AVIANE- levonorgestrel and ethinyl estradiol kit

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:

Proficient Rx LP

INN:

LEVONORGESTREL

composition:

LEVONORGESTREL 0.1 mg

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Aviane (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 Year * Method (1) Typical Use † (2) Perfect Use ‡ (3) (4) Chance § 85 85 Spermicides ¶ 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal # 2 Post-Ovulation 1 CapÞ Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm Þ 20 6 56 Withdrawal 19 4

leaflet_short:

Aviane® (levonorgestrel and ethinyl estradiol tablets USP), 0.10 mg/0.02 mg is available as 28 tablets packaged in cartons (NDC: 63187-889-28) of six blister card dispensers. Each blister card dispenser contains 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, film coated and debossed with dp on one side and 016 on the other side. Each light-green tablet is round and debossed with dp on one side and 519 on the other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. REFERENCES AVAILABLE UPON REQUEST. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Rev. B 4/2017

authorization_status:

Abbreviated New Drug Application

SPC

AVIANE- LEVONORGESTREL AND ETHINYL ESTRADIOL
PROFICIENT RX LP
----------
AVIANE 28 TABLETS
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
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
21 orange active tablets each containing 0.10 mg of levonorgestrel,
USP (-)-13-Ethyl-17-
hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, a totally synthetic
progestogen, and
0.02 mg of ethinyl estradiol, USP, (19-Nor-17α
-pregna-1,3,5(10)-trien-20-yne-3,17-diol).
The inactive ingredients present are: FD&C yellow no. 6 aluminum lake,
hypromellose,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene
glycol, pregelatinized corn starch, sodium starch glycolate and
titanium dioxide.
7 light-green, inert tablets each containing: D&C yellow no. 10
aluminum lake, FD&C blue
no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose
monohydrate,
magnesium stearate, microcrystalline cellulose and pregelatinized corn
starch.
Levonorgestrel, USP
Ethinyl Estradiol, USP
®
C
H
O M.W. 312.45
21
28
2
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
_ABSORPTION_
No specific investigation of the absolute bioavailability of Aviane 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 l