KARIVA- desogestrel/ethinyl estradiol and ethinyl estradiol kit

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Physicians Total Care, Inc.

INN (الاسم الدولي):

DESOGESTREL

تركيب:

DESOGESTREL 0.15 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Kariva® (desogestrel/ethinyl estradiol and ethinyl estradiol) 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 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. Oral contraceptives should not be used in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease - Known or suspected carcinoma of the breast - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - Undiagnosed abnormal genital bleeding - Cholestatic jaundice of

ملخص المنتج:

Kariva® (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets contain 21 round white coated tablets, 2 round light-green tablets and 5 round light-blue coated 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. Each round 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. 28 Tablets, Blister Pack        NDC 54868-4742-0 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

KARIVA - DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
----------
KARIVA
(DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) TABLETS
Rx only
Iss. 12/2009
11001578
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Kariva
(desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets provide
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
(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
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 starch. Kariva
also
contains 5 light-blue round tablets containing 0.01 mg ethinyl
estradiol (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 starch,
stearic acid, titanium dioxide,
triacetin and vitamin E. The molecular weight for desogestrel and
ethinyl estradiol are 310.48 and
296.40 respectively. The structural formulas are as follows:
DESOGESTREL M.W. 310.4 8 MF: C
H O
ETHINYL ESTRADIOL M.W. 296.4 0 MF: C
H
O
The 21 white tablets meet USP Dissolution Test 2.
®
®
®
22
30
20
24
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