ATC code:J ANTIMIBRICANTS FOR SYSTEMIC USE; J01 ANTIBACTERIALS FOR SYSTEMIC USE; J01M ANTIBACTERIALS FROM THE QUINOLON GROUP; J01M A Fluoroquinolones; J01M A02 Ciprofloxacin
Country of manufacture:Slovenia
Diabetics:With caution
Delivery
USPS across the USA
Canada Post across Canada
Payment
Tsiprinol film-coated tablets 500 mg No. 10
434.77 грн.
Description
Instructions for use Tsiprinol film-coated tablets 500 mg No. 10
Composition
active ingredient: ciprofloxacin;
1 film-coated tablet contains 250 mg or 500 mg of ciprofloxacin as ciprofloxacin hydrochloride monohydrate;
250 mg tablets: round, white, film-coated tablets, with a score on one side;
500 mg tablets: oval, white, film-coated tablets, scored on one side.
Pharmacotherapeutic group
Antibacterials for systemic use. Fluoroquinolones. ATX code J01M A02.
Pharmacological properties
Pharmacodynamics
Mechanism of action
The bactericidal effect of ciprofloxacin as a fluoroquinolone antibacterial agent is due to the ability of ciprofloxacin to inhibit type II topoisomerases (DNA gyrase and topoisomerase IV), which are essential in many processes of the DNA life cycle, such as replication, transcription, repair, and recombination.
Mechanism of resistance
Resistance to ciprofloxacin in vitro is usually associated with target site mutations that arise in topoisomerase IV and DNA gyrase by multistep mutations. The degree of cross-resistance between ciprofloxacin and other fluoroquinolones as a result varies. Single mutations do not usually result in clinical resistance, but multiple mutations usually result in clinical resistance to several or all members of the fluoroquinolone class.
Resistance mechanisms that inactivate other antibacterial agents, such as the permeability barrier (inherent in Pseudomonas aeruginosa), and efflux mechanisms may influence susceptibility to ciprofloxacin.
The development of plasmid-mediated resistance encoded by the qnr gene has been reported.
Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines may not affect the antibacterial activity of ciprofloxacin. Organisms resistant to these drugs may be susceptible to ciprofloxacin.
The minimum bactericidal concentration (MBC) usually does not exceed the minimum inhibitory concentration (MIC) by more than 2 times.
Spectrum of antibacterial activity.
Breakpoints separate susceptible strains from strains with intermediate susceptibility, and the latter from resistant strains.
EUCAST recommendations
Microorganisms
Sensitive
Resistant
Enterobacteriaceae
£ 0.25 mg/l
> 0.5 mg/l
Salmonella spp.
≤ 0.06 mg/l
> 0.06 mg/l
Pseudomonas spp.
£ 0.5 mg/l
> 0.5 mg/l
Acinetobacter spp.
£ 1 mg/l
> 1 mg/l
Staphylococcus spp.1
£ 1 mg/l
> 1 mg/l
Haemophilus influenzae
£ 0.06 mg/l
> 0.06 mg/l
Moraxella catarrhalis
£ 0.125 mg/l
> 0.125 mg/l
Neisseria gonorrhoeae
£ 0.03 mg/l
> 0.06 mg/l
Neisseria meningitidis
£ 0.03 mg/l
> 0.03 mg/l
Non-species related control points2
£ 0.25 mg/l
> 0.5 mg/l
1 Staphylococcus spp. – Ciprofloxacin breakpoints are relevant to high-dose therapy.
2 Non-species breakpoints were determined primarily based on pharmacokinetic and pharmacodynamic data and are independent of species-specific MICs. They are used only for species that do not have their own breakpoints and not for species in which susceptibility testing is not recommended.
In vitro susceptibility to ciprofloxacin
The prevalence of acquired resistance of isolated species may vary with location and time, and local information on resistance is therefore necessary, particularly in the treatment of severe infections. Specialist advice should be sought when the local prevalence of resistance is such that the benefit of the medicinal product, at least in some types of infections, is questionable.
The following genera and species of bacteria are generally susceptible to ciprofloxacin in vitro.
When administered orally, ciprofloxacin is rapidly and well absorbed, mainly from the upper small intestine.
The maximum serum concentration (Cmax) is reached after 1-2 hours.
The absolute bioavailability of the drug is 70-80%. Cmax and the total area under the concentration-time curve (AUC) increase in proportion to the increase in dose.
Distribution
The percentage of ciprofloxacin binding to blood proteins is insignificant (20-30%), the active substance is found in the blood plasma mainly in a non-ionized form. Ciprofloxacin freely diffuses into the extravascular space. The significant volume of distribution at steady state, which is 2-3 l/kg of body weight, proves that ciprofloxacin penetrates into tissues in concentrations that can many times exceed the level of the drug in blood serum. Ciprofloxacin reaches high concentrations in various tissues, for example in the lungs (epithelial fluid, alveolar macrophages, biopsy samples), sinuses, inflamed damaged tissues and in tissues of the urinary tract, genital organs (prostate, endometrium), where the total concentration exceeds that in blood plasma.
Metabolism
Low concentrations of the following four metabolites were recorded: diethylciprofloxacin (M1), sulfociprofloxacin (M2), oxociprofloxacin (M3) and formylciprofloxacin (M4). The metabolites demonstrate in vitro antimicrobial activity, but to a lesser extent than the parent compound.
Ciprofloxacin is known to be a moderate inhibitor of CYP 450 1A2 isoenzymes.
Breeding
Ciprofloxacin is excreted mostly unchanged both by the kidneys and through the intestines.
Children.
Pharmacokinetic data in children are limited.
In studies in children, no age-related Cmax and AUC (in children aged 1 year and older) were observed. After multiple administration of the drug (10 mg/kg 3 times a day), no significant increase in Cmax and AUC was observed. In 10 children aged less than 1 year with severe sepsis, Cmax was 6.1 mg/l (range 4.6–8.3 mg/l) after a 1-hour intravenous infusion of 10 mg/kg. This figure was 7.2 mg/l (range 4.7–11.8 mg/l) in children aged 1 to 5 years. AUC values were 17.4 mg*h/l (range 11.8–32.0 mg*h/l) and 16.5 mg*h/l (range 11–23.8 mg*h/l) in the respective age groups. These values are within the normal range observed in adults at therapeutic doses. Based on pharmacokinetic analyses of pediatric patients with various infections, the predicted mean elimination half-life in children is approximately 4–5 hours and the bioavailability of the oral suspension is 60%.
Indication
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 taken into account.
Adults
Lower respiratory tract infections caused by gram-negative bacteria:
exacerbation of chronic obstructive pulmonary disease (in exacerbation of chronic obstructive pulmonary disease, ciprofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are usually recommended for the treatment of these infections);
bronchopulmonary infections in cystic fibrosis or bronchiectasis;
community-acquired pneumonia.
Chronic purulent otitis media.
Severe course of otitis externa.
Exacerbation of chronic sinusitis, especially if caused by gram-negative bacteria.
Urinary tract infections:
uncomplicated acute cystitis.
In uncomplicated acute cystitis, ciprofloxacin should only be used when it is considered inappropriate to use other antibacterial agents that are usually recommended for the treatment of these infections;
acute pyelonephritis;
complicated urinary tract infections;
bacterial prostatitis.
Infectious lesions of the reproductive system:
gonococcal urethritis and cervicitis caused by susceptible strains of Neisseria gonorrhoeae;
epididymo-orchitis, particularly caused by sensitive strains of Neisseria gonorrhoeae;
pelvic inflammatory disease, particularly those caused by sensitive strains of Neisseria gonorrhoeae.
Skin and soft tissue infections caused by gram-negative bacteria.
Bone and joint infections.
Prevention of invasive infections caused by Neisseria meningitidis.
Ciprofloxacin can be used to treat patients with neutropenia if there is a suspicion that the fever is caused by a bacterial infection.
Children and adolescents
Bronchopulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
Complicated urinary tract infections and acute pyelonephritis.
Pulmonary form of anthrax (post-exposure prophylaxis and radical treatment).
Ciprofloxacin can also be used to treat severe infections in children and adolescents when the doctor considers it necessary.
Treatment should be initiated by a physician experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 5.1 and 4.4).
Contraindication
Ciprofloxacin should not be used in cases of hypersensitivity to the active substance of the drug or to other drugs of the fluoroquinolone group, or to any of the excipients of the drug.
The simultaneous use of ciprofloxacin and tizanidine is contraindicated due to clinically significant side effects (arterial hypotension, drowsiness) associated with an increase in the concentration of tizanidine in the blood plasma (see section "Special instructions").
Interaction with other medicinal products and other types of interactions
Effects of other medicinal products on ciprofloxacin
Drugs that prolong the QT interval
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").
Chelate complex formation
When ciprofloxacin is administered orally with drugs containing multivalent cations, mineral supplements (e.g. calcium, magnesium, aluminium, iron), phosphate-binding polymers (e.g. sevelamer or carbonate lactan), sucralfate or antacids, as well as drugs with a high buffer capacity (e.g. didanosine tablets) containing magnesium, aluminium or calcium, the absorption of ciprofloxacin is reduced. Therefore, ciprofloxacin should be taken either 1-2 hours before or at least 4 hours after taking these drugs.
This restriction does not apply to antacids belonging to the class of H2-receptor blockers.
Food, including dairy products
Calcium in food has little effect on absorption. However, simultaneous administration of ciprofloxacin and dairy or mineral-fortified products (such as milk, yoghurt, calcium-fortified orange juice) should be avoided, as absorption of ciprofloxacin may be reduced.
Probenecid
Probenecid affects the renal secretion of ciprofloxacin. Concomitant use of medicinal products containing probenecid and ciprofloxacin leads to an increase in the concentration of ciprofloxacin in the blood serum.
Metoclopramide
Metoclopramide accelerates the absorption of ciprofloxacin, resulting in a faster achievement of Cmax. No effect on the bioavailability of ciprofloxacin was observed.
Omeprazole
Concomitant use of ciprofloxacin and medicinal products containing omeprazole leads to a slight decrease in Cmax and AUC of ciprofloxacin.
Effect of ciprofloxacin on other drugs
Tizanidine
Tizanidine should not be administered concomitantly with ciprofloxacin (see section "Contraindications"). Concomitant administration of ciprofloxacin and tizanidine has been shown to increase tizanidine plasma concentrations (7-fold increase in Cmax, range 4-21-fold; 10-fold increase in AUC, range 6-24-fold). Increased tizanidine serum concentrations are associated with increased hypotensive and sedative effects.
Methotrexate
Concomitant use of ciprofloxacin may slow down the tubular transport (renal metabolism) of methotrexate, which may lead to an increase in the concentration of methotrexate in the blood plasma and an increase in the likelihood of adverse toxic reactions caused by methotrexate. Concomitant use is not recommended (see section "Special instructions").
Theophylline
The simultaneous use of ciprofloxacin and drugs containing theophylline may lead to an undesirable increase in the concentration of theophylline in the blood serum, which in turn may cause the development of adverse reactions. In isolated cases, such adverse reactions may be fatal. If the simultaneous use of these drugs cannot be avoided, the concentration of theophylline in the blood serum should be monitored and its dose should be reduced appropriately (see section "Special instructions").
Other xanthine derivatives
Increased serum concentrations of these xanthines have been reported following concomitant use of ciprofloxacin and medicinal products containing caffeine or pentoxifylline (oxpentifylline).
Phenytoin
Concomitant use of ciprofloxacin and phenytoin may result in increased or decreased serum concentrations of phenytoin, therefore monitoring of drug levels is recommended.
Concomitant use of ciprofloxacin and vitamin K antagonists may potentiate their anticoagulant effects. Increased activity of oral anticoagulants has been reported in patients receiving antibacterial agents, particularly fluoroquinolones. The degree of risk may vary depending on the underlying infection, age, and general condition of the patient, and it is therefore difficult to accurately assess the effect of ciprofloxacin on the increase in the International Normalized Ratio (INR). Frequent monitoring of INR should be performed during and immediately after concomitant use of ciprofloxacin and vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, fluindione).
Ropinirole
In clinical studies, it was found that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, resulted in an increase in Cmax and AUC of ropinirole by 60% and 84%, respectively. Monitoring of side effects of ropinirole and appropriate dose adjustment are recommended during and immediately after concomitant use with ciprofloxacin (see section 4.4).
Clozapine
After concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Clinical monitoring and appropriate dose adjustment of clozapine are recommended during and immediately after concomitant administration with ciprofloxacin (see section 4.4).
Lidocaine
Concomitant use of ciprofloxacin, a moderate inhibitor of cytochrome CYP450 1A2 isoenzymes, and lidocaine-containing medicinal products has been reported to reduce the clearance of intravenous lidocaine by 22%. Despite the normal tolerability of lidocaine treatment, an interaction with ciprofloxacin is possible with concomitant use, which is associated with adverse reactions.
Sildenafil
Cmax and AUC of sildenafil increased approximately 2-fold in healthy volunteers after oral administration of 50 mg sildenafil with 500 mg ciprofloxacin. Therefore, caution should be exercised when co-administering ciprofloxacin with sildenafil, taking into account the risk/benefit ratio.
Duloxetine
In clinical studies, it has been shown that concomitant use of duloxetine with potent inhibitors of the CYP450 1A2 isoenzyme, such as fluvoxamine, may result in an increase in Cmax and AUC of duloxetine. Although there are no clinical data on a possible interaction with ciprofloxacin, similar effects can be expected with the simultaneous use of these drugs (see section "Special instructions").
Cyclosporine
Transient increases in plasma creatinine have been reported with concomitant use of ciprofloxacin and cyclosporine-containing medicinal products. Therefore, frequent (twice weekly) monitoring of plasma creatinine concentration is necessary in such patients.
Agomelatine
In clinical studies, fluvoxamine, a strong inhibitor of the CYP450 1A2 isoenzyme, was found to markedly inhibit the metabolism of agomelatine, resulting in a 60-fold increase in agomelatine exposure. Although no clinical data are available on a possible interaction with ciprofloxacin, a moderate inhibitor of CYP450 1A2, similar effects can be expected with concomitant use (see section 4.4).
Zolpidem
Concomitant use of ciprofloxacin may increase blood levels of zolpidem, therefore concomitant use is not recommended.
Application features
Ciprofloxacin should be avoided in patients who have previously experienced serious adverse reactions to quinolone or fluoroquinolone-containing drugs (see section 4.8). Ciprofloxacin should only be initiated in such patients if no alternative treatment options are available and after careful benefit/risk assessment (see section 4.8).
Severe infections and/or mixed infections caused by Gram-positive or anaerobic bacteria
Ciprofloxacin should not be used as monotherapy for the treatment of severe infections and infections caused by Gram-positive or anaerobic bacteria.
For the treatment of such infections, ciprofloxacin should be used in combination with appropriate antibacterial agents.
Ciprofloxacin is not recommended for the treatment of streptococcal infections due to insufficient efficacy.
Genital tract infections
Fluoroquinolone-resistant strains of Neisseria gonorrhoeae can cause gonococcal urethritis, cervicitis, epididymo-orchitis, and pelvic inflammatory disease.
Empirical therapy with ciprofloxacin for epididymo-orchitis and pelvic inflammatory disease should only be used in combination with other appropriate antibacterial agents (e.g. cephalosporins) except in clinical situations where the presence of ciprofloxacin-resistant strains of Neisseria gonorrhoeae has been excluded.
If clinical improvement does not occur after 3 days, therapy should be reviewed.
Urinary tract infections
Single doses of ciprofloxacin, which can be used for uncomplicated cystitis in premenopausal women, are thought to be less effective than longer-term therapy with the drug. This fact should be taken into account in view of the increasing level of resistance of Escherichia coli to quinolones.
Intra-abdominal infections
Data on the efficacy of ciprofloxacin in the treatment of postoperative intra-abdominal infections are limited.
Traveler's diarrhea
When choosing a drug, information on the resistance to ciprofloxacin of relevant microorganisms in the countries visited by the patient should be taken into account.
Bone and joint infections
Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of microbiological testing.
Pulmonary form of anthrax
The use of the medicinal product in humans is based on in vitro susceptibility data, animal studies and limited human data. The physician should act in accordance with national and/or international protocols for the treatment of anthrax.
Children
The use of ciprofloxacin in children should be carried out in accordance with current official recommendations. Treatment with ciprofloxacin should only be carried out by a doctor with experience in the treatment of children with cystic fibrosis and/or severe infections.
Ciprofloxacin caused arthropathy of the supporting joints in immature animals. Safety data from a randomized, double-blind study of ciprofloxacin in children (ciprofloxacin: n=335, mean age = 6.3 years; comparator: n=349, mean age = 6.2 years; age range 1 to 17 years) showed that the incidence of arthropathy, which is probably related to the drug (as distinct from clinical signs and symptoms related to joint damage), at 42 days from the start of the drug was 7.2% and 4.6% for the main and comparator groups, respectively. The incidence of drug-related arthropathy after 1 year of follow-up was 9% and 5.7%, respectively. The increase in the number of cases of arthropathy related to the drug was not statistically significant. However, treatment with ciprofloxacin in children and adolescents should only be initiated after a careful benefit/risk assessment due to the possible risk of adverse reactions involving the joints and/or surrounding tissues.
Bronchopulmonary infections in cystic fibrosis
Clinical trials included children and adolescents aged 5–17 years. There is more limited experience in children aged 1–5 years.
Complicated urinary tract infections and pyelonephritis
Treatment of urinary tract infections with ciprofloxacin should be considered when other treatment options are not available. Treatment should be based on microbiological findings. Clinical trials have evaluated the use of ciprofloxacin in children and adolescents aged 1–17 years.
Other specific severe infections
The use of ciprofloxacin may be justified by microbiological evidence in other serious infections in accordance with official guidelines or after a careful benefit/risk assessment when other treatments are not suitable or when standard treatment has failed.
The use of ciprofloxacin in specific severe infections other than those mentioned above has not been evaluated in clinical trials and clinical experience is limited. Therefore, special caution is recommended when treating patients with such infections.
Increased sensitivity
Hypersensitivity and allergic reactions, including anaphylaxis and anaphylactoid reactions, may occur after a single dose (see section 4.8) and may be life-threatening. If such a reaction occurs, ciprofloxacin should be discontinued and appropriate treatment instituted.
Prolonged, disabling and potentially irreversible adverse reactions
In patients receiving quinolones and fluoroquinolones, regardless of age and the presence of risk factors, very rare cases of long-term (several months or years) disabling and potentially irreversible serious adverse reactions affecting various body systems (musculoskeletal, nervous system, psyche and sensory organs) have been reported.
Ciprofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and a doctor should be consulted.
Musculoskeletal system
In general, ciprofloxacin should not be used in patients with a history of tendon diseases/disorders associated with the use of quinolones. However, in rare cases, after microbiological investigation of the pathogen and an assessment of the benefit/risk ratio, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, namely in cases of failure of standard therapy or bacterial resistance, when the results of microbiological investigations justify the use of ciprofloxacin.
Tendinitis and tendon rupture (not limited to the Achilles tendon), sometimes bilateral, may occur as early as 48 hours after initiation of treatment with quinolones and fluoroquinolones and even up to several months after discontinuation of treatment. The risk of developing tendinitis and tendon rupture is increased in elderly patients, patients with renal impairment, patients with organ transplants and patients receiving treatment with corticosteroids (see section 4.8). Therefore, concomitant use of corticosteroids should be avoided.
If any signs of tendinitis (e.g. painful swelling, inflammation) occur, ciprofloxacin should be discontinued and alternative treatment should be considered. The affected limb(s) should be treated appropriately (e.g. immobilization). Corticosteroids should not be used if signs of tendinopathy occur.
Patients with myasthenia gravis
Ciprofloxacin should be used with caution in patients with myasthenia gravis, as symptoms may be exacerbated (see section 4.4).
Aortic aneurysm and dissection, regurgitation/valvular insufficiency
Epidemiological studies have shown an increased risk of aortic aneurysm and dissection, as well as aortic and mitral valve regurgitation after taking fluoroquinolones, especially in the elderly. Rare cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal), and regurgitation/insufficiency of any of the heart valves have been reported in patients taking fluoroquinolones (see section "Adverse reactions").
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with a family history of aortic aneurysm or congenital heart valve disease, in patients with previously diagnosed aortic aneurysm and/or aortic dissection, in patients with valvular heart disease, and in the presence of other risk factors:
Risk factors for the development of both aortic aneurysm and/or aortic dissection and heart valve regurgitation/insufficiency: connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Behçet's disease, hypertension, rheumatoid arthritis;
Risk factors for developing aortic aneurysm and dissection: vascular disorders such as Takayasu arteritis or giant cell arteritis, atherosclerosis, Sjögren's syndrome;
Risk factors for the development of regurgitation/heart valve insufficiency: infective endocarditis.
The risk of aortic aneurysm and dissection and rupture is also increased in patients receiving concomitant systemic corticosteroids.
In case of sudden abdominal, chest or back pain, patients should seek immediate medical attention in the emergency department.
Patients should also be advised to seek immediate medical attention in the event of acute shortness of breath, new onset of palpitations, or development of abdominal or lower extremity edema.
Vision impairment
If you experience blurred vision or any noticeable effect on your eyes, you should consult a doctor immediately.
Photosensitivity
Ciprofloxacin has been shown to cause photosensitivity reactions. Patients taking ciprofloxacin are advised to avoid direct sunlight or UV radiation during treatment (see section 4.8).
Central nervous system (CNS)
Ciprofloxacin, like other quinolones, can cause seizures or lower the seizure threshold. Cases of epilepsy have been reported. Ciprofloxacin should be used with caution in patients with CNS disorders who may be predisposed to seizures or status epilepticus. If seizures occur, ciprofloxacin should be discontinued (see section 4.8).
Peripheral neuropathy
Cases of sensory or sensorimotor polyneuropathy resulting in paresthesia, hypoesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones, including ciprofloxacin. Patients taking ciprofloxacin should inform their physician before continuing treatment if they develop symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness, to prevent the development of a potentially irreversible condition (see section "Adverse Reactions").
Psychotic reactions
Psychotic reactions may occur even after the first dose of ciprofloxacin. In rare cases, depression or psychosis may progress to suicidal thoughts and actions, such as suicide or attempted suicide. In such cases, ciprofloxacin should be discontinued and appropriate measures should be taken.
Heart disorders
Fluoroquinolones, including ciprofloxacin, should be used with caution in patients with known risk factors for QT prolongation, including:
with hereditary QT prolongation syndrome;
in case of simultaneous use of drugs that may prolong the QT interval (e.g. class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, neuroleptics);
with uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia);
Elderly patients and women may be more sensitive to drugs that prolong the QT interval. Therefore, fluoroquinolones, including ciprofloxacin, should be used with caution in these groups of patients (see sections "Interaction with other medicinal products and other types of interactions", "Method of administration and dosage", "Overdose" and "Adverse reactions").
Dysglycemia
As with other quinolones, blood glucose disturbances, including both hypoglycaemia and hyperglycaemia, have been reported (see section 4.8), particularly in elderly patients, diabetic patients receiving concomitant oral hypoglycaemic agents (e.g. glibenclamide) or insulin. Close monitoring of blood glucose levels is recommended in diabetic patients.
Gastrointestinal tract
If severe and persistent diarrhoea occurs during or after treatment (even several weeks after treatment), it may indicate the development of antibiotic-associated colitis (a potentially life-threatening condition with a fatal outcome) and requires urgent treatment (see section "Adverse reactions"). In such cases, ciprofloxacin should be discontinued and appropriate therapy should be initiated. Medicinal products that inhibit peristalsis are contraindicated in this clinical situation.
Kidneys and urinary system
Crystalluria has been reported in association with the use of ciprofloxacin (see section 4.8). Patients taking ciprofloxacin should be adequately hydrated and excessive urinary alkalinity should be avoided.
Kidney dysfunction
Since ciprofloxacin is excreted mainly unchanged by the kidneys, patients with impaired renal function should be dose adjusted as indicated in the "Method of administration and dosage" section to avoid an increase in the frequency of adverse reactions caused by accumulation of ciprofloxacin.
Hepatobiliary system
Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin (see section 4.8). Treatment should be discontinued if any signs and symptoms of liver disease (such as anorexia, jaundice, dark urine, pruritus or abdominal tenderness) occur.
Glucose-6-phosphate dehydrogenase deficiency
Hemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin should be avoided in such patients unless the potential benefit outweighs the potential risk. In such cases, hemolysis should be observed.
Resistance
During or after a course of treatment with ciprofloxacin, resistant bacteria may be isolated, with or without clinically apparent superinfection. There may be a certain risk of isolation of ciprofloxacin-resistant bacteria during long courses of treatment and in the treatment of nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.
Cytochrome P450
Ciprofloxacin inhibits CYP450 1A2 and may therefore increase the serum concentrations of concomitantly administered substances that are also metabolised by this enzyme (e.g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine). Therefore, patients taking these substances concomitantly with ciprofloxacin should be closely monitored for clinical signs of overdose. Serum concentrations (e.g. theophylline) may also need to be determined (see section 4.5). The concomitant use of ciprofloxacin and tizanidine is contraindicated.
Methotrexate
Concomitant use of ciprofloxacin and methotrexate is not recommended.
Specifications
Characteristics
Active ingredient
Ciprofloxacin
Adults
Can
ATC code
J ANTIMIBRICANTS FOR SYSTEMIC USE; J01 ANTIBACTERIALS FOR SYSTEMIC USE; J01M ANTIBACTERIALS FROM THE QUINOLON GROUP; J01M A Fluoroquinolones; J01M A02 Ciprofloxacin
Country of manufacture
Slovenia
Diabetics
With caution
Dosage
500 мг
Drivers
With caution
For allergies
With caution
For children
As prescribed by a doctor, taking into account the benefit/risk ratio
Form
Film-coated tablets
Method of application
Inside, solid
Nursing
It is impossible.
Pregnant
It is impossible.
Producer
KRKA
Quantity per package
10 pcs
Trade name
Tsiprinol
Vacation conditions
By prescription
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