TRIVORA- levonorgestrel and ethinyl estradiol kit

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

זמין מ:

RPK Pharmaceuticals, Inc.

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Oral contraceptives 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 I 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Oral contraceptives should not be used in women with any of 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 jaundic

leaflet_short:

Trivora® -28 Tablets (levonorgestrel and ethinyl estradiol tablets—triphasic regimen) are available in 28- tablet blister cards. Six blister cards are packaged in a carton. Each cycle contains 28 tablets as follows: Store at 20° - 25°C (68° - 77°F). [See USP controlled room temperature.]

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TRIVORA- LEVONORGESTREL AND ETHINYL ESTRADIOL
RPK PHARMACEUTICALS, INC.
----------
TRIVORA -28
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
TRIPHASIC REGIMEN
PHYSICIAN LABELING
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Each Trivora cycle of 28 tablets consists of three different drug
phases as follows:
Phase 1 comprised of 6 blue tablets, each containing 0.050 mg of
levonorgestrel (d(-)13
beta-ethyl-17-alpha-ethinyl-17- beta-hydroxygon-4-en-3-one), a totally
synthetic
progestogen, and 0.030 mg of ethinyl estradiol (19-
nor-17α-pregna-1,3,5(10)-trien-20-
yne-3, 17-diol); phase 2 comprised of 5 white tablets, each containing
0.075 mg
levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised
of 10 pink tablets,
each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl
estradiol; then followed
by 7 peach inert tablets. The inactive ingredients present in the
blue, white and pink
tablets are lactose monohydrate, magnesium stearate, povidone and
starch (corn).
Each blue tablet also contains FD&C Blue #1. Each pink tablet also
contains FD&C Red
#40. Each inactive peach tablet contains the following inactive
ingredients: anhydrous
lactose, FD&C Yellow #6, lactose monohydrate, magnesium stearate and
microcrystalline cellulose.
Levonorgestrel
Ethinyl Estradiol
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Combination oral contraceptives prevent pregnancy by suppressing
ovulation.
INDICATIONS AND USAGE
Oral contraceptives 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 I 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 and the IUD, depends upon the
reliability with which they
are used. Correct and consistent use of methods can result in lowe