LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol tablets

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Levonorgestrel (UNII: 5W7SIA7YZW) (Levonorgestrel - UNII:5W7SIA7YZW), Ethinyl Estradiol (UNII: 423D2T571U) (Ethinyl Estradiol - UNII:423D2T571U)

Disponible depuis:

Xiromed, LLC.

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.   TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD 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 Combination oral contraceptives should not be used in women with any of the following conditions:   Thrombophlebitis or thromboembolic disorders.   A past history of deep

Descriptif du produit:

Elifemme® tablets (levonorgestrel and ethinyl estradiol) are available in 28-tablet blister cards. One blister card is packaged in a primary carton (NDC 70700-104-84) . Three Primary Cartons are Packaged into a Outer Carton (NDC 70700-104-85) or Six Primary Cartons are packaged into a Outer Carton (NDC 70700-104-86) . Each cycle contains 28 tablets as follows: Six blue tablets containing 0.05 mg of levonorgestrel and 0.03 mg of ethinyl estradiol. The blue tablets are round in shape debossed "XI" on one side and “2” on the other side. Five peach tablets containing 0.075 mg of levonorgestrel and 0.04 mg of ethinyl estradiol. The peach tablets are round in shape debossed "XI" on one side and “3” on the other side. Ten pink tablets containing 0.125 mg of levonorgestrel and 0.03 mg of ethinyl estradiol. The pink tablets are round in shape with debossed "XI" on one side and “4” on the other side. Seven white inert tablets. The white inert tablets are round in shape with debossed "XI" on one side and “1” on the other side. Store at 20° to 25°C (68 ° to 77°F). [See USP controlled room temperature.] References available upon request.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL
ESTRADIOL
TABLETS
XIROMED, LLC.
----------
ELIFEMME
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, 0.05 MG/0.03 MG, 0.075
MG/0.04 MG, 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 Elifemme
cycle of 28 tablets consists of three different drug phases as
follows: Phase 1
comprised of 6 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 peach 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
white inert tablets. The inactive ingredients present in the blue,
peach and pink tablets are lactose
monohydrate, magnesium stearate, povidone, and pregelatinised starch.
Each blue tablet also contains
FD&C Blue # 2 lake. Each peach tablet also contains D & C yellow # 10
aluminium lake and FD&C Red
# 40 lake. Each pink tablets also contains FD & C Red # 40 lake. Each
inert white tablet contains the
following inactive ingredients: anhydrous lactose, corn starch,
crospovidone, magnesium stearate and
povidone.
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
enterohepat