INCASSIA- norethindrone tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)

可用日期:

Aurobindo Pharma Limited

INN（国际名称）:

NORETHINDRONE

组成:

NORETHINDRONE 0.35 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

1. Indications  Progestin- only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin- only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Emergency Contraceptive Pills Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactational Amenorrhea Method LAM is a highly effective, temporary method of contraception.10 Source: Trussell, J, Contraceptive Efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. - Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who exp

產品總結:

Incassia (Norethindrone Tablets USP, 0.35 mg) are light yellow to yellow, round, flat faced beveled edge tablets, debossed with ‘S’ on one side and ‘14’ on other side of the tablet and are available in Blister Pack Containing 28 tablets. The blister packs are available in the following packages:     Carton of 1 Pouch                               NDC 65862-925-87     Carton of 3 Pouches                           NDC 65862-925-88     Carton of 6 Pouches                           NDC 65862-925-92     Carton of 1 Blister Pack                  NDC 65862-925-28     Carton of 3 Blister Packs                 NDC 65862-925-85      Carton of 6 Blister Packs                 NDC 65862-925-86  STORAGE Store at controlled room temperature 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].

授权状态:

Abbreviated New Drug Application

产品特点

INCASSIA - NORETHINDRONE TABLET
AUROBINDO PHARMA LIMITED
---------- INCASSIA
(NORETHINDRONE TABLETS USP, 0.35 MG)
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT ORAL CONTRACEPTIVES DO NOT PROTECT
AGAINST
TRANSMISSION OF HIV (AIDS) AND OTHER SEXUALLY TRANS MITTED DISEASES
(STDS )
SUCH AS CHLAMYDIA, GENITAL HERPES, GENITAL WARTS, GONORRHEA, HEPATITIS
B, AND
SYPHILIS.
DESCRIPTION
Each light yellow to yellow Incassia tablet provides a continuous oral
contraceptive
regimen of 0.35 mg norethindrone USP daily, and the inactive
ingredients include corn
starch, D&C Yellow No. 10 aluminum lake, FD&C Yellow # 6 aluminum
lake, lactose
monohydrate, magnesium stearate, povidone and talc.
The chemical name for norethindrone is
17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-
one. The structural formula follows:
CLINICAL PHARMACOLOGY
1. MODE OF ACTION
Incassia progestin-only oral contraceptives prevent conception by
suppressing ovulation
in approximately half of users, thickening the cervical mucus to
inhibit sperm
penetration, lowering the mid-cycle LH and FSH peaks, slowing the
movement of the
ovum through the fallopian tubes, and altering the endometrium.
2. PHARMACOKINETICS
_ABSORPTION _
Norethindrone is rapidly absorbed with maximum plasma concentrations
occurring
®
®
within 1 to 2 hours after Incassia administration (see Table 1).
Norethindrone appears to
be completely absorbed following oral administration; however, it is
subject to first pass
metabolism resulting in an absolute bioavailability of approximately
65%.
Peak plasma concentrations occur approximately 1 hour after
administration (mean
T
1.2 hours). The mean (SD) C
was 4816.8 (1532.6) pg/mL and generally
occurred within 1 hour (mean) of tablet administration, ranging from
0.5 to 2 hours. The
mean (SD) C
was 885 (250) pg/mL, however, the mean concentration at 24 hrs was
130 (47) pg/mL.
Table 1 provides summary statistics of the pharmacokinetic parameters
associated with
single dose Incassia administration.
TABLE 1: MEAN ± SD PHARMACOKINETIC PARAMETERS FOLLOWING SINGLE DO