DESOGESTREL AND ETHINYL ESTRADIOL 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 and Ethinyl Estradiol Tablets, USP 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 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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women  Continuing Use at  One Year a Method (1) Typical Use b (2) Perfect Use c (3) (4) Chance d 85 85 Spermicides e 26 6 40 Periodic Abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal f 2 Post-Ovulation 1 Withdrawal 19 4 Cap g Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm g 20 6 56 Condom h Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only 0.5 Combined 0.1 IUD Progesterone T 2 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Adapted from Hatcher et al., 1998, ref #1. a)  Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b)  Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. c) Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. d)  The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. e) Foams, creams, gels, vaginal suppositories, and vaginal film. f)  Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. g) With spermicidal cream or jelly. h)  Without spermicides. 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 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 - Hepatic adenomas or carcinomas - Known or suspected pregnancy - Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see WARNINGS, Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment ).

leaflet_short:

Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP are available in 28 days regimen of blister pack (NDC 79929-020-05) as follows: 21 White to off white, round, biconvex, film coated tablets, debossed with FT1 on one side and plain on other side containing 0.15 mg desogestrel and 0.02 mg ethinyl estradiol, 2 light-green coloured, round, biconvex, film coated tablets debossed with FT3 on one side and plain on other side containing inert ingredients and 5 Yellow coloured, round, biconvex, film coated tablets, debossed with FT2 on one side and plain on other side containing 0.01 mg ethinyl estradiol. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. The blister packs are available in boxes of 3.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL-
DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
NAARI PTE. LIMITED
----------
DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events
from combination
oral contraceptive (COC) use. This risk increases with age,
particularly in women over 35
years of age, and with the number of cigarettes smoked. For this
reason, COCs,
including Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl
Estradiol Tablets,
USP, are contraindicated in women who are over 35 years of age and
smoke (see
CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol
Tablets, USP provide
an oral contraceptive regimen of 21 white to off 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 lactose monohydrate,
pregelatinized starch
(Maize starch), povidone K-30, vitamin E, stearic acid, colloidal
anhydrous silica, purified
talc, magnesium stearate, Hypromellose, Polyethylene glycol and
followed by 2 inert
light-green round tablets with the following inactive ingredients
/lactose monohydrate,
pregelatinized starch (Starch 1500), colloidal anhydrous silica, talc,
magnesium stearate,
hypromellose, triacetin, titanium dioxide, FD&C blue no. 1 aluminium
lake, D&C yellow no.
10 aluminium lake, FD&C yellow no. 6 aluminium lake. Desogestrel and
Ethinyl Estradiol
Tablets, USP and Ethinyl Estradiol Tablets, USP also contains 5 yellow
coloured 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 lactose
monohydrate, pregelatinized
starch (Maize starch), povidone K-30, vitamin E, stearic acid,
colloidal anhydro