VIENVA TM- levonorgestrel and ethinyl estradiol

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Sandoz Inc

INN:

LEVONORGESTREL

composition:

LEVONORGESTREL 0.1 mg

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

VienvaTM (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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, the IUD, and Norplant® System, 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 Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3 Method (1) Typical Use1 (2) Perfect Use2 (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 6 2 Post-Ovulation 1 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 56 Withdrawal 19 4 C

leaflet_short:

VienvaTM (levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg) are available as follows: Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are white, round, debossed with SZ on one side and L2 on the other side. The 7 inert tablets are peach, round, debossed with SZ on one side and J1 on the other side. NDC 0781-5575-15, one carton containing 3 individual blister cartons Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature ].

authorization_status:

Abbreviated New Drug Application

SPC

VIENVA TM- LEVONORGESTREL AND ETHINYL ESTRADIOL
SANDOZ INC
----------
VIENVA
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP) 0.1 MG/0.02 MG
RX ONLY
.
PATIENTS SHOULD BE COUNSELED THAT ORAL CONTRACEPTIVES DO NOT PROTECT
AGAINST TRANSMISSION OF HIV
(AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES (STDS) SUCH AS
CHLAMYDIA, GENITAL HERPES, GENITAL
WARTS, GONORRHEA, HEPATITIS B, AND SYPHILIS.
DESCRIPTION
Each active, white tablet (21) contains 0.1 mg of levonorgestrel,
d(-)-13β-ethyl-17α-ethinyl-17β-
hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of
ethinyl estradiol, 17α-ethinyl-
1,3,5(10)-estratriene-3, 17β-diol.
The inactive ingredients present in the active tablet are: corn
starch, crospovidone, lactose
monohydrate, magnesium stearate, povidone, and pregelatinized starch.
The inactive ingredients present in the inert tablet are: corn starch,
crospovidone, FD&C Red # 40 lake,
D&C Yellow #10 lake, lactose anhydrous, magnesium stearate, povidone.
CLINICAL PHARMACOLOGY
MODE OF ACTION
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
ABS ORPTION
No specific investigation of the absolute bioavailability of
levonorgestrel and ethinyl estradiol in
TM
No specific investigation of the absolute bioavailability of
levonorgestrel and ethinyl estradiol in
humans has been conducted. However, literature indicates that
levonorgestrel is rapidly and completely
absorbed after oral administration (bioavailability about 100%) 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
bioavailability of ethinyl estradiol is
between 38% and 48%.
After a single dose of levonorgestr