CAZIANT TRIPHASIC REGIMEN- desogestrel and ethinyl estradiol

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

REMEDYREPACK INC.

INN (Medzinárodný Name):

DESOGESTREL

Zloženie:

DESOGESTREL 0.1 mg

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Caziant (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. % 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 63 Calendar 9 Ovulation Method 3 Sympto-Thermal # 2 Post-Ovulation 1 Withdrawal 19 4 Cap Þ Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm Þ 20 6 56 Condom

Prehľad produktov:

Caziant ® (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 51862-238-03 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.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CAZIANT TRIPHASIC REGIMEN- DESOGESTREL AND ETHINYL ESTRADIOL
REMEDYREPACK INC.
----------
CAZIANT
(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
Caziant
(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.
Caziant 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).
Receptor-binding studies, as well as studies in animals, have shown
that etonogestrel, the biologically
active