BREVICON norethindrone and ethinyl estradiol

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)

Fáanlegur frá:

Actavis Pharma, Inc.

INN (Alþjóðlegt nafn):

NORETHINDRONE

Samsetning:

NORETHINDRONE 0.5 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

New Drug Application

Vara einkenni

BREVICON- NORETHINDRONE AND ETHINYL ESTRADIOL
NORINYL- NORETHINDRONE AND ETHINYL ESTRADIOL
NORINYL- NORETHINDRONE AND MESTRANOL
ACTAVIS PHARMA, INC.
----------
BREVICON
(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP, 0.5 MG/0.035 MG)
_NORINYL_
_1+35 _
(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.035 MG)
REVISED: SEPTEMBER 2017
RX ONLY
PHYSICIAN LABELING
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
ORAL CONTRACEPTIVE AGENTS
DESCRIPTION
_BREVICON_ Tablets provide a continuous oral contraceptive regimen
consisting of 21 blue tablets
containing norethindrone 0.5 mg and ethinyl estradiol 0.035 mg and 7
orange tablets containing inert
ingredients.
_NORINYL_
_1+35 _Tablets provide a continuous oral contraceptive regimen
consisting of 21 yellow-green
tablets containing norethindrone 1 mg and ethinyl estradiol 0.035 mg
and 7 orange tablets containing
inert ingredients.
Norethindrone is a potent progestational agent with the chemical name
17-Hydroxy-19-Nor-17α-pregn-
4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical
name 19-nor-17α-pregna-1,3,5(10)-
trien-20-yne-3,17-diol. Mestranol is an estrogen with the chemical
name 3-Methoxy-19-nor-17α-
pregna-1,3,5(10)-trien-20-yn-17-ol. Their structural formulae follow:
®
_®_
®
®
The blue BREVICON tablets contain the following inactive ingredients:
FD&C Blue No. 1, lactose,
magnesium stearate, povidone, and starch.
The yellow-green NORINYL 1+35 tablets contain the following inactive
ingredients: D&C Green No.
5, D&C Yellow No. 10, lactose, magnesium stearate, povidone, and
starch.
The inactive orange tablets in the 28-day regimens of BREVICON and
NORINYL 1+35 contain the
following ingredients: FD&C Yellow No. 6, lactose, microcrystalline
cellulose, and magnesium
stearate.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotrophins.
Although the primary
mechanism of this action is inhibition of ovulation, other alterations
inc