Prempro 0.625mg/2.5mg Tab28 Peach
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. Establish a routine by taking your medication at the same time every day. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of reach of children and pets. Properly dispose of unused or expired medications. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses.
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 new or worsening symptoms with your doctor promptly.
- Attend all scheduled follow-up appointments and screenings (e.g., mammograms).
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 experience 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, 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 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 medical help immediately if you experience 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
High calcium levels have been reported in some people with cancer taking this medication. 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 Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling tired or weak
Back pain
Headache
Upset stomach or vomiting
Gas
Stomach pain or cramps
Bloating
Enlarged or tender breasts
Hair loss
This is not an exhaustive list of 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.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache or migraine
- Sudden partial or complete loss of vision
- Sudden shortness of breath or chest pain
- Pain, swelling, or redness in one or both legs
- Weakness or numbness in an arm or leg, especially on one side of the body
- Slurred speech or difficulty speaking
- Yellowing of the skin or eyes (jaundice)
- Unusual vaginal bleeding or spotting after menopause
- Lump in the breast or breast changes
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 is contraindicated 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 is crucial to ensure your safety while taking this medication. Do not initiate, discontinue, or modify the dose of any medication without consulting your doctor first.
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 advise you to stop taking this medication before certain surgical procedures, and will provide guidance on when to resume treatment after the surgery or procedure.
If you have diabetes, you will need to closely monitor your blood sugar levels. Additionally, 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 advised by your doctor.
It is vital to maintain regular breast exams, gynecology check-ups, and 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 about your treatment.
To minimize potential risks, limit your alcohol consumption and avoid smoking, as it increases the risk of heart disease. If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, consult your doctor, as this may increase your risk of blood clots.
This medication may cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and protective clothing and eyewear to minimize your risk.
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 treatment, 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 your doctor to discuss potential risks to your baby.
Osteoporosis
To maximize the effectiveness of this medication, it is essential to use it in conjunction with calcium and vitamin D supplements and engage in weight-bearing exercises, such as walking or physical therapy. Follow 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 women
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
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort): May significantly decrease estrogen and progestin plasma concentrations, potentially reducing therapeutic effects and increasing risk of breakthrough bleeding.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): May increase estrogen and progestin plasma concentrations, potentially leading to increased adverse effects.
- Thyroid hormone replacement therapy: Estrogens can increase thyroid-binding globulin (TBG), leading to increased circulating total thyroid hormone levels and potentially requiring an increased dose of thyroid hormone.
Moderate Interactions
- Anticoagulants (e.g., warfarin): Estrogens may diminish the anticoagulant effect of warfarin. Close monitoring of INR is recommended.
- Corticosteroids: Estrogens may decrease the clearance of corticosteroids, leading to increased pharmacologic effects.
- Cyclosporine: Estrogens may inhibit the metabolism of cyclosporine, leading to increased plasma concentrations and potential toxicity.
- Lamotrigine: Estrogens may decrease lamotrigine plasma concentrations, potentially reducing seizure control.
Minor Interactions
- Ascorbic acid (Vitamin C): May increase estrogen levels by inhibiting sulfate conjugation.
- Acetaminophen: May increase estrogen levels by inhibiting sulfate conjugation.
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; establish baseline.
Timing: Prior to initiation of therapy
Rationale: To screen for breast cancer before starting HRT.
Timing: Prior to initiation of therapy
Rationale: Estrogens can affect lipid metabolism; establish baseline.
Timing: Prior to initiation of therapy
Rationale: To screen for gynecological conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: Annually
Target: Normal
Action Threshold: Any significant change or new symptom
Frequency: Annually or as clinically indicated
Target: Normal
Action Threshold: Sustained elevation
Frequency: Annually or as clinically indicated by physician
Target: Normal
Action Threshold: Abnormal findings
Frequency: Annually or as clinically indicated by physician
Target: Normal
Action Threshold: Abnormal findings
Frequency: Regularly, at least annually
Target: Resolution of menopausal symptoms, absence of severe adverse effects
Action Threshold: Persistent or worsening symptoms, new or severe adverse effects
Symptom Monitoring
- Unusual vaginal bleeding or spotting
- Breast lumps or changes
- Chest pain, shortness of breath, sudden severe headache, vision changes, slurred speech, weakness or numbness in an arm or leg (signs of blood clot, stroke, MI)
- Leg pain, swelling, or tenderness (signs of DVT)
- Yellowing of skin or eyes (jaundice)
- Severe abdominal pain
- Memory loss or cognitive decline
Special Patient Groups
Pregnancy
Prempro is contraindicated during pregnancy. There is no indication for use in pregnancy, and there is evidence of fetal harm.
Trimester-Specific Risks:
Lactation
Prempro is not recommended for use 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
Prempro is not indicated for use in pediatric patients. Safety and effectiveness have not been established in this population.
Geriatric Use
In the WHI study, women 65 years of age and older had a higher risk of stroke and probable dementia when treated with conjugated estrogens plus medroxyprogesterone acetate compared to placebo. Use with caution in older women, considering the increased risks of cardiovascular events and dementia. Lowest effective dose for the shortest duration is particularly important in this population.
Clinical Information
Clinical Pearls
- Prempro is a continuous combined HRT regimen, meaning both estrogen and progestin are taken daily, which typically results in no monthly bleeding for most women after an initial adjustment period.
- Always use the lowest effective dose for the shortest duration consistent with treatment goals, especially given the black box warnings.
- Regular follow-up, including annual physical exams, mammograms, and blood pressure checks, is crucial.
- Counsel patients thoroughly on the black box warnings regarding cardiovascular events, breast cancer, and dementia.
- Consider non-hormonal alternatives for menopausal symptoms if the risks of HRT outweigh the benefits for the individual patient.
Alternative Therapies
- Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) for vasomotor symptoms (e.g., paroxetine, venlafaxine)
- Gabapentin for vasomotor symptoms
- Clonidine for vasomotor symptoms
- Bisphosphonates or other anti-resorptive agents for osteoporosis prevention/treatment (e.g., alendronate, risedronate)
- Lifestyle modifications (diet, exercise, avoiding triggers for hot flashes)