SLYND
SLYND- drospirenone
Exeltis USA, Inc.
1 INDICATIONS AND USAGE
SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy.
2 DOSAGE AND ADMINISTRATION
2.1 How to Use SLYND
SLYND is dispensed in a blister card. SLYND should be started using a Day 1 start.
Starting SLYND in females with no current use of hormonal contraception (Day 1 Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product.
Tablet Color: • SLYND active tablets are white (Day 1 to Day 24). • SLYND inert tablets are green (Day 25 to Day 28). | Day 1 Start: • Take first white active tablet on the first day of menses. • Take subsequent white active tablets once daily at the same time each day for a total of 24 days. • Take one green inert tablet daily for 4 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet). |
Switching from another contraceptive method to SLYND | Start SLYND:
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Refer to the Patient Information and Instructions for Use for additional instructions for counseling patient concerning proper use |
2.2 How to Take SLYND
SLYND (white active and green inert tablets) is swallowed whole once a day. Take one tablet daily for 28 consecutive days; one white active tablet daily during the first 24 days and one green inert tablet daily during the 4 following days. Tablets must be taken every day at about the same time of the day so that the interval between two tablets is always 24 hours.
2.3 Missed Doses
| Take the missed tablet as soon as possible. Continue taking one tablet a day until the pack is finished. |
| Take the last missed tablet as soon as possible. Continue one tablet a day until the pack is finished (one or more missed tablet(s) will remain in the blister pack). Additional non-hormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. |
| Skip the missed pill days and continue taking one tablet a day until the pack is finished. |
2.4 Advice in Case of Gastrointestinal Disturbances
If vomiting or diarrhea occurs within 3-4 hours after tablet taking, the new tablet (scheduled for the next day) should be taken as soon as possible. The new tablet should be taken within 12 hours of the usual time of tablet-taking if possible. If more than two tablets are missed, the advice concerning missed tablets, including using backup non-hormonal contraception, given above is applicable.
3 DOSAGE FORMS AND STRENGTHS
SLYND is supplied in blister cards, each containing 24 round, film-coated, unscored, white tablets and 4 round, film-coated, unscored green tablets.
- Each white tablet contains 4 mg of drospirenone. White tablets are debossed with an “E” on one side and a “D” on the other side
- Each green tablet is inert and does not contain drospirenone. Green tablets are debossed with an “E” on one side and a “4” on the other side.
4 CONTRAINDICATIONS
SLYND is contraindicated in females with the following conditions:
- Renal impairment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7)]
- Adrenal insufficiency [see Warnings and Precautions (5.1)]
- Presence or history of cervical cancer or progestin sensitive cancers [see Warnings and Precautions (5.4)]
- Liver tumors, benign or malignant, or hepatic impairment [see Warnings and Precautions (5.5) and Use in Specific Populations (8.6)]
- Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]
5 WARNINGS AND PRECAUTIONS
5.1 Hyperkalemia
SLYND contains drospirenone, a progestin, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to a 25 mg dose of spironolactone. SLYND is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Females receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration should have their serum potassium concentration checked prior to starting treatment and during the first treatment cycle. Consider monitoring serum potassium concentration in females at increased risk for hyperkalemia i.e., those females who take a strong CYP3A4 inhibitor long-term and concomitantly with SLYND. Strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin [ see Drug Interactions (7) ]. Monitor females taking SLYND who later develop medical conditions and/or begin medication that put them at an increased risk for hyperkalemia.
Most females with hyperkalemia in the clinical development studies of SLYND had mild potassium elevations and/or isolated increases that returned to normal while still on study medication. No concurrent adverse reactions were attributed to hyperkalemia. In the pivotal trial, two females (0.2%) with persistent potassium elevations discontinued SLYND.
5.2 Thromboembolic Disorders
Epidemiological studies have not indicated an association between progestin-only preparations and an increased risk of myocardial infarction, cerebral thromboembolism, or venous thromboembolism.
Combined oral contraceptives containing drospirenone and ethinyl estradiol may be associated with a higher risk of venous thromboembolism (VTE) than those containing some other progestins in combination with ethinyl estradiol. It is unknown whether the risk of VTE is increased with drospirenone alone; however, if there is a risk, it is expected to be lower than that of drospirenone in combination with ethinyl estradiol.
When prescribing SLYND, consider the increased risk of thromboembolism inherent in the postpartum period and in females with a history of thromboembolism
Discontinue SLYND if arterial or venous thromboembolic events occur. Consider discontinuing SLYND, if feasible, in case of SLYND prolonged immobilization due to surgery or illness.
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