NORETHINDRONE ACETATE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Aurobindo Pharma Limited

INN (International Nazwa):

NORETHINDRONE ACETATE

Skład:

NORETHINDRONE ACETATE 5 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Norethindrone Acetate Tablets, USP   Norethindrone acetate tablets, USP  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, USP  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. 

Podsumowanie produktu:

Norethindrone Acetate Tablets USP , 5 mg are white to off white, oval, flat-faced, beveled-edge tablets scored on one side. Debossed with “S” and “12” on either side of scoreline on one side and plain on the other side. Bottles of 50                  NDC 65862-715-50 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahabubnagar (Dt)-509302 India Revised: 12/2016

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

NORETHINDRONE ACETATE - NORETHINDRONE ACETATE TABLET
AUROBINDO PHARMA LIMITED
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NORETHINDRONE ACETATE TABLETS, USP
RX ONLY
DESCRIPTION
Norethindrone acetate tablets, USP - 5 mg oral tablets.
Norethindrone acetate tablets, 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 creamy white,
odorless, crystalline powder.
Norethindrone acetate tablets, USP contain the following inactive
ingredients: anhydrous lactose,
magnesium stearate, methylene chloride, 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 in 29 healthy female volunteers are summarized
in Table 1.
TABLE 1. PHARMACOKINETIC PARAMETERS AFTER A SINGLE DOSE OF
NORETHINDRONE ACETATE IN HEALTHY WOMEN
NORETHINDRONE ACETATE
(N=29)
ARITHMETIC
MEAN ± SD
AUC = area under the curve,
C
= maximum plasma concentration,
t
= time at maximum plasma concentration,
t
= half-life,
SD = standard deviation.
Norethindrone (NET)
AUC (0-inf)(ng/mL*h)
166.9 ± 56.28
C
(ng/mL)
26.19 ± 6.19
t
(h)
1.83 ± 0.58
t
(h)
8.51 ± 2.19
_EFFECT OF FOOD_
The effect of food administration on the pharmacokinetics of
norethindrone acetate has not been studied.
_DISTRIBUTION _
_ _
Norethindrone is 36% bound to sex hormone-binding globulin (SHBG) and
61% bound to albumin.