TRIVORA levonogestrel and ethinyl estradiol

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Tilgjengelig fra:

Watson Pharma, Inc.

INN (International Name):

LEVONORGESTREL

Sammensetning:

LEVONORGESTREL 0.05 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TRIVORA- LEVONOGESTREL AND ETHINYL ESTRADIOL
WATSON PHARMA, INC.
----------
REVISED: NOVEMBER 2007 IN-5427/S
PHYSICIAN LABELING
TRIVORA
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
TRIPHASIC REGIMEN
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.
CLINICAL PHARMACOLOGY
Combination oral contraceptives primarily 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).
PHARMACOKINETICS
_Absorption_
Levonorgestrel is rapidly and completely absorbed after oral
administration (bioavailability about
100%). Levonorgestrel is not subject to first-pass metabolism or
enterohepatic circulation and
therefore does not undergo variations in absorption after oral
adminis