AUROVELA 1.5/30- norethindrone acetate and ethinyl estradiol tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Aurobindo Pharma Limited

INN (আন্তর্জাতিক নাম):

NORETHINDRONE ACETATE

রচনা:

NORETHINDRONE ACETATE 1.5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Aurovela 1.5/30 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 o

পণ্য সারাংশ:

Aurovela® 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP, 1.5 mg/30 mcg)  is white to off-white, round, flat-faced, beveled-edge, uncoated tablets, debossed with ‘S’ on one side and ‘69’ on other side of the tablet.             1 pouch of 21 tablets                          NDC 65862-935-21             Carton of 3 Pouches                           NDC 65862-935-74             Carton of 5 Pouches                           NDC 65862-935-54 Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

AUROVELA 1.5/30 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
AUROBINDO PHARMA LIMITED
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AUROVELA 1.5/30
(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 1.5/30, are contraindicated in
women who
are over 35 years of age and smoke (see CONTRAINDICATIONS and
WARNINGS).
DESCRIPTION
Aurovela 1.5/30 is progestogen-estrogen combination.
Each white to off-white tablet contains norethindrone acetate USP (17
alpha-ethinyl-19-
nortestosterone acetate), 1.5 mg; ethinyl estradiol USP (17 alpha
-ethinyl-1,3,5(10)-
estratriene-3, 17 beta-diol), 30 mcg. Each white to off-white tablet
contains the following
inactive ingredients: compressible sugar, croscarmellose sodium,
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 1.5/30 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).
Norethindrone
acetate and eth