Bazedoxifene/Conjugated Estrogen, Oral

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KEY POINTS

• This medicine is taken by mouth to help reduce the chances of developing osteoporosis, or to reduce hot flashes in postmenopausal women. Take it exactly as directed.
• You should take hormones only when you need them, at the lowest effective dosage, and only for as long as you need them. Estrogen increases the risk of stroke, blood clots in the lungs and legs, heart disease, breast cancer, and possibly dementia. Also, estrogen taken without progestin increases the risk of uterine cancer if you still have your uterus. Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: estrogen antagonist/hormone

Generic and brand names: bazedoxifene/conjugated estrogen, oral; Duavee

What is this medicine used for?

This medicine is taken by mouth to help reduce the chances of developing osteoporosis (loss of bone mass) in postmenopausal women (women who no longer have regular monthly periods).

This medicine is also used to reduce hot flashes after menopause.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A bleeding disorder
• A hysterectomy (removal of the uterus)
• A stroke or transient ischemic attack (TIA)
• Asthma
• Blood clots in your legs, lungs, brain, or eyes
• Cancer of the breast, uterus, cervix, or vagina
• Depression
• Diabetes
• Heart disease or a heart attack
• Hereditary angioedema
• High blood pressure
• High cholesterol or high triglycerides
• Liver, gallbladder, or kidney disease
• Lupus
• Migraines or headaches along with vomiting, double vision, unsteadiness, weakness, or personality changes
• Porphyria (nerve pain or sensitivity to sunlight)
• Problems with calcium levels in the blood
• Seizures
• Thyroid problems
• Unexplained vaginal bleeding
• Yellowing of the eyes or skin (jaundice) during pregnancy or during past use of hormonal birth control

Tell your healthcare provider if you have recently had a long period of bed rest after major surgery or a broken bone in a cast.

Tell your provider if you have a family history of heart disease, heart attack, blood clots, strokes, breast cancer, lupus, or other conditions.

Tell your healthcare provider if you smoke. Smoking while you are using this medicine increases the risk of serious side effects such as heart attack, stroke, and blood clots. The risk increases with age and the number of cigarettes smoked a day. Talk to your healthcare provider about ways to quit smoking.

Tell your provider if you take any other hormonal medicines. You should not take any other estrogen medicine while you are taking this medicine.

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your health care provider right away. Do not breast-feed while you are receiving this medicine without your healthcare provider’s approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Read the information sheet that comes in the medicine package. Follow these directions carefully. If you do not understand how to use this medicine, ask your healthcare provider or pharmacist to explain. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it longer than prescribed.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine at the same time each day. You may take it with or without food. Swallow the tablet whole. Do not break, crush, or chew the tablet.

Do not remove this medicine from the blister pack until right before you are ready to take it. Do not put this medicine in pill boxes or pill organizers.

Follow your healthcare provider's instructions about taking calcium and vitamin D supplements.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: headache, nausea, vomiting, breast tenderness, drowsiness, tiredness, stomach pain, dizziness, vaginal bleeding.

What should I watch out for?

Estrogen increases the risk of stroke, blood clots in the lungs and legs, heart disease, breast cancer, and possibly dementia. Also, estrogen taken without progestin increases the risk of uterine cancer if you still have your uterus.

Most experts now recommend short-term use if hormone therapy is needed. You should take hormones only when you need them, at the lowest effective dosage, and only for as long as you need them. The risk of medical problems such as stroke or cancer increases further with higher doses and longer treatments. Talk with your healthcare provider about this.

You need to see your provider regularly (every 6 months) for checkups to find out if this medicine is still needed and if you are having any side effects. Keep all your appointments. Do not take this medicine for longer than 1 year without a complete physical exam.

You should also have a pelvic exam, breast exam, and mammogram every year or as often as your healthcare provider advises.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. You may need to stop taking hormones at least 4 to 6 weeks before the surgery and bedrest. Tell healthcare providers you are taking this medicine before you have lab tests. This medicine may change blood sugar, cholesterol, liver function, and thyroid levels.

If you wear contact lenses and notice a change in your vision or it becomes difficult to wear your lenses, contact your healthcare provider.

This medicine may increase your HDL cholesterol levels, decrease your LDL levels, and increase your blood triglyceride levels. Talk to your healthcare provider about this.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; swelling of your lips, tongue and throat); sudden, severe vomiting; sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; crushing chest pain or chest heaviness; coughing up blood; sudden shortness of breath; unexplained swelling.

Serious (Report these to your healthcare provider right away.): Unexplained vaginal bleeding; dizziness; fainting; breast lumps; redness, warmth, or swelling in your hands, ankles or feet; increased blood pressure; discomfort from contact lenses, vision changes; yellowing of the skin or eyes, especially with fever, unusual tiredness, loss of appetite, dark urine, or light-colored bowel movements.

Other: Breast tenderness, nausea, vomiting, diarrhea, dizziness, mild stomach pain or heartburn, acne, hair loss, cramping, muscle spasms or neck pain, throat pain, minor bloating, depression, anxiety, weight gain or loss, mild headache, sensitivity to the sun; darkening of skin on the face.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as chloramphenicol, ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), norfloxacin (Noroxin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, clomipramine, desipramine (Norpramin), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, and nortriptyline (Pamelor)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ethotoin (Peganone), felbamate (Felbatol), fosphenytoin (Cerebyx), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Aprepitant (Emend) and fosaprepitant (Emend)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as anastrozole (Arimidex), dabrafenib (Tafinlar), exemestane (Aromasin), letrozole (Femara), and tamoxifen
• Cimetidine (Tagamet)
• Corticosteroids such as cortisone, dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dantrolene (Dantrium)
• Diabetes medicines such as acarbose (Precose), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Doxepin (Silenor)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), and tipranavir (Aptivus)
• Isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, Zenatane)
• Medicines to treat breathing or lung problems such as aminophylline and theophylline
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Natural remedies such as alfalfa, black cohosh, bloodroot, chasteberry, dong quai, evening primrose oil, ginseng, licorice, red clover, saw palmetto, soy, St. John's wort, topical progesterone, and wild yam
• Other estrogen hormones such as conjugated estrogens (Premarin), esterified estrogen hormones (Estratab, Menest), estradiol (Climara, Estrace, Estraderm, Vivelle), and estropipate (Ogen)
• Raloxifene (Evista)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Warfarin (Coumadin)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the blister pack at room temperature. Do not put this medicine into another container. Protect it from heat, high humidity, and bright light. Discard any unused medicine after 60 days.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.