Femhrt Low Dose 0.5/2.5 Tabs 28s

Ethinyl estradiol is a synthetic estrogen that acts by binding to estrogen receptors in target tissues, leading to the expression of estrogen-responsive genes. Norethindrone acetate is a synthetic progestin that acts by binding to progesterone receptors, inducing secretory changes in the endometrium and counteracting the proliferative effects of estrogen on the endometrium. In combination, they provide hormone replacement therapy to alleviate menopausal symptoms and prevent osteoporosis.

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, fatigue, 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, fainting, or changes in vision
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 vision
Depression or other mood changes
Breast changes: lump, 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 vaginal bleeding or spotting
Fluid retention: swelling, 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, fatigue, headache, upset stomach or vomiting, constipation, or bone pain

Common Side Effects

Most people experience no side effects or only mild side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

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 (avoid sun exposure, use sunscreen, and protective clothing)
Diarrhea
Vaginal bleeding or spotting

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ 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 conditions, 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 sunlight or radiation
+ Hysterectomy (removal of the uterus)
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed
* A history of jaundice (yellowing of the skin) during pregnancy or with estrogen use, such as hormonal birth control

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to ensure safe use of this medication. Do not start, stop, or change the dose of any medication without consulting your doctor.

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 inactive 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 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 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, consult 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. Discuss the risks associated with smoking with your doctor.

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. Discuss the benefits and risks of using this medication with your doctor.

This medication is not intended for use in children. Consult your doctor for further guidance.

• Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use may reduce efficacy of aromatase inhibitors.
• Certain antineoplastic agents (e.g., fulvestrant) - may interfere with their mechanism of action.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) - may significantly decrease estrogen/progestin levels, leading to reduced efficacy and increased risk of breakthrough bleeding.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, 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), requiring increased thyroid hormone dose.
• Corticosteroids (e.g., prednisone) - estrogens may decrease the clearance of corticosteroids, leading to increased effects and toxicity.
• Anticoagulants (e.g., warfarin) - estrogens may alter the effects of anticoagulants; close monitoring of INR is required.

• Antidiabetic agents (e.g., insulin, metformin) - estrogens may impair glucose tolerance, requiring adjustment of antidiabetic therapy.
• Lamotrigine - estrogens may decrease lamotrigine levels, potentially leading to loss of seizure control.
• Cyclosporine - estrogens may inhibit cyclosporine metabolism, increasing its plasma concentrations and risk of toxicity.

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

• Unusual vaginal bleeding or spotting
• Breast lumps or changes
• Severe headaches or migraines
• Sudden partial or complete loss of vision
• Sudden onset of proptosis, diplopia, or migraine
• Signs of blood clot (e.g., sudden chest pain, shortness of breath, pain/swelling in leg)
• Signs of stroke (e.g., sudden numbness or weakness, confusion, trouble speaking, vision problems)
• Signs of heart attack (e.g., chest pain, discomfort, shortness of breath, cold sweat, nausea, lightheadedness)
• Jaundice or other signs of liver problems
• Significant mood changes or depression

Contraindicated in pregnancy. There is no indication for Femhrt Low Dose in pregnancy, and there is evidence of fetal harm.

Not recommended during lactation. Estrogens and progestins are excreted in breast milk and may decrease the quantity and quality of breast milk. Potential adverse effects on the breastfed infant are possible.

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

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 treated with conjugated estrogens plus medroxyprogesterone acetate. Consider the lowest effective dose for the shortest duration consistent with treatment goals. Regular reassessment of the need for continued therapy is crucial.

• Femhrt Low Dose is a continuous combined HRT, meaning both estrogen and progestin are taken daily, which typically results in amenorrhea (no bleeding) in most women after the first few months.
• This formulation is specifically for postmenopausal women and is NOT for contraception.
• Patients should be advised of the Black Box Warning regarding increased risks of cardiovascular events, breast cancer, and probable dementia.
• Regular follow-up appointments, including annual physical exams, mammograms, and pelvic exams, are crucial while on HRT.
• Therapy should be individualized, and the lowest effective dose for the shortest duration consistent with treatment goals should be used.
• Patients should be educated on the signs and symptoms of serious adverse events (e.g., blood clots, stroke, heart attack) and instructed to seek immediate medical attention if they occur.

• Selective Estrogen Receptor Modulators (SERMs) for osteoporosis prevention (e.g., raloxifene)
• Non-hormonal treatments for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
• Bisphosphonates or other anti-resorptive agents for osteoporosis (e.g., alendronate, zoledronic acid)
• Lifestyle modifications (diet, exercise, smoking cessation) for overall health and bone density.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.