Description
Drospirenone and estradiol combination is used to treat moderate to severe symptoms of menopause (eg, feelings of warmth in the face, neck, and chest, sudden strong feelings of heat and sweating [hot flashes], and vaginal problems).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of drospirenone and estradiol combination in the pediatric population. Use of drospirenone and estradiol combination is not indicated for use in children.
Geriatric
Appropriate studies on the relationship of age to the effects of drospirenone and estradiol combination have not been performed in the geriatric population. However, elderly patients are more likely to have breast cancer, stroke, or dementia which may require caution in patients receiving drospirenone and estradiol combination.
Breastfeeding
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.
Drug Interactions
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.
- Atazanavir
- Boceprevir
- Cobicistat
- Fezolinetant
- 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.
- Abametapir
- Amifampridine
- Amobarbital
- Amoxicillin
- Ampicillin
- Amprenavir
- Apalutamide
- Aprepitant
- Armodafinil
- Artemether
- Avacopan
- Bacampicillin
- Belzutifan
- Betamethasone
- Bexarotene
- Bosentan
- Bupropion
- Butabarbital
- Butalbital
- Carbamazepine
- Carbenicillin
- Cefaclor
- Cefadroxil
- Cefdinir
- Cefditoren
- Cefixime
- Cefpodoxime
- Cefprozil
- Ceftazidime
- Ceftibuten
- Cefuroxime
- Cenobamate
- Ceritinib
- Clarithromycin
- Clobazam
- Cloxacillin
- Colesevelam
- Conivaptan
- Cosyntropin
- Cyclacillin
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.
- Amitriptyline
- Atazanavir
- Clomipramine
- Diazepam
- Doxepin
- Ginseng
- Imipramine
- Lamotrigine
- Levothyroxine
- Licorice
- Lorazepam
- Selegiline
- Tacrine
- Temazepam
- Tipranavir
- Triazolam
- Voriconazole
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 is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Tobacco
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
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
- Bleeding problems or
- Blood clots (eg, deep vein thrombosis, pulmonary embolism), active or history of or
- Breast cancer, known or suspected, or a history of or
- Dementia or
- Heart attack, active or history of or
- Kidney disease or
- Liver disease or
- Protein C, protein S, or antithrombin deficiency, or other known blood clotting disorders or
- Stroke, active or history of or
- Tumors (estrogen-dependent, including cancer of the uterus), 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
- Obesity or
- Otosclerosis (ear disorder) or
- Porphyria (an enzyme problem) or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
Proper Use
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 liquid. Do not break, crush, or chew it. You may take this medicine with or without food.
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.
Take this medicine at the same time each day. If you miss a dose, take it as soon as possible. If more than 24 hours have passed since you missed a dose, do not take the missed dose. If you forgot to take the tablets for several days, bleeding may occur.
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 form (tablets):
- For moderate to severe hot flashes:
- 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 moderate to severe vaginal problems or dryness:
- 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 moderate to severe hot flashes:
Missed Dose
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.
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
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 chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.
Using this medicine for a long period of time may increase your risk of endometrial cancer, breast cancer, or uterine cancer. Talk with your doctor about this risk. Do not use this medicine if you have had your uterus (womb) removed (hysterectomy). 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.
This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.
Tell your doctor or dentist who treats you knows that you are using this medicine before any kind of surgery (eg, surgery that will require inactivity for a long time) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also affect the results of certain medical tests.
Check with your doctor immediately if severe headache, 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 take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
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:
More common
- Breast pain
- full or bloated feeling
- heavy non-menstrual vaginal bleeding
- pressure in the stomach
- surgery
- 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
- Anxiety
- blurred vision
- change in vision
- chest pain or discomfort
- clear or bloody discharge from nipple
- confusion
- constipation
- cough
- coughing up blood
- depression
- difficulty with speaking
- dimpling of the breast skin
- dizziness or lightheadedness
- double vision
- dry mouth
- fainting
- fast heartbeat
- headache
- 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
- slow speech
- sore on the skin of the breast that does not heal
- stomach pain
- sudden or severe headache
- 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
- chest tightness
- chills
- diarrhea
- difficulty breathing
- ear congestion
- fever
- 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
- shivering
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- 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.
DRG-20063089
