LEVONORGESTREL AND ETHINYL ESTRADIOL kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals NY LLC

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table II: 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 First Year of Use % of Women Continuing Use at One Year* Method Typical Use† Perfect Use‡ (1) (2) (3) (4) Chance# 85 85 SpermicidesÞ 26 6 40 Periodic abstinence

Product summary:

Levonorgestrel and ethinyl estradiol tablets, USP, 0.1 mg/0.02 mg are available as follows: NDC  60219-1531-6                           Blister Pack of 28 Tablets 21 active tablets: white, round biconvex, film-coated tablet debossed with “C4” on one side. 7 inert tablets: yellow, round biconvex, film-coated tablet debossed with “C2” on one side. Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Made in Germany Distributed by: Amneal Pharmaceuticals of New York, LLC Brookhaven, NY 11719 Rev. 07-2023-04

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL
ESTRADIOL
AMNEAL PHARMACEUTICALS NY LLC
----------
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP
0.1 MG/0.02 MG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST
HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES (STDS)
SUCH AS
CHLAMYDIA, GENITAL HERPES, GENITAL WARTS, GONORRHEA, HEPATITIS B, AND
SYPHILIS.
DESCRIPTION
Each active, white tablet (21) contains 0.1 mg of levonorgestrel, USP,
d (-)-13β-ethyl-
17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic
progestogen, and 0.02 mg
of ethinyl estradiol, USP, 17α-ethinyl-1,3,5(10)-estratriene-3,
17β-diol. The inactive
ingredients present are lactose monohydrate, magnesium stearate,
microcrystalline
cellulose, polacrilin potassium and Aqua Polish White 014.17 MS which
contains
hydroxypropylcellulose, hydrogenated cottonseed oil,
hydroxypropylmethylcellulose,
talc, and titanium dioxide.
Each inactive, yellow tablet (7) contains the following inactive
ingredients: lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polacrilin potassium and
Aqua Polish Yellow 024.15 MS which contains hydroxypropylcellulose,
hydrogenated
cottonseed oil, hydroxypropylmethylcellulose, ferric oxide red, ferric
oxide yellow, talc,
and titanium dioxide.
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
es