NORGESTIMATE AND ETHINYL ESTRADIOL kit

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

RPK Pharmaceuticals, Inc.

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg and Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)]. Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are 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. Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)]. Norgestimate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: There is little or no increased risk of birth defects in women who inadvertently use COCs during

Produkt oversigt:

Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg are available in blister packs containing 28 tablets, as follows: NDC 68462-309-29 1 carton containing 3 blister card of 28 tablets Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are available in blister packs containing 28 tablets, as follows: NDC 68462-565-29 1 carton containing 3 blister card of 28 tablets

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL ESTRADIOL
RPK Pharmaceuticals, Inc.
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DETAILED PATIENT LABELING
Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg
PLEASE NOTE: This labeling is revised from time to time as important
new medical information
becomes available. Therefore, please review this labeling carefully.
This product (like all oral contraceptives) does not protect against
HIV infection (AIDS) and other
sexually transmitted diseases.
Norgestimate and Ethinyl Estradiol Tablets USP Regimen
Each blue tablet contains 0.25 mg norgestimate USP and 0.035 mg
ethinyl estradiol USP. Each light
green tablet contains inert ingredients.
INTRODUCTION
Any woman who considers using oral contraceptives (the birth control
pill or the pill) should understand
the benefits and risks of using this form of birth control. This
patient labeling will give you much of the
information you will need to make this decision and will also help you
determine if you are at risk of
developing any of the serious side effects of the pill. It will tell
you how to use the pill properly so that it
will be as effective as possible. However, this labeling is not a
replacement for a careful discussion
between you and your healthcare professional. You should discuss the
information provided in this
labeling with him or her, both when you first start taking the pill
and during your revisits. You should also
follow your healthcare professional’s advice with regard to regular
check-ups while you are on the pill.
EFFECTIVENESS OF ORAL CONTRACEPTIVES FOR
CONTRACEPTION
Oral contraceptives or "birth control pills" or "the pill" are used to
prevent pregnancy and are more
effective than most other non-surgical methods of birth control. When
they are taken correctly without
missing any pills, the chance of becoming pregnant is approximately 1%
per year (1 pregnancy per 100
women per year of use). Typical failure rates, including women who do
not always take the pill correctly,
are approximately 5% per year (5 pr

Produktets egenskaber

NORGESTIMATE AND ETHINYL ESTRADIOL- 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
NORGESTIMATE AND
ETHINYL ESTRADIOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS.
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS, 0.25 MG/0.035 MG, FOR ORAL
USE
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS, 0.18 MG/0.035 MG, 0.215
MG/0.035 MG,
0.25 MG/0.035 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.11) 04/2022
INDICATIONS AND USAGE
Norgestimate and ethinyl estradiol tablets are estrogen/progestin
COCs, indicated for use by women to
prevent pregnancy. (1.1)
Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215
mg/0.035 mg, 0.25 mg/0.035 mg are
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 menarche.
Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215
mg/0.035 mg, 0.25 mg/0.035 mg
should be used for the treatment of acne only if the patient desires
an oral contraceptive for birth control.
(1.2)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg,
consist of 28 round, flat faced beveled
edged, uncoated tablets in the following order (3):
•
•
Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg,
0.215 mg/0.035 mg, 0.25 mg/0.035
mg, consist of 28 round, flat faced beveled edged, uncoated tablets in
the following order (3):
•
•
•
•
CONTRAINDICATIONS
Norgestimate and ethinyl estradiol tablets are contraindicated in
women over 35 years old who
smoke. (4)
Cigarette smoking increases the risk of serious cardiovascular