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Syeda Generic Name & Formulations
Legal Class
Rx
General Description
Drospirenone 3mg, ethinyl estradiol 30micrograms (21 tabs); inert (7 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—3
Manufacturer
Syeda Indications
Indications
Oral contraception.
Syeda Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Pre-menarche: not applicable.
Syeda 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. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Syeda Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Syeda 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). Nursing mothers: not recommended.
Syeda Pharmacokinetics
See Literature
Syeda Interactions
Interactions
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Syeda 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.
Syeda Adverse Reactions
Adverse Reactions
Premenstrual syndrome, headache/migraine, breast pain/tenderness/discomfort, nausea, vomiting, abdominal pain/tenderness/discomfort, mood changes; depression, pulmonary embolism, toxic skin eruption, uterine leiomyoma, serious thromboembolic events.
Syeda Clinical Trials
See Literature
Syeda Note
Not Applicable
Syeda Patient Counseling
See Literature
