NORETHINDRONE ACETATE- norethindrone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

INN (International Name):

NORETHINDRONE ACETATE

Composition:

NORETHINDRONE ACETATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norethindrone acetate tablets, USP is 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, USP 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

Product summary:

Norethindrone acetate tablets, USP, 5 mg, are supplied as white to off-white oval, biconvex tablets debossed with “AN” bisect “475” on one side and plain on the other side. They are available as follows: Bottles of 90:               NDC 42291-650-90 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NORETHINDRONE ACETATE- NORETHINDRONE TABLET
AvKARE
----------
PATIENT INFORMATION
Norethindrone Acetate Tablets
Read this PATIENT INFORMATION before you start taking norethindrone
acetate tablets and read what
you get each time you refill norethindrone acetate tablets. There may
be new information. This
information does not take the place of talking to your healthcare
provider about your medical condition.
What is the most important information I should know about
norethindrone acetate (A Progestin
Hormone) tablets?
•
Do not use norethindrone acetate if you are pregnant, breastfeeding or
are trying to conceive.
•
Do not use norethindrone acetate if you have had a previous blood
clot, stroke, or heart attack.
•
Do not use norethindrone acetate if you are postmenopausal.
What is norethindrone acetate?
Norethindrone acetate is similar to the progesterone hormones
naturally produced by the body.
What are norethindrone acetate tablets used for?
Norethindrone acetate tablets are used for the treatment of secondary
amenorrhea (absence of menstrual
periods in women who have previously had a menstrual period who are
not pregnant), the treatment of
endometriosis, and the treatment of irregular menstrual periods due to
hormone imbalance.
Who should not take norethindrone acetate tablets?
You should not take norethindrone acetate tablets if you are
postmenopausal, pregnant or breast-feeding.
You should not take norethindrone acetate tablets if you have the
following conditions:
•
Known or suspected pregnancy. Norethindrone acetate tablets are not
indicated during pregnancy
as it may cause fetal harm when administered to pregnant women. There
is an increased risk of
minor birth defects in children whose mothers take norethindrone
acetate during the first 4 months
of pregnancy (mild masculinization of the external genitalia of the
female fetus, as well as
hypospadias in the male fetus). If you take norethindrone acetate and
later find out you were
pregnant, talk with your healthcare provider right away.
•
History of

Summary of Product characteristics

NORETHINDRONE ACETATE- NORETHINDRONE TABLET
AVKARE
----------
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, USP. It is a
white, or creamy white, crystalline powder.
Norethindrone acetate tablets, USP contain the following inactive
ingredients: lactose,
magnesium stearate, and microcrystalline cellulose.
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
Norethindrone (NET)
AUC = area under the curve,
C
= maximum plasma concentration,
t
= time at maximum plasma concentration,
t
= half-life,
SD = standard deviation
AUC
(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
FIGURE 1. MEAN PLASMA CONCENTRATION PROFILE AFTER A SINGLE DOSE OF 5
MG
ADMINISTERED TO 29 HEALTHY FEMALE VOLUNTEERS UNDER FASTING CONDITIONS
_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)