RiteMED Ciprofloxacin Warnings

Safety and effectiveness of ciprofloxacin in pediatric and adolescents (less than 18 years of age) except for use in inhalational anthrax (post-exposure), pregnant women ad lactating women have not been established.
Ciprofloxacin caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produced erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species.
Achilles and other tendon ruptures that required surgical repair or resulted to prolonged disability have been reported with ciprofloxacin and other quinolones. Discontinue Ciprofloxacin if the patient experiences pain, inflammation or rupture of a tendon.
Convulsions, increased intracranial pressure and toxic psychosis have been reported in patients receiving quinolones, including Ciprofloxacin. Ciprofloxacin may also cause CNS events including: dizziness, confusion, tremors, hallucinations, depression and rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving ciprofloxacin, discontinue the drug and institute appropriate measures. Use ciprofloxacin with caution in patients with known or suspected CNS disorders that may predispose to seizure threshold (e.g. severe cerebral arteriosclerosis, epilepsy), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g. certain drug therapy, renal dysfunction).
Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline.
These reactions have included cardiac arrest, seizure, status epilepticus and respiratory failure. Although similar serious adverse effects have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by Ciprofloxacin cannot be eliminated. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage appropriately.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. In such cases, administer oxygen, intravenous steroids, and airway management, including intubation.
Rarely, severe hypersensitivity reactions characterized by rash, fever, eosinophilia, jaundice and hepatic necrosis with fatal outcome have also been reported in patients receiving Ciprofloxacin along with other drugs. Discontinue Ciprofloxacin at the first appearance of a skin rash or any other sign of hypersensitivity.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ciprofloxacin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis." After pseudomembranous colitis has been established, initiate therapeutic measures. Mild causes of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consider management with fluids and electrolytes, protein supplementation and treatment with antibacterial drug clinically effective against Clostridium difficile colitis.
Ciprofloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Advise all patients with gonorrhea to have a serologic test for syphilis at the time of diagnosis and to have a follow-up serologic test for syphilis after three months.