Drospirenone and Estradiol

Angeliq

Angeliq is a hormone replacement therapy approved by the FDA to treat symptoms of menopause, such as hot flashes, night sweats, and vaginal dryness. This medication combines two hormones, estradiol, and drospirenone, which help alleviate these symptoms. It’s important to follow medical guidance when taking Angeliq due to risks like increased chances of uterine cancer, blood clots, and other severe conditions. This medication should not be used by women who are pregnant, have had certain cancers, or have had a hysterectomy. Regular monitoring by a healthcare provider is essential to adjust the treatment as necessary and to conduct safety screenings such as mammograms. Side effects can range from mild, like headaches and nausea, to severe, including heart attack and stroke. Angeliq should be used carefully under strict medical supervision to manage menopause symptoms effectively while minimizing potential risks.

Product Overview

Angeliq is a prescription medication formulated as a combination of drospirenone and estradiol, designed to alleviate symptoms associated with menopause. These symptoms include severe hot flashes, night sweats, vaginal dryness, and irritation, which result from decreased estrogen levels in postmenopausal women. Angeliq compensates for this hormonal deficiency, helping to restore balance and reduce discomfort. The typical dosage involves daily oral administration, with specific guidelines depending on the patient’s current hormone therapy regimen or medical history. For instance, patients new to hormone therapy or those shifting from a continuous hormone therapy can start this medication anytime, whereas those from cyclic hormone therapies should begin Angeliq after completing the current cycle.

Despite its benefits, this medication poses substantial health risks. It may significantly increase the risk of developing blood clots, strokes, and heart attacks. The risk of cancers such as breast, uterine, and ovarian cancer is also heightened. Because of these risks, Angeliq includes a boxed warning outlining these severe potential side effects. Furthermore, this medication is contraindicated in women who have certain pre-existing conditions, including unexplained vaginal bleeding, severe liver disease, or a history of certain cancers.

It’s crucial for users to engage in regular medical consultations, adhere strictly to prescribed dosages, and promptly report any adverse symptoms or unusual bleeding. Regular screenings like mammograms and pelvic exams are recommended as part of the ongoing monitoring while on this medication. Women should consider all risks and benefits of hormone replacement therapy in consultation with their healthcare providers before starting treatment with Angeliq.

Uses of Angeliq

Angeliq is used to treat several symptoms associated with menopause, including:

• Burning sensations in the vaginal area caused by menopause
• Vaginal dryness
• Night sweats
• Hot flashes
• Flushes

How to Use Angeliq?

Dosage

It comes in the form of a tablet and has one strength: 

• Angeliq 1mg tablet

Recommended Dosage of Angeliq

Moderate to Severe Hot Flashes:

• For Adults: Take one tablet daily. The tablet is available in two strengths:
  • One tablet contains 0.25 milligrams (mg) of drospirenone and 0.5 mg of estradiol.
  • Another contains 0.5 mg of drospirenone and 1 mg of estradiol.
• For Children: Use is not recommended.

Moderate to Severe Vaginal Dryness & Other Problems:

• For Adults: Take one tablet once a day. Each tablet contains 0.5 milligrams (mg) of drospirenone and 1 mg of estradiol.
• For Children: Use is not recommended.

[Note: These recommendations may vary from person to person. Discuss them with your doctor, and they’ll customize your dosage accordingly.]

How to Take It?

• Angeliq should be taken continuously without breaks.
• If you are new to estrogen treatments or are currently using a continuous hormone combination product, you can start Angeliq at any time.
• If you are switching from a hormone therapy that includes breaks or cycles of different hormones, complete your current hormone cycle before beginning Angeliq.
• If you are using Angeliq primarily for dryness in the vulvar and vaginal area, consider topical treatments applied directly to the area as an alternative.
• The dosage of Angeliq varies for different patients. Always follow your doctor’s instructions or the directions on the prescription label. The details provided here are average dosages; do not alter your dose unless advised by your doctor.
• The amount of medicine you take depends on its strength.
• The number of doses per day, the time between doses, and the duration of treatment depend on the medical condition being treated.
• Take Angeliq precisely as your doctor has prescribed. Follow all the directions on your prescription label and review all medication guides or instruction sheets.
• Do not chew, dissolve, crush, or break the Angeliq tablet. Swallow it whole.
• Take the medicine at the same time each day to maintain an even level in your blood.
• Angeliq may increase the risk of conditions that could lead to uterine cancer. Your doctor may prescribe progestin to help lower this risk. Immediately report any unusual vaginal bleeding.
• If you need major surgery or will be on long-term bed rest, you might need to stop using this medicine temporarily. Make sure any doctor or surgeon treating you knows you are taking Angeliq.
• Regularly check your progress with your doctor to decide if you should continue using Angeliq. Perform self-exams of your breasts for lumps monthly and get regular mammograms.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Angeliq Work?

Angeliq is used to alleviate symptoms of menopause. It helps reduce hot flashes, which are episodes of flushing and sweating in the upper body and face. Additionally, it addresses dryness, itching, and burning sensations around the vagina. These symptoms arise when a woman’s body produces less estrogen than usual. Angeliq contains two types of hormones: an estrogen (estradiol) and a progestin (drospirenone). Progestin is included in estrogen replacement therapies to decrease the risk of uterine cancer. Women who have had a hysterectomy (removal of the uterus) do not require progestin and should not use this combination medication. If treatment is needed solely for vaginal symptoms of menopause, consider using products applied directly inside the vagina before trying oral medications, skin-absorbed treatments, or injections.

Important Safety Information

Side Effects

Common side effects of Angeliq include:

• Mood changes
• Stomach pain
• Vaginal itching or discharge
• Breakthrough bleeding
• Nausea
• Headache
• Fluid retention (rapid weight gain, swelling)
• Diarrhea
• Changes in your menstrual periods
• Breast pain

Serious side effects of Angeliq may include:

• Jaundice (yellowing of the skin or eyes)
• Sudden vision loss
• A lump in your breast
• Swelling and rapid weight gain
• Unusual vaginal bleeding
• Memory problems, confusion, and unusual behavior
• Stroke symptoms may include: 
  • Sudden severe headache
  • Weakness or numbness (especially on one side of the body)
  • Slurred speech
  • Problems with vision or balance
• Heart attack symptoms may include: 
  • Sweating
  • Pain spreading to your jaw or shoulder
  • Chest pain or pressure
  • Nausea
• Blood clotting signs may consist of:
  • Coughing up blood
  • Stabbing chest pain
  • Sudden vision loss
  • Pain or warmth in one or both legs
  • Feeling short of breath
• High blood sugar signs may consist of:
  • Increased thirst
  • Increased urination
  • Dry mouth
  • Fruity breath odor

[Note: This list may not cover all possible side effects. Always consult with your healthcare provider for medical advice about side effects.]

Warnings

• Do not use Angeliq if you have any of the following conditions: liver disease, unexplained vaginal bleeding, a bleeding disorder, kidney disease, coronary artery disease, an adrenal gland disorder, if you are planning to have major surgery, if you have had your uterus removed (hysterectomy), or if you have ever had a heart stroke, attack, or cancer of the breast, blood clot, uterus/cervix, or vagina.
• Angeliq should not be taken if you are pregnant. Using Angeliq may raise your probability of developing a condition that could lead to uterine cancer. It’s important to report any unusual vaginal bleeding immediately.
• Taking Angeliq can also increase your risk of blood clots, strokes, heart attacks, and cancers of the breast, uterus, or ovaries. Angeliq should not be used as a preventive measure against stroke, heart disease, or dementia.

Boxed Warning

• Cardiovascular Risks and Dementia: Using combined estrogen and progestogen therapy increases the risk of heart-related issues such as strokes and blood clots, as well as a type of lung clot called pulmonary embolism. This therapy also raises the risk of heart attacks in postmenopausal women between the ages of 50 and 79. Additionally, it may increase the likelihood of developing probable dementia in women aged 65 and older. This therapy should not be used to prevent cardiovascular diseases or dementia. This therapy is not suitable for preventing cardiovascular diseases or dementia. Discuss the individual benefits and risks with your patient before starting treatment.
• Breast Cancer: There is an increased risk of invasive breast cancer with the use of combined estrogen and progestogen therapy. Estrogen plus progestogen therapy should be prescribed at the lowest effective doses and for the shortest time that aligns with treatment goals and personal health risks.
• Endometrial Cancer: Using estrogen alone can increase the risk of cancer of the lining of the uterus (endometrial cancer) in women who still have a uterus. To lower this risk, a progestogen can be added to the therapy. Any postmenopausal woman experiencing unusual or recurring bleeding should be evaluated for endometrial cancer.
• Estrogen-alone Therapy: It may also increase the risks of stroke and deep vein thrombosis (blood clots in veins) in postmenopausal women between the ages of 50 and 79. Similar to combined therapy, there is an increased risk of probable dementia in women aged 65 and older using estrogen alone. This therapy should not be used for the prevention of cardiovascular diseases or dementia.

These therapies have specific uses and come with significant risks. It is crucial to weigh the benefits against the risks and consider the individual’s health profile before prescribing these medications. Always aim to use the minimal effective dose for the shortest possible time.

Precautions

• Your doctor should monitor your health regularly, every 3 to 6 months, to determine whether you should continue using this medication. Unless your doctor advises otherwise, you may need a pelvic exam, breast exam, and mammogram (breast X-ray) to check for any side effects. Make sure to keep all your appointments.
• Although it is rare for a postmenopausal woman to become pregnant, it is crucial to know that taking this medication during pregnancy can harm your unborn baby. If you suspect you might be pregnant while on this medication, inform your doctor immediately.
• This medication can increase your risk of developing blood clots, strokes, or heart attacks, and this risk may persist even after you stop taking it. Your risk is higher if you have high blood pressure, high cholesterol, diabetes, are overweight, or smoke. If you experience confusion, double vision, difficulty speaking, chest pain, headaches, or any loss of movement in your legs, arms, or facial muscles, contact your doctor right away.
• Using this medication over a long period may raise your risk of cancers such as endometrial, breast, or uterine cancer. Discuss these risks with your doctor. You should not use this medication if you have undergone a hysterectomy (removal of the uterus). If you notice any unusual vaginal bleeding, contact your doctor right away.
• There is also an increased risk of developing dementia when using this medication, particularly in women who are 65 years old or older.
• Additionally, this medication may heighten your risk of gallbladder disease. If you experience stomach pains, nausea, or vomiting, it’s important to inform your doctor immediately.
• Before undergoing any type of surgery, including those that might involve a long period of inactivity or emergency treatment, inform your doctor or dentist that you are taking this medication. Your doctor will determine if you should continue using this medicine. It may also influence the results of some medical tests.
• If you experience a severe headache, sudden loss of vision, or any other changes in vision while on this medication, contact your doctor immediately. You may be referred to an ophthalmologist (eye doctor) for further examination.
• While taking this medicine, be cautious about your alcohol consumption and try to limit it.

Other Important Precautions

• Allergies: Inform your doctor if you have ever had any unusual or allergic reactions to this medication or any other medications. Also, disclose any other allergies you may have, including those to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.
• Pediatric Use: Studies have not been conducted to determine the effects of drospirenone and estradiol combination in children. This medication is not recommended for use in the pediatric population.
• Geriatric Use: No specific studies have been done on the effects of drospirenone and estradiol in older adults. However, elderly patients may be at increased risk of developing conditions like breast cancer, stroke, or dementia, which could necessitate caution when using this medication.
• Breastfeeding: There is insufficient research to determine the risk to an infant when this medication is used during breastfeeding. Weigh the potential benefits against the risks before deciding to take this medication while breastfeeding.

Contraindications

• Do not use Angeliq if you are allergic to drospirenone or estradiol.
• Avoid using Angeliq if you have any of the following conditions:
  • Liver disease
  • Unexplained vaginal bleeding that has not been evaluated by a doctor
  • A bleeding disorder
  • Kidney disease
  • A history of hormone-related cancer, including cancers of the cervix/uterus, breast, or vagina
  • An adrenal gland disorder
  • A history of heart attack, stroke, or blood clot
  • A previous hysterectomy (removal of the uterus)
  • Coronary artery disease

Missed Dose

• If you miss a dose of Angeliq, take it as soon as you remember.
• If it has been more than 24 hours since your missed dose, do not take the missed dose.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Overdose

• An overdose of estrogen and progestogen can lead to nausea, vomiting, tenderness in the breasts, abdominal pain, drowsiness, fatigue, and withdrawal bleeding in women.
• If an overdose occurs, stop taking Angeliq and start appropriate symptomatic treatment.
• Seek emergency medical attention or call the Poison Help line immediately.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

Storage

• Store the medication in its original container, securely closed, and out of children’s reach.
• Keep it at room temperature, away from heat and moisture (avoid storing it in the bathroom).
• Do not flush the medication down the toilet.
• Dispose of unneeded medications through a medicine take-back program. Contact your pharmacist or local waste/recycling department for details about take-back programs in your area.
• Keep all medications out of sight and reach of children. Note that common containers like pill minders, eye drop bottles, and others are not child-proof and can be opened easily by young children.
• Use safety caps on medications and store them in a high, secure place away from children’s sight and reach.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Angeliq Interactions

When taking Angeliq, understanding drug interactions is crucial, as they can affect how your medications work and may increase the risk of serious side effects. It’s important to maintain an updated list of all medications you use, including over-the-counter drugs, prescription medicines, and herbal products. Share this list with your doctor and pharmacist, and always consult them before starting, stopping, or changing the dosage of any medication.

Medications Known to Interact with Angeliq

• Aromatase Inhibitors: Drugs like Anastrozole and Exemestane are used primarily for breast cancer treatment. Interacting with Angeliq may impact their effectiveness.
• Atazanavir/Cobicistat: This combination is used in HIV treatment and can affect how Angeliq is metabolized in your body.
• Corticosteroids: Prednisone is often used for inflammation; combining these with Angeliq can enhance their effects.
• Fezolinetant: A medication used in specific health conditions that could interact with Angeliq.
• Ospemifene: Used mainly for certain postmenopausal conditions, it may have interactions with Angeliq.
• Raloxifene and Tamoxifen: Both are medications used in the management of breast cancer and osteoporosis, known to interact with Angeliq.
• Tizanidine: A muscle relaxant that could have its effect altered when taken with Angeliq.
• Tranexamic Acid: Used to control excessive bleeding, its interaction with Angeliq could alter its effectiveness.
• Warfarin: A blood thinner that may have its effects heightened when used with Angeliq.

Concerns with Potassium Levels: Drospirenone, a component of Angeliq, may increase potassium levels in the blood. It is crucial to monitor potassium intake and avoid other substances that could further increase these levels.

• Aliskiren
• NSAIDs like Naproxen, Ibuprofen
• Angiotensin Receptor Blockers like Valsartan, Losartan
• ACE Inhibitors like Lisinopril, Enalapril
• Heparin
• Potassium-Sparing Diuretics like Spironolactone, Eplerenone, Triamterene

Impact on Estrogen Removal: Certain medications can alter how estrogen, a component of Angeliq, is removed from the body, impacting its overall effectiveness.

• Seizure Medications: Phenytoin, Carbamazepine
• Azole Antifungals: Itraconazole
• Rifamycins: Rifabutin
• Macrolide Antibiotics: Erythromycin
• St. John’s Wort: Known to decrease the effectiveness of hormonal treatments by increasing the metabolism of estrogen.

It’s essential to discuss potential interactions with your healthcare provider to tailor your treatment plan and prevent adverse effects. Adjustments may be needed based on the combination of drugs being taken. Always follow medical advice regarding drug interactions and manage your health carefully.

[Note: This isn’t a complete list, and there could be other drugs that interact with Angeliq. Make sure to tell your doctor any prescription, over-the-counter medicines, and herbal products you’re taking.]

Angeliq Alternatives

• Combipatch patch (estradiol–norethindrone acetate)
• Premarin (conjugated estrogens)
• Premarin Vaginal Cream (Conjugated Estrogens)
• Evamist topical spray (estradiol)
• Estrace vaginal cream (0.01% estradiol)
• Angeliq (drospirenone-estradiol)
• Paroxetine CR (Paroxetine Hydrochloride)
• Estrace
• Actonel
• Elestrin gel
• Evista (raloxifene)
• Prempro (conjugated estrogens–medroxyprogesterone acetate)
• Menostar patch
• Climara patch (estradiol)
• Estring vaginal ring insert (estradiol)
• Mimvey
• Duavee (conjugated estrogens-bazedoxifene)
• Vivelle-Dot patch
• Alendronate
• Delestrogen injection
• Femring vaginal ring insert (estradiol)
• Climara Pro patch (estradiol-levonorgestrel)
• Jinteli
• Estrogel topical gel (0.06% estradiol)
• Ibandronate
• Vagifem vaginal tablet (estradiol)
• Menest
• Nubeqa (darolutamide)
• Minivelle patch
• Reclast injection
• Yuvafem vaginal tablet
• Activella
• Regorafenib (Stivarga)
• Depo-estradiol injection

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

Frequently Asked Questions

When is the best time to take Angeliq?

You can take Angeliq (drospirenone/estradiol) with or without food. If you experience nausea, a common side effect, taking it with food may help. To achieve the best results, it’s important to take this medication at the same time every day for consistent hormonal levels.

Can you lose belly fat on HRT?

Yes, it’s possible to lose belly fat while on hormone replacement therapy (HRT). Many women find that HRT helps them lose weight by restoring their metabolism to a state similar to before menopause. However, progesterone in HRT can sometimes lead to fluid retention, which might look like weight gain. Adjustments to the treatment plan can be made to reduce this effect.

How do you avoid weight gain on HRT?

To avoid weight gain while on hormone replacement therapy (HRT), there are several strategies you can use. First, focusing on balancing your hormones is key. Regular exercise and maintaining a healthy diet can boost your metabolism, helping your body burn fat more effectively. Additionally, managing stress is important because stress can lead to the release of cortisol, a hormone that can contribute to weight gain.

What are the benefits of taking Angeliq?

Angeliq combines two medicines: drospirenone and estradiol. Estradiol, a form of estrogen, replenishes the estrogen that your body stops producing during menopause. This helps alleviate symptoms like hot flashes and dryness in the vaginal area. Drospirenone, a type of progestin, safeguards the uterus and aids in reducing the risk of uterine cancer.

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