PREVIFEM- norgestimate and ethinyl estradiol

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

から入手可能:

RPK Pharmaceuticals, Inc.

処方タイプ:

PRESCRIPTION DRUG

適応症:

Previfem® (norgestimate/ethinyl estradiol tablets) and Tri-Previfem® (norgestimate/ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Tri-Previfem® (norgestimate/ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Previfem® (norgestimate/ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)] . Do not prescribe Previfem® or Tri-Previfem® to women who are known to have the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] Have deep vein thrombosis or pulmonary embolism, now or in the past [s

製品概要:

Previfem® Previfem® (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of 6 blister pack tablet dispensers containing 28 tablets as follows: 21 blue tablets containing 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol which are round, unscored, film-coated tablets debossed with “93” and “748” on each side and 7 light-green, round, film-coated tablets debossed with “93” and “743” containing inert ingredients. Blister pack tablet dispenser NDC 0603-7642-01. Boxes of 6 blister pack tablet dispensers NDC 0603-7642-17. Tri-Previfem® Tri-Previfem® (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of 6 blister pack tablet dispensers, each blister pack tablet dispenser contains 28 tablets as follows: Each white tablet contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. Each light-blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Each blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Each light-green tablet contains inert ingredients. The white tablets are round, unscored film-coated, imprinted with “93” on one side and “746” on the other side; the light-blue tablets are round, unscored film-coated, imprinted with “93” on one side and “747” on the other side; the blue tablets are round, unscored film-coated, imprinted with “93” on one side and “748” on the other side; the light-green tablets are round, film-coated, imprinted with “93” on one side and “743” on the other side. Blister pack tablet dispenser NDC 0603-7663-01. Boxes of 6 blister pack tablet dispensers NDC 0603-7663-17.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

PREVIFEM- NORGESTIMATE AND ETHINYL ESTRADIOL
RPK PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREVIFEM OR TRI-PREVIFEM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PREVIFEM AND
TRI-PREVIFEM .
PREVIFEM AND TRI-PREVIFEM (NORGESTIMATE/ETHINYL ESTRADIOL TABLETS),
FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PREVIFEM OR TRI-PREVIFEM (NORGESTIMATE/ETHINYL ESTRADIOL TABLETS) ARE
CONTRAINDICATED IN WOMEN
OVER 35 YEARS OLD WHO SMOKE. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVES (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions (5.3) 08/2017
INDICATIONS AND USAGE
Previfem (norgestimate/ethinyl estradiol tablets) and Tri-Previfem
(norgestimate/ethinyl estradiol tablets) are
estrogen/progestin COCs, indicated for use by women to prevent
pregnancy. (1.1)
Tri-Previfem (norgestimate/ethinyl estradiol tablets) is also
indicated for the treatment of moderate acne vulgaris in
females at least 15 years of age, who have no known contraindications
to oral contraceptive therapy and have achieved
me narche .
Tri-Previfem (norgestimate/ethinyl estradiol tablets) should be used
for the treatment of acne only if the patient desires
an oral contraceptive for birth control. (1.2)
DOSAGE AND ADMINISTRATION
• Take one tablet daily by mouth at the same time every day. (2.2)
• Take tablets in the order directed on the blister pack. (2.2)
• Do not skip or delay tablet intake. (2.2)
DOSAGE FORMS AND STRENGTHS
Previfem (norgestimate/ethinyl estradiol tablets) consists of 28
round, unscored, film-coated tablets in the following order
(3):
• 21 blue tablets each containing 0.25 mg norgestimate and 0.035 mg
ethinyl estradiol
• 7 light-green tablets (inert)
Tri-Previfem (norgestimate/ethinyl estradiol tablets) co