Ciprobay Special Precautions

Severe infections and/or infections due to Gram-positive or anaerobic bacteria: For the treatment of severe infections, staphylococcal infections and infections involving anaerobic bacteria, Ciprofloxacin (Ciprobay) should be used in combination with an appropriate antibacterial agent.
Streptococcus pneumoniae infections: Ciprofloxacin (Ciprobay) is not recommended for treatment of pneumococcal infections due to limited efficacy against Streptococcus pneumoniae.
Genital tract infections: Genital tract infections may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates. In genital tract infections thought or known to be due to Neisseria gonorrhoeae, it is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory testing.
Cardiac disorders: Ciprofloxacin (Ciprobay) is associated with cases of QT prolongation (see Adverse Reactions). As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging medications. Elderly patients may also be more susceptible to drug-associated effects on the QT interval. Precaution should be taken when using Ciprofloxacin (Ciprobay) with concomitant drugs that can result in prolongation with the QT interval (e.g. class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see Interactions) or in patients with risk factors for QT prolongation or torsade de pointes (e.g. congenital long QT syndrome, uncorrected electrolyte imbalance such as hypokalemia or hypomagnesemia and cardiac disease such as heart failure, myocardial infarction, or bradycardia).
Children and adolescents: As with medicinal products in its class, ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals (see Adverse Reactions). The analysis of available safety data from ciprofloxacin use in patients less than 18 years of age, the majority of whom had cystic fibrosis, did not disclose any evidence of drug-related cartilage or articular damage. The use of Ciprofloxacin (Ciprobay) for indications other than the treatment of acute pulmonary exacerbation of cystic fibrosis caused by Pseudomonas aeruginosa infection (children aged 5-17 years), complicated urinary tract infections and pyelonephritis due to Escherichia coli (children aged 1-17 years), and for the use in inhalational anthrax (post-exposure) was not studied. For other indications, clinical experience is limited.
Hypersensitivity: In some instances, hypersensitivity and allergic reactions may occur following a single dose (see Adverse Reactions), a physician should be informed immediately.
Anaphylactic/anaphylactoid reactions in very rare instances can progress to a life-threatening shock, in some instances after the first administration (see Adverse Reactions). In these cases, Ciprofloxacin (Ciprobay) has to be discontinued and medical treatment (e.g. treatment for shock) is required.
Gastrointestinal system: In the event of severe and persistent diarrhea during or after treatment, a physician must be consulted since this symptom can hide a serious intestinal disease (life-threatening pseudomembranous colitis with possible fatal outcome), requiring immediate treatment (see Adverse Reactions). In such cases, Ciprofloxacin (Ciprobay) must be discontinued and appropriate therapy initiated (e.g. vancomycin, orally, 4 x 250 mg/day). Medicinal products that inhibit peristalsis are contraindicated in this situation.
Hepatobiliary system: Cases of hepatic necrosis and life-threatening hepatic failure have been reported with Ciprofloxacin (Ciprobay). In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued (see Adverse Reactions).
There can be a temporary increase in transaminases, alkaline phosphatase, or cholestatic jaundice, especially in patients with previous liver damage, who are treated with Ciprofloxacin (Ciprobay) (see Adverse Reactions).
Myasthenia gravis: Ciprofloxacin (Ciprobay) should be used with caution in patients with myasthenia gravis, because symptoms can be exacerbated.
Musculoskeletal system: Ciprofloxacin (Ciprobay) should be used with caution in patients with myasthenia gravis, because symptoms can be exacerbated.
Tendinitis and tendon rupture: Tendinitis and tendon rupture (predominantly Achilles tendon), sometimes bilateral, may occur with Ciprofloxacin (Ciprobay), even within the first 48 hours of treatment. Cases occurring up to several months after completion of therapy have been reported (see Adverse Reactions). The risk of tendinopathy may be increased in elderly patients, during strenuous physical activity, in patients treated concomitantly with corticosteroids, in patients with renal impairment and patients with solid organ transplants.
At any sign of tendinitis (e.g. painful swelling, inflammation), the affected extremity should be kept at rest, any inappropriate physical exercise should be avoided, a physician should be consulted and the antibiotic treatment should be discontinued. Ciprofloxacin (Ciprobay) should be used with caution in patients with a history of tendon disorders related to fluoroquinolone treatment.
Seizures: Ciprofloxacin (Ciprobay), like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. In epileptics and patients who have suffered from previous central nervous system (CNS) disorders (e.g. lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure or stroke), Ciprofloxacin (Ciprobay) should only be used where the benefits of treatment exceed the risks, since these patients are endangered because of possible undesirable CNS effects. Cases of status epilepticus have been reported (see Adverse Reactions). If seizures occur, Ciprofloxacin (Ciprobay) should be discontinued.
Psychiatric Reactions: Psychiatric reactions may occur even after the first administration of fluoroquinolones, including Ciprofloxacin (Ciprobay). In rare cases, depression or psychotic reactions can progress to suicidal ideations/thoughts and self-injurious behavior, such as attempted or completed suicide (see Adverse Reactions). In the event that the patient develops these reactions, Ciprofloxacin (Ciprobay) should be discontinued and appropriate measures instituted.
Peripheral neuropathy: Cases of sensory or sensorimotor polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias, or weakness have been reported in patients receiving fluoroquinolones including Ciprofloxacin (Ciprobay). Patients under treatment with Ciprofloxacin (Ciprobay) should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop (see Adverse Reactions).
Skin and appendages: Ciprofloxacin has been shown to produce photosensitivity reactions. Patients taking Ciprofloxacin (Ciprobay) should avoid direct exposure to excessive sunlight or UV-light. Therapy should be discontinued if photosensitization (i.e. sunburn-like skin reactions) occurs (see Adverse Reactions).
Cytochrome P450: Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 enzymes. Care should be taken when other medicinal products are administered concomitantly which are metabolized via the same enzymatic pathway (e.g. tizanidine, theophylline, methylxantines, caffeine, duloxetine, ropinirole, clozapine, olanzapine, agomelatine). Increased plasma concentrations associated with drug-specific undesirable effects may be observed due to inhibition of their metabolic clearance by ciprofloxacin (see Interactions).
Dysglycemia: As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with Ciprobay. In Ciprobay-treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g. sulfonylurea) or with insulin. In diabetic patients, careful monitoring of blood glucose is recommended (see Adverse Reactions).
Injection site reaction: Solution for infusion: Local intravenous site reactions have been reported with the intravenous administration of Ciprofloxacin (Ciprobay) (see Adverse Reactions). 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.
Interaction with tests: Ciprofloxacin in vitro potency may interfere with the Mycobacterium tuberculosis culture test by suppression of mycobacterial growth, causing false negative results in specimens from patients currently taking Ciprofloxacin (Ciprobay).
Aortic aneurysm and dissection: Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet´s disease, hypertension, known atherosclerosis).
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Effects on ability to drive or use machines: Fluoroquinolones including ciprofloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (see Adverse Reactions). This applies particularly in combination with alcohol.