This combination product contains 2 medications: conjugated estrogens and bazedoxifene.
Together, they are used to help control episodes of sweating and sensation of heat, often referred to as "hot flashes" and "night sweats," associated with menopause.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
Each oval, biconvex, pink modified-release tablet branded with "0.45/20" in black ink on one side contains 0.45 mg of conjugated estrogens in an extended release core and 20 mg of bazedoxifene (as bazedoxifene acetate) in an immediate release coating. Nonmedicinal ingredients: ascorbic acid, black iron oxide, calcium phosphate tribasic, hydroxyethylcellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltitol, microcrystalline cellulose, poloxamer 188, polyethylene glycol, polydextrose, povidone, powdered cellulose, propylene glycol, red iron oxide, sucrose, sucrose palmitic acid ester, and titanium dioxide.
The recommended adult dose of bazedoxifene – conjugated estrogens is one tablet, taken by mouth, once a day. Swallow the tablet whole with some water. It may be taken at any time of day, but it should be taken at the same time every day for best effect.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. Keep this medication in its blister pack until you are ready to use. After opening the foil pouch that the blister pack comes in, this medication must be used within 45 days.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Do not take this medication if you:
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Note the following important information about estrogen replacement therapy:
The Women’s Health Initiative (WHI) study results indicated an increased risk of heart attack, stroke, breast cancer, blood clots in the lungs, and blood clots in the leg veins in postmenopausal women during 5 years of treatment with 0.625 mg conjugated equine estrogens and 2.5 mg medroxyprogesterone compared to women receiving sugar tablets. Other combinations of estrogen and progestins were not studied. However, until additional data are available, the risks should be assumed to be similar for other hormone replacement products. This means the following:
Blood clotting disorders: The use of estrogens is associated with an increased risk of blood clots in the lungs (pulmonary embolism) and legs (deep vein thrombosis). If you have or have had a heart attack, stroke, heart disease, a blood clot in your leg, or medical conditions that increase your risk of blood clots, you should not use this medication.
The risk of developing blood clots also increases with age, a personal or family history of blood clots, smoking, and obesity. It is also increased if you are immobilized for prolonged periods or have major surgery. If possible, this medication should be stopped 4 weeks before major surgery. Talk about the risk of blood clots with your doctor.
Blood pressure: Women may experience increased blood pressure when using estrogen replacement therapy. Talk to your doctor about how often you should have your blood pressure checked.
Bone disease: If you have bone disease due to cancer or a metabolic condition causing too much calcium in your body, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Breast and ovarian cancer: Studies indicate an increased risk of breast and ovarian cancer with long-term use of estrogen replacement therapy. Women with a history of breast cancer should not use estrogens. Women who have breast nodules, fibrocystic disease, abnormal mammograms, or a strong family history of breast cancer should be closely monitored by their doctor.
Women taking estrogens should have regular breast examinations and should be instructed in breast self-examination. The estradiol patch must not be applied to the breasts, as it may have harmful effects on the breast tissue.
Dementia: Women over the age of 65 receiving combined hormone replacement therapy (estrogen and progestin or estrogen alone) may be at increased risk of developing dementia (loss of memory and intellectual function). If you are over 65, talk to your doctor about whether you should be tested for dementia.
Diabetes: Estrogens may affect blood sugar control. If you have diabetes or are at risk of developing diabetes (e.g., have a family history of diabetes, have high blood pressure or high cholesterol, or are obese), carefully monitor your blood glucose levels while using this medication.
Endometrial cancer: There is evidence from several studies that estrogen replacement therapy can increase the risk of cancer of the endometrium (lining of the uterus). Taking a SERM, such as bazedoxifene, along with the estrogen reduces this risk of endometrial cancer.
Break-through bleeding may occur early in treatment with this medication. If you develop any abnormal vaginal bleeding later on while using this medication, contact your doctor. If you have or have had endometrial cancer, you should not use this medication.
Endometriosis: Estrogen replacement therapy can cause endometriosis to reappear or get worse. If you have or have had endometriosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Fibroids: This medication may worsen fibroids by causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.
Fluid retention: Estrogen may cause fluid retention, and worsen heart disease, kidney disease, or asthma. Talk to your doctor if you have any concerns. If you experience worsening of these conditions while using this medication, contact your doctor.
Follow-up examinations: It is important to have a follow-up examination 3 to 6 months after starting this medication to assess your response to treatment. Examinations should be done at least once a year after the first one.
Gallbladder disease: This medication can aggravate gallbladder disease or increase the risk of developing it. If you have gallbladder disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Heart disease and stroke: Studies indicate an increased risk of heart disease and stroke with estrogen for postmenopausal women. If you experience symptoms of a heart attack (chest pain, tightness or pressure, sweating, nausea, feeling of impending doom) or stroke (sudden dizziness, headache, loss of speech, changes in vision, weakness or numbness in the arms and legs) while taking this medication, get immediate medical attention.
High cholesterol or triglycerides: Estrogen and bazedoxifene may increase triglyceride levels in those who already have high levels. If you have increased cholesterol or triglycerides, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney function: Estrogen can affect how calcium and phosphorus are used by your body. If you have kidney disease, this may be a concern and you should discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: If you have reduced liver function, you may require special monitoring by your doctor while you use this medication. Make sure to tell your doctor if you have ever had liver problems. People with active liver disease or liver tumours should not use estrogen.
If you experience symptoms of liver problems (e.g., yellowing of the skin or eyes, abdominal pain, loss of appetite, dark urine, pale stools, nausea, or vomiting), contact your doctor immediately.
Migraine headaches: If you have migraines with aura (headache is associated with symptoms such as flashes of light, tingling sensations, blind spots, muscle weakness, and difficulty speaking either before or during the headache), you should not use this medication.
For some people who experience migraine headaches, estrogen can aggravate the condition. Talk to your doctor if you notice any change in your migraine pattern while using estrogen.
Seizures: Estrogens may increase your risk of having a seizure. If you have a seizure disorder or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Thyroid disease: Estrogen may affect how thyroid hormone is used by the body. If you are taking thyroid medication to supplement an underactive thyroid gland, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: Estrogen should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking estrogen, it may affect your baby. This medication is not recommended for breast-feeding women.
Children: This medication is not intended for children or adolescents.
Seniors: The safety and effectiveness of this medication have not been determined for adult women older than 75 years of age.
There may be an interaction between bazedoxifene – conjugated estrogen and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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