Description
Bazedoxifene and conjugated estrogens combination is used to treat moderate to severe symptoms of menopause (eg, feelings of warmth in the face, neck, and chest, and sudden strong feelings of heat and sweating [hot flashes]). This medicine is also used to prevent osteoporosis (thinning of the bones) after menopause.
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
Use of bazedoxifene and conjugated estrogens combination is not indicated for use in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bazedoxifene and conjugated estrogens combination in the elderly. However, elderly patients are more likely to have certain unwanted effects (eg, dementia), which may require caution in patients receiving this medicine. Use of bazedoxifene and conjugated estrogens combination is not recommended in females 75 years of age and older.
Breastfeeding
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.
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 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.
- Amifampridine
- Bupropion
- Cosyntropin
- Donepezil
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.
- Etoricoxib
- Ginseng
- Levothyroxine
- Licorice
- Tipranavir
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. Discuss with your healthcare professional the use of your medicine with 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
- Blood clots (eg, 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
- 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), known or suspected—Should not be used in patients with these conditions.
- Asthma 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
- Hypertension (high blood pressure) or
- Hypertriglyceridemia (high triglycerides or fats in the blood) or
- Hypocalcemia (low calcium in the blood) or
- Hypothyroidism (an underactive thyroid) or
- Jaundice during pregnancy or from using hormonal therapy in the past or
- Liver tumors or
- Migraine headache or
- Obesity or
- Porphyria (an enzyme problem) or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
- Kidney disease—Use is not recommended. This medicine has not been studied in patients with this condition.
Proper Use
Take this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use 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.
Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.
Your doctor may also want you to take vitamin D and calcium supplements while taking this medicine.
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.
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 and prevention of osteoporosis:
- Adults—One tablet once a day. Each tablet contains 20 milligrams (mg) of bazedoxifene and 0.45 mg of conjugated estrogens.
- Children—Use is not recommended.
- For moderate to severe hot flashes and prevention of osteoporosis:
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.
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep your medicine in the original package until you are ready to use it. Do not place the tablets in pill boxes or pill organizers. After opening the foil pouch, use the medicine within 60 days.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. 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.
Do not take other medicines that contain estrogen or progestin while you are being treated with this medicine.
Do not use this medicine if you are pregnant or can become pregnant. 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.
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, overweight, or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move your arms, legs or facial muscle, or an inability to speak.
Using this medicine may increase your risk of endometrial cancer, breast cancer, or uterine 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 females 65 years of age and older.
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).
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.
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:
Incidence not known
- Acid or sour stomach
- anxiety
- backache
- belching
- bloating
- change in vaginal discharge
- chest pain
- chills
- clear or bloody discharge from the nipple
- confusion
- constipation
- cough
- darkened urine
- difficulty with speaking
- dimpling of the breast skin
- dizziness or lightheadedness
- double vision
- fainting
- fast heartbeat
- fever
- full or bloated feeling or pressure in the stomach
- headache
- heartburn
- inability to move the arms, legs, or facial muscles
- inability to speak
- indigestion
- inverted nipple
- loss of appetite
- lump in the breast or under the arm
- nausea
- pain or feeling of pressure in the pelvis
- pain, redness, or swelling in the arm or leg
- pains in the stomach, side, or abdomen, possibly radiating to the back
- persistent crusting or scaling of the nipple
- redness or swelling of the breast
- slow speech
- sore on the skin of the breast that does not heal
- stomach discomfort, upset, or pain
- swelling of the abdominal or stomach area
- trouble breathing
- vaginal bleeding
- vomiting
- yellow eyes or skin
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
- Diarrhea
- muscle spasm
- throat pain
- upper abdominal or stomach pain
Less common
- Neck pain
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.
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