Cifran, pills 500mg, 10pcs

Composition

Active ingredients:

ciprofloxacin hydrochloride 594.14 mg, equivalent to ciprofloxacin 500 mg.

Auxiliary substances:

microcrystalline cellulose 50.08 mg,

corn starch 36.62 mg,

magnesium stearate 7.48 mg,

purified talc 4.56 mg,

colloidal anhydrous silicon 9.36 mg,

sodium starch glycolate 47.76 mg,

purified water* q. s.

Film shell material:

Opadrai-OU-858910 white 26.88 mg, purified talc 2.44 mg, purified talc q. s., purified water.

Pharmacological action

Pharmaceutical group:

antimicrobial agent-fluoroquinolone.

Pharmaceutical action:  

Cyfran, like other fluorinated quinolones, blocks bacterial DNA gyrase, thereby suppressing the function of bacterial DNA. Cyfran is active against gram-positive and gram-negative pathogens, including strains resistant to penicillins, cephalosporins and / or aminoglycosides. The spectrum of action of Cyfran 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., Opportunistic bacteria, 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.

Anaerobic bacteria, mycobacteria, mycoplasmas, rickettsias, chlamydia, Nocardia asteroides, Ureaplasma urealyticum, pale spirochete, viruses, fungi and protozoa are insensitive to the drug.

Indications

Urinary tract infections, gonorrhea, pneumonia, skin and soft tissue infections, bone and joint infections, intestinal infections, barley, blood poisoning.

Contraindications

Hypersensitivity to Cifran, severe renal impairment, epilepsy.

Side effects

From the digestive system:  

Often: nausea, diarrhea.

Infrequently: abdominal pain; vomiting; flatulence; anorexia; changes in liver tests-alanine aminotransferase (ALT) and aspartate aminotransferase (ACT), alkaline phosphatase; jaundice; hyperbilirubinemia.

Rare: oral candidiasis, jaundice, including cholestatic, pseudomembranous colitis.

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

From the side of the skin:  

Infrequently: a rash.

From the hematopoietic system:  

Infrequently: eosinophilia.

Rarely: anemia, leukopenia (granulocytopenia), leukocytosis, increased or decreased prothrombin index, thrombocytopenia, thrombocytosis, neutropenia. Very rare: hemolytic anemia, pancytopenia (including life-threatening), agranulocytosis, in extremely rare cases, life-threatening bone marrow depression.

From the urinary system:  

Infrequently: increased creatinine and urea nitrogen levels.

Musculoskeletal disorders:  

Infrequently: arthralgia.

Rare: myalgia (muscle pain), joint swelling.

Very rare: myasthenia gravis, tendinitis (mainly Achilles tendons), partial or complete rupture of tendons (mainly Achilles tendons), exacerbation of myasthenia gravis symptoms, arthritis, muscle weakness, exacerbation of myasthenia gravis symptoms.

From the central nervous system:  

Infrequently: headache, dizziness, sleep disorders, anxiety, confusion.

Rare: migraines, hallucinations, sweating, paresthesia (including peripheral paralgesia), anxiety, nightmares, depression, tremors, seizures, hyperesthesia, agitation, disorientation, dysesthesia, hypesthesia, vertigo.

Very rare: large seizures, unstable gait, psychosis, increased intracranial pressure, ataxia, increased muscle tone, muscle cramps, impaired coordination of movements.

Frequency unknown: peripheral neuropathy and polyneuropathy.

From the side of the skin:  

Infrequently: pruritus, urticaria, maculopapular rash.

Very rare: petechiae, erythema multiforme, erythema nodosum, persistent skin rashes.

From the side of the senses:  

Infrequently: taste disorders.

Rare: tinnitus, temporary hearing disorders, visual disturbances (diplopia, color perception disorders), hearing loss.

Very rare: parosmia, anosmia.

Other services:  

Infrequently: asthenia (feeling weak, tired), candidiasis.

Rarely: peripheral edema, hyperglycemia, pain in the extremities, back pain, chest pain.

Very rare: increased activity of amylase, lipase.

From the cardiovascular system:  

Rarely: tachycardia, a feeling of “rush” of blood to the face, a decrease in blood pressure, fainting, vasodilation.

Very rare: vasculitis.

Frequency unknown: prolongation of the Q-T interval, ventricular arrhythmias (including the “pirouette” type).

Allergic reactions:  

Rare: anaphylactic reactions, fever, angioedema.

Very rare: anaphylactic shock, skin rash, serum sickness-like reactions, Stevens-Johnson syndrome (malignant exudative erythema), Lyell’s syndrome (toxic epidermal necrolysis).

Respiratory system disorders:  

Rare: dyspnoea, laryngeal edema, respiratory disorders (including bronchospasm).

From the side of the skin:  

Rare: photosensitivity reactions.

From the urogenital system:  

Rare: acute renal failure, impaired renal function, vaginal candidiasis, hematuria, crystalluria, interstitial nephritis.

In addition, the following adverse events were observed: cerebral artery thrombosis, polyuria, albuminuria, and urinary retention. The association of these adverse events with the use of ciprofloxacin has not been reliably confirmed.

Interaction

When didanosine is co-administered with ciprofloxacin, the effect of ciprofloxacin decreases due to the formation of ciprofloxacin complexes with aluminum and magnesium salts contained in didanosine.

Simultaneous use of ciprofloxacin with theophylline may lead to an increase in the concentration of theophylline in blood plasma, due to competitive inhibition in the cytochrome P 450 binding sites, which leads to an increase in the half-life of theophylline and an increased risk of toxic effects associated with theophylline.

Concomitant use of sucralfate, antacids, drugs with a large buffer capacity (for example, antiretroviral drugs), as well as drugs containing aluminum, zinc, iron or magnesium ions may cause a decrease in the absorption of ciprofloxacin, so ciprofloxacin should be taken either 1-2 hours before or 4 hours after taking these drugs.

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

Concomitant use of ciprofloxacin, dairy products or mineral-rich beverages (such as milk, yogurt, or calcium-rich orange juice) should be avoided, as the absorption of ciprofloxacin may decrease. However, calcium in other foods does not significantly affect the absorption of ciprofloxacin.

With the combined use of ciprofloxacin and omeprazole, there may be a slight decrease in the maximum concentration (Cmax) of the drug in blood plasma and a decrease in the area under the concentration-time curve (AUC).

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

With the simultaneous use of ciprofloxacin and anticoagulants (including warfarin), the bleeding time is prolonged.

With the simultaneous use of ciprofloxacin and cyclosporin, the nephrotoxic effect of the latter increases. Concomitant therapy with ciprofloxacin and cyclosporine resulted in a short-term increase in plasma creatinine concentrations. In such cases, it is necessary to determine the concentration of creatinine in the blood twice a week.

In some cases, the simultaneous use of ciprofloxacin and glibenclamide may increase the effect of glibenclamide (hypoglycemia).

Co-use of uricosuric drugs, including probenecid, slows down the rate of excretion of ciprofloxacin by the kidneys (up to 59%) and increases the concentration of ciprofloxacin in blood plasma.

Concomitant use of ciprofloxacin may slow down the tubular transport (renal metabolism) of methotrexate, which may be accompanied by an increase in the concentration of methotrexate in blood plasma. This may increase the likelihood of side effects of methotrexate. In this regard, patients receiving combined therapy with methotrexate and ciprofloxacin should be carefully monitored.

Metoclopramide accelerates the absorption of ciprofloxacin, reducing the time required to reach its maximum concentration in blood plasma. The bioavailability of ciprofloxacin does not change.

As a result of a clinical study with the participation of healthy volunteers, when ciprofloxacin and tizanidine were used simultaneously, an increase in the concentration of tizanidine in blood plasma was revealed: an increase in Cmax by 7 times (from 4 to 21 times), an increase in AUC by 10 times (from 6 to 24 times). Hypotensive and sedative side effects are associated with an increase in the concentration of tizanidine in the blood serum. Thus, the simultaneous use of ciprofloxacin and tizanidine is contraindicated.

Ciprofloxacin can be used in combination with other antibiotics. As shown in in vitro studies, the combined use of ciprofloxacin and beta-lactam antibiotics, as well as aminoglycosides, was accompanied mainly by an additive and indifferent effect; relatively rarely, an increase in the effect of both drugs was observed, and very rarely — a weakening.

How to take, course of use and dosage

Inside on an empty stomach, without chewing, with a small amount of liquid. It can be taken regardless of food intake. If the drug is used on an empty stomach, the Active ingredient is absorbed faster. In this case, tablets should not be washed down with dairy products or fortified with calcium (for example, milk, yogurt, juices with a high calcium content). Calcium contained in regular food does not affect the absorption of ciprofloxacin.

The dose of ciprofloxacin depends on the severity of the disease, type of infection, body condition, age, weight, and kidney function of the patient. Recommended doses: 

Adults:

Lower respiratory tract infections (acute and chronic (in the acute stage) bronchitis, pneumonia, bronchiectasis, infectious complications of cystic fibrosis) of mild and moderate severity-500 mg 2 times a day, in severe cases-750 mg 2 times a day. The course of treatment is 7-14 days.

ENT infections (otitis media, acute sinusitis) – 500 mg 2 times a day, the course of treatment is 10 days.

Infections of bones and joints (osteomyelitis, septic arthritis) – mild to moderate severity-500 mg 2 times a day, in severe cases-750 mg 2 times. The course of treatment is up to 4-6 weeks.

Skin and soft tissue infections (infected ulcers, wounds, burns, abscesses, phlegmon) of mild and moderate severity — 500 mg 2 times a day, in severe cases-750 mg 2 times a day. The course of treatment is 7-14 days.

Campylobacteriosis, shigellosis, travelers ‘ diarrhea-500 mg 2 times a day, the course of treatment is 5-7 days.

Typhoid fever — 500 mg 2 times a day for 10 days.

Complicated intra-abdominal infections (in combination with metronidazole) — 500 mg 2 times a day for 7-14 days.

Infections of the kidneys and urinary tract (cystitis, pyelonephritis) — 250 mg, complicated-500 mg 2 times a day. The course of treatment is 7-14 days. Uncomplicated cystitis in women — 250 mg 2 times a day for 3 days.

Uncomplicated gonorrhea — 250-500 mg once.

Chronic bacterial prostatitis-500 mg 2 times a day, the course of treatment is 28 days.

Other infections (see the section “Indications”) – 500 mg 2 times a day. Septicemia, peritonitis (especially when infected with Pseudomonas, Staphylococcus or Streptococcus) – 750 mg 2 times a day.

Prevention and treatment of pulmonary anthrax — 500 mg 2 times a day for 60 days.

When treating elderly patients, ciprofloxacin should be administered as low as possible, based on the severity of the disease and creatinine clearance (for example, with a creatinine clearance of 30-50 ml/min, the recommended dose of ciprofloxacin is 250-500 mg every 12 hours).

Children:

For the treatment of complications of cystic fibrosis of the lungs caused by Pseudomonas aeruginosa, in children aged 5 to 17 years,20 mg/kg of body weight is prescribed orally 2 times a day (the maximum dose is 1500 mg). The duration of treatment is 10-14 days.

For the prevention and treatment of the pulmonary form of anthrax,15 mg/kg of body weight is prescribed orally 2 times a day (do not exceed the maximum single dose of 500 mg and the daily dose of 1000 mg).

The drug should be started immediately after suspected or confirmed infection.

The total duration of ciprofloxacin treatment for pulmonary anthrax is 60 days.

Overdose

In the case of oral overdose, reversible toxic effects on the renal parenchyma were observed in several cases. Therefore, in case of overdose, in addition to standard measures (gastric lavage, the use of emetics, the introduction of large amounts of liquid, the creation of an acidic reaction in the urine), it is also recommended to monitor kidney function and take magnesium – and calcium-containing antacids that reduce the absorption of ciprofloxacin.

The specific antidote is not known. It is necessary to carefully monitor the patient’s condition, perform gastric lavage, carry out the usual emergency measures, and ensure sufficient fluid intake. With the help of hemo-and peritoneal dialysis, only a small amount (less than 10%) of the drug can be removed.

Special instructions

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

Ciprofloxacin should not be used as the drug of first choice in outpatient treatment of patients with pneumonia caused by bacteria of the genus Pneumococcus.

In some cases, adverse reactions from the central nervous system may occur after the first use of the drug. In very rare cases, psychosis can manifest itself in suicidal attempts. In these cases, ciprofloxacin should be discontinued immediately.

Patients with epilepsy, seizures in the anamnesis, vascular diseases and organic brain damage due to the threat of side effects from the central nervous system ciprofloxacin should be prescribed only for “vital indications”, in cases where the expected clinical effect exceeds the possible risk of side effects of the drug.

If severe or prolonged diarrhea occurs during or after ciprofloxacin treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and appropriate treatment.

The use of drugs that suppress intestinal motility is contraindicated. Patients, especially those who have had liver disease, may experience cholestatic jaundice, as well as a temporary increase in the activity of “liver” transaminases and alkaline phosphatase.

Compliance with the appropriate dosage regimen is required when prescribing the drug to patients with renal and hepatic insufficiency.

Sometimes after taking the first dose of ciprofloxacin, allergic reactions may occur, rarely-anaphylactic shock. Ciprofloxacin should be discontinued immediately in these cases and appropriate treatment should be provided.

Elderly patients who have previously been treated with glucocorticosteroids may experience cases of ruptured Achilles tendon.

If tendon pain occurs or if the first signs of tendinitis appear, treatment should be discontinued due to the fact that individual cases of inflammation and even tendon rupture have been described during treatment with fluoroquinolones.

During treatment with ciprofloxacin, it is necessary to avoid contact with direct sunlight, as photosensitization reactions may occur when taking ciprofloxacin. Treatment should be discontinued if there are symptoms of photosensitivity (for example, changes in the skin that resemble sunburn).

Ciprofloxacin is known to be a moderate inhibitor of the CYP1A2 isoenzyme.

Caution should be exercised when ciprofloxacin is co-administered with drugs that are metabolized by this isoenzyme, such as theophylline, methylxanthine, and caffeine, since an increase in the concentration of these drugs in the blood serum may cause corresponding side effects.

To avoid the development of crystalluria, it is unacceptable to exceed the recommended daily dose, as well as sufficient fluid intake (while maintaining normal diuresis) and maintaining an acidic urine reaction.

For genital infections suspected to be caused by fluoroquinolone-resistant strains of Neisseria gonorrhoeae, local information on ciprofloxacin resistance should be taken into account and the sensitivity of the pathogen should be confirmed in laboratory volumes.

Influence on the ability to drive vehicles and mechanisms: 

Patients taking ciprofloxacin should exercise caution when driving a car and engaging in other potentially dangerous activities that require increased attention and speed of psychomotor reactions.

Form of production

Cyfran tablets, coated white or almost white, round, with chamfers and the designation “CFT” on one side and “500” on the other, as well as rhombuses on both sides.

Storage conditions

At a temperature not exceeding 25 °C, in sealed packaging

Shelf life

3 years

Active ingredient

Ciprofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Urinary Tract Infections, Infectious Diseases, Eye Infections, Intestinal Infections, Pneumonia, Biliary Tract Infections, Skin Infections, Respiratory Tract Infections, Otitis