September 2, 2015
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Enjuvia

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Enjuvia




Indications
Dosage
How Supplied

INDICATIONS

Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause

Treatment Of Moderate To Severe Vaginal Dryness And Pain With Intercourse, Symptoms Of Vulvar And Vaginal Atrophy, Due To Menopause

Limitation of Use

When prescribing solely for the treatment of moderate to severe vaginal dryness and pain with intercourse, topical vaginal products should be considered.

DOSAGE AND ADMINISTRATION

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer [see BOXED WARNING].

A woman without a uterus does not need progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see WARNINGS AND PRECAUTIONS].

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be reevaluated periodically as clinically appropriate to determine if treatment is still necessary.

Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause

ENJUVIA therapy consists of a single tablet taken orally once daily.

  • ENJUVIA 0.3 mg
  • ENJUVIA 0.45 mg
  • ENJUVIA 0.625 mg
  • ENJUVIA 0.9 mg
  • ENJUVIA 1.25 mg

Women should be started at the lowest approved dose of 0.3 mg ENJUVIA daily. Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.

Treatment Of Moderate To Severe Vaginal Dryness And Pain With Intercourse, Symptoms Of Vulvar And Vaginal Atrophy, Due To Menopause

ENJUVIA therapy consists of a single tablet taken orally once daily.

  • ENJUVIA 0.3 mg

When prescribing solely for the treatment of moderate to severe vaginal dryness and pain during intercourse, topical vaginal products should be considered.

HOW SUPPLIED

Dosage Forms And Strengths

ENJUVIA is available as tablets in 0.3 mg, 0.45 mg 0.625 mg, 0.9 mg, and 1.25 mg strengths.

ENJUVIA (synthetic conjugated estrogens, B) Tablets

0.3 mg: The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of: 100 Tablets NDC 51285-406-02

0.45 mg: The tablets are oval, mauve, film-coated, and debossed with “E” on one side and “2” on the reverse and are available in bottles of: 100 Tablets NDC 51285-407-02

0.625 mg: The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of: 100 Tablets NDC 51285-408-02

0.9 mg: The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of: 100 Tablets NDC 51285-409-02

1.25 mg: The tablets are oval, yellow, film-coated, and debossed with “E” on one side and “4” on the reverse and are available in bottles of: 100 Tablets NDC 51285-410-02

Storage And Handling

Store at 20° to 25°C (68° to 77°F); excursions are permitted to 15 to 30®C (59 to 86®F) [See USP Controlled Room Temperature].

Keep this and all drugs out of the reach of children.

Dispense in a tight container with a child-resistant closure.

Pharmacist: Include one “PATIENT INFORMATION” leaflet with each prescription.

Manufactured By: Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised: June 2015

Last reviewed on RxList: 7/14/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Enjuvia - User Reviews

Enjuvia User Reviews

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