EMOQUETTE- desogestrel and ethinyl estradiol kit

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Доступно од:

REMEDYREPACK INC.

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Emoquette ® (desogestrel and ethinyl estradiol tablets) are 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Chance f 85 85 Spermicides g 26 6

Резиме производа:

Emoquette ® (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg are available as follows: Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are round, orange, film- NDC: 70518-2137-00 NDC: 70518-2137-01 PACKAGING: 6 in 1 CARTON, 1 in 1 CARTON, 1 in 1 BLISTER PACK TYPE 0 PACKAGING: 3 in 1 CARTON, 1 in 1 CARTON, 1 in 1 BLISTER PACK TYPE 0 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

EMOQUETTE- DESOGESTREL AND ETHINYL ESTRADIOL
REMEDYREPACK INC.
----------
EMOQUETTE
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP)
0.15 MG/0.03 MG
RX ONLY
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL CONTRACEPTIVE USE. THIS RISK INCREASES WITH AGE,
PARTICULARLY IN WOMEN OVER 35 YEARS OF AGE, AND WITH THE NUMBER OF
CIGARETTES SMOKED. FOR THIS REASON, COMBINATION ORAL CONTRACEPTIVES,
INCLUDING DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, SHOULD NOT BE
USED
BY WOMEN WHO ARE OVER 35 YEARS OF AGE AND SMOKE.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
EMOQUETTE
(desogestrel and ethinyl estradiol tablets, USP) provide an oral
contraceptive regimen of 21 orange round tablets each containing 0.15
mg desogestrel
(13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol)
and 0.03 mg
ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5
(10)-trien-20-yne-3,17,diol). Inactive
ingredients include alpha-tocopherol, colloidal silicon dioxide, corn
starch, FD&C yellow 5
aluminum lake, FD&C yellow 6 aluminum lake, hypromellose 2910, lactose
monohydrate,
polysorbate, povidone, red iron oxide, stearic acid, titanium dioxide
and triacetin. Each
green tablet contains the following inactive ingredients: corn starch,
colloidal silicon
dioxide, FD&C blue 2 aluminum lake, hypromellose 2910, lactose
monohydrate,
magnesium stearate, polysorbate, povidone, titanium dioxide,
triacetin, and yellow iron
oxide.
USP Dissolution Test 2 used.
®
®
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Combined 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 changes in the endometrium which reduce the likelihood of
implantation.
Receptor binding studies, as we