Label: TYDEMY- drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium kit

  • NDC Code(s): 68180-904-73, 68180-905-74, 68180-910-74
  • Packager: Lupin Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 16, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TYDEMY safely and effectively. See full prescribing information for TYDEMY. TYDEMY (drospirenone, ethinyl estradiol and levomefolate ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

    Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications (4)].

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  • 1 INDICATIONS AND USAGE
    1.1 Oral Contraceptive - TydemyTM is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Folate Supplementation - Tydemy is indicated in females of reproductive ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 How to Take Tydemy - Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets) is available in blister pack containing 28 tablets packed in a pouch. Such three pouches ...
  • 4 CONTRAINDICATIONS
    Tydemy is contraindicated in females who are known to have or develop the following conditions: Renal impairment - Adrenal insufficiency - A high risk of arterial or venous thrombotic ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Thromboembolic Disorders and Other Vascular Problems - Stop drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if an arterial or venous ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ...
  • 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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There is no use for contraception in pregnancy; therefore, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should ...
  • 10 OVERDOSAGE
    There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea. DRSP is a spironolactone ...
  • 11 DESCRIPTION
    Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - COCs lower the risk of becoming pregnant primarily by suppressing ovulation. 12.2 Pharmacodynamics - Drospirenone is a spironolactone analogue with ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 24 month oral carcinogenicity study in mice dosed with 10 mg/kg/day DRSP alone or - 1 + 0.01, 3 + 0.03 and 10 + 0.1 mg/kg/day of ...
  • 14 CLINICAL STUDIES
    14.1 Oral Contraceptive Clinical Trial - In the clinical efficacy studies of Yasmin® (3 mg DRSP/0.03 mg EE) of up to 2 years duration, 2,629 subjects completed 33,160 cycles of use without any ...
  • 15 REFERENCES
    US Preventive Services Task Force. Folic Acid for the Prevention of Neural Tube Defects: US Preventive Services Task Force Recommendation Statement. Ann Intern Med 2009;150:626-631. Seeger, J.D. ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets) is available in blister pack containing 28 tablets packed in a ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and ...
  • SPL PATIENT PACKAGE INSERT
    Guide for Using Tydemy™ (tye-DEM-ee) WARNING TO WOMEN WHO SMOKE - Do not use Tydemy if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Tydemy™ (drosperinone, ethinyl estradiol, and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg) Rx only - NDC 68180-904-71 - Blister Label: 28 ...
  • INGREDIENTS AND APPEARANCE
    Product Information