LEVORA- 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:

Physicians Total Care, Inc.

INN (שם בינלאומי):

LEVONORGESTREL

הרכב:

LEVONORGESTREL 0.15 mg

מסלול נתינה (של תרופות):

ORAL

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.1 The efficacy of these contraceptive methods, except sterilization, 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 who have the following conditions: - Thrombophlebitis or thromboembolic disorders Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease Cerebral vascular or coronary artery disease - Known or suspected carcinoma of the breast Known or suspected carcinoma of the breast - C

leaflet_short:

Levora® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets USP):           NDC 54868-4607-0       Each white tablet is unscored, round in shape, with 15/30 debossed on one side and WATSON on the other side, and contains 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol. Levora® 0.15/30-28 is packaged in cartons of six tablet dispensers. Each tablet dispenser contains 21 white (active) tablets and 7 peach (inert) tablets. Inert tablets are unscored, round in shape with WATSON debossed on one side and P1 on the other side. Store at controlled room temperature 15°-25°C (59°-77°F).

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

LEVORA - LEVONORGESTREL AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
----------
_WATSON PHARMA_
REVISED: MAY 2005
IN-5262/S
PHYSICIAN LABELING
_LEVORA_
_0.15/30-28_
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.15 MG/0.03 MG)
RX ONLY
SUPPLEMENTAL PATIENT MATERIAL
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
ORAL CONTRACEPTIVE AGENTS DESCRIPTION
_LEVORA_
_0.15/30-28 TABLETS_ provide an oral contraceptive regimen consisting
of 21 white tablets
containing levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg
followed by 7 peach tablets containing
inert ingredients.
Levonorgestrel is a totally synthetic progestogen with the chemical
name (–)-13-Ethyl-17-hydroxy-
18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an
estrogen with the chemical name 19-
Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural
formulae follow:
LEVONORGESTREL
®
®
ETHINYL ESTRADIOL
The white Levora
0.15/30 tablets contain the following inactive ingredients:
croscarmellose sodium,
lactose, magnesium stearate, microcrystalline cellulose, and povidone.
The inactive peach tablets in the 28-day regimen of Levora
0.15/30 contain the following inactive
ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose
Monohydrate, Magnesium Stearate
and Microcrystalline Cellulose.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotrophins.
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 may
reduce the likelihood of implantation).
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 o