Femhrt 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
Hormone Replacement Therapy (HRT)
Pharmacologic Class
Estrogen/Progestin Combination; Estrogen Receptor Agonist; Progesterone Receptor Agonist
Pregnancy Category
Category X
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Femhrt is a medication containing two female hormones, estrogen and progestin. It is used by women after menopause to help with symptoms like hot flashes and to help prevent thinning of bones (osteoporosis). The progestin is included to protect the lining of the uterus from the effects of estrogen.
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, call 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, call your doctor before starting to take it again.
Lifestyle & Tips
- Take one tablet at the same time each day, with or without food.
- Do not skip doses. If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not take two doses at once.
- Maintain a healthy lifestyle, including a balanced diet rich in calcium and vitamin D, and regular weight-bearing exercise, to support bone health.
- Avoid smoking, as it increases the risk of serious cardiovascular side effects.
- Limit alcohol consumption.
- Discuss any new or worsening symptoms with your doctor promptly.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (1 mg norethindrone acetate / 5 mcg ethinyl estradiol) orally once daily, continuously.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
menopausalSymptoms:
For the treatment of moderate to severe vasomotor symptoms associated with menopause.
osteoporosisPrevention:
For the 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 dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
Not recommended due to potential for fluid retention and exacerbation of renal dysfunction.
Dialysis:
Not recommended.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Not recommended due to impaired metabolism of estrogens and progestins.
Severe:
Contraindicated due to impaired metabolism and potential for cholestasis.
Pharmacology
Mechanism of Action
Femhrt combines an estrogen (ethinyl estradiol) and a progestin (norethindrone acetate). Estrogens act by binding to estrogen receptors in target tissues, leading to gene transcription and protein synthesis, alleviating menopausal symptoms and preventing bone loss. The 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: ~40-45%; Norethindrone: ~64%
Tmax:
Ethinyl Estradiol: ~2 hours; Norethindrone: ~1-2 hours
FoodEffect:
Food may slightly delay absorption but does not significantly affect bioavailability.
Distribution:
Vd:
Ethinyl Estradiol: ~4-13 L/kg; Norethindrone: ~4 L/kg
ProteinBinding:
Ethinyl Estradiol: >95% (primarily to albumin); Norethindrone: ~61% to albumin, ~36% to SHBG
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: ~13-27 hours; Norethindrone: ~5-14 hours
Clearance:
Ethinyl Estradiol: ~5-10 mL/min/kg; Norethindrone: ~0.4 L/hr/kg
ExcretionRoute:
Primarily renal (urine) and fecal (bile)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Symptomatic relief for vasomotor symptoms may begin within weeks, but full effect may take 2-3 months. Bone density effects are gradual over months to years.
PeakEffect:
Peak symptomatic relief typically within 3-6 months.
DurationOfAction:
Daily dosing provides continuous 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 daily oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. These risks apply to Femhrt as well.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting.
Signs of low calcium levels: muscle cramps or spasms, numbness and tingling, or seizures.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Depression or other mood changes.
A lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Severe or persistent spotting or vaginal bleeding.
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing.
Additional Serious Side Effects
Blood clots: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm, or trouble speaking or swallowing.
High calcium levels (more common in people with cancer): weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain.
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following symptoms, 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
This is not an exhaustive list of possible 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.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Severe or persistent spotting or vaginal bleeding.
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing.
Additional Serious Side Effects
Blood clots: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm, or trouble speaking or swallowing.
High calcium levels (more common in people with cancer): weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain.
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following symptoms, 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
This is not an exhaustive list of possible 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 chest pain or shortness of breath (signs of blood clot in lungs)
- Sudden severe headache, vision changes, slurred speech, or weakness/numbness on one side of the body (signs of stroke)
- Pain, swelling, or redness in one leg (signs of deep vein thrombosis)
- New breast lump or changes in breast tissue
- Unusual vaginal bleeding or spotting after menopause
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
- Sudden partial or complete loss of vision
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 use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack or stroke
+ High blood pressure
+ Liver tumor 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 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, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe use of this medication.
It is essential to inform your doctor about the following conditions and situations to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack or stroke
+ High blood pressure
+ Liver tumor 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 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, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe use of this medication.
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 affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
This medication may 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. Regularly undergo blood work and other laboratory tests as recommended by your doctor.
It is crucial to maintain regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you frequently consume grapefruit juice or eat grapefruit, discuss this with your doctor.
This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel 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. Discuss the risks associated with smoking with your doctor.
The risk of certain side effects, including heart attack, stroke, breast cancer, ovarian cancer, and others, may vary depending on factors such as the duration of estrogen use, whether it is taken with or without a progestin, and other individual factors. Consult with your doctor to understand the benefits and risks of using this medication.
This medication is not intended for use in children. Consult with your doctor if you have any questions or concerns.
If you anticipate being 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 affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
This medication may 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. Regularly undergo blood work and other laboratory tests as recommended by your doctor.
It is crucial to maintain regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you frequently consume grapefruit juice or eat grapefruit, discuss this with your doctor.
This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel 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. Discuss the risks associated with smoking with your doctor.
The risk of certain side effects, including heart attack, stroke, breast cancer, ovarian cancer, and others, may vary depending on factors such as the duration of estrogen use, whether it is taken with or without a progestin, and other individual factors. Consult with your doctor to understand the benefits and risks of using this medication.
This medication is not intended for use in children. Consult with your doctor if you have any questions or concerns.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding may occur in females.
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive; there is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Drugs that induce CYP3A4 leading to significantly reduced estrogen/progestin levels (e.g., certain aromatase inhibitors, some antineoplastics if used concurrently for specific conditions where HRT is contraindicated).
- Certain Hepatitis C virus (HCV) direct-acting antiviral combinations (e.g., ombitasvir/paritaprevir/ritonavir with or without dasabuvir) due to risk of ALT elevations.
Major Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, phenytoin, St. John's Wort): May decrease estrogen/progestin levels, leading to reduced efficacy and increased risk of breakthrough bleeding.
- CYP3A4 inhibitors (e.g., azole antifungals like ketoconazole, macrolide antibiotics like erythromycin, grapefruit juice): May increase estrogen/progestin levels, potentially increasing adverse effects.
- Thyroid hormone replacement therapy (e.g., levothyroxine): Estrogens can increase thyroid-binding globulin (TBG), potentially increasing thyroid hormone requirements.
- Lamotrigine: Estrogens can decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
Moderate Interactions
- Antibiotics (e.g., ampicillin, tetracycline): May alter gut flora, potentially interfering with enterohepatic recirculation of estrogens, leading to reduced efficacy (though clinical significance is debated).
- Corticosteroids: Estrogens may decrease the clearance of corticosteroids, leading to increased pharmacologic effects.
- Cyclosporine: Estrogens may inhibit the metabolism of cyclosporine, leading to increased plasma concentrations and potential toxicity.
Minor Interactions
- Acetaminophen: May increase ethinyl estradiol levels by inhibiting sulfation.
- Ascorbic acid (Vitamin C): May increase ethinyl estradiol levels by inhibiting sulfation.
Monitoring
Baseline Monitoring
Complete medical history and physical examination
Rationale: To identify contraindications, risk factors (e.g., cardiovascular disease, breast cancer), and establish baseline health status.
Timing: Prior to initiation of therapy.
Blood pressure
Rationale: Estrogens can cause fluid retention and may affect blood pressure.
Timing: Prior to initiation.
Breast examination and mammography
Rationale: To screen for breast cancer, as HRT may increase breast cancer risk.
Timing: Prior to initiation and as clinically indicated.
Pelvic examination and Pap test
Rationale: To screen for gynecological conditions, including cervical cancer.
Timing: Prior to initiation and as clinically indicated.
Lipid profile (cholesterol, triglycerides)
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation.
Liver function tests
Rationale: To assess hepatic function, as hormones are metabolized in the liver.
Timing: Prior to initiation, especially if history of liver disease.
Routine Monitoring
Annual physical examination
Frequency: Annually
Target: N/A
Action Threshold: N/A
Blood pressure
Frequency: Annually or more frequently if indicated
Target: Normal range for age
Action Threshold: Significant elevation (e.g., >140/90 mmHg) warrants evaluation and potential discontinuation.
Breast examination and mammography
Frequency: Annually (breast exam); mammography per screening guidelines
Target: N/A
Action Threshold: New breast lump or abnormal mammogram requires immediate investigation.
Pelvic examination and Pap test
Frequency: Per screening guidelines (e.g., every 1-3 years)
Target: N/A
Action Threshold: Abnormal results require further evaluation.
Assessment of menopausal symptoms
Frequency: Annually
Target: Symptom control with lowest effective dose
Action Threshold: Persistent or worsening symptoms, or desire to discontinue, warrants re-evaluation of therapy.
Assessment of bleeding patterns
Frequency: Regularly, especially during initial months
Target: Absence of unscheduled bleeding or predictable withdrawal bleeding (if applicable to regimen)
Action Threshold: Persistent, irregular, or heavy bleeding requires investigation to rule out endometrial pathology.
Symptom Monitoring
- Signs and symptoms of thromboembolic events (e.g., sudden chest pain, shortness of breath, severe leg pain/swelling, sudden vision changes, slurred speech, weakness/numbness on one side of body)
- Signs of breast cancer (e.g., new lump, skin changes, nipple discharge)
- Signs of liver dysfunction (e.g., jaundice, dark urine, abdominal pain)
- Changes in mood or cognitive function
- Fluid retention (e.g., swelling of ankles/feet, weight gain)
Special Patient Groups
Pregnancy
Femhrt is contraindicated in pregnancy. There is no indication for use in pregnancy. Estrogen and progestin combinations are not indicated for use during pregnancy and have been shown to cause fetal harm.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including genital abnormalities.
Second Trimester:
Not applicable, contraindicated.
Third Trimester:
Not applicable, contraindicated.
Lactation
Femhrt is contraindicated during lactation. Estrogens and progestins are excreted in breast milk and can decrease the quantity and quality of breast milk. Potential adverse effects on the nursing infant have been reported.
Infant Risk:
High (L4 - Possibly hazardous; L5 - Contraindicated). Can cause decreased milk production and potential adverse effects on the infant (e.g., jaundice, breast enlargement).
Pediatric Use
Femhrt is 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 receiving combined estrogen plus progestin therapy. Consider the lowest effective dose for the shortest duration consistent with treatment goals, and regularly re-evaluate the need for continued therapy.
Clinical Information
Clinical Pearls
- Always use the lowest effective dose for the shortest duration consistent with treatment goals.
- Periodically re-evaluate the need for continued therapy, typically at 3-6 month intervals or annually.
- Counsel patients on the Black Box Warnings regarding cardiovascular events, breast cancer, and dementia.
- Emphasize the importance of regular follow-up examinations, including breast exams and mammograms.
- Investigate any persistent, irregular, or heavy vaginal bleeding to rule out endometrial pathology.
- Consider non-hormonal alternatives for menopausal symptoms, especially in women with contraindications or high-risk factors for HRT.
Alternative Therapies
- Selective Estrogen Receptor Modulators (SERMs) for osteoporosis (e.g., raloxifene)
- Non-hormonal treatments for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Lifestyle modifications (e.g., diet, exercise, stress reduction, avoiding triggers for hot flashes)
Cost & Coverage
Average Cost:
$150 - $300 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand); Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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 the medication taken, the amount, and the time it happened.