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LILETTA
Contraception
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Drug Name:

LILETTA Rx

Generic Name and Formulations:
Levonorgestrel 52mg; intrauterine system (IUD).

Company:
Allergan

Therapeutic Use:

Indications for LILETTA:

Prevention of pregnancy for up to 4yrs.

Adult:

See full labeling. Insert into uterine cavity as directed. Reexamine and evaluate 4–6wks after insertion; then yearly or more if needed. Remove or replace after 4yrs.

Children:

Pre-menarche: not recommended.

Contraindications:

Post-coital contraception. Congenital or acquired uterine anomaly including fibroids. Acute or history of pelvic inflammatory disease (PID) unless there has been a subsequent intrauterine pregnancy. Acute endometritis. Infected abortion in past 3 months. Uterine or cervical neoplasia. Breast or other hormone-sensitive cancer. Uterine bleeding of unknown etiology. Untreated acute cervicitis or vaginitis. Active liver disease or tumor. Conditions associated with increased susceptibility to pelvic infections. Retained IUD. Pregnancy.

Warnings/Precautions:

History or risk of ectopic pregnancy. Assure suitable uterine anatomy before inserting. Risk of spontaneous abortion, miscarriage, sepsis, premature labor or delivery, congenital anomalies: remove if pregnant. Consider risks of PID before using. Bleeding pattern alterations: exclude endometrial pathology prior to insertion in women with persistent bleeding. Risk of perforation, expulsion and ovarian cysts. Increased risk of perforation in lactating women or if inserted in women with fixed retroverted uteri or during postpartum period; delay insertion a minimum ≥6wks, until involution is complete after delivery or a second trimester abortion. Breast cancer. Evaluate and consider patients' clinical conditions prior to use risk (eg, leukemia, AIDS, IV drug abuser). Anticoagulant therapy or coagulopathies. Cervical stenosis. Predisposition to syncope, bradycardia, other vasovagal reactions. Remove device if any of these occur: uterine or cervical perforation, embedment, pregnancy, symptomatic actinomycosis, pelvic infection, endometritis, any sign of expulsion. Consider removal if coagulopathy, migraine, transient cerebral ischemia, severe or frequent headache, marked increase in BP, severe arterial disease, uterine/cervical malignancy, or jaundice occurs. Nursing mothers.

Interactions:

Caution with anticoagulants; consider removal.

Pharmacological Class:

Progestin IUD.

Adverse Reactions:

Vaginal and vulvovaginal infections, acne, headache/migraine, nausea/vomiting, dyspareunia, abdominal pain, breast tenderness/pain, pelvic discomfort/pain, depression; irregular bleeding, ectopic pregnancy, sepsis, PID, perforation, expulsion, ovarian cysts.

How Supplied:

System—1

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