Cipronat Special Precautions

Administration particulars: Caution must be exercised if the drug is prescribed in patients with pronounced cerebral atherosclerosis, cerebral circulation disorders and renal function impairment.
In case of allergic reactions, which may be manifested as early as the first dose, the drug therapy must be cancelled immediately. UV radiation is contraindicated during Cipronat treatment. In patients with epilepsy, history of convulsions, vascular diseases and organic brain lesions, Cipronat can only be prescribed by vital indications due to central nervous system risk of side effects. If heavy and protracted diarrhea develops during or after Cipronat treatment it should be ruled out the possibility of pseudomembrane colitis which requires immediate cancellation of the drug and prescription of appropriate treatment. During Cipronat treatment patients should cut down activities that require concentration and rapid reactions. Certain laboratory parameters may change during Cipronat treatment: urine hypostasis, temporary increase of blood serum carbamide, creatinine, bilirubin and liver transaminase concentrations; individual cases of hyperglycemia, crystalluria or erythuria; and change of prothrombin parameters. In patients with impaired hepatic and/or renal functions monitoring of blood Cipronat concentrations should be recommended. Cipronat is not recommended for treatment of acute tonsillitis (tonsillar quinsy).
Gastrointestinal tract: In case severe and persistent diarrhea develops during or after drug therapy medical attention should be sought, as these symptoms may conceal severe gastrointestinal condition (such as potentially lethal pseudomembrane colitis) requiring immediate treatment. In such cases administration of Cipronat must be stopped immediately and appropriate therapy initiated.
Peristalsis-inhibiting drugs are contraindicated.
Transitory increase in transaminase and alkaline phosphatase activity or cholestatic jaundice may be observed, especially in patients with history of liver disease.
Nervous system: Patients with epilepsy and history of central nervous system disorders (such as low convulsive threshold, history of convulsive fits, reduced cerebral circulation, brain structure alterations, and stroke) may use Cipronat only if the expected benefit exceeds the potential risk.
In some cases, central nervous system side effects are observed as early as after the first dose of Cipronat. In individual cases depression or psychosis may manifest and progress. In such cases administration of Cipronat must be stopped.
Increased hypersensitivity to the drug: In some cases, hypersensitivity and allergic reactions are observed as early as after the first Cipronat administration. In such cases patient's physician must be informed immediately. In individual cases anaphylactic/anaphylactoid reactions may progress, up to life-threatening shock. In separate cases they are observed as early as the first Cipronat administration. In such cases administration of Cipronat must be stopped, and appropriate therapy initiated immediately.
Musculoskeletal system: At any signs of tendinitis (such as painful swelling) Cipronat administration must be stopped.
The patient should avoid physical load and should seek medical attention.
Tendon rupture (especially heel tendon) was observed primarily in elderly patients or patients with history of glucocorticoid treatment.
Skin: Cipronat was shown to cause photosensitivity reactions. Patients receiving Cipronat treatment must avoid intense ultraviolet irradiation. In case of photosensitivity reactions (e.g. similar to sunburns) Cipronat therapy must be stopped.
Cytochrome P450: Ciprofloxacin is a known moderate inhibitor of cytochrome P40 1A2 enzymes. Caution must be exercised if Cipronat is administered concurrently with drugs that are metabolized by such enzymes as theophylline, methylxanthine, caffeine, duloxetine and others since increase in blood serum concentration of these drugs may cause specific side effects.
Effect on ability to drive and operate other machines: The use of Cipronat has a negative impact on work requiring quick psychomotor reactions (participation in traffic, driving and machinery operating).
Use in Children: The drug is contraindicated for administration in children.
As other drugs of this class Cipronat was shown to cause joint arthropy in impuberal animals.
Analysis of available safety data on administration of Cipronat in patients under 18 years of age showed no evidence of cartilage or joint damage associated with drug treatment.