ENSKYCE- desogestrel and ethinyl estradiol kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

LUPIN LIMITED

INN (International Name):

ETHINYL ESTRADIOL

Sammensetning:

ETHINYL ESTRADIOL 0.03 mg

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Enskyce 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 Enskyce, 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. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.4 Lactation Amenorrhea Method: LAM is a high

Produkt oppsummering:

Enskyce Tablets are available in a wallet (NDC 68180-882-11) containing 28 tablets packed in a pouch (NDC 68180-882-11). Such three pouches are packaged in a carton (NDC 68180-882-13). Each wallet contains 28 film-coated tablets in the following order: Each of the 21 light orange, round, biconvex, film-coated tablet contains 0.15 mg of Desogestrel and 0.03 mg of ethinyl estradiol and is debossed with "LU" on one side and "L21" on the other side. Each of the 7 green coloured, round, biconvex film-coated tablet contains inert ingredients and is debossed with "LU" on one side and "L22" on the other side. STORAGE: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ENSKYCE - DESOGESTREL AND ETHINYL ESTRADIOL
LUPIN LIMITED
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ENS KYCE™
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
0.15 MG/0.03 MG
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
Enskyce™ (desogestrel and ethinyl estradiol tablets USP), 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
Enskyce™ (desogestrel and ethinyl estradiol tablets USP) provides an
oral contraceptive regimen of 21
light 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 colloidal silicon
dioxide, corn starch, hypromellose,
lactose monohydrate, magnesium stearate, polyethylene glycol,
povidone, stearic acid, talc, titanium
dioxide, and vitamin E. Each green tablet contains the following
inactive ingredients: corn starch, D&C
Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 carmine Aluminium Lake,
FD&C Yellow No. 6
Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate,
polyethylene glycol, talc and
titanium dioxide
Enskyce meets USP Dissolution Test 2.
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 well as studies in animals, ha