NORTREL 7/7/7 (28 DAY REGIMEN)- norethindrone and ethinyl estradiol kit

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Teva Pharmaceuticals USA, Inc.

INN (Internationale Bezeichnung):

NORETHINDRONE

Zusammensetzung:

NORETHINDRONE 0.5 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Nortrel® 7/7/7 (norethindrone and ethinyl estradiol tablets USP, 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year1 Method (1) Typical Use2 (2) Perfect Use3 (3)

Produktbesonderheiten:

Nortrel® 7/7/7 (norethindrone and ethinyl estradiol tablets USP, 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) is packaged in cartons of six blister cards (NDC 0555-9012-58). Each card contains 28 tablets, as follows: 7 light yellow, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 951 on the other side (0.5 mg norethindrone, USP and 0.035 mg ethinyl estradiol, USP); 7 blue, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 942 on the other side (0.75 mg norethindrone, USP and 0.035 mg ethinyl estradiol, USP); 7 peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 943 on the other side (1 mg norethindrone, USP and 0.035 mg ethinyl estradiol, USP), and 7 white, round, flat-faced, beveled-edge, unscored, inert tablets, debossed with stylized b on one side and 944 on the other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

NORTREL 7/7/7 (28 DAY REGIMEN)- NORETHINDRONE AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
----------
NORTREL 7/7/7
(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP,
0.5/0.035 MG, 0.75/0.035 MG, AND 1/0.035 MG)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
Cigarette smoking increases the risk of serious cardiovascular events
from
combination oral contraceptive use. This risk increases with age,
particularly in
women over 35 years of age, and with the number of cigarettes smoked.
For this
reason, combination oral contraceptives, including Nortrel
7/7/7, should not be
used by women who are over 35 years of age and smoke.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
COMBINED ORAL CONTRACEPTIVES
The following product is a combined oral contraceptive containing the
progestational
compound norethindrone and the estrogenic compound ethinyl estradiol.
NORTREL 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP, 0.5/0.035
MG, 0.75/0.035 MG, AND 1/0.035 MG):
Each light yellow tablet contains 0.5 mg of norethindrone, USP and
0.035 mg of ethinyl
estradiol, USP and the inactive ingredients include D&C yellow no. 10
aluminum lake,
lactose monohydrate, magnesium stearate and pregelatinized corn
starch. Each blue
tablet contains 0.75 mg of norethindrone, USP and 0.035 mg of ethinyl
estradiol, USP
and the inactive ingredients include FD&C blue no. 1 aluminum lake,
lactose
monohydrate, magnesium stearate and pregelatinized corn starch. Each
peach tablet
contains 1 mg of norethindrone, USP and 0.035 mg of ethinyl estradiol,
USP and the
inactive ingredients include FD&C yellow no. 6 aluminum lake, lactose
monohydrate,
magnesium stearate and pregelatinized corn starch. Each white tablet
contains only inert
ingredients as follows: lactose monohydrate, magnesium stearate, and
pregelatinized
corn starch.
The chemical name for norethindrone, USP is
17-Hydroxy-19-nor-17α-pregn-4-en-20-
yn-3-one, and for ethinyl estradiol, USP is 19-