NORTREL 21 DAY- norethindrone and ethinyl estradiol tablet NORTREL 28 DAY- norethindrone and ethinyl estradiol kit

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

NORETHINDRONE

Sammensætning:

NORETHINDRONE 1 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Nortrel 1/35 and Nortrel 0.5/35 Tablets are 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. % 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) (4) Chance4   85 85 Spermicides5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal6 2 Post-Ovulation 1 Cap7   Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm7   20 6 56 Withdrawal 19 4 Condom8   Female (R

Produkt oversigt:

Nortrel® 1/35 (norethindrone and ethinyl estradiol tablets USP), 1 mg/0.035 mg 21 Day Regimen blister cards contain 21 yellow, round flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 949 on the other side. Each tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Cartons of 3 Blister Cards (NDC 0555-9009-42) Nortrel® 1/35 (norethindrone and ethinyl estradiol tablets USP), 1 mg/0.035 mg 28 Day Regimen blister cards contain 21 yellow, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 949 on the other side and 7 white, round, flat-faced, beveled-edge, unscored, inert tablets, debossed with stylized b on one side and 944 on the other side. Cartons of 6 Blister Cards (NDC 0555-9010-58) Nortrel® 0.5/35 (norethindrone and ethinyl estradiol tablets USP), 0.5 mg/0.035 mg 28 Day Regimen blister cards contain 21 light yellow, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 941 on the other side and 7 white, round, flat-faced, beveled-edge, unscored, inert tablets, debossed with stylized b on one side and 944 on the other side. Cartons of 3 Blister Cards (NDC 0555-9008-67) 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NORTREL 21 DAY- NORETHINDRONE AND ETHINYL ESTRADIOL TABLET
NORTREL 28 DAY- NORETHINDRONE AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
----------
NORTREL
(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP)
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
0.5/35 and 1/35,
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
Each of the following products is a combination oral contraceptive
containing the
progestational compound norethindrone and the estrogenic compound
ethinyl estradiol:
NORTREL 1/35 TABLETS:
Each yellow tablet contains 1 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 white
tablet in the 1/35 package contains only inert ingredients as follows:
lactose
monohydrate, magnesium stearate, and pregelatinized corn starch.
NORTREL 0.5/35 TABLETS:
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 white
tablet in the 0.5/35 package 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, for ethinyl estradiol, USP is
19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-
diol.
The structural formulas are as follows:
NORETHINDRONE, USP