NORETHINDRONE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Glenmark Pharmaceuticals Inc., USA

INN (שם בינלאומי):

NORETHINDRONE

הרכב:

NORETHINDRONE 0.35 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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:

leaflet_short:

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).

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

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