LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Доступно од:

LUPIN LIMITED

INN (Међународно име):

ETHINYL ESTRADIOL

Састав:

ETHINYL ESTRADIOL 0.03 mg

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Oral contraceptives 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 II 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. NA - not available Combination oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders. A past history of deep-vein thrombophlebitis or thromboembolic disorders. Cerebral-vascular or coronary-artery disease. Thrombogenic valvulopathies. Thrombogenic rhythm disorders. Diabetes with vascular involvement. Uncontrolled hypertension. Known or suspected carcinoma of the breast. Carcinoma of the endometrium or other known or suspecte

Резиме производа:

Levonorgestrel and ethinyl estradiol tablets USP (triphasic regimen) are available in a wallet containing 28 tablets (NDC 68180-857-11). Three such wallets are packed in a carton (NDC 68180-857-13). Each cycle contains 28 tablets as follows: Store at 25°C (77°F); excursions permitted to 15 to 30° C (59 to 86° F) [See USP controlled room temperature]. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. References available upon request. The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products. Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) – 454 775 INDIA August 2015                                                                                                    ID# : 226795

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL
ESTRADIOL
LUPIN LIMITED
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DETAILED PATIENT LABELING
This product (like all oral contraceptives) is intended to prevent
pregnancy. It does not protect against
HIV infection (AIDS) and other sexually transmitted diseases.
INTRODUCTION
Any woman who considers using oral contraceptives (the birth-control
pill or the pill) should understand
the benefits and risks of using this form of birth control. This
leaflet will give you much of the
information you will need to make this decision and will also help you
determine if you are at risk of
developing any of the serious side effects of the pill. It will tell
you how to use the pill properly so that it
will be as effective as possible. However, this leaflet is not a
replacement for a careful discussion between
you and your health-care provider. You should discuss the information
provided in this leaflet with him or
her, both when you first start taking the pill and during your
revisits. You should also follow your health-
care provider’s advice with regard to regular check-ups while you
are on the pill.
EFFECTIVENESS OF ORAL CONTRACEPTIVES
Oral contraceptives or "birth-control pills" or "the pill" are used to
prevent pregnancy and are more
effective than other nonsurgical methods of birth control. When they
are taken correctly, the chance of
becoming pregnant is less than 1.0% when used perfectly, without
missing any pills. Average failure rates
are 5% per year. The chance of becoming pregnant increases with each
missed pill during the menstrual
cycle.
In comparison, average failure rates for other nonsurgical methods of
birth control during the first year of
use are as follows:
Table: Percentage of Women Experiencing an Unintended Pregnancy during
the First Year of Use of a Contraceptive
d
NA - not available
*
Depending on method (calendar, ovulation, symptothermal,
post-ovulation)Adapted from Hatcher RA et al,
Contraceptive Technology: 17th Revised Edition. NY,NY: Ardent Media,
Inc., 1998
Meth

Карактеристике производа

LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL
ESTRADIOL
LUPIN LIMITED
----------
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.05 MG/0.03 MG,
0.075 MG/0.04 MG AND
0.125 MG/0.03 MG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Each levonorgestrel and ethinyl estradiol tablets USP cycle of 28
tablets consists of three different
drug phases as follows: Phase 1 comprised of 6 light blue tablets,
each containing 0.05 mg of
levonorgestrel (d(-)-13
beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally
synthetic
progestogen, and 0.03 mg of ethinyl estradiol
(19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol);
phase 2 comprised of 5 white to off white tablets, each containing
0.075 mg levonorgestrel and 0.04 mg
ethinyl estradiol; and phase 3 comprised of 10 pink tablets, each
containing 0.125 mg levonorgestrel and
0.03 mg ethinyl estradiol; then followed by 7 orange inert tablets.
The inactive ingredients present in the
light blue, white to off white and pink tablets are corn starch,
lactose monohydrate, magnesium stearate
and povidone. Each light blue tablet also contains FD & C Blue #1.
Each pink tablet also contains FD &
C Red #40. Each inactive orange tablet contains the following inactive
ingredients: croscarmellose
sodium, FD&C Yellow #6, lactose monohydrate, magnesium stearate and
microcrystalline cellulose.
CLINICAL PHARMACOLOGY
Combination oral contraceptives primarily 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
_ABSORPTION_
Levonorgestrel is rapidly and completely absorbed after oral
administration (bioavailability about
100%). Levonorgestrel is not subject to first-pass metabolism or
enterohepati