GILDESS 1.5/30 norethindrone acetate and ethinyl estradiol tablet film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Qualitest Pharmaceuticals

INN (Medzinárodný Name):

NORETHINDRONE ACETATE

Zloženie:

NORETHINDRONE ACETATE 1.5 mg

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

GILDESS 1.5/30- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET,
FILM COATED
PAR PHARMACEUTICAL
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GILDESS 1.5/30
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP)
NORETHINDRONE ACETATE (1.5 MG) AND ETHINYL ESTRADIOL (0.03 MG)
TABLETS,
USP
(Each light green tablet contains 1.5 mg norethindrone acetate and
0.03 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 light green tablet contains norethindrone acetate (17
alpha-ethinyl-19-nortestosterone acetate), 1.5
mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17
beta-diol), 0.03 mg. Also contains
colloidal silicon dioxide, compressible sugar, croscarmellose sodium,
D&C Yellow #10 aluminum
lake, FD&C Blue #1 aluminum lake, FD&C Yellow #6 aluminum lake,
hypromellose, 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
administr