Vagifem (Estradiol Vaginal Tablets)

18 tabs for $112.00

Vagifem - 10mcg
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Description

Estradiol vaginal tablets belong to a class of medications called local estrogen replacement therapy. An ovary produces estrogen, which is a type of hormone.

Estradiol, a form of estrogen, is contained in Vagifem vaginal inserts. The female sex hormone estrogen regulates a wide range of bodily functions.

Ovaries produce less estrogen during menopause, resulting in symptoms such as vaginal atrophy. When estradiol vaginal tablets are inserted into the vagina, they release estradiol, which thickens and supplies the vaginal tissues. Two to three weeks after treatment, symptoms usually improve.

Please mention to your healthcare prescriber if your medical regime includes insulin.

After menopause, vaginal changes may be uncomfortable and can be treated. A number of symptoms can occur, including vaginal dryness, irritation, itching, and soreness; painful urination; and pain and bleeding while sexually active (see side effects tab for more information).  Medications (such as Vagifem) that are applied directly inside the vagina should be used first when treating only vaginal symptoms of menopause. Because more estrogen is absorbed when taken by mouth, absorbed through the skin, or injected, oral estrogen may have more side effects.

Vagifem should not be used for conditions for which it was not prescribed. Do not give Vagifem to anyone else, even if they have the same symptoms as you. They may be harmed by it. You should keep Vagifem out of reach of children.

A vaginal insert containing 10 mcg of estradiol, Vagifem is a small, white, round, film-coated device. In a disposable applicator, each vaginal insert measures 6 mm in diameter.

The safety and effectiveness of Vagifem in children are unknown.

Before Taking Vagifem

In addition to allergies to estradiol, Vagifem should not be taken if you have:

An unusual amount of vaginal bleeding without a doctor’s examination;

Liver disease;

An existing heart condition, a stroke, or a blood clot;

An increased risk of blood clots due to heart disease or hereditary blood disorders

A history of hormone-related cancer, or breast, uterine, or vaginal cancer.

Pregnant women should not use Vagifem. If you become pregnant during treatment, inform your doctor immediately.

It is possible to develop blood clots, strokes, or heart attacks if you use Vagifem vaginal inserts. High blood pressure, diabetes, high cholesterol, obesity, and smoking put you at even greater risk.

There is no evidence that vagifem can prevent heart disease, stroke, or dementia. You may actually be at greater risk of developing these conditions if you take this medicine.

To make sure Vagifem is safe for you, tell your doctor if you have:

Heart disease;

Jaundice or liver problems caused by pregnancy or hormone use;

Kidney disease;

Gallbladder disease;

Asthma (taking asthma medication, such as Trelegy);

Seizures or epilepsy;

Migraines;

Lupus;

Fibroid tumors or endometriosis;

Hereditary angioedema;

Porphyria (genetic enzyme disorder affecting the nervous system and skin);

A thyroid disorder; or

A high or low calcium level in your blood.

Breast, uterine, and ovarian cancers are possible side effects of estradiol use. You should discuss this risk with your doctor.

Breast milk production can be slowed by estradiol. If you are breastfeeding, tell your doctor.

Precautions

If you are allergic to estradiol or have any other allergies, tell your doctor or pharmacist before taking it. Inactive ingredients may cause allergic reactions or other problems with this product. For more information, contact your pharmacist.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots), family or personal history of a certain swelling disorder (angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, mental/mood disorders (such as dementia, depression), a certain blood disorder (porphyria).

It is not a good idea to smoke or use tobacco. Women over 35 who smoke and take estrogen are at an increased risk of stroke, blood clots, high blood pressure, and heart attacks.

Consult your doctor if you are having surgery or will be confined to a chair or bed for a long period of time (such as a long flight). The use of estrogen products increases your risk of blood clots. Taking special precautions or stopping this medication may be necessary.

There is a possibility that this medication may cause blotchy, dark patches on your face or skin (melasma). This effect may be exacerbated by sunlight. Don’t spend too much time in the sun. Sunlamps and tanning booths should be avoided. When spending time outdoors, wear sunscreen and protective clothing.

If you wear contact lenses or are nearsighted, you may experience vision problems or trouble wearing them. You should consult your eye doctor if you experience any of these problems.

Usage

Take Vagifem exactly as prescribed by your doctor. Be sure to read all medication guides and instructions on your prescription label.

There is a possibility that estradiol may increase your risk of developing uterine cancer. To lower this risk, your doctor may prescribe a progestin. If you experience any unusual bleeding in your vaginal area, call your doctor immediately.

Before and after inserting Vagifem, wash your hands.

A disposable applicator comes with each Vagifem tablet. After one use, throw away the tablet applicator.

Instructions for use of the applicator:

Remove one applicator at a time.

The applicator can be removed from the plastic wrap by separating it from it. When you open the package, if the insert has not fallen out of the package but has come out of the applicator, carefully place it back into it. When handling the insert, please keep your hands clean and dry.

You should hold the applicator so that your finger can press the plunger with one hand.

The next step is to choose the position that is most comfortable for you for vaginal insertion of Vagifem vaginal inserts, e.g. reclining or standing.

Gently and comfortably guide the applicator through the vaginal opening using the other hand. Use a new insert-filled applicator if the insert falls out of the applicator before insertion.

To insert the applicator, insert it (without forcing) as far as you are comfortable with, or until half of the applicator is inside your vagina.

To fully depress the plunger, gently press the plunger once the insert-filled applicator has been inserted. As a result, the insert will be ejected into your vagina, where it will dissolve over a period of time.

You can dispose of the applicator in the same manner as a plastic tampon applicator after depressing the plunger. It is no longer useful and should be disposed of properly. Any time of day is suitable for insertion. Vagifem vaginal inserts should be applied at the same time every day. Your pharmacist or healthcare provider can answer any questions you may have.

To determine whether this treatment should be continued, your doctor should check your progress regularly. When using Vagifem, you should self-examine your breasts monthly for lumps and have a mammogram every year.

Vagifem may need to be stopped for a short period of time if you need major surgery or will be on long-term bed rest. It is important that your doctor or surgeon knows you are using Vagifem.

Dosage

In general, a progestin should also be considered when estrogen is prescribed for a postmenopausal woman with a uterus in order to reduce the risk of endometrial cancer. It is not necessary for a woman without a uterus to take a progestin. The use of a progestin is sometimes necessary for hysterectomy patients with endometriosis. The lowest effective dose and shortest duration of estrogen treatment, alone or with a progestin, should be used according to the individual’s treatment goals and risks. To determine if treatment is still needed in postmenopausal women, clinical evaluations should be performed periodically.

Using the supplied applicator, Vagifem is administered intravaginally as follows: 1 tablet daily for 2 weeks, followed by 1 tablet twice weekly (e.g., Tuesday and Friday). Women are generally recommended to start at the dosage of 10 mcg.

The vaginal tablet containing 10 mcg or 25 mcg of estradiol is white, round, film-coated, and bi-convex. A disposable applicator is used to administer each 6 mm-diameter vaginal tablet.

Side Effects

Just like any medication, you may face common or severe side effects. Hence, why it is vital to discuss your medical history with your healthcare professional.

Please share any allergies with your prescriber, as you may be allergic to Vagifem. Some of the symptoms of an allergic reaction include: hives; difficulty breathing; swelling of your face, lips, tongue, and/or throat.

If you experience any of the following symptoms, call your doctor right away:

Symptoms of a heart attack – pain in your chest, pain in your jaw or shoulder, nausea, sweating;

Stroke symptoms – numbness or weakness (especially on one side of the body), severe headache, slurred speech, difficulties with vision or balance;

Blood clot symptoms – sudden vision loss, stabbing chest pain, shortness of breath, coughing up blood, pain or warmth in one or both legs;

Inflammation or tenderness in your stomach;

A yellowing of the skin or eyes (jaundice);

Problems with memory, confusion, unusual behavior;

Pain in the pelvis, unusual vaginal bleeding;

If you have a lump in your breast;

Symptoms of high calcium levels in your blood include nausea, vomiting, constipation, increased thirst and urination, muscle weakness, bone pain, fatigue.

The following are common side effects of Vagifem:

Stomach cramps, nausea, vomiting, and bloating;

Headache;

Swelling in your hands or feet, weight gain;

Breast pain; or

Itching or discharge in the vaginal area, changes in your menstrual cycle, breakthrough bleeding.

In addition to those listed here, there may be other side effects as well. In case of side effects, consult your doctor. You may report side effects to FDA at 1-800-FDA-1088.

Drug Interactions

Certain medications cannot be taken at the same time. There are some drugs that may affect the blood levels of other drugs you take, which can cause side effects or make the medications less effective.

Estradiol can interact with a wide variety of drugs. Prescription and over-the-counter medicines, vitamins, and herbal products fall into this category. This list does not include all possible interactions. All your current medicines and any medicines you start or stop using should be disclosed to your doctor.

Vagifem (estradiol topical) interacts with 200 drugs, including 7 major, 179 moderate, and 14 minor interactions.  

The 7 major are:

Carfilzomib

Dantrolene

Hemin

Lenalidomide

Pomalidomide

Thalidomide

Tranexamic acid

Pregnancy

It is not recommended to use Vagifem during pregnancy. In children born to women who used estrogens and progestins as oral contraceptives inadvertently during early pregnancy, there does not appear to be an increased risk of birth defects.

It is not recommended to use Vagifem during lactation. It has been shown that estrogen administration to nursing women reduces the quantity and quality of breast milk. Women receiving estrogen have been found to produce detectable amounts of estrogen in their breast milk.

Overdose

911 should be called if someone is overdosing and has serious symptoms, such as passing out or having trouble breathing. Otherwise, contact a poison control center immediately. Residents of the US can contact their local poison control center at 1-800-222-1222.  Overdose symptoms include nausea and vomiting, unusual vaginal bleeding.

Missed Dose

The missed dose should be skipped if it is near the time of the next dose. Your next dose should be taken at the regular time. Trying to catch up should not be done by doubling the dose.

Ingredients

A small, white, film-coated tablet containing estradiol is known as a Vagifem (estradiol vaginal insert). Additionally, each tablet contains hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Polyethylene glycol and hypromellose are found in the film coating.

The Vagifem tablet is packaged in a blister pack with a disposable applicator. Eight or 18 applicators with tablets are contained in each carton.

Storage

You may store this product at a temperature of 25°C (77°F); excursions are permitted to 15°C – 30°C (59°F – 86°F). Keep out of the refrigerator.  

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