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Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Obstetrics/Gynecology (Women’s Health)

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Floxin Tablets (ofloxacin tablets)

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

Company: Ortho-McNeil Pharmaceutical
Approval Status: Approved January 1997
Treatment Area: pelvic inflammatory disease (PID)

General Information

Floxin has been approved for the treatment of pelvic inflammatory disease (PID), a condition that afflicts one million women in the United States each year. PID can lead to serious complications, including infertility. Previous PID treatment required injections or intravenous medication combination with oral antibiotics.

Floxin can now be taken orally twice a day for two weeks to treat PID. The anti-infective has been widely used in the United States since 1991 to treat a wide range of genitourinary tract infections, including urinary tract infections, gonorrhea and chlamydial infection.

Clinical Results

In multicenter studies, which evaluated the safety and effectiveness of oflaxacin as a monotherapy in the treatment of acute, uncomplicated PID, subjects received 400 mg of ofloxacin twice daily for 10 to 14 days. Ninety-eight percent of subjects experienced clinical cure, including subjects with severe disease. At long-term follow-up, no clinical evidence of relapse or re-infection was noted.

Side Effects

Overall, most adverse events were not serious, the most common being nausea, fungal infection and abdominal pain.

Additional Information

Currently about 200,000 women are hospitalized each year for PID at an average hospital stay of 4.8 days. Current estimates are that $4.2 billion is spent on the treatment of PID and its complications.

Pelvic inflammatory disease is thought to occur when an infection of the genital tract spreads from the cervix, up into the uterus, fallopian tubes and ovaries. PID can develop from several days to several months after infection with a sexually transmitted disease (STD), most commonly gonorrhea or chlamydial infection. Left untreated, the condition can lead to chronic pelvic pain, abnormal pregnancies and infertility in many instances. PID is one of the most serious complications of sexually transmitted infections among women that leads to nearly a quarter million hospitalizations and more than 100,000 surgical procedures each year.

The most common symptom of PID is dull pain or tenderness in the lower abdomen. Other possible symptoms include bleeding between menstrual periods, increased or changed vaginal discharge, pain during intercourse, nausea and /or vomiting, fever, and chills.