Fax in this samples request form to get your complimentary samples of Lo Loestrin® Fe and Minastrin® 24 Fe.
 

Low-dose options for a range of patients

Lo Loestrin Fe

Only available ultra–low-dose OC with just 10 mcg of daily ethinyl estradiol in a 24/2/2 regimen for short, lighter periods1,2,*,†

Minastrin 24 Fe

Low-dose, 20 mcg-option with 24/4 dosing for cycle control and less bleeding by Cycle 62,7,‡,**

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Please print out the form provided and fax the completed form to 1-877-801-9949.

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  • 1-year (thirteen 28-day cycles), multicenter, open-label study of 1270 women aged 18 to 35 years that was designed to assess the efficacy of Lo Loestrin Fe for a total of 12,482 twenty-eight–day evaluable cycles of exposure.1
  • Mean duration of withdrawal bleeding was <2 days per cycle and patient-reported intensity of withdrawal bleeding was lighter than normal.1,2
  • Efficacy and safety were assessed in an open-label, randomized, active-controlled, multicenter study of 743 women aged 18 to 45 years who received a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 mcg swallowed whole for up to six 28-day cycles, providing a total of 3823 treatment cycles of exposure. A total of 583 women completed 6 cycles of treatment. Minastrin 24 Fe is bioequivalent to these tablets. Subjects were randomized to treatment groups in a 4:1 ratio of test drug to active comparator (21-day regimen of the exact same combination). The modified intent-to-treat population consisted of 705 women in the 24-day regimen group and 181 in the 21-day group.2,7
  • Mean median duration of withdrawal bleeding was 2.42 days when averaged over Cycle 2 through Cycle 6. Patient-reported intensity of withdrawal bleeding was lighter than normal.2,7
INDICATIONS AND USAGE
Lo Loestrin® Fe and Minastrin® 24 Fe are estrogen/progestin combination oral contraceptives (COCs) indicated for use by females of reproductive age to prevent pregnancy. Efficacy in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated. For detailed instructions on Dosage and Administration for Lo Loestrin Fe and Minastrin 24 Fe, please refer to the respective product Full Prescribing Information.
IMPORTANT SAFETY INFORMATION
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

Contraindications
Lo Loestrin Fe or Minastrin 24 Fe are contraindicated in pregnant patients, and those with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.

Warnings and Precautions
Discontinue Lo Loestrin Fe or Minastrin 24 Fe if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Lo Loestrin Fe or Minastrin 24 Fe should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding. If jaundice occurs, treatment should be discontinued.

Lo Loestrin Fe or Minastrin 24 Fe should not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease. Women who are pre-diabetic or diabetic, should be monitored while using Lo Loestrin Fe or Minastrin 24 Fe. Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia. Patients using Lo Loestrin Fe or Minastrin 24 Fe who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated.

Adverse Reactions
In the clinical trial for Lo Loestrin Fe, the most common adverse reactions (incidence ≥2%) were nausea/vomiting, headache, bleeding irregularities, dysmenorrhea, weight fluctuation, breast tenderness, acne, abdominal pain, anxiety, and depression.

In the clinical trial for Minastrin 24 Fe, the most common adverse reactions (incidence ≥2%) were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.

Lo Loestrin Fe or Minastrin 24 Fe will not protect against HIV infection (AIDS) or other sexually transmitted diseases.

To report a Suspected Adverse Reaction from one of our products, please contact Actavis Drug Safety Department at 1-800-272-5525.

Please see Full Prescribing Information for Lo Loestrin Fe or Full Prescribing Information for Minastrin 24 Fe, including Boxed Warning.

REFERENCES
  1. Lo Loestrin® Fe prescribing information. Rockaway, NJ: Warner Chilcott (US), LLC; 2012.
  2. Data on file. Rockaway, NJ: Warner Chilcott (US), LLC.
  3. US Food and Drug Administration. Guidance for industry: labeling for combined oral contraceptives. http://www.fda.gov/downloads/Drugs/Guidance/ComplianceRegulatoryInformation/Guidances/ucm075075.pdf. Published March 2004. Accessed May 21, 2014.
  4. The Alan Guttmacher Institute. Fulfilling the promise: public policy and U.S. family planning clinics. http://www.guttmacher.org/pubs/fulfill.pdf. Accessed June 26, 2014.
  5. Oral contraceptive survey. Harris Poll. July 2014.
  6. Sech L, Segall-Gutierrez P, Silverstein E, et al. Oral contraceptives. The Merck Manual Web site. http://www.merckmanuals.com/professional/gynecology_and_obstetrics/family_planning/oral_contraceptives.html#v8579722. Updated August 2013. Accessed January 29, 2014.
  7. Minastrin® 24 Fe prescribing information. Rockaway, NJ: Warner Chilcott (US), LLC; 2013.