DESCRIPTION
LEVLITE® 28 tablets
Each cycle of LEVLITE® 28 (levonorgestrel and ethinyl estradiol tablets, USP) consists of 21 pink active tablets each containing 0.100 mg levonorgestrel and 0.020 mg ethinyl estradiol; and seven white tablets - inert. The inactive ingredients are Calcium Carbonate USP, Corn Starch NF, Ferric Oxide/red/E 172 NF, Ferric Oxide/yellow/E 172 NF, Glycerin 85% Ph. Eur./DAB, Lactose Monohydrate NF, Magnesium Stearate NF, Montanglycol Wax (Wax E) DAB, Polyethylene glycol 6,000 NF, Povidone 25,000 USP, Povidone 700,000 USP, Pregelatinized Starch NF (Modified Starch), Sucrose NF, Talc USP and Titanium Dioxide, E 171 USP. TRI-LEVLEN® 21 tablets
Each cycle of TRI-LEVLEN® 21 (Levonorgestrel and Ethinyl Estradiol Tablets--Triphasic Regimen) tablets consists of three different drug phases as follows: Phase 1 comprised of 6 brown film-coated tablets, each containing 0.050 mg of levonorgestrel (d)(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17(alpha)-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white film-coated tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and, phase 3 comprised of 10 light-yellow film-coated tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol. The inactive ingredients present are cellulose, iron oxides, lactose, magnesium stearate, polacrilin potassium, polyethylene glycol, titanium dioxide, and hydroxypropyl methylcellulose.
TRI-LEVLEN® 28 tablets
Each cycle of TRI-LEVLEN® 28 (Levonorgestrel and Ethinyl Estradiol Tablets--Triphasic Regimen) tablets consists of three different drug phases as follows: Phase 1 comprised of 6 brown film-coated tablets, each containing 0.050 mg of levonorgestrel (d)(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17 (alpha)-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white film-coated tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light-yellow film-coated tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 light-green film-coated inert tablets. The inactive ingredients present are cellulose, F D & C Blue 1, iron oxides, lactose, magnesium stearate, polacrilin potassium, polyethylene glycol, titanium dioxide, and hydroxypropyl methylcellulose.
LEVLEN® 21 tablets:
Each LEVLEN® 21 tablet (Levonorgestrel and Ethinyl Estradiol Tablets) contains 0.15 mg of levonorgestrel (d)(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol (19-nor-17 (alpha)-pregna-1,3,5(10)-trien-20-yne-3, 17-diol). The inactive ingredients present are cellulose, FD&C Yellow 6, lactose, magnesium stearate, and polacrillin potassium.
LEVLEN® 28 tablets:
21 light-orange LEVLEN® tablets (Levonorgestrel and Ethinyl Estradiol Tablets), each containing 0.15 mg of levonorgestrel (d)(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol (19-nor-17 (alpha)-pregna-1,3,5(10)-trien-20-yne-3, 17-diol), and 7 pink inert tablets. The inactive ingredients present are cellulose, D&C Red 30, FD&C Yellow 6, lactose, magnesium stearate, and polacrillin potassium.
Levonorgestrel has a molecular weight of 312.4 and a molecular formula of C21H28O2. Ethinyl estradiol has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows:
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