LEENA norethindrone and ethinyl estradiol

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Actavis Pharma, Inc.

INN (International Adı):

NORETHINDRONE

Kompozisyon:

NORETHINDRONE .5 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

New Drug Application Authorized Generic

Ürün özellikleri

LEENA- NORETHINDRONE AND ETHINYL ESTRADIOL
ACTAVIS PHARMA, INC.
----------
LEENA® (NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP)
2000006255
REVISED: APRIL 2014
PHYSICIAN LABELING
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
ORAL CONTRACEPTIVE AGENTS
DESCRIPTION
_LEENA_
provides a continuous oral contraceptive regimen of 7 light blue
tablets, 9 light yellow-green
tablets, 5 more light blue tablets, and then 7 orange tablets. Each
light blue tablet contains norethindrone
0.5 mg and ethinyl estradiol 0.035 mg, each light 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 light yellow-green _Leena_ tablets contain the following inactive
ingredients: D&C Green No. 5,
D&C Yellow No. 10, lactose, magnesium stearate, povidone, and starch.
The light blue _Leena_ 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
®
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