SKYLA

Product Category

US FDA-Approved Medicine

Formulation

LEVONORGESTREL (13.5 mg). Intrauterine Device; sterile intrauterine system consisting of a T-shaped polyethylene frame with a steroid reservoir containing 13.5 mg levonorgestrel packaged within a sterile inserter. Release rate = 14 μg/day after 24 days and declines to 5 μg/day after 3 years. Reservoir is a mixture of levonorgestrel and silicone (PDMS) and is covered by a semi-opaque silicone membrane, composed of PDMS and colloidal silica. A ring composed of 99.95% pure silver is located at the top of the vertical stem close to the horizontal arms and is visible by ultrasound. The polyethyelene of the T-body is compounded with barium sulfate, which makes it radiopaque. A monofilament brown polyethylene removal thread (colored with iron oxide) is attached to a loop at the end of the vertical stem of the T-body.

Status

Prescription