Orcipol film-coated tablets blister pack No. 10

Instructions Orcipol film-coated tablets blister No. 10

Composition

active ingredients: ciprofloxacin, ornidazole;

1 film-coated tablet contains ciprofloxacin (as ciprofloxacin hydrochloride) 500 mg and ornidazole 500 mg;

excipients: corn starch, sodium starch glycolate, povidone (K30), croscarmellose sodium, magnesium stearate, colloidal anhydrous silicon dioxide, talc;

shell composition: hypromellose (E 15), titanium dioxide (E 171), iron oxide yellow (E 172), propylene glycol, talc.

Dosage form

Film-coated tablets.

Main physicochemical properties: capsule-shaped, film-coated tablets, pale yellow to yellow in color, embossed with "ORCP" on one side and a score on the other.

Pharmacotherapeutic group

Combined antibacterial agents. Ciprofloxacin, ornidazole. ATX code J01R A12.

Pharmacological properties

Pharmacodynamics

Orcipol is a combined antimicrobial and antiprotozoal drug, the pharmacological action of which is due to the properties of the active substances that make up its composition: ciprofloxacin (a derivative of a second-generation fluoroquinolone) and ornidazole (a derivative of
5-nitroimidazole).

Ciprofloxacin inhibits the bacterial DNA gyrase enzyme and inhibits bacterial DNA synthesis; causes morphological changes in the membrane and cell wall of bacteria, which leads to rapid cell death. Acts on microorganisms in a state of growth and rest. Has a wide spectrum of antimicrobial action, active against a number of anaerobic gram-positive and gram-negative microorganisms: Staphylococcus spp. (including strains that produce and do not produce penicillinase, methicillin-resistant strains), Streptococcus spp. (including strains S. pneumoniae and S. pyogenes), Enterococcus spp., Listeria monocytogenes; Enterobacter spp., Haemophilus influenzae, Klebsiella spp., Legionella spp., Moraxella catarrhalis, Morganella morganii, Neisseria spp., Proteus spp., Pseudomonas aeruginosa, Salmonella spp., Shigella spp., Vibrio cholerae, Campylobacter spp., Citrobacter spp., Yersinia enterocolitica, E.coli and others - Mycobacterium tuberculosis, Chlamydia trachomatis and Mycoplasma hominis. Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroids, Treponema pallidum are resistant to ciprofloxacin.

The mechanism of action of ornidazole is associated with disruption of the structure of DNA-sensitive microorganisms. It is active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, as well as some anaerobic bacteria (including Bacteroides spp., Clostridium spp., Fusobacterium spp. and anaerobic cocci).

Pharmacokinetics

Ciprofloxacin.

Absorption.

After oral administration, ciprofloxacin is rapidly and well absorbed, mainly from the upper small intestine. Bioavailability is 70–80%. Maximum plasma concentration (Cmax) is reached after 1–2 hours.

Distribution.

The binding of ciprofloxacin to plasma proteins is insignificant (20–30%), and the substance is found in the blood plasma mainly in a non-ionized form. Ciprofloxacin can freely diffuse into the extravascular space. The significant volume of distribution at steady state, which reaches 2–3 l/kg of body weight, proves that ciprofloxacin penetrates into the tissues in concentrations that can many times exceed the level of ciprofloxacin in the blood plasma.

Metabolism.

Small concentrations of the following four metabolites of ciprofloxacin have been recorded: diethylciprofloxacin (M1), sulfociprofloxacin (M2), oxociprofloxacin (M3), and formylciprofloxacin (M4). Metabolites M1–M3 exhibit in vitro antimicrobial activity similar to or lower than that of nalidixic acid. M4 is at least equivalent to norfloxacin in terms of in vitro antimicrobial activity.

Breeding.

Ciprofloxacin is excreted mostly unchanged both by the kidneys and through the intestines.

Ornidazole.

Absorption.

After oral administration, ornidazole is rapidly absorbed from the gastrointestinal tract. Bioavailability is 90%. Cmax is reached within 3 hours.

Distribution.

The binding of ornidazole to plasma proteins is approximately 13%. It penetrates into the cerebrospinal fluid, other body fluids and tissues. The concentration of ornidazole in plasma is in the range of 6–36 mg/l.

Metabolism.

Ornidazole is metabolized in the liver to form mainly 2-hydroxymethyl and α-hydroxymethyl metabolites. Both metabolites are less active against Trichomonas vaginalis and anaerobic bacteria than unchanged ornidazole.

Breeding.

The half-life of ornidazole is approximately 13 hours. After a single dose, 85% of the dose is excreted within the first 5 days, mainly as metabolites. About 4% of the dose is excreted unchanged by the kidneys.

Special categories of patients.

Children.

The pharmacokinetics of ciprofloxacin and ornidazole in children are similar to those in adults.

Indication

Treatment of mixed infections caused by pathogens (microorganisms and protozoa) sensitive to the components of the drug.

Adults.

Urinary tract infections:

uncomplicated acute cystitis*;

acute pyelonephritis;

complicated urinary tract infections;

bacterial prostatitis.

Genital tract infections:

epididymitis.

Sexually transmitted infections.

Children.

Urinary tract infections:

complicated urinary tract infections;

acute pyelonephritis.

* Only if other antibacterial agents commonly prescribed for the treatment of such infections are considered ineffective or inappropriate.

Contraindication

Hypersensitivity to the active substances, fluoroquinolone derivatives, nitroimidazole derivatives and/or excipients of the drug.

Epilepsy, multiple sclerosis.

Central nervous system damage with a lowered seizure threshold (after traumatic brain injury, stroke, inflammatory processes in the brain and meninges).

Prolonged QT interval, uncompensated hypokalemia, concomitant use with class IA (zinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmics.

Pathological blood lesions or other hematological abnormalities.

Concomitant use with tizanidine.

Interaction with other medicinal products and other types of interactions

Ciprofloxacin.

QT-prolonging agents: Concomitant use with ciprofloxacin may prolong the QT interval. Concomitant use with QT-prolonging agents (e.g. class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) should be undertaken with caution (see section 4.4).

Chelation complex formation. When ciprofloxacin is administered orally with medicinal products containing multivalent cations and mineral supplements (such as calcium, magnesium, aluminium, iron), phosphate-binding polymers (such as sevelamer or lanthanum carbonate), sucralfate or antacids, as well as medicinal products with a high buffer capacity (such as didanosine in tablet form) containing magnesium, aluminium or calcium, the absorption of ciprofloxacin is reduced. Therefore, ciprofloxacin should be taken either 1-2 hours before or at least 4 hours after taking these medicinal products. This restriction does not apply to antacids belonging to the class of H2-receptor blockers.

Food and dairy products. Calcium in food slightly reduces the absorption of ciprofloxacin. However, simultaneous administration of ciprofloxacin and dairy or mineral-fortified products (such as milk, yogurt, calcium-fortified orange juice) should be avoided.

Probenecid: When used simultaneously with ciprofloxacin, an increase in the level of the latter in the blood plasma is possible.

Metoclopramide: When used simultaneously with ciprofloxacin, its absorption may be accelerated, resulting in a faster peak plasma concentration. No effect on the bioavailability of ciprofloxacin was observed.

Omeprazole: When used simultaneously with ciprofloxacin, a slight decrease in Cmax and AUC of the latter is possible.

Tizanidine. In a clinical study in healthy volunteers, concomitant use of ciprofloxacin and tizanidine resulted in an increase in plasma tizanidine levels (7-fold increase in Cmax, range 4-21-fold; 10-fold increase in AUC, range 6-24-fold). Hypotensive and sedative adverse reactions are associated with increased plasma tizanidine concentrations. Concomitant use of these agents is contraindicated (see Contraindications).

Methotrexate: Concomitant use with ciprofloxacin may increase the plasma levels of methotrexate, which may increase the risk of methotrexate-induced toxic reactions. Concomitant use of these agents is not recommended (see section 4.4).

Theophylline. When used simultaneously with ciprofloxacin, an increase in theophylline levels in the blood plasma is possible, which can lead to the development of adverse reactions. In isolated cases, such adverse reactions can be life-threatening or fatal. In the case of simultaneous use of these agents, it is recommended to monitor the level of theophylline in the blood plasma and, if necessary, adjust its dosage (see section "Special instructions").

Other xanthine derivatives: Increased plasma levels of these xanthine derivatives have been reported following concomitant administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline).

Nonsteroidal anti-inflammatory drugs (NSAIDs). Animal studies have shown that the combination of very high doses of quinolones (gyrase inhibitors) and certain NSAIDs (except acetylsalicylic acid) can provoke seizures.

Cyclosporine: Transient increases in plasma creatinine have been reported with concomitant use of ciprofloxacin and cyclosporine-containing medicinal products. Frequent (twice weekly) monitoring of plasma creatinine concentrations is recommended when these medicinal products are used concomitantly.

Phenytoin: Concomitant use with ciprofloxacin may increase phenytoin plasma levels. Monitoring of phenytoin plasma levels is recommended when these agents are used concomitantly.

Duloxetine: In clinical studies, it has been shown that concomitant use of duloxetine with strong CYP450 1A2 inhibitors such as fluvoxamine may result in increased AUC and Cmax of duloxetine. Although there are no clinical data on a possible interaction with ciprofloxacin, similar effects can be expected with concomitant use of these drugs (see section 4.4).

Clozapine: After concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, plasma concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Clinical monitoring and appropriate dose adjustment of clozapine are recommended during and immediately after concomitant administration with ciprofloxacin (see section 4.4).

Lidocaine: Concomitant administration of ciprofloxacin (a moderate inhibitor of cytochrome P450 1A2) and lidocaine-containing medicinal products has been shown to reduce the clearance of intravenous lidocaine by 22% in healthy subjects. Despite the normal tolerability of lidocaine treatment, an interaction with ciprofloxacin is possible, associated with adverse reactions when these agents are used concomitantly.

Ropinirole. In clinical studies, concomitant use of ropinirole with ciprofloxacin (a moderate inhibitor of the CYP450 1A2 isoenzyme) was shown to increase ropinirole Cmax and AUC by 60% and 84%, respectively. Monitoring of ropinirole side effects and appropriate dose adjustment are recommended during and immediately after concomitant use with ciprofloxacin (see section 4.4).

Sildenafil: After co-administration of 50 mg sildenafil and 500 mg ciprofloxacin, the Cmax and AUC of sildenafil increased approximately 2-fold in healthy volunteers. Caution should be exercised and the risk/benefit ratio should be considered when these agents are co-administered.

Zolpidem: Concomitant use with ciprofloxacin may increase plasma levels of zolpidem. Concomitant use of these agents is not recommended.

Agomelatine: In clinical studies, fluvoxamine (a strong inhibitor of CYP450 1A2) has been shown to significantly inhibit the metabolism of agomelatine, resulting in a 60-fold increase in agomelatine exposure. Although there are no clinical data on a possible interaction with ciprofloxacin (a moderate inhibitor of CYP450 1A2), similar effects can be expected when these drugs are used concomitantly (see section 4.4).

Ornidazole.

5-fluorouracil, phenobarbital and other inducers of liver enzymes. The circulation period of ornidazole in the blood plasma is reduced. In case of simultaneous use of these agents with ornidazole, increased monitoring of the patient's condition should be carried out.

Cimetidine and other enzyme inhibitors: The circulation period of ornidazole in the blood plasma increases.

Oral anticoagulants. The effect of oral coumarin anticoagulants is enhanced. In case of simultaneous use with ornidazole, increased monitoring of the patient's condition and correction of the dosage of oral anticoagulants should be carried out.

Vecuronium bromide. The muscle relaxant effect of vecuronium bromide is prolonged.

Alcoholic beverages and drugs. Although ornidazole (unlike metronidazole) does not inhibit aldehyde dehydrogenase, the possibility of a disulfiram-like reaction after drinking alcohol cannot be completely ruled out. Alcoholic beverages should not be consumed during treatment and for at least 3 days after stopping the drug.

Application features

Ciprofloxacin.

Ciprofloxacin should be avoided in patients with a history of serious adverse reactions to quinolones or fluoroquinolones (see section 4.8). Treatment of such patients should only be initiated if no alternative treatment is available and after careful benefit/risk assessment (see also section 4.8).

Use in severe infections and/or mixed infections caused by gram-positive or anaerobic bacteria.

Ciprofloxacin should not be used as monotherapy for the treatment of severe infections and infections caused by Gram-positive or anaerobic bacteria. For the treatment of these infections, ciprofloxacin should be used in combination with appropriate antibacterial agents.

Use in streptococcal infections (including Streptococcus pneumoniae).

Ciprofloxacin is not recommended for the treatment of streptococcal infections due to insufficient efficacy.

Use for infections of the reproductive system.

Fluoroquinolone-resistant strains of Neisseria gonorrhoeae can cause gonococcal urethritis, cervicitis, epididymo-orchitis, and pelvic inflammatory disease.

Therefore, ciprofloxacin should be used for the treatment of gonococcal urethritis or cervicitis only if ciprofloxacin resistance in Neisseria gonorrhoeae has been excluded.

Empirical therapy with ciprofloxacin for epididymo-orchitis and pelvic inflammatory disease should only be used in combination with other appropriate antibacterial agents (e.g. cephalosporins) except in clinical situations where the presence of ciprofloxacin-resistant strains of Neisseria gonorrhoeae has been excluded. If clinical improvement does not occur after 3 days, therapy should be reviewed.

Fluoroquinolone resistance in Escherichia coli, the most common pathogen causing urinary tract infections, varies across the European Union. Physicians are advised to consider the local prevalence of fluoroquinolone resistance in Escherichia coli when prescribing therapy.

Single doses of ciprofloxacin, which can be used for uncomplicated cystitis in premenopausal women, are thought to be less effective than longer-term ciprofloxacin therapy. This fact should be taken into account in view of the increasing resistance of Escherichia coli to quinolones.

Use in complicated urinary tract infections and pyelonephritis.

Treatment of urinary tract infections with ciprofloxacin should be considered when other treatments are not possible. Treatment should be based on microbiological results.

Other specific severe infections.

The use of ciprofloxacin may be justified on the basis of microbiological evidence in other serious infections in accordance with official guidelines or after careful benefit/risk assessment when other treatments are not suitable or when standard treatment has failed.

The use of ciprofloxacin in specific severe infections other than those mentioned above has not been evaluated in clinical trials and clinical experience is limited. Therefore, caution is recommended when treating patients with such infections.

Risk of hypersensitivity reactions.

Hypersensitivity and allergic reactions, including anaphylactic/anaphylactoid reactions, may occur after a single dose of ciprofloxacin (see section 4.8) and may be life-threatening. In such cases, the medicinal product should be discontinued and appropriate medical treatment should be initiated if necessary.

Prolonged, disabling and potentially irreversible serious adverse reactions.

In very rare cases, prolonged (months or years), disabling and potentially irreversible adverse reactions affecting various, and sometimes multiple, body systems (including musculoskeletal, nervous, mental and sensory) have been reported in patients receiving quinolones and fluoroquinolones, regardless of age and existing risk factors. The drug should be discontinued immediately at the first signs or symptoms of any adverse reaction and a doctor should be consulted.

Risk of tendinitis and tendon rupture.

In general, the drug should not be used in patients with a history of tendon diseases/disorders associated with the use of quinolones. However, in rare cases, after microbiological examination of the pathogen and an assessment of the benefit/risk ratio, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, in particular in cases of failure of standard therapy or bacterial resistance, when the results of microbiological studies justify the use of ciprofloxacin.

Tendinitis and tendon rupture (not limited to the Achilles tendon, sometimes bilateral) may occur within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after stopping treatment (see section 4.8). The risk of tendinitis and tendon rupture is increased in elderly patients, patients with renal impairment, patients with solid organ transplants and patients receiving concomitant corticosteroids. Therefore, concomitant use of corticosteroids should be avoided.

At the first sign of tendinitis (e.g. painful swelling, inflammation), the drug should be discontinued and alternative treatment should be considered. Corticosteroids should not be used if signs of tendinopathy occur.

Use in patients with myasthenia gravis.

The drug should be used with caution in patients with myasthenia gravis due to possible exacerbation of the symptoms of this disease (see section "Adverse reactions").

Aortic aneurysm/dissection and regurgitation/heart valve insufficiency.

Epidemiological studies have reported an increased risk of aortic aneurysm and dissection, particularly in the elderly, and of aortic and mitral valve regurgitation following the use of fluoroquinolones. Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal cases), and of regurgitation/insufficiency of any of the cardiac valves have been reported in patients receiving fluoroquinolones (see section 4.8).

Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with a positive family history of aneurysm or congenital heart valve disease, or with an existing diagnosis of aortic aneurysm and/or dissection, or with heart valve disease, or in the presence of other risk factors or predisposing conditions.

in aortic aneurysm and dissection (e.g. vascular disorders such as Takayasu arteritis or giant cell arteritis, or known atherosclerosis, or Sjögren's syndrome);

with regurgitation/heart valve insufficiency (e.g. infective endocarditis).

The risk of aortic aneurysm and dissection and rupture may be increased in patients receiving concomitant systemic corticosteroids.

Patients should seek immediate medical attention in the emergency department if they experience sudden abdominal, chest, or back pain.

Patients should be advised to seek immediate medical attention in the event of acute shortness of breath, new onset of palpitations, or development of abdominal or lower extremity edema.

Risk of vision impairment.

Visual disturbances have been reported with ciprofloxacin. If you experience visual impairment or other visual effects, you should seek medical attention immediately.

Risk of photosensitivity reactions.

Ciprofloxacin has been shown to cause photosensitivity reactions. Patients are advised to avoid direct sunlight or UV radiation while taking the drug (see section 4.8).

Risk of lawsuits.

Ciprofloxacin, like other quinolones, is known to cause convulsions or lower the seizure threshold. Cases of status epilepticus have been reported. The drug should be used with caution in patients with central nervous system disorders who may be predisposed to seizures. If seizures occur, the drug should be discontinued (see section "Adverse Reactions").

Risk of peripheral polyneuropathy.

Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypoesthesia, dysesthesia or weakness have been reported with quinolones, including ciprofloxacin. Patients should consult their doctor if they develop symptoms of neuropathy such as pain, burning, tingling, numbness or weakness to prevent potentially irreversible damage (see section 4.8).

Risk of psychotic reactions.

Psychotic reactions may occur even after the first use of ciprofloxacin. In rare cases, depression or psychosis may progress to suicidal thoughts and actions, such as suicide or attempted suicide. In these cases, the drug should be discontinued.

Risk of heart disorders.

The drug should be used with caution in patients with known risk factors for QT prolongation, such as:

hereditary long QT syndrome;

simultaneous use of drugs that can prolong the QT interval (e.g., class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, neuroleptics);

uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia);

presence of heart disease (e.g. heart failure, myocardial infarction, bradycardia).

Elderly patients and women may be more sensitive to drugs that prolong QTc. The drug should be used with caution in such patients (see sections: "Interaction with other medicinal products and other types of interactions", "Method of administration and dosage", "Adverse reactions").

Risk of dysglycemia.

Changes in blood glucose levels (including both hyperglycemia and hypoglycemia) have been reported with the use of quinolones, especially in diabetic patients receiving concomitant oral hypoglycemic agents (e.g. glibenclamide) or insulin (see section 4.8). Cases of hypoglycemic coma have been reported. Patients with diabetes should have their plasma glucose levels closely monitored.

Effect on the digestive tract.

The occurrence of severe and persistent diarrhoea during or after the use of ciprofloxacin (even several weeks after treatment) may indicate the development of antibiotic-associated colitis (life-threatening, with possible fatal outcome) and requires urgent treatment (see section "Adverse reactions"). In such cases, the use of the drug should be discontinued and appropriate therapy should be initiated. Medicinal products that inhibit peristalsis are contraindicated in this clinical situation.

Effects on the kidneys and urinary system.

Crystalluria has been reported with ciprofloxacin (see section 4.8). Patients should be adequately hydrated during treatment with the drug. Excessive alkalinity of the urine should be avoided.

Effect on the hepatobiliary system.

Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin (see section 4.8). If any signs and symptoms of liver disease (such as anorexia, jaundice, dark urine, pruritus or abdominal tenderness) occur, the drug should be discontinued.

Use in patients with renal impairment.

Since ciprofloxacin is excreted mainly unchanged by the kidneys, patients with impaired renal function should be dose adjusted according to the information provided in the "Method of administration and dosage" section to avoid an increase in the frequency of adverse reactions caused by accumulation of ciprofloxacin.

Hemolytic reactions have been reported in such patients with ciprofloxacin. Use of the drug in such patients should be avoided unless the expected benefit outweighs the potential risk. In such cases, the patient should be monitored for hemolysis.

Risk of developing resistance.

During or after a course of treatment with ciprofloxacin, resistant bacteria may be isolated with or without clinically apparent superinfection. There may be a certain risk of isolation of bacteria resistant to ciprofloxacin during long courses of treatment and in the treatment of nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.

Concomitant use with drugs metabolized by the cytochrome P450 enzyme.

Ciprofloxacin inhibits CYP1A2 and may therefore lead to increased plasma levels of concomitantly administered drugs that are also metabolized by this enzyme (e.g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine). Patients should be closely monitored for clinical signs of overdose when these drugs are administered concomitantly with ciprofloxacin. Plasma levels (particularly theophylline) may also need to be measured (see section 4.5). Concomitant use of ciprofloxacin and tizanidine is contraindicated.

Concomitant use with methotrexate.

Concomitant use of the medicinal product with methotrexate is not recommended (see section “Interaction with other medicinal products and other types of interactions”).

Impact on laboratory test results.

Ciprofloxacin may interfere with in vitro culture results for Mycobacterium tuberculosis by inhibiting the growth of mycobacterial cultures, which may lead to false-negative culture results in patients taking ciprofloxacin.

Ornidazole.

When using high doses of the drug and in case of treatment for more than 10 days, clinical and laboratory monitoring is recommended.

When using the drug, if there is a history of blood disorders, monitoring of leukocytes is recommended, especially during repeated courses of treatment.

During the use of ornidazole, it is possible to increase the severity of disorders of the central or peripheral nervous system. In the event of peripheral neuropathy, impaired coordination of movements (ataxia), dizziness or clouding of consciousness, the use of the drug should be discontinued.

During the use of ornidazole, exacerbation of candidomycosis may occur, which will require appropriate treatment.

In case of simultaneous use with lithium, lithium, creatinine and electrolyte concentrations in blood plasma should be monitored.

The effects of other drugs may be increased or decreased during treatment with ornidazole.

The drug should be used with caution in patients with impaired liver function.

Use during pregnancy or breastfeeding

Pregnancy.

Data on the use of ciprofloxacin in pregnant women demonstrate the absence of malformations or feto/neonatal toxicity. Animal studies do not indicate direct or indirect toxic effects with respect to reproductive function. Effects on immature cartilage tissue have been observed in young animals and animals exposed to quinolones before birth, therefore it cannot be excluded that ciprofloxacin may be harmful to the articular cartilage of the newborn/fetus.

Controlled studies of the use of ornidazole in pregnant women have not been conducted. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive function.

The drug is contraindicated during pregnancy.

Breastfeeding period.

Ciprofloxacin passes into breast milk. It is not known whether ornidazole passes into breast milk. Due to the potential risk of damage to articular cartilage in newborns, the use of the drug is contraindicated during breastfeeding.

Ability to influence reaction speed when driving vehicles or other mechanisms

Ciprofloxacin.

Ciprofloxacin may affect the patient's ability to drive or operate machinery due to nervous system reactions. Therefore, the ability to drive or operate machinery may be impaired.

Ornidazole.

Ornidazole may affect the ability to drive and use machines. When using ornidazole, symptoms such as vertigo, drowsiness, rigidity, dizziness, tremor, convulsions, impaired coordination, and temporary loss of consciousness may occur. Patients should be aware of the possibility of such symptoms and refrain from driving or using machines if they occur.

Method of administration and doses

Method of application.

The medicine is intended for oral use.

The tablets should be swallowed whole, without splitting or chewing, before meals or 2 hours after meals.

Dosage.

The dosage of the drug and the duration of treatment depend on the sensitivity of microorganisms, the severity and type of the infectious process. The course of treatment for acute infections is 5–7 days.

Usually, the drug is used in a dose of 1 tablet 2 times a day for 5 days, then continue taking ciprofloxacin for another 2–5 days. Treatment should be continued for at least 3 days after the disappearance of clinical symptoms of the disease.

Unless otherwise prescribed, the following daily doses are recommended for the following diseases:

uncomplicated acute urinary tract infections - 1 tablet 2 times a day for 3 days;

uncomplicated acute cystitis in women (before menopause) - 1 tablet once;

complicated urinary tract infections - 1 tablet 2 times a day for 7 days;

uncomplicated gonorrhea (including extragenital foci of infection) - 1 tablet once;

adnexitis, bacterial prostatitis, orchoepididymitis - 1 tablet 2 times a day. The duration of the course of treatment is determined by the sensitivity of the pathogen to the drug and the clinical picture. Treatment should be continued for at least 3 more days after the symptoms of the disease disappear and until the temperature is completely normalized.

Elderly patients (> 65 years).

Elderly patients should be given the lowest possible doses, depending on the severity of the disease and renal and hepatic function.

Patients with impaired liver function.

There is no need for dosage adjustment of ciprofloxacin in such patients. In patients with severe hepatic impairment, the dosing interval should be doubled.

Patients with renal impairment.

Recommended initial and maintenance doses for patients with renal impairment

Patients with impaired renal and hepatic function.

In patients with renal and hepatic impairment, the dosage should be adjusted depending on renal function (see section “Patients with renal impairment, including patients undergoing hemodialysis”).

No studies have been conducted on the dosing of ciprofloxacin in children with renal and/or hepatic impairment.

Children

The medicine should be used in children over 15 years of age.

The use of the drug in children should be carried out in accordance with current official recommendations.

Ciprofloxacin can be used in children as a second- and third-line drug for the treatment of complicated urinary tract infections and acute pyelonephritis caused by Escherichia coli.

Treatment of children should be initiated only after careful assessment of the risk/benefit ratio due to the possibility of developing adverse reactions from the joints and/or surrounding tissues.

Clinical experience with the use of ciprofloxacin in children for other indications is limited.

Overdose

Ciprofloxacin.

Overdose of 12 g of ciprofloxacin has been reported to result in symptoms of