, especially in women 65 years of age or older, due to an increased risk of probable dementia as observed in the WHIMS study. Use the lowest effective dose for the shortest duration consistent with treatment goals and risks. Regular re-evaluation of the need for continued therapy is important.
Clinical Information
Clinical Pearls
- This specific low-dose combination (1 mg Norethindrone / 5 mcg Ethinyl Estradiol) is primarily indicated for menopausal hormone therapy (MHT) to manage vasomotor symptoms and prevent osteoporosis, not for contraception.
- Always use the lowest effective dose for the shortest duration consistent with treatment goals and risks, and periodically re-evaluate the need for continued therapy.
- Patients with an intact uterus must receive a progestin along with estrogen to reduce the risk of endometrial hyperplasia and cancer.
- Educate patients thoroughly on the black box warnings, particularly regarding the increased risks of cardiovascular events, stroke, breast cancer, and probable dementia.
- Advise patients to report any abnormal vaginal bleeding immediately, as it may be a sign of endometrial pathology.
- Consider discontinuing HRT at least 4 to 6 weeks prior to elective surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.
Alternative Therapies
- Selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) for vasomotor symptoms (e.g., paroxetine, venlafaxine).
- Gabapentin for vasomotor symptoms.
- Clonidine for vasomotor symptoms.
- Bisphosphonates (e.g., alendronate, risedronate) for osteoporosis prevention/treatment.
- Selective estrogen receptor modulators (SERMs) (e.g., bazedoxifene/conjugated estrogens, ospemifene) for specific menopausal symptoms or osteoporosis.
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about what was taken, the amount, and the time it happened.