Prempro 0.625mg/5mg Tabs 28 (blue)
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 to establish a routine. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area.
Missing 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Do not smoke, as smoking increases the risk of blood clots, stroke, and heart attack, especially when taking hormones.
- Maintain a healthy diet and engage in regular weight-bearing exercise to support bone health.
- Discuss any concerns about diet, exercise, or smoking cessation with your healthcare provider.
- Limit alcohol intake.
Available Forms & 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 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, 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 pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision.
Changes in eyesight or loss of eyesight, bulging eyes, or changes in how contact lenses feel.
Breast lump, breast pain or soreness, or nipple discharge.
Pelvic pain.
Vaginal itching or discharge, or abnormal vaginal bleeding.
Depression or other mood changes.
Memory problems or loss.
This medication may cause fluid retention, leading to swelling or weight gain. If you experience swelling, weight gain, or trouble breathing, inform your doctor.
Seek immediate medical attention if you notice signs of a blood clot, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Trouble speaking or swallowing
In some people with cancer, high calcium levels have been reported with medications like this one. If you experience signs of high calcium levels, such as weakness, confusion, fatigue, headache, upset stomach or vomiting, constipation, or bone pain, contact your doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Feeling tired or weak
Back pain
Headache
Upset stomach or vomiting
Gas
Stomach pain or cramps
Bloating
Enlarged breasts
Tender breasts
* Hair loss
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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 severe headache or migraines
- Sudden vision changes (e.g., partial or complete loss of vision)
- Numbness or weakness in an arm or leg, especially on one side of the body
- Trouble speaking or understanding speech
- Sudden chest pain, shortness of breath, or coughing up blood
- Pain, swelling, or tenderness in one or both legs (especially calf)
- Yellowing of the skin or eyes (jaundice)
- New breast lump or nipple discharge
- Unusual vaginal bleeding or spotting after menopause
- Severe abdominal pain
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ 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
Hysterectomy (removal of the uterus)
Pregnancy or potential pregnancy. Note: This medication should not be taken during pregnancy.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. Your doctor may instruct you to stop taking this medication before certain surgical procedures, and will advise you on when to resume taking it after the surgery or procedure.
If you have diabetes, you will need to closely monitor your blood sugar levels. Additionally, be aware that this medication may cause high blood pressure, so it is crucial to have your blood pressure checked regularly as directed by your doctor.
High triglyceride levels have been associated with this medication, so if you have a history of elevated triglycerides, inform your doctor. Regular blood tests and bone density checks are also necessary, as directed by your doctor.
It is vital to maintain regular breast exams and gynecology check-ups, and to perform breast self-exams as instructed by your doctor. This medication may affect certain laboratory tests, so be sure to inform all your healthcare providers and lab personnel that you are taking this medication.
To minimize potential risks, limit your alcohol consumption and avoid smoking, as it increases the risk of heart disease. Discuss your smoking habits with your doctor. If you consume grapefruit juice or eat grapefruit regularly, consult with your doctor about potential interactions.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss the risks of blood clots with your doctor. This medication may cause dark skin patches on your face, so avoid sun exposure, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.
The risk of certain side effects, including heart attack, stroke, breast cancer, and ovarian cancer, may vary depending on factors such as the duration of estrogen therapy, whether it is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of this medication with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, consult with your doctor about potential risks to your baby.
Osteoporosis
To maximize the effectiveness of this medication, it is essential to combine it with calcium and vitamin D supplements, as well as weight-bearing exercises like walking or physical therapy. Follow the diet and exercise plan recommended by your doctor to maintain strong bones and overall health.
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. Contact a poison control center or seek immediate medical attention. Call 1-800-222-1222 for poison control assistance.
Drug Interactions
Major Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, St. John's Wort): May decrease estrogen and progestin concentrations, potentially reducing efficacy.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir, grapefruit juice): May increase estrogen and progestin concentrations, potentially increasing adverse effects.
Moderate Interactions
- Thyroid hormones (e.g., levothyroxine): Estrogens can increase thyroid-binding globulin (TBG), potentially increasing thyroid hormone requirements.
- Corticosteroids (e.g., prednisone): Estrogens may decrease the clearance of corticosteroids, leading to increased pharmacologic effects.
- Anticoagulants (e.g., warfarin): Estrogens may alter the effects of anticoagulants; monitor INR/PT.
Minor Interactions
- Not available
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 HRT may increase risk.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Rationale: To screen for gynecological conditions, including endometrial or cervical cancer.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation of therapy
Rationale: To assess hepatic function, as the drug is metabolized in the liver.
Timing: Prior to initiation of therapy, if clinically indicated
Routine Monitoring
Frequency: Annually
Target: Normal
Action Threshold: Any significant changes or new symptoms
Frequency: Annually or as clinically indicated
Target: Normal
Action Threshold: Sustained elevation
Frequency: Annually (breast exam); mammography per national guidelines
Target: Normal
Action Threshold: New lumps, pain, or abnormal findings
Frequency: Annually or as clinically indicated
Target: Normal
Action Threshold: Abnormal bleeding, pain, or abnormal findings
Frequency: Annually
Target: Symptom control with lowest effective dose
Action Threshold: Persistent symptoms, new adverse effects, or desire to discontinue
Symptom Monitoring
- Unusual vaginal bleeding or spotting
- New breast lumps or changes
- Leg pain, swelling, or tenderness (signs of DVT)
- Sudden chest pain, shortness of breath, or coughing up blood (signs of PE)
- Sudden severe headache, vision changes, slurred speech, weakness or numbness in an arm or leg (signs of stroke)
- Chest pain or discomfort, pain radiating to arm, back, neck, jaw, or stomach (signs of MI)
- Yellowing of skin or eyes (jaundice)
- Severe abdominal pain
- Memory loss or cognitive decline
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for Prempro in pregnancy, and there is evidence of fetal harm.
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 nursing infant are possible.
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established.
Geriatric Use
Increased risk of stroke, deep vein thrombosis, pulmonary embolism, and probable dementia in women 65 years of age or older. Use the lowest effective dose for the shortest duration consistent with treatment goals. Careful risk-benefit assessment is crucial.
Clinical Information
Clinical Pearls
- Prempro is a combination hormone therapy, meaning it contains both estrogen and progestin. The progestin component is crucial for women with an intact uterus to reduce the risk of endometrial cancer associated with unopposed estrogen.
- This medication is not for the prevention of heart disease, stroke, or dementia. The risks of these serious conditions may outweigh the benefits for some women, especially older women.
- Always use the lowest effective dose for the shortest duration possible to manage menopausal symptoms.
- Regular follow-up appointments, including annual physical exams, breast exams, and mammograms, are essential while on HRT.
- Report any unusual vaginal bleeding, breast lumps, or symptoms of blood clots (e.g., leg pain, chest pain, shortness of breath) immediately to your healthcare provider.
- Consider non-hormonal alternatives for menopausal symptoms or osteoporosis prevention if risks of HRT outweigh benefits for the individual patient.
Alternative Therapies
- For vasomotor symptoms (hot flashes): SSRIs/SNRIs (e.g., paroxetine, venlafaxine), gabapentin, clonidine, fezolinetant (Veozah).
- For vaginal atrophy: Local vaginal estrogen products (creams, rings, tablets).
- For osteoporosis prevention: Bisphosphonates (e.g., alendronate, risedronate), Selective Estrogen Receptor Modulators (SERMs) (e.g., raloxifene), denosumab, teriparatide, abaloparatide, romosozumab, calcium and vitamin D supplementation.