국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)
Actavis Pharma, Inc.
NORETHINDRONE
NORETHINDRONE 0.35 mg
ORAL
PRESCRIPTION DRUG
Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 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. Table 1 lists the pregnancy rates for users of all major methods of contraception. Jolivette ® Tablets have not been studied for and are not indicated for use in emergency contraception. Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: - Known or suspected pregnancy - Known or suspected carcinoma of the breast - Undiagnosed abnormal genital bleeding - Hypersensitivity to any component of this product - Benign or malignant liver tumors - Acute liver disease 1. Open the compact. Place the blister into the compact, with the tablets facing up, so that the V notch in the blister card matches up with the V-shaped post at the top of the compact. Press down firmly on each edge of t
Jolivette® is available in a blister card (NDC 52544-892-28) with a tablet dispenser (unfilled). The blister card contains 28 lime green tablets. Each lime green, round, flat-faced, beveled edge tablet contains 0.35 mg norethindrone and is imprinted WATSON on one side and 892 on the other side. Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F). Keep out of reach of children.
New Drug Application
JOLIVETTE- NORETHINDRONE TABLET ACTAVIS PHARMA, INC. ---------- JOLIVETTE (NORETHINDRONE) TABLETS PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION JOLIVETTE TABLETS Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, modified corn starch, and povidone. NORETHINDRONE Meets USP Dissolution Test 2 CLINICAL PHARMACOLOGY 1. MODE OF ACTION Jolivette 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 0.5%. However, the typical failure rate is estimated to be closer to 5%, 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. % OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY WITHIN THE 전체 문서 읽기