PREMPHASE- conjugated estrogens and medroxyprogesterone acetate kit PREMPRO- conjugated estrogens and medroxyprogesterone acetate tablet, sugar coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (ESTROGENS, CONJUGATED - UNII:IU5QR144QX), MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G) (MEDROXYPROGESTERONE - UNII:HSU1C9YRES)

Tilgjengelig fra:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (International Name):

ESTROGENS, CONJUGATED

Sammensetning:

ESTROGENS, CONJUGATED 0.625 mg

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

PREMPRO or PREMPHASE therapy should not be used in women with any of the following conditions: PREMPRO and PREMPHASE should not be used during pregnancy [see Contraindications (4)] . There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. PREMPRO and PREMPHASE should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogen and progestin have been identified in the breast milk of women receiving these drugs. Caution should be exercised when PREMPRO or PREMPHASE is administered to a nursing woman. PREMPRO and PREMPHASE are not indicated in children. Clinical studies have not been conducted in the pediatric population. There have not been sufficient numbers of geriatric women involved in clinical studies utilizing PREMPRO or PREMPHASE to determine whether those over 65 years of age differ from younger subjects in their response to PREMPRO or PREMPHASE. The Women's Health Initiative Studies In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies (14.6)] . In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Clinical Studies (14.6)] . The Women's Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin or estrogen-alone when compared to placebo [see Warnings and Precautions (5.3), and Clinical Studies (14.7)] . Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see Warnings and Precautions (5.3), and Clinical Studies (14.7)] . The effects of renal impairment on the pharmacokinetics of PREMPRO or PREMPHASE have not been studied. The effects of hepatic impairment on the pharmacokinetics of PREMPRO or PREMPHASE have not been studied.

Produkt oppsummering:

PREMPRO therapy consists of a single tablet to be taken once daily. PREMPRO 0.3 mg/1.5 mg NDC 0046-1105-11, carton includes 1 blister card containing 28 oval, cream tablets. PREMPRO 0.45 mg/1.5 mg NDC 0046-1106-11, carton includes 1 blister card containing 28 oval, gold tablets. PREMPRO 0.625 mg/2.5 mg NDC 0046-1107-11, carton includes 1 blister card containing 28 oval, peach tablets. PREMPRO 0.625 mg/5 mg NDC 0046-1108-11, carton includes 1 blister card containing 28 oval, light-blue tablets. PREMPHASE therapy consists of two separate tablets; one maroon Premarin tablet taken daily on days 1 through 14 and one light-blue tablet taken on days 15 through 28. NDC 0046-2575-12, carton includes 1 blister card containing 28 tablets (14 oval, maroon Premarin tablets and 14 oval, light-blue tablets). The appearance of PREMPRO tablets is a trademark of Pfizer Inc. The appearance of PREMARIN tablets is a trademark of Pfizer Inc. The appearance of the conjugated estrogens/medroxyprogesterone acetate combination tablets is a trademark. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

New Drug Application

Preparatomtale

PREMPHASE- CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE
PREMPRO- CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE TABLET,
SUGAR COATED
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREMPRO/PREMPHASE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PREMPRO/PREMPHASE.
PREMPRO (CONJUGATED ESTROGENS/MEDROXYPROGESTERONE ACETATE TABLETS)
PREMPHASE (CONJUGATED ESTROGENS PLUS
MEDROXYPROGESTERONE ACETATE TABLETS)
INITIAL U.S. APPROVAL: 1995
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER
AND PROBABLE DEMENTIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ESTROGEN PLUS PROGESTIN THERAPY
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ESTROGEN-ALONE THERAPY
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RECENT MAJOR CHANGES
Warnings and Precautions, Malignant Neoplasms (5.2)
2/2024
INDICATIONS AND USAGE
PREMPRO/PREMPHASE is an estrogen plus progestin indicated in a woman
with a uterus for:
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DOSAGE AND ADMINISTRATION
PREMPRO: one tablet containing conjugated estrogens (CE) plus
medroxyprogesterone acetate (MPA) taken orally once daily. (2)
PREMPHASE: one maroon tablet containing 0.625 mg CE taken orally on
days 1 through 14, and one light-blue tablet containing 0.625
mg CE plus 5.0 mg MPA taken orally on days 15 through 28. (2)
DOSAGE FORMS AND STRENGTHS
PREMPRO Tablets: 0.3 mg CE plus 1.5 mg MPA, 0.45 mg CE plus 1.5 mg
MPA, 0.625 mg CE plus 2.5 mg MPA, 0.625 mg CE plus 5 mg
MPA.
PREMPHASE Tablets: 0.625 mg CE, 0.625 mg CE plus 5 mg MPA. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
®
®
ESTROGEN PLUS PROGESTIN THERAPY SHOULD NOT BE USED FOR THE PREVENTION
OF CARDIOVASCULAR DISEASE OR DEMENTIA
(5.1, 5.3)
THE WOMEN'S HEALTH INITIATIVE (WHI) ESTROGEN PLUS PROGESTIN SUBSTUDY
REPORTED INCREASED RISKS OF STROKE, DEEP
VEIN THROMBOSIS (DVT), PULMONARY EMBOLISM (PE), AND MYOCARDIAL
INFARCTION (MI) (5.1)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED R