CESIA- desogestrel and ethinyl estradiol kit

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

desogestrel (UNII: 81K9V7M3A3) (desogestrel - UNII:81K9V7M3A3), ethinyl estradiol (UNII: 423D2T571U) (estradiol - UNII:4TI98Z838E)

थमां उपलब्ध:

Prasco Laboratories

INN (इंटरनेशनल नाम):

desogestrel and ethinyl estradiol

फार्मास्यूटिकल फॉर्म:

KIT

रचना:

0.1 mg

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Cesia® (desogestrel/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 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. 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 (current or history) - Valvular heart disease with thrombogenic complications - Severe hypertension - Diabetes with vascular involvement - Headaches with focal neurological symptoms - Major surgery w

उत्पाद समीक्षा:

Cesia® (desogestrel/ethinyl estradiol) Tablets are available in a 28-day blister card within a recyclable plastic dispenser. Each 28-day treatment cycle pack consists of four different dosing phases, as follows: 7 coated, round light yellow tablets (debossed with "T0 R" on one side and "Organon*" on the other side) containing 0.100 mg desogestrel and 0.025 mg ethinyl estradiol; 7 coated, round orange tablets (debossed with "T6 R" on one side and "Organon*" on the other side) containing 0.125 mg desogestrel and 0.025 mg ethinyl estradiol; and 7 coated, round red tablets (debossed with "T1 R" on one side and "Organon*" on the other side) containing 0.150 mg desogestrel and 0.025 mg ethinyl estradiol. Seven round green tablets (debossed with "K2 H" on one side and "Organon*" on the other side) contain inert ingredients.      Boxes of 3      NDC 66993-615-28 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

उत्पाद विशेषताएं

CESIA- DESOGESTREL AND ETHINYL ESTRADIOL
PRASCO LABORATORIES
----------
CESIA
(DESOGESTREL/ETHINYL ESTRADIOL) TABLETS
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Cesia
(desogestrel/ethinyl estradiol) 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 light yellow tablets containing 0.100 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 red tablets containing 0.150 mg desogestrel and 0.025 mg ethinyl
estradiol. Inactive ingredients
include vitamin E, pregelatinized starch, stearic acid, lactose
monohydrate, hydroxypropyl
methylcellulose, polyethylene glycol, titanium dioxide, talc, yellow
ferric oxide (in light yellow and
orange tablets), and red ferric oxide (in orange and red tablets).
Cesia
also contains 7 green tablets
with the following inert ingredients: lactose monohydrate, corn
starch, magnesium stearate,
hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide,
FD&C Blue No. 2 aluminum
lake, yellow ferric oxide, and talc. The molecular weights for
desogestrel and ethinyl estradiol are
310.48 and 296.40, respectively. The structural formulas are as
follows:
DESOGESTREL
ETHINYL ESTRADIOL
C
H O
C
H O
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 metabol