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:India
Diabetics:With caution
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Ciprofloxacin Euro film-coated tablets 500 mg blister No. 10
249.16 грн.
Description
Instructions Ciprofloxacin Euro film-coated tablets 500 mg blister No. 10
Composition
active ingredient: ciprofloxacin;
1 tablet of 250 mg contains 297 mg of ciprofloxacin hydrochloride, which corresponds to 250 mg of ciprofloxacin;
1 tablet of 500 mg contains 594 mg of ciprofloxacin hydrochloride, which corresponds to 500 mg of ciprofloxacin;
Main physicochemical properties: round biconvex tablets, film-coated, white to yellowish-white (250 mg); capsule-shaped tablets, film-coated, with a score on one side, white to yellowish-white (500 mg).
Pharmacotherapeutic group
Antibacterials for systemic use. Fluoroquinolone group. ATX code J01M A02.
Pharmacological properties
Pharmacodynamics.
Mechanism of action.
Ciprofloxacin is highly effective in vitro against a wide range of Gram-negative and Gram-positive pathogens. The mechanism of antibacterial action is due to the ability of ciprofloxacin to inhibit type II topoisomerases (DNA gyrase and topoisomerase IV), which are essential for many processes of the DNA life cycle, such as replication, transcription, repair and recombination.
Efficacy mainly depends on the ratio between the maximum serum concentration (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for the bacterial pathogen and on the value of the area under the curve (AUC) and MIC.
Resistance to ciprofloxacin in vitro is usually associated with target site mutations that arise in bacterial topoisomerases and DNA gyrase by multistep mutations. Single mutations are more likely to result in reduced susceptibility than clinical resistance. However, multiple mutations usually result in clinical resistance to ciprofloxacin and cross-resistance to quinolones.
Resistance mechanisms that inactivate other antibiotics, such as decreased permeability of the bacterial outer wall (inherent in Pseudomonas aeruginosa) and active drug efflux from the cell, may affect susceptibility to ciprofloxacin. Plasmid-mediated resistance encoded by the qnr antibiotic resistance gene has been reported.
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
£ 0.5 mg/l
> 1 mg/l
Pseudomonas
£ 0.5 mg/l
> 1 mg/l
Acinetobacter
£ 1 mg/l
> 1 mg/l
Staphylococcus spp.1
£ 1 mg/l
> 1 mg/l
Haemophilus influenzae and
Moraxella catarrhalis
£ 0.5 mg/l
> 0.5 mg/l
Neisseria gonorrhoeae
£ 0.03 mg/l
> 0.06 mg/l
Neisseria meningitidis
£ 0.03 mg/l
> 0.06 mg/l
Non-species related control points *
£ 0.5 mg/l
> 1 mg/l
1 Staphylococcus spp. – Ciprofloxacin breakpoints apply to high-dose therapy.
* Non-species breakpoints were determined primarily based on pharmacokinetic and pharmacodynamic data and are independent of species-specific MICs. They are only used for species that do not have their own breakpoints and not for species in which susceptibility testing is not recommended.
The prevalence of acquired resistance of isolated species may vary with location and time, therefore local information on resistance is necessary, especially when treating severe infections. Specialist advice should be sought when the local prevalence of resistance is such that the benefit of the agent, at least in some types of infections, is questionable.
The following genera and species of bacteria are generally susceptible in vitro to ciprofloxacin (for Streptococcus species, see section "Special instructions for use"):
Sensitive (usually) types of microorganisms
Gram-positive aerobic microorganisms
Bacillus anthracis (1)
Gram-negative aerobic microorganisms
Aeromonas spp.
Brucella spp.
Citrobacter koseri
Francisella tularensis
Haemophilus ducreyi
Haemophilus influenzae*
Legionella spp.
Moraxella catarrhalis*
Neisseria meningitidis
Pasteurella spp.
Salmonella spp.*
Shigella spp.*
Vibrio spp.
Yersinia pestis
Anaerobic microorganisms
Mobiluncus
Other microorganisms
Chlamydia trachomatis ($)
Chlamydia pneumoniae ($)
Mycoplasma hominis ($)
Mycoplasma pneumoniae ($)
Species in which resistance may develop
Aerobic Gram-positive microorganisms
Enterococcus faecalis ($)
Staphylococcus spp.* (2)
Aerobic Gram-negative microorganisms
Acinetobacter baumannii+
Burkholderia cepacia+*
Campylobacter spp.+*
Citrobacter freundii*
Enterobacter aerogenes
Enterobacter cloacae*
Escherichia coli*
Klebsiella oxytoca
Klebsiella pneumoniae*
Morganella morganii*
Neisseria gonorrhoeae*
Proteus mirabilis*
Providencia spp.
Pseudomonas aeruginosa*
Pseudomonas fluorescens
Serratia marcescens*
Anaerobic microorganisms
Peptostreptococcus spp.
Propionibacterium acnes
Microorganisms initially resistant to ciprofloxacin
Aerobic Gram-positive microorganisms
Actinomyces
Enterococcus faecium
Listeria monocytogenes
Aerobic Gram-negative microorganisms
Stenotrophomonas maltophilia
Anaerobic microorganisms
Except for the above
Other microorganisms
Mycoplasma genitalium
Ureaplasma urealyticum
* Clinical efficacy has been demonstrated against susceptible isolates in approved clinical indications.
+ Resistance rate ≥ 50% in one or more EU countries.
($) Natural average susceptibility in the absence of an acquired resistance mechanism.
(1) Studies in experimental animals infected by airborne Bacillus anthracis spores have shown that administration of antibiotics immediately after exposure to the pathogen helps prevent disease if the number of spores can be reduced below the infectious dose. Recommendations for the use of ciprofloxacin are based primarily on in vitro susceptibility data in animals, together with limited data from humans. Two months of oral ciprofloxacin 500 mg twice daily is considered effective in preventing anthrax infection in adults. The physician should refer to national and/or international protocols for the treatment of anthrax.
(2) Methicillin-resistant S. aureus is very often also resistant to fluoroquinolones. The rate of methicillin resistance among all staphylococcal species is about 20–50% and is usually high in hospital isolates.
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential, or reproductive toxicity.
Like many other quinolones, ciprofloxacin is phototoxic in animals at clinically relevant exposure levels. Photomutagenicity/photocarcinogenicity data indicate a weak photomutagenic or photooncogenic effect of ciprofloxacin in vitro and in animal studies. This effect is comparable to that of other gyrase inhibitors.
Research on the effects on joints
Similar to other gyrase inhibitors, ciprofloxacin may cause damage in the large weight-bearing joints of young animals.
The extent of cartilage damage varies with age, species and dose; the extent of damage can be reduced by reducing weight-bearing on the joints. Studies in adult animals (rats, dogs) have not shown any signs of cartilage damage. In a study in young beagle dogs, ciprofloxacin at therapeutic doses resulted in joint changes after two weeks of treatment that were maintained after five months.
Pharmacokinetics.
Absorption
After oral administration of ciprofloxacin tablets at a dose of 250 mg, 500 mg and 750 mg, ciprofloxacin is rapidly and well absorbed, mainly from the upper small intestine.
Maximum serum concentrations are reached after 1–2 hours.
Single doses of 100–750 mg resulted in dose-dependent maximum serum concentrations (Cmax) between 0.56 and 3.7 mg/L. Serum concentrations increased proportionally with doses up to 1000 mg.
The absolute bioavailability of the drug is 70-80%. An oral dose of ciprofloxacin 500 mg every 12 hours was characterized by a total area under the concentration-time curve (AUC) equivalent to that after intravenous infusion of 400 mg ciprofloxacin, which was carried out over 60 minutes every 12 hours.
Distribution
The percentage of ciprofloxacin binding to blood proteins is insignificant (20–30%), it is present 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 (urine, prostate, endometrium).
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 mainly unchanged by both the kidneys and the intestines. The plasma half-life in individuals with normal renal function is approximately 4–7 hours.
Ciprofloxacin elimination (% dose) after oral administration
Name
Ways of withdrawal
With urine
With feces
Ciprofloxacin
44.7
25.0
Metabolites (M1–M4)
11.3
7.5
Renal clearance is 180–300 ml/kg/h, and total clearance is 480–600 ml/kg/h. Ciprofloxacin is subject to glomerular filtration and tubular secretion. In severe renal impairment, the half-life of ciprofloxacin is up to 12 hours.
Non-renal clearance of ciprofloxacin is primarily due to transintestinal secretion and metabolism. 1% of the dose is excreted via the biliary tract. Ciprofloxacin is present in high concentrations in bile.
Children.
Pharmacokinetic data in children are limited. A study of ciprofloxacin in children did not demonstrate an age-related relationship between Cmax and AUC. No significant increase in Cmax and AUC was observed after multiple dosing (10 mg/kg three times daily). In ten children with severe sepsis aged <1 year, Cmax was 6.1 mg/l (range 4.6–8.3 mg/l) after a 1-hour intravenous infusion of 10 mg/kg. This 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 11.0–23.8 mg∗h/l) in the respective age groups. These values are within the normal range observed in adults at the therapeutic dose. Based on the patient population and pharmacokinetic analysis 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 50 to 80%.
Indication
The drug is indicated for the treatment of the following infections (see sections "Special instructions for use" and "Pharmacological properties"). 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, including bronchitis*;
- bronchopulmonary infections in cystic fibrosis or bronchiectasis;
- community-acquired pneumonia.
Chronic purulent otitis media.
Exacerbation of chronic sinusitis, especially if caused by gram-negative bacteria*.
Urinary tract infections:
- uncomplicated acute cystitis*;
- acute pyelonephritis;
- complicated urinary tract infections;
- bacterial prostatitis.
Infections affecting 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 susceptible strains of Neisseria gonorrhoeae.
Skin and soft tissue infections caused by gram-negative bacteria.
Bone and joint infections.
Malignant external otitis.
Pulmonary form of anthrax (post-exposure prophylaxis and radical treatment).
Fever in patients with neutropenia caused by 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 only be initiated by a physician experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).
*Only if other antibacterial agents commonly prescribed for the treatment of this infection are ineffective or inappropriate.
Contraindication
Do not use in case of hypersensitivity to the active substance - ciprofloxacin - or to other drugs of the fluoroquinolone group, or to any of the excipients of the medicinal product.
The simultaneous use of ciprofloxacin and tizanidine is contraindicated (see section "Interaction with other medicinal products and other types of interactions").
Interaction with other medicinal products and other types of interactions
Effect of other drugs 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
This restriction does not apply to antacids belonging to the class of H2-receptor blockers.
Food and 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 probenecid-containing medicinal products and ciprofloxacin leads to an increase in serum ciprofloxacin concentrations.
Metoclopramide
Metoclopramide accelerates the absorption of ciprofloxacin, resulting in a faster peak plasma concentration. 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 Contraindications). Concomitant administration of ciprofloxacin and tizanidine has been shown to increase plasma concentrations of tizanidine (7-fold increase in Cmax, range 4-21-fold; 10-fold increase in AUC, range 6-24-fold). Hypotensive and sedative adverse reactions are associated with increased serum concentrations of tizanidine.
Methotrexate
Concomitant administration 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. This increases the likelihood of adverse toxic reactions caused by methotrexate. Concomitant administration 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 life-threatening or 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 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.
Cyclosporine
Transient increases in plasma creatinine have been reported with concomitant administration of ciprofloxacin and cyclosporine-containing medicinal products. Therefore, frequent (twice weekly) monitoring of plasma creatinine concentrations is necessary in these patients.
Vitamin K antagonists
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 administration of ciprofloxacin and vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, fluindione).
Duloxetine
Co-administration of duloxetine with strong CYP450 1A2 inhibitors such as fluvoxamine has been reported to increase duloxetine AUC and Cmax. Although there are no clinical data on a possible interaction with ciprofloxacin, similar effects can be expected when these drugs are administered concomitantly (see section 4.4).
Ropinirole
Co-administration of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, has been shown to increase ropinirole AUC and Cmax by 60% and 84%, respectively. Monitoring for adverse reactions of ropinirole and appropriate dose adjustment are recommended during and immediately following co-administration with ciprofloxacin (see section 4.4).
Lidocaine
Concomitant use of ciprofloxacin, a moderate inhibitor of cytochrome P450 1A2, and lidocaine-containing medicinal products has been shown to reduce the clearance of intravenous lidocaine by 22% in healthy subjects. Despite the normal tolerability of lidocaine treatment, an interaction with ciprofloxacin associated with adverse reactions may occur with concomitant use of these medicinal products.
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).
Sildenafil
Cmax and AUC of sildenafil increased approximately two-fold in healthy volunteers after oral administration of 50 mg sildenafil and concomitant administration of 500 mg ciprofloxacin. Therefore, caution should be exercised when co-administering the drug with sildenafil and the risk/benefit ratio should be considered.
Oral hypoglycemic agents
Hypoglycemia has been reported with concomitant administration of ciprofloxacin and oral antidiabetic agents, especially sulfonylureas (e.g. glibenclamide, glimepiride), probably due to potentiation of the action of oral antidiabetic agents by ciprofloxacin (see section 4.8).
Duloxetine
Clinical studies have shown that concomitant use of duloxetine with strong CYP450 1A2 inhibitors, such as fluvoxamine, may result in increased AUC and Cmax of duloxetine. Although there are no clinical data on a possible interaction with ciprofloxacin, similar effects can be expected when these drugs are used concomitantly (see section 4.4).
Nonsteroidal anti-inflammatory drugs
Animal studies have shown that the combination of very high doses of quinolones (gyrase inhibitors) and certain nonsteroidal anti-inflammatory drugs (except acetylsalicylic acid) can provoke seizures.
Agomelatine
In clinical studies, fluvoxamine, a strong inhibitor of the CYP450 1A2 isoenzyme, was found to moderately 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 its simultaneous use (see “Cytochrome P450” in the “Special Instructions” section).
Zolpidem
Concomitant administration of ciprofloxacin may increase the blood level of zolpidem, therefore concomitant use of these drugs is not recommended.
Application features
Ciprofloxacin should be avoided in patients who have had a history of serious adverse reactions to quinolone or fluoroquinolone-containing medicinal products (see section 4.8). Ciprofloxacin should only be initiated in these patients if no alternative treatment options are available and after a careful benefit/risk assessment (see also section 4.8).
Aortic aneurysm/dissection and heart valve regurgitation
Epidemiological data suggest an increased risk of aortic aneurysm or dissection with the use of fluoroquinolones, especially in elderly patients.
Cases of aortic aneurysm and aortic dissection, including aortic rupture (including fatal cases), and other adverse reactions have been reported in patients receiving fluoroquinolones (see section 4.8). Fluoroquinolones should therefore only be used after careful benefit-risk assessment and after consideration of other treatment options in patients with a family or personal history of aortic aneurysm or aortic dissection, or heart failure, or in the presence of other risk factors, such as:
- risk factors for both aortic aneurysm and aortic dissection and heart failure: connective tissue diseases such as Marfan syndrome, vascular Ehlers-Danlos syndrome, Turner syndrome, Behçet's disease, hypertension, rheumatoid arthritis;
- risk factors for aortic aneurysm and dissection: vascular diseases such as Takayasu arteritis or giant cell arteritis, atherosclerosis or Sjögren's syndrome;
- risk factors for regurgitation/heart valve insufficiency: infective endocarditis.
The risk of developing aortic aneurysms and dissection, as well as their rupture, is increased in patients receiving concomitant treatment with systemic corticosteroids.
In case of sudden abdominal, chest or back pain, patients should be advised to seek immediate medical attention in the emergency department.
Patients should also seek immediate medical attention if they experience acute shortness of breath, a new attack of rapid heartbeat, or develop swelling of the abdomen or lower extremities.
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 severe infections, infections caused by staphylococci or anaerobic bacteria, ciprofloxacin should be used in combination with appropriate antibacterial agents.
Ciprofloxacin is not recommended for the treatment of streptococcal infections due to insufficient efficacy.
Infections of the reproductive system.
Accordingly, ciprofloxacin should be used for the treatment of gonococcal urethritis or cervicitis only if ciprofloxacin resistance in Neisseria gonorrhoeae has been excluded.
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.
Fluoroquinolone resistance in Escherichia coli, the most common pathogen causing urinary tract infections, varies across the European Union. Physicians are advised to consider the local prevalence of fluoroquinolone resistance in Escherichia coli when prescribing therapy.
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 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 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
Use in humans is based on in vitro susceptibility testing, animal studies and limited human data. The physician should follow 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. In 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), the incidence of arthropathy 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% in the main and comparator groups, respectively. The incidence of arthropathy related to the drug 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 treatments are not possible. Treatment should be based on microbiological results.
The use of ciprofloxacin in children has been studied in the age group of patients 1–17 years.
Other specific severe infections
The use of ciprofloxacin may be justified by microbiological evidence in other 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, caution is recommended when treating patients with such infections.
Hypersensitivity to the drug
In some cases, hypersensitivity and allergic reactions may occur after the first dose of ciprofloxacin (see section "Adverse reactions"), which should be reported to the doctor immediately.
In rare cases, anaphylactic/anaphylactoid reactions may progress to a state of shock that is life-threatening. In some cases, they have been observed after the first dose of ciprofloxacin. In such cases, ciprofloxacin should be discontinued and medical treatment (treatment of anaphylactic shock) should be initiated immediately.
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 microbiological results justify the use of ciprofloxacin. Tendinitis or tendon rupture (especially of the Achilles tendon), sometimes bilateral, may occur with ciprofloxacin during the first 48 hours of treatment. Tendon inflammation or rupture may occur even up to several months after the end of ciprofloxacin treatment. The risk of tendinopathy may be increased in elderly patients, patients with impaired renal function, patients with organ transplantation or in patients receiving concomitant corticosteroids (see section 4.8). Concomitant use of corticosteroids should be avoided.
If any signs of tendinitis (such as painful swelling, inflammation) occur, ciprofloxacin should be discontinued. The affected limb should be rested.
Corticosteroids should not be used if signs of tendinopathy are present.
Ciprofloxacin should be used with caution in patients with myasthenia gravis due to possible exacerbation of the symptoms of this disease (see section "Adverse reactions").
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).
Vision impairment
If you experience blurred vision or any noticeable effect on your eyes, you should consult a doctor immediately.
Central nervous system
Quinolones cause seizures or lower the seizure threshold. Ciprofloxacin should be used with caution in patients with CNS disorders who may be predisposed to seizures. Cases of status epilepticus have been reported. If seizures occur, ciprofloxacin should be discontinued (see section 4.8). 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 these cases, ciprofloxacin should be discontinued and appropriate measures should be taken in the clinical situation.
Heart disorders
Fluoroquinolones, including ciprofloxacin, should be used with caution in patients with known risk factors for QT prolongation, including:
- with hereditary syndrome of prolongation of the QT interval;
- in case of concomitant 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);
- in case of heart disease (e.g. heart failure, myocardial infarction, bradycardia).
Women tend to have longer QTc intervals than men and may be more sensitive to drugs that prolong the QTc interval. Elderly patients may also be more sensitive to the effects of drugs on the QT interval.
Therefore, fluoroquinolones, including ciprofloxacin, should be used with caution in these patient groups (see sections “Method of administration” and “Dosage and administration”).
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
India
Diabetics
With caution
Dosage
500 мг
Drivers
With caution
For allergies
With caution
For children
By doctor's prescription
Form
Film-coated tablets
Method of application
Inside, solid
Nursing
It is impossible.
Pregnant
It is impossible.
Producer
Unique Pharmaceutical Laboratories
Quantity per package
10 pcs
Trade name
Ciprofloxacin
Vacation conditions
By prescription
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