Yaz

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  • Acne
  • Contraception
  • Mood disorders
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

    • Yaz Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Drospirenone 3mg, ethinyl estradiol 20micrograms (24 tabs); inert (4 tabs).

    Pharmacological Class

    Progestin + estrogen.

    How Supplied

    Packs—3

    Manufacturer

    Bayer Corporation

    Generic Availability

    YES

    Mechanism of Action

    Lowers risk of becoming pregnant by primarily suppressing ovulation. Cervical mucus changes may inhibit sperm penetration. Endometrial changes reduce likelihood of implantation.

    Yaz Indications

    Indications

    Moderate acne vulgaris in females ≥14 years of age, who have no known contraindications to oral contraceptive therapy, have achieved menarche, and desire contraception.

    Yaz Dosage and Administration

    Adult

    1 tab daily for 28 days; repeat.

    Children

    Premenarche: not recommended.

    Administration

    Take on first day of menstrual period (Day 1 Start) or on the first Sunday after the onset of menstrual period (Sunday Start). Should be taken in the order directed on the package.

    Nursing Considerations

    Take on first day of menstrual period (Day 1 Start) or on the first Sunday after the onset of menstrual period (Sunday Start). Use non-hormonal back-up contraceptive during first 7 days. In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3–4 hours after tablet-taking, this can be regarded as a missed tablet.

    Yaz Contraindications

    Contraindications

    Renal impairment. Adrenal insufficiency. 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). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

    Yaz Boxed Warnings

    Boxed Warning

    Cigarette smoking increases risk of serious cardiovascular events.

    Yaz Warnings/Precautions

    Warnings/Precautions

    Increased risk of cardiovascular events (eg, stroke, MI) 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. Hyperkalemia or risk thereof. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. History of depression; monitor and discontinue if serious depression recurs. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Pregnancy: discontinue if occurs. Nursing mothers: use other methods of contraception until breastfeeding is discontinued.

    Yaz Pharmacokinetics

    Absorption

    • Absolute bioavailability: ~76% (drospirenone); ~40% (ethinyl estradiol).

    • Serum concentrations of drospirenone and ethinyl estradiol reached peak levels within 1–2 hours after administration.

    Distribution

    • Apparent volume of distribution: 4 L/kg (drospirenone); 4–5 L/kg (ethinyl estradiol).

    • Drospirenone binds about 97% to other serum proteins. Ethinyl estradiol is bound to serum albumin approximately 98.5%.

    Metabolism

    Hepatic (CYP3A4)

    Elimination

    Fecal, renal.

    Yaz Interactions

    Interactions

    See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Yaz prior to starting HCV regimen and restart 2wks after completion. Monitor serum K+ during 1st cycle with drugs that increase potassium (eg, ACE inhibitors, ARBs, NSAIDs, K+-sparing diuretics, K+ supplements, heparin, aldosterone antagonists); consider monitoring in high-risk patients taking concomitant long-term strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, indinavir, boceprevir, clarithromycin). May be antagonized by CYP3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate) (use backup contraception). May be affected by pro­tease inhibitors, NNRTIs, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.

    Yaz Adverse Reactions

    Adverse Reactions

    Headache/migraine, menstrual irregularities, metrorrhagia, nausea, vomiting, breast pain/tenderness, mood changes, headache, fatigue, irritability, decreased libido, increased weight, affect lability; hypertension, chloasma, serious thromboembolic events, liver disease.

    Yaz Clinical Trials

    See Literature

    Yaz Note

    Not Applicable

    Yaz Patient Counseling

    See Literature

    Yaz Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Drospirenone 3mg, ethinyl estradiol 20micrograms (24 tabs); inert (4 tabs).

    Pharmacological Class

    Progestin + estrogen.

    How Supplied

    Packs—3

    Manufacturer

    Bayer Corporation

    Generic Availability

    YES

    Mechanism of Action

    Lowers risk of becoming pregnant by primarily suppressing ovulation. Cervical mucus changes may inhibit sperm penetration. Endometrial changes reduce likelihood of implantation.

    Yaz Indications

    Indications

    Oral contraception.

    Yaz Dosage and Administration

    Adult

    1 tab daily for 28 days; repeat.

    Children

    Premenarche: not recommended.

    Administration

    Take on first day of menstrual period (Day 1 Start) or on the first Sunday after the onset of menstrual period (Sunday Start). Should be taken in the order directed on the package.

    Nursing Considerations

    Take on first day of menstrual period (Day 1 Start) or on the first Sunday after the onset of menstrual period (Sunday Start). Use non-hormonal back-up contraceptive during first 7 days. In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3–4 hours after tablet-taking, this can be regarded as a missed tablet.

    Yaz Contraindications

    Contraindications

    Renal impairment. Adrenal insufficiency. 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). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

    Yaz Boxed Warnings

    Boxed Warning

    Cigarette smoking increases risk of serious cardiovascular events.

    Yaz Warnings/Precautions

    Warnings/Precautions

    Increased risk of cardiovascular events (eg, stroke, MI) 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. Hyperkalemia or risk thereof. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. History of depression; monitor and discontinue if serious depression recurs. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Pregnancy: discontinue if occurs. Nursing mothers: use other methods of contraception until breastfeeding is discontinued.

    Yaz Pharmacokinetics

    Absorption

    • Absolute bioavailability: ~76% (drospirenone); ~40% (ethinyl estradiol).

    • Serum concentrations of drospirenone and ethinyl estradiol reached peak levels within 1–2 hours after administration.

    Distribution

    • Apparent volume of distribution: 4 L/kg (drospirenone); 4–5 L/kg (ethinyl estradiol).

    • Drospirenone binds about 97% to other serum proteins. Ethinyl estradiol is bound to serum albumin approximately 98.5%.

    Metabolism

    Hepatic (CYP3A4)

    Elimination

    Fecal, renal.

    Yaz Interactions

    Interactions

    See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Yaz prior to starting HCV regimen and restart 2wks after completion. Monitor serum K+ during 1st cycle with drugs that increase potassium (eg, ACE inhibitors, ARBs, NSAIDs, K+-sparing diuretics, K+ supplements, heparin, aldosterone antagonists); consider monitoring in high-risk patients taking concomitant long-term strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, indinavir, boceprevir, clarithromycin). May be antagonized by CYP3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate) (use backup contraception). May be affected by pro­tease inhibitors, NNRTIs, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.

    Yaz Adverse Reactions

    Adverse Reactions

    Headache/migraine, menstrual irregularities, metrorrhagia, nausea, vomiting, breast pain/tenderness, mood changes, headache, fatigue, irritability, decreased libido, increased weight, affect lability; hypertension, chloasma, serious thromboembolic events, liver disease.

    Yaz Clinical Trials

    See Literature

    Yaz Note

    Not Applicable

    Yaz Patient Counseling

    See Literature

    Yaz Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Drospirenone 3mg, ethinyl estradiol 20micrograms (24 tabs); inert (4 tabs).

    Pharmacological Class

    Progestin + estrogen.

    How Supplied

    Packs—3

    Manufacturer

    Bayer Corporation

    Generic Availability

    YES

    Mechanism of Action

    Lowers risk of becoming pregnant by primarily suppressing ovulation. Cervical mucus changes may inhibit sperm penetration. Endometrial changes reduce likelihood of implantation.

    Yaz Indications

    Indications

    Treatment of premenstrual dysphoric disorder in women who choose an oral contraceptive as the method of birth control.

    Yaz Dosage and Administration

    Adult

    1 tab daily for 28 days; repeat.

    Children

    Premenarche: not recommended.

    Administration

    Take on first day of menstrual period (Day 1 Start) or on the first Sunday after the onset of menstrual period (Sunday Start). Should be taken in the order directed on the package.

    Nursing Considerations

    Take on first day of menstrual period (Day 1 Start) or on the first Sunday after the onset of menstrual period (Sunday Start). Use non-hormonal back-up contraceptive during first 7 days. In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3–4 hours after tablet-taking, this can be regarded as a missed tablet.

    Yaz Contraindications

    Contraindications

    Renal impairment. Adrenal insufficiency. 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). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

    Yaz Boxed Warnings

    Boxed Warning

    Cigarette smoking increases risk of serious cardiovascular events.

    Yaz Warnings/Precautions

    Warnings/Precautions

    Increased risk of cardiovascular events (eg, stroke, MI) 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. Hyperkalemia or risk thereof. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. History of depression; monitor and discontinue if serious depression recurs. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Pregnancy: discontinue if occurs. Nursing mothers: use other methods of contraception until breastfeeding is discontinued.

    Yaz Pharmacokinetics

    Absorption

    • Absolute bioavailability: ~76% (drospirenone); ~40% (ethinyl estradiol).

    • Serum concentrations of drospirenone and ethinyl estradiol reached peak levels within 1–2 hours after administration.

    Distribution

    • Apparent volume of distribution: 4 L/kg (drospirenone); 4–5 L/kg (ethinyl estradiol).

    • Drospirenone binds about 97% to other serum proteins. Ethinyl estradiol is bound to serum albumin approximately 98.5%.

    Metabolism

    Hepatic (CYP3A4)

    Elimination

    Fecal, renal.

    Yaz Interactions

    Interactions

    See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Yaz prior to starting HCV regimen and restart 2wks after completion. Monitor serum K+ during 1st cycle with drugs that increase potassium (eg, ACE inhibitors, ARBs, NSAIDs, K+-sparing diuretics, K+ supplements, heparin, aldosterone antagonists); consider monitoring in high-risk patients taking concomitant long-term strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, indinavir, boceprevir, clarithromycin). May be antagonized by CYP3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate) (use backup contraception). May be affected by pro­tease inhibitors, NNRTIs, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.

    Yaz Adverse Reactions

    Adverse Reactions

    Headache/migraine, menstrual irregularities, metrorrhagia, nausea, vomiting, breast pain/tenderness, mood changes, headache, fatigue, irritability, decreased libido, increased weight, affect lability; hypertension, chloasma, serious thromboembolic events, liver disease.

    Yaz Clinical Trials

    See Literature

    Yaz Note

    Not Applicable

    Yaz Patient Counseling

    See Literature

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