Cipro (ciprofloxacin hydrochloride) - 3 indications

Scroll down for information on each indication:

• Cystitis; approved 04/01/1996
• Complicated intra-abdominal infections; approved 12/01/1996
• Acute sinusitis; approved 06/01/1997

General Information

Cipro (ciprofloxacin hydrochloride) is a fluoroquinolone antibacterial.

Cipro is specifically indicated for the following:

• adult female patients with acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.
• adult patients with complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
• adult patients with acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

Cipro is supplied as tablets and as oral suspension. Scroll down to see recommended dosing for each indication.

Mechanism of Action

Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents. The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.

Side Effects

Adverse effects associated with the use of Cipro may include, but are not limited to, the following:

• nausea
• diarrhea
• abnormal liver function tests 
• vomiting
• rash

The Cipro drug label comes with the following Black Box Warning: Fluoroquinolones, including Cipro have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including: 1) Tendinitis and tendon rupture, 2) Peripheral neuropathy, 3) Central nervous system effects. Discontinue Cipro immediately and avoid the use of fluoroquinolones, including Cipro, in patients who experience any of these serious adverse reactions • Fluoroquinolones, including Cipro, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Cipro in patients with known history of myasthenia gravis. • Because fluoroquinolones, including Cipro, have been associated with serious adverse reactions, reserve Cipro for use in patients who have no alternative treatment options for the following indications: 1) Acute exacerbation of chronic bronchitis, 2) Acute uncomplicated cystitis and 3) Acute sinusitis.

Indication 1 - Cystitis

approved 04/01/1996

Dosing/Administration

The recommended dose is 250 mg every 12 hours for 3 days.

Clinical Trial Results

No trial data posted on prescription drug label.

Indication 2 - Complicated intra-abdominal infections

approved 12/01/1996

Dosing/Administration

The recommended dose is 500 mg every 12 hours for 7 to 14 days.

Clinical Trial Results

No trial data posted on prescription drug label.

Indication 3 - Acute sinusitis

approved 06/01/1997

Dosing/Administration

The recommended dose is 500 mg every 12 hours for 10 days.

Clinical Trial Results

No trial data posted on prescription drug label.