AUROVELA FE- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit

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

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Aurovela Fe 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 preg

পণ্য সারাংশ:

Aurovela® Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP 1.5 mg/30 mcg and ferrous fumarate tablets, 75 mg) are 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. Each brown mottled, round, flat-faced beveled-edge tablet contains 75 mg ferrous fumarate and is debossed with “S” on one side and “57” on other side of the tablet. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. 1 Pouch of 28 tablets                   NDC 65862-941-87 Carton of 3 Pouches                    NDC 65862-941-88 Carton of 5 Pouches                    NDC 65862-941-58 Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

AUROVELA FE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS
FUMARATE
AUROBINDO PHARMA LIMITED
----------
AUROVELA FE 1.5/30
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS
FUMARATE TABLETS)
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 Fe 1.5/30, are contraindicated in women who are
over 35 years of
age and smoke (see CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
Aurovela Fe 1.5/30 is progestogen-estrogen combination.
Aurovela Fe 1.5/30: Each provides a continuous dosage regimen
consisting of 21 oral
contraceptive tablets and seven ferrous fumarate tablets. The ferrous
fumarate tablets
are present to facilitate ease of drug administration via a 28-day
regimen, are non-
hormonal, and do not serve any therapeutic purpose.
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:
®
Each brown placebo tablet contains the following ingredients:
croscarmellose sodium,
ferrous fumarate, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
Nat spearmint FL, povidone and sucralose. The ferrous fumarate tablets
do not serve
any therapeutic purpose.
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 cervic