AZURETTE desogestrel/ethinyl estradiol and

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Watson Pharma, Inc.

INN (Nama Antarabangsa):

DESOGESTREL

Komposisi:

DESOGESTREL 0.15 mg

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

AZURETTE- DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
WATSON PHARMA, INC.
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AZURETTE
AZURETTE®
(Desogestrel/Ethinyl Estradiol and
Ethinyl Estradiol Tablets)
Revised: June 2013
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Azurette® (desogestrel/ethinyl estradiol and ethinyl estradiol)
tablets provide an oral contraceptive
regimen of 21 active white tablets, each containing 0.15 mg
desogestrel (13-ethyl-11-methylene-18,19-
dinor-17 alpha-pregn-4-en-20-yn-17-ol), 0.02 mg ethinyl estradiol
(19-nor-17 alpha-pregna-1,3,5 (10)-
trien-20-yne-3,17-diol), followed by 2 inactive green tablets, then
followed by 5 active blue tablets.
The 5 active blue tablets contain 0.01 mg ethinyl estradiol. The
molecular weights for desogestrel and
ethinyl estradiol are 310.48 and 296.40 respectively. The structural
formulas are as follows:
The 21 active white tablets and 5 active blue tablets contain the
following inactive ingredients:
anhydrous lactose, colloidal silicon dioxide, corn starch, povidone,
stearic acid and vitamin E. The 5
active blue tablets also contain FD&C Blue No. 1. The 2 inactive green
tablets contain the following
inactive ingredients: anhydrous lactose, D&C Yellow No. 10, FD&C Blue
No. 2, magnesium stearate
and microcrystalline cellulose.
Meets USP Dissolution test 2.
CLINICAL PHARMACOLOGY
Combination 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 the
endometrium (which reduce the likelihood
of implantation).
Receptor binding studies, as well as studies in animals, have shown
that etonogestrel, the biologically
active metabolite of desogestrel, combines high progestational
activity with minimal intrinsic
androgenicity (91,92). The relevance of this latter finding in humans
is unknown.
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