Ciclodin IV Infusion Bag Special Precautions

Healthcare professionals are advised to avoid prescribing fluoroquinolones to patients who have aortic aneurysm or at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular disease, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients. The benefit of using fluoroquinolones to these patients should be assessed by the prescribers prior to initiation of therapy. It should be prescribed to these patients only when no other treatment options are available.
Ciprofloxacin is administered cautiously to the following patients: Patients with severe renal impairments.
Patients with history of convulsive diseases (Potential risk of convulsion).
Elderly patients.
Patients with known or suspected CNS disorders, e.g., severe cerebral arteriosclerosis (Potential risk of convulsion).
Patients with vein disorders.
Patients with myasthenia gravis (May worsen the symptoms).
Patients receiving theophylline.
Patients with deficiency of glucose-6-phosphate dehydrogenase (G-6-PD) (Hemolysis may occur rarely).
Patients receiving phenylacetate (e.g., fenbufen, flurbiprofen) or propionate non-steroidal anti-inflammatory drugs (Potential risk of convulsion).
General precautions: To reduce the development of drug-resistant bacteria, it is recommended that ciprofloxacin should be used for the minimum period required for the treatment after determining the susceptibility of the bacteria to ciprofloxacin.
As like other quinolones, ciprofloxacin has been known to trigger seizures or lower the seizure threshold. In patients with increased risk of epilepsy and CNS disorders (e.g., decreased seizure threshold, history of convulsion, decreased cerebral blood flow, changes in brain structure or stroke), CNS adverse reactions may occur and therefore they should be informed with the risks. Ciprofloxacin should only be administered if the potential therapeutic benefit justifies the potential risk. In some cases, CNS reactions occurred following the first dose and in rare cases depression or psychotic reactions have progressed to suicidal ideation/thoughts and self-endangering behaviors as of attempted or completed suicide. When these depression, psychotic reactions, suicidal ideation and actions occur, discontinue ciprofloxacin and institute appropriate measures.
Pseudomembranous colitis has been reported with use of nearly all antibacterial agents, including ciprofloxacin, and may range in severity from mild to fatal colitis. Therefore, the patients with diarrhea after the administration of antibacterial agents should be cautious. Toxins produced by Clostridium difficile is reported to be the primary cause of the colitis. Discontinue ciprofloxacin immediately when pseudomembranous colitis is suspected, and appropriate adjunctive ± specific treatment (e.g., administration of oral vancomycin) should be instituted. Under this clinical condition, avoid using any medicines that may disturb the intestinal peristalsis.
Photosensitivity may occur due to ciprofloxacin. Patients should minimize or avoid exposure to excessive natural or artificial UV light in order to prevent any photosensitivity reactions (e.g., sunlight lamps or tanning beds). Discontinue the therapy if any signs for phototoxicity reactions (i.e., rash, eruption, pruritus) occur.
Sensory or sensorimotor polyneuropathy triggering dysesthesia, hypoesthesia, and perception disorder have been reported in patient receiving fluoroquinolones, including ciprofloxacin. If the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, the patients should discuss with physicians before continuing the therapy.
Fluoroquinolones, including ciprofloxacin, have been associated with other central nervous system events, therefore, it could affect to the driving or operating machinery, especially when ciprofloxacin is taken with alcohol.
I.V. Infusion of sodium chloride contained in injection: In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.), the additional sodium load should be taken into account.
Ciprofloxacin has been associated with prolongation of the QT interval, caution should be taken in patients with known prolongation of the QT interval, risk factors for QT prolongation or torsade de pointes (for example, congenital long QT syndrome, uncorrected electrolyte imbalance, such as hypokalemia or hypomagnesemia and cardiac disease, such as heart failure, myocardial infarction, or bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents(amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics. Women tend to have longer baseline QTc interval than men, which may lead them much sensitive to drugs known to delay QT interval.
Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens. In such infections ciprofloxacin must be co-administered with other appropriate antibacterial agents.
Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
Genital tract infections may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates. For genital tract infections, empirical ciprofloxacin should only be considered in combination with another appropriate antibacterial agent unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking ciprofloxacin.
Local intravenous site reactions have been reported with the intravenous administration of ciprofloxacin. These reactions are more frequent if the infusion time is 30 minutes or less. These may appear as local skin reactions which resolve rapidly upon completion of the infusion. Subsequent intravenous administration is not contraindicated unless the reactions recur or worsen.
Cases of hepatic necrosis, life-threatening hepatic failure have been reported with ciprofloxacin. In the event of any signs and symptoms of hepatitis (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), discontinue treatment immediately. There can be a temporary increase in transaminases, alkaline phosphatase, or cholestatic jaundice in patients with previous liver damage, who are treated with ciprofloxacin.
Monitor the patient for rare shock. Discontinue ciprofloxacin when hypotensive, dyspnea, feeling of pressure to the chest occurs, and institute appropriate measures.
Cautions should be taken in patients with ciprofloxacin since rhabdomyolysis accompanied with acute decline in renal function, which features muscle pain, impotent feeling, elevated creatinine kinase (CK), and serum, urine myoglobin, can occur. Muscle weakness can occur, and the symptoms may be worsened especially in patients with myasthenia gravis.
Interstitial pneumonia accompanied with cough, dyspnea, and abnormalities in chest x-rays, eosinophilia, and other symptoms may occur. Discontinue ciprofloxacin when these symptoms occur and give patient appropriate treatment such as administration of adrenocortical steroids.
Use in Children: Quinolones, including ciprofloxacin, cause arthropathy and osteochondrosis in weight bearing joints of juvenile animals. In addition, the safety data showed no evidence of cartilage or joint damage in association with ciprofloxacin when used in juvenile cystic fibrosis patients under 18 years old.
Ciprofloxacin should not be used in pediatric population and growing adolescent under age 18 for the safety and efficacy of ciprofloxacin to these patients have not been established.
Use in the Elderly: Ciprofloxacin is known to be substantially excreted by the kidney. Since some older individuals experience reduced renal function by virtue of their advance age, care should be taken in dose selection for elderly patients.