NECON 1/35 (28 DAY REGIMEN)- norethindrone and ethinyl estradiol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

NORETHINDRONE

Composition:

NORETHINDRONE 1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Necon 1/35 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 Year*  Method (1) Typical Use† (2) Perfect Use‡ (3) (4) Chance§  85 85 Spermicides¶ 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal# 2 Post-Ovulation 1 CapÞ  Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 DiaphragmÞ  20 6 56 Withdrawal 19 4 Condomß  Female (Reality® ) 21 5 56 Male 14 3 61

Product summary:

Necon® 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 0093-3303-16) 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NECON 1/35 (28 DAY REGIMEN)- NORETHINDRONE AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
----------
NECON
(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
Necon 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:
NECON 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.
The structural formulas are as follows:
NORETHINDRONE, USP
®
®
®
C
H O M.W. 298.42
ETHINYL ESTRADIOL, USP
C
H O M.W. 296.40
CLINICAL PHARMACOLOGY
COMBINED ORAL CONTRACEPTIVES
Combined 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).
INDICATIONS AND USAGE
Necon 1/35 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 typ