Setlakin
Generic name:levonorgestrel and ethinyl estradiol
Dosage form: tablets
Drug class:Contraceptives
Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (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 are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4)].
Indications and Usage for Setlakin
SetlakinTM (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.
Setlakin Dosage and Administration
How to Start SetlakinTM
SetlakinTM is dispensed in an Extended-Cycle Tablet Dispenser [see How Supplied/Storage and Handling (16)]. SetlakinTM should be started on a Sunday (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
Instruct patients to take SetlakinTM once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, SetlakinTM should be taken exactly as directed and at intervals not exceeding 24 hours. For patient instructions regarding missed pills, see FDA-approved patient labeling