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Cenestin

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Cenestin

Indications
Dosage
How Supplied

INDICATIONS

Cenestin (synthetic conjugated estrogens) therapy is indicated for the:

  1.  Treatment of moderate to severe vasomotor symptoms associated with the menopause.
    •  0.45 mg Cenestin (synthetic conjugated estrogens)
    •  0.625 mg Cenestin (synthetic conjugated estrogens)
    •  0.9 mg Cenestin (synthetic conjugated estrogens)
    •  1.25 mg Cenestin (synthetic conjugated estrogens)
  2.  Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
    •  0.3 mg Cenestin (synthetic conjugated estrogens)

DOSAGE AND ADMINISTRATION

When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. 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. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (See BOXED WARNINGS and WARNINGS.) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

  1. For treatment of moderate to severe vasomotor symptoms associated with the menopause.
    •  Cenestin (synthetic conjugated estrogens) 0.45 mg
    •  Cenestin (synthetic conjugated estrogens) 0.625 mg
    •  Cenestin (synthetic conjugated estrogens) 0.9 mg
    •  Cenestin (synthetic conjugated estrogens) 1.25 mg
      Patients should be started with Cenestin (synthetic conjugated estrogens) 0.45 mg daily. Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider. The lowest effective dose of Cenestin (synthetic conjugated estrogens) for the treatment of moderate to severe vasomotor symptoms has not been determined.
  2.  For treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
    •  Cenestin (synthetic conjugated estrogens) 0.3 mg daily

HOW SUPPLIED

Cenestin (synthetic conjugated estrogens, A) Tablets are available as:

0.3 mg: Round, green, film-coated, and are debossed with letters, dp, and number, 41.

Available in bottles of:

30 NDC 51285-441-30
100 NDC 51285-441-02
1000 NDC 51285-441-05

0.45 mg: Round, orange, film-coated, and are debossed with letters, dp, and number, 46.

Available in bottles of:

30 NDC 51285-446-30
100 NDC 51285-446-02
1000 NDC 51285-446-05

0.625 mg: Round, red, film-coated, and are debossed with letters, dp, and number, 42.

Available in bottles of:

30 NDC 51285-442-30
100 NDC 51285-442-02
1000 NDC 51285-442-05

0.9 mg: Round, white, film-coated, and are debossed with letters, dp, and number, 43.

Available in bottles of:

30 NDC 51285-443-30
100 NDC 51285-443-02
1000 NDC 51285-443-05

1.25 mg: Round, blue, film-coated, and are debossed with letters, dp, and number, 44.

Available in bottles of:

30 NDC 51285-444-30
100 NDC 51285-444-02
1000 NDC 51285-444-05

Store at 20-25°C (68-77°F); excursions are permitted to15-30°C (59-86°F) [See USP Controlled Room Temperature].

Keep out of the reach of children. Dispense in tight container. Dispense in child-resistant packaging.

Keep out of the reach of children.

Manufactured By: Duramed Pharmaceuticals, Inc. Subsidiary of Barr Pharmaceuticals, Inc. Pomona, NY 10970. Revised SEPTEMBER 2004. FDA rev date: 10/28/2004

Last reviewed on RxList: 10/16/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

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