Angeliq 0.5-1mg Tablets 28's
WARNING: Do not use this drug to prevent heart disease or dementia. A study of women taking an estrogen with a progestin showed a raised chance of heart attack, stroke, blood clot, breast cancer, and dementia. The chance of stroke, blood clot, and dementia was also raised when the estrogen was taken alone. Not all products and doses were studied. It is not known if the same effects may happen with this drug.The chance of endometrial cancer may be raised with the use of estrogen alone in patients with a uterus. Use of a progestin along with estrogen may lower the risk. Call your doctor right away if you have unexplained or long-lasting vaginal bleeding.Use this drug for the shortest time needed at the lowest useful dose. Your doctor will talk with you on a regular basis to see if you need to keep taking this drug. @ COMMON USES: It is used to treat hot flashes or vaginal irritation and dryness caused by menopause. If you have been given this drug for some other reason, talk with your doctor for more information.
Drug Class
Hormone Replacement Therapy (HRT)
Pharmacologic Class
Estrogen-progestin combination; Estrogen receptor agonist; Progestin (with antimineralocorticoid and antiandrogenic activity)
Pregnancy Category
Category X
FDA Approved
Sep 2005
DEA Schedule
Not Controlled
Overview
What is this medicine?
Angeliq is a hormone medicine containing two female hormones, estradiol (an estrogen) and drospirenone (a progestin). It is used to relieve common symptoms of menopause, such as hot flashes and night sweats, and to help prevent thinning of bones (osteoporosis) after menopause. The progestin helps protect the lining of your uterus from changes that can be caused by estrogen alone.
How to Use This Medicine
Taking Your Medication Correctly
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. You can take it with or without food, but if you experience stomach upset, taking it with food may help. Swallow the tablet whole - do not chew, break, or crush it. If you have difficulty swallowing, consult your doctor for guidance.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding bathrooms and areas with high humidity. 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 explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it has been more than 24 hours since the missed 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. If you forget to take several doses, you may be at risk of bleeding - consult your doctor for advice on how to proceed.
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. You can take it with or without food, but if you experience stomach upset, taking it with food may help. Swallow the tablet whole - do not chew, break, or crush it. If you have difficulty swallowing, consult your doctor for guidance.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding bathrooms and areas with high humidity. 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 explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it has been more than 24 hours since the missed 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. If you forget to take several doses, you may be at risk of bleeding - consult your doctor for advice on how to proceed.
Lifestyle & Tips
- Maintain a healthy diet rich in calcium and Vitamin D to support bone health.
- Engage in regular weight-bearing exercise to help prevent osteoporosis.
- Avoid smoking, as it increases the risk of blood clots, stroke, and heart attack.
- Limit alcohol consumption.
- Discuss any concerns about diet, exercise, or lifestyle with your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (0.5 mg estradiol / 0.25 mg drospirenone or 1 mg estradiol / 0.5 mg drospirenone) orally once daily, continuously.
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
vasomotorSymptoms:
Lowest effective dose for the shortest duration consistent with treatment goals.
osteoporosisPrevention:
Lowest effective dose for the shortest duration consistent with treatment goals.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor serum potassium during the first treatment cycle in patients with mild renal impairment (CrCl 50-80 mL/min) and concomitant use of potassium-sparing drugs.
Moderate:
Use with caution; monitor serum potassium during the first treatment cycle in patients with moderate renal impairment (CrCl 30-50 mL/min) and concomitant use of potassium-sparing drugs. Contraindicated if CrCl < 30 mL/min.
Severe:
Contraindicated (CrCl < 30 mL/min) due to risk of hyperkalemia with drospirenone.
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Contraindicated.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Estradiol is an estrogen that acts by binding to estrogen receptors in target tissues, alleviating menopausal symptoms (e.g., vasomotor symptoms) and preventing bone loss. Drospirenone is a synthetic progestin that counteracts the estrogen-induced proliferation of the endometrium, reducing the risk of endometrial hyperplasia and carcinoma. Drospirenone also possesses antimineralocorticoid activity (which can lead to hyperkalemia) and antiandrogenic activity.
Pharmacokinetics
Absorption:
Bioavailability:
Estradiol: ~5% (oral); Drospirenone: ~76%
Tmax:
Estradiol: 6-8 hours; Drospirenone: 1 hour
FoodEffect:
Estradiol: Minor decrease in Cmax and AUC; Drospirenone: No clinically significant effect.
Distribution:
Vd:
Estradiol: ~1.2 L/kg; Drospirenone: ~4 L/kg
ProteinBinding:
Estradiol: ~98% (to albumin and SHBG); Drospirenone: ~97% (to albumin, not SHBG or CBG)
CnssPenetration:
Yes (estradiol for central effects like hot flashes)
Elimination:
HalfLife:
Estradiol: ~13-17 hours; Drospirenone: ~30-34 hours
Clearance:
Estradiol: High hepatic clearance; Drospirenone: ~1.2-1.5 mL/min/kg
ExcretionRoute:
Estradiol: Urine (primarily as glucuronide and sulfate conjugates); Drospirenone: Urine (40-50%) and feces (50-60%)
Unchanged:
Estradiol: <10%; Drospirenone: <1%
Pharmacodynamics
OnsetOfAction:
Gradual, symptom relief typically within weeks to months for full effect.
PeakEffect:
Varies by symptom; bone density effects are long-term.
DurationOfAction:
Daily dosing provides continuous hormonal levels.
Safety & Warnings
BLACK BOX WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg] relative to placebo. The WHI Memory Study (WHIMS), an ancillary study of WHI, reported an increased risk of probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily oral CE (0.625 mg) combined with MPA (2.5 mg) relative to placebo. These risks apply to Angeliq as well. Other doses of oral CE and MPA, and other combinations and dosage forms of estrogens and progestins, were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. Therefore, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Side Effects
Serious Side Effects: Seek Medical Help 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 attention right away:
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.
Liver Problems: Dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, change in balance, abnormal heartbeat, seizures, loss of appetite, or severe upset stomach or vomiting.
High Blood Pressure: Severe headache or dizziness, passing out, or changes in eyesight.
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.
Pancreatitis: Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Neurological Symptoms: Weakness on one side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
Eye Problems: Changes in eyesight or loss, bulging eyes, or changes in how contact lenses feel.
Breast Changes: Lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal Symptoms: Vaginal itching or discharge, or abnormal vaginal bleeding.
Mental Health Changes: Depression or other mood changes, memory problems, or loss.
Fluid Retention: Swelling, weight gain, or trouble breathing.
Blood Clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, change of color, or pain in a leg or arm, or trouble speaking or swallowing.
High Calcium Levels: Weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain (especially in people with cancer).
Common Side Effects
Most people do not experience serious side effects, but may have minor or mild side effects. If you experience any of the following, contact your doctor if they bother you or do not go away:
Headache
Diarrhea, upset stomach, or vomiting
Stomach pain or cramps
Bloating
Weight gain
Enlarged breasts
Tender breasts
Vaginal bleeding or spotting
Reporting Side Effects
This is not a complete 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.
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 right away:
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.
Liver Problems: Dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, change in balance, abnormal heartbeat, seizures, loss of appetite, or severe upset stomach or vomiting.
High Blood Pressure: Severe headache or dizziness, passing out, or changes in eyesight.
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.
Pancreatitis: Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Neurological Symptoms: Weakness on one side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
Eye Problems: Changes in eyesight or loss, bulging eyes, or changes in how contact lenses feel.
Breast Changes: Lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal Symptoms: Vaginal itching or discharge, or abnormal vaginal bleeding.
Mental Health Changes: Depression or other mood changes, memory problems, or loss.
Fluid Retention: Swelling, weight gain, or trouble breathing.
Blood Clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, change of color, or pain in a leg or arm, or trouble speaking or swallowing.
High Calcium Levels: Weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain (especially in people with cancer).
Common Side Effects
Most people do not experience serious side effects, but may have minor or mild side effects. If you experience any of the following, contact your doctor if they bother you or do not go away:
Headache
Diarrhea, upset stomach, or vomiting
Stomach pain or cramps
Bloating
Weight gain
Enlarged breasts
Tender breasts
Vaginal bleeding or spotting
Reporting Side Effects
This is not a complete 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, dizziness, or fainting
- Sudden vision changes (e.g., partial or complete loss of vision)
- Sudden numbness or weakness in your arm or leg, especially on one side of your body
- Chest pain or heaviness, pain spreading to arm or shoulder, nausea, sweating, general ill feeling (signs of heart attack)
- Sudden shortness of breath, coughing up blood (signs of blood clot in lungs)
- Pain, swelling, or tenderness in your leg (signs of blood clot in leg)
- New breast lump or changes in your breasts
- Unusual vaginal bleeding (e.g., bleeding that is heavy, persistent, or occurs after menopause has been established)
- Yellowing of your skin or eyes (jaundice)
- Severe stomach pain
- Symptoms of high potassium (e.g., muscle weakness, fatigue, slow heart rate, tingling in hands/feet)
Before Using This Medicine
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 and its symptoms.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Kidney disease
+ Liver disease
+ Poor adrenal function
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Previous removal of the uterus (hysterectomy)
* Pregnancy or suspected pregnancy. Note: This medication should not be taken during pregnancy.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues 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 adjust the dosage of any medication without first consulting 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 and its symptoms.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Kidney disease
+ Liver disease
+ Poor adrenal function
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Previous removal of the uterus (hysterectomy)
* Pregnancy or suspected pregnancy. Note: This medication should not be taken during pregnancy.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues 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 adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
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 immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged immobility may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
Additionally, if you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor.
Be aware that medications like this one may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
This drug may also lead to elevated triglyceride levels. If you have a history of high triglyceride levels, notify your doctor. Furthermore, have your blood work and other laboratory tests performed as scheduled by your doctor.
Regular breast exams, gynecology check-ups, and breast self-exams, as directed by your doctor, are crucial while taking this medication.
This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this drug.
If you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor. Limit your alcohol intake and avoid smoking, as it increases the risk of heart disease. Consult with your doctor if you smoke.
If you are using this medication solely to treat vaginal dryness, itching, and burning, consult with your doctor to determine if a topical medication might be a more suitable option for you.
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.
If you are 65 years 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 any potential risks to your baby.
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 your risk of developing blood clots.
If you have diabetes (high blood sugar), consult with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
Additionally, if you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor.
Be aware that medications like this one may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
This drug may also lead to elevated triglyceride levels. If you have a history of high triglyceride levels, notify your doctor. Furthermore, have your blood work and other laboratory tests performed as scheduled by your doctor.
Regular breast exams, gynecology check-ups, and breast self-exams, as directed by your doctor, are crucial while taking this medication.
This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this drug.
If you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor. Limit your alcohol intake and avoid smoking, as it increases the risk of heart disease. Consult with your doctor if you smoke.
If you are using this medication solely to treat vaginal dryness, itching, and burning, consult with your doctor to determine if a topical medication might be a more suitable option for you.
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.
If you are 65 years 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 any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Dizziness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in females)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is symptomatic and supportive; there is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) in patients with renal impairment or high baseline potassium due to increased risk of hyperkalemia with drospirenone.
- Drugs that increase serum potassium (e.g., potassium-sparing diuretics, ACE inhibitors, ARBs, NSAIDs, heparin, aldosterone antagonists) in patients with renal impairment or high baseline potassium.
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May significantly increase estradiol and drospirenone exposure, leading to increased adverse effects.
- CYP3A4 inducers (e.g., carbamazepine, rifampin, phenytoin, phenobarbital, St. John's Wort): May decrease estradiol and drospirenone exposure, potentially reducing efficacy and increasing risk of breakthrough bleeding.
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil): May increase estradiol and drospirenone exposure, requiring caution and monitoring.
- Thyroid hormone replacement therapy: Estrogens can increase thyroid-binding globulin (TBG), leading to increased circulating total thyroid hormone levels and potentially increased thyroid hormone dose requirements.
Minor Interactions
- Not specifically categorized as minor for this combination, but general drug interactions for estrogens and progestins apply.
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including blood pressure, breast and pelvic examination)
Rationale: To identify contraindications, risk factors, and establish baseline health status.
Timing: Prior to initiation of therapy.
Mammography
Rationale: To screen for breast cancer prior to initiating estrogen therapy.
Timing: Prior to initiation, and periodically thereafter as per standard guidelines.
Lipid profile
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation.
Liver function tests
Rationale: To assess hepatic function, as the drug is contraindicated in severe hepatic impairment.
Timing: Prior to initiation.
Serum potassium
Rationale: To assess baseline potassium levels, especially in patients with renal impairment or on concomitant potassium-sparing drugs, due to drospirenone's hyperkalemic potential.
Timing: Prior to initiation, and during the first treatment cycle if risk factors present.
Routine Monitoring
Annual physical examination (including blood pressure, breast and pelvic examination)
Frequency: Annually
Target: Normal for age and health status
Action Threshold: Significant changes or abnormalities warrant further investigation.
Mammography
Frequency: Periodically, as per standard guidelines (e.g., every 1-2 years)
Target: No suspicious findings
Action Threshold: New masses, calcifications, or other suspicious findings require immediate follow-up.
Serum potassium
Frequency: Periodically, especially during the first cycle and with concomitant use of potassium-sparing drugs or in patients with renal impairment.
Target: 3.5-5.0 mEq/L
Action Threshold: Potassium > 5.0 mEq/L or significant increase from baseline requires dose adjustment or discontinuation of Angeliq or concomitant medications.
Blood pressure
Frequency: Regularly (e.g., every 3-6 months)
Target: <130/80 mmHg (or individualized target)
Action Threshold: Sustained elevation requires evaluation and management.
Symptom Monitoring
- Signs and symptoms of thromboembolic events (e.g., chest pain, shortness of breath, sudden severe headache, sudden vision changes, pain/swelling in leg)
- Signs and symptoms of breast cancer (e.g., new breast lump, nipple discharge, skin changes)
- Abnormal vaginal bleeding (e.g., persistent, recurrent, or heavy bleeding)
- Signs of liver dysfunction (e.g., jaundice, severe abdominal pain)
- Symptoms of hyperkalemia (e.g., fatigue, muscle weakness, bradycardia, paresthesias)
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for Angeliq in pregnancy, and there is evidence of fetal harm.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including genital abnormalities in female fetuses.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
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 breastfed infant are unknown but possible.
Infant Risk:
L4 (Possibly Hazardous) - Potential for adverse effects on the infant (e.g., feminization, effects on development) and reduction of milk supply.
Pediatric Use
Angeliq is not indicated for use in pediatric patients. Safety and efficacy have not been established in this population.
Geriatric Use
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 receiving combined estrogen and progestin therapy. Consider the lowest effective dose for the shortest duration. Closely monitor for cardiovascular events and cognitive changes.
Clinical Information
Clinical Pearls
- Angeliq contains drospirenone, a progestin with antimineralocorticoid activity, which can lead to hyperkalemia. Monitor serum potassium, especially in patients with renal impairment or those taking other potassium-sparing drugs (e.g., ACE inhibitors, ARBs, NSAIDs, potassium-sparing diuretics).
- This medication is for continuous combined therapy, meaning both hormones are taken daily without a break, which typically results in amenorrhea or infrequent, light bleeding after the initial adjustment period.
- Always use the lowest effective dose for the shortest duration consistent with treatment goals to minimize risks, especially cardiovascular events, stroke, and breast cancer.
- Patients should be advised to report any signs of blood clots (e.g., sudden chest pain, shortness of breath, leg pain/swelling), stroke (e.g., sudden severe headache, numbness/weakness on one side), or breast changes immediately.
- Regular follow-up appointments, including physical exams and mammograms, are crucial while on HRT.
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 (e.g., alendronate, risedronate) for osteoporosis prevention/treatment.
- Selective Estrogen Receptor Modulators (SERMs) (e.g., bazedoxifene/conjugated estrogens, ospemifene) for specific menopausal symptoms or osteoporosis.
- Non-pharmacological interventions (e.g., lifestyle modifications, dietary changes, exercise) for menopausal symptoms and bone health.
Cost & Coverage
Average Cost:
$150 - $250 per 28 tablets
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription drug)
General Drug Facts
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 details. 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 information about the medication taken, the amount, and the time it happened.