LESSINA- levonorgestrel and ethinyl estradiol kit

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Teva Pharmaceuticals USA, Inc.

INN (Isem Internazzjonali):

LEVONORGESTREL

Kompożizzjoni:

LEVONORGESTREL 0.1 mg

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 III 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. % of Women Experiencing an Accidental Pregnancy within the First Year of Use % of Women Continuing Use at One Year3 Method (1) Typical Use1  (2) Perfect Use2  (3) (4) Chance4 85 85 Spermicides5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal6 2 Post ovulation 1 Withdrawal 19 4 Cap7 Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm7 20 6 5

Sommarju tal-prodott:

Lessina® (levonorgestrel and ethinyl estradiol tablets USP 0.1 mg/ 0.02 mg) are packaged in blister cards. Each card contains 21 pink, round, film-coated, biconvex, unscored tablets, debossed stylized b on one side and 965 on the other side, and 7 white, round, biconvex, unscored tablets, debossed stylized b on one side and 208 on the other side. Available in cartons of 3 blister cards (NDC: 0555-9014-67). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

LESSINA- LEVONORGESTREL AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
----------
LESSINA
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED
DISEASES.
9014
RX ONLY
DESCRIPTION
Each cycle of Lessina
28 (levonorgestrel and ethinyl estradiol tablets USP) consists of
21 pink active tablets each containing 0.1 mg levonorgestrel, USP and
0.02 mg ethinyl
estradiol, USP; and seven white inert tablets. The inactive
ingredients include anhydrous
lactose, FD&C red no. 40 aluminum lake, hypromellose, magnesium
stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80, corn
starch, and titanium
dioxide. Each white tablet contains only inert ingredients as follows:
anhydrous lactose,
hypromellose, microcrystalline cellulose, and magnesium stearate.
The structural formulas are as follows:
LEVONORGESTREL, USP
C
H O MOLECULAR WEIGHT: 312.4
ETHINYL ESTRADIOL, USP
®
®
21
28
2
C
H O MOLECULAR WEIGHT: 296.4
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).
PHARMACOKINETICS
ABSORPTION
No specific investigation of the absolute bioavailability of
levonorgestrel and ethinyl
estradiol tablets in humans has been conducted. However, literature
indicates that
levonorgestrel is rapidly and completely absorbed after oral
administration and is not
subject to first-pass metabolism. Ethinyl estradiol is rapidly and
almost completely
absorbed from the gastrointestinal tract but, due to first-pass
metabolism in gut
mucosa and liver, the absolute bioavailability of ethinyl estradiol is
about 40%. After a
single dose of three levonorgestrel and ethinyl estradiol tablets to
17 women under
fasting conditions, th