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:

Physicians Total Care, Inc.

INN (International Name):

DESOGESTREL

Composition:

DESOGESTREL 0.1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Velivet™ (desogestrel and ethinyl estradiol, USP) Tablets are 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 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. 100 Emergency Contraceptive Pills : Treatment initiated within 72 hours after unprotected intercourse reduces risk of pregnancy by at least 75% Lactational Amenorrhea Method : LAM is a highly effective, temporary method of contraception. Source: Trussell J, Stewart F, Contraceptive Efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition . Oral contraceptives shou

Product summary:

Velivet™ (desogestrel and ethinyl estradiol tablets, USP - triphasic regimen) are 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; 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; 7 pink, round, film-coated, biconvex, unscored tablets (debossed with a stylized b on one side and 335 on the other side) containing 0.15 mg desogestrel and 0.025 mg ethinyl estradiol and seven white, round, biconvex, unscored tablets (debossed with stylized b on one side and 334 on the other side) containing inert ingredients. Blisterpack of 1 NDC 54868-5031-0 Storage 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

VELIVET TRIPHASIC REGIMEN- DESOGESTREL AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
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VELIVET
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP - TRIPHASIC REGIMEN)
RX ONLY 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, USP) Tablets are a triphasic oral
contraceptive containing
two active components, desogestrel and ethinyl estradiol. 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 (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, and 7 pink tablets containing 0.15 mg desogestrel and 0.025
mg ethinyl estradiol. Inactive
ingredients include colloidal silicon dioxide, hypromellose, lactose
monohydrate, polyethylene glycol,
polysorbate 80, povidone, pregelatinized 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 starch. The structural formulas are as
follows:
The 7 beige, 7 pink and 7 orange tablets meets 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).
Receptor binding studies, as well as studies in animals, have shown
that etonogestrel, the biologically
active meta