Unique Oral Contraceptives

Along with varying doses of ethinyl estradiol and different progestins, there are also formulation modifications that may benefit various patient situations. In the United States, these formulations include products such as Loestrin-24 Fe, Seasonale, Seaso-nique, Ortho Tri-Cyclen, Estrostep Fe, Yasmin, Yaz, Mircette, Ovcon 35, and Lybrel. Each of these products may show benefit in certain women owing to their unique characteristics.

Loestrin-24 Fe (norethindrone/ethinyl estradiol) is an extended cycle preparation which contains a low-dose estrogen, a high amount of progestin, and medium andro-genic activity. Similar to other low-dose estrogen combination OCs, Loestrin-24 Fe may offer a smaller margin of error when pills are missed but offers the potential advantage of fewer estrogen-related side effects (e.g., nausea and breast tenderness). Unlike the typical 28 pill packs which contain 21 active tablets and seven placebo tablets, Loestrin-24 Fe contains 24 active tablets and 4 placebo tablets, allowing for shorter menstrual periods and fewer menstrual-related symptoms, such as menstrual-related headaches, menorrhagia, and anemia.

Seasonale (levonorgestrel/ethinyl estradiol) is a mono phasic combination that is packaged as a 91-day treatment cycle with 84 active tablets that are taken consecutively followed by seven placebo tablets. The extended cycle length of this product allows for one menstrual cycle per "season," or four per year. This formulation may be appealing to women with perimenstrual side effects or those at higher risk for anemia with menstrual bleeding. Seasonale may improve anxiety, headache, fluid retention, dysmenorrhea, breast tenderness, bloating, and menstrual migraines. However, in the SEA 301 clinical trial comparing the efficacy of Seasonale with that of an equivalent-dosage 28-day cycle regimen, 7.7% versus 1.8% of women discontinued prematurely

for unacceptable bleeding. The risk of intermenstrual bleeding and/or spotting is

higher for patients taking Seasonale than for patients taking 28-day-regimen COCs.

Seasonique (levonorgestrel/ethinyl estradiol) is also an extended cycle preparation which is similar to Seasonale, but instead contains seven tablets with low-dose estrogen rather than placebo. Menstruation-related problems which may improve with Seasonique include menstrual-related headaches, menorrhagia, and anemia. In addi tion, endometriosis-related menstrual pain may be relieved by providing a continuous

regimen without a pill-free interval.

Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) and Estrostep Fe (norethindrone acetate/ethinyl estradiol) both have an approved indication for treatment of moderate acne vulgaris in females 15 years of age or older desiring contraception who have not responded adequately to conventional antiacne medication. This can help clinicians to streamline medications by serving dual purposes.

Yasmin and Yaz (drospirenone/ethinyl estradiol) are the only oral contraceptives that contain the progestin drospirenone. This hormone not only has antiandrogenic properties but also showed antimineralcorticoid activity in preclinical trials. It has a unique application in young women who experience problems associated with producing too much androgen. Drospirenone is a spironolactone analog, and the 3 mg dose available in Yasmin and Yaz has antimineralocorticoid activity equal to 25 mg spironolactone. It can affect the sodium and water balance in the body, although it has not shown superior efficacy for side effects such as bloating compared with other oral contraceptives. Caution should be used in women with chronic conditions or

other medications that may affect serum potassium. It is advised to check a baseline potassium level in patients at risk for hyperkalemia, such as those taking angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers. Yaz (drospirenone/ ethinyl estradiol) is an extended cycle preparation which contains a low-dose estrogen and antimineralocorticoid and antiandrogenic activity. Like Loestrin-24 Fe, Yaz contains 24 active tablets and four placebo tablets, allowing for shorter menstrual periods and fewer menstrual-related symptoms, such as menstrual-related headaches, menor-rhagia, and anemia.

Mircette (desogestrel/ethinyl estradiol) has a unique dosing schedule. After the usual 21 active tablets, there are only two tablets with inert ingredients. The last five tablets in the package have 10 mcg of ethinyl estradiol. In theory, this may minimize bleeding during the menstrual cycle, although the clinical significance of this dosing schedule has not been established.30 It is important to counsel patients to complete the entire pack and not to discard the last 7 days of medication.

Another unique formulation is a chewable tablet available to women who have difficulty swallowing medications. Ovcon 35 (norethindrone/ethinyl estradiol) has all 28

tablets in chewable form and has added spearmint flavoring.

Finally, Lybrel (levonorgestrel/ethinyl estradiol) is the first continuous cycle OC approved by the FDA. Active pills are taken every day throughout the year with no pill-free interval. The major advantage of this product is elimination of menstrual periods, resulting in improvement in or elimination of menstrual-related symptoms (e.g., headaches, menorrhagia, anemia, and endometriosis-related menstrual pain). The most bothersome side effect associated with Lybrel is a high incidence of spotting and breakthrough bleeding during the initial months of use. It appears as though the incidence of breakthrough bleeding with Lybrel decreases with continued use.3

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