Generic Name and Formulations:
Drospirenone 3mg, ethinyl estradiol 20micrograms (24 tabs); inert (4 tabs).
Company:
Bayer Healthcare Pharmaceuticals Inc.
Moderate acne vulgaris in females ≥14 years of age, who have no known contraindications to oral contraceptive therapy, have achieved menarche, and desire contraception.
1 tab daily for 28 days; repeat.
Not applicable.
Progestin + estrogen.
Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Renal, hepatic, or adrenal insufficiency. Severe hypertension. Valvular heart disease. Diabetes with vascular involvement. Headaches with focal neurological symptoms. Major surgery with prolonged immobilization. Heavy smoking (>15 cigarettes per day) and over age 35. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X).
Hypertriglyceridemia. Discontinue if thrombotic events, jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see literature). Monitor K+ during 1st cycle if risk of hyperkalemia. Nursing mothers: not recommended.
Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. Potentiated by ascorbic acid, acetaminophen, itraconazole, ketoconazole. Plasma concentrations may increase or decrease with concomitant HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors. May affect measurement of sex hormone-binding globulin levels. Monitor K+ during 1st cycle with drugs that increase potassium (eg, ACE inhibitors, angiotensin receptor blockers, NSAIDs, K+ sparing diuretics).
Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.
Hepatic (CYP3A4)
Fecal, renal.
YES
Packs—3
Oral contraception.
1 tab daily for 28 days; repeat.
Not applicable.
Progestin + estrogen.
Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Renal, hepatic, or adrenal insufficiency. Severe hypertension. Valvular heart disease. Diabetes with vascular involvement. Headaches with focal neurological symptoms. Major surgery with prolonged immobilization. Heavy smoking (>15 cigarettes per day) and over age 35. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X).
Hypertriglyceridemia. Discontinue if thrombotic events, jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see literature). Monitor K+ during 1st cycle if risk of hyperkalemia. Nursing mothers: not recommended.
Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. Potentiated by ascorbic acid, acetaminophen, itraconazole, ketoconazole. Plasma concentrations may increase or decrease with concomitant HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors. May affect measurement of sex hormone-binding globulin levels. Monitor K+ during 1st cycle with drugs that increase potassium (eg, ACE inhibitors, angiotensin receptor blockers, NSAIDs, K+ sparing diuretics).
Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.
Hepatic (CYP3A4)
Fecal, renal.
YES
Packs—3
Treatment of premenstrual dysphoric disorder in women who choose an oral contraceptive as the method of birth control.
1 tab daily for 28 days; repeat.
Not applicable.
Progestin + estrogen.
Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Renal, hepatic, or adrenal insufficiency. Severe hypertension. Valvular heart disease. Diabetes with vascular involvement. Headaches with focal neurological symptoms. Major surgery with prolonged immobilization. Heavy smoking (>15 cigarettes per day) and over age 35. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X).
Hypertriglyceridemia. Discontinue if thrombotic events, jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see literature). Monitor K+ during 1st cycle if risk of hyperkalemia. Nursing mothers: not recommended.
Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. Potentiated by ascorbic acid, acetaminophen, itraconazole, ketoconazole. Plasma concentrations may increase or decrease with concomitant HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors. May affect measurement of sex hormone-binding globulin levels. Monitor K+ during 1st cycle with drugs that increase potassium (eg, ACE inhibitors, angiotensin receptor blockers, NSAIDs, K+ sparing diuretics).
Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.
Hepatic (CYP3A4)
Fecal, renal.
YES
Packs—3