Ciprofloxacin-Teva, 500 mg 10 pcs

Urinary tract infections, Bronchitis, Adnexitis, Salmonellosis, Otitis media, Lung inflammation (pneumonia), Infectious diseases, Respiratory tract infections, Skin infections, Eye infections, Intestinal infections

Uncomplicated and complicated infections caused by microorganisms sensitive to

ciprofloxacin.

For adult patients

• Respiratory tract infections. Ciprofloxacin is recommended for

Pneumonias caused by Klebsiella spp, Enterobacter spp., Proteus spp., Esherichia coli,

Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionella spp. and

Staphylococci;

• infections of the middle ear (otitis media), especially if these infections are caused by

Gram-negative microorganisms, including Pseudomonas aeruginosa;

• eye infections;

• Kidney infections and/or complicated urinary tract infections;

• gender organ infections, including adnexitis, gonorrhea, prostatitis;
• • infections of the abdomen (bacterial infections of the gastrointestinal tract,

  biliary tract, peritonitis;

  • Skin and soft tissue infections;
  • bone and joint infections;
  • sepsis;
  • infections or prevention of infections in immunocompromised patients

  (immunosuppressed patients or patients with neutropenia);

  • Selective intestinal decontamination in immunocompromised patients;
  • prevention and treatment of inhalational anthrax (infection with Bacillus

  anthracis);

  • prevention of invasive infections caused by Neisseria meningitides.

  To treat the following infectious and inflammatory diseases, ciprofloxacin

  can only be used as an alternative to other antimicrobial

  drugs:

  • acute sinusitis;
  • uncomplicated urinary tract infections.

  The current official guidelines for the use of antibacterial agents must be taken into consideration.

  Children

  • Treating complications caused by Pseudomonas aeruginosa in children with cystic fibrosis

  Lungs from 5 to 17 years of age;

  • prevention and treatment of inhalational anthrax (infection with Bacillus

  anthracis) from 3 to 18 years (for this dosage form).

  The use of ciprofloxacin in children should be initiated only after a benefit/risk assessment due to possible adverse effects on joints and periarticular tissues.

Indications

Uncomplicated and complicated infections caused by susceptible

ciprofloxacin by microorganisms.

For adult patients

Respiratory tract infections. Ciprofloxacin is recommended for

pneumonia caused by Klebsiella spp., Enterobacter spp., Proteus spp., Esherichia coli,

Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionella spp. And

staphylococci;

middle ear infections (otitis media), especially if these infections are caused by

gram-negative microorganisms, including Pseudomonas aeruginosa;

eye infections;
kidney infections and/or complicated urinary tract infections;
genital infections, including adnexitis, gonorrhea, prostatitis;
abdominal infections (bacterial infections of the gastrointestinal tract,

biliary tract, peritonitis);

skin and soft tissue infections;
bone and joint infections;
sepsis;
infections or prevention of infections in immunocompromised patients

(patients taking immunosuppressants or patients with neutropenia);

selective intestinal decontamination in patients with reduced immunity;
prevention and treatment of pulmonary anthrax (infection with Bacillus

anthracis);

prevention of invasive infections caused by Neisseria meningitides.

For the treatment of the following infectious and inflammatory diseases, ciprofloxacin

can only be used as an alternative to other antimicrobials

drugs:

acute sinusitis;
uncomplicated urinary tract infections.

Current official guidelines on the rules must be taken into account

use of antibacterial agents.

Children

Treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis

lungs from 5 to 17 years;

prevention and treatment of pulmonary anthrax (infection with Bacillus

anthracis) from 3 to 18 years (for this dosage form).

The use of ciprofloxacin in children should be started only after assessing the benefit/risk ratio due to possible side effects on joints and periarticular tissues

Pharmacological effect

Pharmacological group
Quinolones/fluoroquinolones

Special instructions

Severe infections, staphylococcal infections and infections caused by gram-positive and anaerobic bacteria

In the treatment of severe infections, staphylococcal infections and infections caused by anaerobic bacteria, ciprofloxacin should be used in combination with appropriate antibacterial agents.

Infections caused by Streptococcus pneumoniae

Ciprofloxacin is not recommended for the treatment of infections caused by Streptococcus pneumoniae due to its limited effectiveness against the pathogen.

Genital tract infections

For genital infections suspected of being caused by strains of Neisseria gonorrhoeae resistant to fluoroquinolones, information about local resistance to ciprofloxacin should be taken into account and the sensitivity of the pathogen should be confirmed by laboratory tests.

Urinary tract infections

Ftroquinolone resistance in Escherichia coli, the most common pathogen causing urinary tract infections, varies depending on the region of the Russian Federation. When prescribing, it is recommended to take into account the local prevalence of Escherichia coli resistance to fluoroquinolones.

Heart disorders

Ciprofloxacin has an effect on prolonging the QT interval (see section “Side effects”). Given that women have a longer average QT interval compared to men, they are more sensitive to drugs that cause QT prolongation. Elderly patients also have increased sensitivity to the effects of drugs that prolong the interval

Use ciprofloxacin with caution in combination with drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, and antipsychotics (see Drug Interactions section)) or in patients with an increased risk of QT prolongation or torsade de pointes (TdP) (e.g., congenital long interval syndrome). QT, uncorrected electrolyte imbalances such as hypokalemia or hypomagnesemia, and heart disease such as heart failure, myocardial infarction, bradycardia).

Use in children

Ciprofloxacin, like other drugs in this class, has been found to cause arthropathy of large joints in animals. When analyzing the current data on the safety of ciprofloxacin in children under 18 years of age, most of whom have cystic fibrosis, no connection was established between cartilage or joint damage and taking the drug. It is not recommended to use ciprofloxacin in children for the treatment of diseases other than the treatment of complications of cystic fibrosis of the lungs (in children from 5 to 17 years of age) associated with Pseudomonas aeruginosa and for the treatment and prevention of pulmonary anthrax (after suspected or proven infection with Bacillus anthracis).

Hypersensitivity

Sometimes, after taking the first dose of ciprofloxacin, hypersensitivity to the drug may develop (see section “Side Effects”), including allergic reactions, which should be reported to your doctor immediately. In rare cases, after the first use, anaphylactic reactions up to anaphylactic shock may occur. In these cases, the use of ciprofloxacin should be stopped immediately and appropriate treatment should be carried out.

Gastrointestinal tract

If severe and prolonged diarrhea occurs during or after treatment with ciprofloxacin, 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 motility is contraindicated.

Hepatobiliary system

When using ciprofloxacin, cases of liver necrosis and life-threatening liver failure have been reported. If you have the following signs of liver disease, such as anorexia, jaundice, dark urine, itching, a painful abdomen, you should stop taking ciprofloxacin (see section “Side effects”).

Patients taking ciprofloxacin who have had liver disease may experience a temporary increase in liver transaminases and alkaline phosphatase or cholestatic jaundice.

Musculoskeletal system

Patients with myasthenia gravis should use ciprofloxacin with caution, as exacerbation of symptoms is possible.

At the first signs of tendonitis (painful swelling in the joint area, inflammation), the use of ciprofloxacin should be stopped and physical activity should be avoided, because there is a risk of tendon rupture, and consult a doctor.

When taking ciprofloxacin, cases of tendonitis and tendon rupture (mainly the Achilles tendon), sometimes bilaterally, may occur within the first 48 hours after the start of therapy. Inflammation and rupture of the tendon may occur even several months after stopping treatment with ciprofloxacin. Elderly patients, patients with renal failure, and organ transplant patients concomitantly receiving corticosteroid treatment have an increased risk of tendinopathy.

Ciprofloxacin should be used with caution in patients with a history of tendon diseases associated with quinolones.

Nervous system

Ciprofloxacin, like other fluoroquinolones, can provoke seizures and lower the seizure threshold. In patients with epilepsy and a history of central nervous system diseases (for example, a decrease in the seizure threshold, a history of seizures, cerebrovascular accidents, organic brain lesions or stroke) due to the risk of developing adverse reactions from the central nervous system, ciprofloxacin should be used only in cases where the expected clinical effect outweighs the possible risk of developing side effects of the drug.

When using ciprofloxacin, cases of status epilepticus have been reported (see section “Side effects”).

If seizures occur, use of the drug should be discontinued.

Psychiatric reactions may occur even after the first use of fluoroquinolones, including ciprofloxacin. In rare cases, depression or psychotic reactions may progress to suicidal ideation and suicide completion (see section “Side effects”). In case of development of any side effects from the central nervous system, including mental disorders, it is necessary to immediately discontinue the drug Ciprofloxacin-Teva and start

appropriate therapy. In these cases, it is recommended to switch to therapy with an antibiotic other than a fluoroquinolone, if possible.

In patients taking fluoroquinolones, including ciprofloxacin, cases of sensory or sensorimotor polyneuropathy, hypoesthesia, dysesthesia or weakness have been reported. If symptoms such as pain, burning, tingling, numbness, or weakness occur, patients should inform their doctor before continuing to use the drug.

Skin

When taking ciprofloxacin, a photosensitivity reaction may occur, so patients should avoid contact with direct sunlight and UV light.

Treatment should be stopped if symptoms of photosensitivity are observed (for example, changes in the skin reminiscent of sunburn, see section “Side effects”).

Cytochrome P450

Ciprofloxacin is known to be a moderate inhibitor of CYP450 1A2 isoenzymes. Caution should be exercised when using ciprofloxacin simultaneously with drugs metabolized by these enzymes, such as theophylline.

methylxanthine, caffeine, duloxetine, ropinirole, clozapine, olanzapine, agomelatine – since the increase in the concentration of these drugs in the blood serum is caused

inhibition of their metabolism by ciprofloxacin may cause specific adverse reactions. The simultaneous use of ciprofloxacin and tizanidine is contraindicated.

To avoid the development of crystalluria, it is unacceptable to exceed the recommended daily dose; sufficient fluid intake and maintaining an acidic urine reaction are also necessary.

In vitro, ciprofloxacin may interfere with the bacteriological study of Mycobacterium tuberculosis, inhibiting its growth, which can lead to false negatives

results in diagnosing this pathogen in patients taking ciprofloxacin.

Dysglycemia

As with other fluoroquinolones, changes in blood glucose concentrations, including hypo- and hyperglycemia, are possible when using ciprofloxacin. During therapy

ciprofloxacin dysglycemia may occur more often in elderly patients and patients with diabetes mellitus receiving concomitant oral therapy

hypoglycemic drugs (for example, sulfonylureas) or insulin. When using ciprofloxacin in such patients, the risk of developing

hypoglycemia, up to hypoglycemic coma. It is necessary to inform patients about the symptoms of hypoglycemia (confusion, dizziness, ravenous appetite, headache, nervousness, palpitations or increased heart rate, pale skin, perspiration, trembling, weakness). If the patient develops hypoglycemia, treatment with ciprofloxacin should be stopped immediately and appropriate therapy should be initiated. In these cases, it is recommended to switch to therapy with another antibiotic other than

fluoroquinolones, if possible. When treating with ciprofloxacin in elderly patients and patients with diabetes mellitus, careful monitoring of blood glucose concentrations is recommended.

Aneurysm and aortic dissection

Epidemiological studies have reported an increased risk of aortic aneurysm and aortic dissection after taking fluoroquinolones, especially in elderly patients.

Fluoroquinolones should therefore only be used after careful benefit/risk assessment and consideration of other treatment options in patients with a family history of aortic aneurysm or in patients with a known aneurysm

aortic aneurysm and/or aortic dissection or in the presence of other risk factors or conditions predisposing to the development of aortic aneurysm or aortic dissection (eg, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behçet’s disease, hypertension, atherosclerosis).

In case of sudden pain in the abdomen, chest, or back, patients should immediately seek medical attention at the emergency room.

Influence on the ability to drive vehicles and machinery

Fluoroquinolones, including ciprofloxacin, may impair the ability of patients to drive a car and engage in other potentially hazardous activities that require increased attention and speed of psychomotor reactions due to their effect on the central nervous system.

Active ingredient

Ciprofloxacin

Composition

1 tablet contains:

active substance:

ciprofloxacin 500.0 mg (ciprofloxacin hydrochloride monohydrate 582.2 mg);

excipients: microcrystalline cellulose 73.30 mg, povidone K-30 37.50 mg, croscarmellose sodium 42.00 mg, colloidal silicon dioxide 7.50 mg, magnesium stearate 7.50 mg;

shell Opadry white Y-1-7000H: hypromellose – 6.250 mg, titanium dioxide 3.1250 mg, macrogol-400 – 0.6250 mg.

Pregnancy

The use of ciprofloxacin is contraindicated during pregnancy and breastfeeding. The safety of 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 excluded, and therefore ciprofloxacin should not be prescribed to pregnant women. In animal studies, no teratogenic effects (malformations) were established.

Ciprofloxacin is excreted into breast milk. Due to the potential risk of damage to articular cartilage in newborns, ciprofloxacin should not be given to breastfeeding women.

Use in children

The use of ciprofloxacin is contraindicated in children under 3 years of age (for this dosage form and dosage). Ciprofloxacin is not recommended for use in children

up to 18 years of age for the treatment of other infectious diseases, except for the treatment of complications of cystic fibrosis of the lungs (in children from 5 to 17 years of age) caused by Pseudomonas aeruginosa, and for the treatment and prevention of pulmonary anthrax (after suspected or

proven infection with Bacillus anthracis). The use of ciprofloxacin in children 9 should be started only after assessing the benefit/risk ratio due to possible

side effects on joints and periarticular tissues.

With caution

For diseases of the central nervous system: epilepsy, decreased seizure threshold (or a history of seizures), severe cerebral atherosclerosis, cerebrovascular accident, organic brain lesions or stroke; mental illness (depression, psychosis); severe renal and/or liver failure, tendon damage during previous treatment with quinolones; increased risk of prolongation of the QT interval or the development of torsades de pointes (for example, congenital long QT syndrome, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (for example, hypokalemia, hypomagnesemia)); simultaneous use of drugs that prolong the QT interval (including class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics);

simultaneous use with inhibitors of the CYP450 1A2 isoenzyme (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine,

agomelatine); myasthenia gravis; deficiency of glucose-6-phosphate dehydrogenase; use in elderly patients; in patients with a family history of aortic aneurysm or in patients with a known aortic aneurysm and/or aortic dissection or

presence of other risk factors or conditions that predispose to the development of aortic aneurysm or aortic dissection (eg, Marfan syndrome, Ehlers-Danlos syndrome

vascular type, Takayasu arteritis, giant cell arteritis, Behcet’s disease, arterial hypertension, atherosclerosis) (see section “Special instructions”).

Contraindications

Hypersensitivity to ciprofloxacin or other drugs from the group

fluoroquinolones, as well as excipients (see section “Composition”).

The simultaneous use of ciprofloxacin and tizanidine due to clinical

significant side effects (hypotension, drowsiness) associated with increased

concentrations of tizanidine in blood plasma (see section “Interaction with other

medicines”).

Children under 3 years of age (for this dosage form and dosage).
Pregnancy.
Breastfeeding period.

Side Effects

The adverse reactions listed below are classified as follows:

“very often” (≥ 10), “often” (from ≥1/100 to <1/10), “infrequently” (from ≥1/1000 to <1/100),

“rare” (from ≥1/10,000 to <1/1000), “very rare” (≤ 10,000), “frequency unknown.”

Adverse reactions that were recorded only during post-marketing

observations, and the frequency of which has not been estimated, are designated “frequency unknown.”

Infectious and parasitic diseases

Uncommon: mycotic superinfections.

Rare: pseudomembranous colitis (in very rare cases, possibly fatal)

outcome)

Blood and lymphatic system disorders

Uncommon: eosinophilia.

Rarely: leukopenia, anemia, neutropenia, leukocytosis, thrombocytopenia, thrombocythemia.

Very rare: hemolytic anemia, agranulocytosis, pancytopenia (life-threatening),

bone marrow suppression (life-threatening).

Immune system disorders

Rarely: allergic reactions, allergic edema/angioedema.

Very rare: anaphylactic reactions, anaphylactic shock (life-threatening),

serum sickness.

Endocrine system disorders

Frequency unknown: syndrome of inappropriate antidiuretic hormone secretion.

Metabolic and nutritional disorders

Uncommon: decreased appetite and amount of food eaten.

Rarely: hyperglycemia, hypoglycemia.

Frequency unknown: severe hypoglycemia, up to the development of hypoglycemic

coma, especially in elderly patients, patients with diabetes mellitus, taking

oral hypoglycemic drugs or insulin.

Mental disorders

Uncommon: psychomotor hyperactivity/agitation.

Rare: confusion and disorientation, anxiety, dream disturbance

(nightmares), depression (increased self-harm behavior such as

suicidal acts/thoughts, as well as attempted suicide or successful suicide),

hallucinations.

Very rare: psychotic reactions (increased behavior with the aim of self-harm, such

such as suicidal acts/thoughts, as well as attempted suicide or successful suicide).

Frequency unknown: impaired attention, nervousness, memory impairment, delirium.

Nervous system disorders

Uncommon: headache, dizziness, sleep disturbance, taste disturbance.

Rarely: paresthesia and dysesthesia, hypoesthesia, tremor, convulsions (including seizures

epilepsy), vertigo.

Very rare: migraine, impaired coordination of movements, impaired sense of smell,

hyperesthesia, intracranial hypertension (cerebral pseudotumor symptoms).

Frequency unknown: peripheral neuropathy and polyneuropathy.

Visual disorders

Rarely: visual disturbances.

Very rare: impaired color perception.

Hearing and labyrinth disorders

Rare: tinnitus, hearing loss.

Very rare: hearing impairment.

Heart disorders

Rarely: tachycardia.

Frequency unknown: QT interval prolongation, ventricular arrhythmias (including torsade de pointes)*.

Vascular disorders

Rarely: vasodilation, decreased blood pressure, fainting.

Very rare: vasculitis.

Respiratory, thoracic and mediastinal disorders

Rarely: breathing problems (including bronchospasm).

Gastrointestinal disorders

Common: nausea, diarrhea.

Uncommon: vomiting, abdominal pain, dyspepsia, flatulence.

Very rare: pancreatitis.

Disorders of the liver and biliary tract

Uncommon: increased activity of liver transaminases, increased bilirubin concentration.

Rarely: liver dysfunction, jaundice, hepatitis (non-infectious).

Very rare: necrosis of liver tissue (in extremely rare cases, progressing to life-threatening liver failure).

Skin and subcutaneous tissue disorders

Uncommon: rash, itching, urticaria.

Rarely: photosensitivity, blistering.

Very rare: petechiae, minor erythema multiforme, erythema nodosum, syndrome

Stevens-Johnson (malignant exudative erythema), including potentially life-threatening; Lyell’s syndrome (toxic epidermal necrolysis), including potentially life-threatening ones.

Frequency unknown: acute generalized pustular exanthema.

Musculoskeletal and connective tissue disorders

Uncommon: arthralgia.

Rarely: myalgia, arthritis, increased muscle tone, muscle cramps.

Very rare: muscle weakness, tendonitis, tendon rupture (mainly Achilles), exacerbation of myasthenia gravis symptoms.

Renal and urinary tract disorders

Uncommon: renal dysfunction.

Rarely: renal failure, hematuria, crystalluria, tubulointerstitial nephritis.

General and administration site disorders

Uncommon: pain of nonspecific etiology, general malaise, fever.

Rarely: swelling, sweating (hyperhidrosis).

Very rare: gait disturbance.

Influence on the results of laboratory and instrumental studies

Uncommon: increased alkaline phosphatase activity in the blood.

Rarely: changes in prothrombin levels, increased amylase activity.

Not known: increased INR (in patients receiving vitamin K antagonists).

*more often in patients who are predisposed to developing prolongation of the QT interval.

The incidence of the following adverse reactions with intravenous administration and with

the use of step therapy with ciprofloxacin (with intravenous administration of the drug followed by oral administration) is higher than when taking the drug orally:

often – vomiting, increased activity of “liver” transaminases, rash;

uncommon – thrombocytopenia, thrombocythemia, confusion and disorientation,

hallucinations, paresthesia and dysesthesia, convulsions, vertigo, visual impairment, loss

hearing loss, tachycardia, vasodilation, decreased blood pressure, reversible liver dysfunction, jaundice, renal failure, edema;

rarely – pancytopenia, bone marrow depression, anaphylactic shock, psychotic

reactions, migraine, olfactory impairment, hearing impairment, vasculitis, pancreatitis, liver tissue necrosis, petechiae, tendon rupture.

Children

Arthropathy has been frequently reported in children.

The incidence of arthropathy (arthralgia, arthritis) listed above is based on clinical studies in adult patients. In children, the incidence of arthropathy is assessed as frequent.

Interaction

Drugs that cause QT prolongation

Caution should be exercised when ciprofloxacin, like other fluoroquinolones, is used concomitantly in patients receiving drugs that cause

prolongation of the QT interval (for example, class I A or class III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics) (see section “Special Instructions”).

Chelation formation

Simultaneous intake of tablet forms of ciprofloxacin and cation-containing drugs, mineral supplements containing calcium, magnesium, aluminum, iron,

sucralfate, antacids, polymeric phosphate compounds (such as sevelamer, lanthanum carbonate) and drugs with a large buffer capacity (such as tablets

didanosine) containing magnesium, aluminum or calcium, reduces the absorption of ciprofloxacin. In such cases, ciprofloxacin should be taken either 1-2 hours before,

or 4 hours after taking these drugs.

This restriction does not apply to medicinal products belonging to the class

H2-histamine receptor blockers.

Eating food and dairy products

The concomitant use of ciprofloxacin and dairy products or mineral-fortified drinks (eg, milk, yogurt, calcium-fortified orange juice) should be avoided as absorption of ciprofloxacin may be impaired.

decrease. However, calcium contained in other foods does not significantly affect the absorption of ciprofloxacin.

Metoclopramide

Metoclopramide accelerates the absorption of ciprofloxacin (when taken orally), resulting in a shorter time to reach maximum plasma concentrations of ciprofloxacin. No effect on the bioavailability of ciprofloxacin was found.

Omeprazole

With the simultaneous use of ciprofloxacin and drugs containing omeprazole, there may be a slight decrease in the maximum concentration of the drug in plasma and a decrease in the area under the concentration-time pharmacokinetic curve.

Theophylline

The simultaneous use of ciprofloxacin and drugs containing theophylline may cause an undesirable increase in the concentration of theophylline in the blood plasma and,

accordingly, the occurrence of theophylline-induced adverse events; in very rare cases these adverse events may be life-threatening

patient. If the simultaneous use of these two drugs is unavoidable, it is recommended to constantly monitor the concentration of theophylline in the blood plasma and, if necessary, reduce the dose of theophylline (see section “Special instructions”, cytochrome P450).

Other xanthine derivatives

The simultaneous use of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline) may lead to an increase in the concentration of xanthine derivatives in the blood serum.

Nonsteroidal anti-inflammatory drugs

The combination of very high doses of quinolones (DNA gyrase inhibitors) and some non-steroidal anti-inflammatory drugs (except acetylsalicylic acid) can provoke seizures.

Cyclosporine

With the simultaneous use of ciprofloxacin and drugs containing cyclosporine, a short-term transient increase in plasma creatinine concentration was observed. In such cases, it is necessary to determine twice a week

creatinine concentration in the blood.

Oral hypoglycemic agents

With the simultaneous use of ciprofloxacin and oral hypoglycemic agents, mainly sulfonylureas (for example, glibenclamide, glimepiride), the development of hypoglycemia is presumably due to an increased effect of oral hypoglycemic agents (see section “Side effects”).

Probenecid

Probenecid slows down the rate of excretion of ciprofloxacin by the kidneys. The simultaneous use of ciprofloxacin and drugs containing probenecid leads to an increase in the concentration of ciprofloxacin in the blood plasma.

Phenytoin18

With the simultaneous use of ciprofloxacin and phenytoin, a change (increase or decrease) in the content of phenytoin in the blood plasma was observed. To avoid

to weaken the anticonvulsant effect of phenytoin due to a decrease in its concentration, as well as to prevent adverse events associated with an overdose of phenytoin when discontinuing ciprofloxacin, it is recommended

monitor phenytoin therapy in patients taking both drugs, including measuring phenytoin plasma levels throughout the entire period

simultaneous use of both drugs and for a short time after completion of combination therapy.

Methotrexate

With the simultaneous use of methotrexate and ciprofloxacin, the renal tubular transport of methotrexate may slow down, which may be accompanied by an increase in the concentration of methotrexate in the blood plasma. This may increase the likelihood of developing side effects of methotrexate. In this regard, patients receiving concomitant therapy with methotrexate and ciprofloxacin should be closely monitored.

Tizanidine

As a result of a clinical study involving healthy volunteers, with the simultaneous use of ciprofloxacin and drugs containing tizanidine, an increase in the concentration of tizanidine in the blood serum was revealed: an increase in the maximum concentration (Cmax) by 7 times (from 4 to 21 times), an increase in the AUC (area under the pharmacokinetic concentration-time curve) by 10 times (from 6 to 24 times). An increase in tizanidine serum concentrations may cause a decrease in blood pressure and drowsiness. Therefore, the simultaneous use of ciprofloxacin and drugs containing tizanidine is contraindicated.

Duloxetine

Clinical studies have shown that simultaneous

the use of duloxetine and potent inhibitors of the CYP450 1A2 isoenzyme (such as fluvoxamine) may lead to an increase in the AUC and Cmax of duloxetine. Although there is no clinical data on possible interactions with ciprofloxacin, the likelihood of such an interaction can be anticipated when ciprofloxacin and duloxetine are used concomitantly.

Ropinirole

The simultaneous use of ropinirole and ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, leads to an increase in the Cmax and AUC of ropinirole by 60 and 84%19, respectively. Monitor for adverse effects of ropinirole during coadministration with ciprofloxacin and for a short time thereafter.

completion of combination therapy.

Lidocaine

In a study on healthy volunteers, it was found that the simultaneous use of drugs containing lidocaine and ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, leads to a decrease in the clearance of lidocaine by 22%

when administered intravenously. Despite the good tolerability of lidocaine

simultaneous use with ciprofloxacin may increase side effects due to interaction (see section “Special instructions”, Cytochrome P450).

Clozapine

With simultaneous use of clozapine and ciprofloxacin at a dose of 250 mg for 7 days, an increase in serum concentrations of clozapine and N-desmethylclozapine by 29% and 31%, respectively, was observed. The condition should be monitored

patient and, if necessary, adjust the dosage regimen of clozapine during its combined use with ciprofloxacin and for a short time

after completion of combination therapy (see section “Special Instructions”, Cytochrome P450).

Sildenafil

With simultaneous use in healthy volunteers of ciprofloxacin at a dose of 500 mg

and sildenafil at a dose of 50 mg, there was a 2-fold increase in Cmax and AUC of sildenafil. In this regard, the use of this combination is possible only after assessing the benefit/risk ratio.

Agomelatine

In clinical studies, it was demonstrated that fluvoxamine, being a strong inhibitor of the CYP450 1A2 isoenzyme, significantly inhibits metabolism

agomelatine, resulting in a 60-fold increase in agomelatine exposure. Although there is no clinical evidence of a possible interaction with ciprofloxacin, a moderate CYP450 1A2 inhibitor, similar effects can be expected when agomelatine and ciprofloxacin are administered concomitantly.

Zolpidem

With the simultaneous use of zolpidem and ciprofloxacin, an increase in the concentration of zolpidem in the blood plasma is possible. The simultaneous use of drugs containing these substances is not recommended.

Vitamin K antagonists

Concomitant use of ciprofloxacin and vitamin K antagonists (eg,

warfarin, acenocoumarol, phenprocoumon, fluindon) can lead to an increase in their anticoagulant effect. The magnitude of this effect may vary depending on

concomitant infections, age and general condition of the patient, so it is difficult to assess

the effect of ciprofloxacin on increasing MHO (international normalized ratio). MHO should be monitored fairly frequently during joint

the use of ciprofloxacin and vitamin K antagonists, as well as for a short time after completion of combination therapy.

Overdose

Treatment: specific antidote is unknown.

It is necessary to carefully monitor the patient’s condition, perform gastric lavage, carry out the usual emergency measures, and ensure sufficient fluid intake.

Using hemo- or peritoneal dialysis, only a small (less than 10%) amount of the drug can be removed.

Storage conditions

Store at a temperature not exceeding 25°C.
Keep out of the reach of children.

Shelf life

3 years. Do not use after expiration date.

Manufacturer

Teva Pharmaceutical Works Private Limited Company, Hungary