Femhrt 1/5 Tablets

Manufacturer ACTAVIS Active Ingredient Ethinyl Estradiol and Norethindrone (MHT)(ETH in il es tra DYE ole & nor eth IN drone) Pronunciation ETH-in-il ES-tra-DYE-ole & nor-ETH-in-drone
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.
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Drug Class
Menopausal Hormone Therapy (MHT)
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Pharmacologic Class
Estrogen and Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Aug 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Femhrt is a medication containing two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone). It is used by women after menopause to help relieve symptoms like hot flashes and vaginal dryness. The progestin helps protect the uterus from certain risks associated with estrogen.
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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 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 way to dispose of your medication. You may also want to explore 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 resume your regular schedule. Do not take two doses at the same time or take extra doses. If you miss taking your medication for several days in a row, contact your doctor before restarting your medication.
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Lifestyle & Tips

  • Do not smoke, as smoking increases the risk of serious cardiovascular side effects (blood clots, stroke, heart attack) with hormone therapy.
  • Maintain a healthy diet and engage in regular physical activity.
  • Discuss any concerns about bone health, as this medication can help prevent osteoporosis.
  • Attend all scheduled doctor appointments and screenings (e.g., mammograms, pelvic exams).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet (0.005 mg Ethinyl Estradiol / 1 mg Norethindrone Acetate) orally once daily
Dose Range: 0.005 - 1 mg

Condition-Specific Dosing:

menopausalSymptoms: For the treatment of moderate to severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: Use with caution; monitor for adverse effects.
Dialysis: Not specifically studied; use with caution.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Use with caution; monitor for adverse effects.
Severe: Contraindicated in severe hepatic impairment.

Pharmacology

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Mechanism of Action

Ethinyl estradiol is a synthetic estrogen that replaces the declining endogenous estrogen production in postmenopausal women, alleviating menopausal symptoms. Norethindrone acetate is a synthetic progestin that counteracts the estrogen-induced proliferation of the endometrium, thereby reducing the risk of endometrial hyperplasia and carcinoma in women with an intact uterus receiving estrogen therapy.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-80%
Tmax: Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours
FoodEffect: Minimal effect on absorption.

Distribution:

Vd: Ethinyl Estradiol: 2-4 L/kg; Norethindrone: ~4 L/kg
ProteinBinding: Ethinyl Estradiol: >95% (to albumin and SHBG); Norethindrone: ~61% (to albumin and SHBG)
CnssPenetration: Limited for Ethinyl Estradiol; Yes for Norethindrone

Elimination:

HalfLife: Ethinyl Estradiol: 13-27 hours; Norethindrone: 5-14 hours
Clearance: Not available
ExcretionRoute: Renal and fecal (as metabolites)
Unchanged: <1% for both
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Pharmacodynamics

OnsetOfAction: Days to weeks for symptom relief
PeakEffect: Gradual, maintained with daily dosing
DurationOfAction: Maintained with daily dosing

Safety & Warnings

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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 developing 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. Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins, were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. Therefore, the lowest effective dose should be used for the shortest duration consistent with treatment goals and risks for the individual woman.
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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 immediate medical attention:

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.

Common Side Effects

Most people do not experience severe side effects, but some may have mild or moderate side effects. If you notice any of the following symptoms and they bother you or do not go away, contact your doctor:

Appetite changes.
Weight gain or loss.
Dizziness or headache.
Upset stomach or vomiting.
Stomach cramps.
Bloating.
Enlarged or tender breasts.
Diarrhea.
Vaginal bleeding or spotting.
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, use sunscreen, and wear protective clothing and eyewear).

Reporting Side Effects

This list is not exhaustive, and you may experience other 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.
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Seek Immediate Medical Attention If You Experience:

  • Sudden chest pain or shortness of breath (possible blood clot in lungs)
  • Sudden severe headache, dizziness, or vision changes (possible stroke)
  • Sudden numbness or weakness on one side of the body (possible stroke)
  • Pain, swelling, or redness in one leg (possible deep vein thrombosis)
  • Yellowing of the skin or eyes (jaundice), dark urine, or light-colored stools (possible liver problems)
  • New breast lump or changes in existing breast lumps
  • Unusual vaginal bleeding or spotting after menopause
  • Severe abdominal pain
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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 treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
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 (angina) 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 problems, including:
+ Endometrial cancer, cervical cancer, or vaginal cancer
+ Unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
+ Chloasma (dark skin patches) or increased sensitivity to the sun 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
* A history of jaundice (yellowing of the skin) during pregnancy or with estrogen use (e.g., hormonal birth control)

This list is not exhaustive. It is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to ensure safe treatment. Do not start, stop, or change the dose of any medication without consulting your doctor.
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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. Ensure that your blood pressure is checked regularly, as advised by your doctor.

Additionally, this drug may lead to increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly have your blood work and other laboratory tests checked, as recommended by your doctor.

It is crucial to maintain regular breast exams and gynecology check-ups, and to 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.

For optimal effectiveness, this medication should be used in conjunction with calcium and vitamin D supplements, as well as 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. Consult with your doctor about quitting smoking.

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.
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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

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Major Interactions

  • Aromatase inhibitors (e.g., anastrozole, exemestane, letrozole) - concurrent use may reduce efficacy of aromatase inhibitors.
  • Tamoxifen - concurrent use may reduce efficacy of tamoxifen.
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Moderate Interactions

  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) - may decrease estrogen/progestin levels, reducing efficacy and increasing risk of breakthrough bleeding.
  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, ritonavir, grapefruit juice) - may increase estrogen/progestin levels, increasing risk of adverse effects.
  • Thyroid hormone replacement (e.g., levothyroxine) - estrogens can increase thyroid-binding globulin (TBG), potentially increasing thyroid hormone requirements.
  • Corticosteroids (e.g., prednisone) - estrogens can decrease corticosteroid clearance, leading to increased effects.
  • Anticoagulants (e.g., warfarin) - may alter anticoagulant effects; monitor INR.
  • Lamotrigine - estrogens may decrease lamotrigine levels, reducing seizure control.
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Minor Interactions

  • Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
  • Acetaminophen - may increase ethinyl estradiol levels.

Monitoring

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Baseline Monitoring

Complete medical history and physical examination

Rationale: To identify contraindications, risk factors, and establish baseline health status.

Timing: Prior to initiation of therapy

Blood pressure

Rationale: Estrogens can affect blood pressure.

Timing: Prior to initiation of therapy

Breast examination and mammography

Rationale: To screen for breast cancer, as MHT can increase risk.

Timing: Prior to initiation of therapy, as per screening guidelines

Pelvic examination and Pap test

Rationale: To screen for gynecological conditions and cervical cancer.

Timing: Prior to initiation of therapy, as per screening guidelines

Lipid profile

Rationale: Estrogens can affect lipid metabolism.

Timing: Prior to initiation of therapy

Liver function tests (LFTs)

Rationale: MHT is metabolized in the liver; contraindicated in severe hepatic impairment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Annual physical examination

Frequency: Annually

Target: Not applicable

Action Threshold: Not applicable

Blood pressure

Frequency: Annually or as clinically indicated

Target: Normal range

Action Threshold: Significant elevation may require dose adjustment or discontinuation.

Breast examination and mammography

Frequency: Annually or as per screening guidelines

Target: No abnormalities

Action Threshold: New lumps, pain, or suspicious findings require further investigation.

Pelvic examination and Pap test

Frequency: Annually or as per screening guidelines

Target: No abnormalities

Action Threshold: Abnormal bleeding or suspicious findings require further investigation.

Symptom assessment (e.g., hot flashes, vaginal dryness, mood)

Frequency: Regularly (e.g., every 3-6 months initially, then annually)

Target: Symptom control with lowest effective dose

Action Threshold: Inadequate symptom control or intolerable side effects may require dose adjustment or alternative therapy.

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Symptom Monitoring

  • Hot flashes
  • Night sweats
  • Vaginal dryness
  • Mood changes
  • Sleep disturbances
  • Abnormal vaginal bleeding (spotting, heavy bleeding)
  • Breast tenderness or lumps
  • Leg pain or swelling
  • Chest pain or shortness of breath
  • Sudden severe headache or vision changes
  • Yellowing of skin or eyes (jaundice)

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy. There is no indication for Femhrt in pregnancy, and there is evidence of fetal risk. Estrogen and progestin use during pregnancy is associated with an increased risk of birth defects.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital anomalies, including cardiovascular and limb defects, if used during early pregnancy.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended during lactation. Estrogens and progestins are excreted in breast milk and may reduce the quantity and quality of breast milk. Potential adverse effects on the infant have been reported.

Infant Risk: Possible decrease in milk production; potential for adverse effects on the infant (e.g., jaundice, breast enlargement).
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Pediatric Use

Not indicated for use in pediatric patients. Safety and efficacy have not been established.

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Geriatric Use

Women 65 years of age or older have an increased risk of stroke, deep vein thrombosis, pulmonary embolism, myocardial infarction, and probable dementia when using MHT. Use the lowest effective dose for the shortest duration consistent with treatment goals and risks. Careful risk-benefit assessment is crucial.

Clinical Information

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Clinical Pearls

  • Femhrt is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis. It is not indicated for the prevention of cardiovascular disease or dementia.
  • Always use the lowest effective dose for the shortest duration consistent with treatment goals and risks for the individual woman.
  • Regular monitoring, including annual physical exams, breast exams, mammograms, and pelvic exams, is crucial.
  • Counsel patients on the Black Box Warning risks, especially cardiovascular events, breast cancer, and dementia.
  • Discontinue Femhrt if any signs of thrombotic disorders (e.g., DVT, PE, stroke, MI) occur.
  • Consider non-hormonal therapies for menopausal symptoms if hormone therapy is contraindicated or not desired.
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Alternative Therapies

  • Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., paroxetine, venlafaxine) for vasomotor symptoms.
  • Gabapentin for vasomotor symptoms.
  • Clonidine for vasomotor symptoms.
  • Ospemifene for dyspareunia (vaginal dryness).
  • Local vaginal estrogen for vaginal symptoms only.
  • Lifestyle modifications (e.g., diet, exercise, avoiding triggers, layered clothing) for vasomotor symptoms.
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Cost & Coverage

Average Cost: $100 - $200 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand; generic often Tier 1)
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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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.