Thursday, May 13, 2010

What's new: Four-Phase Oral Contraceptive

FDA just approved a new oral contraceptive that provides four phases of estrogen–progestin therapy during the menstrual cycle - Natazia, which consists of estradiol valerate and the progestin dienogest. It also is the first contraceptive to contain the bioidentical synthetic estrogen estradiol valerate, rather than ethinyl estradiol.

The package contains five colored tablets over the course of 28 days:
a yellow tablet containing 3 mg of estradiol valerate on days 1 and 2,
a red tablet containing 2 mg of estradiol valerate and 2 mg of dienogest on days 3–7, a light yellow tablet containing 2 mg of estradiol valerate and 3 mg of dienogest on days 8–24,
a dark red tablet containing 1 mg of estradiol valerate on days 25 and 26,
and a white tablet containing inert ingredients on days 27 and 28.

As with other contraceptives, it warned against use in women who are pregnant or have undiagnosed abnormal genital bleeding, an estrogen- or progestin-sensitive cancer, liver tumors or disease, or a high risk for arterial or venous thrombotic diseases. The product's boxed warning advises against use of the oral contraceptive by women who smoke and are older than age 35 because of teh increased risk for cardiovascular events.

There is also advice against use in women taking drugs that are cytochrome P-450 isoenzyme 3A4 inducers.

Adverse events most commonly (≥2%) reported with estradiol valerate/dienogest use included headache, including migraines (13.2%); metrorrhagia and irregular menstruation (8.0%); breast pain, discomfort, or tenderness (6.6%); nausea/vomiting (6.5%); acne (3.9%); and weight gain (2.8%).

It would be marketed in the US.

The four-phase OC is available in Europe under a different brand - Qlaira.

Source:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm211176.htm
http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3332
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You can read more about oral contraceptive(OC) here and about different 'phasics' OC here.

Most of the OCs available locally are monophasic except for Trinordiol which is tri-phasic.

All OCs are by precription-only.

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