Cifran, 500 mg 10 pcs

Pharmgroup:

The antimicrobial agent is a fluoroquinolone.

Pharmic action:

Cyfran, like other fluorinated quinolones, blocks bacterial DNA gyrase, thus suppressing the DNA function of the bacteria. Cifran is active against Gram-positive and Gram-negative pathogens, including strains resistant to penicillins, cephalosporins and and/or aminoglycosides. The spectrum of action of Cifran covers such 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 anaerobic bacteria, mycobacteria, mycoplasmas, rickettsia, chlamydia, Nocardia asteroides, Ureaplasma urealyticum, pale spirochete, viruses, fungi and protozoa are not sensitive to the drug.

Indications

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

Active ingredient

Composition

Active substances:

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 silica 9.36 mg,

sodium starch glycolate 47.76 mg,

purified water* q.s.

Film coating material:

Opadray-OÒ®-858910 white 26.88 mg, purified talc 2.44 mg, purified talc q.s, purified water.

How to take, the dosage

Ingestion on an empty stomach, without chewing, with a small amount of liquid. It may be taken independently of meals. If the drug is taken on an empty stomach, the active substance is absorbed more quickly. In this case, the tablets should not be washed down with dairy products or calcium-enriched products (e.g., milk, yogurt, juices with high calcium content). Calcium contained in ordinary foods has no effect on 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:

Infections of the lower respiratory tract (acute and chronic (acute stage) bronchitis, pneumonia, bronchiectatic disease, infectious complications of cystic fibrosis) of mild and moderate severity – 500 mg 2 times a day, with a severe course – 750 mg 2 times a day. The course of treatment is 7-14 days.

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

Bone and joint infections (osteomyelitis, septic arthritis) of mild to moderate severity – 500 mg 2 times a day, with a severe course – 750 mg 2 times. The course of treatment is up to 4-6 weeks.

Infections of the skin and soft tissues (infected ulcers, wounds, burns, abscesses, phlegmon) of mild to moderate severity – 500 mg 2 times a day, with a severe course – 750 mg 2 times a day. The course of treatment is 7-14 days.

Campylobacteriosis, shigellosis, traveler’s 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 daily 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 – 7-14 days. Uncomplicated cystitis in women – 250 mg 2 times a day for 3 days.

Uncomplicated gonorrhea – 250-500 mg once daily.

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

Other infections (see 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 inhalational anthrax – 500 mg 2 times a day for 60 days.

When treating elderly patients, the lowest possible dose of ciprofloxacin should be used, 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 treatment of complications of pulmonary cystic fibrosis caused by Pseudomonas aeruginosa in children aged 5 to 17 years, an oral dose of 20 mg/kg body weight 2 times/day is prescribed. (maximum dose is 1500 mg). The duration of treatment is 10-14 days.

In prophylaxis and treatment of inhalational anthrax administer orally 15 mg/kg of body weight 2 times per day (maximum single dose should not be exceeded – 500 mg and daily dose – 1000 mg).

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

The total duration of ciprofloxacin therapy for inhalational anthrax is 60 days.

Interaction

Concomitant use of didanosine with ciprofloxacin decreases the effect of ciprofloxacin due to the formation of complexes of ciprofloxacin with aluminum and magnesium salts contained in didanosine.

The concomitant administration of ciprofloxacin with theophylline may lead to increased plasma concentrations of theophylline due to competitive inhibition at cytochrome P450 binding sites, which leads to longer half-life of theophylline and increased risk of theophylline-associated toxic effects.

The simultaneous use of sucralfate, antacids, drugs with high buffer capacity (e.g., antiretroviral drugs), as well as drugs containing aluminum, zinc, iron or magnesium ions may cause decreased 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.

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

When ciprofloxacin and omeprazole are used in combination, there may be a slight decrease in the maximum plasma concentration (Cmax) of the drug 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) may provoke seizures.

The simultaneous use of ciprofloxacin and anticoagulants (including warfarin) prolongs bleeding time.

Concomitant use of ciprofloxacin and cyclosporine increases nephrotoxic effects of the latter. When concomitant therapy with ciprofloxacin and cyclosporine a transient increase in plasma creatinine concentration was observed. In such cases, blood creatinine concentration should be determined twice a week.

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

The co-administration of uricosuric drugs, including probenecid slows down the rate of renal excretion of ciprofloxacin (up to 59%) and increases the plasma concentration of ciprofloxacin.

Concomitant administration of ciprofloxacin may inhibit tubular transport (renal metabolism) of methotrexate, which may be accompanied by increased plasma concentrations of methotrexate. This may increase the likelihood of side effects of methotrexate. Therefore, patients receiving combined therapy with methotrexate and ciprofloxacin should be closely monitored.

Methoclopramide accelerates absorption of ciprofloxacin, shortening the time required to reach its maximum plasma concentration. The bioavailability of ciprofloxacin does not change.

Special Instructions

Ciprofloxacin, like other drugs in this class, has been found to cause arthropathy of large joints in animals. When analyzing the current data on the safety of ciprofloxacin use in children under 18 years of age, most of whom have pulmonary cystic fibrosis, no association between cartilage or joint damage with taking the drug has been found No use of ciprofloxacin in children for the treatment of other diseases is recommended, except for the treatment of complications of pulmonary cystic fibrosis (in children from 5 to 17 years of age) associated with Pseudomonas aeruginosa and for the treatment and prevention of inhalational anthrax (after suspected or proven infection with Bacillus anthracis).

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

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

Patients with a history of epilepsy, seizures, vascular disease, and organic brain lesions due to the risk of adverse reactions in the central nervous system should be prescribed ciprofloxacin only for “vital signs” in cases when the expected clinical effect exceeds the possible risk of adverse drug reaction.

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

The use of drugs that inhibit intestinal peristalsis is contraindicated. In patients, especially those who have had liver disease, cholestatic jaundice and temporary increase of “liver” transaminases and alkaline phosphatase activity may be noted.

Matching the appropriate dosing regimen is required when prescribing the drug to patients with renal and hepatic impairment.

Sometimes after the first dose of ciprofloxacin allergic reactions may be observed; rarely – anaphylactic shock. Administration of ciprofloxacin in these cases should be stopped immediately and appropriate treatment should be given.

In elderly patients previously treated with glucocorticosteroids there may be cases of Achilles tendon rupture.

If tendon pain occurs or if there are the first signs of tendinitis, treatment should be discontinued, as there have been isolated cases of inflammation and even tendon rupture during treatment with fluoroquinolones.

When treated with ciprofloxacin, contact with direct sunlight should be avoided because photosensitization reactions may occur when taking ciprofloxacin. Treatment should be discontinued if photosensitization symptoms are observed (e.g., skin changes resembling sunburns).

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

We should use caution when using ciprofloxacin concomitantly with drugs metabolized by this isoenzyme, such as theophylline, methylxanthine, and caffeine, since the increased serum concentration of these drugs may cause related side effects.

The recommended daily dose should not be exceeded to avoid crystalluria, and adequate fluid intake (while maintaining normal diuresis) and maintenance of an acidic urine reaction are also necessary.

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

Impact on the ability to drive vehicles, machinery:

Patients taking ciprofloxacin should exercise caution when driving and engaging in other potentially hazardous activities that require increased attention and rapid psychomotor reactions.

Contraindications

Hypersensitivity to the drug Cifran, severe renal dysfunction, epilepsy.

Side effects

Digestive system disorders:

Often: nausea, diarrhea.

Infrequent: 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 rarely: candidiasis, hepatitis, liver tissue necrosis (in extremely rare cases progressing to life-threatening liver failure), life-threatening pseudomembranous colitis with possible death, pancreatitis.

Skin disorders:

Infrequent: rash.

Hematopoietic system disorders:

Infrequent: eosinophilia.

Rare: anemia, leukopenia (granulocytopenia), leukocytosis, increased or decreased prothrombin index, thrombocytopenia, thrombocytosis, neutropenia. Very rarely: hemolytic anemia, pancytopenia (including life-threatening), agranulocytosis; in very rare cases of life-threatening bone marrow suppression.

Urinary system disorders:

Infrequent: increased creatinine and urea nitrogen levels.

Skeletal and muscular system disorders:

Infrequent: arthralgia.

Rarely: myalgia (muscle pain), joint swelling.

very rarely: 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.

The central nervous system:

Infrequent: headache, dizziness, sleep disorders, restlessness, confusion.

Rarely: migraine, hallucinations, sweating, paresthesias (including peripheral paralgesia), anxiety, nightmares, depression, tremors, seizures, hyperesthesia, agitation, disorientation, dysesthesia, hypoesthesia, vertigo.

Very rare: grand mal seizures, unstable gait, psychosis, increased intracranial pressure, ataxia, increased muscle tone, muscle cramps, movement coordination disorders.

Prevalence unknown: peripheral neuropathy and polyneuropathy.

Skin disorders:

Infrequent: itching, urticaria, maculopapular rash.

very rarely: petechiae, erythema multiforme, erythema nodosa, persistent skin rash.

Sensory organs:

Infrequent: taste disorder.

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

Very rare: parosmia, anosmia.

Other:

Infrequent: asthenia (feeling of weakness, fatigue), candidiasis.

Rare: peripheral edema, hyperglycemia, pain in extremities, back pain, chest pain.

Very rare: increased activity of amylase, lipase.

Cardiovascular system disorders:

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

Very rare: vasculitis.

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

Allergic reactions:

Rarely: anaphylactic reactions, fever, angioedema.

very rarely: anaphylactic shock, skin rash, reactions similar to serum sickness, Stevens-Johnson syndrome (malignant exudative erythema), Lyell syndrome (toxic epidermal necrolysis).

Respiratory system disorders:

Rarely: dyspnea, laryngeal edema, respiratory disorders (including bronchospasm).

Skin disorders:

Rarely: photosensitivity reactions.

Anxiety to the urogenital system:

Rarely: acute renal failure, renal dysfunction, vaginal candidiasis, hematuria, crystalluria, interstitial nephritis.

In addition, the following adverse events have been reported: cerebral artery thrombosis, polyuria, albuminuria, urinary retention. Relation of the mentioned adverse events with ciprofloxacin use has not been confirmed reliably.

Overdose

In case of overdose when ingested, reversible toxic effects on the renal parenchyma have been observed in several cases. Therefore, in case of overdose, in addition to standard measures (gastric lavage, use of vomiting preparations, administration of large amounts of fluids, creation of acidic urine reaction), it is also recommended to monitor renal function and take magnesium- and calcium-containing antacids that reduce absorption of ciprofloxacin.

A specific antidote is not known. It is necessary to carefully monitor the patient’s condition, perform gastric lavage, carry out the usual first aid measures, and ensure adequate fluid intake. Only a small amount (less than 10%) of the drug may be eliminated by hemo- and peritoneal dialysis.

Similarities