ORTHO MICRONOR® TABLETS (NORETHINDRONE)

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Janssen Pharmaceuticals, Inc.

INN (इंटरनेशनल नाम):

NORETHINDRONE

रचना:

NORETHINDRONE 0.35 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. ORTHO MICRONOR® 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 - It's best to take your first POP on the first day of your menstrual period (Day 1 Start). If you use a Day 1 Start, you are protected from becoming pregnant as soon as you take your first pill. - If you decide to tak

उत्पाद समीक्षा:

ORTHO MICRONOR® (0.35 mg norethindrone) Tablets are available in a single pouch containing a VERIDATE® blister card (refill) of 28 tablets (NDC 50458-194-28). The blister card contains 28 lime green, round, flat faced, beveled edge tablets, imprinted "ORTHO 0.35" on both sides. ORTHO MICRONOR® Tablets are packaged in a carton containing 6 pouches and 6 unfilled VERIDATE® Tablet Dispensers (NDC 50458-194-06). ORTHO MICRONOR® (0.35 mg norethindrone) Tablets are also available for clinic usage in a VERIDATE® Tablet Dispenser (unfilled) and VERIDATE® refills (NDC 50458-194-23 and NDC 50458-194-12). ORTHO MICRONOR® (0.35 mg norethindrone) Tablets are available in a DIALPAK® Tablet Dispenser (unfilled) and DIALPAK® refills (NDC 50458-194-00 and NDC 50458-194-16). STORAGE: Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F). Keep out of reach of children.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

ORTHO MICRONOR- NORETHINDRONE TABLET
JANSSEN PHARMACEUTICALS, INC.
----------
ORTHO MICRONOR
TABLETS
(NORETHINDRONE)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
ORTHO MICRONOR 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
ORTHO MICRONOR 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.
% OF WOMEN EXPERIENCING AN
UN