Orcepol VM, 500 mg+500 mg 10 pcs

Indications

Mixed bacterial infections caused by susceptible gram-positive and gram-negative microorganisms in combination with anaerobic microorganisms and/or protozoa: infectious-inflammatory diseases of the abdominal cavity and biliary tract, kidneys (pyelonephritis) and/or complicated infections of the urinary tract, genitals and pelvic organs (adnexitis, prostatitis, epididymitis).

When using Orcepol VM, the official national recommendations for the appropriate use of antibacterial drugs, as well as the sensitivity of pathogens in a particular region should be taken into account.

Active ingredient

Ornidazole, Ciprofloxacin

Composition

Active ingredients: ciprofloxacin hydrochloride – 554.92 mg converted to ciprofloxacin 500.00 mg, ornidazole – 500.00 mg;

Excipients: sodium carboxymethyl starch – 141.44 mg, sodium croscarmellose – 50.00 mg, povidone K29/32 – 17.40 mg, magnesium stearate – 7.80 mg, colloidal silicon dioxide – 16.60 mg, talc – 9.30 mg, corn starch – to 1420.00 mg;

Film Coating: Opadray II Yellow 02F22025 – 42.00 mg, consisting of: hypromellose – 26.25 mg, titanium dioxide – 11.23 mg, macrogol – 2.625 mg, iron oxide yellow dye – 1.47 mg, talc – 0.42 mg.

How to take, the dosage

The drug Orcepol VM is taken orally 1 hour before a meal or 2 hours after a meal, without chewing, with plenty of water.

The course of treatment for acute infections is 5-7 days, and for chronic infections the course is 10-14 days, in a dose of 1 tablet 2 times a day.

The drug should be continued for 2 days after the cure of symptoms.

Interaction

Ornidazole

Unlike other nitroimidazole derivatives, ornidazole does not inhibit acetaldehyde dehydrogenase and is therefore not incompatible with alcohol.

Ornidazole increases the effect of indirect coumarin anticoagulants, which requires appropriate adjustment of their dose.

The concomitant use with phenobarbital and other inducers of microsomal liver enzymes reduces the half-life of ornidazole from the blood plasma.

The co-administration of ornidazole with inhibitors of microsomal liver enzymes (e.g., cimetidine) reduces the blood plasma half-life of ornidazole.

Ciprofloxacin

Drugs that cause prolongation of the QT interval

. Caution should be exercised when using ciprofloxacin concomitantly with other fluoroquinolones in patients receiving medications that cause prolongation of the QT interval (e.g., Class IA or Class III antiarrhythmic drugs, tricyclic antidepressants, macrolides, neuroleptics).

The formation of chelate compounds

Concomitant administration of tablet forms of ciprofloxacin and cationic drugs; mineral supplements containing calcium, magnesium, aluminum, iron; sucralfate, antacids, polymeric phosphate compounds (such as sevelamer, lanthanum carbonate) and drugs with large buffer capacity (such as didanosine tablets) containing magnesium, aluminum or calcium reduce absorption of ciprofloxacin. In such cases, the drug should be taken either 1-2 h before or 4 h after taking these drugs.

This restriction does not apply to drugs belonging to the class of H₂-histamine receptor blockers.

Ingestion of food and dairy products

Combined use of ciprofloxacin and dairy products or mineral-rich beverages (e.g., milk, yogurt, calcium-rich orange juice) should be avoided because absorption of ciprofloxacin may be decreased by doing so. However, calcium in other foods has no significant effect on absorption of ciprofloxacin.

Omeprazole

When combined use of ciprofloxacin and drugs containing omeprazole, a slight decrease in the maximum plasma concentration of ciprofloxacin and a decrease in the area under the pharmacokinetic curve “concentration-time” may be observed.

Theophylline

The concomitant use of ciprofloxacin and drugs containing theophylline may cause an undesirable increase in plasma concentration of theophylline and consequently the occurrence of theophylline-induced adverse events; in very rare cases these adverse events may be life-threatening. If concomitant use of the two drugs is unavoidable, continuous monitoring of plasma theophylline concentrations and, if necessary, reduction of theophylline dose is recommended.

Other xanthine derivatives

The concomitant use of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline) can increase plasma concentrations of xanthine derivatives.

Non-steroidal anti-inflammatory drugs

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

Cyclosporine

In concomitant use of ciprofloxacin and drugs containing cyclosporine a transient increase in plasma creatinine concentration was observed. In such cases, blood creatinine concentration should be determined twice a week.

Peroral hypoglycemic agents

In concomitant use of ciprofloxacin and oral hypoglycemic agents, primarily sulfonylureas (e.g., glibenclamide, glimepiride), hypoglycemia has been suggested to increase the effect of the oral hypoglycemic agents.

Probenecid

Probenecid slows down the rate of renal excretion of ciprofloxacin. Concomitant use of ciprofloxacin and drugs containing probenecid leads to increased concentrations of ciprofloxacin in the blood plasma.

Phenytoin

Concomitant use of ciprofloxacin and phenytoin has been observed to alter (increase or decrease) the plasma levels of phenytoin. To avoid impairment of the anticonvulsant effect of phenytoin due to decreased concentrations, and to prevent adverse events associated with phenytoin overdose when ciprofloxacin is discontinued, it is recommended to monitor phenytoin therapy in patients taking both drugs, including determination of plasma phenytoin content throughout the period of simultaneous use of both drugs and for a short time after completion of combined therapy.

Methotrexate

Concomitant use of methotrexate and ciprofloxacin may inhibit renal channel transport of methotrexate, which may be accompanied by increased plasma concentrations of methotrexate. This may increase the likelihood of side effects of methotrexate. Therefore, patients receiving concomitant therapy with methotrexate and ciprofloxacin should be closely monitored.

Tyzanidine

In a clinical study with healthy volunteers the concomitant use of ciprofloxacin and agents containing tizanidine resulted in increase of tizanidine concentration in plasma: 7-fold increase in Cmax (4-21 fold) and 10-fold increase in AUC (6-24 fold). Increased tizanidine plasma concentration may cause decreased blood pressure and drowsiness. Thus, concomitant use of ciprofloxacin and drugs containing tizanidine is contraindicated.

Duloxetine

In clinical studies it has been shown that concomitant use of duloxetine and potent inhibitors of CYP450 1A2 isoenzyme (such as fluvoxamine), may lead to increased AUC and Cmax of duloxetine. Although there are no clinical data on possible interaction with ciprofloxacin, it is possible to foresee the possibility of such interaction when ciprofloxacin and duloxetine are used simultaneously.

Ropinirole

The concomitant use of ropinirole and ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, results in a 60 and 84% increase in Cmax and AUC of ropinirole, respectively. Adverse effects of ropinirole should be monitored during its co-administration with ciprofloxacin and for a short time after completion of combined therapy.

Lidocaine

In a study in healthy volunteers, it was found that concomitant use of drugs containing lidocaine and ciprofloxacinf, a moderate inhibitor of CYP450 1A2 isoenzyme, leads to a 22% decrease in lidocaine clearance when administered intravenously. Although lidocaine is well tolerated when used concomitantly with ciprofloxacin, there may be increased side effects due to the interaction.

When using clozapine and ciprofloxacin concomitantly at a dose of 250 mg for 7 days, there was an increase in plasma concentrations of clozapine and N-desmethylclozapine of 29% and 31%, respectively. The patient’s condition should be monitored and, if necessary, the dosing regimen of clozapine should be adjusted during its co-administration with ciprofloxacin and for a short time after completion of combined therapy.

Sildenafil

Concomitant use of ciprofloxacin 500 mg and sildenafil 50 mg in healthy volunteers resulted in a 2-fold increase in Cmax and AUC of sildenafil. Therefore, the use of this combination is possible only after an assessment of the benefit/risk ratio.

Vitamin K antagonists

The co-administration of ciprofloxacin and vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, fluindione) may increase their anticoagulant effect. The magnitude of this effect may vary depending on co-infections, age, and general condition of the patient, so it is difficult to assess the effect of ciprofloxacin on MHO (international normalized ratio) increase. MHO should be monitored frequently enough during coadministration of ciprofloxacin and vitamin K antagonists, as well as for a short time after completion of combined therapy.

Agomelatine

In clinical studies it has been shown that fluvoxamine as a strong inhibitor of CYP450 1A2 isoenzyme markedly inhibits the metabolism of agomelatine, resulting in a 60-fold increase in agomelatine exposure. Although there are no clinical data on possible interaction with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, similar effects can be expected when agomelatine and ciprofloxacin are used simultaneously.

Zolpidem

The co-administration of ciprofloxacin and zolpidem is not recommended because it may lead to increased plasma concentrations of zolpidem.

Special Instructions

When treating with high doses of ornidazole or for a treatment duration of 10 days, regular laboratory and clinical monitoring is recommended.

The treatment of trichomoniasis should be simultaneous treatment of sexual partners.

Caution should be exercised in patients with CNS diseases, such as multiple sclerosis.

In patients receiving therapy with lithium preparations, plasma concentrations of lithium, electrolytes and creatinine should be monitored during treatment with ornidazole.

There is some risk in patients with liver damage, brain damage, and alcohol abuse.

In patients on hemodialysis, there is a shortened half-life. Correction of the dose of the drug (additional dose of ornidazole before or after hemodialysis) may be required.

The effects of other medications may increase or decrease while using the drug.

Patients with diseases caused by Candida spp.may have a worsening course of this disease.

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

. In the treatment of severe infections, staphylococcal infections and infections due to 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 because of its limited effectiveness against the pathogen.

Genital tract infections

In genital infections suspected to be caused by fluoroquinolone-resistant strains of Neisseria gonorrhoeae, information about local resistance to ciprofloxacin should be considered and sensitivity of the pathogen should be confirmed by laboratory tests.

Urinary tract infections

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

Cyprofloxacin has an effect on QT interval prolongation. Given that women are characterized by longer average QT interval duration compared to men, they are more sensitive to drugs that cause QT interval prolongation. Elderly patients also have an increased sensitivity to the action of drugs that cause prolongation of the QT interval. The preparation should be used with caution in combination with the drugs prolonging the QT interval (for example, antiarrhythmic drugs of classes IA and III, tricyclic antidepressants, macrolides and antipsychotic drugs) or in patients with increased risk of QT interval prolongation or development of “pirouette” type arrhythmia (for example patients with congenital long QT syndrome, uncorrelated electrolyte imbalances such as hypokalemia or hypomagnesemia, and heart disease such as heart failure, myocardial infarction, bradycardia).

The use in children

Ciprofloxacin, like other drugs in this class, has been found to cause arthropathy of large joints in animals. Use of the drug in children under 18 years of age is contraindicated because the risk of damage to the cartilage growth zones of the child’s bones cannot be completely excluded.

Hypersensitivity

In some cases hypersensitivity to the drug may develop after the first dose, including allergic reactions, and the attending physician should be informed immediately. In rare cases after the first use anaphylactic reactions up to anaphylactic shock may occur. In these cases the use of the drug should be stopped immediately and appropriate treatment should be carried out.

Gastrointestinal tract

In case of severe and prolonged diarrhea during or after ciprofloxacin treatment the diagnosis of pseudomembranous colitis should be excluded which requires immediate drug withdrawal and appropriate treatment (oral vancomycin at a dose of 250 mg 4 times daily). The use of drugs suppressing intestinal peristalsis is contraindicated in this situation.

Hepatobiliary system

When using ciprofloxacin there have been cases of liver necrosis and life-threatening liver failure. In the presence of the following signs of liver disease, such as anorexia, jaundice, dark urine, itching, painful abdomen – the drug should be stopped.

In patients taking ciprofloxacin who have had liver disease, there may be a temporary increase in “hepatic” transaminases and alkaline phosphatase activity or cholestatic jaundice.

Musculoskeletal system

Patients with severe myasthenia gravis should use diprofloxacin with caution because exacerbation of symptoms is possible. At the first signs of tendinitis (painful swelling of the joint area, inflammation) the drug should be stopped, physical activity should be avoided as there is a risk of tendon rupture, and the patient should consult a physician.

When using ciprofloxacin, there may be cases of tendonitis and tendon rupture (mainly Achilles tendon), sometimes bilaterally, during the first 48 hours of therapy. Inflammation and tendon rupture can occur even several months after ciprofloxacin treatment termination. Elderly patients and patients with tendon diseases concomitantly treated with glucocorticosteroids have an increased risk of tendinopathy.

The drug should be used with caution in patients with a history of tendon disease associated with quinolones.

Nervous system

Ciprofloxacin, like other fluoroquinolones, may provoke, seizures and lower the seizure threshold. In patients with epilepsy and patients who have CNS disorders (e.g., decreased seizure threshold, history of seizures, cerebral hemorrhage, organic brain damage or stroke) due to the risk of CNS adverse reactions, ciprofloxacin should be used only when the expected clinical effect exceeds the possible risk of side effects of the drug.

When using ciprofloxacin, cases of epileptic status have been reported. If seizures occur the use of the drug should be discontinued.

Mental reactions may occur even after the first use of fluoroquinolones, including ciprofloxacin. In rare cases, depression or psychotic reactions may progress to suicidal thoughts and suicide attempts, including completed ones. In the case of any central nervous system side effects, including mental disorders, Orcepol VM must be immediately withdrawn and appropriate therapy initiated. In these cases it is recommended to switch to therapy with another antibiotic other than fluoroquinolones, if possible.

In patients taking fluoroquinolones, including ciprofloxacin, there have been cases of sensory or sensorimotor polyneuropathy, hypoesthesia, dysesthesia or weakness. If symptoms such as pain, burning, tingling, numbness, or weakness occur, patients should inform their physician before continuing this medication.

Dysglycemia

As with other fluoroquinolones, the use of ciprofloxacin may cause changes in blood glucose concentrations, including hypo- and hyperglycemia. During ciprofloxacin therapy, dysglycemia may occur more frequently in elderly patients and patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic agents (such as sulfonylureas) or insulin. When using ciprofloxacin in such patients the risk of hypoglycemia increases, up to hypoglycemic coma. Patients should be informed about the symptoms of hypoglycemia (confusion, dizziness, “wolfish” appetite, headache, nervousness, palpitations or increased pulse rate, pale skin, sweating, trembling, weakness). If the patient develops hypoglycemia, ciprofloxacin treatment should be stopped immediately and appropriate therapy should be started. In these cases, it is recommended to switch to therapy with another antibiotic other than fluoroquinolones, if possible. During treatment with ciprofloxacin in elderly patients, in patients with diabetes mellitus, close monitoring of blood glucose concentrations is recommended.

The skin

When taking ciprofloxacin a photosensitization reaction may occur, so patients should avoid contact with direct sunlight and UV light. Treatment should be discontinued if photosensitization symptoms are observed (e.g., skin changes similar to sunburns).

Cytochrome P450

Ciprofloxacin is known to be a moderate inhibitor of CYP450 1A2 isoenzymes. Caution should be exercised when concomitant use of ciprofloxacin and drugs metabolized by these enzymes, such as theophylline, methylxanthine, caffeine, duloxetine, ropinirole, clozapine, olanzapine, agomelatine, because increase of plasma concentration of these drugs due to inhibition of their metabolism by ciprofloxacin may cause specific adverse reactions. To avoid development of crystalluria, the recommended daily dose should not be exceeded, and adequate fluid intake and maintenance of an acidic urine reaction are also necessary.

In in vitro conditions, ciprofloxacin may interfere with the bacteriological study of Mycobacterium tuberculosis by inhibiting its growth, which may lead to false negative results when diagnosing this pathogen in patients taking ciprofloxacin.

Influence on the ability to drive vehicles, mechanisms

At the time of treatment it is not recommended to drive vehicles and engage in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Oval biconvex film-coated tablets with light yellow color, engraved “ORCP” on one side and a separating line on the other.

Contraindications

– Increased individual sensitivity to ornidazole or other nitroimidazole derivatives, to ciprofloxacin other drugs from the group of fluoroquinolones, as well as to excipients of the drug;

– pregnancy, breastfeeding;

– children under 18 years of age;

– organic diseases of the central nervous system (CNS);

– pathological blood changes and abnormalities of blood cells;

– concomitant use with tizanidine due to clinically significant side effects (arterial hypotension, somnolence) associated with increased plasma concentration of tizanidine;

– severe hepatic impairment, renal impairment (creatinine clearance less than 60 ml/min).

With caution

– In diseases of the central nervous system: Epilepsy; decreased seizure threshold (or history of seizures); marked atherosclerosis of cerebral vessels; impaired cerebral circulation; multiple sclerosis;

p> – mental illness (depression, psychosis);

– moderate to mild hepatic insufficiency;

– tendonitis with previous treatment with quinolones;

– Increased risk of QT interval prolongation or pirouette arrhythmia (e.g., congenital prolonged QT syndrome, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (e.g., hypokalemia, hypomagnesemia);

The concomitant use of medications that prolong the QT interval (including those that prolong the QT interval).ч. tricyclic antidepressants, macrolides, neuroleptics). – concomitant use with CYP450 1A2 isoenzyme inhibitors (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine, agomelatine);

– concomitant use of lithium preparations.

– myasthenia gravis;

– glucose-6-phosphate dehydrogenase deficiency;

– use in elderly patients;

– alcoholism;

– In patients with diabetes who are receiving concomitant therapy with oral hypoglycemic drugs (e.g., sulfonylureas) or insulin.

Side effects

The frequency of side effects below was determined according to the World Health Organization classification: very common (more than 10%); common (more than 1% and less than 10%); infrequent (more than 0.1% and less than 1%); rare (more than 0.01% and less than 0.1%); very rare (less than 0.01%), including individual reports; frequency not known (cannot be estimated using available data).

Ornidazole-associated

.Blood and lymphatic system disorders

not infrequently: suppression of medullary hematopoiesis, neutropenia.

Nervous system disorders

often: dizziness, drowsiness, fatigue, headache;

rarely: tremor, muscle stiffness, impaired movement coordination, seizures, temporary loss of consciousness, sensory or mixed peripheral neuropathy.

Gastrointestinal disorders

frequently: gastrointestinal disorders, including nausea, vomiting, diarrhea, “metallic” taste in the mouth.

Liver and biliary tract disorders

frequency unknown:change in alanine aminotransferase and aspartate aminotransferase activity, jaundice.

Disorders of the immune system

not infrequent: manifestations of skin reactions and hypersensitivity reactions (rash, itching, urticaria, Quincke’s edema).

Ciprofloxacin-associated

Infectious and parasitic diseases

infrequent: Mycotic superinfections; p rarely: pseudomembranous colitis (in very rare cases with possible fatal outcome).

Blood and lymphatic system disorders

infrequent: eosinophilia; p rarely: leukopenia, anemia, neutropenia, leukocytosis, thrombocytopenia, thrombocythemia; overy rarely: Hemolytic anemia, agranulocytosis, pancytopenia (life-threatening), bone marrow suppression (life-threatening). Immune system disorders

Rare: allergic reactions, allergic edema / angioedema;

o very rare: anaphylactic reactions, anaphylactic shock (life-threatening), serum sickness.

Metabolic and nutritional disorders

infrequent: decreased appetite and the amount of food taken;

frequently: hyperglycemia, hypoglycemia;

frequency unknown: severe hypoglycemia, up to the development of hypoglycemic coma, especially in elderly patients, diabetic patients taking oral hypoglycemic drugs or insulin.

Psychiatric disorders

infrequent: psychomotor hyperactivity/anxiety;

rarely: confusion and disorientation, anxiety, disturbed dreams (nightmares), depression (increased self-harm behaviors such as suicidal behaviors/thoughts, and attempted or successful suicide), hallucinations;

very rarely: psychotic reactions (increased self-harm behaviors such as suicidal acts/thoughts and attempted or successful suicide);

frequency unknown: attention deficits, nervousness, memory impairment, delirium.

Nervous system disorders

infrequent: headache, dizziness, sleep disturbance, taste disturbance; p rarely: paresthesias and dysesthesias, hypoesthesia, tremor, seizures (including epilepsy attacks), vertigo; overy rarely: migraine, impaired coordination of movements, impaired sense of smell, hyperesthesia, intracranial hypertension (cerebral pseudo-tumor-like symptoms); frequency unknown: peripheral neuropathy and polyneuropathy.

Visual disorders

rarely: visual disturbances; overy rarely: impaired color perception.

Hearing and labyrinth disorders

Rarely: tinnitus, hearing loss; overy rarely: hearing disorders.

Cardiac disorders

seldom: tachycardia; hasto unknown: QT interval prolongation, ventricular arrhythmias (including pirouette type)*.

Vascular disorders

Rarely: vasodilation, decreased blood pressure, syncope; overy rarely: vasculitis.

Disorders of the respiratory system, chest and mediastinum

rarely: respiratory disorders (including bronchospasm).

Gastrointestinal disorders

often: nausea, diarrhea;

infrequent: vomiting, abdominal pain, dyspepsia, flatulence; overy rare: pancreatitis.

disorders of the liver and biliary tract

infrequent: increased activity of “hepatic” transaminases, increased concentration of bilirubin;

p rarely: liver dysfunction, jaundice, hepatitis (non-infectious);

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

Skin and subcutaneous tissue disorders

infrequent: rash, itching, urticaria; p rarely: photosensitization, blistering; overy rare: petechiae, erythema moforma minor, nodular erythema, Stevens-Johnson syndrome (malignant exudative erythema), including potentially life-threatening Lyell syndrome (toxic epidermal necrolysis);

hasto unknown: acute generalized pustular exanthema.

Muscular and connective tissue disorders

infrequent: arthralgia;

p rarely: Myalgia, arthritis, increased muscle tone, muscle cramps;

overy rarely: muscle weakness, tendonitis, tendon rupture (mostly Achilles), exacerbation of myasthenia gravis symptoms.

Renal and urinary tract disorders

infrequent: impaired renal function;

p rarely: renal failure, hematuria, crystalluria, tubulointerstitial nephritis.

General disorders and disorders together administration

often: injection site reactions; nfrequently: Pain syndrome of nonspecific etiology, general malaise, fever;

rarely: edema, increased sweating (hyperhidrosis); overy rarely: gait disturbance.

Influence on the results of laboratory and instrumental studies

infrequent: increased activity of alkaline phosphatase in the blood;

p rare: altered prothrombin, increased amylase activity;

hnot known: increased MHO (in patients receiving vitamin K antagonists).

*frequently in patients with a predisposition to develop QT interval prolongation.

The incidence of the following adverse reactions is higher with intravenous injection and with step therapy with ciprofloxacin (intravenous injection followed by oral administration) than with oral administration:

frequent – vomiting, increased “hepatic” transaminase activity, rash;

infrequent – thrombocytopenia, thrombocythemia, confusion and disorientation, hallucinations, paresthesias and dysesthesias, seizures, vertigo, visual disturbances, hearing loss, tachycardia, vasodilation, decreased blood pressure, reversible liver function impairment, jaundice, renal failure, edema;

rarely – pancytopenia, bone marrow depression, anaphylactic shock, psychotic reactions, migraine, sense of smell, hearing disorders, vasculitis, pancreatitis, liver tissue necrosis, petechiae, tendon rupture.

Children

The development of arthropathies has often been 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 estimated to be frequent.

Overdose

Symptoms due to ornidazole: loss of consciousness, headache, dizziness, shivering, convulsions, dyspeptic disorders and the occurrence of other dose-dependent symptoms, but in a more severe form.

Ciprofloxacin-related symptoms: reversible toxic effects on the renal parenchyma.

Treatment:In case of overdose, in addition to standard measures (gastric lavage followed by activated charcoal; administration of plenty of fluids; creation of an acidic urine reaction to prevent crystalluria), monitoring of renal function (including urine pH and acidity) and taking magnesium- and calcium-containing antacids, which reduce the absorption of ciprofloxacin, are also recommended. Only small amounts of ciprofloxacin (less than 10%) are excreted by hemo- or peritoneal dialysis. Symptomatic therapy is indicated. There is no specific antidote. In case of convulsions diazepam administration is prescribed.

Pregnancy use

Pregnancy

The safety of ciprofloxacin use in pregnant women has not been established. However, based on the results of animal studies, the possibility of adverse effects on articular cartilage in newborns cannot be completely excluded, and therefore the drug is contraindicated for use in pregnancy.

Breast-feeding period

The use of the drug is contraindicated during breast-feeding.

Ornidazole and ciprofloxacin penetrate into the breast milk. Because of the potential risk of articular cartilage damage in newborns, the use of the drug is contraindicated during breastfeeding. If it is necessary to use the drug during breastfeeding, discontinue breastfeeding. Breast-feeding may be resumed not earlier than 48 hours after the last dose of the drug.