Label: SLYND- drospirenone kit

  • NDC Code(s): 0642-7470-01, 0642-7470-02
  • Packager: Exeltis USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 31, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND - ® (drospirenone) tablets, for oral use ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy.
  • 2 DOSAGE AND ADMINISTRATION
    2.1 How to Use SLYND - SLYND is dispensed in a blister card. SLYND should be started using a Day 1 start. Table 1 Instructions for Starting or Switching SLYND - Starting SLYND in females ...
  • 3 DOSAGE FORMS AND STRENGTHS
    SLYND is supplied in blister cards, each containing 24 round, film-coated, unscored, white tablets and 4 round, film-coated, unscored green tablets. Each white tablet contains 4 mg of ...
  • 4 CONTRAINDICATIONS
    SLYND is contraindicated in females with the following conditions: Renal impairment - [see - Warnings and Precautions (5.1) and - Use in Specific ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hyperkalemia - SLYND contains drospirenone, a progestin, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to a 25 mg dose ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in other sections of the labeling: Hyperkalemia - [see - Warnings and Precautions (5.1)] Bleeding ...
  • 7 DRUG INTERACTIONS
    Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. 7.1 Effects of other ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use oral ...
  • 10 OVERDOSAGE
    There have been no reports of serious deleterious effects from overdosage of SLYND. Symptoms that may occur include nausea, vomiting, and vaginal bleeding. There are no antidotes and treatment ...
  • 11 DESCRIPTION
    SLYND (drospirenone) is for use as an oral contraceptive. It is supplied as clear to a slightly opaque PVC-PVDC/Aluminum blister cards, each holding of 24 white tablets each containing 4 mg of ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - SLYND progestin-only oral contraceptive lowers the risk of becoming pregnant primarily by suppressing ovulation. 12.2 Pharmacodynamics - Drospirenone is a ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 24-month oral carcinogenicity study in mice with doses up to 10 mg/kg/day DRSP, equating to 2 times the maximum clinical exposure ...
  • 14 CLINICAL STUDIES
    Pregnancy Prevention - The efficacy of SLYND was evaluated in Study CF111/303 (NCT02269241). This single arm multicenter, clinical trial was conducted in the U.S. The efficacy population ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - SLYND (drospirenone) tablets is packaged in clear to a slightly opaque PVC-PVDC/Aluminum blister cards. Each blister card holds 24 white round active film-coated tablets, each ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved Patient Labeling (Patient Information and Instructions for Use). SLYND and Dosing Instructions - Advise females on proper daily use of SLYND and what ...
  • SPL UNCLASSIFIED SECTION
    Distributed by: Exeltis USA, Inc. Florham Park, NJ 07932 - © 2024 All rights reserved. Slynd is a registered trademark of Chemo Research SL
  • PATIENT INFORMATION SLYND (slind) (drospirenone) tablets, for oral use
    Progestin pills help to lower the chance of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs). What is ...
  • Instructions For Use SLYND (slind) (drospirenone) tablets, for oral use
    Important Information about taking SLYND - Before you start taking SLYND - Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the ...
  • PRINCIPAL DISPLAY PANEL - 4 mg Tablet Blister Card Carton
    NDC 0642-7470-01 - Rx only - Slynd - ® (drospirenone) tablets, 4 mg - 1 blister card with 28 tablets / Oral Use Exeltis - THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT ...
  • INGREDIENTS AND APPEARANCE
    Product Information