NEXT CHOICE- levonorgestrel tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Rebel Distributors Corp.

Designación común internacional (DCI):

LEVONORGESTREL

Composición:

LEVONORGESTREL 0.75 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Levonorgestrel tablets are a prescription-only emergency contraceptive, for women age 17 and younger, that can be used to prevent pregnancy following unprotected intercourse or a known or suspected contraceptive failure. This product is not approved for nonprescription use. To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet must be taken 12 hours later. Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the levonorgestrel tablets regimen consisting of the emergency use of two progestin pills. POPs however, are not recommended for use in the following conditions: - Known or suspected pregnancy Known or suspected pregnancy - Hypersensitivity to any component of the product Hypersensitivity to any component of the product There is no information about dependence assoc

Resumen del producto:

Levonorgestrel Tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced embossed with “475” on one side and “WATSON” on the other side. Available as: Unit-of-use NDC 0591-0475-36 Store levonorgestrel 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]. *The following are registered trademarks of their respective manufacturers: Reality® is manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera® is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant® is manufactured by and a registered trademark of Population Council; Ovral® , Alesse® , Triphasil® and Lo Ovral® /Wyeth Pharmaceuticals, Inc.; Nordette® /Duramed Pharmaceuticals, Inc.; Levlen® and Tri- Levlen® /Bayer Healthcare. Watson Laboratories, Inc . Corona, CA 92880 USA Phone: [phone] 14816-3 Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

NEXT CHOICE - LEVONORGESTREL TABLET
REBEL DISTRIBUTORS CORP.
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LEVONORGESTREL TABLETS, 0.75 MG
PHYSICIAN LABELING
LEVONORGESTREL TABLETS, 0.75 MG
RX ONLY FOR WOMEN AGE 17 AND YOUNGER
THIS PRODUCT IS NOT APPROVED FOR NONPRESCRIPTION USE.
Levonorgestrel tablets are a prescription–only emergency
contraceptive for women age 17 and
younger. This product is not approved for nonprescription use.
Levonorgestrel tablets are intended to
prevent pregnancy after known or suspected contraceptive failure or
unprotected intercourse.
Emergency contraceptive pills (like all oral contraceptives) do not
protect against infection with HIV
(the virus that causes AIDS) and other sexually transmitted diseases.
DESCRIPTION
Emergency contraceptive tablet. Each levonorgestrel tablet contains
0.75 mg of a single active steroid
ingredient, levonorgestrel
[18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17α)-(-)-],
a
totally synthetic progestogen. The inactive ingredients present are
colloidal silicon dioxide, corn
starch, FD&C Yellow #6, magnesium stearate, povidone, and lactose
monohydrate. Levonorgestrel has
a molecular weight of 312.45, and the following structural and
molecular formulas:
C H O
CLINICAL PHARMACOLOGY
Emergency contraceptives are not effective if the woman is already
pregnant. Levonorgestrel tablets
are believed to act as an emergency contraceptive principally by
preventing ovulation or fertilization
(by altering tubal transport of sperm and/or ova). In addition, they
may inhibit implantation (by altering the
endometrium). They are not effective once the process of implantation
has begun.
PHARMACOKINETICS
21
28
2
_Absorption_
No specific investigation of the absolute bioavailability of
levonorgestrel tablets in humans has been
conducted. However, literature indicates that levonorgestrel is
rapidly and completely absorbed after
oral administration (bioavailability about 100%) and is not subject to
first pass metabolism. After a
single dose of levonorgestrel tablets (0.75 mg) administered to 16
women und