CYCLESSA desogestrel and ethinyl estradiol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Organon USA Inc.

INN (International Name):

desogestrel

Composition:

desogestrel 0.1 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

CYCLESSA- DESOGESTREL AND ETHINYL ESTRADIOL
ORGANON USA INC.
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CYCLESSA TABLETS (DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
CYCLESSA Tablets (desogestrel and ethinyl estradiol tablets USP) is a
triphasic oral contraceptive
containing two active components, desogestrel and ethinyl estradiol.
Each 28-day treatment cycle pack
consists of three active dosing phases: 7 light yellow tablets
containing 0.100 mg desogestrel (13-
ethyl-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-17-ol) and 0.025
mg ethinyl estradiol (19-nor-
17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); 7 orange tablets
containing 0.125 mg desogestrel and
0.025 mg ethinyl estradiol, and 7 red tablets containing 0.150 mg
desogestrel and 0.025 mg ethinyl
estradiol. Inactive ingredients include vitamin E, pregelatinized
starch, stearic acid, lactose
monohydrate, hydroxypropyl methylcellulose, polyethylene glycol,
titanium dioxide, talc, yellow ferric
oxide (in light yellow and orange tablets), and red ferric oxide (in
orange and red tablets). CYCLESSA
also contains 7 green tablets with the following inert ingredients:
lactose monohydrate, corn starch,
magnesium stearate, hydroxypropyl methylcellulose, polyethylene
glycol, titanium dioxide, FD&C Blue
No. 2 aluminum lake, yellow ferric oxide, and talc. The molecular
weights for desogestrel and ethinyl
estradiol are 310.48 and 296.40, respectively. The structural formulas
are as follows:
DESOGESTREL
ETHINYL ESTRADIOL
C
H O
C
H O
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 etono