Vagifem

Vagifem Medication Information:

Vagifem medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.

Vagifem 10 mcg
Vagifem 25 mcg

What is Vagifem

Vagifem can aid the user in maintaining normal sexual relations between her and her partner. It is a form of hormone replacement therapy.

How does Vagifem Work

Vagifem is a medication for menopausal and post-menopausal women who experience vaginal dryness as well as thinning of the walls of the vagina, also called atrophic vaginitis. This condition occurs when estrogen levels decrease and the production of vaginal fluid begins to cease. Starting with perimenopause, the lining of the vagina starts to shrink and lose its elasticity, sometimes prompting itching and cracking. Other symptoms include pain, bleeding with intercourse, inflammation, and infections. Vagifem provides estrogen to the vagina in pill form where it is needed without passing through the entire body. It also reduces urgency of and irritation upon urination.

How to take Vagifem

Women will find that using Vagifem is easy. They may take it in pill form. It comes with a pre-loaded applicator. Insert one pill per day into the vagina for two weeks. Thereafter insert one pill per day twice per week or as directed by your healthcare professional. Results normally occur very quickly, often within the first two weeks, however, it may take up to seven weeks to see the full effect of the treatment. Insertion can occur at any time of the day but it should take place at the same time every day. Adhering to the dosing schedule faithfully should yield good results.

Side Effects

The immediately observed side effects of this medication are mild. The ones commonly reported in clinical studies include headache, abdominal pain, back pain, upper respiratory tract infection, vaginal itching, and vaginal yeast infection. Vagifem contributes to the normal complications experienced with estrogen replacement therapy, including increased risk of cancer. A common one is endometrial cancer. Three case studies indicated that the risk of developing this disease was 4.5 to 13.9 percent greater for users than for nonusers. The risk occurred independently of other known risk factors. To minimize the danger, the lowest dose of estrogen should be used and the treatment should be discontinued as soon as possible.

Other Brand Names:

Another brand name for this medication is Estradiol.

Safety Information

The are several contraindications for this drug. These include known or suspected breast carcinoma, known or suspected estrogen-dependent neoplasia, abnormal genital bleeding, known or suspected pregnancy, porphyria, hypersensitivity to any Vagifem ingredients, active thrombophlebitis or throm-boembolic disorders or any past history thereof, except in cases of breast malignancy. Person with a history of jaundice should not use Vagifem. Vagifem may increase water retention which may affect those with asthma, epilepsy, migraines, or heart or kidney problems. Do not take if you have any problem with clotting especially after estrogen usage. Do not use if you have any infection of the vaginal area.

Dosage

There is only one dose of Vagifem. It is 25mcg.

Visual Description:

Vagifem comes in an applicators containing one pill each. They are packaged in a blister pack containing one applicator.

About Vagifem

What Vagifem is used for

Vagifem (estradiol vaginal tablets) is used for the treatment of the symptoms of atrophic vaginitis due to estrogen deficiency.

Addition of a progestin is not recommended.

Vagifem should be used only under the supervision of a doctor, with regular follow-up at least once a year to identify side effects associated with its use. Your first follow-up visit should be within 3 to 6 months of starting treatment. Your visit may include a blood pressure check, a breast exam, a Pap smear and pelvic exam. You should have a mammogram before starting treatment and at regular intervals as recommended by your doctor. Your doctor may recommend some blood tests.

You should carefully discuss the risks and benefits of hormone therapy (HT) with your doctor. You should regularly talk with your doctor about whether you still need treatment with HT.

What Vagifem does

Vagifem provides estrogen in and around the vagina. This helps to reduce dryness and discomfort you are experiencing in the urinary and genital area. Estrogen is made in your body by your ovaries. At some point, usually between the ages of 45 and 55, the ovaries decrease the amount of estrogen produced or stop producing estrogen all together. At this time, women go through the “change of life” or menopause. Monthly periods stop. Some women experience irritating feelings of warmth, heat and sweating (hot flashes).

Others find that the tissues of the vagina and urinary tract become thin and dry. This can be very uncomfortable and you may feel itching, burning and pain. Some women feel pain during sex. The same feelings may occur if the ovaries are surgically removed.

When Vagifem should not be used

Vagifem should NOT be used under these conditions:

  • Known or suspected estrogen-dependent carcinoma

  • Overgrowth of the lining of the uterus (endometrial hyperplasia)

  • Known or suspected, or past history of breast cancer

  • Unexpected or unusual vaginal bleeding

  • Known or suspected pregnancy

  • Breast feeding

  • Have or have had blood clot disorders, including blood clots in the leg, lung or thrombophlebitis

  • Allergic to estradiol or any of the ingredients in Vagifem

What the medicinal ingredient is

17β-Estradiol.

What the important nonmedicinal ingredients for Vagifem are

Lactose, maize starch, methylhydroxypropylcellulose, magnesium stearate and polyethylene glycol 6000.

What dosage forms Vagifem comes in

Vagifem is available as vaginal tablets, supplied in cartons of 15 vaginal tablets. Each tablet is pre-loaded into the applicator and contains 25 µg estradiol.


Warnings and Precautions

Carcinogenesis and Mutagenesis

Breast Cancer

The results of the WHI trial indicated no difference in the risk of breast cancer in post-menopausal women with prior hysterectomy taking oral estrogen-alone compared to women taking placebo.

Estrogens should not be taken by women who have a personal history of breast cancer.

In addition, women with a family history of breast cancer or women with a history of breast lumps, breast biopsies or abnormal mammograms (breast x-rays) should consult with their doctor before starting HT.

Women should have a mammogram before starting HT and at regular intervals during treatment as recommended by their doctor.

Regular breast examinations by a doctor and regular breast self-examinations are recommended for all women. You should review technique for breast self-examination with your doctor.

Overgrowth of the lining of the uterus and cancer of the uterus

Vagifem has not been shown to increase risk of overgrowth of the lining of the uterus and cancer of the uterus.

Ovarian Cancer

Use of estrogen alone and estrogen plus progestin therapies for 5 or more years has been associated with increased risk of ovarian cancer.

Heart Disease and Stroke

The results of the WHI trial indicated an increased risk of stroke and coronary heart disease in post-menopausal women taking combined oral estrogen plus progestin compared to women taking placebo.

In postmenopausal women taking oral estrogen-alone HT, the results of the WHI indicated an increased risk of stroke, but no difference in the risk of coronary heart disease in post-menopausal women with prior hysterectomy taking oral estrogen-alone compared to women taking placebo.

Abnormal Blood Clotting

Use of oral estrogen with or without progestin by menopausal woman is associated with increased risk of blood clots.

The risk of blood clots also increases with age, if you or a family member has had blood clots, if you smoke or if you are severely overweight. The risk of blood clots is also temporarily increased if you are immobilized for long periods of time and following major surgery. You should discuss risk factors for blood clots with your doctor since blood clots can be life-threatening or cause serious disability.

Gallbladder Disease

The use of oral estrogens by postmenopausal women has been associated with an increased risk of gallbladder disease requiring surgery.

Dementia

Use of combined oral estrogen plus progestin in women age 65 and over is associated with increased risk of probable dementia.

BEFORE you use Vagifem talk to your doctor or pharmacist if you

  • have a history of allergy or intolerance to any medications or other substances

  • have a personal history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer

  • have experienced any unusual or undiagnosed vaginal bleeding

  • have a history of uterine fibroids or endometriosis

  • have a history of liver disease, jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy

  • have a history of migraine headache

  • have a history of high blood pressure

  • have a personal or family history of blood clots, or a personal history of heart disease or stroke

  • have a history of kidney disease, asthma or epilepsy (seizures)

  • have been diagnosed with diabetes

  • are pregnant or may be pregnant

  • If you think you may have a vaginal infection


Interactions with Vagifem

Tell your doctor or pharmacist if you are taking any other medications, including prescription medications, over-the-counter medications, vitamins or herbal products.


Proper Use of Vagifem

Vagifem Facts

Post-menopause is the last stage of the female reproductive cycle and begins one year following the last menstrual period.

The primary ingredient in Vagifem is estradiol, a type estrogen produced in women prior to menopause.

Vagifem is used to treat atrophic vaginitis, which is caused by a lack of estrogen during and after menopause.

More than 75% of post-menopausal women experience atrophic vaginitis.

 

Technical Information