VELIVET TRIPHASIC REGIMEN- 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:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

DESOGESTREL

Composition:

DESOGESTREL 0.1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Velivet (desogestrel and ethinyl estradiol tablets) 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 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE 2: 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 * Method Typical Use † Perfect Use ‡ (1) (2) (3) (4) Chance§ 85 85 Spermicides¶ 26 6 40 Periodic abstinence 25

Product summary:

Velivet ® (desogestrel and ethinyl estradiol tablets USP - triphasic regimen) is available in a 28 day blister card tablet dispenser. Each 28 day treatment cycle pack consists of four different dosing phases, as follows: 7 beige, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 333 on the other side) containing 0.1 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 orange, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 332 on the other side) containing 0.125 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 pink, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 335 on the other side) containing 0.15 mg desogestrel and 0.025 mg ethinyl estradiol, USP and seven white, round, biconvex, unscored tablets (debossed with stylized b on one side and 334 on the other side) containing inert ingredients. Boxes of 3 NDC 0555-9051-67 Storage 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

VELIVET TRIPHASIC REGIMEN- DESOGESTREL AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
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VELIVET
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP - TRIPHASIC REGIMEN)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Velivet
(desogestrel and ethinyl estradiol tablets USP) is a triphasic oral
contraceptive
containing two active components, desogestrel and ethinyl estradiol,
USP. Each 28 day
treatment cycle pack consists of three active dosing phases: 7 beige
tablets containing
0.1 mg desogestrel
(13-ethyl-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-17-ol)
and 0.025 mg ethinyl estradiol, USP
(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,
USP, and 7 pink tablets containing 0.15 mg desogestrel and 0.025 mg
ethinyl estradiol,
USP. Inactive ingredients include colloidal silicon dioxide,
hypromellose, lactose
monohydrate, polyethylene glycol, polysorbate 80, povidone,
pregelatinized corn starch,
stearic acid, titanium dioxide and vitamin E. Beige tablets also
contain iron oxide red and
iron oxide yellow. Pink and orange tablets also contain FD&C Red No.
40 Aluminum Lake
and FD&C Yellow No. 6 Aluminum Lake. Velivet also contains 7 white
tablets with the
following inert ingredients: lactose anhydrous, magnesium stearate,
microcrystalline
cellulose and pregelatinized corn starch. The structural formulas are
as follows:
The 7 beige, 7 pink and 7 orange tablets meet 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 (which reduce the likelihood of
implantation).
®
®
uterus) and the endometrium (which reduce the likelihood of
implantation).
Receptor-binding