ENPRESSE- levonorgestrel and ethinyl estradiol kit

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Teva Pharmaceuticals USA, Inc.

INN (Isem Internazzjonali):

LEVONORGESTREL

Kompożizzjoni:

LEVONORGESTREL 0.050 mg

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD Method Perfect Use Typical Use Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Depo-Provera® (injectable progestogen) 0.3 0.3 Oral contraceptives 5              Combined 0.1 NA              Progestin only 0.5 NA IUD              Progesterone 1.5 2.0              Copper T 380A 0.6 0.8 Condom (male) without spermicide 3 14 (female) without sp

Sommarju tal-prodott:

Enpresse® (levonorgestrel and ethinyl estradiol tablets USP – triphasic regimen), are available in packages of six cyclic dispensers. Each cycle contains 28 round tablets as follows: six pink, round, film-coated, biconvex tablets debossed with dp on one side and 510 on the other side, each containing 0.050 mg levonorgestrel and 0.030 mg ethinyl estradiol; five white, round, film-coated, biconvex tablets debossed with dp on one side and 511 on the other side, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; ten orange, round, film-coated, biconvex tablets debossed with dp on one side and 512 on the other side, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol and seven light-green, round, inert tablets debossed with dp on one side and 519 on the other side. NDC: 0555-9047-58 References available upon request. Store at  20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Brands listed are the trademarks of their respective owners. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. E 9/2022

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ENPRESSE- LEVONORGESTREL AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
----------
ENPRESSE
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP – TRIPHASIC
REGIMEN)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Each Enpresse (levonorgestrel and ethinyl estradiol tablets USP –
triphasic regimen)
cycle of 28 tablets consists of three different drug phases as
follows: Phase 1
comprised of 6 pink tablets, each containing 0.050 mg of
levonorgestrel (d(-)-13 beta-
ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally
synthetic progestogen,
and 0.030 mg of ethinyl estradiol
(19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol);
phase 2 comprised of 5 white tablets, each containing 0.075 mg
levonorgestrel and
0.040 mg ethinyl estradiol; and phase 3 comprised of 10 orange
tablets, each containing
0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed
by 7 light-green
inert tablets. The inactive ingredients present are hypromellose,
lactose monohydrate,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
and pregelatinized
corn starch. Coloring agents used are as follows: pink, 0.050 mg/0.030
mg tablets: D&C
Yellow No. 10 Aluminum Lake and D&C Red No. 7 Calcium Lake; white,
0.075 mg/0.040
mg tablets: none; orange, 0.125 mg/0.030 mg tablets: FD&C Yellow No. 6
Aluminum
Lake, 38-42%; and light-green, inert tablets: D&C Yellow No. 10
Aluminum Lake, FD&C
Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.
LEVONORGESTREL, USP MW: 312.45 MF: C
H O
ETHINYL ESTRADIOL, USP MW: 296.40 MF: C
H O
®
®
21
28
2
20
24
2
CLINICAL PHARMACOLOGY
Mechanism of Action
Combination oral contraceptives prevent pregnancy primarily by
suppressing ovulation.
INDICATIONS AND USAGE
Oral contraceptives are indicated for the prevention of pregnancy in
women who elect to
use this product as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical
accidental p