Ethinyldrug info
168 HR ethinyl estradiol 0.000417 MG/HR / levonorgestrel 0.00167 MG/HR Transdermal System [Twirla]
What it is used for
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitation of Use Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m 2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m 2. TWIRLA is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitation of Use Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m 2 before prescribing.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 30, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
TWIRLA (levonorgestrel and ethinyl estradiol) transdermal system (TDS) contains 2.60 mg levonorgestrel (LNG) (17α)-(–) [13-ethyl-17¬hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one], a progestin, and 2.30 mg ethinyl estradiol (EE), [(17α)-19-norpregna-1, 3, 5-trien-20-yne-3, 17-diol] an estrogen (Figure 3). Figure 3. Structural Formulas TWIRLA is designed to provide daily exposure of 40 mcg LNG and 10 mcg EE. TWIRLA is a matrix type TDS consisting of a 15 cm 2 active adhesive laminate center, surrounded by a peripheral inactive adhesive laminate. The entire area of TWIRLA is 28 cm 2. TWIRLA consists of 5 layers and a release liner which is removed and discarded prior to application. The two innermost layers contain the active ingredients (LNG and EE), as well as inactive components. Proceeding from the outer surface toward the surface adhering to the skin, the layers are a woven peripheral backing layer, which is etched with “TWIRLA Levonorgestrel 40 mcg/day Ethinyl Estradiol 10 mcg/day”; an inactive peripheral acrylic adhesive layer; an inactive peripheral polyisobutylene adhesive layer; an internal membrane to separate the active adhesive matrix from the inactive adhesive laminate; the active adhesive matrix (Figure 4). Figure 4. Schematic Depiction of the TWIRLA TDS The inactive components are acrylic adhesives, capric acid, copovidone, crospovidone, dimethyl sulfoxide, ethyl lactate, lauryl lactate, polybutene, polyester internal membrane, polyester release liner, polyisobutylene adhesives, and woven polyester backing membrane. TWIRLA is not made with latex. figure-2 figure-3
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 30, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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