LILLOW- levonorgestrel and ethinyl estradiol kit

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Amneal Pharmaceuticals NY LLC

INN (Kansainvälinen yleisnimi):

LEVONORGESTREL

Koostumus:

LEVONORGESTREL 0.15 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 Method Perfect Use Typical Use Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Depo-Provera® (injectable progestogen) 0.3 0.3 Oral contraceptives 5 Combined 0.1 NA Progestin only 0.5 NA IUD Progesterone 1.5 2 Copper T 380A 0.6 0.8 Condom (male) without spermicide 3 14 (Female) without spermicide 5 21 Cervical cap Nulliparous women 9 20 Par

Tuoteyhteenveto:

Lillow® (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg) are available as follows: NDC 69238-1554-6                Blister Pack of 28 Tablets 21 active tablets - white, round, biconvex, film-coated tablet, debossed with ‘C5’ on one side. 7 inert tablets - yellow, round, biconvex, film-coated tablet, debossed with ‘C2’ on one side. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. References available upon request. Made in Germany Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2017-03

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

LILLOW- LEVONORGESTREL AND ETHINYL ESTRADIOL
AMNEAL PHARMACEUTICALS NY LLC
----------
LILLOW (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP)
0.15 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
21 white Lillow tablets, each containing 0.15 mg of levonorgestrel,
USP, (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, USP, (19-nor-17α-pregna-1,3,5
(10)-trien-20-yne-3,17-
diol), and 7 yellow inert tablets. The inactive ingredients present in
both tablets are
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
and polacrilin
potassium. White tablets are coated with Aqua Polish White 014.17 MS
which contains
hydrogenated cottonseed oil, hydroxypropylcellulose,
hydroxypropylmethylcellulose, talc
and titanium dioxide. Yellow inert tablets are coated with Aqua Polish
Yellow 024.15 MS
which contains hydrogenated cottonseed oil, hydroxypropylcellulose,
hydroxypropylmethylcellulose, ferric oxide red, ferric oxide yellow,
talc, and titanium
dioxide.
®
®
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).
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
The efficacy of these contraceptive methods, except sterilization and
the IUD, depends
upon th