AUROVELA 1/20- norethindrone acetate and ethinyl estradiol tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Tersedia dari:

Aurobindo Pharma Limited

INN (Nama Internasional):

NORETHINDRONE ACETATE

Komposisi:

NORETHINDRONE ACETATE 1 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Aurovela 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. 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. - Oral contraceptives are contraindicated in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease - Current diagnosis of, or history of, breast cancer, which may be hormone sensitive - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - Undiagnosed abnormal genital bleeding - Cholestatic jaundice of pregnancy

Ringkasan produk:

Aurovela® 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/20 mcg) are light yellow to yellow, round, flat-faced, beveled-edge, uncoated tablets, debossed with 'S' on one side and '64' on other side of the tablet.         1 Pouch of 21 tablets   NDC 65862-939-21         Carton of 3 Pouches    NDC 65862-939-88         Carton of 5 Pouches    NDC 65862-939-54 Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Aurobindo Pharma Limited
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Revised: 11/2023
Document Id: e42c0b14-e08a-4e77-8ead-8b44fb472f5f
34391-3
Set id: 6765becf-7b51-4f33-ac13-70fcd01decf7
Version: 12
Effective Time: 20231121
Aurobindo Pharma Limited

Karakteristik produk

AUROVELA 1/20 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
AUROBINDO PHARMA LIMITED
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AUROVELA 1/20
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP)
RX ONLY
WARNING:
CIGARETTE
SMOKING
AND
SERIOUS
CARDIOVASCULAR
EVENTS
Cigarette smoking increases the risk of serious cardiovascular events
from
combination
oral
contraceptive
(COC)
use.
This
risk
increases
with
age,
particularly in women over 35 years of age, and with the number of
cigarettes
smoked. For this reason, COCs, including Aurovela 1/20, are
contraindicated in
women who are over 35 years of age and smoke (see CONTRAINDICATIONS
and
WARNINGS).
DESCRIPTION
Aurovela 1/20 is progestogen-estrogen combination.
Each light yellow to yellow tablet contains norethindrone acetate USP
(17 alpha-ethinyl-
19-nortestosterone acetate), 1 mg; ethinyl estradiol USP (17
alpha-ethinyl-1,3,5(10)-
estratriene-3, 17 beta-diol), 20 mcg. Each light yellow to yellow
tablet contains the
following inactive ingredients: compressible sugar, croscarmellose
sodium, D&C Yellow
No. 10 aluminum lake, lactose monohydrate, magnesium stearate,
microcrystalline
cellulose, povidone, and vitamin E.
The structural formulas are as follows:
®
Meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
Combination 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).
PHARMACOKINETICS
The pharmacokinetics of Aurovela 1/20 have not been characterized;
however, the
following pharmacokinetic information regarding norethindrone acetate
and ethinyl
estradiol is taken from the literature.
ABSORPTION
Norethindrone acetate appears to be completely and rapidly
deacetylated to
norethindrone after oral administration, since the disposition of
norethindrone acetate is
indistinguishable from that of orally administered norethindrone (1).