Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)
Aurobindo Pharma Limited
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Διαβάστε το πλήρες έγγραφο