ARANELLE- norethindrone and ethinyl estradiol kit

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Teva Pharmaceuticals USA, Inc.

INN (Isem Internazzjonali):

NORETHINDRONE

Kompożizzjoni:

NORETHINDRONE 0.5 mg

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.1 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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3 Method (1) Typical Use1 (2) Perfect Use2 (3) (4) Chance4 85 85 Spermicides5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal6 2 Post-ovulation 1 Withdrawal 19 4 Cap7 Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nullipar

Sommarju tal-prodott:

Aranelle® - 28-Day Regimen (norethindrone and ethinyl estradiol tablets USP 0.5/0.035 mg and 1/0.035 mg) – Each blister card contains 12 light yellow, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 341 on the other side each containing 0.5 mg norethindrone and 0.035 mg ethinyl estradiol; 9 white, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 342 on the other side each containing 1 mg norethindrone and 0.035 mg ethinyl estradiol; and 7 peach, round, flat-faced, beveled-edge, unscored placebo tablets, debossed with stylized b on one side and 343 on the other side. The first row contains 7 light yellow tablets; the second row contains 7 white tablets; the third row contains 2 white and 5 light yellow tablets and the fourth row contains 7 peach inert tablets. Available in a box of 3 blister cards (NDC: 0555-9066-67). 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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ARANELLE- NORETHINDRONE AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
----------
ARANELLE
(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
ARANELLE 28-DAY REGIMEN (norethindrone and ethinyl estradiol tablets
USP) provides
a continuous oral contraceptive regimen of 7 light yellow tablets, 9
white tablets, 5 more
light yellow tablets, and then 7 peach tablets. Each light yellow
tablet contains
norethindrone, USP 0.5 mg and ethinyl estradiol, USP 0.035 mg, each
white tablet
contains norethindrone, USP 1 mg and ethinyl estradiol, USP 0.035 mg,
and each peach
tablet contains inert ingredients.
Norethindrone, USP is a potent progestational agent with the chemical
name 17-
Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol, USP is
an estrogen with
the chemical name 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol.
Their structural
formulae follow.
Norethindrone, USP
Ethinyl Estradiol, USP
The light yellow tablet contains the following inactive ingredients,
D&C yellow no. 10
aluminum lake, lactose monohydrate, magnesium stearate, and
pregelatinized starch.
The white tablet contains the following inactive ingredients, lactose
monohydrate,
magnesium stearate, and pregelatinized starch.
The inactive peach tablets contain the following inactive ingredients,
anhydrous lactose,
FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline
cellulose, and
pregelatinized starch.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotrophins.
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 may reduce the likelihood of
implantation).
®
®
INDICATIONS AND USAGE
Oral contraceptives are indicated for the prevention of pregnancy in
women who elect to
use this produ