SIMPESSE- levonorgestrel and ethinyl estradiol and ethinyl estradiol kit

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Aurobindo Pharma Limited

INN:

LEVONORGESTREL

composition:

LEVONORGESTREL 0.15 mg

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Simpesse® (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Simpesse is contraindicated in females who are known to have or develop the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include females who are known to:         –   Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)].         –   Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions (5.1)].         –   Have cerebrovascular disease [see Warnings and Precautions (5.1)]         –   Have coronary artery disease [see Warnings and Precautions (5.1)].         –   Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)].         –   Have inherited or acquired hypercoagulopathies [see Warnings and

leaflet_short:

How Supplied Simpesse tablets (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 Wallets, each containing a 13-week supply of tablets: 84 white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 light blue tablets each containing 0.01 mg of ethinyl estradiol. The white tablets are round, biconvex, beveled-edge, debossed with “S” on one side and “27” on other side. The light blue tablets are mottled, round, biconvex, beveled-edge, debossed with “S” on one side and “45” on other side.             Pouch of 1 Extended-Cycle Wallet                  NDC 65862-864-94             Carton of 2 Pouches                                         NDC 65862-864-95 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

authorization_status:

Abbreviated New Drug Application

SPC

SIMPESSE- LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIMPESSE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIMPESSE.
SIMPESSE (LEVONORGESTREL/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._
SIMPESSE 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.
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 01/2023
Warnings and Precautions, Malignant Neoplasms (5.11) 04/2022
INDICATIONS AND USAGE
Simpesse is 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
Simpesse consists of 84 white tablets containing 0.15 mg
levonorgestrel and 0.03 mg ethinyl estradiol,
and 7 light blue tablets containing 0.01 mg ethinyl estradiol. (3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop if a thrombotic or thromboembolic event occurs.
Stop at least 4 weeks before and
through 2 weeks after major surgery. Start no earlier than 4 weeks
after delivery, in women who are not
breastfeeding. Consider cardiovascular risk factors before initiating
in all fem