NECON 777- 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:

Actavis Pharma, Inc.

INN (International Name):

norethindrone

Composition:

norethindrone 0.5 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NECON 7/7/7® 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. NECON 7/7/7® has not been studied for and is not indicated for use in emergency contraception. Oral contraceptives should not be used in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Known thrombophilic conditions - Cerebral vascular or coronary artery disease (current or history) - Valvular heart disease with complications - Persistent blood pressure

Product summary:

NECON 7/7/7® Tablets are available in a blister card (NDC 52544-165-41) with a tablet dispenser (unfilled). The blister card contains 28 tablets, as follows: 7 white, round, flat-faced, beveled edged tablets imprinted with "Ortho 535" on both sides (0.5 mg norethindrone and 0.035 mg ethinyl estradiol), 7 light peach, round, flat-faced, beveled edged tablets imprinted with "Ortho 75" on both sides (0.75 mg norethindrone and 0.035 mg ethinyl estradiol), 7 peach, round, flat-faced, beveled edged tablets imprinted with "Ortho 135" on both sides (1 mg norethindrone and 0.035 mg ethinyl estradiol) and 7 green, round, flat-faced, beveled edged tablets imprinted "Ortho" on both sides containing inert ingredients. Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F). Keep out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

NECON 777- NORETHINDRONE AND ETHINYL ESTRADIOL
ACTAVIS PHARMA, INC.
----------
NECON 7/7/7 TABLETS
(NORETHINDRONE/ETHINYL ESTRADIOL)
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 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.
NECON 7/7/7 TABLETS: Each white tablet contains 0.5 mg of norethindrone and 0.035
mg of ethinyl
estradiol. Inactive ingredients include lactose, magnesium stearate
and pregelatinized corn starch. Each
light peach tablet contains 0.75 mg of norethindrone and 0.035 mg of
ethinyl estradiol. Inactive
ingredients include FD&C Yellow No. 6, lactose, magnesium stearate and
pregelatinized corn starch.
Each peach tablet contains 1 mg of norethindrone and 0.035 mg of
ethinyl estradiol. Inactive ingredients
include FD&C Yellow No. 6, lactose, magnesium stearate and
pregelatinized corn starch. Each green
tablet contains only inert ingredients, as follows: D&C Yellow No. 10
Aluminum Lake, FD&C Blue No.
2 Aluminum Lake, lactose, magnesium stearate, microcrystalline
cellulose and pregelatinized corn
starch.
The chemical name for norethindrone is
17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, and for
ethinyl estradiol is
19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural
formulas are
as follows:
CLINICAL PHARMACOLOGY
COMBINED ORAL CONTRACEPTIVES
®
®
®
Combined oral contraceptives act by suppression of gonadotropins.
Although the primary mechanism of
t