AZURETTE- desogestrel/ethinyl estradiol 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.

INN (International Name):

DESOGESTREL

Composition:

DESOGESTREL 0.15 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azurette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year * (4) Method   (1) Typical Use † (2) Perfect Use ‡   (3) Chance§   85 85 Spermicides¶ 26 6 40 Periodi

Product summary:

Azurette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) contains 21 round, white, film-coated, biconvex tablets, 2 round, light-green tablets and 5 round, light-blue, film-coated, biconvex tablets in a blister card. Each white tablet (debossed with “dp ” on one side and “021 ” on the other side) contains 0.15 mg desogestrel and 0.02 mg ethinyl estradiol, USP. Each light-green tablet (debossed with “dp ” on one side and “331 ” on the other side) contains inert ingredients. Each light-blue tablet (debossed with “dp ” on one side and “022 ” on the other side) contains 0.01 mg ethinyl estradiol, USP. Box of 6 Blister Cards (NDC: 51862-072-06) 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZURETTE- DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
MAYNE PHARMA INC.
----------
AZURETTE
(DESOGESTREL/ETHINYL ESTRADIOL 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
Azurette
(desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP)
provides 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), 0.02 mg
ethinyl estradiol, USP (19-nor-17
alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive
ingredients which include colloidal
silicon dioxide, hypromellose, lactose monohydrate, polyethylene
glycol, povidone, pregelatinized
corn starch, stearic acid, and vitamin E, followed by 2 inert
light-green, round tablets with the following
inactive ingredients: FD&C blue no. 1 aluminum lake, FD&C yellow no. 6
aluminum lake, D&C yellow
no. 10 aluminum lake, lactose monohydrate, magnesium stearate,
microcrystalline cellulose and
pregelatinized corn starch. Azurette also contains 5 light-blue, round
tablets containing 0.01 mg ethinyl
estradiol, USP (19-nor-17 alpha-pregna-1,3,5
(10)-trien-20-yne-3,17-diol) and inactive ingredients
which include colloidal silicon dioxide, FD&C blue no. 1 aluminum
lake, FD&C blue no. 2 aluminum
lake, hypromellose, lactose monohydrate, polydextrose, polyethylene
glycol, povidone, pregelatinized
corn starch, stearic acid, titanium dioxide, triacetin and vitamin E.
The structural formulas are as
follows:
DESOGESTREL
C
H O M.W. 310.48
ETHINYL ESTRADIOL, USP
®
®
22
30
C
H O M.W. 296.40
The 21 white tablets meet 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