Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)
REMEDYREPACK INC.
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. Method (1) % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year * Typical Use † (2) Perfect Use ‡ (3) (4) No method § 85 85 Spermicides ¶ 28 18 42 Fertility awareness-based methods 24 47 Standard Days method # 5 Two Day method # 4 Ovulation method # 3 Symptothermal # 0.4 Withdrawal 22 4 46 Sponge 36 Parous women 24 20 Nulliparous women 12 9 Condom Þ Female (fc) 21 5 41 Male 18 2 4
Norethindrone tablets USP, 0.35 mg are available in a blister pack containing 28 yellow, round, flat faced, beveled edge tablets, debossed 220 on one side and other side plain. NDC: 70518-3113-00 PACKAGING: 3 in 1 CARTON, 1 in 1 POUCH, 28 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep this and all medications out of the reach of children. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
NORETHINDRONE- NORETHINDRONE TABLET REMEDYREPACK INC. ---------- 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 NORETHINDRONE TABLETS, USP Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn starch, D&C Yellow No. 10, ethyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and talc. Meets USP Dissolution Test 2 CLINICAL PHARMACOLOGY 1. MODE OF ACTION Norethindrone tablets 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. Aqra d-dokument sħiħ