AMETHYST- levonorgestrel and ethinyl estradiol tablet

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:

Teva Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amethyst™ (levonorgestrel and ethinyl estradiol tablets) is 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 contrace

Product summary:

Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP), 90 mcg levonorgestrel, USP and 20 mcg ethinyl estradiol, USP, is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows: 28 white, round, flat-faced, beveled edge tablets, debossed with “Y45 ” on one side and “TV ” on the other side (NDC 0480-3472-24). 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. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 1/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMETHYST- LEVONORGESTREL AND ETHINYL ESTRADIOL TABLET
TEVA PHARMACEUTICALS, INC.
----------
AMETHYST™
(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, USP (17α)-
(–)13-ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally
synthetic
progestogen, and 20 mcg of ethinyl estradiol, USP
(17α)-19-norpregna-1,3,5(10)-trien-
20-yne-3,17-diol. The inactive ingredients present are croscarmellose
sodium, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, and
povidone.
Levonorgestrel, USP
C
H
O M.W. 312.45
21
28
2
Ethinyl Estradiol, USP
C
H
O M.W. 296.40
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
Amethyst™ 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 an