PIMTREA- desogestrel/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:

Northstar Rx LLC

INN (שם בינלאומי):

DESOGESTREL

הרכב:

DESOGESTREL 0.15 mg

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

PIMTREA™ (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. Adapted from Hatcher et al., 1998, Ref#1. 1 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. 2 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 durin

leaflet_short:

PIMTREA™ (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets contain 21 round dark blue tablets, 2 round white tablets and 5 round green tablets in a blister card (NDC  16714-404-01)  within a recyclable plastic dispenser. Each dark blue tablet (debossed with "M3" on one side) contains 0.15 mg desogestrel and 0.02 mg ethinyl estradiol. Each green tablet (debossed with "M4" on one side) contains 0.01 mg ethinyl estradiol. Each white tablet (debossed with "P" on one side and the "N " on the other side) contains inert ingredients. PIMTREA™ Tablets are available in the following: Carton of 1                                                      NDC 16714-404-02 Carton of 3                                                      NDC 16714-404-03 Carton of 6                                                      NDC 16714-404-04 Storage Store at controlled room temperature 20–25°C (68–77°F). Rx Only

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PIMTREA - DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
NORTHSTAR RX LLC
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PIMTREA
(DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS, USP)
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
PIMTREA™ (desogestrel/ethinyl estradiol and ethinyl estradiol
tablets) provide an oral contraceptive
regimen of 21 dark blue 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:
titanium dioxide, macrogol/PEG 400
NF, hydroxypropyl-methylcellulose/hypromellose, FD&C Red #40, FD&C
Yellow #6, FD&C Blue
#1, lactose monohydrate, povidone, stearic acid and pregelatinized
starch, followed by 2 white tablets
with the following inactive ingredients: titanium dioxide,
polydextrose, hypromellose, triacetin,
macrogol/polyethylene glycol 8000, lactose, magnesium stearate and
pregelatinized corn starch.
PIMTREA™ also contains 5 green 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: titanium dioxide,
macrogol/PEG 3000 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C
Red #40, FD&C Yellow #5,
FD&C Blue #1, iron oxide yellow, iron oxide black, lactose
monohydrate, magnesium stearate and
pregelatinized starch. The molecular weights for desogestrel and
ethinyl estradiol are 310.48 and
296.40 respectively. The structural formulas are as follows:
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