LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Lupin Pharmaceuticals, Inc.

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD NA - not available Levonorgestrel and Ethinyl Estradiol Tablet is contraindicated in females who are known to have or develop 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 or history of breast cancer, which may be hormone sensitive. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior pill use. Hepatic adenomas and carcinomas. Known or suspected pregnancy. Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations (see WARNINGS, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

Каталог на резюме:

Levonorgestrel and ethinyl estradiol tablets USP (tablets-triphasic regimen) are available in a blister containing 28 tablets (NDC 68180-857-71). Three such blisters are packed in a carton (NDC 68180-857-73). Each cycle contains 28 tablets as follows: 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 Revised: June 2022                                                                                                            

Статус Оторизация:

Abbreviated New Drug Application

Листовка

LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL
ESTRADIOL
Lupin Pharmaceuticals, Inc.
----------
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. Typical failure rates
are less than 3.0% per year. The chance of becoming pregnant increases
with each missed pill during the
menstrual cycle.
In comparison, typical failure rates for other nonsurgical methods of
birth control during first year of use
are as follows:
TABLE: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING
THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD
NA - not available
Method
Perfect use
Average use
Levonorgestrel implants
0.05
0.05
Male sterilization
0.1
0.15
Female sterilization
0.5
0.5
Depo-Provera®
(Injectable progestogen)

Данни за продукта

LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL
ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
----------
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
Mechanism of Action
Combination oral contraceptives prevent pregnancy primarily by
suppressing ovulation.
INDICATIONS AND USAGE
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 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 and the IUD, depends upon