Product Overview
Composition
1 coated tablet contains ciprofloxacin hydrochloride monohydrate in a dose,
pharmachologic effect
Tsiprolet is an antimicrobial drug of the fluoroquinolone group.
plays an important role in the reproduction of bacterial DNA.
and reproduction.
The spectrum of action of ciprofloxacin includes the following types of gram (-) and gram (+) microorganisms:
Proteus (indole-positive and indole-negative), Providencia, Morganella, Yersinia, Vibrio, Aeromonas,
Plesiomonas, Pasteurella, Haemlobacteris, Campusella , Moraxella, Branhamella,
Acinetobacter, Brucella, Staphylococcus, Sreptococcus agalactiae, Listeria, Corynebacterium, Chlamydia.
Ciprofloxacin is effective against beta-lactamase-producing bacteria.
Streptococcus pyogenes, Streptococcus pneumonia, Streptococcus viridans, Mycoplasma hominis, Mycobacterium tuberculosis,
Mycobacterium fortuitum.
Anaerobes are, with some exceptions, moderately sensitive (Peptococcus, Peptostreptococcus) or resistant (Bacteroides).
Ciprofloxacin has no effect on Treponema pallidum and fungi.
there is no plasmid resistance.
aminoglycosides or tetracyclines.
Ciprofloxacin does not disturb the normal intestinal and vaginal microflora.
Pharmacokinetics:
Maximum plasma concentrations are reached after 60-90 minutes.
Ciprofloxacin penetrates well into organs and tissues.
Approximately 2 hours after ingestion or intravenous administration, it is found in tissues and body fluids at many times higher concentrations than in blood serum.
Ciprofloxacin is excreted from the body mainly unchanged, mainly through the kidneys.
Significant amounts of the drug are also excreted in bile and feces,
therefore only significant renal dysfunction leads to a slowdown in excretion.
Indications
Uncomplicated and complicated infections caused by microorganisms sensitive to ciprofloxacin.
Adults
- respiratory tract infections. Ciprofloxacin is recommended for pneumonia caused by Klebsiella spp.,
Enterobacter spp., Proteus spp., Escherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis,
Legionella spp. and staphylococci;
- infections of the middle ear (otitis media), paranasal sinuses (sinusitis), especially if these infections are caused by gram-negative microorganisms, including Pseudomonas aeruginosa or staphylococci;
- eye infections;
- infections of the kidneys and / or urinary tract;
- genital infections, including adnexitis, gonorrhea, prostatitis;
- infections of the abdominal cavity (bacterial infections of the gastrointestinal tract, biliary tract, peritonitis);
- infections of the skin and soft tissues;
- sepsis;
- infections or prevention of infections in immunosuppressed patients (patients taking immunosuppressants or patients with neutropenia);
- Selective bowel decontamination in immunocompromised patients;
- prevention and treatment of pulmonary anthrax (infection with Bacillus anthracis);
- prevention of invasive infections caused by Neisseria meningitidis.
It is necessary to take into account the current official guidelines on the rules for the use of antibacterial drugs.
Children
- treatment of complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years old;
- prevention and treatment of pulmonary anthrax (infection with Bacillus anthracis).
Adults
- respiratory tract infections. Ciprofloxacin is recommended for pneumonia caused by Klebsiella spp.,
Enterobacter spp., Proteus spp., Escherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis,
Legionella spp. and staphylococci;
- infections of the middle ear (otitis media), paranasal sinuses (sinusitis), especially if these infections are caused by gram-negative microorganisms, including Pseudomonas aeruginosa or staphylococci;
- eye infections;
- infections of the kidneys and / or urinary tract;
- genital infections, including adnexitis, gonorrhea, prostatitis;
- infections of the abdominal cavity (bacterial infections of the gastrointestinal tract, biliary tract, peritonitis);
- infections of the skin and soft tissues;
- sepsis;
- infections or prevention of infections in immunosuppressed patients (patients taking immunosuppressants or patients with neutropenia);
- Selective bowel decontamination in immunocompromised patients;
- prevention and treatment of pulmonary anthrax (infection with Bacillus anthracis);
- prevention of invasive infections caused by Neisseria meningitidis.
It is necessary to take into account the current official guidelines on the rules for the use of antibacterial drugs.
Children
- treatment of complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years old;
- prevention and treatment of pulmonary anthrax (infection with Bacillus anthracis).
Application during pregnancy and lactation
The safety of using ciprofloxacin in pregnant women has not been established.
However, based on the results of animal studies, the possibility of adverse effects on the articular cartilage of newborns cannot be completely ruled out, therefore, ciprofloxacin should not be prescribed to pregnant women.
At the same time, in the course of studies on animals, teratogenic effects (malformations) have not been established.
Ciprofloxacin is excreted in breast milk.
Contraindications
Hypersensitivity to ciprofloxacin or other drugs from the fluoroquinolone group,
Simultaneous use of ciprofloxacin and tizanidine due to clinically significant side effects (hypotension, drowsiness),
With care:
Severe liver failure and diseases of the central nervous system (CNS):
renal failure; damage to the tendons during previous treatment with quinolones;
increased risk of QT interval prolongation or pirouette arrhythmias
[eg, congenital long QT interval syndrome, heart disease
(heart failure, myocardial infarction, bradycardia), or electrolyte imbalance
simultaneous use with inhibitors of isoenzyme 1A2
(including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine); myasthenia gravis;
deficiency of glucose-6-phosphate dehydrogenase;
use in elderly patients.
as well as excipients (see section "Composition").
associated with an increase in the concentration of tizanidine in blood plasma (see section "Interaction with other drugs").
Severe liver failure and diseases of the central nervous system (CNS):
epilepsy, a decrease in the seizure threshold (or a history of seizures);
pronounced atherosclerosis of the vessels of the brain; violation of cerebral circulation;
organic brain damage or stroke; mental illness (depression, psychosis);
increased risk of QT interval prolongation or pirouette arrhythmias
[eg, congenital long QT interval syndrome, heart disease
(heart failure, myocardial infarction, bradycardia), or electrolyte imbalance
(for example, with hypokalemia, hypomagnesemia)];
simultaneous use of drugs that prolong the QT interval (including antiarrhythmic class IA and III, tricyclic antidepressants, macrolides, antipsychotics);
(including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine); myasthenia gravis;
deficiency of glucose-6-phosphate dehydrogenase;
use in elderly patients.
Side effects
The adverse reactions listed below were classified as follows:
"very often" (> 1/10 appointments), "often" (1/10 - 1/100 appointments),
"infrequently" (1/100 - 1/1000 appointments), "rarely "(1/1000 - 1/10 000 appointments),
Adverse reactions that were recorded only during post-marketing observations and the frequency of which was not assessed
Infectious and parasitic diseases
Blood and lymphatic system disorders
Uncommon - eosinophilia;
rarely - leukopenia, anemia, neutropenia, leukocytosis, thrombocytopenia, thrombocythemia;
Immune system disorders
Rarely - allergic reactions, allergic edema / angioedema;
Metabolic and nutritional disorders
Uncommon - decreased appetite and food intake;
Mental disorders
Uncommon - psychomotor hyperactivity / agitation;
often - confusion and disorientation, anxiety, disturbed dreams (nightmares), depression (increased behavior with the purpose of self-harm, such as suicidal acts / thoughts, as well as attempted suicide or successful suicide), hallucinations;
Nervous system disorders
Uncommon - headache, dizziness, sleep disturbance;
rarely - paresthesia and dysesthesia, hypesthesia, tremor, convulsions (including epileptic seizures), vertigo;
Violations of the organ of vision
Hearing disorders and labyrinthine disorders
Rarely - tinnitus, hearing loss;
Heart disorders
Vascular disorders
Rarely - vasodilation, lowering of blood pressure, feeling of "rush" of blood to the face;
Respiratory, Chest and Mediastinal Disorders
Disorders from the gastrointestinal tract
Often - nausea, diarrhea; infrequently - vomiting, abdominal pain, dyspepsia, flatulence;
Liver and biliary tract disorders
Uncommon - increased activity of "hepatic" transaminases, increased concentration of bilirubin;
rarely - liver dysfunction, jaundice, hepatitis (non-infectious);
Violations of the skin and subcutaneous tissues
Uncommon - rash, itching, urticaria; rarely - photosensitivity, blistering;
Musculoskeletal and connective tissue disorders
Uncommon - arthralgia; rarely - myalgia, arthritis, increased muscle tone, muscle cramps;
Renal and urinary tract
disorders Uncommon - renal dysfunction;
General disorders and disorders at the injection site
Often - reactions at the injection site;
infrequently - pain syndrome of non-specific etiology, general malaise, fever;
Laboratory and instrumental data
Uncommon - increased activity of alkaline phosphatase in the blood; rarely - a change in the content of prothrombin, an increase in amylase activity; frequency unknown - increased international normalized ratio (INR) in patients receiving vitamin K antagonists.
The incidence of the following adverse reactions with intravenous administration and with the use of stepwise therapy with ciprofloxacin (with intravenous administration of the drug followed by its intake) is higher than when the drug is taken orally:
Rarely - pancytopenia, bone marrow depression, anaphylactic shock, psychotic reactions, migraine, olfaction disorders, hearing impairment, vasculitis, pancreatitis, liver tissue necrosis, petechiae, tendon rupture.
Children - Children have been frequently reported to develop arthropathies.
"very often" (> 1/10 appointments), "often" (1/10 - 1/100 appointments),
"infrequently" (1/100 - 1/1000 appointments), "rarely "(1/1000 - 1/10 000 appointments),
"Very rare" (<1 / 10,000 appointments), "often unknown".
marked "unknown".
Uncommon - mycotic superinfection; rarely - pseudomembranous colitis (in very rare cases with a possible fatal outcome).
Uncommon - eosinophilia;
rarely - leukopenia, anemia, neutropenia, leukocytosis, thrombocytopenia, thrombocythemia;
very rarely - hemolytic anemia, agranulocytosis, pancytopenia (life-threatening), bone marrow suppression (life-threatening).
Rarely - allergic reactions, allergic edema / angioedema;
very rarely - anaphylactic reactions, anaphylactic shock (life-threatening), serum sickness.
Uncommon - decreased appetite and food intake;
rarely - hyperglycemia, hypoglycemia.
Uncommon - psychomotor hyperactivity / agitation;
often - confusion and disorientation, anxiety, disturbed dreams (nightmares), depression (increased behavior with the purpose of self-harm, such as suicidal acts / thoughts, as well as attempted suicide or successful suicide), hallucinations;
very rarely - psychotic reactions (increased behavior for the purpose of self-harm, such as suicidal acts / thoughts, as well as attempted suicide or successful suicide).
Uncommon - headache, dizziness, sleep disturbance;
rarely - paresthesia and dysesthesia, hypesthesia, tremor, convulsions (including epileptic seizures), vertigo;
very rarely - migraine, impaired coordination of movements, impaired sense of smell, hyperesthesia, intracranial hypertension (cerebral pseudotumor symptoms); frequency unknown - peripheral neuropathy and polyneuropathy.
Rarely - visual disturbances; very rarely - a violation of color perception.
Rarely - tinnitus, hearing loss;
very rarely - hearing impairment.
Rarely - tachycardia; frequency unknown - lengthening of the QT interval, ventricular arrhythmias (including the "pirouette" type) *.
Rarely - vasodilation, lowering of blood pressure, feeling of "rush" of blood to the face;
very rarely - vasculitis.
Rarely, breathing disorder (including bronchospasm).
Often - nausea, diarrhea; infrequently - vomiting, abdominal pain, dyspepsia, flatulence;
very rarely - pancreatitis.
Uncommon - increased activity of "hepatic" transaminases, increased concentration of bilirubin;
rarely - liver dysfunction, jaundice, hepatitis (non-infectious);
very rarely - necrosis of liver tissue (in extremely rare cases, progressing to life-threatening liver failure).
Uncommon - rash, itching, urticaria; rarely - photosensitivity, blistering;
very rarely - petechiae, small form erythema multiforme, erythema nodosum, Stevens-Johnson syndrome (malignant exudative erythema), including potentially life-threatening Lyell's syndrome (toxic epidermal necrolysis), including potentially life-threatening; frequency unknown - acute generalized pustular exanthema.
Uncommon - arthralgia; rarely - myalgia, arthritis, increased muscle tone, muscle cramps;
very rarely - muscle weakness, tendonitis, tendon rupture (mainly Achilles), exacerbation of myasthenia gravis symptoms.
disorders Uncommon - renal dysfunction;
rarely - renal failure, hematuria, crystalluria, tubulointerstitial nephritis.
Often - reactions at the injection site;
infrequently - pain syndrome of non-specific etiology, general malaise, fever;
rarely - edema, sweating (hyperhidrosis); very rarely - gait disturbance.
Uncommon - increased activity of alkaline phosphatase in the blood; rarely - a change in the content of prothrombin, an increase in amylase activity; frequency unknown - increased international normalized ratio (INR) in patients receiving vitamin K antagonists.
* - more often in patients with a predisposition to the development of lengthening of the QT interval.
Often - vomiting, increased activity of "liver" transaminases, rash.
Uncommon - thrombocytopenia, thrombocythemia, confusion and disorientation, hallucinations, paresthesia and dysesthesia, convulsions, vertigo, visual impairment, hearing loss, tachycardia, vasodilation, decreased blood pressure, reversible liver dysfunction, jaundice, renal failure, edema.
Children - Children have been frequently reported to develop arthropathies.
Interaction
With the simultaneous use of Ciprolet with didanosine, the absorption of ciprofloxacin is reduced due to the formation of complexes of ciprofloxacin with aluminum and magnesium salts contained in didanosine.
Simultaneous reception of Tsiprolet and theophylline can lead to an increase in the concentration of theophylline in the blood plasma,
due to competitive inhibition in the binding sites of cytochrome P450, which leads to an increase in T1 / 2 of theophylline and an increase in the risk of developing toxic effects associated with theophylline.
Simultaneous administration of antacids, as well as preparations containing aluminum, zinc, iron or magnesium ions, can cause a decrease in the absorption of ciprofloxacin, therefore the interval between the appointment of these drugs should be at least 4 hours.
With the simultaneous use of Tsiprolet and anticoagulants, the bleeding time is lengthened.
With the simultaneous use of Ciprolet and cyclosporine, the nephrotoxic effect of the latter is enhanced.
How to take, course of administration and dosage
The dose of Tsiprolet depends on the severity of the disease, the type of infection, the condition of the body, age, body weight and kidney function.
In uncomplicated diseases of the kidneys and urinary tract, 250 mg is prescribed 2 times / day, and in severe cases, 500 mg 2 times / day.
For diseases of the lower respiratory tract of moderate severity - 250 mg 2 times / day, and in more severe cases - 500 mg 2 times / day.
For the treatment of gonorrhea, a single dose of Ciprolet® is recommended at a dose of 250-500 mg.
For gynecological diseases, enteritis and colitis with severe course and high fever, prostatitis,
osteomyelitis is prescribed at 500 mg 2 times / day (for the treatment of common diarrhea, you can use a dose of 250 mg 2 times / day).
The tablets should be taken on an empty stomach with plenty of fluids.
The duration of treatment depends on the severity of the disease, but treatment should always be continued for at least another 2 days after the symptoms of the disease disappear.
Usually the duration of treatment is 7-10 days.
Overdose
Treatment: it is necessary to carefully monitor the patient's condition, perform a gastric lavage, carry out the usual emergency measures, and ensure an adequate supply of fluid.
With the help of hemo- or peritoneal dialysis, only a small (less than 10%) amount of the drug can be removed.
The specific antidote is unknown.
Description
White or almost white, round, biconvex, film-coated tablets with a smooth surface on both sides.
The view at the break is a white or almost white mass.
The view at the break is a white or almost white mass.
Special instructions
Severe infections, staphylococcal infections and infections due to gram-positive and anaerobic bacteria
In the treatment of severe infections, staphylococcal infections and infections due to anaerobic bacteria,
Ciprofloxacin is not recommended for the treatment of Streptococcus pneumoniae infections,
Genital tract infections
For genital infections suspected to be caused by fluoroquinolone-resistant strains of Neisseria gonorrhoeae,
Cardiac Disorders
Ciprofloxacin has an effect on prolongation of the QT interval. Given that women have a longer mean QT interval compared to men, they are more sensitive to drugs that cause QT interval prolongation.
Ciprofloxacin should be used with caution in combination with drugs that prolong the QT interval (for example, antiarrhythmics of classes I A and III, tricyclic antidepressants, macrolides and antipsychotic drugs) -
see the section "Interaction with other drugs", or in patients at increased risk prolongation of the QT interval / development of arrhythmias of the "pirouette" type (for example, with congenital prolongation of the QT interval, uncorrected electrolyte imbalance,
The use of
ciprofloxacin in children , like other drugs of this class, causes arthropathy of large joints in animals.
Hypersensitivity
In rare cases, after the first application, anaphylactic reactions may occur, including anaphylactic shock.
Gastrointestinal tract
If severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment (vancomycin orally at a dose of 250 mg 4 times a day).
Hepatobiliary system
With the use of ciprofloxacin, cases of liver necrosis and life-threatening liver failure have been observed.
Musculoskeletal system
Patients with severe myasthenia gravis should use ciprofloxacin with caution, as symptoms may worsen.
When using ciprofloxacin, there may be cases of tendonitis and tendon rupture (mainly Achilles tendon),
Inflammation and rupture of the tendon can occur even several months after stopping ciprofloxacin treatment.
Nervous system
With the use of ciprofloxacin, cases of development of status epilepticus have been reported.
Mental reactions may occur even after the first use of fluoroquinolones, including ciprofloxacin.
If the patient develops one of these reactions, you should stop taking the drug Tsiprolet and inform your doctor about it.
Skin
Cytochrome P450
Ciprofloxacin is a moderate inhibitor of CYP450 1A2 isoenzymes.
Prevention of crystalluria
Diagnostics of the infection due to Mycobacterium spp.
In vitro, ciprofloxacin may interfere with bacteriological testing of Mycobacterium tuberculosis,
Fluoroquinolones, including ciprofloxacin, can interfere with the ability of patients to drive and engage in other potentially hazardous activities that require increased attention and speed of psychomotor reactions due to the effect on the central nervous system.
In the treatment of severe infections, staphylococcal infections and infections due to anaerobic bacteria,
ciprofloxacin should be used in combination with appropriate antibacterial drugs.
Streptococcus pneumoniae infections
due to limited effectiveness against the pathogen.
For genital infections suspected to be caused by fluoroquinolone-resistant strains of Neisseria gonorrhoeae,
local information on ciprofloxacin resistance should be considered and the susceptibility of the pathogen confirmed by laboratory tests.
Ciprofloxacin has an effect on prolongation of the QT interval. Given that women have a longer mean QT interval compared to men, they are more sensitive to drugs that cause QT interval prolongation.
Elderly patients are also hypersensitive to these drugs.
see the section "Interaction with other drugs", or in patients at increased risk prolongation of the QT interval / development of arrhythmias of the "pirouette" type (for example, with congenital prolongation of the QT interval, uncorrected electrolyte imbalance,
such as hypokalemia or hypomagnesemia, as well as with heart diseases such as heart failure, myocardial infarction, bradycardia).
ciprofloxacin in children , like other drugs of this class, causes arthropathy of large joints in animals.
When analyzing the currently available data on the safety of ciprofloxacin use in children under 18 years of age, most of whom have pulmonary cystic fibrosis, no connection has been established between damage to cartilage or joints with taking the drug.
It is not recommended to use ciprofloxacin in children for the treatment of diseases other than the treatment of complications of pulmonary cystic fibrosis (in children 5 to 17 years old) associated with Pseudomonas aeruginosa and for the treatment and prevention of pulmonary anthrax (after suspected or proven infection with Bacillus anthracis).
Sometimes, after taking the first dose of ciprofloxacin, hypersensitivity to the drug may develop (see section "Side effects"), including allergic reactions, which should be immediately reported to the attending physician.
In these cases, the use of the drug ciprofloxacin should be stopped immediately and appropriate treatment carried out.
If severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment (vancomycin orally at a dose of 250 mg 4 times a day).
In this situation, the use of drugs that suppress intestinal peristalsis is contraindicated.
With the use of ciprofloxacin, cases of liver necrosis and life-threatening liver failure have been observed.
If there are symptoms of liver disease such as anorexia, jaundice, dark urine, itching, painful stomach, the use of ciprofloxacin should be discontinued.
In patients taking ciprofloxacin and having had liver disease, there may be a temporary increase in the activity of "hepatic" transaminases and alkaline phosphatase, or cholestatic jaundice.
Patients with severe myasthenia gravis should use ciprofloxacin with caution, as symptoms may worsen.
At the first signs of tendinitis (painful swelling, inflammation in the joint area), treatment with ciprofloxacin should be discontinued and physical exertion should be excluded, since there is a risk of tendon rupture, and consult a doctor.
sometimes bilaterally, already within the first 48 hours after starting therapy.
In elderly patients and in patients with tendon diseases simultaneously receiving treatment with glucocorticosteroids, there is an increased risk of tendinopathy.
Ciprofloxacin should be used with caution in patients with a history of indications of tendon disease associated with the intake of quinolones.
Ciprofloxacin, like other fluoroquinolones, can induce seizures and lower the seizure threshold.
For patients with epilepsy and previous CNS diseases (lowering the seizure threshold, history of seizures, cerebrovascular accident, organic brain damage or stroke), due to the threat of CNS side reactions, ciprofloxacin should be used only after evaluating the benefit / risk.
If seizures occur, the drug should be discontinued.
In rare cases, depression or psychotic reactions can progress to suicidal thoughts and suicidal attempts, including completed ones (see the section "Side effects").
In patients taking fluoroquinolones, including ciprofloxacin, there have been cases of sensory or sensorimotor polyneuropathy, hypesthesia, dysesthesia, or weakness.
If symptoms such as pain, burning, tingling, numbness, weakness occur, patients should inform the doctor before continuing to use the drug.
During the period of therapy, a photosensitization reaction may occur, therefore patients should avoid contact with direct sunlight and UV light.
Treatment should be discontinued if symptoms of photosensitivity are observed (for example, skin changes resemble sunburn, see section "Side effects").
Ciprofloxacin is a moderate inhibitor of CYP450 1A2 isoenzymes.
Caution should be exercised with the simultaneous use of ciprofloxacin and drugs metabolized by these enzymes (including theophylline, methylxanthine, caffeine, duloxetine, ropinirole, clozapine, olanzapine), since an increase in the concentration of these drugs in serum, due to inhibition of their metabolism by ciprofloxacin, can cause specific adverse reactions.
In order to avoid the development of crystalluria, it is unacceptable to exceed the recommended daily dose, it is also necessary to have sufficient fluid intake and maintain an acidic urine reaction.
In vitro, ciprofloxacin may interfere with bacteriological testing of Mycobacterium tuberculosis,
suppressing its growth, which can lead to false negative results in the diagnosis of this pathogen in patients taking ciprofloxacin.
Release form
Pills
Storage conditions
In a dark place at a temperature not exceeding 25 ° C.
Shelf life
3 years.
