INN: Ciprofloxacin

Manufacturer: Sun Pharmaceutical Industries Ltd

Anatomical-therapeutic-chemical classification: Ciprofloxacin

Registration number in the Republic of Kazakhstan: No. RK-LS-5No. 021197

Registration period: 19.02.2015 - 19.02.2020

Instructions

Tradename

International nonproprietary name

Ciprofloxacin

Dosage form

Film-coated tablets, 500 mg

Compound

One tablet contains

active substance- ciprofloxacin hydrochloride 582.37 mg (equivalent to ciprofloxacin) 500.00 mg

Excipients: microcrystalline cellulose (Avicel PH101), corn starch, corn starch (for gluing), magnesium stearate, talc, anhydrous colloidal silicon dioxide, sodium starch glycolate (type A), purified water

Shell: purified water, opadry OY-S-58910 white (hypromellose E464, titanium dioxide E171, polyethylene glycol 400, talc E553

Description

White to off-white, capsule-shaped, film-coated tablets, debossed with “500” on one side and plain on the other side.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Antimicrobial drugs are quinolone derivatives. Fluoroquinolones. Ciprofloxacin.

ATX code J01MA02

Pharmacological properties

Pharmacokinetics

Suction

After oral administration, ciprofloxacin is rapidly absorbed from the upper small intestine, reaching maximum serum concentration (Cmax) after 60-90 minutes. Eating does not affect the degree of absorption of the drug. After taking a single dose of 250 mg and 500 mg, Cmax is 0.8-2.0 mg/l and 1.5-2.9 mg/l, respectively. Absolute bioavailability is 70-80%. Cmax has a linear dependence on the dose taken.

Distribution

The volume of distribution of ciprofloxacin is 2-3 l/kg, which ensures uniform distribution throughout organs and tissues. Since the degree of binding to plasma proteins is only 20-30% and most of the drug is present in the blood plasma in non-ionized form, almost the entire dose taken is distributed unbound into the extravascular space.

Metabolism/Excretion

Metabolized in the liver. The half-life is 3-5 hours. It is mainly excreted unchanged in the urine, partially in the form of metabolites. About 10% is excreted through the intestines, about 1% of ciprofloxacin is excreted in the bile.

Pharmacokinetics in special groups of patients. The results of pharmacokinetic studies of ciprofloxacin in elderly patients indicate only a slight prolongation of the half-life. These differences in pharmacokinetics are not clinically significant .

Kidney failure. In patients with reduced renal function, the half-life of ciprofloxacin is slightly longer. In some cases, dosage adjustment may be required .

Liver failure. In preliminary studies involving patients with stable liver cirrhosis, no significant changes in the pharmacokinetic parameters of ciprofloxacin were identified. However, the pharmacokinetics of ciprofloxacin in patients with acute liver failure has not been fully studied.

Interdrug interactions. If you take a ciprofloxacin tablet with food, the absorption of the drug is slowed down, resulting in the maximum concentration of ciprofloxacin in the blood being reached after almost 2 hours, and not after 1 hour. At the same time, the absorption of ciprofloxacin is generally not impaired. When combined with antacids containing magnesium or aluminum hydroxide, the bioavailability of ciprofloxacin may be reduced by 90% .

Ciprofloxacin is contraindicated for use in patients receiving tizanidine .

Ciprofloxacin reduces the clearance of theophylline, which may lead to increased serum theophylline concentrations and an increased risk of CNS disorders and other adverse reactions. Ciprofloxacin also reduces the clearance of caffeine and inhibits the formation of its metabolite paraxanthine .

Pharmacodynamics

Mechanism of action. The bactericidal effect of ciprofloxacin is due to the inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are necessary for replication, transcription, repair and recombination of bacterial DNA.

Mechanism of resistance development. Resistance to fluoroquinolones is predominantly associated with mutations in DNA gyrase genes, disruption of the permeability of the outer cell membrane of bacteria, or activation of efflux proteins, which lead to the removal of fluoroquinolones from the cell. In conditions in vitro Resistance to ciprofloxacin develops slowly through multistep mutations. The incidence of resistance to ciprofloxacin as a result of spontaneous mutations usually varies from< 10-9 до 1 x 10-6.

Cross resistance. There is no cross-resistance between ciprofloxacin and antimicrobial drugs of other classes.

Ciprofloxacin is active against most strains of the following bacteria, both under conditions in vitro, and in clinical practice for the treatment of infections.

Gram-positive bacteria:Enterococcus faecalis(only strains sensitive to vancomycin),Staphylococcus aureusAndStaphylococcusepidermidis (methicillin-sensitive strains only),Staphylococcus saprophyticus, Streptococcus pneumoniae (only strains sensitive to penicillin), Streptococcus pyogenes

Gram-negative bacteria:Campylobacter jejuni, Citrobacter koseri (diversus), Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Salmonella typhi, Serratia marcescens, Shigella boydii, Shigella dysenteriae, Shigella flexneri, Shigella sonnei.

The activity of ciprofloxacin against Bacillus anthracis was demonstrated under conditions in vitro and based on the use of serum drug levels as a surrogate marker .

Indications for use

Uncomplicated and complicated infections caused by microorganisms sensitive to ciprofloxacin:

Respiratory tract infections. Ciprofloxacin is recommended to be prescribed for pneumonia caused by Klebsiella spp., Enterobacter spp., Proteus spp., Esherichia coli, Pseudomonas spp., Haemophilus spp., Branhamella spp., Legionella spp., Staphylococcus spp.

Infections of the middle ear (otitis media), sinuses (sinusitis), especially if these infections are caused by gram-negative microorganisms, including Pseudomonas spp. or Staphylococcus spp.

Eye infections

Kidney and urinary tract infections

Infections of the genital organs, including adnexitis, prostatitis

Gonorrhea

Abdominal infections (bacterial infections of the gastrointestinal or biliary tract, peritonitis)

Skin and soft tissue infections

Septicemia, bacteremia, infections, or prevention of infections in immunocompromised patients (eg, patients taking immunosuppressants or with neuropenia)

Children and teenagers:

- in the treatment of complications caused by Pseudomonas aeruginosa in children over 6 years of age with cystic fibrosis

Prevention and treatment of pulmonary anthrax (infection with Bacillus anthracis)

Directions for use and doses

The drug should be taken on an empty stomach with sufficient liquid.

For adults

For mild to moderate infections: 250-500 mg twice daily.

For severe and complicated infections: 750 mg twice a day.

The duration of Cifran therapy depends on the type and severity of the infection, and the clinical and bacteriological response of the patient should be taken into account. For most infections, treatment should be continued for at least 48 hours after symptoms have resolved. The usual duration of therapy is 5-10 days, but severe or complicated infections may require a longer course of treatment.

The maximum single dose is 750 mg.

Maximum daily dose - 1500 mg

Dosage regimen for impaired renal or liver function

With creatinine clearance from 30 to 60 ml/min/1.73 m2 or its plasma concentration from 1.4 to 1.9 mg/100 ml, the maximum dose of ciprofloxacin should be 800 mg/day (200-400 mg every 12 h.). When creatinine clearance is below 30 ml/min/1.73 m2 or its plasma concentration is from 2 mg/100 ml and above, the maximum dose of ciprofloxacin should be 400 mg/day (200-400 mg every 24 hours). For patients on hemodialysis, the dosage regimen is 200-400 mg every 24 hours; on days of hemodialysis, the drug is taken after this procedure. Patients on peritoneal dialysis: 200-400 mg every 24 hours.

Side effects

Often ≥1%,< 10%

Nausea, diarrhea

Uncommon ≥ 0.1%,< 1%

Asthenia (feeling of weakness, increased fatigue), candidiasis

Abdominal pain, vomiting, anorexia, changes in liver test values ​​- ALT and AST, alkaline phosphatase, hyperbilirubinemia

Eosinophilia, leukopenia

Increased levels of creatinine and urea nitrogen

Arthralgia

Headache, dizziness, sleep disturbances, agitation, restlessness, confusion

Itching, urticaria, maculopapular rash

Taste disturbance

Rarely

Limb pain, back pain, chest pain

Tachycardia, symptoms of vasodilation (feeling of heat, feeling of a rush of blood to the face), decreased blood pressure, fainting

Oral candidiasis, jaundice (including cholestatic), pseudomembranous colitis

Anemia, leukopenia (granulocytopenia), leukocytosis, increased or decreased prothrombin levels, thrombocytopenia, thrombocytosis

Anaphylactic reactions, fever

Myalgia (muscle pain), joint swelling

Migraine, hallucinations, sweating, paresthesia (including peripheral paralgesia), anxiety, nightmares, depression, tremor, convulsions, hyperesthesia

Dyspnea, laryngeal edema

Photosensitivity reactions

Tinnitus, temporary hearing impairment, visual impairment (diplopia, color vision impairment), taste impairment

Glomerulonephritis, acute renal failure, vaginal candidiasis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, hematuria, crystalluria, interstitial nephritis, decreased nitrogen excretory function of the kidneys

Peripheral edema, hyperglycemia

Very rarely< 0.01%

Vasculitis (petechiae, hemorrhagic bullae, papules with crusting)

Candidiasis, hepatitis, liver tissue necrosis (in extremely rare cases progressing to life-threatening liver failure), life-threatening pseudomembranous colitis with possible fatal outcome, pancreatitis

Hemolytic anemia, pancytopenia (including life-threatening), agranulocytosis, in extremely rare cases life-threatening bone marrow suppression

Anaphylactic shock, skin rash, serum sickness-like reactions, Stevens-Johnson syndrome (erythema malignant exudative erythema), Lyell's syndrome (toxic epidermal necrosis)

Myasthenia gravis, tendonitis (mainly Achilles tendons), partial or complete rupture of tendons (mainly Achilles tendons), exacerbation of myasthenia gravis symptoms

Insomnia, peripheral neuropathy, paralgesia (anomaly in the perception of pain), fainting, grand mal seizures, according to the literature, thrombosis of the cerebral arteries is possible, psychosis, intracranial hypertension, ataxia, hyperesthesia, increased muscle tone, muscle twitching, unsteady gait,

Petechiae, erythema multiforme, erythema nodosum, persistent skin rash

Parosmia, anosmia

Increased amylase and lipase activity

The connection of the following adverse events - thrombosis of cerebral arteries, polyuria, albuminuria, urinary retention - with the use of ciprofloxacin orally has not been reliably confirmed.

Contraindications

Hypersensitivity to ciprofloxacin and quinolone antibacterial drugs

Pregnancy and lactation

Epilepsy

- simultaneous use with tizanidine

Children and adolescents up to 18 years of age (with the exception of bronchopulmonary diseases associated with cystic fibrosis, as well as the prevention and treatment of pulmonary anthrax)

Drug interactions

Drugs that cause QT prolongation

Caution should be exercised during the simultaneous use of ciprofloxacin, as well as other fluoroquinolones, 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

Concomitant use 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 didanosine tablets) 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 drugs belonging to the class of histamine H2 receptor blockers.

Eating food and dairy products

The simultaneous use of ciprofloxacin and dairy products or drinks fortified with minerals (for example, milk, yogurt, calcium-fortified orange juice) should be avoided as the absorption of ciprofloxacin may be reduced. However, calcium contained in other foods does not significantly affect the absorption of ciprofloxacin.

Omeprazole

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

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 can be life-threatening for the 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 the concentration of creatinine in the blood twice a week.

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.

Phenytoin

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 a weakening of the anticonvulsant effect of phenytoin due to a decrease in its concentration, as well as to prevent adverse events associated with phenytoin overdose when discontinuing ciprofloxacin, it is recommended to monitor phenytoin therapy in patients taking both drugs, including determination of phenytoin plasma levels throughout the period of simultaneous use of both drugs and 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 AUC (area under 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 the simultaneous 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%, respectively. Monitor for adverse effects of ropinirole during coadministration with ciprofloxacin and for a short time after 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 22% decrease in the clearance of lidocaine when administered intravenously. Despite the good tolerability of lidocaine when used simultaneously with ciprofloxacin, increased side effects due to interaction are possible (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 patient's condition should be monitored and, if necessary, the dosage regimen of clozapine should be adjusted 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 of ciprofloxacin at a dose of 500 mg and sildenafil at a dose of 50 mg in healthy volunteers, 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.

Vitamin K antagonists

The combined use of ciprofloxacin and vitamin K antagonists (for example, warfarin, acenocoumarol, phenprocoumon, fluindone) may 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 INR (international normalized ratio). MHO should be monitored frequently during concomitant use of ciprofloxacin and vitamin K antagonists, as well as for a short time after completion of combination therapy.

special instructions

When treating 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

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.

Heart disorders

Ciprofloxacin has an effect on prolongation of 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 QT interval. Ciprofloxacin should be used with caution in combination with drugs that prolong the QT interval (for example, class I A and III antiarrhythmic drugs, tricyclic antidepressants, macrolides and antipsychotic drugs) (see section "Interaction with other drugs"), or in patients with increased risk of QT prolongation or torsade de pointes (eg, congenital long QT syndrome, uncorrected electrolyte imbalance such as hypokalemia or hypomagnesemia, and heart disease such as heart failure, myocardial infarction, bradycardia).

Use in children

It was found that ciprofloxacin, like other drugs of this class, causes 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 has been established between cartilage or joint damage with 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 (in children 5 to 17 years of age) associated with Pseudomonas aeruginosa and for the treatment and prevention of pulmonary anthrax (after suspected or proven infection 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 the drug Cifran OD 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

Cases of liver necrosis and life-threatening liver failure have been reported with the use of ciprofloxacin. If you have the following signs of liver disease, such as anorexia, jaundice, dark urine, itching, painful abdomen, you should stop taking Cifran (see section “Side Effects”).

Patients taking the drug Cifran and who have had liver disease may experience a temporary increase in the activity of liver transaminases and alkaline phosphatase or cholestatic jaundice.

Musculoskeletal system

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

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

When taking the drug Cifran, 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 Cifran. There is an increased risk of tendinopathy in elderly patients and in patients with tendon diseases who are concomitantly treated with corticosteroids.

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

Nervous system

The drug Cifran, like other fluoroquinolones, can provoke convulsions 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 when the expected clinical effect exceeds the possible risk of developing a side effect of the drug.

Cases of status epilepticus have been reported when using the drug Cifran (see section "Side effects"). If seizures occur, use of the drug should be discontinued. Mental reactions can occur even after the first use of fluoroquinolones, including the drug Cifran. In rare cases, depression or psychotic reactions may progress to suicidal thoughts and suicide attempts, including completed ones (see section "Side effects"). If the patient develops one of these reactions, you should stop taking Cifran and tell your doctor.

Cases of sensory or sensorimotor polyneuropathy, hypoesthesia, dysesthesia or weakness have been reported in patients taking fluoroquinolones, including Cifran. 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 the drug Cifran, a photosensitivity reaction may occur, so patients should avoid contact with direct sunlight and UV light. Treatment should be discontinued if symptoms of photosensitivity are observed (for example, changes in the skin reminiscent of sunburn, see section “Side effects”).

Cytochrome P450

It is known that ciprofloxacin is a moderate inhibitor of CYP 450 1A2 isoenzymes. Caution should be exercised when using the drug Tsifran simultaneously with drugs metabolized by these enzymes, such as tizanidine. theophylline, methylxanthine, caffeine, duloxetine, ropinirole, clozapine, olanzapine, since an increase in the concentration of these drugs in the blood serum, due to inhibition of their metabolism by ciprofloxacin, can cause specific adverse reactions.

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 conditions in vitro ciprofloxacin may interfere with bacteriological testing Mycobacterium tuberculosis, suppressing its growth, which can lead to false negative results when diagnosing this pathogen in patients taking the drug Cifran.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms.

During treatment, you should refrain from driving vehicles and servicing machines and mechanisms that require increased concentration and speed of psychomotor reactions, as adverse reactions such as dizziness, convulsions, and confusion are possible.

Overdose

Symptoms: dizziness, headache, fatigue, gastrointestinal disorders, liver and kidney dysfunction.

Treatment: gastric lavage, taking activated charcoal, antacids containing calcium and magnesium to reduce the absorption of ciprofloxacin, symptomatic therapy. A sufficient amount of fluid must be prescribed. By hemodialysis or peritoneal dialysis, ciprofloxacin is removed from the body only in small quantities (less than 10%).

Release form and packaging

10 tablets are placed in a blister pack made of polyvinylidene chloride/polyvinyl chloride film and printed varnished aluminum foil.

1 contour package along with instructions for medical use is placed in a cardboard pack.

Storage conditions

Store in a dry place at a temperature not exceeding 25⁰C.

Keep out of the reach of children.

Shelf life

Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

On prescription

Manufacturer

Sun Pharmaceutical Ind Ltd

District Sirmour

Himachal Pradesh - 173025, India

Registration Certificate Holder

Sun Pharmaceutical Ind Ltd, India

Address of the organization that receives claims from consumers on the quality of products (goods) in the territory of the Republic of Kazakhstan and is responsible for post-registration monitoring of the safety of the medicinal product

Representative office of Sun Pharmaceutical Ind Ltd in the Republic of Kazakhstan

Almaty, st. Manasa 32A, BC SAT, office 602

tel.: 8-800-080-5202

email address: [email protected]

Attached files

159548391477976527_ru.doc	125 kb
601019581477977684_kz.doc	49.84 kb

Cifran is an antibiotic produced by one of the largest pharmaceutical companies in India, Ranbaxy Laboratories Ltd.

The active ingredient in Cifran is ciprofloxacin hydrochloride (equivalent to ciprofloxacin 500 mg), which is used to treat bacterial infections.

Pharmachologic effect:

Ciprofloxacin belongs to a group of drugs called quinolones/fluoroquinolones. They inhibit DNA relaxation and inhibit DNA gyrase in sensitive organisms and contribute to the “breakage” of double-stranded DNA. Metabolized in the liver, half-life: 2-5 hours (in children), 3-5 hours (in adults). Excretion: urine (30-50%), feces (15-43%).

Indications for use for adults:

• bronchial infections;
• diseases of the ENT organs;
• toothache and gumboil (locally);
• typhoid fever caused by Salmonella typhoid;
• gonorrhea;
• eye infections;
• tuberculosis;
• bacterial diarrhea caused by E. coli, Campylobacter jeunii or various types of Shigella;
• kidney infections;
• sepsis;
• infections of joints and bones caused by Enterobacter cloacae, Serracia marcescens or Pseudomonas aeruginosa;
• infections of soft tissues and skin structure;
• anthrax.

Indications for use of "Cifran" for children:

• Treatment and prevention of anthrax.
• Complications caused by Pseudomonas aeruginosa in children aged 5 to 17 years with cystic fibrosis of the lungs.

Cifran is available as film-coated tablets in dosages of 250 mg and 500 mg, as eye drops and as a concentrate for infusion.

"Cifran": instructions for use during pregnancy and lactation

Most studies have not found an increased risk of birth defects when women took ciprofloxacin or other quinolone/fluoroquinolone antibiotics during the first trimester of pregnancy. Because these studies included mostly women taking ciprofloxacin for only 5-7 days, the effects of long-term use of Cifran are unknown. However, there was no increased risk of birth defects in a small number of infants exposed to longer periods of ciprofloxacin use.

Only a gynecologist who monitors a woman during pregnancy and breastfeeding can decide whether the benefits of Tsifran for the mother outweigh the possible danger of the drug for the fetus.

Several side effects may be associated with the use of Cifran. The most common ones include:

• nausea;
• headache;
• rash;
• redness of the skin (especially when in the sun). It is advisable to use sunscreen when going outside after taking Cifran;
• metallic taste in the mouth;
• vomiting;
• stomach ache;
• diarrhea.

More serious side effects (rare, but not excluded):

• Cramps.
• Fainting.
• Severe skin rashes.
• Damage to the liver, which is manifested by the following symptoms: jaundice (yellowing of the skin and eyes), dark urine, nausea, vomiting, loss of appetite, pain in the right upper abdomen.
• Swelling of the tendons, especially in women over 60 years of age. Swelling, in turn, increases the likelihood of tendon rupture during physical activity. Swelling of the tendons may occur several months after stopping the use of Cifran.
• Although Cifran is used to treat infections caused by low white blood cell counts, it can itself reduce the number of white blood cells in the body. This leads to a deterioration in the functioning of the immune system and also increases the patient's susceptibility to infections.
• Photosensitivity (abnormally high sensitivity to sunlight).
• Worsening of symptoms in patients with psychiatric disorders. This may lead to thoughts of suicide.

Contraindications:

• Allergy to ciprofloxacin.
• Myasthenia gravis (autoimmune disease of the neuromuscular system).
• Epilepsy.
• Heart diseases.
• Kidney or liver diseases.

Should not be combined with the following drugs:

• Tizanidine is used to treat muscle spasticity. Threat: the risk of side effects indicated in the description of “Tsifran” (instructions for use) increases.
• Warfarin is a drug used in the treatment of bleeding disorders. Threat: increased risk of bleeding.
• Theophylline is used to open the airways in the treatment of asthma. Threat: simultaneous use of Theophylline and Tsifran can lead to convulsions, as well as heart rhythm disturbances.
• Sildenafil (Viagra) is a drug used in the treatment of erectile dysfunction. Threat: the level of sildenafil in the blood increases, side effects of Viagra are likely to occur.
• "Pentoxifylline-Teva" - used to improve peripheral circulation. Threat: Blood levels of this drug increase and the risk of side effects increases.
• Omeprazole is a drug that is used to kill Helicobacter Pylori and to treat gastroesophageal reflux disease. Threat: the level of “Cifran” in the blood decreases, thereby deteriorating the effectiveness of this drug.
• Calcium, magnesium or iron supplements (including in the form of effervescent tablets). Threat: the effectiveness of Tsifran is reduced.
• Antacids are medications that neutralize stomach acid. Threat: the effectiveness of Tsifran is reduced.
• Cifran tablets can increase the stimulating effect of caffeine.

note

Patients who are about to undergo surgery (including dental surgery) should warn the surgeon or anesthesiologist about taking Cifran. This medication may affect other medications used during surgery.

Although the drug is commonly used for certain bacterial infections, it is not always effective, so it is important that your doctor order tests to determine whether Cifran is appropriate. The instructions for use include not only a wide range of indications, but also numerous contraindications, so you should not self-medicate.

How to take "Cifran" for prostatitis and other diseases

"Cifran" tablets are often prescribed for the initial symptoms of prostatitis. It has an excellent spectrum of activity against uropathogens and quite a few intestinal bacteria living in the perineum react to this drug. About 80% of bacterial cases of prostatitis are caused by Escherichia coli, the remaining cases of inflammation of the prostate gland are mainly caused by bacteria from the genus Enterobacter, Klebsiella, Enterobacterium proteus, Pseudomonas aeruginosa or staphylococci. Ciprofloxacin is effective against all of these bacteria.

Unfortunately, it has little activity against anaerobic bacteria (chlamydia and mycoplasma), which allows pathogens to establish themselves in the prostate, and repeated courses of Cifran predictably fail and precious treatment time is wasted.

For adults with initial symptoms of bacterial prostatitis, Cifran tablets are usually prescribed at a dosage of 500 mg twice a day for two to four weeks. However, precise instructions on how to take Cifran will be given to the patient by the attending urologist, based on the severity of the disease.

A study conducted in South Korea found that the combination of garlic and ciprofloxacin was superior to ciprofloxacin alone for the treatment of chronic bacterial prostatitis. Researchers evaluated the antimicrobial and anti-inflammatory properties of garlic, along with the synergistic effect of garlic, along with ciprofloxacin, in adult male rats with chronic bacterial prostatitis.

A total of 41 rats with the disease were randomly assigned to four treatment groups: control, garlic, which received ciprofloxacin alone, and garlic plus ciprofloxacin. After three weeks of treatment, rats in the garlic group had a statistically significant reduction in bacterial growth and improved symptoms of prostate inflammation compared to the control group. However, the group given garlic plus ciprofloxacin had a greater reduction in bacterial growth and a significant improvement in prostate inflammation symptoms compared to the group treated with ciprofloxacin.

These results suggest that garlic may provide both antimicrobial and anti-inflammatory benefits, as well as a synergistic effect with ciprofloxacin.

Patients with prostatitis taking Cifran usually complain of side effects such as nausea (2.5%), diarrhea (1.6%), vomiting (1%) and rash (1%).

How to take Cifran orally:

• The recommended dose for adults ranges from 250 mg to 750 mg, twice daily. Depending on the type of infection being treated, you may need to take Cifran for 3 to 28 days.
• For uncomplicated cystitis, the course of treatment lasts 3 days, for moderate or severe forms it lasts 1-2 weeks.
• For urethritis, course treatment lasts from 8 to 10 days.
• For otitis, sore throat, tonsillitis, the course of treatment is, on average, 5 days.
• For gastrointestinal infections, depending on the severity, treatment takes from 7 to 28 days.
• The course of treatment with Cifran for urinary tract infections is 7-10 days.
• For bone and joint infections, you may need to take Cifran for up to 3 months.
• The tablets should not be chewed; they have an unpleasant taste.
• "Cifran" tablets can be taken with food or on an empty stomach.
• Although ciprofloxacin can be taken with meals that include dairy products, the drug should not be taken alone with milk or calcium-fortified foods.
• Do not take antacids, calcium, magnesium, iron supplements, or multivitamins 6 hours before or 2 hours after taking Cifran.

How to take Cifran intravenously:

• The standard course of infusion therapy (treatment with intravenous solution) “Cifran” for acute infections is 5-7 days.
• Cifran is administered intravenously over a short period of time (from 30 minutes to an hour).
• The Cifran infusion contains 0.9% w/v sodium chloride solution.
• The infusion is compatible with all intravenous fluids.

"Tsifran": dosage for adults and children, price and analogues of the drug

The course of treatment and dose of Cifran will depend on the type of bacterial infection.

The dosage prescribed by the doctor may differ from that indicated in the article.

"Tsifran": dosage for adults:

• Acute sinusitis (mild to moderate): 500 mg twice daily or 400 mg twice daily by infusion (intravenously) for 10 days. The infusion method of using Cifran differs from the oral infusion method in that the drug is administered through a dropper.
• Bone and joint infections (mild to moderate): 500 mg twice daily or 400 mg infusion twice daily for 30 days.
• Chronic bacterial prostatitis (mild or moderate severity). Dosage indicated for chronic bacterial prostatitis caused by Escherichia coli or Proteus Mirabilis: 500 mg twice daily or 400 mg infusion twice daily for 28 days.
• Chronic otitis media: 500 mg twice daily or 400 mg by infusion twice daily for 1-2 weeks.
• Infectious diarrhea: 500 mg twice daily for 5-7 days.
• Lower respiratory tract infections (mild to moderate): 500 mg twice daily or 400 mg infusion twice daily for one to two weeks.
• Skin structure infections (mild to moderate): 500 mg twice daily or 400 mg IV twice daily for one to two weeks.
• Urinary tract infections (mild/uncomplicated): 250 mg twice daily for 3 days.
• Urethral and gonococcal infections (uncomplicated): 250-500 mg once.
• Anthrax, post-exposure therapy and prophylaxis: 500 mg twice daily or 400 mg infusion daily for 60 days.

Elderly patients are prescribed a reduced number of Cifran tablets. The dosage is calculated based on the severity of symptoms and signs of the disease, as well as creatinine clearance. For example, if this indicator is from 30 to 50 ml/min, the dose of Cifran is from 250 to 500 mg twice a day.

"Cifran" is not the first choice drug in pediatrics (with the exception of anthrax), due to the increased incidence of side effects (including arthropathy) compared to the control group. There are no dosing data available for pediatric patients with renal impairment.

"Tsifran": dosage for children from 5 to 17 years:

1. Pulmonary anthrax (post-exposure therapy).
   Solution for infusion: at a rate of 10 mg/kg, twice a day, for two months. The individual dose should not exceed 400 mg.
   Tablets: at a rate of 15 mg/kg, twice daily for two months; the individual dose should not exceed 500 mg.
2. Cystic fibrosis.
   Tablets: at the rate of 40 mg/kg/day, twice a day. The individual dose should not exceed 2 g/day.
   Solution for infusion: 20-30 mg/kg/day, every 8 hours. The individual dose should not exceed 1.2 g/day.

A large overdose of ciprofloxacin can cause kidney damage.

In animal studies, very large doses of ciprofloxacin caused breathing problems, vomiting and seizures.

Analogues of "Tsifran":

• Baycip tablets - 500 mg. Manufacturer: Bayer.
• Cebran tablets - 500 mg. Manufacturer: Blue Corss.
• Ciplox tablets - 500 mg. Manufacturer: Cipla.
• Ciprowin tablets - 500 mg. Manufacturer: Alembic Pharma.
• Alcipro tablets - 500 mg. Manufacturer: Alkem Labs.
• Cipronat tablets - 500 mg. Manufacturer: Natco Pharma.
• Ciprofen tablets - 500 mg. Manufacturer: Franklin Labs.
• Ciprobid tablets - 500 mg. Manufacturer: Cadila Pharma.
• Quintor tablets - 500 mg. Manufacturer: Torrent Pharma.
• Ear and eye drops "Betatsiprol" - 0.3%. Manufacturer: Beta-Lek.
• Ificipro solution for infusion - 2 mg/ml. Manufacturer: UNIQUE PHARMACEUTICAL Laboratories.

The price of “Tsifran” in various pharmacies in Russia varies from 51 rubles (for 10 tablets of 250 mg each) to 92 rubles (for tablets of 500 mg each).

The cost of “Cifran” in the form of an injection solution is from 44 to 56 rubles.

The price of “Cifran” in the form of eye drops is from 48 to 60 rubles.

Composition and release form

1 film-coated tablet contains ciprofloxacin hydrochloride monohydrate 250 or 500 mg, in a cold-pressed blister or blister of 10 pcs. respectively; There are 1 or 10 blisters in a box.

100 ml of solution for infusion contains ciprofloxacin lactate 200 mg; in bottles of 100 ml, in a box 1 bottle.

1 ml eye drops - ciprofloxacin hydrochloride 3 mg; in bottles of 10 ml, in a box 1 bottle.

pharmachologic effect

pharmachologic effect- bactericidal, antibacterial, broad spectrum antibacterial.

Blocks bacterial DNA gyrase and disrupts bacterial DNA synthesis, leading to the death of the bacterial cell.

Pharmacokinetics

Rapidly absorbed from the gastrointestinal tract, bioavailability after oral administration is about 70%. After a single dose of 250 and 500 mg, the average peak serum concentrations are 1.5 and 2.5 μg/L, respectively, and are many times greater than the MIC 90 for most microorganisms. After intravenous administration of 200 mg, the serum concentration is 3.8 mcg/ml. Distributes evenly and reaches therapeutic concentrations in most tissues and fluids. The level of protein binding is low (19-40%). It is excreted unchanged in urine, as well as in bile and feces.

Indications for the drug Tsifran ®

Infections: respiratory, genitourinary tract, gynecological, bones and joints, ENT organs, gastrointestinal, abdominal; prostatitis, gonorrhea, sepsis, peritonitis.

Contraindications

Hypersensitivity, children's age (up to 12 years).

Use during pregnancy and breastfeeding

Contraindicated, stop breastfeeding.

Side effects

Tsifran is well tolerated.

From the gastrointestinal tract: diarrhea, nausea, vomiting.

From the side of the central nervous system: headache, anxiety.

Allergic reactions: hypersensitivity (rash, Quincke's edema).

Others: arthralgia.

Interaction

The effect is reduced by antacids containing magnesium or aluminum hydroxide. Enhances the effect of theophylline.

Directions for use and doses

Infections of ENT organs: orally - 250-500 mg 2 times a day; IV, drip - 200 mg 2 times a day.

Urinary tract infections: orally - 250-500 mg 2 times a day; IV, drip - 200-400 mg 2 times a day.

Particularly severe infections (sepsis, osteomyelitis, peritonitis): IV, drip - 400 mg 2 times / day, then orally - 500-750 mg / day.

For gonorrhea (uncomplicated): orally - 500 mg once.

Lower respiratory tract infections, exacerbation of chronic bronchitis, pneumonia: orally - 500 mg 2 times a day.

Eye drops. For mild to moderate illnesses: 1-2 drops into the lower conjunctival sac of the affected eye every 4 hours.

In case of severe disease: 2 drops/hour until improvement is achieved, course - 5-7 days.

Treatment is continued for an additional 3 days after the clinical symptoms of infection disappear.

Precautionary measures

Prescribe with caution to patients with central nervous system pathology (severe cerebral atherosclerosis, epilepsy). To prevent crystalluria, drink plenty of water. Patients with renal failure require dose adjustment.

special instructions

When administering eye drops and other ophthalmic medications, the interval between their administration should be at least 5 minutes.

Storage conditions for the drug Tsifran ®

At a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life of the drug Tsifran ®

film-coated tablets 250 mg - 3 years.

film-coated tablets 500 mg - 3 years.

eye drops 3 mg/ml - 2 years.

solution for infusion 2 mg/ml - 2 years.

solution for infusion 200 mg/100 ml - 2 years.

Do not use after the expiration date stated on the package.

Synonyms of nosological groups

Category ICD-10	Synonyms of diseases according to ICD-10
A04.9 Bacterial intestinal infection, unspecified	Bacterial intestinal infections
	Gastrointestinal infections
	Intestinal bacterial infections
	Digestive tract infections
	Infectious and inflammatory diseases of the gastrointestinal tract
	Infectious disease of the gastrointestinal tract
	Intestinal infection
	Intestinal infection
	Acute intestinal infection
	Acute infectious disease of the gastrointestinal tract
	Acute intestinal disease affecting the colon
A09 Diarrhea and gastroenteritis of presumably infectious origin (dysentery, bacterial diarrhea)	Bacterial diarrhea
	Bacterial dysentery
	Bacterial infections of the gastrointestinal tract
	Bacterial gastroenteritis
	Diarrhea bacterial
	Diarrhea or dysentery of amoebic or mixed etiology
	Diarrhea of ​​infectious origin
	Diarrhea during antibacterial therapy
	Traveler's diarrhea
	Travelers' diarrhea due to changes in diet and diet
	Diarrhea due to antibiotic therapy
	Dysenteric bacteria carriage
	Dysenteric enteritis
	Dysentery
	Bacterial dysentery
	Dysentery mixed
	Gastrointestinal infection
	Gastrointestinal infections
	Infectious diarrhea
	Infectious disease of the gastrointestinal tract
	Infection of the biliary tract and gastrointestinal tract
	Gastrointestinal infection
	Summer diarrhea
	Nonspecific acute diarrhea of ​​infectious nature
	Nonspecific chronic diarrhea of ​​infectious nature
	Acute bacterial diarrhea
	Acute diarrhea due to food poisoning
	Acute dysentery
	Acute bacterial gastroenteritis
	Acute gastroenterocolitis
	Acute enterocolitis
	Subacute dysentery
	Chronic diarrhea
	Refractory diarrhea in patients with AIDS
	Staphylococcal enteritis in children
	Staphylococcal enterocolitis
	Toxic diarrhea
	Chronic dysentery
	Enteritis
	Infectious enteritis
	Enterocolitis
A41.9 Septicemia, unspecified	Bacterial septicemia
	Severe bacterial infections
	Generalized infections
	Generalized systemic infections
	Generalized infections
	Wound sepsis
	Septic-toxic complications
	Septicopyemia
	Septicemia
	Septicemia/bacteremia
	Septic diseases
	Septic conditions
	Septic shock
	Septic condition
	Toxic-infectious shock
	Septic shock
	Endotoxin shock
A54 Gonococcal infection	Gonococcal infections
	Disseminated gonococcal infection
	Disseminated gonorrheal infection
H00.0 Hordeolum and other deep inflammations of the eyelids	Meibomyitis
	Meibomite
	Barley
H01.0 Blepharitis	Blepharitis
	Inflammation of the eyelids
	Inflammatory diseases of the eyelids
	Demodectic blepharitis
	Superficial bacterial eye infection
	Superficial eye infection
	Squamous blepharitis
H04.3 Acute and unspecified inflammation of the lacrimal ducts	Bacterial dacryocystitis
	Dacryocystitis
	Chronic dacryocystitis
H10.5 Blepharoconjunctivitis	Blepharoconjunctivitis
	Staphylococcal blepharoconjunctivitis
	Chronic blepharoconjunctivitis
H10.9 Conjunctivitis, unspecified	Secondarily infected conjunctivitis
	Hyperpapillary conjunctivitis
	Catarrhal conjunctivitis
	Year-round conjunctivitis
	Non-purulent conjunctivitis
	Non-purulent forms of conjunctivitis
	Non-purulent conjunctivitis
	Non-infectious conjunctivitis
	Subacute conjunctivitis
	Trachomal conjunctivitis
H16 Keratitis	Adenoviral keratitis
	Bacterial keratitis
	Spring keratitis
	Deep keratitis without epithelial damage
	Deep keratitis without damage to the epithelium
	Discoid keratitis
	Arborescent keratitis
	Keratitis rosacea
	Keratitis with corneal destruction
	Superficial keratitis
	Superficial punctate keratitis
	Punctate keratitis
	Traumatic keratitis
H16.0 Corneal ulcer	Allergic marginal corneal ulcer
	Allergic corneal ulcer
	Bacterial corneal ulcer
	Purulent corneal ulcer
	Purulent corneal ulcers
	Corneal ulceration
	Ulcerations of the superficial layers of the cornea
	Keratitis with corneal ulceration
	Keratomalacia
	Corneal ulcer
	Corneal marginal ulcer
	Recurrent corneal erosions
	Recurrent corneal ulcers
	Septic corneal ulcer
	Traumatic corneal erosion
	Trophic ulcers of the cornea
	Epithelial punctate keratitis
	Corneal erosion
	Regional ulcer
	Corneal ulcer
	Ulcerative keratitis
H16.2 Keratoconjunctivitis	Bacterial keratoconjunctivitis
	Vernal keratoconjunctivitis
	Deep forms of adenoviral keratoconjunctivitis
	Infectious conjunctivitis and keratoconjunctivitis caused by Chlamydia trachomatis
	Acute allergic keratoconjunctivitis
	Phlyctenular keratoconjunctivitis
	Chronic allergic keratoconjunctivitis
H60 Otitis externa	ENT infections
	Infections of the external auditory canal
	Outer ear infections
	Acute catarrhal inflammation of the external auditory canal
H66 Suppurative and unspecified otitis media	Bacterial ear infections
	Inflammation of the middle ear
	ENT infections
	Infectious and inflammatory diseases of the ENT organs
	Infectious and inflammatory diseases of the ear
	Infectious diseases of the ENT organs with severe pain syndrome
	Ear infection
	Infectious otitis media
	Persistent inflammation of the middle ear in children
	Ear pain due to otitis media
H70 Mastoiditis and related conditions	Mastoiditis
J01 Acute sinusitis	Inflammation of the paranasal sinuses
	Inflammatory diseases of the paranasal sinuses
	Purulent-inflammatory processes of the paranasal sinuses
	Infectious and inflammatory disease of ENT organs
	Sinus infection
	Combined sinusitis
	Exacerbation of sinusitis
	Acute inflammation of the paranasal sinuses
	Acute bacterial sinusitis
	Acute sinusitis in adults
	Subacute sinusitis
	Acute sinusitis
	Sinusitis
J03.9 Acute tonsillitis, unspecified (angina agranulocytic)	Angina
	Sore throat, alimentary-hemorrhagic
	Sore throat secondary
	Primary tonsillitis
	Sore throat follicular
	Sore throats
	Bacterial tonsillitis
	Inflammatory diseases of the tonsils
	Throat infections
	Catarrhal sore throat
	Lacunar tonsillitis
	Acute sore throat
	Acute tonsillitis
	Tonsillitis
	Acute tonsillitis
	Tonsillar tonsillitis
	Follicular tonsillitis
	Follicular tonsillitis
J04 Acute laryngitis and tracheitis	Infectious and inflammatory disease of ENT organs
	Laryngitis
	Laryngitis acute
	Acute tracheitis
	Pharyngolaryngitis
J06 Acute upper respiratory tract infections of multiple and unspecified localization	Bacterial infections of the upper respiratory tract
	Bacterial respiratory infections
	Pain due to colds
	Pain in infectious and inflammatory diseases of the upper respiratory tract
	Viral respiratory disease
	Viral respiratory tract infections
	Inflammatory disease of the upper respiratory tract
	Inflammatory diseases of the upper respiratory tract
	Inflammatory diseases of the upper respiratory tract with difficult to separate sputum
	Inflammatory diseases of the respiratory tract
	Secondary infections with influenza
	Secondary infections due to colds
	Influenza conditions
	Difficulty secreting sputum in acute and chronic respiratory diseases
	Upper respiratory tract infections
	Upper respiratory tract infections
	Respiratory tract infections
	ENT infections
	Infectious and inflammatory diseases of the upper respiratory tract
	Infectious and inflammatory diseases of the upper respiratory tract and ENT organs
	Infectious and inflammatory diseases of the upper respiratory tract in adults and children
	Infectious and inflammatory diseases of the upper respiratory tract
	Infectious inflammation of the respiratory tract
	Respiratory tract infection
	Qatar of the upper respiratory tract
	Catarrhal inflammation of the upper respiratory tract
	Catarrhal disease of the upper respiratory tract
	Catarrhal phenomena from the upper respiratory tract
	Cough in diseases of the upper respiratory tract
	Cough with a cold
	Fever due to influenza
	ARVI
	acute respiratory infections
	Acute respiratory infection with symptoms of rhinitis
	Acute respiratory infection
	Acute infectious-inflammatory disease of the upper respiratory tract
	Acute cold
	Acute respiratory disease
	Acute respiratory disease of influenza nature
	Sore throat or nose
	Cold
	Colds
	Colds
	Respiratory infection
	Respiratory viral infections
	Respiratory diseases
	Respiratory infections
	Recurrent respiratory tract infections
	Seasonal colds
	Seasonal colds
	Frequent colds and viral diseases
J18 Pneumonia without specifying the pathogen	Alveolar pneumonia
	Community-acquired pneumonia atypical
	Community-acquired pneumonia, non-pneumococcal
	Pneumonia
	Inflammatory lung disease
	Lobar pneumonia
	Respiratory and lung infections
	Lower respiratory tract infections
	Lobar pneumonia
	Lymphoid interstitial pneumonia
	Nosocomial pneumonia
	Exacerbation of chronic pneumonia
	Acute community-acquired pneumonia
	Acute pneumonia
	Focal pneumonia
	Pneumonia abscess
	Pneumonia bacterial
	Pneumonia lobar
	Pneumonia focal
	Pneumonia with difficulty in sputum discharge
	Pneumonia in patients with AIDS
	Pneumonia in children
	Septic pneumonia
	Chronic obstructive pneumonia
	Chronic pneumonia
J40 Bronchitis, not specified as acute or chronic	Allergic bronchitis
	Asthmatic bronchitis
	Asthmoid bronchitis
	Bacterial bronchitis
	Bronchitis
	Allergic bronchitis
	Asthmatic bronchitis
	Smoker's bronchitis
	Smokers' bronchitis
	Inflammation of the lower respiratory tract
	Bronchial disease
	Qatar smoker
	Smokers cough
	Cough due to inflammatory diseases of the lungs and bronchi
	Disturbance of bronchial secretion
	Bronchial dysfunction
	Acute tracheobronchitis
	Subacute bronchitis
	Rhinotracheobronchitis
	Rhinotracheobronchitis
	Tracheobronchitis
	Chronic lung diseases
K65 Peritonitis	Abdominal infection
	Intraperitoneal infections
	Intra-abdominal infections
	Diffuse peritonitis
	Abdominal infections
	Abdominal infections
	Abdominal infection
	Gastrointestinal tract infection
	Spontaneous bacterial peritonitis
M00-M03 Infectious arthropathy	Infectious arthritis
	Arthritis pyogenic
	Arthritis septic
	Joint infections
M60.0 Infectious myositis	Muscle abscess
	Soft tissue infections
	Infectious myositis
	Pyomyositis
	Specific infectious processes in soft tissues
M65.0 Tendon sheath abscess	Soft tissue infections
M65.1 Other infectious tenosynovitis	Soft tissue infections
	Tenosynovitis infectious
M71.0 Abscess of bursa	Soft tissue infections
M71.1 Other infectious bursitis	Bacterial bursitis
	Infectious bursitis
	Soft tissue infections
N39.0 Urinary tract infection without established location	Asymptomatic bacteriuria
	Bacterial urinary tract infections
	Bacterial urinary tract infections
	Bacteriuria
	Bacteriuria asymptomatic
	Chronic latent bacteriuria
	Asymptomatic bacteriuria
	Asymptomatic massive bacteriuria
	Inflammatory disease of the urinary tract
	Inflammatory disease of the genitourinary tract
	Inflammatory diseases of the bladder and urinary tract
	Inflammatory diseases of the urinary system
	Inflammatory diseases of the urinary tract
	Inflammatory diseases of the urogenital system
	Fungal diseases of the urogenital tract
	Fungal infections of the urinary tract
	Urinary tract infections
	Urinary tract infections
	Urinary tract infections
	Urinary tract infections
	Urinary tract infections
	Urinary tract infections caused by enterococci or mixed flora
	Uncomplicated genitourinary tract infections
	Complicated urinary tract infections
	Infections of the genitourinary system
	Urogenital infections
	Urinary tract infections
	Urinary tract infection
	Urinary tract infection
	Urinary tract infection
	Urinary tract infection
	Urinary tract infection
	Urogenital tract infection
	Uncomplicated urinary tract infections
	Uncomplicated urinary tract infections
	Uncomplicated genitourinary tract infections
	Exacerbation of chronic urinary tract infection
	Retrograde kidney infection
	Recurrent urinary tract infections
	Recurrent urinary tract infections
	Recurrent urinary tract infections
	Mixed urethral infections
	Urogenital infection
	Urogenital infectious and inflammatory disease
	Urogenital mycoplasmosis
	Urological disease of infectious etiology
	Chronic urinary tract infection
	Chronic urinary tract infections
	Chronic infectious diseases of the urinary system
N41 Inflammatory diseases of the prostate gland	Prostate disease
	Genital infection
	Prostatitis
	Chronic nonspecific prostatitis
N49 Inflammatory diseases of the male genital organs, not elsewhere classified	Bacterial diseases of the urogenital tract
	Bacterial infections of the genitourinary system
	Genital infections in men
	Urogenital infections
	Infectious diseases of the reproductive system
	Infectious diseases of the genital organs
	Infectious lesions of the male genital tract
	Chronic inflammatory diseases of the pelvic organs
N70-N77 Inflammatory diseases of the female pelvic organs	Pelvic organ infections
	Genital infections in women
	Urogenital infections
N74.3 Gonococcal inflammatory diseases of the female pelvic organs (A54.2+)	Gonorrheal diseases
	Gonorrhea
	Gonococcal urethritis
R78.8.0* Bacteremia	Bacteremia
	Persistent bacteremia
Z100* CLASS XXII Surgical practice	Abdominal surgery
	Adenomectomy
	Amputation
	Angioplasty of coronary arteries
	Carotid angioplasty
	Antiseptic treatment of skin for wounds
	Antiseptic hand treatment
	Appendectomy
	Atherectomy
	Balloon coronary angioplasty
	Vaginal hysterectomy
	Corona bypass
	Interventions on the vagina and cervix
	Bladder interventions
	Intervention in the oral cavity
	Restorative and reconstructive operations
	Hand hygiene of medical personnel
	Gynecological surgery
	Gynecological interventions
	Gynecological surgeries
	Hypovolemic shock during surgery
	Disinfection of purulent wounds
	Disinfection of wound edges
	Diagnostic interventions
	Diagnostic procedures
	Diathermocoagulation of the cervix
	Long surgical operations
	Replacing fistula catheters
	Infection during orthopedic surgery
	Artificial heart valve
	Cystectomy
	Short-term outpatient surgery
	Short-term operations
	Short-term surgical procedures
	Cricothyroidotomy
	Blood loss during surgery
	Bleeding during surgery and in the postoperative period
	Culdocentesis
	Laser coagulation
	Laser coagulation
	Laser coagulation of the retina
	Laparoscopy
	Laparoscopy in gynecology
	CSF fistula
	Minor gynecological operations
	Minor surgical interventions
	Mastectomy and subsequent plastic surgery
	Mediastinotomy
	Microsurgical operations on the ear
	Mucogingival surgeries
	Stitching
	Minor surgeries
	Neurosurgical operation
	Immobilization of the eyeball in ophthalmic surgery
	Orchiectomy
	Complications after tooth extraction
	Pancreatectomy
	Pericardectomy
	Rehabilitation period after surgery
	The period of convalescence after surgical interventions
	Percutaneous transluminal coronary angioplasty
	Pleural thoracentesis
	Pneumonia postoperative and post-traumatic
	Preparing for surgical procedures
Preparing for surgery
Preparing the surgeon's hands before surgery
Preparing the colon for surgery
Postoperative aspiration pneumonia during neurosurgical and thoracic operations
Postoperative nausea
Postoperative bleeding
Postoperative granuloma
Postoperative shock
Early postoperative period
Myocardial revascularization
Resection of the apex of the tooth root
Gastric resection
Bowel resection
Resection of the uterus
Liver resection
Small bowel resection
Resection of part of the stomach
Reocclusion of the operated vessel
Bonding tissue during surgery
Removing stitches
Condition after eye surgery
Condition after surgery
Condition after surgical interventions in the nasal cavity
Condition after gastrectomy
Condition after resection of the small intestine
Condition after tonsillectomy
Condition after removal of the duodenum
Condition after phlebectomy
Vascular surgery
Splenectomy
Sterilization of surgical instruments
Sterilization of surgical instruments
Sternotomy
Dental operations
Dental intervention on periodontal tissues
Strumectomy
Tonsillectomy
Thoracic surgery
Thoracic operations
Total gastrectomy
Transdermal intravascular coronary angioplasty
Transurethral resection
Turbinectomy
Removal of a tooth
Cataract removal
Cyst removal
Tonsil removal
Removal of fibroids
Removal of mobile baby teeth
Removal of polyps
Removing a broken tooth
Removal of the uterine body
Removing stitches
Urethrotomy
CSF duct fistula
Frontoethmoidohaymorotomy
Surgical infection
Surgical treatment of chronic limb ulcers
Surgery
Surgery in the anal area
Colon surgery
Surgical practice
Surgical procedure
Surgical interventions
Surgical interventions on the gastrointestinal tract
Surgical interventions on the urinary tract
Surgical interventions on the urinary system
Surgical interventions on the genitourinary system
Heart surgery
Surgical procedures
Surgical operations
Vein surgery
Surgical intervention
Vascular surgery
Surgical treatment of thrombosis
Surgery
Cholecystectomy
Partial gastrectomy
Transperitoneal hysterectomy
Percutaneous transluminal coronary angioplasty
Percutaneous transluminal angioplasty
Coronary artery bypass surgery
Tooth extirpation
Extirpation of baby teeth
Pulp extirpation
Extracorporeal circulation
Tooth extraction
Tooth extraction
Cataract extraction
Electrocoagulation
Endourological interventions
Episiotomy
Ethmoidotomy

Compound

1 film-coated tablet contains ciprofloxacin 500 mg; excipients: microcrystalline cellulose, starch

corn, magnesium stearate, purified talc, anhydrous colloidal silicon dioxide, sodium starch glycolate, hydroxypropyl methylcellulose, macrogol 400, titanium dioxide (E 171).

Description

white or off-white, round, film-coated tablets, beveled and marked "CFT" on one side and "500" on the other, and diamond-shaped designs on both sides;

pharmachologic effect

Cifran, like other fluorinated quinolones, blocks bacterial DNA gyrase, as a result of which it suppresses the function of bacterial DNA. Cifran is active against gram-positive and gram-negative pathogens, including strains resistant to penicillins, cephalosporins and/or aminoglycosides. The spectrum of action of Tsifran covers the following microorganisms:

aerobic gram-negative bacteria - Escherichia coli, Klebsiella spp., Salmonella spp., Proteus spp., Shigella spp., Yersinia spp., Enterobacter spp., Morganella morganii, Providencia spp., Vibrio spp., Citrobacter spp., Serratia spp., Campylobacter spp., Pseudomonas aeruginosa, P. cepacia, Neisseria gonorrhoeae, N. meningitidis, Haemophilus influenzae, H. ducreyi, Acinetobacter** spp., Moraxella catarrhalis, Gardnerella vaginalis, Pasteurella multocida, Helicobacter pylori;

aerobic gram-positive bacteria - staphylococci, including strains that produce penicillinase and strains resistant to methicillin, streptococci, including Streptococcus pneumoniae, Listeria monocytogenes, Corynebacterium spp..

The following are insensitive to the drug: anaerobic bacteria, mycobacteria, mycoplasma, rickettsia, chlamydia, Nocardia asteroides, Ureaplasma urealyticum, spirochete pallidum, viruses, fungi and protozoa.

Pharmacokinetics

Ciprofloxacin is rapidly absorbed after oral administration, its bioavailability is 70%. Food does not affect the degree of absorption of the drug, but may slightly reduce the rate of absorption. Peak concentrations of ciprofloxacin in the blood reach 1.5 mcg/ml and 2.5 mcg/ml within 1-2 hours after taking an oral dose of 250 mg and 500 mg, respectively. The half-life of the drug is 3.5-4.5 hours; it can be prolonged in elderly patients, and in cases of severe renal failure it can last up to 8 hours. The half-life may be slightly prolonged in patients with severe liver cirrhosis. The pharmacokinetics of Cifran does not change in patients with cystic fibrosis. The drug reaches therapeutic concentrations in almost all tissues and fluids of the body. Protein binding of ciprofloxacin is low - 19-40%. Ciprofloxacin passes through the placenta and is excreted in breast milk. 40-50% of the drug is excreted in the urine unchanged, and approximately 15% in the form of metabolites. Almost 20-35% of the drug is excreted in bile and feces.

Indications for use

Treatment of infections caused by microorganisms sensitive to the drug, including mixed infections that are caused by two or more microorganisms:

Adults.

Lower respiratory tract infections caused by gram-negative bacteria:

Exacerbation of chronic obstructive pulmonary disease;

Bronchopulmonary diseases in cystic fibrosis and bronchiectasis; -

Pneumonia.

Chronic acute otitis media;

Exacerbation of chronic sinusitis, especially caused by gram-negative bacteria;

Urinary tract infections;

Gonococcal urethritis and cervicitis;

Epididymitis orchioepididymitis, including those caused by Neisseria gonorrhoeae;

Inflammatory diseases of the pelvic organs, including cases of gonorrheal etiology.

When treating genital tract infections where gonorrhea is suspected, it is especially important to obtain information about the absence of resistance to ciprofloxacin and confirm sensitivity with laboratory tests

Gastrointestinal tract infections (including traveler's diarrhea);

Intra-abdominal infections;

Skin and soft tissue infections caused by gram-negative bacteria;

Malignant otitis externa;

Bone and joint infections;

Treatment of infections in patients with neutropenia;

Prevention of infections in patients with neutropenia;

Anthrax (post-exposure prophylaxis and treatment of the disease).

Children and teenagers

Bronchopulmonary diseases in children with cystic fibrosis caused by Pseudomonas aeruginosa;

Complicated urinary tract infections and pyelonephritis;

Anthrax (post-exposure prophylaxis and treatment of the disease). Ciprofloxacin may be used to treat severe infections in children and adolescents. Treatment should only be prescribed by a specialist experienced in treating cystic fibrosis and/or severe infections in children and adolescents.

Contraindications

Hypersensitivity (allergy) to ciproofloxacin or antibacterial drugs of the fluoroquinolone group

Glucose-6-phosphate dehydrogenase deficiency

Epilepsy (including history)

Reducing the seizure threshold (including after traumatic brain injury, stroke or inflammatory processes in the central nervous system)

Concomitant use of ciprofloxacin and tizanidine due to clinically significant side effects (hypotension, drowsiness) associated with increased plasma concentrations of tizanidine

Childhood and adolescence up to 16 - 18 years (until growth and skeletal formation are completed)

Pregnancy

Lactation period.

Pseudomembranous colitis

Directions for use and doses

Doses of Cifran are established depending on the type, severity and localization of the infection, the type of microorganism and susceptibility to ciprofloxacin, the condition of the body, the patient’s kidney function, as well as body weight in children and* adolescents.

The duration of treatment depends on the severity of the disease, clinical and bacteriological results.

Treatment of infections caused by certain microorganisms (eg, Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher doses of ciprofloxacin, as well as concomitant administration of other appropriate antibacterial drugs.

For the treatment of certain infections (eg, pelvic inflammatory disease, intra-abdominal infections, infections in patients with neutropenia, or infections of bones and joints), concomitant therapy with other appropriate antibacterial drugs may be prescribed.

Poe/strong patients

Elderly patients should be treated according to the severity of the infection and creatinine clearance.

Kidney and liver failure

In patients with impaired liver function, no dose adjustment is required.

Features of use in children with impaired liver or kidney function have not been studied.

Mode of application

The tablets should be swallowed whole with a small amount of liquid, regardless of meals. However, if the drug is taken on an empty stomach, the absorption of the active substance will occur faster. Ciprofloxacin tablets should not be taken with dairy products (milk, yogurt) or juices fortified with minerals (eg calcium-fortified orange juice). In severe cases or if the patient is unable to take tablets (for example, patients on enteral nutrition), it is recommended to begin treatment with intravenous ciprofloxacin followed by oral administration of the drug.

Side effect

From the gastrointestinal tract:

Nausea, diarrhea, vomiting, dyspepsia, abdominal pain, flatulence, loss of appetite; cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis.

If severe, prolonged diarrhea occurs during or after treatment, you should consult a doctor, since this symptom may conceal a serious intestinal disease (pseudomembranous colitis), which requires immediate treatment. In such cases, ciprofloxacin should be discontinued and appropriate treatment should be initiated (eg, vancomycin orally, 250 mg x 4 times daily). In this case, the use of drugs that suppress peristalsis is contraindicated.

From the nervous system:

Dizziness, fainting, headache, fatigue, anxiety, trembling; very rare: insomnia, peripheral paralysis, sweating, unsteady gait, convulsions, increased intracranial pressure, anxiety, nightmares, cranial hypertension, anxiety, confusion, depression, hallucinations, as well as other manifestations of psychotic reactions (occasionally even progressing to states in which the patient may cause harm to himself), thrombosis of the cerebral arteries. Sometimes these reactions appear after the first use of ciprofloxacin. In such cases, you should stop using the drug and consult a doctor immediately.

From the senses:

Very rare: disturbances of taste and smell, visual disturbances (for example, diplopia, changes in color vision), tinnitus, temporary hearing impairment.

Photosensitivity

Ciprofloxacin has potential phototoxicity. Patients taking ciprofloxacin should avoid direct sunlight and intense ultraviolet radiation. In case of

photosensitivity (the appearance of burn-like symptoms) should be stopped.

From the hematopoietic system:

Eosinophilia, leukocytopenia, granulocytopenia, anemia, thrombocytopenia; very rare: leukocytosis, thrombocytosis, hemolytic anemia.

From the urinary system:

Hematuria; crystalluria (primarily with alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, hematuria, decreased nitrogen excretory function of the kidneys, interstitial nephritis.

From the musculoskeletal system:

Joint pain, joint swelling; very rarely: general weakness, muscle pain: arthralgia, arthritis, tendovaginitis, myalgia. In isolated cases, achillotendinitis was observed during the use of ciprofloxacin. However, isolated cases of partial or complete rupture of the Achilles tendon were observed, mainly in elderly patients who had previously received systemic treatment with glucocorticoids. Therefore, if any symptoms of achilles tendinitis (for example, painful swelling) appear, you should stop using ciprofloxacin and consult a doctor.

Allergic reactions:

Sometimes allergic reactions occur after the first use of ciprofloxacin. In such cases, you should stop using the drug and consult a doctor immediately. ^

Skin reactions, for example: rash, itching, drug fever.

Very rare: Pinpoint skin hemorrhages (petechiae), blisters,

accompanied by bleeding (hemorrhagic bullae), papules with crust formation, vasculitis.

Erythema nodosum, exudative polymorphic erythema (small forms).

Stevens-Johnson syndrome a (malignant exudative erythema), Lyell's syndrome.

Interstitial nephritis, hepatitis, necrosis of liver tissue, in rare cases progressing to life-threatening liver failure. Anaphylactic/anaphylactoid reactions (for example, swelling of the face or larynx; shortness of breath progressing to life-threatening shock), sometimes appearing after the first dose of the drug. In such cases, Ciprofloxacin should be discontinued and appropriate treatment should be resorted to (for example, therapy for anaphylactic shock).

From the cardiovascular system:

Tachycardia, heart rhythm disturbances, arterial hypotension, “flushes” of blood to the skin of the face.

Other side effects:

Tenosynovitis, increased photosensitivity, transient renal dysfunction, including renal failure, drug fever, pinpoint hemorrhages (petechiae), swelling of the face or larynx; shortness of breath Prolonged or repeated use of ciprofloxacin can lead to the development of superinfection caused by resistant microorganisms or yeast-like fungi.

From the laboratory parameters:

A temporary increase in transaminase and alkaline phosphatase levels or cholestatic jaundice may occur, especially in patients with a history of liver disease; there may be a temporary increase in the level of urea, creatinine or bilirubin in the blood serum; in some cases: hyperglycemia, crystalluria or hematuria.

Note for drivers:

Even when used as prescribed, this drug may reduce your reaction time to such an extent that your ability to drive or operate automated systems may be impaired. This negative impact is aggravated when alcohol is consumed simultaneously with therapy.

Overdose

Symptoms: There are no specific symptoms of overdose. Treatment: there is no specific antidote; general emergency measures, gastric lavage, administration of activated charcoal are recommended; hemodialysis and peritoneal dialysis are additionally recommended

Interaction with other drugs

Increases the concentration of theophylline (and other xanthines, for example, caffeine), oral hypoglycemic drugs in the blood plasma, indirect anticoagulants and lengthens their T1/2, increases the severity of the decrease in the prothrombin index, due to a slight decrease in the activity of microsomal oxidation processes in hepatocytes (the severity of this effect is weaker than cimetidine). If the simultaneous use of ciprofloxacin and theophylline is unavoidable, constant monitoring of the concentration of theophylline in the blood plasma is necessary until its dosage is reduced accordingly.

When taken simultaneously, it enhances the effect of indirect anticoagulants. Studies have shown that the combination of very high doses of quinolones (gyrase inhibitors) and certain non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) can cause seizures.

When combined with other antimicrobial drugs, synergism is usually observed (beta-lactams, aminoglycosides, clindamycin, metronidazole); can be successfully used in combination with azlocillin and ceftazidime for infections caused by Pseudomonas spp.; with mezlocillin, azlocillin and other beta-lactam antibiotics - for streptococcal infections; with isoxazolepenicillins and vancomycin - for staphylococcal infections; with metronidazole and clindamycin - for an. With simultaneous therapy with ciprofloxacin and cyclosporine, a short-term increase in the concentration of creatinine in the blood plasma was observed. In this regard, in such cases it is necessary to determine the level of creatinine in the blood twice a week.

The simultaneous use of ciprofloxacin and warfarin may enhance the effect of the latter.

In some cases, the simultaneous use of ciprofloxacin and glibenclamide may enhance the effect of glibenclamide (hypoglycemia). Probenecid slows down the rate of excretion of ciprofloxacin by the kidneys. The simultaneous use of probenecid and ciprofloxacin increases the concentration of ciprofloxacin in plasma and blood.

Metoclopramide accelerates the absorption of ciprofloxacin, reducing the period of time required to achieve its maximum plasma concentration. However, the bioavailability of ciprofloxacin does not change. Co-administration of uricosuric drugs leads to a slowdown in elimination (up to 50%) and an increase in plasma concentrations of ciprofloxacin. Drugs that alkalinize urine (citrates, sodium bicarbonate, carbonic anhydrase inhibitors) reduce solubility (the likelihood of crystal uria increases).

Oral administration together with iron-containing preparations, sucralfate, bismuth preparations and antacid preparations containing Mg, Al and Ca ions leads to a decrease in the absorption of ciprofloxacin, so it should be prescribed either 1-2 hours before or no less than 4 hours after taking antacids. When used simultaneously with didanosine, the absorption of ciprofloxacin is reduced due to the formation of complexes of ciprofloxacin with the aluminum and magnesium salts contained in didanosine.

Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs that prolong the QT interval (eg, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics)

Features of application

Severe infectious diseases and mixed infectious processes caused by gram-positive and anaerobic pathogenic flora Ciprofloxacin monotherapy is not suitable for the treatment of severe infections and diseases that can be caused by anaerobic pathogenic flora.

In these cases, ciprofloxacin should be prescribed simultaneously with other antibacterial drugs.

Streptococcal infection (including Streptococcus pneumoniae)

Infections of the genital tract w

Epididymo-orchitis and pelvic diseases can be caused by fluoroquinolone-resistant Neisseria gonorrhoeae. Ciprofloxacin should be co-administered with other antibacterial drugs, unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not observed within 3 days, then treatment should be reconsidered. Intra-abdominal infectious diseases

There is limited data on the effectiveness of ciprofloxacin for the treatment of postoperative intraperitoneal infections.

Traveler's diarrhea When choosing ciprofloxacin, it is necessary to take into account information about drug resistance of the relevant pathogenic microorganism in the country being visited.

Infectious diseases of bones and joints

Ciprofloxacin should be prescribed in combination with other

antimicrobial drugs and only after a microbiological study.

anthrax

Use in humans is based on in vitro susceptibility studies and animal studies. Information on the use of the drug in humans is limited. The treating doctor should refer to national and/or international documents related to the treatment of the specified disease.

Children and teenagers

Treatment can only be prescribed by a specialist experienced in the treatment of cystic fibrosis and/or severe infectious diseases in children and adolescents. Safety data obtained from randomized, double-blind studies of ciprofloxacin in children have identified cases of possible drug-related arthropathy (identified by clinical signs and symptoms). The incidence of the disease over a one-year period was 9.0% and 5.7%. Treatment should be started only after assessing the benefit/risk ratio, as joint-related adverse reactions may occur.

Bronchopulmonary infectious diseases

Clinical studies included children and adolescents aged 5-17 years. There are limited data regarding the treatment of children aged 1 to 5 years.

Complicated urinary tract infections and pyelonephritis Treatment with ciprofloxacin should be considered in cases where treatment with other drugs is not possible, and only after microbiological analysis.

Clinical studies included children and adolescents aged 1 to 17 years.

Other specific severe infectious diseases Ciprofloxacin is used in the treatment of other severe infectious diseases in accordance with official guidelines or after a careful assessment of the benefit/risk ratio in cases where other treatment is not possible, or after an unfavorable outcome of conventional treatment, and only after microbiological analysis.

Hypersensitivity

After taking a single dose of the drug, hypersensitivity reactions may occur, including anaphylactic and anaphylactoid """ reactions. If these reactions occur, it is necessary to stop taking the drug and prescribe appropriate conservative treatment.

Musculoskeletal system

At the first signs of tendinitis (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.

In elderly patients with tendon diseases, or those previously treated with corticosteroids, cases of tendon rupture (mainly Achilles tendon) may occur.

Ciprofloxacin should be used with caution in patients with a history of tendon diseases associated with quinolones. Fluoroquinvlones, including ciprofloxacin, reduce neuromuscular transmission and may worsen muscle weakness in individuals with myasthenia gravis. Photosensitivity

Ciprofloxacin has been shown to cause photosensitivity reactions. Patients taking ciprofloxacin should avoid direct exposure to sunlight and UV radiation.

central nervous system

It is known that quinolones can initiate a seizure and lower the seizure threshold, due to the stimulating effect of ciprofloxacin on the central nervous system. Cifran should be used with caution in patients with diseases of the central nervous system that provoke seizures, and if these phenomena occur, stop taking the drug.

Cases of polyneuropathy (based on neurological symptoms such as pain, burning, agitation) have been reported in patients receiving ciprofloxacin. If symptoms of this disease occur, including pain, burning, tinnitus, numbness and/or weakness, the drug should be discontinued to prevent the development of an irreversible condition.

The cardiovascular system

Caution should be exercised when using fluoroquinolones, including coprofloxacin, in patients with known risk factors for QT prolongation, such as:

Congenital long QT syndrome

Concomitant use of drugs known to prolong the QT interval (eg, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics)

Electrolyte imbalance (eg, hypokalemia, hypomagnesemia)

Elderly age

Heart disease (eg, heart failure, myocardial infarction, bradycardia).

Gastrointestinal tract

The presence of severe and persistent diarrhea during or after treatment with the drug (including several weeks after treatment) may indicate pseudomembranous colitis (life-threatening, possibly fatal), requiring immediate treatment. In such cases, it is necessary to immediately discontinue ciprofloxacin and begin appropriate treatment. The use of antiperistaltic drugs in this situation is contraindicated.

Renal and urinary system

During treatment with ciprofloxacin, to avoid the development of crystalluria, it is necessary to ensure that the patient receives a sufficient amount of fluid. Hepatobiliary system

Cases of liver necrosis and life-threatening

liver failure associated with the use of tsshtr fav-kvaiiia.„D.,

if any signs or symptoms appear

(such as anorexia, jaundice, dark urine, itching or a tense abdomen), treatment with the drug must be stopped.

Glucose-b-phosphate degmoduogenase deficiency

In patients with glucose-6-phosphate dehydrogenase deficiency, the use of ciprofloxacin may cause hemolytic reactions. It is necessary to avoid prescribing the drug to such patients, except in cases where the potential benefit outweighs the possible risk. In this case, the potential for hemolysis should be monitored.

Resistance

During long-term therapy and in cases of treatment of nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas, there may be a potential risk of isolation of ciprofloxacin-resistant bacteria. Cytochrome P450

Ciprofloxacin inhibits CYP1A2, thereby causing an increase in serum concentrations of drugs metabolized by this enzyme (for example, theophylline, clozapine, ropinirole, tizanidine). Patients taking these drugs concomitantly with ciprofloxacin should be under medical supervision to identify clinical signs of overdose.

Effect on laboratory parameters

When assessing the results of bacteriological tests, the in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis should be taken into account.

The drug reduces the speed of psychomotor reactions, which must be taken into account when driving vehicles and working with mechanisms that require concentration.

Release form

10 tablets in a blister; 1 blister in a cardboard box.

Storage conditions

Store in a dry place, out of reach of children, at a temperature not exceeding 25°C.

Instructions for use:

Cifran is an antibacterial drug from the quinolone/fluoroquinolone group.

Pharmacological action of Tsifran

Cifran is a broad-spectrum antimicrobial drug, the main active ingredient of which is ciprofloxacin. The therapeutic effect of the drug is based on the mechanism of inhibiting the bacterial enzyme and disrupting the synthesis of their DNA. In addition, Cifran is able to increase the permeability of the cell membrane of harmful microorganisms (in particular bacteria) and have a bactericidal effect on them. The drug affects both bacteria in the reproduction phase and those at rest.

Cifran is active against a number of aerobic gram-negative bacteria, including Enterobacter spp, Escherichia coli, Citrobacter spp, Shigella spp, Morganella morganii, Moraxella spp, Salmonella spp and others. Tsifran's activity against aerobic gram-positive bacteria was also noted: Listeria monocytogenes, Staphylococcus aureus, Streptococcus pneumoniae and a number of others, including strains that produce penicillinase. Finally, the drug is active against intracellular bacteria: Brucella spp, Chlamydia trachomatis, Legionella spp, Mycoplasma hominis.

However, the instructions for Cifran note the resistance of anaerobic bacteria to the drug.

The post-antibiotic effect after taking the drug lasts up to 6 hours, which helps prevent further bacterial growth.

In addition, treatment with Cifran does not disrupt the natural microflora of the vagina and intestines.

Release form

Three forms of the drug are available in pharmacy chains:

• Tablets with a mass fraction of ciprofloxacin 250 or 500 mg. The tablets are coated and packaged in a cardboard box in quantities of 10 or 100 pieces;
• Solution for infusion containing ciprofloxacin in the amount of 2 mg in 1 ml of Cifran. The content of the drug in one bottle is 100 ml. The bottle is placed in a box;
• Eye drops. 1 ml of drops contains 3 mg of ciprofloxacin. The drops are packaged in a dark glass bottle and placed in a cardboard box.

Indications for use of Tsifran

Indications for Cifran are infectious and inflammatory diseases caused by microorganisms sensitive to the action of the drug. According to the instructions for Cifran, the drug is effective for the following diseases:

• for infections of the genitourinary system (including chronic and acute pyelonephritis, cystitis, prostatitis, epididymitis);
• for respiratory tract infections, which include bronchopneumonia, pneumonia, exacerbation of chronic bronchitis, acute bronchitis, pleurisy, empyema, infected bronchiectasis, lung abscesses;
• for gonorrhea, urethritis, proctitis, pharyngitis, including forms caused by resistant gonococci;
• for infections of the ENT organs, including otitis media and external, mastoiditis, sinusitis;
• for infections of soft tissues and skin, including wounds and burns, infected ulcers, cellulitis, abscesses;
• for gastrointestinal infections, including peritonitis, cholangitis, typhoid fever, intra-abdominal abscesses, gallbladder empyema;
• for infectious and inflammatory diseases of the pelvic organs, including endometritis and salpingitis;
• for infections of joints and bones, including chronic and acute osteomyelitis, septic arthritis;
• for septicemia, bacteremia, infections in patients with a weakened immune system.

The instructions for Tsifran describe the effectiveness of intravenous administration of the drug in the prevention of postoperative infections.

Contraindications

Treatment with Cifran is not recommended in case of hypersensitivity to quinols, in particular to ciprofloxacin. Also contraindications are pregnancy and lactation, age under 12 years.

The use of Cifran by some groups of patients is permissible only under the condition of careful medical supervision during treatment, these include:

• patients with severe cerebral atherosclerosis;
• patients with cerebrovascular accidents;
• patients with diagnosed mental illness;
• patients with epileptic syndrome and epilepsy;
• patients with severe liver and/or kidney failure;
• elderly patients.

Instructions for use of Tsifran

The dosage during treatment with Cifran is set strictly individually, based on the severity of the disease, type of pathogen, body weight, patient age and kidney function.

For children over 12 years of age, Cifran is indicated in an amount of 5-10 mg/kg body weight per day. In this case, the dosage is divided into two doses. It is preferable to take the tablets before meals.

Cifran in the form of intravenous infusion is administered to adults in the amount of 200 mg twice a day for infections of the lower extremities and urinary tract. The drug is administered slowly. For other infections, Cifran should be administered at the same rate in the amount of 200 mg every 12 hours.

For septicemia and bacteremia, up to 400 mg of the drug is administered every 12 hours.

In case of severe renal impairment, the daily dose is reduced by 2 times.

The duration of IV use of Cifran 200 mg is 60 minutes.

In some cases, after a course of IV administration of Cifran, you should switch to oral administration of the drug.

The duration of treatment with Cifran and drug analogues is determined by the doctor based on the patient’s individual parameters. It is recommended to carry out treatment for at least 5-7 days for acute infectious diseases; after the clinical symptoms of infection disappear, the course of treatment is extended for another 3 days.

It is recommended to instill eye drops 1-2 drops into the lower conjunctival sac of the affected eye every 4 hours for mild to moderate diseases. gravity. In case of severe disease, the indications for Cifran are as follows: every hour, 2 drops until improvement occurs. After this, the dose of the drug is reduced.

Side effects of Tsifran

The use of Tsifran and analogues of the drug in rare cases can cause a number of undesirable reactions. You should familiarize yourself with their list before starting your appointment:

• abdominal pain, flatulence, vomiting, nausea, hepatitis;
• paresthesia, headache, irritability, dizziness, confusion, migraine, fainting, depression, tremors of extremities;
• disturbances of smell, vision and taste, hearing loss;
• heart rhythm disturbances, tachycardia;
• leukopenia, eosinophilia, anemia, leukocytosis, hemolytic anemia, thrombocytosis;
• hypoprothrombinemia, hyperglycemia, increased activity of liver transaminases;
• hematuria, glomerulonephritis, polyuria, dysuria, urinary retention, urethral bleeding;
• arthralgia, myalgia, tenosynovitis, arthritis, tendon ruptures;
• general weakness, photosensitivity, superinfections (in the form of candidiasis, pseudomembranous colitis).

Analogues of the drug

Drugs similar in mode of action and composition to Tsifran include:

• Basijen;
• Afenoxin;
• Alcipro;
• Ificipro;
• Quintor;
• Quipro;
• Oftocipro et al.

Storage conditions