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Levonorgestrel and Ethinyl Estradiol
Overview
What is SETLAKIN?
SETLAKIN (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen , and 7 white inert tablets (without hormones).
The structural formulas for the active components are:
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17 )-, (-)-.
Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17 )-.
● Each pink active tablet contains the following inactive ingredients: polyvinyl alcohol,titanium dioxide,talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake,lactose, magnesium stearate, pregelatinized corn starch and microcrystalline cellulose
● Each white inert tablet contains the following inactive ingredients: titanium dioxide,polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose,magnesium stearate and pregelatinized corn starch.
What does SETLAKIN look like?
What are the available doses of SETLAKIN?
SETLAKIN (levonorgestrel and ethinyl estradiol tablets) are available as round, coated, biconvex, unscored tablets, packaged in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets in the following order:
● 84 pink tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol; with a debossed "S1" on one side
● 7 white inert tablets debossed with "P" on one side and "" on the other side.
What should I talk to my health care provider before I take SETLAKIN?
● Nursing Mothers: Advise use of another contraceptive method. SETLAKIN can decrease milk production. ()
How should I use SETLAKIN?
SETLAKIN is an estrogen/progestin COC indicated for use by women to prevent pregnancy. ()
SETLAKIN is dispensed in an Extended-Cycle Tablet Dispenser
SETLAKIN should be started on a Sunday (see ). 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 SETLAKIN once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, SETLAKIN should be taken exactly as directed and at intervals not exceeding 24 hours. For patient instructions regarding missed pills, see .
What interacts with SETLAKIN?
Sorry No Records found
What are the warnings of SETLAKIN?
Sorry No Records found
What are the precautions of SETLAKIN?
Sorry No Records found
What are the side effects of SETLAKIN?
Sorry No records found
What should I look out for while using SETLAKIN?
● A high risk of arterial or venous thrombotic diseases ()
● Liver tumors or liver disease ()
● Undiagnosed abnormal uterine bleeding ()
● Pregnancy ()
● Breast cancer or other estrogen- or progestin-sensitive cancer ()
● Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ()
What might happen if I take too much SETLAKIN?
There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
How should I store and handle SETLAKIN?
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
Non-Clinical Toxicology
● A high risk of arterial or venous thrombotic diseases ()● Liver tumors or liver disease ()
● Undiagnosed abnormal uterine bleeding ()
● Pregnancy ()
● Breast cancer or other estrogen- or progestin-sensitive cancer ()
● Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ()
Use COCs with caution in women with cardiovascular disease risk factors.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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