Ciprofloxacin | Digital tablet 500 mg, 10 pcs.
Special Price
$14.55
Regular Price
$22.00
In stock
SKU
BID494282
Release form
Film-coated tablets.
Film-coated tablets.
Release form
Film-coated tablets.
Packing
10 pcs.
Pharmacological action
Broad-spectrum antimicrobial agent from the group of fluoroquinolones.
It is bactericidal. The drug inhibits the bacterial DNA gyrase enzyme, as a result of which the replication and synthesis of bacterial cellular proteins is impaired.
Ciprofloxacin acts on gram-negative microorganisms during dormancy and division (since it affects not only DNA gyrase, but also causes cell wall lysis), and gram-positive microorganisms only during division. Low toxicity to macroorganism cells is explained by the lack of DNA gyrase in them. While taking ciprofloxacin, there is no parallel development of resistance to other antibacterial drugs that do not belong to the group of gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibacterial drugs.
Ciprofloxacin resistance develops slowly and gradually. When using ciprofloxacin, there were no cases of plasmid resistance, which often develops with the use of beta-lactam antibiotics, aminoglycosides and tetracyclines. Bacteria containing the plasmid are also highly sensitive to ciprofloxacin.
The use of ciprofloxacin does not produce parallel resistance of pathogens to antibiotics of other groups: β-lactam antibiotics, aminoglycosides, tetracyclines, macrolides, sulfonamides, derivatives of trimethoprim or nitrofuran. Therefore, ciprofloxacin is highly effective against bacteria resistant to antibiotics of these groups.
Ciprofloxacin remains effective against pathogens resistant to other gyrase inhibitors.
Due to its chemical structure, ciprofloxacin is highly effective against strains producing -lactamases.
Indications
Adults
Infectious and inflammatory diseases caused by microorganisms sensitive to ciprofloxacin:
Diseases of the lower respiratory tract (acute and chronic (acute) bronchitis, pneumonia, bronchiectatic disease, infectious complications of cystic fibrosis)
infections of the LOP organs (otitis media, acute sinusitis)
infections of the kidneys and urinary tract (cystitis, pyelonephritis)
Eye infections
complicated intra-abdominal infections (in combination with metro including adnexitis, chronic bacterial prostatitis
Gallbladder and biliary tract infections
sepsis
uncomplicated gonorrhea
typhoid fever,
campylobacteriosis, shigellosis, travelers' diarrhea srlkp dlkp infections of the skin and soft tissues (infected ulcers, wounds, burns, abscesses, phlegmon)
infection of bones and joints (osteomyelitis, septic arthritis)
infection against the background of immunodeficiency (occurring in the treatment of immunosuppressive drugs or in patients with neutropenia)
selective intestinal decontamination in patients with reduced immunity
Prevention of infections during surgical interventions.
prevention and treatment of pulmonary anthrax.
Children:
Therapy for complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years.
Prevention and treatment of pulmonary anthrax (Bacillus anthracis infection).
Contraindications
Pregnancy.
Breastfeeding period.
Children and adolescents under 18 years of age. Ciprofloxacin is not recommended for children under 18 years of age for the treatment of other infectious diseases, except for the treatment of complications of pulmonary cystic fibrosis (in children from 5 to 17 years old) caused by Pseudomonas aeruginosa, and for the treatment and prevention of pulmonary anthrax (after an alleged or proven infection with Bacillus anthracis).
Hypersensitivity to ciprofloxacin or other fluoroquinolone drugs.
Pseudomembranous colitis.
Concomitant use of ciprofloxacin and tizanidine due to clinically significant side effects (risk of pronounced decrease in blood pressure, drowsiness) associated with an increase in the concentration of tizanidine in blood plasma
Hypersensitivity to other components of the drug.
Caution:
Severe cerebral arteriosclerosis, cerebrovascular accident, organic brain damage or stroke, mental illness (depression, psychosis), epilepsy, decreased seizure threshold (or history of seizures), severe renal and / or liver failure, old age, congenital prolongation of the QT interval, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (for example, with hypokalemia, hypomagnesemia), simultaneous taking drugs that extend the QT interval (including Antarctic IA and Class III), simultaneous use with inhibitors of CYP 450 1A2 isoenzymes (including theophylline, methylxanthine, caffeine, duloxetine, clozapine), patients with a history of indications for tendon diseases, associated with the use of quinolones.
Use during pregnancy and lactation
The use of the drug during pregnancy and during breastfeeding is contraindicated.
Special instructions
It was found that ciprofloxacin, like other drugs of this class, causes arthropathy of large joints in animals. When analyzing the current safety data on the use of ciprofloxacin in children under 18 years of age, most of which have cystic fibrosis, there is no connection between damage to cartilage or joints with taking the drug. Ciprofloxacin in children is not recommended for the treatment of other diseases, except for the treatment of complications of cystic fibrosis. lungs (in children from 5 to 17 years old) associated with Pseudomonas aeruginosa and for the treatment and prevention of pulmonary anthrax (after suspected or proven infection Bacillus anthracis).
In outpatient treatment of patients with pneumonia caused by bacteria of the genus Pneumococcus, ciprofloxacin should not be used as the drug of first choice.
In some cases, adverse reactions from the central nervous system may occur after the first use of the drug. In very rare cases, psychosis can occur with suicidal attempts. In these cases, ciprofloxacin should be discontinued immediately.
In patients with a history of seizures, a history of seizures, vascular diseases, and organic brain damage due to the risk of adverse reactions from the central nervous system, ciprofloxacin should be prescribed only for "vital indications", in cases where the expected clinical effect exceeds the possible risk of side effects action of the drug.
If severe or prolonged diarrhea occurs during or after treatment with ciprofloxacin, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate withdrawal of the drug and the appointment of appropriate treatment.
The use of drugs that suppress intestinal motility is contraindicated. Patients, especially those who have had liver disease, may have cholestatic jaundice, as well as a temporary increase in the activity of “liver” transaminases and alkaline phosphatase.
Compliance with the appropriate dosage regimen is required when prescribing the drug to patients with renal and hepatic insufficiency.
Sometimes, even after taking the first dose of ciprofloxacin, allergic reactions can occur, rarely anaphylactic shock. Reception of ciprofloxacin in these cases should be stopped immediately and appropriate treatment should be carried out.
Elderly patients previously treated with glucocorticosteroids may experience cases of rupture of the Achilles tendon.
If you experience pain in the tendons or when the first signs of tendonitis appear, treatment should be discontinued due to the fact that isolated cases of inflammation and even rupture of tendons during treatment with fluoroquinolones have been described.
During treatment with ciprofloxacin, contact with direct sunlight should be avoided, since photosensitization reactions may occur with ciprofloxacin. Treatment should be discontinued if symptoms of photosensitivity are observed (for example, a change in the skin that resembles sunburn).
Ciprofloxacin is known to be a moderate inhibitor of the CYP1A2 isoenzyme.
Caution should be exercised while using ciprofloxacin and drugs metabolized by this isoenzyme, such as theophylline, methylxanthine, caffeine, as an increase in the concentration of these drugs in the blood serum can cause corresponding side effects.
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 (subject to normal diuresis) and to maintain an acidic urine reaction.
For genital infections presumably caused by fluoroquinolone resistant Neisseria gonorrhoeae strains, local information on ciprofloxacin resistance should be considered and pathogen susceptibility should be confirmed in laboratory teCmax.
Impact on the ability to drive vehicles and mechanisms:
Caution is advised to patients taking ciprofloxacin when driving and engaging in other potentially dangerous activities, requiring increased attention and speed of psychomotor reactions.
Composition
Active ingredients: ciprofloxacin hydrochloride 594.14 mg, equivalent to ciprofloxacin 500 mg.
Excipients: microcrystalline cellulose 50.08 mg, corn starch 36.62 mg, magnesium stearate 7.48 mg, purified talcum 4.56 mg, colloidal anhydrous silicon 9.36 mg, sodium starch glycolate 47.76 mg, purified water * qs
Film material: Opadray-OY-858910 white 26.88 mg, purified talc 2.44 mg, purified talc qs, purified water.
Dosage and administration
Inside an empty stomach, without chewing, with a small amount of liquid. May be taken without regard to meals. If the drug is used on an empty stomach, the active substance is absorbed faster. In this case, tablets should not be washed down with dairy products or fortified with calcium (for example, milk, yogurt, juices with a high calcium content). Calcium in normal foods does not affect the absorption of ciprofloxacin.
The dose of ciprofloxacin depends on the severity of the disease, the type of infection, the condition of the body, the age, weight and kidney function of the patient. Recommended doses:
Adults:
Lower respiratory tract infections (acute and chronic (in the acute stage) bronchitis, pneumonia, bronchiectasis, infectious complications of cystic fibrosis) mild to moderate severity - 500 mg 2 times a day, with severe course - 750 mg 2 times a day. The course of treatment is 7-14 days.
Infections of the LOP organs (otitis media, acute sinusitis) - 500 mg 2 times a day, treatment 10 days.
Infections of bones and joints (osteomyelitis, septic arthritis) - mild to moderate severity - 500 mg 2 times a day, in severe cases - 750 mg 2 times. The course of treatment is up to 4-6 weeks.
Infections of the skin and soft tissues (infected ulcers, wounds, burns, abscesses, phlegmon) of mild to moderate severity - 500 mg 2 times a day, in severe cases - 750 mg 2 times a day. The course of treatment is 7-14 days.
Campylobacteriosis, shigellosis, diarrhea of “travelers” - 500 mg 2 times a day, course of treatment 5-7 days.
Typhoid fever - 500 mg 2 times a day for 10 days.
Complicated intra-abdominal infections (in combination with metronidazole) - 500 mg 2 times a day for 7-14 days.
Infections of the kidneys and urinary tract (cystitis, pyelonephritis) - 250 mg, complicated - 500 mg 2 times a day. The course of treatment is 7-14 days. Uncomplicated cystitis in women - 250 mg 2 times a day for 3 days.
Uncomplicated gonorrhea - 250–500 mg once.
Chronic bacterial prostatitis - 500 mg 2 times a day, the course of treatment is 28 days.
Other infections (see section "Indications") - 500 mg 2 times a day. Septicemia, peritonitis (especially with infection with Pseudomonas, Staphylococcus or Streptococcus) - 750 mg 2 times a day.
Prevention and treatment of pulmonary anthrax - 500 mg 2 times a day for 60 days.
In the treatment of elderly patients, the lowest possible doses of ciprofloxacin should be used, based on the severity of the disease and creatinine clearance (for example, with creatinine clearance of 30-50 ml / min, the recommended dose of ciprofloxacin is 250-500 mg every 12 hours).
Children:
For the treatment of pulmonary cystic fibrosis complications caused by Pseudomonas aeruginosa in children aged 5 to 17 years, 20 mg / kg of body weight is prescribed orally 2 times / day. (maximum dose 1500 mg). The duration of treatment is 10-14 days.
For the prevention and treatment of pulmonary anthrax, 15 mg / kg body weight 2 times / day is prescribed orally (the maximum single dose should not be exceeded - 500 mg and the daily dose - 1000 mg).
Acceptance of the drug should begin immediately after the suspected or confirmed infection.
The total duration of ciprofloxacin administration for pulmonary anthrax is 60 days.
Side effects of the
Digestive system:
Often: nausea, diarrhea.
Infrequently: abdominal pain vomiting flatulence anorexia changes in liver function tests - alanine aminotransferase (ALT) and aspartate aminotransferase (ACT), jaundice alkaline phosphatase hyperbilirubinemia.
Rarely: candidiasis of the oral cavity, jaundice, including cholestatic, pseudomembranous colitis.
Very rare: candidiasis, hepatitis, liver tissue necrosis (in extremely rare cases progressing to life-threatening liver failure), life-threatening pseudomembranous colitis with a possible fatal outcome, pancreatitis.
From the skin:
Infrequently: rash.
From the hematopoietic system:
Infrequently: eosinophilia.
Rarely: anemia, leukopenia (granulocytopenia), leukocytosis, an increase or decrease in prothrombin, thrombocytopenia, thrombocytosis, neutropenia. Very rarely: hemolytic anemia, pancytopenia (including life-threatening), agranulocytosis, in extremely rare cases, life-threatening bone marrow depression.
Urinary:
Infrequently: increased creatinine and urea nitrogen.
From the musculoskeletal system:
Infrequently: arthralgia.
Rarely: myalgia (muscle pain), swelling of the joints.
Very rare: myasthenia gravis, tendonitis (mainly Achilles tendons), partial or complete rupture of tendons (mainly Achilles tendons), exacerbation of symptoms of myasthenia gravis, arthritis, muscle weakness, exacerbation of symptoms of myasthenia gravis.
From the central nervous system:
Infrequently: headache, dizziness, sleep disturbances, anxiety, confusion.
Rarely: migraine, hallucinations, sweating, paresthesias (including peripheral paralgesia), anxiety, nightmares, depression, tremors, convulsions, hyperesthesia, agitation, disorientation, dysesthesia, hypesthesia, vertigo.
Very rare: large seizures, unstable gait, psychosis, increased intracranial pressure, ataxia, increased muscle tone, muscle cramps, impaired coordination of movements.
Frequency unknown: peripheral neuropathy and polyneuropathy.
From the skin:
Infrequently: itching, urticaria, maculopapular rash.
Very rare: petechiae, erythema multiforme, erythema nodosum, persistent skin rashes.
On the part of the sensory organs:
Infrequently: taste disturbance.
Rarely: tinnitus, temporary hearing impairment, visual disturbances (diplopia, impaired color perception), hearing loss.
Very rarely: parosmia, anosmia.
Other:
Infrequently: asthenia (feeling weak, tired), candidiasis.
Rarely: peripheral edema, hyperglycemia, limb pain, back pain, chest pain.
Very rare: increased activity of amylase, lipase.
From the cardiovascular system:
Rarely: tachycardia, sensation of a "rush" of blood to the face, decreased blood pressure, fainting, vasodilation.
Very rare: vasculitis.
Frequency unknown: prolongation of the QT interval, ventricular arrhythmias (including pirouette type).
Allergic reactions:
Rarely: anaphylactic reactions, fever, angioedema.
Very rare: anaphylactic shock, skin rash, serum-like reactions, Stevens-Johnson syndrome (malignant exudative erythema), Lyell's syndrome (toxic epidermal necrolysis).
From the respiratory system:
Rarely: dyspnea, laryngeal edema, respiratory failure (including bronchospasm).
From the skin:
Rarely: photosensitivity reactions.
From the urogenital system:
Rarely: acute renal failure, impaired renal function, vaginal candidiasis, hematuria, crystalluria, interstitial nephritis.
In addition, the following adverse events were noted: cerebral artery thrombosis, polyuria, albuminuria, urinary retention. The relationship of these adverse events with the use of ciprofloxacin has not been reliably confirmed.
Drug interaction
With the simultaneous use of didanosine with ciprofloxacin, the effect of ciprofloxacin is reduced due to the formation of complexes of ciprofloxacin with aluminum and magnesium salts contained in didanosine.
Concomitant use of ciprofloxacin with theophylline can lead to an increase in theophylline concentration in blood plasma due to competitive inhibition in the binding sites of cytochrome P450, which leads to an increase in the half-life of theophylline and an increased risk of toxic effects associated with theophylline.
The concomitant use of sucralfate, antacids, drugs with a large buffer capacity (for example, antiretroviral drugs), as well as drugs containing aluminum, zinc, iron or magnesium ions, can cause a decrease in the absorption of ciprofloxacin, so ciprofloxacin should be taken either in 1-2 hours before or 4 hours after taking these drugs.
This restriction does not apply to antacids belonging to the class of H2 receptor blockers.
The simultaneous use of ciprofloxacin, dairy products or mineral-fortified drinks (such as milk, yogurt, calcium-fortified orange juice) should be avoided, as this may reduce the absorption of ciprofloxacin. However calcium part of other foods does not significantly affect the absorption of ciprofloxacin.
With the combined use of ciprofloxacin and omeprazole, there may be a slight decrease in the maximum concentration (Cmax) of the drug in blood plasma and a decrease in the area under the concentration-time curve (AUC).
A combination of very high doses of quinolones (gyrase inhibitors) and some non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) can cause seizures.
With the simultaneous use of ciprofloxacin and anticoagulants (including warfarin), bleeding time lengthens.
With the simultaneous use of ciprofloxacin and cyclosporine, the nephrotoxic effect of the latter is enhanced. With simultaneous therapy with ciprofloxacin and cyclosporine, a short-term increase in plasma creatinine concentration was observed. In such cases, it is necessary to determine the concentration of creatinine in the blood twice a week.
In some cases, the simultaneous use of ciprofloxacin and glibenclamide may enhance the effect of glibenclamide (hypoglycemia).
Co-administration of uricosuric drugs, including probenecid, slows down the rate of ciprofloxacin elimination by the kidneys (up to 59%) and increases the concentration of ciprofloxacin in the blood plasma.
With the simultaneous administration of ciprofloxacin, tubular transport (renal metabolism) of methotrexate may be slowed, which may be accompanied by an increase in the concentration of methotrexate in blood plasma. In this case, the likelihood of side effects of methotrexate may increase. In this regard, patients receiving combination therapy with methotrexate and ciprofloxacin should be closely monitored.
Metoclopramide accelerates the absorption of ciprofloxacin, shortening the period of time required to reach its maximum concentration in blood plasma. In this case, the bioavailability of ciprofloxacin does not change.
As a result of a clinical study involving healthy volunteers with the simultaneous use of ciprofloxacin and tizanidine, an increase in the concentration of tizanidine in blood plasma was revealed: an increase in Cmax by 7 times (from 4 to 21 times), an increase in AUC by 10 times (from 6 to 24 times). With an increase in the concentration of tizanidine in serum, hypotensive and sedative side effects are associated. Thus, the simultaneous use of ciprofloxacin and tizanidine is contraindicated.
Ciprofloxacin may be used in combination with other antibiotics. As shown in in vitro studies, the combined use of ciprofloxacin and -Lactam antibiotics, as well as aminoglycosides, was accompanied mainly by an additive and indifferent effect, relatively rarely, an increase in the action of both drugs was observed, and very rarely, a decrease.
Overdose
In the event of an overdose with oral administration, reversible toxic effects on the renal parenchyma were noted in several cases. Therefore, in the case of overdose, in addition to carrying out standard activities (gastric lavage, use of vomiting, the introduction of a large amount of fluid, creating an acidic urine reaction), it is also recommended to monitor the function of the kidneys and take magnesium and calcium-containing antacids that reduce the absorption of ciprofloxacin.
No specific antidote known. It is necessary to carefully monitor the patient's condition, to do gastric lavage, to carry out usual emergency measures, to ensure sufficient fluid intake. With hemo- and peritoneal dialysis, only a small amount (less than 10%) of the drug can be removed.
Storage conditions
Do not store above 25 РC, protected from moisture.
Keep out of the reach and sight of children.
Shelf life
3 years.
Deystvuyushtee substance
Ciprofloxacin
Terms and conditions
prescription
dosage form
tablets
Possible product names
FIGURE 0.5 N10 TABLE P / O
Digital tablet 500mg tab. cover film about. X10 (R)
Digital 500mg No. 10
Digital 500mg No. 10 tab
Digital 500MG. No. 10 TAB.
San Pharmaceutical Industries Ltd, India
Film-coated tablets.
Packing
10 pcs.
Pharmacological action
Broad-spectrum antimicrobial agent from the group of fluoroquinolones.
It is bactericidal. The drug inhibits the bacterial DNA gyrase enzyme, as a result of which the replication and synthesis of bacterial cellular proteins is impaired.
Ciprofloxacin acts on gram-negative microorganisms during dormancy and division (since it affects not only DNA gyrase, but also causes cell wall lysis), and gram-positive microorganisms only during division. Low toxicity to macroorganism cells is explained by the lack of DNA gyrase in them. While taking ciprofloxacin, there is no parallel development of resistance to other antibacterial drugs that do not belong to the group of gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibacterial drugs.
Ciprofloxacin resistance develops slowly and gradually. When using ciprofloxacin, there were no cases of plasmid resistance, which often develops with the use of beta-lactam antibiotics, aminoglycosides and tetracyclines. Bacteria containing the plasmid are also highly sensitive to ciprofloxacin.
The use of ciprofloxacin does not produce parallel resistance of pathogens to antibiotics of other groups: β-lactam antibiotics, aminoglycosides, tetracyclines, macrolides, sulfonamides, derivatives of trimethoprim or nitrofuran. Therefore, ciprofloxacin is highly effective against bacteria resistant to antibiotics of these groups.
Ciprofloxacin remains effective against pathogens resistant to other gyrase inhibitors.
Due to its chemical structure, ciprofloxacin is highly effective against strains producing -lactamases.
Indications
Adults
Infectious and inflammatory diseases caused by microorganisms sensitive to ciprofloxacin:
Diseases of the lower respiratory tract (acute and chronic (acute) bronchitis, pneumonia, bronchiectatic disease, infectious complications of cystic fibrosis)
infections of the LOP organs (otitis media, acute sinusitis)
infections of the kidneys and urinary tract (cystitis, pyelonephritis)
Eye infections
complicated intra-abdominal infections (in combination with metro including adnexitis, chronic bacterial prostatitis
Gallbladder and biliary tract infections
sepsis
uncomplicated gonorrhea
typhoid fever,
campylobacteriosis, shigellosis, travelers' diarrhea srlkp dlkp infections of the skin and soft tissues (infected ulcers, wounds, burns, abscesses, phlegmon)
infection of bones and joints (osteomyelitis, septic arthritis)
infection against the background of immunodeficiency (occurring in the treatment of immunosuppressive drugs or in patients with neutropenia)
selective intestinal decontamination in patients with reduced immunity
Prevention of infections during surgical interventions.
prevention and treatment of pulmonary anthrax.
Children:
Therapy for complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years.
Prevention and treatment of pulmonary anthrax (Bacillus anthracis infection).
Contraindications
Pregnancy.
Breastfeeding period.
Children and adolescents under 18 years of age. Ciprofloxacin is not recommended for children under 18 years of age for the treatment of other infectious diseases, except for the treatment of complications of pulmonary cystic fibrosis (in children from 5 to 17 years old) caused by Pseudomonas aeruginosa, and for the treatment and prevention of pulmonary anthrax (after an alleged or proven infection with Bacillus anthracis).
Hypersensitivity to ciprofloxacin or other fluoroquinolone drugs.
Pseudomembranous colitis.
Concomitant use of ciprofloxacin and tizanidine due to clinically significant side effects (risk of pronounced decrease in blood pressure, drowsiness) associated with an increase in the concentration of tizanidine in blood plasma
Hypersensitivity to other components of the drug.
Caution:
Severe cerebral arteriosclerosis, cerebrovascular accident, organic brain damage or stroke, mental illness (depression, psychosis), epilepsy, decreased seizure threshold (or history of seizures), severe renal and / or liver failure, old age, congenital prolongation of the QT interval, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (for example, with hypokalemia, hypomagnesemia), simultaneous taking drugs that extend the QT interval (including Antarctic IA and Class III), simultaneous use with inhibitors of CYP 450 1A2 isoenzymes (including theophylline, methylxanthine, caffeine, duloxetine, clozapine), patients with a history of indications for tendon diseases, associated with the use of quinolones.
Use during pregnancy and lactation
The use of the drug during pregnancy and during breastfeeding is contraindicated.
Special instructions
It was found that ciprofloxacin, like other drugs of this class, causes arthropathy of large joints in animals. When analyzing the current safety data on the use of ciprofloxacin in children under 18 years of age, most of which have cystic fibrosis, there is no connection between damage to cartilage or joints with taking the drug. Ciprofloxacin in children is not recommended for the treatment of other diseases, except for the treatment of complications of cystic fibrosis. lungs (in children from 5 to 17 years old) associated with Pseudomonas aeruginosa and for the treatment and prevention of pulmonary anthrax (after suspected or proven infection Bacillus anthracis).
In outpatient treatment of patients with pneumonia caused by bacteria of the genus Pneumococcus, ciprofloxacin should not be used as the drug of first choice.
In some cases, adverse reactions from the central nervous system may occur after the first use of the drug. In very rare cases, psychosis can occur with suicidal attempts. In these cases, ciprofloxacin should be discontinued immediately.
In patients with a history of seizures, a history of seizures, vascular diseases, and organic brain damage due to the risk of adverse reactions from the central nervous system, ciprofloxacin should be prescribed only for "vital indications", in cases where the expected clinical effect exceeds the possible risk of side effects action of the drug.
If severe or prolonged diarrhea occurs during or after treatment with ciprofloxacin, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate withdrawal of the drug and the appointment of appropriate treatment.
The use of drugs that suppress intestinal motility is contraindicated. Patients, especially those who have had liver disease, may have cholestatic jaundice, as well as a temporary increase in the activity of “liver” transaminases and alkaline phosphatase.
Compliance with the appropriate dosage regimen is required when prescribing the drug to patients with renal and hepatic insufficiency.
Sometimes, even after taking the first dose of ciprofloxacin, allergic reactions can occur, rarely anaphylactic shock. Reception of ciprofloxacin in these cases should be stopped immediately and appropriate treatment should be carried out.
Elderly patients previously treated with glucocorticosteroids may experience cases of rupture of the Achilles tendon.
If you experience pain in the tendons or when the first signs of tendonitis appear, treatment should be discontinued due to the fact that isolated cases of inflammation and even rupture of tendons during treatment with fluoroquinolones have been described.
During treatment with ciprofloxacin, contact with direct sunlight should be avoided, since photosensitization reactions may occur with ciprofloxacin. Treatment should be discontinued if symptoms of photosensitivity are observed (for example, a change in the skin that resembles sunburn).
Ciprofloxacin is known to be a moderate inhibitor of the CYP1A2 isoenzyme.
Caution should be exercised while using ciprofloxacin and drugs metabolized by this isoenzyme, such as theophylline, methylxanthine, caffeine, as an increase in the concentration of these drugs in the blood serum can cause corresponding side effects.
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 (subject to normal diuresis) and to maintain an acidic urine reaction.
For genital infections presumably caused by fluoroquinolone resistant Neisseria gonorrhoeae strains, local information on ciprofloxacin resistance should be considered and pathogen susceptibility should be confirmed in laboratory teCmax.
Impact on the ability to drive vehicles and mechanisms:
Caution is advised to patients taking ciprofloxacin when driving and engaging in other potentially dangerous activities, requiring increased attention and speed of psychomotor reactions.
Composition
Active ingredients: ciprofloxacin hydrochloride 594.14 mg, equivalent to ciprofloxacin 500 mg.
Excipients: microcrystalline cellulose 50.08 mg, corn starch 36.62 mg, magnesium stearate 7.48 mg, purified talcum 4.56 mg, colloidal anhydrous silicon 9.36 mg, sodium starch glycolate 47.76 mg, purified water * qs
Film material: Opadray-OY-858910 white 26.88 mg, purified talc 2.44 mg, purified talc qs, purified water.
Dosage and administration
Inside an empty stomach, without chewing, with a small amount of liquid. May be taken without regard to meals. If the drug is used on an empty stomach, the active substance is absorbed faster. In this case, tablets should not be washed down with dairy products or fortified with calcium (for example, milk, yogurt, juices with a high calcium content). Calcium in normal foods does not affect the absorption of ciprofloxacin.
The dose of ciprofloxacin depends on the severity of the disease, the type of infection, the condition of the body, the age, weight and kidney function of the patient. Recommended doses:
Adults:
Lower respiratory tract infections (acute and chronic (in the acute stage) bronchitis, pneumonia, bronchiectasis, infectious complications of cystic fibrosis) mild to moderate severity - 500 mg 2 times a day, with severe course - 750 mg 2 times a day. The course of treatment is 7-14 days.
Infections of the LOP organs (otitis media, acute sinusitis) - 500 mg 2 times a day, treatment 10 days.
Infections of bones and joints (osteomyelitis, septic arthritis) - mild to moderate severity - 500 mg 2 times a day, in severe cases - 750 mg 2 times. The course of treatment is up to 4-6 weeks.
Infections of the skin and soft tissues (infected ulcers, wounds, burns, abscesses, phlegmon) of mild to moderate severity - 500 mg 2 times a day, in severe cases - 750 mg 2 times a day. The course of treatment is 7-14 days.
Campylobacteriosis, shigellosis, diarrhea of “travelers” - 500 mg 2 times a day, course of treatment 5-7 days.
Typhoid fever - 500 mg 2 times a day for 10 days.
Complicated intra-abdominal infections (in combination with metronidazole) - 500 mg 2 times a day for 7-14 days.
Infections of the kidneys and urinary tract (cystitis, pyelonephritis) - 250 mg, complicated - 500 mg 2 times a day. The course of treatment is 7-14 days. Uncomplicated cystitis in women - 250 mg 2 times a day for 3 days.
Uncomplicated gonorrhea - 250–500 mg once.
Chronic bacterial prostatitis - 500 mg 2 times a day, the course of treatment is 28 days.
Other infections (see section "Indications") - 500 mg 2 times a day. Septicemia, peritonitis (especially with infection with Pseudomonas, Staphylococcus or Streptococcus) - 750 mg 2 times a day.
Prevention and treatment of pulmonary anthrax - 500 mg 2 times a day for 60 days.
In the treatment of elderly patients, the lowest possible doses of ciprofloxacin should be used, based on the severity of the disease and creatinine clearance (for example, with creatinine clearance of 30-50 ml / min, the recommended dose of ciprofloxacin is 250-500 mg every 12 hours).
Children:
For the treatment of pulmonary cystic fibrosis complications caused by Pseudomonas aeruginosa in children aged 5 to 17 years, 20 mg / kg of body weight is prescribed orally 2 times / day. (maximum dose 1500 mg). The duration of treatment is 10-14 days.
For the prevention and treatment of pulmonary anthrax, 15 mg / kg body weight 2 times / day is prescribed orally (the maximum single dose should not be exceeded - 500 mg and the daily dose - 1000 mg).
Acceptance of the drug should begin immediately after the suspected or confirmed infection.
The total duration of ciprofloxacin administration for pulmonary anthrax is 60 days.
Side effects of the
Digestive system:
Often: nausea, diarrhea.
Infrequently: abdominal pain vomiting flatulence anorexia changes in liver function tests - alanine aminotransferase (ALT) and aspartate aminotransferase (ACT), jaundice alkaline phosphatase hyperbilirubinemia.
Rarely: candidiasis of the oral cavity, jaundice, including cholestatic, pseudomembranous colitis.
Very rare: candidiasis, hepatitis, liver tissue necrosis (in extremely rare cases progressing to life-threatening liver failure), life-threatening pseudomembranous colitis with a possible fatal outcome, pancreatitis.
From the skin:
Infrequently: rash.
From the hematopoietic system:
Infrequently: eosinophilia.
Rarely: anemia, leukopenia (granulocytopenia), leukocytosis, an increase or decrease in prothrombin, thrombocytopenia, thrombocytosis, neutropenia. Very rarely: hemolytic anemia, pancytopenia (including life-threatening), agranulocytosis, in extremely rare cases, life-threatening bone marrow depression.
Urinary:
Infrequently: increased creatinine and urea nitrogen.
From the musculoskeletal system:
Infrequently: arthralgia.
Rarely: myalgia (muscle pain), swelling of the joints.
Very rare: myasthenia gravis, tendonitis (mainly Achilles tendons), partial or complete rupture of tendons (mainly Achilles tendons), exacerbation of symptoms of myasthenia gravis, arthritis, muscle weakness, exacerbation of symptoms of myasthenia gravis.
From the central nervous system:
Infrequently: headache, dizziness, sleep disturbances, anxiety, confusion.
Rarely: migraine, hallucinations, sweating, paresthesias (including peripheral paralgesia), anxiety, nightmares, depression, tremors, convulsions, hyperesthesia, agitation, disorientation, dysesthesia, hypesthesia, vertigo.
Very rare: large seizures, unstable gait, psychosis, increased intracranial pressure, ataxia, increased muscle tone, muscle cramps, impaired coordination of movements.
Frequency unknown: peripheral neuropathy and polyneuropathy.
From the skin:
Infrequently: itching, urticaria, maculopapular rash.
Very rare: petechiae, erythema multiforme, erythema nodosum, persistent skin rashes.
On the part of the sensory organs:
Infrequently: taste disturbance.
Rarely: tinnitus, temporary hearing impairment, visual disturbances (diplopia, impaired color perception), hearing loss.
Very rarely: parosmia, anosmia.
Other:
Infrequently: asthenia (feeling weak, tired), candidiasis.
Rarely: peripheral edema, hyperglycemia, limb pain, back pain, chest pain.
Very rare: increased activity of amylase, lipase.
From the cardiovascular system:
Rarely: tachycardia, sensation of a "rush" of blood to the face, decreased blood pressure, fainting, vasodilation.
Very rare: vasculitis.
Frequency unknown: prolongation of the QT interval, ventricular arrhythmias (including pirouette type).
Allergic reactions:
Rarely: anaphylactic reactions, fever, angioedema.
Very rare: anaphylactic shock, skin rash, serum-like reactions, Stevens-Johnson syndrome (malignant exudative erythema), Lyell's syndrome (toxic epidermal necrolysis).
From the respiratory system:
Rarely: dyspnea, laryngeal edema, respiratory failure (including bronchospasm).
From the skin:
Rarely: photosensitivity reactions.
From the urogenital system:
Rarely: acute renal failure, impaired renal function, vaginal candidiasis, hematuria, crystalluria, interstitial nephritis.
In addition, the following adverse events were noted: cerebral artery thrombosis, polyuria, albuminuria, urinary retention. The relationship of these adverse events with the use of ciprofloxacin has not been reliably confirmed.
Drug interaction
With the simultaneous use of didanosine with ciprofloxacin, the effect of ciprofloxacin is reduced due to the formation of complexes of ciprofloxacin with aluminum and magnesium salts contained in didanosine.
Concomitant use of ciprofloxacin with theophylline can lead to an increase in theophylline concentration in blood plasma due to competitive inhibition in the binding sites of cytochrome P450, which leads to an increase in the half-life of theophylline and an increased risk of toxic effects associated with theophylline.
The concomitant use of sucralfate, antacids, drugs with a large buffer capacity (for example, antiretroviral drugs), as well as drugs containing aluminum, zinc, iron or magnesium ions, can cause a decrease in the absorption of ciprofloxacin, so ciprofloxacin should be taken either in 1-2 hours before or 4 hours after taking these drugs.
This restriction does not apply to antacids belonging to the class of H2 receptor blockers.
The simultaneous use of ciprofloxacin, dairy products or mineral-fortified drinks (such as milk, yogurt, calcium-fortified orange juice) should be avoided, as this may reduce the absorption of ciprofloxacin. However calcium part of other foods does not significantly affect the absorption of ciprofloxacin.
With the combined use of ciprofloxacin and omeprazole, there may be a slight decrease in the maximum concentration (Cmax) of the drug in blood plasma and a decrease in the area under the concentration-time curve (AUC).
A combination of very high doses of quinolones (gyrase inhibitors) and some non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) can cause seizures.
With the simultaneous use of ciprofloxacin and anticoagulants (including warfarin), bleeding time lengthens.
With the simultaneous use of ciprofloxacin and cyclosporine, the nephrotoxic effect of the latter is enhanced. With simultaneous therapy with ciprofloxacin and cyclosporine, a short-term increase in plasma creatinine concentration was observed. In such cases, it is necessary to determine the concentration of creatinine in the blood twice a week.
In some cases, the simultaneous use of ciprofloxacin and glibenclamide may enhance the effect of glibenclamide (hypoglycemia).
Co-administration of uricosuric drugs, including probenecid, slows down the rate of ciprofloxacin elimination by the kidneys (up to 59%) and increases the concentration of ciprofloxacin in the blood plasma.
With the simultaneous administration of ciprofloxacin, tubular transport (renal metabolism) of methotrexate may be slowed, which may be accompanied by an increase in the concentration of methotrexate in blood plasma. In this case, the likelihood of side effects of methotrexate may increase. In this regard, patients receiving combination therapy with methotrexate and ciprofloxacin should be closely monitored.
Metoclopramide accelerates the absorption of ciprofloxacin, shortening the period of time required to reach its maximum concentration in blood plasma. In this case, the bioavailability of ciprofloxacin does not change.
As a result of a clinical study involving healthy volunteers with the simultaneous use of ciprofloxacin and tizanidine, an increase in the concentration of tizanidine in blood plasma was revealed: an increase in Cmax by 7 times (from 4 to 21 times), an increase in AUC by 10 times (from 6 to 24 times). With an increase in the concentration of tizanidine in serum, hypotensive and sedative side effects are associated. Thus, the simultaneous use of ciprofloxacin and tizanidine is contraindicated.
Ciprofloxacin may be used in combination with other antibiotics. As shown in in vitro studies, the combined use of ciprofloxacin and -Lactam antibiotics, as well as aminoglycosides, was accompanied mainly by an additive and indifferent effect, relatively rarely, an increase in the action of both drugs was observed, and very rarely, a decrease.
Overdose
In the event of an overdose with oral administration, reversible toxic effects on the renal parenchyma were noted in several cases. Therefore, in the case of overdose, in addition to carrying out standard activities (gastric lavage, use of vomiting, the introduction of a large amount of fluid, creating an acidic urine reaction), it is also recommended to monitor the function of the kidneys and take magnesium and calcium-containing antacids that reduce the absorption of ciprofloxacin.
No specific antidote known. It is necessary to carefully monitor the patient's condition, to do gastric lavage, to carry out usual emergency measures, to ensure sufficient fluid intake. With hemo- and peritoneal dialysis, only a small amount (less than 10%) of the drug can be removed.
Storage conditions
Do not store above 25 РC, protected from moisture.
Keep out of the reach and sight of children.
Shelf life
3 years.
Deystvuyushtee substance
Ciprofloxacin
Terms and conditions
prescription
dosage form
tablets
Possible product names
FIGURE 0.5 N10 TABLE P / O
Digital tablet 500mg tab. cover film about. X10 (R)
Digital 500mg No. 10
Digital 500mg No. 10 tab
Digital 500MG. No. 10 TAB.
San Pharmaceutical Industries Ltd, India
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