NORETHINDRONE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Mylan Pharmaceuticals Inc.

INN (mednarodno ime):

NORETHINDRONE

Sestava:

NORETHINDRONE 0.35 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 CondomÞ    Female (fc) 21 5 41    Male 18 2 43 Diaphragmß 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 co

Povzetek izdelek:

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. Carton of 3 tri-laminated aluminium pouches (NDC 0378-7272-53), each pouch contains one blister pack of 28 tablets. 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. REFERENCE

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

NORETHINDRONE- NORETHINDRONE TABLET
MYLAN PHARMACEUTICALS 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. UNITE