Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)
Glenmark Pharmaceuticals Inc., USA
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 0.3%. 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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year Method (1) Typical Use (2) Perfect Use (3) (4) No method4 85 85 Spermicides 28 18 42 Fertility awareness-based methods 24 47 Standard Days method6 5 TwoDay method6 4 Ovulation method6 3 Symptothermal method6 0.4 Withdrawal 22 4 46 Sponge 36 Parous women 24 20 Nulliparous women 12 9 Condom7 Female (fc) 21 5 41 Male 18 2 43 Diaphragm8 12 6 57 Combined pill and progestin-only pill 9 0.3 67 Norelgestromin and ethinyl estradiol patch 9 0.3 67 NuvaRing 9 0.3 67 Depo-Provera 6 0.2 56 Intrauterine contraceptives ParaGard (copper T) 0.8 0.6 78 Mirena (LNg) 0.2 0.2 80 Implanon 0.05 0.05 84 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.10 100 Notes: Norethindrone 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:
Norethindrone tablets, USP 0.35 mg are available in 28-tablet dispensers as light yellow to yellow round, flat faced beveled edged, uncoated tablets with ‘305’ debossed on one side and a ‘G’ on the other side. Carton of 3 Dispensers each containing 28 tablets (NDC 68462-305-29).
Abbreviated New Drug Application
NORETHINDRONE- NORETHINDRONE TABLET GLENMARK PHARMACEUTICALS INC., USA ---------- NORETHINDRONE TABLETS, USP 0.35 MG PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION Each tablet contains 0.35 mg norethindrone, USP. Inactive ingredients include colloidal silicon dioxide, corn starch, D&C Yellow No. 10, ethyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, methylene chloride, isopropyl alcohol and talc. CLINICAL PHARMACOLOGY 1. MODE OF ACTION Norethindrone 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 FIR Preberite celoten dokument