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"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.



Vagifem Patient Information including How Should I Take

What should I discuss with my healthcare provider before using estradiol vaginal (local) (Vagifem)?

You should not use estradiol vaginal if you have:

  • a bleeding or blood-clotting disorder;
  • a history of stroke or circulation problems;
  • abnormal vaginal bleeding that a doctor has not checked; or
  • any type of breast, uterine, or hormone-dependent cancer.

To make sure you can safely use estradiol vaginal, tell your doctor if you have any of these other conditions:

  • high blood pressure, angina, or heart disease;
  • high cholesterol or triglycerides;
  • liver disease;
  • kidney disease;
  • asthma;
  • epilepsy or other seizure disorder;
  • migraines;
  • diabetes;
  • depression;
  • gallbladder disease; or
  • if you have had your uterus removed (hysterectomy).

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol vaginal.

Long-term estradiol treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use estradiol vaginal if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Estradiol may decrease breast milk flow and have other effects on milk composition. Do not use estradiol without first talking to your doctor if you are breast-feeding a baby.

How should I use estradiol vaginal (local) (Vagifem)?

Some estradiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms involving the secretions and surrounding tissues of the vagina. Other vaginal estradiol products are used for treating menopause symptoms affecting the vagina as well as other parts of the body (such as hot flashes). This type of vaginal estradiol has "systemic" effects, meaning that it can affect parts of the body other than where the medicine is placed or applied.

The information in this leaflet is specific to estradiol vaginal products that are used for local treatment of symptoms.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

To use the estradiol vaginal ring:

  • Squeeze the sides of the ring together and insert it into the vagina as far as possible. You should not be able to feel the ring once it is in place. If you can feel it, use a finger to push it in farther. It is not possible for the ring to go too far in or become lost.
  • Leave the ring in place for 90 days. If the ring ever falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to push it in farther. After 90 days, remove the ring. Your doctor may want you to replace it with a new ring.
  • The ring does not need to be removed during sexual intercourse. Neither partner should be able to feel the ring when it is in place. If the ring is bothersome, you may remove it, rinse it with warm water, and reinsert it after intercourse.
  • To remove the ring, loop a finger through the ring and gently pull it from the vagina.

To use the estradiol vaginal cream:

  • Using the marked applicator provided, measure the prescribed dose of cream.
  • Lie on your back with your knees drawn up, sit, or stand in a position that allows you comfortable access to the vaginal area. Gently insert the applicator deep into your vagina and press in the plunger to empty the cream from the applicator into the vagina.
  • Take apart the applicator and wash it with mild soap and warm water. Allow the applicator to dry completely before using it again.

To use the estradiol vaginal tablets:

  • Each vaginal tablet is supplied in a disposable applicator.
  • Lie on your back with your knees drawn up, sit, or stand in a position that allows you comfortable access to the vaginal area. Gently insert the applicator deep into your vagina and press in the plunger to empty the tablet into the vagina.
  • Throw the applicator away.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol vaginal.

Store this medication at room temperature away from moisture and heat.

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