Taytulla

— THERAPEUTIC CATEGORIES —
  • Contraception
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Taytulla Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Norethindrone 1mg, ethinyl estradiol 20micrograms (24 soft gelatin caps); inert+ (4 soft gelatin caps); + contains ferrous fumarate 75mg.

    Pharmacological Class

    Progestin + estrogen.

    How Supplied

    Blister cards—5

    Manufacturer

    AbbVie

    Generic Availability

    NO

    Mechanism of Action

    Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

    Taytulla Indications

    Indications

    Oral contraception.

    Taytulla Dosage and Administration

    Adult

    1 cap daily for 28 days; repeat. Switching from other hormonal contraception: see full labeling.

    Children

    Premenarchal: not recommended.

    Administration

    Take at the same time every day. Sunday start: Take first active softgel cap on first Sunday after menstruation begins. If period begins on Sunday, take first active softgel cap that day. Take 1 active softgel cap daily for 24 days, then 1 maroon inactive softgel cap daily for 4 days; repeat. Use other contraception (condom, spermicide) for first 7 days of administration. Day 1 start: Start during the first 24hrs of menstruation. Take 1 active softgel cap daily for 24 days, then 1 maroon inactive softgel cap daily for 4 days. Missed dose: see full labeling.

    Nursing Considerations

    Take at the same time every day. Sunday start: Take first active softgel cap on first Sunday after menstruation begins. If period begins on Sunday, take first active softgel cap that day. Take 1 active softgel cap daily for 24 days, then 1 maroon inactive softgel cap daily for 4 days; repeat. Use other contraception (condom, spermicide) for first 7 days of administration. Day 1 start: Start during the first 24hrs of menstruation. Take 1 active softgel cap daily for 24 days, then 1 maroon inactive softgel cap daily for 4 days. Missed dose: see full labeling.

    Taytulla Contraindications

    Contraindications

    High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Undiagnosed abnormal uterine bleeding. Breast or other estrogen- or progestin-sensitive neoplasms. Hepatic disease or tumors. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

    Taytulla Boxed Warnings

    Boxed Warning

    Cigarette smoking and serious cardiovascular events.

    Taytulla Warnings/Precautions

    Warnings/Precautions

    Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Cardiovascular disease. Gallbladder disease. Pregnancy-related cholestasis. Diabetes. Prediabetes. Uncontrolled dyslipidemia. Hypertriglyceridemia. Depression. Hereditary angioedema. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea, retinal vein thrombosis. Cholasma gravidarum. Monitor blood pressure. Do regular complete physical exams. BMI >35kg/m2: not evaluated. May need non-hormonal contraception with Sunday starts or postpartum use (see full labeling). Pregnancy: discontinue if occurs. Postmenopausal women, nursing mothers: not recommended.

    Taytulla Pharmacokinetics

    Absorption

    Absolute bioavailability: ~64% (norethindrone); 43% (ethinyl estradiol). Steady-state was reached by Day 17 (for norethindrone) and by Day 13 (for ethinyl estradiol).

    Distribution

    Volume of distribution: 2–4 L/kg.

    Plasma protein bound: >95%.

    Metabolism

    Hepatic.

    Elimination

    Renal, fecal.

    Taytulla Interactions

    Interactions

    See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Taytulla prior to starting HCV regimen and restart 2wks after completion. May be antagonized by CYP3A4 or other enzyme inducers (eg, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, St. John’s wort); use backup contraception. May be potentiated by atorvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors (eg, itraconazole, ketoconazole). May be affected by HIV/HCV protease inhibitors or NNRTIs. May antagonize lamotrigine; adjust dose. May need dose adjustment of thyroid or cortisol hormones. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins, sex hormone binding globulins).

    Taytulla Adverse Reactions

    Adverse Reactions

    Headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, weight gain; breakthrough bleeding, amenorrhea, oligomenorrhea, cholasma, liver disease.

    Taytulla Clinical Trials

    See Literature

    Taytulla Note

    Not Applicable

    Taytulla Patient Counseling

    See Literature

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