Prempro 0.45mg/1.5mg Tabs 28's
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, it's essential to 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
To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, 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 or healthcare provider. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program.
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 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 the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed, usually once daily at the same time.
- Do not smoke, as smoking significantly increases the risk of blood clots, heart attack, and stroke while on hormone therapy.
- Maintain a healthy diet rich in calcium and Vitamin D, and engage in regular weight-bearing exercise to support bone health.
- Attend all scheduled doctor's appointments and screenings, including annual physicals, mammograms, and pelvic exams.
- Report any unusual vaginal bleeding, breast lumps, or severe side effects to your doctor immediately.
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 help right away:
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-related symptoms: lump in the breast, breast pain or soreness, or nipple discharge.
Pelvic pain.
Vaginal symptoms: itching, discharge, or abnormal 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.
Blood Clots and High Calcium Levels
Seek immediate medical attention if you experience signs of a blood clot, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Trouble speaking or swallowing
High calcium levels have been reported in some people with cancer taking medications like this one. If you experience any of the following symptoms, contact your doctor right away:
Weakness
Confusion
Fatigue
Headache
Upset stomach or vomiting
Constipation
Bone pain
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Feeling tired or weak
Back pain
Headache
Upset stomach or vomiting
Gas
Stomach pain or cramps
Bloating
Enlarged breasts
Tender breasts
Hair loss
This is not an exhaustive list of potential side effects. If you have questions or concerns, 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 severe headache, dizziness, or fainting
- Sudden vision changes or loss
- Chest pain, shortness of breath, coughing up blood
- Pain, swelling, or tenderness in one leg (especially calf or thigh)
- Weakness or numbness in an arm or leg, especially on one side of the body
- Slurred speech or difficulty speaking
- New breast lump or changes in the breast
- Unusual vaginal bleeding or spotting after menopause
- Yellowing of the skin or eyes (jaundice)
- 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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of developing blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Previous removal of the uterus (hysterectomy)
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
This medication may interact with other medications or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. This list is not exhaustive, and your doctor and pharmacist need to be aware of all your medications and health problems to determine if it is safe for you to take this medication.
Precautions & Cautions
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. 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, it is crucial to closely monitor your blood sugar levels while taking this medication. Additionally, be aware that this medication may cause high blood pressure, so follow your doctor's instructions for regular blood pressure checks.
High triglyceride levels have been associated with this medication, so notify your doctor if you have a history of elevated triglycerides. Regular blood tests and bone density checks are also necessary, as directed by your doctor.
To ensure your overall health, maintain a regular schedule of breast exams, gynecology check-ups, and breast self-exams, as advised by your doctor. Be aware that this medication may affect certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
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 regularly consume grapefruit juice or eat grapefruit, consult with your doctor about potential interactions.
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 the risk of blood clots.
This medication may cause dark skin patches on your face, so avoid excessive sun exposure, sunlamps, and tanning beds. Use sunscreen and protective clothing and eyewear to minimize your risk. Be aware that the risk of certain side effects, such as heart attack, stroke, breast cancer, and ovarian cancer, may vary depending on factors like the duration of estrogen use, combination with 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 to discuss potential risks to your baby.
Osteoporosis Prevention
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements, and engage in weight-bearing exercises, such as walking or physical therapy, as directed by your doctor. Adhere to the diet and exercise plan recommended by your doctor to maintain optimal bone 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. In case of suspected overdose, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Major Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole): Concurrent use may reduce efficacy of aromatase inhibitors.
- Tranexamic acid: Increased risk of thrombosis.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort): May decrease estrogen and progestin levels, reducing efficacy.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, erythromycin, ritonavir, grapefruit juice): May increase estrogen and 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.
- Anticoagulants (e.g., warfarin): Estrogens may alter clotting factors, potentially affecting anticoagulant response. Close monitoring of INR is recommended.
- Corticosteroids: Estrogens may decrease the clearance of corticosteroids, leading to increased effects.
Minor Interactions
- Lamotrigine: Estrogens may decrease lamotrigine levels, potentially leading to loss of seizure control.
- Cyclosporine: Estrogens may increase cyclosporine levels, increasing risk of toxicity.
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.
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation.
Rationale: To screen for pre-existing breast abnormalities and establish baseline for breast cancer surveillance.
Timing: Prior to initiation, as per screening guidelines.
Rationale: To screen for gynecological conditions and cervical cancer.
Timing: Prior to initiation, as per screening guidelines.
Routine Monitoring
Frequency: Annually
Target: Normal
Action Threshold: Any significant change or new symptom.
Frequency: Annually, or more frequently if indicated.
Target: <130/80 mmHg (general guideline)
Action Threshold: Sustained elevation requiring intervention.
Frequency: Annually, or as per national screening guidelines.
Target: No suspicious findings
Action Threshold: New mass, calcifications, or other suspicious findings requiring further investigation.
Frequency: Annually, or as per national screening guidelines.
Target: Normal
Action Threshold: Abnormal bleeding, pain, or suspicious findings.
Frequency: Monthly (self-exam), Annually (clinical exam)
Target: No new lumps or changes
Action Threshold: Any new lump, skin changes, nipple discharge, or pain.
Frequency: Regularly (e.g., every 3-6 months initially, then annually)
Target: Improved/controlled symptoms
Action Threshold: Worsening symptoms, new symptoms, or intolerable side effects.
Symptom Monitoring
- Unusual vaginal bleeding or spotting
- New breast lump or changes
- Chest pain, shortness of breath, sudden severe headache
- Sudden vision changes or loss
- Pain, swelling, or redness in leg (DVT symptoms)
- Yellowing of skin or eyes (jaundice)
- Severe abdominal pain
- Memory loss or cognitive decline (especially in older women)
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
Contraindicated during lactation. Estrogens and progestins are excreted in human milk and may decrease the quantity and quality of breast milk. Potential adverse effects on the breastfed infant are unknown but possible.
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established.
Geriatric Use
Use with caution in women aged 65 years and older. The WHI study showed an increased risk of probable dementia in women 65 years and older. The lowest effective dose for the shortest duration consistent with treatment goals should be used. Regular reassessment of the need for continued therapy is crucial.
Clinical Information
Clinical Pearls
- Prempro 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.
- The primary goal of HRT is to manage menopausal symptoms and/or prevent osteoporosis; it is NOT for the prevention of cardiovascular disease or dementia.
- Always discuss the Black Box Warning risks (cardiovascular events, breast cancer, dementia) with patients before initiating therapy.
- Regular monitoring, including annual mammograms and pelvic exams, is crucial for women on HRT.
- Consider discontinuing therapy or reducing dose if symptoms are well-controlled or if risks outweigh benefits, especially after 3-5 years of use.
- Patients should be advised to report any abnormal vaginal bleeding immediately, as it may require investigation to rule out endometrial pathology.
Alternative Therapies
- Estrogen-only therapy (e.g., Premarin, Estrace) for women with hysterectomy.
- Progestin-only therapy (e.g., Provera) for specific indications.
- Selective Estrogen Receptor Modulators (SERMs) (e.g., ospemifene for dyspareunia, raloxifene for osteoporosis prevention).
- Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine).
- Local vaginal estrogen for isolated vaginal atrophy symptoms.
- Bisphosphonates or other anti-resorptive agents for osteoporosis treatment/prevention.