LEVORA levonorgestrel and ethinyl estradiol

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Disponibbli minn:

Watson Pharma, Inc.

INN (Isem Internazzjonali):

LEVONORGESTREL

Kompożizzjoni:

LEVONORGESTREL 0.15 mg

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

LEVORA- LEVONORGESTREL AND ETHINYL ESTRADIOL
WATSON PHARMA, INC.
----------
LEVORA® 0.15/30-28 TABLETS
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, 0.15MG/0.03MG)
RX ONLY
REVISED: JANUARY 2014
219275-1
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
21 white Levora® 0.15/30-28 tablets, each containing 0.15 mg of
levonorgestrel, (d(-)-13 betaethyl-17-
alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic
progestogen, and 0.03 mg of ethinyl
estradiol, (19-nor-17a-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and
7 peach inert tablets.
The white Levora® 0.15/30 tablets contain the following inactive
ingredients: croscarmellose sodium,
lactose, magnesium stearate, microcrystalline cellulose, and povidone.
The inactive peach tablets in the 28-day regimen of Levora® 0.15/30
contain the following inactive
ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose
Monohydrate, Magnesium Stearate
and Microcrystalline Cellulose.
LEVONORGESTREL
ETHINYL ESTRADIOL
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 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