Drospirenone (21 brand names, 2 dosage forms, 2 routes)
Available dosage forms: TABLET, TABLET, CHEWABLE.
Routes of administration: ORAL, ORAL-28.
Brand Names
- ANGELIQ
- BEYAZ
- DROSPIRENONE
- DROSPIRENONE AND ESTRADIOL
- DROSPIRENONE AND ETHINYL ESTRADIOL
- DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
- KEMEYA
- KYRA
- LO-ZUMANDIMINE
- LORYNA
- MELAMISA
- NEXTSTELLIS
- NIKKI
- SAFYRAL
- SLYND
- SYEDA
- TYDEMY
- YAELA
- YASMIN
- YAZ …and 1 more
Boxed Warning
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications (4)].
Contraindications
Vestura is contraindicated in females who are known to have or develop the following conditions: Renal impairment Adrenal insufficiency A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )] Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )] Have coronary artery disease [see Warnings and Precautions ( 5.1 )] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ( 5.1)] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )] Have uncontrolled hypertension [see Warnings and Precautions ( 5.6 )] Have diabetes mellitus with vascular disease [see Warnings and Precautions ( 5.8 )] Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions ( 5.9 )] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions ( 5.10 )] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions ( 5.3 )] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions ( 5.4 ) and Use in Specific Populations ( 8.7 )] Use of Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir due to the potential for ALT elevations [see Warnings and Precautions ( 5.5 ) and Drug Interactions ( 7.3 )].
Adverse Reactions
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.4 )]
Drug Interactions
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Mechanism of Action
COCs lower the risk of becoming pregnant primarily by suppressing ovulation.
Overdosage
There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea. DRSP is a spironolactone analogue which has anti-mineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.