DESOGESTREL AND ETHINYL ESTRADIOL- desogestrel and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mayne Pharma Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desogestrel and ethinyl estradiol tablets, USP are 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 I 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 desogestrel and ethinyl estradiol tablets 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. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregna

Product summary:

Desogestrel and ethinyl estradiol tablets, USP contain 21 round orange tablets, and 7 round white tablets in a blister card (NDC 51862-514-01). Each orange tablet (debossed with "S3" on one side) contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each white tablet (debossed with "P" on one side and "N " on the other side) contains inert ingredients. Desogestrel and ethinyl estradiol tablets, USP are available in the following configurations: Carton of 1 NDC 51862-514-02 Carton of 3 NDC 51862-514-03 Carton of 6 NDC 51862-514-06 Store at 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESOGESTREL AND ETHINYL ESTRADIOL - DESOGESTREL AND ETHINYL ESTRADIOL
MAYNE PHARMA INC.
----------
RX ONLY
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 desogestrel and
ethinyl estradiol
tablets, 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
Desogestrel and ethinyl estradiol tablets, USP provide an oral
contraceptive regimen of
21 orange 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).
Each "active" orange tablet with "S3" debossed on one side contains
the following
inactive ingredients: lactose monohydrate, pregelatinized corn starch,
povidone, stearic
acid, vitamin E, HPMC/hypromellose, titanium dioxide,
macrogol/polyethylene glycol, D&C
Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide
Yellow, FD&C
Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each "inactive"
reminder white,
biconvex, round tablets with "P" debossed on one side and "N" on the
other side
contains the following inactive ingredients: titanium dioxide,
polydextrose, hypromellose,
triacetin, polyethylene glycol, lactose, magnesium stearate, and
pregelatinized corn
starch.
The 21 orange 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 c