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Levonorgestrel

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Overview

What is LILETTA?

LILETTA (levonorgestrel-releasing intrauterine system) contains 52 mg of levonorgestrel, a progestin, and is intended to provide an initial release rate of 19.5 mcg/day of levonorgestrel.

Levonorgestrel USP, (-)-13-ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, the active ingredient in LILETTA, has a molecular weight of 312.45, a molecular formula of CHO, and the following structural formula:



What does LILETTA look like?



What are the available doses of LILETTA?

LILETTA is a levonorgestrel-releasing intrauterine system consisting of a T-shaped polyethylene frame with a drug reservoir containing 52 mg levonorgestrel, packaged within a sterile inserter.

What should I talk to my health care provider before I take LILETTA?

How should I use LILETTA?

LILETTA is indicated for prevention of pregnancy for up to 4 years. The system should be replaced after 4 years if continued use is desired.

Release rate of levonorgestrel (LNG) is 19.5 mcg/day initially and declines progressively to approximately 17.0 mcg/day at 1 year, 14.8 mcg/day at 2 years, 12.9 mcg/day at 3 years and 11.3 mcg/day at 4 years after insertion; LILETTA can be removed at any time but must be removed by the end of the fourth year. ()

To be inserted by a trained healthcare provider using strict aseptic technique. Follow insertion instructions exactly as described. ()

Patient should be re-examined and evaluated 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. ()


What interacts with LILETTA?

Sorry No Records found


What are the warnings of LILETTA?

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What are the precautions of LILETTA?

Sorry No Records found


What are the side effects of LILETTA?

Sorry No records found


What should I look out for while using LILETTA?

The use of LILETTA is contraindicated when one or more of the following conditions exist:


What might happen if I take too much LILETTA?

Sorry No Records found


How should I store and handle LILETTA?

Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.LILETTA (levonorgestrel-releasing intrauterine system), containing 52 mg levonorgestrel, is packaged together with an inserter in a peelable pouch, and is available in a carton of one sterile unit. NDC # 52544-035-54. LILETTA is supplied sterile. LILETTA is sterilized with ethylene oxide. Do not resterilize. For single use only. Do not use if the inner pouch is damaged or opened. Insert before the end of the month shown on the pouch. Store at 20 – 25°C (68 – 77°F), with excursions permitted between 15 – 30°C (59 – 86°F) [See USP Controlled Room Temperature]. Store pouch in outer carton until use to protect from light.LILETTA (levonorgestrel-releasing intrauterine system), containing 52 mg levonorgestrel, is packaged together with an inserter in a peelable pouch, and is available in a carton of one sterile unit. NDC # 52544-035-54. LILETTA is supplied sterile. LILETTA is sterilized with ethylene oxide. Do not resterilize. For single use only. Do not use if the inner pouch is damaged or opened. Insert before the end of the month shown on the pouch. Store at 20 – 25°C (68 – 77°F), with excursions permitted between 15 – 30°C (59 – 86°F) [See USP Controlled Room Temperature]. Store pouch in outer carton until use to protect from light.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The local mechanism by which continuously released LNG provides contraception has not been conclusively demonstrated. Studies of LNG-releasing IUSs suggest several mechanisms for pregnancy prevention: prevention of fertilization due to the thickening of the cervical mucus, which inhibits sperm passage through the cervix, and inhibition of sperm mobility and function (capacitation), and alteration of the endometrium.

Non-Clinical Toxicology
The use of LILETTA is contraindicated when one or more of the following conditions exist:

The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

Evaluate women for ectopic pregnancy if they become pregnant with LILETTA in place because the likelihood of a pregnancy being ectopic is increased with LILETTA. Approximately half of pregnancies that occur with LILETTA in place are likely to be ectopic. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed periods or if an amenorrheic woman starts bleeding. If an ectopic pregnancy is confirmed, LILETTA should be removed.

The incidence of ectopic pregnancy in the clinical trial with LILETTA, which excluded women with a history of ectopic pregnancy who did not have a subsequent intrauterine pregnancy, was approximately 0.16 per 100 women-years. The risk of ectopic pregnancy in women who have a history of ectopic pregnancy and use LILETTA is unknown. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection have a higher risk of ectopic pregnancy. Ectopic pregnancy may require surgery and may result in loss of fertility.

Tell women who choose LILETTA about the risks of ectopic pregnancy, including the loss of fertility. Teach them to recognize and report to their healthcare provider promptly any signs of ectopic pregnancy.

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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