NORETHINDRONE ACETATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

NORETHINDRONE ACETATE

Composition:

NORETHINDRONE ACETATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 are available as: 5 mg: White, oval, flat-faced, beveled-edge, scored tablet. Debossed with stylized b on one side and 211/5 on the scored side. Available in bottles of 50 tablets (NDC 0555-0211-10). Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. A 10/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORETHINDRONE ACETATE- NORETHINDRONE ACETATE TABLET
TEVA PHARMACEUTICALS USA, INC.
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NORETHINDRONE ACETATE TABLETS USP
DESCRIPTION
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, or creamy
white, crystalline powder. The structural formula is as follows:
C
H O M.W. 340.46
Each Norethindrone Acetate Tablet USP, for oral administration,
contains norethindrone acetate, USP 5
mg. In addition, each tablet contains the following inactive
ingredients: anhydrous 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)
22
28
3
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
_Effect of Food_
The effect of food administration on