Allina Health

Pronunciation:

droe-SPYE-re-none, es-tra-DYE-ol

Brand Names:

• Angeliq

Dosage Forms:

• Tablet

Warnings:

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported .

Classifications:

Therapeutic—

Estrogen/Progestin Combination

Pharmacologic—

Progestin

Uses of This Medicine:

Drospirenone and estradiol are female hormones called progestins and estrogens that make up this combination medicine. These female hormones are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen in postmenopausal women who still have a uterus. Estrogen helps relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness. Estrogen can also help to relieve a genital skin condition called vaginal or vulvar atrophy. Progestin helps to regulate the effects of estradiol.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. However, use of drospirenone/estradiol by postmenopausal women 65 years of age and older may increase the chances of dementia.

Pregnancy—

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Isotretinoin
• Theophylline
• Tizanidine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Amoxicillin
• Ampicillin
• Amprenavir
• Aprepitant
• Bacampicillin
• Betamethasone
• Bexarotene
• Bosentan
• Carbamazepine
• Clarithromycin
• Colesevelam
• Cyclosporine
• Darunavir
• Delavirdine
• Doxycycline
• Efavirenz
• Etravirine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Ginseng
• Griseofulvin
• Itraconazole
• Ketoconazole
• Lamotrigine
• Levothyroxine
• Licorice
• Minocycline
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Nevirapine
• Oxcarbazepine
• Oxytetracycline
• Phenobarbital
• Phenytoin
• Pioglitazone
• Prednisolone
• Primidone
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rosuvastatin
• Rufinamide
• Selegiline
• St John's Wort
• Tacrine
• Tetracycline
• Tipranavir
• Topiramate
• Troglitazone
• Troleandomycin
• Voriconazole
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine
• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal genital or vaginal bleeding of unknown causes or
• Adrenal gland problems or
• Breast cancer, known, suspected or history of, or
• Cancer of the uterus or
• Liver problems or disease—This medicine should NOT be used.

• Asthma or
• Diabetes or
• Endometriosis or
• Epilepsy (seizures) or
• High cholesterol or triglycerides (or history of) or
• Hypocalcemia (too little calcium in the blood) or
• Hyponatremia (too little sodium in the blood) or
• Liver tumor, benign, or
• Lupus or
• Migraine or
• Porphyria (problem with metabolism causing stomach pain and mental confusion)—This medicine should be used with caution. It can cause these conditions to become worse.

• Blood clots in deep veins or the pulmonary artery or
• Heart attack, active or recent (within the past year) or
• Stroke, active or recent—This medicine should NOT be used.

• Blood clot risk factors (e.g., obesity, personal or family history of blood clots, or lupus) or
• Heart disease risk factors (e.g., diabetes, high cholesterol, high blood pressure, obesity, tobacco use)—Your doctor will help you lower your chances of having heart disease.

• Heart problems or
• Liver problems—These conditions could be affected by fluid retention (e.g., water weight gain). The patient should be observed when taking this medicine because estradiol may cause some fluid retention.

• Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

Proper Use of This Medicine:

Read the enclosed patient leaflet carefully before taking this medicine.

You should not take this medicine if you have had a hysterectomy.

You should not take this medicine to prevent heart disease or dementia.

Tell your doctor if you take any medicine or supplement that increases potassium levels. Your doctor may want to prescribe a different medicine for you or have your blood tested to check potassium levels.

Swallow the tablet whole. Do not crush or chew.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets):
  • For treating a genital skin condition (vaginal or vulvar atrophy), or vasomotor symptoms of menopause:
    • Adults—Oral, 1 tablet (drospirenone 0.5 milligram (mg)/estradiol 1 mg) once a day.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular visits every 3 to 6 months to discuss whether you need to continue taking this medicine.

If you are going to have surgery or will be on bed rest, you need to inform your doctor. You may need to stop taking drospirenone/estradiol during this time.

Check with your doctor immediately if vaginal bleeding occurs.

It is important that you check your breasts by self-examination regularly and have clinical examinations and mammography as required by your doctor. Report unusual breast lumps or discharge right away.

If you are scheduled for any lab tests, tell your doctor or lab technician that you are taking this medicine. Certain blood tests are affected by estradiol.

Tell your doctor about any risk factors for heart disease that you may have, such as high blood pressure, diabetes, tobacco use, high cholesterol, and obesity. It is important that you work with your doctor to lower these risk factors.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

More common

Breast pain

full or bloated feeling

heavy nonmenstrual vaginal bleeding

pressure in the stomach

surgery

swelling of abdominal or stomach area

Less common

Bloating or swelling of face, arms, hands, legs, or feet

change in vaginal discharge

increased clear or white vaginal discharge

pain or feeling of pressure in pelvis

rapid weight gain

tingling of hands or feet

unusual weight gain or loss

vaginal bleeding

Incidence not known

Abdominal pain

anxiety

blurred vision

change in vision

chest pain or discomfort

clear or bloody discharge from nipple

confusion

constipation

cough

coughing up blood

depression

difficulty in speaking

dimpling of breast skin

dizziness or lightheadedness

double vision

dry mouth

fainting

fast heartbeat

headache

headache, severe and throbbing

inability to move arms, legs, or facial muscles

inability to speak

incoherent speech

increased urination

inverted nipple

loss of appetite

lump in breast or under the arm

metallic taste

muscle weakness

nausea and vomiting

numbness or weakness in your arm or leg, or on one side of your body

pain or discomfort in arms, jaw, back, or neck

pain or redness in your lower leg (calf)

persistent crusting or scaling of nipple

poor insight and judgment

problems with memory, vision, speech, or walking

redness or swelling of breast

seeing double

shortness of breath

slow speech

sore on the skin of the breast that does not heal

sudden or severe headache

sudden shortness of breath or troubled breathing

sweating

thirst

trouble recognizing objects

trouble thinking and planning

trouble walking

unusual tiredness or weakness

weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Accidental injury

back pain

body aches or pain

chills

diarrhea

difficulty in breathing

ear congestion

fever, sneezing, or sore throat

general feeling of discomfort or illness

joint pain

loss of voice

muscle aches and pains

nasal congestion

pain in arms or legs

pain or tenderness around eyes and cheekbones

runny nose

shivering

stuffy or runny nose

sweating

tightness of chest or wheezing

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.