TRI-NORINYL norethindrone and ethinyl estradiol

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Actavis Pharma, Inc.

INN (Rahvusvaheline Nimetus):

NORETHINDRONE

Koostis:

NORETHINDRONE 0.5 mg

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

New Drug Application

Toote omadused

TRI-NORINYL- NORETHINDRONE AND ETHINYL ESTRADIOL
ACTAVIS PHARMA, INC.
----------
TRI-NORINYL (NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP)
REVISED: FEBRUARY 2014
RX ONLY
PHYSICIAN LABELING
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
ORAL CONTRACEPTLVE AGENTS
DESCRIPTION
TRI-NORINYL provides a continuous oral contraceptive regimen of 7 blue
tablets, 9 yellow-green
tablets, 5 more blue tablets, and then 7 orange tablets. Each blue
tablet contains norethindrone 0.5 mg and
ethinyl estradiol 0.035 mg, each yellow-green tablet contains
norethindrone 1 mg and ethinyl estradiol
0.035 mg, and each orange tablet contains 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. Their structural formulae follow.
The yellow-green TRI-NORINYL tablets contain the following inactive
ingredients: D&C Green No.
5, D&C Yellow No. 10, lactose, magnesium stearate, povidone, and
starch.
The blue TRI-NORINYL tablets contain the following inactive
ingredients: FD&C Blue No. 1, lactose,
magnesium stearate, povidone, and starch.
®
The inactive orange tablets contain the following inactive
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
include changes in the cervical
mucus (which increase the difficulty of sperm entry into the uterus)
and the endometrium (which may
reduce the likelihood of implantation).
INDICATIONS AND USAGE
Oral contraceptives are indicated for the prevention of pregnancy in
women who elect to use this
product as a method of contraception.
Oral contraceptive products such as Norinyl, which contain 50 mcg of
estrogen