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Duavee (Generic Estrogen and Bazedoxifene)

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WARNING

If you have not had a hysterectomy, using oestrogen raises your risk of developing endometrial cancer, a kind of uterine lining cancer, during therapy or up to 15 years following treatment (surgery to remove the uterus [womb]). The chance of developing endometrial cancer increases with the duration of oestrogen use. Combining oestrogen and bazedoxifene may reduce your risk of developing endometrial cancer. During your treatment, refrain from using any additional estrogen-containing drugs as this could raise your risk of endometrial cancer. If you have cancer now or in the past, as well as any unusual vaginal bleeding, let your doctor know before starting oestrogen therapy. In the event that your vaginal bleeding is atypical, your doctor might advise against taking oestrogen and bazedoxifene. The possibility that you could develop endometrial cancer while receiving treatment or later on will be continuously monitored by your doctor. In the event that you experience any unusual or atypical vaginal bleeding while taking oestrogen, contact your doctor right once.

According to a significant study, estrogen-using women are more likely to experience heart attacks, strokes, blood clots in the legs or lungs, breast cancer, and dementia (loss of mental capacity such as thinking, learning, and understanding). Inform your doctor if you have ever had breast cancer, blood clots, a heart attack, or any other condition that raises your risk of developing blood clots. Also mention any family history of these conditions. Your physician might advise against using oestrogen and bazedoxifene together. Moreover, inform your doctor if you smoke or use tobacco, have breast lumps, an abnormal mammogram, high blood pressure, high cholesterol or fat levels, diabetes, heart disease, lupus (a condition in which the body attacks its own tissues), have any of these conditions or have ever had them (x-ray of the breast used to find breast cancer).

The major medical disorders mentioned above can present with any of the symptoms below. If you have any of the following signs while taking oestrogen and bazedoxifene, call your doctor right away: Speech difficulties, dizziness or faintness, sudden complete or partial vision loss, double vision, numbness or weakness in one arm or leg, crushing chest pain or chest heaviness, coughing up blood, sudden shortness of breath, trouble thinking clearly, remembering, or learning new things, breast lumps or other breast changes, discharge from nipples, or pain, tenderness, or redness in one leg are all symptoms of a sudden severe headache, vomiting, and headache of equal severity.

To help find breast cancer as early as possible, you should check your breasts monthly and get a mammography and breast exam conducted by a doctor once a year. If you have a personal or family history of illness, your doctor will advise you on how to properly inspect your breasts and whether you need to have them checked more frequently than once a year.

If you are undergoing surgery or will be recovering in bed, let your doctor know. In order to reduce your risk of developing blood clots, your doctor may advise you to stop taking oestrogen and bazedoxifene 4–6 weeks before to the procedure or place you on bed rest. When travelling, stand up and move around sometimes because staying seated for an extended period of time increases your chance of developing blood clots.

You can take precautions to lessen your chance of experiencing a significant health issue while taking oestrogen. The prevention of dementia, heart disease, heart attacks, or strokes is not recommended when using oestrogen or bazedoxifene. These hazards can be decreased by using the smallest dose of oestrogen necessary to manage your symptoms and only using it for the duration required. When deciding whether to reduce your oestrogen dosage or stop taking the medicine, consult your doctor sometimes.

Regularly discuss the dangers of oestrogen and bazedoxifene use with your doctor.

Why is this medication prescribed?

Hot flashes, which are abrupt feelings of warmth, particularly in the face, neck, and chest, in menopausal women, are treated with oestrogen and bazedoxifene pills (stage of life when menstrual periods become less frequent and stop and women may experience other symptoms and body changes). In addition, oestrogen and bazedoxifene tablets are used to treat and prevent osteoporosis in postmenopausal women, a condition in which the bones become brittle and brittle and break easily. Estrogen is a member of the hormones drug class, and bazedoxifene is a member of the oestrogen agonist-antagonist drug class. Estrogen functions by substituting for the natural oestrogen produced by the body. By preventing oestrogen from acting on the uterine lining, bazedoxifene lowers the likelihood of uterine cancer-causing proliferation.

How should this medicine be used?

The oral tablet form of the oestrogen and bazedoxifene combo is available. It is typically taken once day, with or without food. Every day, take oestrogen and bazedoxifene at the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take the prescribed dosages of both oestrogen and bazedoxifene. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablet; instead, swallow it whole.

As long as you keep taking the drug, oestrogen and bazedoxifene may help you reduce your symptoms. Without first seeing your doctor, do not discontinue taking oestrogen or bazedoxifene.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking estrogen and bazedoxifene,

  • If you have an allergy to any of the substances in oestrogen and bazedoxifene tablets, any other medications, or oestrogen itself (which is present in many hormone replacement and birth control pills), let your doctor and pharmacist know right once. For a list of the ingredients, consult your pharmacist or look in the patient’s information provided by the manufacturer.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Estrogen and bazedoxifene may be affected by interactions with the non-prescription or natural medications listed below: The St. John’s wort. When beginning to take oestrogen with bazedoxifene, be sure to let your doctor and pharmacist know that you are taking this drug. If you are currently taking oestrogen and bazedoxifene, talk to your doctor before starting this drug.
  • If you have liver illness now or previously, let your doctor know. If you take oestrogen and bazedoxifene, your doctor might advise against it.
  • If you have liver illness now or previously, let your doctor know. If you take oestrogen and bazedoxifene, your doctor might advise against it.
  • Inform your doctor if you ever experienced jaundice (a disorder that causes the skin or eyes to turn yellow) while pregnant or while using an oestrogen product. Furthermore let your doctor know if you have or have had had asthma, diabetes, epilepsy, migraine headaches, endometriosis (a disorder in which the tissue that lines the uterus [womb] develops in other places of the body), or epilepsy. Extremely high or extremely low calcium levels in your blood, hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone), thyroid or kidney disease, hereditary angioedema (inherited condition that causes episodes of swelling in the hands, feet, face, airway, or intestines), or porphyria are all examples of conditions that can cause problems with the skin or nervous system.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor right away if you get pregnant while taking oestrogen and bazedoxifene. The foetus could be harmed by oestrogen and bazedoxifene.
  • See your doctor about alternate methods of preventing osteoporosis if you are using oestrogen to do so, such as exercising and taking calcium and/or vitamin D supplements.

What special dietary instructions should I follow?

If you plan to consume grapefruits or grapefruit juice while taking this medication, consult your doctor.

If you are taking oestrogen to prevent osteoporosis, ask your doctor how you might increase your intake of calcium and vitamin D.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Side effects from oestrogen and bazedoxifene are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Heartburn
  • Abdominal pain
  • Diarrhoea
  • Muscles cramping
  • Stiff neck
  • Unwell throat
  • Dizziness

Certain adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT CAUTION section:

  • Enlarged eyes
  • Enlargement of the throat, lips, tongue, eyes, or face
  • Hoarseness
  • Breathing or swallowing challenges

The combination of oestrogen and bazedoxifene may raise your risk of developing ovarian cancer or gallbladder illness, both of which require surgical intervention. The dangers of using this drug should be discussed with your doctor.

Further side effects from oestrogen and bazedoxifene are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly wrapped in the foil pouch and blister pack it was packaged in, away from youngsters. Keep it away from excessive heat and moisture at room temperature (not in the bathroom). If you receive multiple foil pouches containing medication, wait until you have consumed the contents of the first bag before opening the subsequent one. Any unused medication in a foil pouch should be discarded 60 days after it has been opened. Make a note of the date you opened the bag. Tablets should not be taken out of the blister pack until you are ready to do so. Never keep medications in a pillbox or a similar container.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Nausea
  • Vomiting
  • Breast sensitivity
  • Dizziness
  • Abdominal pain
  • Tiredness
  • Uterine bleeding

What other information should I know?

Keep all of your doctor’s appointments.

Inform the lab staff and your doctor that you are taking oestrogen and bazedoxifene prior to any laboratory test.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Duavee®
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