NORETHINDRONE ACETATE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

Предлага се от:

Ingenus Pharmaceuticals, LLC

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Norethindrone acetate tablets are indicated for the treatment of secondary amenorrhea, endometriosis, and  abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Norethindrone acetate tablets are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. - Known or suspected pregnancy. There is no indication for norethindrone acetate tablets in pregnancy. (See PRECAUTIONS .) - Undiagnosed vaginal bleeding - Known, suspected or history of cancer of the breast - Active deep vein thrombosis, pulmonary embolism or history of these conditions - Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial  infarction) - Impaired liver function or liver disease - As a diagnostic test for pregnancy - Hypersensitivity to any of the drug components

Каталог на резюме:

Norethindrone acetate tablets, USP are available as: 5 mg: White to off-white, oval, flat beveled edged tablet. 'P658' is engraved on one side, and a breakline on the reverse. Available as follows: Bottle of 50                        NDC    50742-267-50 Bottle of 500                      NDC    50742-267-05 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Rx Only Revised: 05/2019 I0093 Rev B Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Made in China ingenus

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

NORETHINDRONE ACETATE- NORETHINDRONE ACETATE TABLET
INGENUS PHARMACEUTICALS, LLC
----------
NORETHINDRONE ACETATE TABLETS, USP
RX ONLY
DESCRIPTION
Norethindrone acetate tablets, USP - 5 mg oral tablets.
Norethindrone acetate, USP
(17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate),
a synthetic, orally active progestin, is the acetic acid ester of
norethindrone. It is a white
to yellowish-white, crystalline powder.
Norethindrone acetate tablets, USP contain the following inactive
ingredients: lactose
monohydrate, magnesium stearate, and microcrystalline cellulose.
Meets USP dissolution Test 2.
CLINICAL PHARMACOLOGY
Norethindrone acetate induces secretory changes in an estrogen-primed
endometrium.
On a weight basis, it is twice as potent as norethindrone.
PHARMACOKINETICS
_Absorption:_
Norethindrone acetate is completely and rapidly deacetylated to
norethindrone (NET)
after oral administration, and the disposition of norethindrone
acetate is indistinguishable
from that of orally administered norethindrone. Norethindrone acetate
is rapidly
absorbed from norethindrone acetate tablets, with maximum plasma
concentration of
norethindrone generally occurring at about 2 hours post-dose. The
pharmacokinetic
parameters of norethindrone following single oral administration of
norethindrone
acetate tablets in 29 healthy female volunteers are summarized in
Table 1.
TABLE 1
Pharmacokinetic Parameters after a Single Dose of norethindrone
acetate tablets in Healthy Women
Norethindrone acetate tablets (n=29) Arithmetic Mean ± SD
Norethindrone (NET)
AUC(0-inf)(ng/mL*h)
166.90±56.28
C
(ng/mL)
26.19±6.19
t
(h)
1.83±0.58
t
(h)
8.51±2.19
AUC= area under the curve
C
= maximum plasma concentration
t
= time at maximum plasma concentration
t
= half-life
SD = standard deviation
Figure 1. Mean Plasma Concentration Profile after a Single Dose of 5
mg Administered to
29 Healthy Female Volunteers under Fasting Conditions
max
max
1/2
max
max
1/2
_Effect of Food:_
The effect of food administration on the pharmacokinetics of
norethindrone