EMZAHH- norethindrone tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Aurobindo Pharma Limited

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Emergency Contraception: Emergency contraceptive pills or insertion of a copper intrauterine contraceptive after unprotected intercourse substantially reduces the risk of pregnancy.9 (See Chapter 6.). Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 (See Chapter 18.) Source: Trussell J. Contraceptive Efficacy. In Hatcher RA, Trussell J, Nelson AL, Cates W, Kowal D, Policar M. Contraceptive Techology: Twentieth Revised Edition. New York NY: Ardent Media, 2011. ——————————————————————————————————————————————————————————————————— Notes: 1       Among typical couples who initia

Sommarju tal-prodott:

EmzahhTM (Norethindrone Tablets USP, 0.35 mg) are light yellow to yellow, round, flat faced beveled edged uncoated tablets, debossed with ‘S’ on one side and ‘13’ on other side of the tablet. It is supplied as 28 tablets in a blister pack. The blister packs are available in the following packages: •     The blister packs are packed in pouches and the pouches are packaged in carton Carton of 6 Pouches        NDC 59651-136-92 Carton of 3 Pouches        NDC 59651-136-88 •     The blister pack is packed in carton Carton of 1 Blister Pack     NDC 59651-136-28 STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Keep out of reach of children.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

EMZAHH - NORETHINDRONE TABLET
AUROBINDO PHARMA LIMITED
----------
EMZAHH
(NORETHINDRONE TABLETS, USP)
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
EMZAHH TABLETS
Each tablet contains 0.35 mg norethindrone USP. Inactive ingredients
include anhydrous
lactose, corn starch, D&C Yellow No. 10 aluminum lake, ethylcellulose,
magnesium
stearate, microcrystalline cellulose, povidone, sodium starch
glycolate, and talc.
CLINICAL PHARMACOLOGY
1. MODE OF ACTION
Emzahh progestin-only oral contraceptives prevent conception by
suppressing
ovulation in approximately half of users, thickening the cervical
mucus to inhibit sperm
penetration, lowering the midcycle LH and FSH peaks, slowing the
movement of the
ovum through the fallopian tubes, and altering the endometrium.
2. PHARMACOKINETICS
Serum progestin levels peak about two hours after oral administration,
followed by rapid
distribution and elimination. By 24 hours after drug ingestion, serum
levels are near
baseline, making efficacy dependent upon rigid adherence to the dosing
schedule. There
are large variations in serum levels among individual users.
Progestin-only administration
results in lower steady-state serum progestin levels and a shorter
elimination half-life
than concomitant administration with estrogens.
INDICATIONS AND USAGE
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
0.3%. However, the typical failure rate is estimated to be closer to
9%, due to late or
omitted pills. Table 1 lists the pregnancy rates for users of all
major methods of
contraception.
TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY
DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE
OF
CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE
FIRST
YEAR. UNITED STATES.
Method
(1)
% of Women Exper