ISIBLOOM- desogestrel and ethinyl estradiol kit

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Bryant Ranch Prepack

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

IsibloomTM (desogestrel and ethinyl estradiol tablets) 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. Chancef 85 85 Spermicidesg 26 6 40 Periodic abstinence 25 63   Calendar 9   Ovulation Method 3   Sympto-Thermalh 2   Post-Ovulation 1 Withdrawal 19 4 Capi   Parous Women 40 26 42   Nulliparous Women 20 9 56 Sponge   Parous Women 40 20 42   Nulliparous Women 20 9 56 Diaphragmi 20 6 56 Condomj   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 T380A 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 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.d Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.e Source: Trussel J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York, NY; Irvington Publishers, 1998. 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 treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). e However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. f 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. g Foams, creams, gels, vaginal suppositories, and vaginal film. h Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. i With spermicidal cream or jelly. j Without spermicides. Desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception. Isibloom is contraindicated in females who are known to have or develop the following conditions:

Ապրանքի ամփոփագիր:

IsibloomTM (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg are available as follows: Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are round, orange, film-coated, debossed with SZ on one side and D2 on the other side. The 7 inert tablets are round, green, film-coated, debossed with SZ on one side and J1 on the other. NDC 63629-2333-1, one box containing 3 individual cartons STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ISIBLOOM- DESOGESTREL AND ETHINYL ESTRADIOL
BRYANT RANCH PREPACK
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ISIBLOOM
(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, 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
ISIBLOOM (desogestrel and ethinyl estradiol tablets, USP) provide an
oral
contraceptive regimen of 21 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 alpha-tocopherol, colloidal silicon dioxide, corn
starch, FD&C yellow 5
aluminum lake, FD&C yellow 6 aluminum lake, hypromellose 2910, lactose
monohydrate,
polysorbate, povidone, red iron oxide, stearic acid, titanium dioxide
and triacetin. Each
green tablet contains the following inactive ingredients: corn starch,
colloidal silicon
dioxide, FD&C blue 2 aluminum lake, hypromellose 2910, lactose
monohydrate,
magnesium stearate, polysorbate, povidone, titanium dioxide,
triacetin, and yellow iron
oxide.
USP Dissolution Test 2 used.
CLINICAL PHARMACOLOGY
TM
TM
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 endometrium which reduce the likelihood of
implantation.
Receptor