How Supplied
SLYND (drospirenone) tablets is packaged in clear to a slightly opaque PVC-PVDC/Aluminum blister cards. Each blister card holds 24 white round active film-coated tablets, each containing 4mg of drospirenone and 4 green round inert film-coated tablets that do not contain drospirenone. SLYND is supplied in cardboard cartons containing 1, 3, or 6 blister cards as provided below:
SLYND 1 blister card (1 � 28 tablets) NDC 0642-7470-01
SLYND 3 blister cards (3 � 28 tablets) NDC 0642-7470-03
SLYND 6 blister cards (6 � 28 tablets) NDC 0642-7470-06
16.2 Storage and Handling
Store at 25�C (77�F); excursions permitted from 15 to 30�C (59 to 86�F) [see USP Controlled Room Temperature]. These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND.
SLYND (drospirenone) tablets, for oral use
Initial U.S. Approval: 2001
INDICATIONS AND USAGE
SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
Take one tablet taken daily for 28 days; one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days. (2)
DOSAGE FORMS AND STRENGTHS
SLYND consists of 24 white tablets each containing 4 mg of drospirenone and 4 green inert tablets. (3)
CONTRAINDICATIONS
Renal impairment (4)
Adrenal insufficiency (4)
Presence or history of progestin sensitive cancers (4)
Liver tumors, benign or malignant, or hepatic impairment (4)
Undiagnosed abnormal uterine bleeding (4)
WARNINGS AND PRECAUTIONS
Hyperkalemia: Check serum potassium levels during the first treatment cycle in females receiving daily, long-term treatment for chronic conditions of diseases with medications that may increase serum potassium concentrations. (5.1)
Thromboembolic disorders: Discontinue SLYND if a thromboembolic event occurs. (5.2)
Bone loss: It is unknown if SLYND may cause a clinically relevant loss of bone mineral density. (5.3)
Liver Disease: Discontinue use if jaundice or acute or chronic disturbances of liver function develops. (5.5)
Ectopic pregnancy: Be alert to the possibility of ectopic pregnancy in females who become pregnant or complain of lower abdominal pain while on SLYND. (5.6)
Risk of Hyperglycemia in Patients with Diabetes: Patients with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring. (5.7)
Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes, such as pregnancy, if irregular bleeding or amenorrhea persists. (5.9)
ADVERSE REACTIONS
Most common adverse reactions (>1%) are: acne, metrorrhagia, headache, breast pain, weight increased, dysmenorrhea, nausea, vaginal hemorrhage, libido decreased, breast tenderness, menstruation irregular (6)
To report SUSPECTED ADVERSE REACTIONS, contact Exeltis USA, Inc. at 1-877-324-9349 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of SLYND or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with SLYND. (7.1)
USE IN SPECIFIC POPULATIONS
Pregnancy: Discontinue SLYND if pregnancy occurs (8.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2019
