ORTHO CEPT desogestrel and ethinyl estradiol

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

desogestrel (UNII: 81K9V7M3A3) (desogestrel - UNII:81K9V7M3A3)

Boleh didapati daripada:

Janssen Pharmaceuticals, Inc.

INN (Nama Antarabangsa):

desogestrel

Komposisi:

desogestrel 0.15 mg

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

New Drug Application

Ciri produk

ORTHO CEPT- DESOGESTREL AND ETHINYL ESTRADIOL
JANSSEN PHARMACEUTICALS, INC.
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ORTHO-CEPT TABLETS
(DESOGESTREL AND ETHINYL ESTRADIOL)
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
ORTHO-CEPT , 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
ORTHO-CEPT Tablets provide 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 silicone dioxide, corn starch, ferric
oxide, hypromellose, lactose,
polyethylene glycol, povidone, stearic acid, talc, titanium dioxide,
and vitamin E. Each green tablet
contains the following inactive ingredients: FD&C Blue No.1 Aluminum
Lake, ferric oxide,
hypromellose, lactose, magnesium stearate, polyethylene glycol,
pregelatinized starch, talc and titanium
dioxide.
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 finding in humans is