GILDESS 1/20 norethindrone acetate and ethinyl estradiol tablet film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

Mevcut itibaren:

Qualitest Pharmaceuticals

INN (International Adı):

NORETHINDRONE ACETATE

Kompozisyon:

NORETHINDRONE ACETATE 1 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

GILDESS 1/20- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET, FILM
COATED
PAR PHARMACEUTICAL
----------
GILDESS 1/20
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP)
NORETHINDRONE ACETATE (1 MG) AND ETHINYL ESTRADIOL (0.02 MG) TABLETS,
USP
(Each white tablet contains 1 mg norethindrone acetate and 0.02 mg
ethinyl estradiol.)
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Norethindrone acetate and ethinyl estradiol tablets, USP are
progestogen-estrogen combinations.
Norethindrone acetate and ethinyl estradiol tablets, USP provide a
continuous dosage regimen
consisting of 21 oral contraceptive tablets.
Each white tablet contains norethindrone acetate (17
alpha-ethinyl-19-nortestosterone acetate), 1 mg;
ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17
beta-diol), 0.02 mg. Also contains
compressible sugar, colloidal silicon dioxide, croscarmellose sodium,
hypromellose 2910 6cP,
lactose monohydrate, magnesium stearate, polyethylene glycol 400,
polyethylene glycol 8000,
pregelatinized starch, sodium lauryl sulfate and Vitamin E.
The structural formulas are as follows:
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotropins.
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 reduce the likelihood
of implantation).
PHARMACOKINETICS
The pharmacokinetics of norethindrone acetate and ethinyl estradiol
tablets have not been characterized;
however, the following pharmacokinetic information regarding
norethindrone acetate and ethinyl
estradiol is taken from the literature.
ABS ORPTION
Norethindrone acetate appears to be completely and rapidly
deacetylated to norethindrone after oral
administration, since the disposition of norethindrone acetate is
indistinguishable from that of orally
admini