EMOQUETTE- desogestrel and ethinyl estradiol

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

REMEDYREPACK INC.

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

EMOQUETTE ®  (desogestrel and ethinyl estradiol tablets USP) 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 EMOQUETTE ® , 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. % of Women Experiencing an Unintended Pregnancy Within the First Year of Use Typical Use 1 (2)  Perfect Use 2 (3)

Περίληψη προϊόντος:

EMOQUETTE ® (desogestrel and ethinyl estradiol tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers; each blister pack tablet dispenser contains 28 tablets. Each white tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each light-green tablet contains inert ingredients. The white tablets are round, film-coated, imprinted with “93” on one side and “876” on the other side; the light-green tablets are round, film-coated imprinted with “93” on one side, and “743” on the other side. Blister pack tablet dispenser NDC 0603-7540-01 Boxes of 3 blister pack tablet dispensers NDC 0603-7540-49 Boxes of 6 blister pack tablet dispensers NDC 0603-7540-17

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

EMOQUETTE- DESOGESTREL AND ETHINYL ESTRADIOL
REMEDYREPACK INC.
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EMOQUETTE
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP) 0.15 MG AND 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
EMOQUETTE
, 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) tablets provide an
oral contraceptive
regimen of 21 white 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, hypromellose,
lactose monohydrate, povidone, polyethylene glycol, pregelatinized
starch, stearic acid and vitamin E.
Each light-green tablet contains the following inactive ingredients:
FD&C Blue No. 2 aluminum lake,
hypromellose, iron oxide yellow, lactose monohydrate, magnesium
stearate, polyethylene glycol, and
pregelatinized starch.
®
®
®
Emoquette
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, have shown
that 3-keto-desogestrel, the
biologically active metabolite of desogestrel, combines high
progestational ac