Jolivette® (norethindrone) Tablets

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Actavis Pharma, Inc.

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 0.5%. 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

leaflet_short:

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.

מצב אישור:

New Drug Application

מאפייני מוצר

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