FALESSA- levonorgestrel and ethinyl estradiol kit

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Avion Pharmaceuticals, LLC

INN:

LEVONORGESTREL

composition:

LEVONORGESTREL 0.1 mg

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Levonorgestrel and Ethinyl Estradiol Tablets is 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 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, the IUD, and levonorgestrel implants, 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 currently have the following conditions: Combination oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders A history of deep-vein thrombophlebitis or thromboembolic disorders Cerebrovascular or coronary artery disease (current or past history) Valvular heart disease with thrombogenic complications Thrombogenic rhythm

leaflet_short:

Levonorgestrel and Ethinyl Estradiol Tablets 0.1 mg/0.02 mg is available in a compact blister card (NDC 75854-601-01), containing 28 tablets arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows: Levonorgestrel and Ethinyl Estradiol Tablets are available in the following configurations: Carton of 1      NDC 75854-601-01 Falessa Tablets is available in unit-dose packs of 28 tablets. (75854-501-28) The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

authorization_status:

unapproved drug other

SPC

FALESSA- LEVONORGESTREL AND ETHINYL ESTRADIOL
AVION PHARMACEUTICALS, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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FALESSA KIT
PHYSICIAN LABELING
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT ORAL CONTRACEPTIVES DO NOT PROTECT
AGAINST TRANSMISSION OF HIV
(AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES (STDS) SUCH AS
CHLAMYDIA, GENITAL HERPES GENITAL
WARTS, GONORRHEA, HEPATITIS B, AND SYPHILIS.
DESCRIPTION
21 orange active tablets each containing 0.1 mg of levonorgestrel
d(-)-13β-hydroxygon-4-en-3-one, a
totally synthetic progestogen, and 0.02 mg of ethinyl estradiol,
17α-ethinyl-17β-hydroxygon-4-en-3-
one, a toally synthetic progestogen, and 0.02 mg of ethinyl estradiol,
17α-ethinyl-1,3,5(10)-estratriene-
3, 17β-diol.
The chemical formula of levonorgestrel USP is
18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-
hydroxy-, (17α)-, (-)-, and the chemical formula of ethinyl estradiol
USP is 19-Norpregna-1,3,5(10)-
trien-20-yne-3,17-diol, (17α)-. The structural formulas are as
follows:
The inactive ingredients present are FD&C Yellow #5 Aluminum Lake,
FD&C Yellow #6 Aluminum
Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol,
talc, macrogol/polyethylene
glycol 3350 NF, lecithin (soya), iron oxide black, lactose
monohydrate, magnesium stearate and
pregelantinized corn starch.
Each inactive white tablet (7) contains the following inactive
ingredients: titanium dioxide,
polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol
8000, lactose monohydrate,
magnesium stearate and pregelantinized corn starch.
LEVONORG ESTREL C H O MW: 312.4
21
28
2
ETHINYL ESTRADIOL C
H
O MW: 296.4
CLINICAL PHARMACOLOGY
MODE OF ACTION
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