DESOGESTREL AND ETHINYL ESTRADIOL kit

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Naari Pte Limited

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Desogestrel and ethinyl estradiol tablets USP 0.15 mg/0.03 mg are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Desogestrel and ethinyl estradiol tablets 0.15 mg/0.03 mg has not been studied for and is not indicated for use in emergency contraception. Desogestrel and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Known thrombophilic conditions - Cerebral vascular or coronary artery disease (current or history) - Valvular heart disease with complications - Persistent blood pressure values of ≥ 160 mm Hg systolic or ≥ 100 mg Hg diastolic 102 - Diabetes with vascular involvement - Headaches with focal neurological symptoms - Major surgery with prolonged immobilization - Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - Undiagnosed abnormal genital bleeding - Cholestatic jaundice of pregnancy or jaundice with prior pill use - Acute or chronic hepatocellular disease with abnormal liver function - Hepatic adenomas or carcinomas - Known or suspected pregnancy - Hypersensitivity to any component of this product - Are receiving Hepatitis C drug combinations containing ombitasivir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see section 5 in WARNINGS), Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment).

leaflet_short:

Desogestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg are available in a blister pack (NDC 79929-006-05). The blister pack contains 28 tablets, as follows: 21 light orange, round, biconvex, beveled edged, film coated tablets, debossed with “EY” on one side and “1” on other side containing 0.15 mg desogestrel together with 0.03 mg ethinyl estradiol, and 7 green, round, biconvex, beveled edged, film coated tablets, debossed with “EY” on one side and “2” on other side containing inert ingredients. Desogestrel and ethinyl estradiol tablets USP 0.15 mg/0.03 mg are packaged in a carton containing 3 blister pack. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). ® The brands listed are trademarks of their respective owners.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DESOGESTREL AND ETHINYL ESTRADIOL- DESOGESTREL AND ETHINYL ESTRADIOL
NAARI PTE LIMITED
----------
DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP 0.15 MG/0.03 MG
RX ONLY
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
Cigarette smoking increases the risk of serious cardiovascular events
from
combination oral contraceptive use. This risk increases with age,
particularly in
women over 35 years of age, and with the number of cigarettes smoked.
For this
reason, combination oral contraceptives, including desogestrel and
ethinyl estradiol
tablets 0.15 mg/0.03 mg, should not be used by women who are over 35
years of
age and smoke.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Desogestrel and ethinyl estradiol tablets USP 0.15 mg/0.03 mg provide
an oral
contraceptive regimen of 21 light orange round tablets each containing
0.15 mg
desogestrel (13-ethyl-11-methylene-18,19-dinor-17
alpha-pregn-4-en-20-yn-17-ol) and
0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5
(10)-trien-20-yne-3,17,diol).
Inactive ingredients include colloidal anhydrous silica, corn starch,
ferric oxide red, ferric
oxide yellow, hypromellose, lactose monohydrate, magnesium stearate,
polyethylene
glycol, povidone, stearic acid, talc, titanium dioxide, and vitamin E.
Each green tablet
contains the following inactive ingredients: colloidal anhydrous
silica, FD&C Blue No.2
Aluminum Lake, ferric oxide yellow, hypromellose, lactose monohydrate,
magnesium
stearate, polyethylene glycol, pregelatinized starch (maize), talc and
titanium dioxide.
Desogestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg meet USP
Dissolution
Test 2.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Combined 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 changes in the endometr