Lo Minastrin, (norethindrone acetate, ethinyl estradiol, ferrous fumarate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved July 2013

Specific Treatments:

prevention of pregnancy

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General Information

Lo Minastrin Fe (norethindrone acetate and ethinyl estradiol chewable tablets, ethinyl estradiol tablets and ferrous fumarate tablets) is an estrogen/progestin combined oral contraceptive. It works primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Lo Minastrin Fe is specifically indicated for use by women to prevent pregnancy.

Lo Minastrin is supplied as tablets for oral administration. Lo Minastrin Fe adminitration should begin on Day 1 of the menstrual cycle (that is, the first day of her menstrual bleeding). One blue tablet should be taken daily for 24 consecutive days, followed by one white tablet daily for 2 consecutive days, followed by one brown tablet daily for 2 consecutive days. To achieve maximum contraceptive effectiveness, Lo Minastrin Fe must be taken exactly as directed. The blue tablet should be chewed and swallowed. The patient should drink a full glass (8 ounces) of water immediately after chewing and swallowing the blue tablet. The white tablet and the brown tablet are swallowed.

Clinical Results

FDA Approval
The FDA approval of Lo Minastrin FE was based on results from a clinical trial conducted with norethindrone acetate 1 mg/ethinyl estradiol 10 mcg tablets and ethinyl estradiol 10 mcg tablets. Lo Minastrin Fe is bioequivalent to these norethindrone acetate/ethinyl estradiol tablets and ethinyl estradiol tablets. In a one year (thirteen 28-day cycles) multicenter open-label clinical trial, 1,270 women 18 to 35 years of age, were studied to assess the efficacy of norethindrone acetate/ethinyl estradiol tablets and ethinyl estradiol tablets, completing the equivalent of 12,482 28-day evaluable cycles of exposure. The pregnancy rate (Pearl Index [PI]) in women 18 to 35 years of age was 2.92 pregnancies per 100 women-years of use, based on 28 pregnancies that occurred after the onset of treatment and extending through the 7 days following the last dose of norethindrone acetate/ethinyl estradiol tablets and ethinyl estradiol tablets. The PI includes women who did not take the pill correctly.

Side Effects

Adverse events associated with the use of Lo Minastrin Fe may include, but are not limited to, the following:

  • nausea/vomiting
  • headache
  • bleeding irregularities
  • dysmenorrhea
  • weight change
  • breast tenderness
  • acne
  • abdominal pain
  • anxiety
  • depression

Literature References

Lo Minastrin Fe (norethindrone acetate and ethinyl estradiol chewable tablets, ethinyl estradiol tablets and ferrous fumarate tablets) is an estrogen/progestin combined oral contraceptive. It works primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Additional Information

For additional information regarding Lo Minastrin FE or contraception, please visit the Warner Chilcott web page.