Slynd

— THERAPEUTIC CATEGORIES —
  • Contraception
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Slynd Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Drospirenone 4mg (24 tabs); inert (4 tabs).

    Pharmacological Class

    Progestin.

    How Supplied

    Packs—1, 3, 6

    How Supplied

    Slynd™ (drospirenone) tablets are supplied in cardboard cartons containing 1, 3, or 6 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. 

    • Each white tablet contains 4mg of drospirenone, and is debossed with an “E” on one side and a “D” on the other side.

    • Each green tablet is inert, and is debossed with an “E” on one side and a “4” on the other side.

    Storage

    Store at 25°C (77°F); excursions permitted from 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

    Manufacturer

    Exeltis USA, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Drospirenone is a spironolactone analogue with antimineralocorticoid properties. Its mechanism of action is primarily by suppressing ovulation, thereby lowering the risk of pregnancy.

    Slynd Indications

    Indications

    Oral contraception.

    Slynd Dosage and Administration

    Adult

    Swallow whole. 1 tab daily for 28 days; repeat.

    Adult

    Slynd should be started using a Day 1 start. Swallow whole once a day at the same time of the day (interval between 2 tablets should be 24 hours). Take 1 tablet daily for 28 consecutive days; 1 white active tablet daily during the first 24 days and 1 green inert tablet daily during the 4 following days.

    Starting Slynd

    • For females with no current use of hormonal contraception: use Day 1 start. Take the first white active tablet on the first day of menses then subsequent white tablets at the same time each day for 24 days. Then take 1 green inert tablet daily for 4 days. 

    Switching from another contraceptive method

    • Combined oral contraceptive (COC): Start Slynd on the day when the new pack of the previous COC would have started.

    • Transdermal patch: Start Slynd on the day when next application would have been scheduled.

    • Vaginal ring: Start Slynd on the day when next insertion would have been scheduled.

    • Injection: Start Slynd on the day when next injection would have been scheduled.

    • Intrauterine contraceptive or Implant: Start Slynd on the day of removal.

    Missed Doses

    • If 1 white tablet is missed: take the missed tablet as soon as possible and continue until the pack is finished.

    • If 2 or more white tablets are missed: take the last missed tablet as soon as possible and continue until the pack is finished. Use additional non-hormonal contraception (eg, condoms or spermicide) as back-up if having sex within 7 days after missing tablets.

    • If 1 or more green tablets are missed: skip the missed tablet and continue until the pack is finished.

    Children

    Pre-menarche: not applicable.

    Other Modifications

    Advice in Case of GI Disturbances

    • If vomiting or diarrhea occurs within 3 to 4 hours after taking tablet, take the new tablet (scheduled for the next day) as soon as possible.

    • Take the new tablet within 12 hours of the usual time of tablet-taking if possible.

    Slynd Contraindications

    Contraindications

    Renal impairment. Adrenal insufficiency. Presence or history of progestin sensitive cancers. Liver tumors (benign or malignant). Hepatic impairment. Undiagnosed abnormal uterine bleeding.

    Slynd Boxed Warnings

    Not Applicable

    Slynd Warnings/Precautions

    Warnings/Precautions

    Hyperkalemia or risk thereof. History of thromboembolism. Discontinue if thromboembolic event, jaundice, or liver dysfunction occurs. Consider discontinuing if prolonged immobilization due to surgery or illness. Bone loss. Diabetes. Evaluate for other causes if irregular uterine bleeding or amenorrhea persists. History of depression; monitor and discontinue if serious depression recurs. Postpartum period. Pregnancy: discontinue if occurs.

    Warnings/Precautions

    Hyperkalemia

    • Slynd has the potential for hyperkalemia in high-risk females. Drospirenone is comparable to a 25mg dose of spironolactone. 

    • Females with conditions that predispose to hyperkalemia: see Contraindications.

    • Check serum potassium concentration prior to initiating treatment and during the first cycle in females receiving treatment for chronic conditions of disease with medications that may increase serum potassium concentrations. 

    • Consider monitoring serum potassium concentration in females at increased risk for hyperkalemia (eg, strong CYP3A4 inhibitors).

    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.

    • It is unknown whether the risk for VTE is increased with drospirenone alone, but the risk is expected to be lower than combined oral contraceptives containing drospirenone and ethinyl estradiol.

    • Consider the increased risk for thromboembolism when prescribing Slynd to females in the postpartum period and with a history of thromboembolism.

    • Discontinue if arterial or venous thromboembolic events occur. Consider discontinuing Slynd if possible in the case of prolonged immobilization due to surgery or illness.

    Bone Loss

    • Slynd causes decreased estradiol serum levels, but it is unknown if this leads to a clinically relevant loss of bone mineral density.

    Cervical Cancer

    • There may be an increased risk for cervical cancer or intraepithelial neoplasia.

    Liver Disease

    • Discontinue if jaundice or acute/chronic disturbances of liver function develop.

    • Do not resume use until liver function returns to normal and Slynd causation has been excluded.

    Ectopic Pregnancy

    • Be alert for the possibility of ectopic pregnancy in females who become pregnant or complain of lower abdominal pain during treatment.

    Risk of Hyperglycemia in Patients with Diabetes 

    • Risk for decreased insulin sensitivity. 

    • Diabetic patients may have a greater risk for hyperglycemia and may require medication adjustments or monitoring.

    Bleeding Irregularities and Amenorrhea

    • Breakthrough bleeding and spotting may occur esp. during the first 3 months of use.

    • Consider the possibility of pregnancy if scheduled bleeding does not occur. Consider the possibility of pregnancy at the time of the first missed period and perform diagnostic measures if the patient has not adhered to the prescribed dosing schedule.

    Depression

    • Monitor carefully in females with a history of depression and discontinue if depression recurs to a serious degree.

    Pregnancy Considerations

    Risk Summary

    • Discontinue if pregnancy occurs.

    Nursing Mother Considerations

    Risk Summary

    • Negligible amounts of drospirenone are excreted in the breast milk. In general, no adverse effects have been found on milk production or on the health growth, or development of the infant.

    Pediatric Considerations

    Use of Slynd before menarche is not indicated.

    Geriatric Considerations

    Not studied in postmenopausal females and is not indicated in this population.

    Renal Impairment Considerations

    Contraindicated in females with renal impairment.

     

    Hepatic Impairment Considerations

    Contraindicated in females with hepatic impairment.

    Slynd Pharmacokinetics

    Absorption

    Maximum plasma concentrations of about 27ng/mL are reached at about 2 to 6 hours after a single dose.

    Maximum steady-state concentrations in serum of about 41ng/mL are reached after about 10 days of treatment.

    Distribution

    95% to 97% serum albumin bound. Apparent volume of distribution: ~4 L/kg.

    Metabolism

    Drospirenone is extensively metabolised by reduction and subsequent sulfation after oral administration, and is also subject to oxidative metabolism catalyzed by CYP3A4.

    Elimination

    Terminal disposition phase half-life: ~30 hours. Excretion of drospirenone was nearly complete after 10 days and amounts excreted were slightly higher in feces compared to urine.

    Slynd Interactions

    Interactions

    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, aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, St. John's wort); use backup or alternative method of contraception.

    Slynd Adverse Reactions

    Adverse Reactions

    Acne, metrorrhagia, headache, breast pain, weight increased, dysmenorrhea, nausea, vaginal hemorrhage, libido decreased, breast tenderness, menstruation irregular; serious thromboembolic events, ectopic pregnancy.

    Slynd Clinical Trials

    Clinical Trials

    Pregnancy Prevention

    • The efficacy of Slynd in preventing pregnancy was evaluated in a single arm trial involving 953 female patients ≤35 years of age with 5547 evaluable cycles. Study findings showed that during these cycles, 1.8% of patients (n=17) reported pregnancy, resulting in a Pearl Index of 4.0 (95% CI: 2.3-6.4).

    Slynd Note

    Not Applicable

    Slynd Patient Counseling

    Patient Counseling

    Slynd™ and Dosing Instructions

    • Advise on the proper use of Slynd and what to do with missed doses. 

    • Inform that amenorrhea may occur and check for pregnancy if 2 consecutive periods are missed.

    Counsel patients on the following information:

    • Advise that serum potassium levels should be checked during the first treatment cycle in females receiving treatment for chronic conditions of disease with medications that may increase serum potassium concentrations.

    Use during Pregnancy

    • Do not use Slynd during pregnancy.

    Drug Interactions

    • Consult a healthcare provider if taking herbal supplements (eg, St John’s wort).

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