PLAN B- levonorgestrel tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Доступна з:

Physicians Total Care, Inc.

ІПН (Міжнародна Ім'я):

LEVONORGESTREL

Склад:

LEVONORGESTREL 0.75 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Plan B® is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet should be taken 12 hours later. Plan B is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Plan B is not indicated for routine use as a contraceptive. Plan B is contraindicated for use in the case of known or suspected pregnancy. Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects. In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, gro

Огляд продуктів:

Plan B (levonorgestrel) tablets, 0.75 mg, are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. The tablet is white, round and marked INOR on one side. Available as: Unit-of-use NDC 54868-4894-0 Store Plan B tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP].

Статус Авторизація:

New Drug Application

Характеристики продукта

PLAN B - LEVONORGESTREL TABLET
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PLAN
B SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PLAN B.
PLAN B (LEVONORGESTREL) TABLETS, 0.75MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
Plan B is a progestin-only emergency contraceptive, indicated for
prevention of pregnancy following unprotected
intercourse or a known or suspected contraceptive failure. Plan B is
available only by prescription for women younger than
age 17 years, and available over the counter for women 17 years and
older. Plan B is not intended for routine use as a
contraceptive. (1)
DOSAGE AND ADMINISTRATION
The first tablet is taken orally as soon as possible within 72 hours
after unprotected intercourse. The second tablet should
be taken 12 hours after the first dose. Efficacy is better if Plan B
is taken as soon as possible after unprotected intercourse.
(2)
DOSAGE FORMS AND STRENGTHS
A total of two 0.75 mg tablets taken 12 hours apart as a single course
of treatment (3)
CONTRAINDICATIONS
Known or suspected pregnancy. (4)
WARNINGS AND PRECAUTIONS
Ectopic Pregnancy: Women who become pregnant or complain of lower
abdominal pain after taking Plan B should be
evaluated for ectopic pregnancy. (5.1)
Plan B is not effective in terminating an existing pregnancy. (5.2 )
Effect on menses: Plan B may alter the next expected menses. If menses
is delayed beyond 1 week, pregnancy should
be considered. (5.3)
STI/HIV: Plan B does not protect against STI/HIV. (5.4)
ADVERSE REACTIONS
The most common adverse reactions (≥ 10%) in the clinical trial
included menstrual changes (26%), nausea (23%),
abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%)
and breast tenderness (11%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BARR LABORATORIES AT
1-800-330-1271 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Drugs or herbal products that induce certain enz