ASHLYNA- levonorgestrel and ethinyl estradiol and ethinyl estradiol kit

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Glenmark Pharmaceuticals Inc., USA

ІПН (Міжнародна Ім'я):

LEVONORGESTREL

Склад:

LEVONORGESTREL 0.15 mg

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Ashlyna is indicated for use by females of reproductive potential to prevent pregnancy. Ashlyna is contraindicated in females who are known to have or develop the following conditions: Risk Summary There is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. Risk Summary Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastf

Огляд продуктів:

Ashlyna® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) are available in extended-cycle tablet dispensers, each containing a 13-week supply of tablets: 84 light blue to blue tablets, each containing 0.15 mg of levonorgestrel, USP and 0.03 mg ethinyl estradiol, USP and 7 light yellow to yellow tablets, each containing 0.01 mg of ethinyl estradiol, USP. The light blue to blue tablets are round, film-coated, biconvex, unscored tablets debossed with ‘E1’ on one side. The light yellow to yellow tablets are round, biconvex, film-coated, unscored tablets debossed with ‘D8’ on one side. 1 carton containing 2 individual pouches. Inside each pouch is 1 extended-cycle tablet dispenser containing 84 light blue to blue tablets and 7 light yellow to yellow tablets NDC 68462-646-93 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

ASHLYNA- LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASHLYNA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASHLYNA.
ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL
ESTRADIOL TABLETS), FOR
ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 01/2023
Warnings and Precautions, Malignant Neoplasms (5.2) 04/2022
INDICATIONS AND USAGE
Ashlynais a combination of levonorgestrel, a progestin, and ethinyl
estradiol, an estrogen, indicated for
use by females of reproductive potential to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day for 91 days
in the order directed on the blister
pack. (2)
DOSAGE FORMS AND STRENGTHS
Ashlyna (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15
mg/0.03 mg and Ethinyl Estradiol
Tablets, USP 0.01 mg) consists of 84 light blue to blue tablets
containing 0.15 mg levonorgestrel, USP and
0.03 mg ethinyl estradiol, USP and 7 light yellow to yellow tablets
containing 0.01 mg ethinyl estradiol,
USP. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
ASHLYNA IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE.
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE.
®
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer (4)
Liver tumors or liver disease, acute viral hepatitis or decompensated
cirrhosis (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir (4)
Vascular risks: Stop if a thrombotic or thromboembolic event occurs.
S