NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

Commercializzato da:

Mylan Pharmaceuticals Inc.

INN (Nome Internazionale):

ETHINYL ESTRADIOL

Composizione:

ETHINYL ESTRADIOL 0.02 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Norethindrone acetate and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. % Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method Lowest Expected * Typical † (No contraception)  (85) (85) Oral contraceptives    3       Combined  0.1 N/A ‡       progestin only  0.5 N/A ‡ Diaphragm with spermicidal cream or jelly  6 20 Spermicides alone (foam, creams, gels, vaginal        suppositories and vaginal film)  6 26 Vaginal Sponge           nulliparous  9 20       parous 20 40 Implant  0.05 0.05 Injection: depot medroxyprogesterone acetate  0.3 0.3 IUD           progesterone T  1.5 2.0       copper T 380A  0.6 0.8       LNg 20  0.1 0.1 Condom without spermicides           female  5 21       male  3 14 Cervical Cap with spermicidal cream or jelly           nulliparous  9 20       parous  26 40 Periodic abstinence (all methods)  1-9 25 Withdrawal  4 19 Female sterilization  0.5 0.5 Male sterilization  0.10 0.15  

Dettagli prodotto:

Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg are packaged in a carton of three pouches (NDC 0378-7280-53) and a carton of five pouches (NDC 0378-7280-98); each pouch contains a blister pack of 21 tablets. Each blister pack contains 21 white to off-white , round, flat-faced, unscored tablet debossed with 239 on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL- NORETHINDRONE ACETATE
AND ETHINYL ESTRADIOL TABLET
MYLAN PHARMACEUTICALS INC.
----------
-906780-307848000NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS
USP,
1 MG/0.02 MG
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS
Cigarette smoking increases the risk of serious cardiovascular events
from
combination oral contraceptive (COC) use. This risk increases with
age, particularly
in women over 35 years of age, and with the number of cigarettes
smoked. For
this reason, COCs, including norethindrone acetate and ethinyl
estradiol tablets, are
contraindicated in women who are over 35 years of age and smoke (see
CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP are a
progestogen-estrogen
combination.
Each white to off-white tablet contains norethindrone acetate
(19-Norpregn-4-en-20-yn-
3-one, 17-(acetyloxy)-, (17α) ), 1 mg; ethinyl estradiol
(19-Norpregna-1,3,5(10)-trien-20-
yne-3, 17-diol, (17α)-) , 0.02 mg. Also contains lactose anhydrous,
_dl_-α-tocopherol,
compressible sugar, croscarmellose sodium, lactose monohydrate,
magnesium
stearate, povidone K-25, sodium lauryl sulphate.
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.
_ABSORPTION_
Norethindrone acetate appears to be completely and rapidly
deacetylated to
norethindrone after oral administration, since the disposition of
norethindrone acetate is
indistinguisha