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Skyla Generic Name & Formulations
Legal Class
Rx
General Description
Levonorgestrel 13.5mg; intrauterine system.
Pharmacological Class
Progestin IUD.
How Supplied
System—1
Manufacturer
Generic Availability
NO
Skyla Indications
Indications
Prevention of pregnancy for up to 3yrs.
Skyla Dosage and Administration
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 3yrs.
Children
Pre-menarche: not indicated.
Skyla Contraindications
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. Postpartum endometritis or infected abortion in past 3 months. Uterine or cervical neoplasia. Breast or other progestin-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.
Skyla Boxed Warnings
Not Applicable
Skyla Warnings/Precautions
Warnings/Precautions
Evaluate for ectopic pregnancy. 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 women recently given birth, who are breastfeeding, ≤6 weeks postpartum, if inserted in women with fixed retroverted or not completely involuted uteri. Consider removal if coagulopathy, migraine, transient cerebral ischemia, severe headache, marked increase in BP, severe arterial disease, uterine/cervical malignancy, jaundice, or symptomatic actinomycosis occurs. May be scanned with MRI under specific conditions. Nursing mothers.
Skyla Pharmacokinetics
See Literature
Skyla Interactions
Interactions
Caution with anticoagulants; consider removal.
Skyla Adverse Reactions
Adverse Reactions
Bleeding pattern alterations, vulvovaginitis, abdominal/pelvic pain, acne/seborrhea, ovarian cyst, headache/migraine, dysmenorrhea/uterine spasm; ectopic pregnancy, intrauterine pregnancy, sepsis, PID, perforation, expulsion.
Skyla Clinical Trials
See Literature
Skyla Note
Not Applicable
Skyla Patient Counseling
See Literature
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