New 100mg Cipro Tablets for Acute Uncomplicated Cystitis in Females
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New 100mg Cipro Tablets for Acute Uncomplicated Cystitis in Females

WEST HAVEN, Conn., May 8, 1996 -- Bayer Corporation, Pharmaceutical Division, announced today it is introducing new 100 mg CIPRO(R) (ciprofloxacin HCl) tablets, packaged in a three-day CIPRO Cystitis Pack, for the treatment of acute, uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus. Cystitis is one of the most common urinary tract infections (UTI) in females.

Annually, more than one million women suffer from cystitis, a bacterial infection of the urinary bladder, which causes a strong urge to urinate, frequency or difficulty in urinating, and abdominal/pelvic pain. Approximately one in five women will develop a UTI during her lifetime.

Cipro Cystitis Pack Can Reduce Treatment Costs

The CIPRO Cystitis Pack is designed to quickly and effectively treat cystitis and enhance patient compliance. The convenient blister pack contains a full course of therapy, offering small, easy-to-swallow tablets to be taken twice a day for three days with or without food. The new, short-course therapy can reduce treatment costs compared to other branded regimens. The CIPRO Cystitis Pack has an Average Wholesale Price (AWP) of $14.40. Comparatively, other three-day therapies such as Noroxin(R) and Floxin(R) have an AWP of $16.17 and $18.35 respectively (see chart below).

"While we are extremely pleased that the 100 mg CIPRO tablets achieved a greater than 90 percent efficacy rate in clinical trials, Bayer is particularly excited about the shortened length of treatment time and the convenience that the CIPRO Cystitis Pack provides," explained Steven Jungerwirth, M.D., Bayer Corporation, Pharmaceutical Division.

The U.S. Food and Drug Administration (FDA) cleared 100 mg CIPRO tablets for marketing on April 8, 1996.

Ciprofloxacin should not be administered concurrently with theophylline. The most common side effects reported in the 100 mg CIPRO tablets clinical trials were headache, vaginal moniliasis (yeast infections), nausea pruritis, abdominal pain, dizziness, vaginitis and diarrhea. Rarely, however, were these side effects serious enough to cause women to discontinue therapy.

"If left untreated, UTI can result in potentially serious long-term complications such as kidney infection," said Ira W. Klimberg, M.D., Urology Center of Florida, Ocala, Florida. "When UTI therapy is prescribed, it is essential to take all of the medication as directed," Dr. Klimberg explained. "Although UTI symptoms may disappear in a couple days, if not fully treated with medication, bacteria may retain in the urinary tract. It is imperative to complete the entire treatment regimen to avoid recurring infections."

CIPRO tablets have been marketed by Bayer Corporation in the U.S. since 1987 for the treatment of a wide variety of infectious diseases in adults such as urinary tract, lower respiratory tract, bone and joint, and skin and skin structure infections.

Bayer Corporation is a research-based company with major businesses in health care, chemicals and imaging technologies. The company had 1995 sales of $8 billion. It employs 23,500 people. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $31 billion chemical and pharmaceutical company based in Leverkusen, Germany.

COMPARATIVE PRICING CHART

Agent(A)

AWP(B)

Therapy(C)

CIPRO(R) Cystitis Pack

$14.40

100 mg bid -- 3 days

Bactrim(TM) DS

$25.03

160 mg TMP/800 mg

SMX bid -- 10 days

Septra(R) DS

$24.10

160 mg TMP/800 mg

SMX bid -- 10 days

Macrobid(R)

$17.91

100 mg bid -- 7 days

Floxin(R)

$18.35

200 mg bid -- 3 days

Noroxin(R)

$16.17

400 mg bid -- 3 days


(A) Price comparisons are not intended to compare efficacy.

(B) Calculations based on Average Wholesale Price (AWP) as reported in April 1996 Red Book(R) Update. AWP is from a published price list and may or may not represent the actual price to pharmacists or consumers.

(C) Based on the manufacturer's recommended course of therapy.

Bactrim DS is a trademark of Roche Laboratories.

Septra DS is a registered trademark of Glaxo Wellcome Inc.

Macrobid is a registered trademark of Procter & Gamble Pharmaceuticals.

Floxin is a registered trademark of McNeil Pharmaceutical.

Noroxin is a registered trademark of Roberts Pharmaceutical Corp.

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