LEVONORGESTREL AND ETHINYL ESTRADIOL tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Disponible depuis:

Actavis Pharma, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 Sour

Descriptif du produit:

Levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol are available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 round, white, flat face, beveled edge, uncoated tablets debossed with “295 ” on one side and “WATSON ” on the other side (NDC 0591-0295-28). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. References available upon request. Brands listed are the trademarks of their respective owners.  Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 11/2021

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL
ESTRADIOL TABLET
ACTAVIS PHARMA, INC.
----------
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP
90 MCG/20 MCG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT ORAL CONTRACEPTIVES DO NOT PROTECT
AGAINST
TRANSMISSION OF HIV (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES
(STDS)
SUCH AS CHLAMYDIA, GENITAL HERPES, GENITAL WARTS, GONORRHEA, HEPATITIS
B, AND
SYPHILIS.
DESCRIPTION
Twenty-eight (28) white tablets each containing 90 mcg of
levonorgestrel (17α)-(–)13-
ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally
synthetic progestogen,
and 20 mcg of ethinyl estradiol,
(17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol.
The inactive ingredients present are microcrystalline cellulose,
lactose monohydrate,
magnesium stearate, croscarmellose sodium, and povidone.
CLINICAL PHARMACOLOGY
MODE OF ACTION
Combination oral contraceptives act by suppression of gonadotropins.
Although the
primary mechanism of this action is inhibition of ovulation, other
alterations include
changes in the cervical mucus (which increase the difficulty of sperm
entry into the
uterus) and the endometrium (which reduce the likelihood of
implantation).
PHARMACOKINETICS
ABSORPTION
No specific investigation of the absolute bioavailability of
levonorgestrel and ethinyl
estradiol 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. Ethinyl
estradiol is rapidly and
almost completely absorbed from the gastrointestinal tract but, due to
first-pass
metabolism in gut mucosa and liver, the bioavailability of ethinyl
estradiol is between 38%
and 48%.
A summary of the single dose and multiple dose levonorgestrel and
ethinyl estradiol
pharmacokinetic parameters for 18 women under fasting conditions is
provided in Table
1. The plasma concentrations of levonorgestrel and ethinyl estradiol
reached steady-
state by approximately day 1