Angeliq 0.25-0.5mg 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 and Progestin Combination
Pregnancy Category
Category X
FDA Approved
Jul 2005
DEA Schedule
Not Controlled
Overview
What is this medicine?
Angeliq is a medication for women after menopause. It contains two hormones: an estrogen (estradiol) and a progestin (drospirenone). It helps relieve common menopause symptoms like hot flashes and can also help prevent bone thinning (osteoporosis). The progestin helps protect the lining of the uterus from overgrowth that can be caused by estrogen.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day to establish a routine.
You can take your medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.
Swallow the medication 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 the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for information on drug take-back programs in your area, which can provide a safe and environmentally friendly way to dispose of unwanted medications.
What to Do if You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember, unless it has been more than 24 hours since the missed dose.
If it has been more than 24 hours, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
* If you forget to take several doses, you may be at risk of bleeding. Consult your doctor for advice on how to proceed.
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day to establish a routine.
You can take your medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.
Swallow the medication 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 the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for information on drug take-back programs in your area, which can provide a safe and environmentally friendly way to dispose of unwanted medications.
What to Do if You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember, unless it has been more than 24 hours since the missed dose.
If it has been more than 24 hours, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
* 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
- Do not smoke, as smoking increases the risk of blood clots, heart attack, and stroke, especially when taking hormone therapy.
- Maintain a healthy diet rich in calcium and Vitamin D to support bone health.
- Engage in regular weight-bearing exercise to help maintain bone density.
- Limit alcohol intake.
- Discuss any concerns about diet, exercise, or smoking with your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (0.25 mg Estradiol / 0.5 mg Drospirenone) orally once daily
Dose Range:
0.25 - 0.5 mg
Condition-Specific Dosing:
postmenopausal_symptoms:
One tablet orally once daily for the management of moderate to severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis.
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.
Moderate:
Use with caution; monitor serum potassium during the first treatment cycle. Consider lower starting dose or alternative.
Severe:
Contraindicated due to the anti-mineralocorticoid activity of drospirenone and risk of hyperkalemia.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
Use with caution; monitor serum potassium. Consider lower starting dose or alternative.
Moderate:
Contraindicated.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Estradiol is an estrogen that acts by binding to estrogen receptors in target tissues, regulating gene expression and mediating estrogenic effects. It replaces endogenous estrogen levels in postmenopausal women, alleviating symptoms like vasomotor instability and preventing bone loss. Drospirenone is a synthetic progestin with anti-mineralocorticoid and anti-androgenic activity. It counteracts the estrogen-induced endometrial proliferation, reducing the risk of endometrial hyperplasia and carcinoma. Its anti-mineralocorticoid activity can lead to potassium retention.
Pharmacokinetics
Absorption:
Bioavailability:
Estradiol: ~5% (oral, due to first-pass metabolism); Drospirenone: ~76%
Tmax:
Estradiol: 3-6 hours; Drospirenone: 1-2 hours
FoodEffect:
Food does not significantly affect the bioavailability of drospirenone or estradiol.
Distribution:
Vd:
Estradiol: ~1.2 L/kg; Drospirenone: ~4 L/kg
ProteinBinding:
Estradiol: ~98% (to SHBG and albumin); Drospirenone: ~97% (to albumin, not SHBG)
CnssPenetration:
Limited (hormones can cross BBB, but not primary site of action for HRT)
Elimination:
HalfLife:
Estradiol: ~13-17 hours; Drospirenone: ~30-34 hours (terminal half-life)
Clearance:
Estradiol: ~10-30 L/hr; Drospirenone: ~1.2-1.5 mL/min/kg
ExcretionRoute:
Estradiol: Urine (primarily as glucuronides and sulfates); Drospirenone: Feces (60%) and urine (40%)
Unchanged:
Estradiol: <1%; Drospirenone: <1%
Pharmacodynamics
OnsetOfAction:
Symptomatic relief may begin within weeks, full effect for bone density takes months.
PeakEffect:
Varies by symptom; bone density effects peak over 1-2 years.
DurationOfAction:
Daily dosing maintains therapeutic 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 equine estrogens (CEE) plus medroxyprogesterone acetate (MPA) relative to placebo. The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily oral CEE plus MPA relative to placebo. These risks apply to other estrogen plus progestin products.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 electrolyte problems: 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.
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, change in balance, drooping on one side of the face, or blurred eyesight.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Breast lump, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
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.
Additional Urgent Side Effects:
Signs of a blood clot: 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. If you have cancer and experience any of these symptoms, contact your doctor immediately.
Other Possible Side Effects:
While many people may not experience side effects or only have mild side effects, it's essential to be aware of the following:
Headache
Diarrhea, upset stomach, or vomiting
Stomach pain or cramps
Bloating
Weight gain
Enlarged breasts
Tender breasts
* Vaginal bleeding or spotting
If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects:
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide medical advice on managing 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 electrolyte problems: 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.
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, change in balance, drooping on one side of the face, or blurred eyesight.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Breast lump, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
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.
Additional Urgent Side Effects:
Signs of a blood clot: 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. If you have cancer and experience any of these symptoms, contact your doctor immediately.
Other Possible Side Effects:
While many people may not experience side effects or only have mild side effects, it's essential to be aware of the following:
Headache
Diarrhea, upset stomach, or vomiting
Stomach pain or cramps
Bloating
Weight gain
Enlarged breasts
Tender breasts
* Vaginal bleeding or spotting
If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects:
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Sudden chest pain or heaviness, pain spreading to arm or jaw, nausea, sweating (signs of heart attack)
- Sudden numbness or weakness, especially on one side of the body, sudden severe headache, slurred speech, sudden vision changes (signs of stroke)
- Sudden pain, swelling, or warmth in your leg (signs of deep vein thrombosis)
- Sudden shortness of breath, sharp chest pain, coughing up blood (signs of pulmonary embolism)
- New lump in your breast, changes in breast size or shape, nipple discharge, skin dimpling (signs of breast cancer)
- Unusual vaginal bleeding (e.g., heavy, prolonged, or bleeding after menopause has stopped for a while)
- Yellowing of your skin or eyes, dark urine, severe stomach pain (signs of liver problems)
- Swelling of your face, lips, tongue, or throat, difficulty breathing (signs of severe allergic reaction)
- Mood changes, depression
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 you experienced, including any symptoms that occurred.
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
Hysterectomy (removal of the uterus)
* Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
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 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, including any symptoms that occurred.
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
Hysterectomy (removal of the uterus)
* Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
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.
Precautions & Cautions
Important Warnings and Precautions
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 will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of developing blood clots. Additionally, 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.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor. This medication may cause high blood pressure, so have your blood pressure checked regularly as advised by your doctor. High triglyceride levels have also been associated with this drug, so notify your doctor if you have a history of elevated triglyceride levels. Regularly undergo blood work and other laboratory tests as recommended by your doctor.
It is crucial to maintain regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor. This medication may interfere with certain laboratory tests, so 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 have any concerns.
If you are using this medication solely to treat vaginal dryness, itching, and burning, discuss with your doctor whether 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.
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 will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of developing blood clots. Additionally, 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.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor. This medication may cause high blood pressure, so have your blood pressure checked regularly as advised by your doctor. High triglyceride levels have also been associated with this drug, so notify your doctor if you have a history of elevated triglyceride levels. Regularly undergo blood work and other laboratory tests as recommended by your doctor.
It is crucial to maintain regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor. This medication may interfere with certain laboratory tests, so 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 have any concerns.
If you are using this medication solely to treat vaginal dryness, itching, and burning, discuss with your doctor whether 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
- Abdominal pain
- Drowsiness/fatigue
- Vaginal 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 (1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Contraindicated Interactions
- Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene)
- ACE inhibitors (e.g., lisinopril, enalapril)
- Angiotensin II receptor blockers (ARBs) (e.g., valsartan, losartan)
- Hepatic impairment (moderate to severe)
- Renal impairment (severe)
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may increase drospirenone levels and hyperkalemia risk.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - may decrease estradiol and drospirenone levels, reducing efficacy.
- Corticosteroids (e.g., prednisone) - may increase corticosteroid levels due to reduced clearance by drospirenone's anti-mineralocorticoid activity.
- Thyroid hormone replacement (e.g., levothyroxine) - may require increased thyroid hormone dose due to increased thyroid binding globulin (TBG) by estrogen.
Moderate Interactions
- NSAIDs (e.g., ibuprofen, naproxen) - increased risk of hyperkalemia, especially in patients with renal impairment or other risk factors.
- Grapefruit juice - may increase estradiol and drospirenone levels.
- Anticoagulants (e.g., warfarin) - estrogens may affect coagulation factors, requiring INR monitoring.
- Antidiabetic agents (e.g., insulin, metformin) - estrogens may affect glucose tolerance, requiring adjustment of antidiabetic therapy.
Minor Interactions
- Not available
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.
Lipid profile (total cholesterol, HDL, LDL, triglycerides)
Rationale: Estrogens can affect lipid metabolism; baseline assessment is important.
Timing: Prior to initiation of therapy.
Liver function tests (LFTs)
Rationale: To assess hepatic function, as the drug is contraindicated in moderate to severe hepatic impairment.
Timing: Prior to initiation of therapy.
Serum potassium
Rationale: Drospirenone has anti-mineralocorticoid activity and can increase potassium levels, especially in patients with renal impairment or those on other potassium-sparing drugs.
Timing: Prior to initiation of therapy, and within the first month of therapy, especially if co-administered with other drugs that may increase potassium.
Routine Monitoring
Blood pressure
Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)
Target: <130/80 mmHg (general target)
Action Threshold: Sustained elevation; consider dose adjustment or discontinuation if hypertension develops or worsens.
Breast examination and mammography
Frequency: Annually (breast exam); mammography as per national guidelines (e.g., every 1-2 years for women over 40-50)
Target: Normal findings
Action Threshold: New lumps, pain, nipple discharge, or abnormal mammogram findings require immediate investigation.
Pelvic examination and Pap test
Frequency: Annually (pelvic exam); Pap test as per national guidelines (e.g., every 3-5 years)
Target: Normal findings
Action Threshold: Abnormal bleeding, pain, or abnormal Pap test results require investigation.
Serum potassium
Frequency: Periodically, especially if co-administered with other drugs that may increase potassium (e.g., ACEIs, ARBs, NSAIDs, potassium-sparing diuretics)
Target: 3.5-5.0 mEq/L
Action Threshold: Potassium >5.5 mEq/L or rapidly rising levels; discontinue Angeliq and manage hyperkalemia.
Symptom Monitoring
- Signs of blood clots (e.g., sudden chest pain, shortness of breath, pain/swelling in leg, sudden severe headache, vision changes, slurred speech)
- Signs of breast cancer (e.g., new lump, skin changes, nipple discharge)
- Abnormal vaginal bleeding (e.g., heavy, prolonged, or irregular bleeding)
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain)
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Mood changes, depression
- Fluid retention, swelling
Special Patient Groups
Pregnancy
Angeliq is contraindicated in pregnancy. There is no indication for use in pregnancy. If pregnancy occurs while taking this drug, discontinue immediately.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including genital abnormalities in female fetuses.
Second Trimester:
Not applicable, contraindicated.
Third Trimester:
Not applicable, contraindicated.
Lactation
Angeliq is not recommended during lactation. Estrogens and progestins are excreted in human milk and may decrease milk production and alter milk composition. Potential adverse effects on the infant are unknown.
Infant Risk:
Risk of exposure to hormones; potential for decreased milk supply; unknown long-term effects on infant.
Pediatric Use
Angeliq 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 and older had a higher risk of stroke and probable dementia when taking CEE plus MPA. While Angeliq contains different hormones, similar risks may apply. Use with caution in women 65 years of age or older, and consider the lowest effective dose for the shortest duration consistent with treatment goals and risks.
Clinical Information
Clinical Pearls
- Angeliq is a continuous combined HRT, meaning both hormones are taken daily without a break, which typically results in amenorrhea (no bleeding) in most women after the first few months.
- Due to drospirenone's anti-mineralocorticoid activity, monitor serum potassium, especially in patients with renal impairment or those taking other medications that can increase potassium (e.g., ACEIs, ARBs, NSAIDs, potassium-sparing diuretics).
- Patients should be advised to report any signs of blood clots (e.g., sudden chest pain, leg swelling, severe headache) immediately.
- Regular breast exams and mammograms are crucial, as HRT can increase the risk of breast cancer.
- The decision to use HRT should be individualized, weighing the benefits for symptom relief and osteoporosis prevention against the potential risks of cardiovascular events and certain cancers.
- Consider discontinuing Angeliq at least 4 to 6 weeks before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.
Alternative Therapies
- Selective Estrogen Receptor Modulators (SERMs) for osteoporosis (e.g., raloxifene)
- Non-hormonal treatments for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Bisphosphonates for osteoporosis (e.g., alendronate, risedronate)
- Lifestyle modifications (diet, exercise, smoking cessation) for symptom management and bone health.
Cost & Coverage
Average Cost:
$150 - $250 per 28 tablets
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.