RECLIPSEN 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:

Actavis Pharma, Inc.

INN (International Name):

DESOGESTREL

Composition:

DESOGESTREL 0.15 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RECLIPSEN- DESOGESTREL AND ETHINYL ESTRADIOL
ACTAVIS PHARMA, INC.
----------
RECLIPSEN™
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
REVISED: JANUARY 2015
RX ONLY
PRESCIBING INFORMATION
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
RECLIPSEN, 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
RECLIPSEN Tablets 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, corn starch,
povidone, stearic acid and vitamin E.
RECLIPSEN also contains 7 green tablets containing 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
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 unknown.
PHAR