Drospirenone and estradiol (Oral route)
Unopposed estrogens increase the risk of endometrial cancer in women without a uterus. Estrogen alone or with a progestin should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke and DVT have been reported with estrogen-alone therapy, along with increased risk for endometrial cancer in a woman with a uterus who uses unopposed estrogens. Increased risks of stroke, DVT, pulmonary embolism, myocardial infarction, and invasive breast cancer have been reported with estrogen plus progestin therapy. An increased risk of probable dementia in postmenopausal women aged 65 and older has been reported with estrogen plus progestin therapy. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration possible .
Uses of This Medicine:
Drospirenone and estradiol combination is used to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen in women who still have a uterus (womb). It is also used to treat changes in and around the vagina (such as vaginal dryness, itching, and burning) caused by menopause in women who still have a uterus.
Drospirenone and estradiol are female hormones called progestins and estrogens that make up this combination medicine. This medicine works by preventing symptoms, such as feeling of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (hot flashes) in women during menopause. .
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:
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.
Use of Angeliq® is not indicated in the pediatric population. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of Angeliq® have not been performed in the geriatric population. However, elderly patients may have an increased risk of developing breast cancer, stroke, or dementia.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Tranexamic Acid
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.
- St John's Wort
- Valproic Acid
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.
- Mycophenolate Mofetil
- Mycophenolic Acid
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.
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 or unusual vaginal bleeding or
- Adrenal gland problems or
- Blood clots (e.g., deep vein thrombosis, pulmonary embolism), active or history of or
- Breast cancer, known or suspected, or a history of or
- Heart attack, active or history of or
- Kidney disease or
- Liver disease or
- Protein C or protein S deficiency or other known blood clotting disorders or
- Stroke, active or history of or
- Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.
- Asthma or
- Cancer, history of or
- Chorea minor (nerve problem) or
- Diabetes or
- Edema (fluid retention or body swelling) or
- Endometriosis or
- Epilepsy (seizures) or
- Gallbladder disease or
- Heart disease or
- Hereditary angioedema (swelling of the face, lips, tongue, or throat) or
- Hypercalcemia (high calcium in the blood) or
- Hyperkalemia (high potassium in the blood) or
- Hypertension (high blood pressure) or
- Hypertriglyceridemia (high triglycerides or fats in the blood) or
- Hypocalcemia (low calcium in the blood) or
- Hyponatremia (low sodium in the blood) or
- Hypothyroidism (an underactive thyroid) or
- Jaundice during pregnancy or from using hormonal therapy in the past or
- Liver tumor, benign or
- Migraine headache or
- Otosclerosis (ear disorder) or
- Porphyria (an enzyme problem) or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may cause unwanted side effects.
This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.
This medicine is available in three blister packs containing 28 tablets that need to be taken continuously.
Swallow the tablet whole with liquids. Do not break, crush, or chew it. You may take this medicine with or without food.
Take this medicine at the same time each day. If you missed a dose for more than 24 hours, do not take the missed dose. If you forgot to take the tablets for several days, bleeding may occur.
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 form (tablets):
- For treatment of hot flashes and other symptoms of menopause:
- Adults—One tablet once a day. Each tablet contains 0.25 milligram (mg) of drospirenone and 0.5 mg of estradiol, or 0.5 mg of drospirenone and 1 mg of estradiol
- Children—Use is not recommended.
- For treatment of vulvar and vaginal atrophy caused by menopause:
- Adults—One tablet once a day. Each tablet contains 0.5 milligram (mg) of drospirenone and 1 mg of estradiol.
- Children—Use is not recommended.
- For treatment of hot flashes and other symptoms of menopause:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits every 3 to 6 months to discuss whether you need to continue taking this medicine. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.
It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes or are overweight or smoke cigarettes. Contact your doctor immediately if you experience confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.
Using this medicine may increase your risk of breast cancer or other types of cancer. Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.
Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before you have surgery or if you need to stay in bed for an extended time. This medicine may affect the results of certain medical tests.
Check with your doctor immediately if, severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
While you are taking this medicine be careful to limit the amount of alcohol that you drink.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- More common
- Breast pain
- full or bloated feeling
- heavy non-menstrual vaginal bleeding
- pressure in the stomach
- swelling of the abdominal or stomach area
- Less common
- Bloating or swelling of the face, arms, hands, legs, or feet
- change in vaginal discharge
- increased clear or white vaginal discharge
- pain or feeling of pressure in the pelvis
- rapid weight gain
- tingling of the hands or feet
- unusual weight gain or loss
- vaginal bleeding
- Incidence not known
- Abdominal or stomach pain
- blurred vision
- change in vision
- chest pain or discomfort
- clear or bloody discharge from nipple
- coughing up blood
- difficulty with speaking
- dimpling of the breast skin
- dizziness or lightheadedness
- double vision
- dry mouth
- fast heartbeat
- headache, severe and throbbing
- inability to move the arms, legs, or facial muscles
- inability to speak
- incoherent speech
- increased urination
- inverted nipple
- loss of appetite
- lump in the 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 the arms, jaw, back, or neck
- pain or redness in your lower leg (calf)
- persistent crusting or scaling of the nipple
- poor insight and judgment
- problems with memory, vision, speech, or walking
- redness or swelling of the 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
- trouble recognizing objects
- trouble thinking and planning
- trouble walking
- unusual tiredness or weakness
- weight loss
- More common
- Accidental injury
- back pain
- body aches or pain
- difficulty breathing
- ear congestion
- fever, sneezing, or sore throat
- general feeling of discomfort or illness
- joint pain
- loss of voice
- muscle aches and pains
- pain in the arms or legs
- pain or tenderness around the eyes and cheekbones
- runny nose
- stuffy or runny nose
- tightness of the chest or wheezing
- trouble sleeping
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.
Check with your doctor immediately if any of the following side effects occur:
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:
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.
Last Updated: 6/18/2019