Ciprinol®, solution for infusion, is indicated for the treatment of the following infections (see sections “Pharmacological properties” and “Special instructions for use”). Before starting therapy, special attention should be paid to all available information on resistance to ciprofloxacin.
Official recommendations on the appropriate use of antibacterial drugs should be considered.
Adults
Lower respiratory tract infections caused by gram-negative bacteria: exacerbation of chronic obstructive pulmonary disease; bronchopulmonary infections in cystic fibrosis or bronchiectasis; pneumonia. Chronic purulent otitis media. Exacerbation of chronic sinusitis, especially if caused by gram-negative bacteria. Urinary tract infections. Infectious lesions of the reproductive system: epididymo-orchitis, in particular caused by sensitive strains of Neisseria gonorrhoeae; pelvic inflammatory disease, in particular caused by sensitive strains of Neisseria gonorrhoeae. Gastrointestinal tract infections (e.g. travelers' diarrhea). Intra-abdominal infections. Skin and soft tissue infections caused by gram-negative bacteria. Severe otitis externa. Bone and joint infections. Pulmonary anthrax (post-exposure prophylaxis and radical treatment).
Ciprofloxacin can be used in the treatment of patients with neutropenia if there is a suspicion that the fever is caused by a bacterial infection.
Children and adolescents
Bronchopulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa. Complicated urinary tract infections and pyelonephritis. Pulmonary anthrax (post-exposure prophylaxis and radical treatment).
Ciprofloxacin can be used to treat severe infections in children and adolescents if considered necessary.
Treatment should only be carried out by physicians who have experience in the treatment of fibrosis and/or severe infections in children and adolescents (see sections “Pharmacological properties” and “Special instructions for use”).
Composition
active ingredient: ciprofloxacin;
1 ml 2 mg of ciprofloxacin as lactate;
Excipients: sodium lactate, sodium chloride, hydrochloric acid, water for injections.
The bactericidal effect of ciprofloxacin as a fluoroquinolone antibacterial agent is due to its ability to inhibit type II topoisomerases (DNA gyrase and topoisomerase IV), which are required in many processes of the DNA life cycle, such as replication, transcription, repair, and recombination.
Contraindication
Hypersensitivity to ciprofloxacin or to any component of the drug, as well as to other fluoroquinolones.
Concomitant use of ciprofloxacin and tizanidine due to clinically significant side effects (arterial hypotension, drowsiness) associated with an increase in tizanidine plasma concentrations (see section "Interaction with other medicinal products and other types of interactions").
Method of administration and doses
The dose is determined according to the indications, the severity and location of the infection, the sensitivity of the pathogen(s) to ciprofloxacin, the patient's renal function, and in children and adolescents - by body weight.
The duration of treatment depends on the severity of the disease, the characteristics of the clinical picture, and the type of pathogen.
Method of administration
Ciprofloxacin solution for infusion should be visually inspected prior to use. The solution should be used if there is any sign of cloudiness.
Ciprofloxacin should be administered by infusion. For children, the infusion duration is 60 minutes.
In patients, the infusion time is 60 minutes for 400 mg ciprofloxacin solution for infusion and 30 minutes for 200 mg ciprofloxacin solution for infusion. Slow infusion into a larger vein minimizes patient discomfort and reduces the risk of venous irritation.
The drug solution can be administered diluted or after addition to other infusion solutions (see the "Incompatibility" section).
For single use only. Minimum volume is 50 ml.
Any unused solution should be discarded.
Children
The use of ciprofloxacin in children and adolescents should be in accordance with current official guidelines. Treatment with ciprofloxacin should be carried out by a physician experienced in the treatment of children and adolescents with cystic fibrosis and/or severe infections.
Ciprofloxacin has been shown to cause arthropathy of the supporting joints in immature animals. The increase in the incidence of arthropathy associated with the use of the drug was not statistically significant. However, treatment with ciprofloxacin in children and adolescents should only be initiated after a careful benefit/risk assessment because of the possible risk of adverse reactions involving the joints and/or surrounding tissues.
Application features
Use during pregnancy or breastfeeding
pregnancy
Data on the use of ciprofloxacin in pregnant women demonstrate the absence of malformations or feto-neonatal toxicity. Animal studies do not indicate direct or indirect toxic effects on reproductive function. In young animals and animals exposed to quinolones before birth, effects on immature cartilage tissue have been observed, so the possibility that the drug may be harmful to the articular cartilage of the newborn / fetus cannot be excluded. Therefore, it is better to avoid the use of ciprofloxacin during pregnancy in order to avoid undesirable effects on the fetus.
Ciprofloxacin passes into breast milk. Due to the potential risk of damage to articular cartilage in newborns, ciprofloxacin should not be used during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Ciprofloxacin may affect the patient's ability to drive and use machines due to reactions on the nervous system. Therefore, the ability to drive or use complex machinery may be impaired.
Overdose
An overdose of 12 g has been reported to cause symptoms of moderate toxicity. An overdose of 16 g has been reported to cause acute renal failure. Symptoms of overdose have included dizziness, tremor, headache, convulsions, fatigue, hallucinations, confusion, abdominal discomfort, renal and hepatic failure, as well as crystalluria and hematuria. Reversible renal toxicity has also been reported by the State Traffic Safety Inspectorate.
In addition to standard emergency measures, such as gastric emptying followed by activated charcoal, monitoring of renal function is recommended, including determination of urine pH and, if necessary, increasing its acidity to prevent crystalluria. Patients should be adequately hydrated.
Antacids containing calcium or magnesium may theoretically reduce the absorption of ciprofloxacin in case of overdose.
Only a small amount of ciprofloxacin (<10%) is removed by hemodialysis or peritoneal dialysis.
In case of overdose, symptomatic treatment should be applied. ECG monitoring should be performed due to the possibility of QT prolongation.
Adverse reactions
The most commonly reported adverse drug reactions were nausea, diarrhea, vomiting, transient elevations in transaminase levels, rash, and local reactions at the injection site.
Data on adverse reactions to ciprofloxacin preparations obtained during clinical trials and post-marketing surveillance (oral, parenteral and sequential routes of administration) are presented below.
Interaction with other medicinal products and other types of interactions
Ciprofloxacin, like other fluoroquinolones, should be administered with caution to patients receiving drugs that prolong the QT interval (e.g. class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section "Special warnings and precautions for use").
Storage conditions
Store in a place protected from light. The drug does not require special temperature storage conditions. Keep out of the reach of children.
Shelf life - 5 years.
