Jane S. Ricciuti, RPh, MS

Disclosures

September 20, 2002

In This Article

Oral Contraceptives

Ortho TriCyclen Lo
(0.180 mg of norgestimate and 0.025 mg of ethinyl estradiol)

Manufacturer: Ortho-McNeil Pharmaceutical Corporation

Drug Approval Classification: Original New Drug Application (Approval Date: 8/22/02)

Indication: Ortho TriCyclen Lo tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Dosing: Dialpak tablet dispenser:

Each of the 7 white tablets contains 0.180 mg of the progestational compound norgestimate, together with 0.025 mg of the estrogenic compound ethinyl estradiol.

  • Each of the 7 light-blue tablets contains 0.215 mg of the progestational compound norgestimate, together with 0.025 mg of the estrogenic compound ethinyl estradiol.

  • Each of the 7 dark-blue tablets contains 0.250 mg of the progestational compound norgestimate, together with 0.025 mg of the estrogenic compound ethinyl estradiol.

  • Each of the 7 green tablets contains inert ingredients.

  • Clinical Summary: In an active controlled clinical trial, 1673 subjects completed 11,003 cycles of Ortho TriCyclen Lo and a total of 20 pregnancies were reported in Ortho Tri-Cyclen Lo users. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 2.36 per 100 women-years of use.

    Ortho Tri Cyclen Lo Labeling

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