RECLIPSEN 28 DAY- desogestrel and ethinyl estradiol kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Tilgjengelig fra:

RPK Pharmaceuticals, Inc.

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Reclipsen™ (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Reclipsen (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Table 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPI

Produkt oppsummering:

Reclipsen™ (desogestrel and ethinyl estradiol tablets USP) 28 tablets blister cards contain 21 rose-colored, round, film-coated, unscored, biconvex, tablets and 7 round, unscored white tablets. Each rose-colored tablet (debossed with “dp” on one side and “575” on the other side) contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol, USP. Each white tablet (debossed with “dp” on one side and “570” on the other side) contains inert ingredients. Cartons of 6 blister cards (NDC: 0093-3304-16). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

RECLIPSEN 28 DAY- DESOGESTREL AND ETHINYL ESTRADIOL
RPK PHARMACEUTICALS, INC.
----------
RECLIPSEN
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
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 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™ (desogestrel and ethinyl estradiol tablets USP) blister
cards provide an oral
contraceptive regimen of 21 rose-colored, 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, USP (19-nor-17 alpha-pregna-1,3,5
(10)-trien-20-yne-3,17-
diol). Inactive ingredients include colloidal silicon dioxide, FD&C
Blue No. 2 Aluminum
Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose,
lactose
monohydrate, polyethylene glycol, polysorbate 80, povidone,
pregelatinized corn starch,
stearic acid, titanium dioxide, and vitamin E.
Reclipsen blister cards also contain 7 white “inactive” tablets
for oral administration,
containing the following inactive ingredients: lactose anhydrous,
magnesium stearate,
microcrystalline cellulose and pregelatinized corn starch.
DESOGESTREL
C
H O M.W. 310.48
ETHINYL ESTRADIOL, USP
™
22
30
C
H O M.W. 296.40
The 21 rose-colored 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
changes in the cervical mucus, which increase the difficulty of sperm
entry into the
uterus, and changes in the e