DESOGESTREL AND ETHINYL ESTRADIOL

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3)

Dostupné z:

Northstar Rx LLC

INN (Medzinárodný Name):

DESOGESTREL

Zloženie:

DESOGESTREL 0.15 mg

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DESOGESTREL AND ETHINYL ESTRADIOL- DESOGESTREL AND ETHINYL ESTRADIOL
NORTHSTAR RX LLC
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DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP, 0.15 MG /0.03 MG
WARNINGS: 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, provide an oral
contraceptive regimen of 21 yellow
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). Each “active” yellow tablet with “S3” debossed on
one side contains the following inactive
ingredients: lactose monohydrate, pregelatinized corn starch,
povidone, stearic acid, vitamin E,
HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C
Yellow No. 10 Aluminum
Lake, FD&C Yellow No. 6 Aluminium Lake, Iron Oxide Yellow, FD&C Red
No. 40 Aluminum Lake,
FD&C Blue No. 2 Aluminum Lake. Each “inactive” reminder white,
biconvex, round tablets debossed
with “P” on one side and “N” on the other side, contains the
following inactive ingredients: titanium
dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol,
lactose, magnesium stearate, and
pregelatinized corn starch.
The 21 yellow tablets meet 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
cha