DESOGESTREL AND ETHINYL ESTRADIOL- desogestrel and ethinyl estradiol

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Mylan Pharmaceuticals Inc.

INN (Medzinárodný Name):

DESOGESTREL

Zloženie:

DESOGESTREL 0.15 mg

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg 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. Table 1:  Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use an

Prehľad produktov:

Desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg are available in a carton of 3 pouches (NDC 0378-7282-53); each pouch contains a blister pack of 28 tablets. The blister pack contains 28 tablets, as follows: 21 white, round, biconvex tablets debossed with "227" on one side of the tablet and plain on the other side (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) and 7 green, round, biconvex tablets debossed with "292" on one side of the tablet and plain on the other side. Each green tablet contains inert ingredients. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] REFERENCES

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DESOGESTREL AND ETHINYL ESTRADIOL- DESOGESTREL AND ETHINYL ESTRADIOL
MYLAN PHARMACEUTICALS INC.
----------
RX ONLY
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
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
Desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg 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 anhydrous lactose,
colloidal silicon dioxide, potato
starch, povidone K-30, stearic acid, and _dl_-α-tocopherol. Each
green tablet contains the following
inactive ingredients: FD&C Blue No.1 Aluminium Lake, ferric oxide
yellow, lactose monohydrate,
magnesium stearate and polacrilin potassium.
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 activity with minimal
intrinsic androgenicity.
The relevance of this latter find