PREVIFEM- norgestimate and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Central Texas Community Health Centers

INN (International Name):

NORGESTIMATE

Composition:

NORGESTIMATE 0.25 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Previfem® (norgestimate/ethinyl estradiol tablets USP) and Tri-Previfem® (norgestimate/ethinyl estradiol tablets USP) are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Tri-Previfem® (norgestimate/ethinyl estradiol tablets USP) 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 USP) 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 [se

Product summary:

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. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREVIFEM- NORGESTIMATE AND ETHINYL ESTRADIOL
CENTRAL TEXAS COMMUNITY HEALTH CENTERS
REFERENCE LABEL SET ID: DD15DBD7-75B7-416E-AF55-1E90C2BAB051
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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)
INDICATIONS AND USAGE
Previfem (norgestimate/ethinyl estradiol tablets USP) and Tri-Previfem
(norgestimate/ethinyl estradiol tablets USP) are
estrogen/progestin COCs, indicated for use by women to prevent
pregnancy. (1.1)
Tri-Previfem (norgestimate/ethinyl estradiol tablets USP) 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 USP) 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 USP) 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