Beyaz

— THERAPEUTIC CATEGORIES —
  • 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

    • Beyaz Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Drospirenone 3mg, ethinyl estradiol (as betadex clathrate) 20micrograms, levomefolate calcium 0.451mg (24 pink tabs); levomefolate calcium 0.451mg (4 light orange tabs).

    Pharmacological Class

    Progestin + estrogen + folate.

    How Supplied

    Packs—3

    Manufacturer

    Bayer Corporation

    Mechanism of Action

    Combination oral contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

    Beyaz Indications

    Indications

    Moderate acne vulgaris in women ≥14 years old who choose an oral contraceptive for contraception.

    Beyaz Dosage and Administration

    Adult

    1 tablet daily for 28 days; repeat. Take at the same time daily. Use Day 1 or Sunday start for 1st cycle; use backup method for first 7 days. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle.

    Children

    Pre-menarche: not applicable.

    Beyaz 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 thromboembolism, 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.

    Beyaz Boxed Warnings

    Boxed Warning

    Cigarette smoking increases risk of serious cardiovascular events.

    Beyaz Warnings/Precautions

    Warnings/Precautions

    Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, jaundice, or severe migraine 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. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Pregnancy: avoid; discontinue use during pregnancy. Nursing mothers: not recommended; if possible, use alternative methods of contraception.

     

    Beyaz Pharmacokinetics

    Absorption

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

    • Peak levels of drospirenone and ethinyl estradiol are reached within 1–2 hours after administration.

    Distribution

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

    • ~97% serum protein bound (drospirenone); ~98.5% serum protein bound (ethinyl estradiol).

    Metabolism

    • Hepatic (CYP3A4). 

    Elimination

    • Fecal, renal.
    • Half-life: ~30 hours (drospirenone); ~24 hours (ethinyl estradiol).

    Beyaz Interactions

    Interactions

    See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Beyaz 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. May mask vitamin B12 deficiency (folate).

    Beyaz Adverse Reactions

    Adverse Reactions

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

    Beyaz Clinical Trials

    See Literature

    Beyaz Note

    Not Applicable

    Beyaz Patient Counseling

    See Literature

    Beyaz Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Drospirenone 3mg, ethinyl estradiol (as betadex clathrate) 20micrograms, levomefolate calcium 0.451mg (24 pink tabs); levomefolate calcium 0.451mg (4 light orange tabs).

    Pharmacological Class

    Progestin + estrogen + folate.

    How Supplied

    Packs—3

    Manufacturer

    Bayer Corporation

    Mechanism of Action

    Combination oral contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

    Beyaz Indications

    Indications

    Oral contraception. To raise folate levels in women who choose to use an oral contraceptive for contraception.

    Beyaz Dosage and Administration

    Adult

    1 tablet daily for 28 days; repeat. Take at the same time daily. Use Day 1 or Sunday start for 1st cycle; use backup method for first 7 days. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle.

    Children

    Pre-menarche: not applicable.

    Beyaz 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 thromboembolism, 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.

    Beyaz Boxed Warnings

    Boxed Warning

    Cigarette smoking increases risk of serious cardiovascular events.

    Beyaz Warnings/Precautions

    Warnings/Precautions

    Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, jaundice, or severe migraine 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. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Pregnancy: avoid; discontinue use during pregnancy. Nursing mothers: not recommended; if possible, use alternative methods of contraception.

     

    Beyaz Pharmacokinetics

    Absorption

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

    • Peak levels of drospirenone and ethinyl estradiol are reached within 1–2 hours after administration.

    Distribution

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

    • ~97% serum protein bound (drospirenone); ~98.5% serum protein bound (ethinyl estradiol).

    Metabolism

    • Hepatic (CYP3A4). 

    Elimination

    • Fecal, renal.
    • Half-life: ~30 hours (drospirenone); ~24 hours (ethinyl estradiol).

    Beyaz Interactions

    Interactions

    See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Beyaz 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. May mask vitamin B12 deficiency (folate).

    Beyaz Adverse Reactions

    Adverse Reactions

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

    Beyaz Clinical Trials

    See Literature

    Beyaz Note

    Not Applicable

    Beyaz Patient Counseling

    See Literature

    Beyaz Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Drospirenone 3mg, ethinyl estradiol (as betadex clathrate) 20micrograms, levomefolate calcium 0.451mg (24 pink tabs); levomefolate calcium 0.451mg (4 light orange tabs).

    Pharmacological Class

    Progestin + estrogen + folate.

    How Supplied

    Packs—3

    Manufacturer

    Bayer Corporation

    Mechanism of Action

    Combination oral contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

    Beyaz Indications

    Indications

    Premenstrual dysphoric disorder (PMDD) in women who choose an oral contraceptive for contraception.

    Beyaz Dosage and Administration

    Adult

    1 tablet daily for 28 days; repeat. Take at the same time daily. Use Day 1 or Sunday start for 1st cycle; use backup method for first 7 days. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle.

    Children

    Pre-menarche: not applicable.

    Beyaz 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 thromboembolism, 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.

    Beyaz Boxed Warnings

    Boxed Warning

    Cigarette smoking increases risk of serious cardiovascular events.

    Beyaz Warnings/Precautions

    Warnings/Precautions

    Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, jaundice, or severe migraine 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. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Pregnancy: avoid; discontinue use during pregnancy. Nursing mothers: not recommended; if possible, use alternative methods of contraception.

     

    Beyaz Pharmacokinetics

    Absorption

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

    • Peak levels of drospirenone and ethinyl estradiol are reached within 1–2 hours after administration.

    Distribution

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

    • ~97% serum protein bound (drospirenone); ~98.5% serum protein bound (ethinyl estradiol).

    Metabolism

    • Hepatic (CYP3A4). 

    Elimination

    • Fecal, renal.
    • Half-life: ~30 hours (drospirenone); ~24 hours (ethinyl estradiol).

    Beyaz Interactions

    Interactions

    See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Beyaz 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. May mask vitamin B12 deficiency (folate).

    Beyaz Adverse Reactions

    Adverse Reactions

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

    Beyaz Clinical Trials

    See Literature

    Beyaz Note

    Not Applicable

    Beyaz Patient Counseling

    See Literature

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