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