Estratest Fs 1.25mg/2.5mg Tablets

Esterified Estrogens act by binding to estrogen receptors in target tissues, forming a complex that interacts with DNA to regulate gene expression, leading to physiological effects such as reduction of vasomotor symptoms and prevention of bone loss. Methyltestosterone acts by binding to androgen receptors in target tissues, promoting the development and maintenance of male secondary sex characteristics, and in women, may contribute to libido and overall well-being, particularly when estrogen alone is insufficient.

Serious Side Effects: Seek Medical Attention Immediately

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 help 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 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 stomach upset or vomiting
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Dizziness or passing out
Changes in eyesight or loss of vision
Bulging eyes
Changes in how contact lenses feel
Breast changes, including:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal changes, including:
+ Itching or discharge
+ Abnormal vaginal bleeding
Depression or other mood changes
Memory problems or loss
For females:
+ Deep voice
+ Facial hair
+ Acne
+ Changes in menstrual cycle
+ Enlarged clitoris
Fluid retention, which may cause swelling, weight gain, or trouble breathing

If you experience any of these symptoms, contact your doctor immediately. Additionally, be aware of the following:

Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, changes in color, or pain in a leg or arm
+ Trouble speaking or swallowing

Other Possible Side Effects

Most people do not experience serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:

Headache
Stomach upset or vomiting
Stomach cramps
Bloating
Hair loss
Breast tenderness
Enlarged breasts
Vaginal bleeding or spotting
Changes in sex drive
Weight gain or loss

This is not a comprehensive list of all 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.

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

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Do not take this medication if you are pregnant.
* Breastfeeding. You should not breastfeed while taking this medication.

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. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this drug.

There is a risk of developing high blood pressure with medications like this one. Therefore, it is important to have your blood pressure checked regularly, as advised by your doctor.

Regular blood work and other laboratory tests are necessary while taking this medication. Be sure to follow your doctor's instructions for scheduling these tests.

For women, regular breast exams and gynecology check-ups are vital. Additionally, perform breast self-exams as instructed by your healthcare provider.

This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this drug.

To minimize potential risks, limit your alcohol consumption and avoid cigarette smoking, as smoking increases the risk of heart disease. Discuss this with your doctor if you need help quitting.

If you regularly consume grapefruit juice or eat grapefruit, consult your doctor about potential interactions.

If you anticipate being immobile for extended periods, such as during long trips, bed rest after surgery, or illness, discuss this with your doctor, as prolonged immobility may increase your risk of developing blood clots.

This medication may cause elevated cholesterol and triglyceride levels. Consult your doctor about monitoring and managing these levels.

Additionally, this drug may cause dark skin patches on your face, known as melasma. To minimize this risk, avoid sun exposure, sunlamps, and tanning beds. Use sunscreen with a high SPF, and wear protective clothing and eyewear when outdoors.

In some individuals with cancer, medications like this one may lead to high calcium levels. Be aware of the signs of hypercalcemia, which include weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain. If you experience any of these symptoms, contact your doctor immediately.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

• Aromatase inhibitors (e.g., anastrozole, letrozole) - theoretical antagonism
• Drugs causing cholestasis (due to methyltestosterone hepatotoxicity)

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - may decrease estrogen and methyltestosterone levels, reducing efficacy.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may increase estrogen and methyltestosterone levels, increasing adverse effects.
• Oral anticoagulants (e.g., warfarin) - estrogens can alter clotting factors, requiring INR monitoring and dose adjustment.
• Corticosteroids (e.g., prednisone) - increased risk of fluid retention and edema.

• Thyroid hormones (e.g., levothyroxine) - estrogens can increase thyroid binding globulin (TBG), potentially increasing thyroid hormone requirements.
• Hypoglycemic agents (e.g., insulin, oral antidiabetics) - estrogens may decrease glucose tolerance, requiring dose adjustment.
• Cyclosporine - estrogens may increase cyclosporine levels, increasing toxicity.
• Fluvoxamine - may increase estrogen levels.

• Grapefruit juice - may increase methyltestosterone levels.

• Abnormal vaginal bleeding
• Breast lumps or pain
• Signs of virilization (e.g., deepening voice, hirsutism, clitoral enlargement)
• Signs of fluid retention (e.g., swelling of ankles/feet, weight gain)
• Symptoms of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting, abdominal pain)
• Symptoms of venous thromboembolism (e.g., sudden chest pain, shortness of breath, pain/swelling in leg)
• Symptoms of myocardial infarction or stroke (e.g., sudden severe headache, vision changes, weakness/numbness on one side of body)
• Mood changes, depression

Contraindicated in pregnancy (Category X). There is no indication for use in pregnancy, and there is evidence of fetal harm, including potential for virilization of a female fetus due to the methyltestosterone component.

Contraindicated during lactation (L5). Estrogens and androgens are excreted in breast milk and may decrease milk production. Potential for serious adverse effects in the nursing infant, including virilization.

Not indicated for use in pediatric patients. Safety and efficacy have not been established. Use in children could lead to premature epiphyseal closure and virilization.

Use with caution in geriatric patients. Women 65 years of age or older have an increased risk of probable dementia with estrogen-alone and estrogen plus progestin therapy. The risks of cardiovascular events and breast cancer also increase with age. Use the lowest effective dose for the shortest duration.

• Estratest Fs (Esterified Estrogens/Methyltestosterone) is generally not a first-line hormone therapy for menopausal symptoms due to the added risks of methyltestosterone, particularly hepatotoxicity and virilization.
• The methyltestosterone component is primarily included for women experiencing persistent low libido despite adequate estrogen therapy.
• Patients should be thoroughly counseled on the significant black box warnings associated with both estrogen and androgen components.
• Regular monitoring of liver function tests is crucial due to the hepatotoxic potential of methyltestosterone.
• This combination product is largely historical; many clinicians prefer to manage menopausal symptoms with estrogen-only or estrogen-progestin therapy, and address low libido with separate, often off-label, testosterone preparations if indicated and carefully monitored.

• Estrogen-only hormone therapy (e.g., conjugated estrogens, estradiol) for vasomotor symptoms and vaginal atrophy.
• Estrogen-progestin hormone therapy (e.g., conjugated estrogens/medroxyprogesterone acetate, estradiol/norethindrone) for women with a uterus.
• Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine).
• Testosterone therapy (off-label for women) for hypoactive sexual desire disorder.
• Ospemifene (for dyspareunia due to vulvar and vaginal atrophy).

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.