NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Glenmark Pharmaceuticals Inc., USA

INN (Rahvusvaheline Nimetus):

NORETHINDRONE ACETATE

Koostis:

NORETHINDRONE ACETATE 1 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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. TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % 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 2

Toote kokkuvõte:

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP are available in dispensers each containing 21 white to off-white tablets. Each tablet contains 1 mg of norethindrone acetate, USP and 0.02 mg of ethinyl estradiol, USP. The tablets are white to off-white, uncoated, round, flat-faced beveled-edge, debossed with ‘16’ on one side and ‘G’ on other side. NDC 68462-132-81 1 Carton of 3 Blisters Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL- NORETHINDRONE ACETATE
AND ETHINYL ESTRADIOL TABLET
GLENMARK PHARMACEUTICALS INC., USA
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NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1 MG/ 0.02 MG
RX ONLY
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
progestogen-estrogen
combinations.
Each white to off-white tablet contains norethindrone acetate, USP
(19-Norpregn-4-en-
20-yn-3-one,17-(acetyloxy)-, (17α), 1 mg; ethinyl estradiol
19-Norpregna-1,3,5(10)-
triene-20-yne-3,17-diol, (17 α), 20 mcg. Also contains acacia,
lactose monohydrate,
magnesium stearate, corn starch, sucrose and talc.
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
indistinguishable from that of orally administered norethindrone (1).
Norethindrone
acetate and ethin