Femhrt 1/5 Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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.
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.
Minor Interactions
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
- Acetaminophen - may increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Rationale: To identify contraindications, risk factors, and establish baseline health status.
Timing: Prior to initiation of therapy
Rationale: Estrogens can affect blood pressure.
Timing: Prior to initiation of therapy
Rationale: To screen for breast cancer, as MHT can increase risk.
Timing: Prior to initiation of therapy, as per screening guidelines
Rationale: To screen for gynecological conditions and cervical cancer.
Timing: Prior to initiation of therapy, as per screening guidelines
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation of therapy
Rationale: MHT is metabolized in the liver; contraindicated in severe hepatic impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: Annually
Target: Not applicable
Action Threshold: Not applicable
Frequency: Annually or as clinically indicated
Target: Normal range
Action Threshold: Significant elevation may require dose adjustment or discontinuation.
Frequency: Annually or as per screening guidelines
Target: No abnormalities
Action Threshold: New lumps, pain, or suspicious findings require further investigation.
Frequency: Annually or as per screening guidelines
Target: No abnormalities
Action Threshold: Abnormal bleeding or suspicious findings require further investigation.
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.
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
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:
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.
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established.
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
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.
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.