Cifran OD, 500 mg 10 pcs

A broad-spectrum antimicrobial agent of the group of fluoroquinolones. It has a bactericidal effect. Inhibits DNA-GiRase and inhibits the synthesis of bacterial DNA.

Highly active against most gram-negative bacteria: Pseudomonas aeruginosa, Haemophilus influenzae, Escherichia coli, Shigella spp., Salmonella spp., Neisseria meningitidis, Neisseria gonorrhoeae.

Active against Staphylococcus spp. (including penicillinase producing and non-producing strains, methicillin-resistant strains), some strains of Enterococcus spp., Campylobacter spp., Legionella spp., Mycoplasma spp., Chlamydia spp., Mycobacterium spp.

Ciprofloxacin is active against bacteria producing beta-lactamases.

Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides are resistant to ciprofloxacin. Its action against Treponema pallidum has not been studied sufficiently.

Indications

Cifran® OD is indicated for treatment of the following infections and inflammatory diseases caused by sensitive microorganisms.

– acute sinusitis;

– infectious and inflammatory diseases of the lower respiratory tract, including pneumonia, exacerbation of chronic bronchitis and infectious complications of cystic fibrosis;

– pyelonephritis, cystitis (including complications).

– chronic bacterial prostatitis;

– gonorrhea;

– intra-abdominal infections (including peritonitis, intra-abdominal abscesses, cholangitis, cholecystitis, gallbladder empyema) used in combination with metronidazole

– skin infections;

– infectious diseases of the bones and joints (including acute and chronic bones and joints).

– diarrhea of infectious genesis – including “traveler’s diarrhea”;

– typhoid;

– anthrax.

Active ingredient

Composition

Active ingredient:

Ciprofloxacin – 500 mg.

Auxiliary substances:

Sodium alginate (Keltone LVCR),

Hypromellose,

Sodium bicarbonate,

crospovidone (CLM),

magnesium stearate,

colloidal silicon dioxide (200),

talc.

Film shell:

opadray white 31B58910*, talc, hypromellose, purified water , black writing ink (Opacode-S-l-17823 black).

How to take, the dosage

Individually. Orally – 250-750 mg 2 times a day. The duration of treatment is from 7-10 days to 4 weeks.

For intravenous administration, a single dose is 200-400 mg, the frequency of administration is 2 times per day; treatment duration is 1-2 weeks, and longer, if necessary. It is possible to administer by IV fluids, but drip infusion for 30 minutes is preferable.

When applied topically, 1-2 drops are placed into the lower conjunctival sac of the affected eye every 1-4 hours. The intervals between instillations may be increased after the condition improves.

The maximum daily dose for adults when taken orally is 1.5 g.

Interaction

Due to inhibition of microsomal enzymes in the liver, increases the concentration and prolongs the T1/2 of theophylline and other xanthines (eg, caffeine), oral hypoglycemic drugs (eg, glibenclamide), indirect anticoagulants (eg, warfarin and its derivatives). In case of necessity of concomitant use with the drugs of these groups the drug concentration in blood shall be controlled and the dosage regimen shall be adjusted accordingly.

In the presence of antacids containing magnesium hydroxide or aluminum hydroxide absorption of ciprofloxacin decreases. Thus, concomitant administration of these drugs should be avoided. In such cases ciprofloxacin should be taken either 1-2 hours before or 4 hours after taking these drugs. Didanosine reduces absorption of ciprofloxacin. This is due to the formation of complexes with magnesium salts contained in didanosine preparations.

When combined with probenecid and other drugs that block tubular secretion, renal excretion of ciprofloxacin decreases.

Methoclopramide accelerates absorption of the drug which leads to shorter time to reach Cmax.

The co-administration of uricosuric drugs leads to slower excretion (up to 50%) and increased plasma concentration of ciprofloxacin.

When combined with other antimicrobial agents (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole) synergism is usually observed; it can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp.with meslocillin, azlocillin and other beta-lactam antibiotics in streptococcal infections; with isoxazolylpenicillin and vancomycin in staphylococcal infections; with metronidazole and clindamycin in anaerobic infections.

Cyprofloxacin increases nephrotoxic effects of cyclosporine. There is an increase in serum creatinine concentration. In such patients it is necessary to control this index twice a week.

Special Instructions

Photosensitivity reactions have been observed in some patients receiving fluoroquinolones. Excessive exposure to direct sunlight and UV irradiation should be avoided. In case of photosensitivity reactions, it is recommended to discontinue the drug. Since Cifran® OD is a drug with possible reversible toxic effect on the kidneys, it is not recommended for use in patients with impaired renal function, with creatinine clearance of 29 ml/min or in patients under hemodialysis or peritoneal dialysis.

Pseudomembranous colitis, ranging in severity from mild to life-threatening, is possible with virtually all antimicrobials, including Cifran® OD. If severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate drug withdrawal and appropriate treatment.

In order to avoid the development of crystalluria, the recommended daily dose should not be exceeded, and adequate fluid intake and maintenance of an acidic urine reaction are also necessary.

Patients with a history of epilepsy, history of seizures, vascular disease and organic brain damage, due to the risk of CNS adverse reactions, Cifran® OD should be used only for “vital” indications.

In case of tendon pain or if the first signs of tendovaritis appear, treatment should be stopped (there have been some cases of inflammation and even tendon rupture during treatment with fluoroquinolones).

At the time of treatment, it is necessary to refrain from potentially hazardous activities requiring high attention and rapid mental and motor reactions.

Contraindications

– pseudomembranous colitis;

– age under 18 years;

– pregnancy;

– lactation period;

– hypersensitivity to ciprofloxacin or other drugs from the group of fluoroquinolones;

p> – concomitant use of tizanidine (risk of significant decrease in blood pressure, somnolence);

– chronic renal failure (creatinine clearance less than 29 ml/min, including patients on hemodialysis).

With caution:

– marked cerebral vascular atherosclerosis; impaired cerebral circulation; mental illness;

– epilepsy;

– Renal insufficiency (creatinine clearance 35-50 ml/min);

– Significant hepatic insufficiency, advanced age;

– Tendonitis in previous treatment with fluoroquinolones.

Side effects

Digestive system disorders: nausea, vomiting, diarrhea, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with past liver disease), hepatitis, hepatonecrosis.

Nervous system disorders:dizziness, photophobia, insomnia, paresthesias, irritability, headache, increased fatigue, anxiety, tremor, “nightmares” dreams, peripheral paralgesia (abnormal perception of pain sense), increased intracranial pressure, confusion, depression, hallucinations, and others. manifestations of psychotic reactions (occasionally progressing to states in which the patient can harm himself), migraine, syncope, cerebral artery thrombosis.

Sense organs: disorders of taste and smell, visual disturbances (diplopia, altered color perception), tinnitus, decreased hearing.

Cardiovascular system disorders: tachycardia, heart rhythm disorders, decreased blood pressure, “rushes” of blood to the face.

Hematopoietic system disorders: eosinophilia, leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.

Laboratory parameters: hypoprothrombinemia, increased activity of “hepatic” transaminases, hypercreatininemia, hyperbilirubinemia, hyperglycemia, increased activity of alkaline phosphatase and lactate dehydrogenase.

Urinary system disorders: hematuria, crystalluria (especially with alkaline urine reaction and low diuresis), acute interstitial nephritis (with possible development of acute renal failure), glomerulonephritis, dysuria, polyuria, urine retention, albuminuria, urethral bleeding, reduced renal nitrogen excretion function.

Allergic reactions: skin itching, urticaria, formation of blisters accompanied by bleeding and appearance of small nodules forming scabs, drug fever, pinpoint hemorrhages on the skin (petechiae), Facial or laryngeal edema, dyspnea, vasculitis, erythema nodosa, erythema multiforme, erythema malignant exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

Motor system disorders: arthralgia, arthritis, tendovaginitis, tendon tears, myalgia.

Others: increased sweating, photosensitivity, general weakness, superinfections (candidiasis, pseudomembranous colitis).

Overdose

Possible reversible toxic effects on the kidneys;

There is no specific antidote, so it is necessary to induce vomiting or gastric lavage and conduct symptomatic therapy:

– to carry out measures to adequately hydrate the body (infusion therapy);

– to carry out supportive therapy.

Only small amounts of ciprofloxacin (< 10%) may be removed by hemo- and peritoneal dialysis.

Pregnancy use

Cyfran® OD is not recommended for use during pregnancy.

Cyprofloxacin is excreted into the breast milk, so during lactation, if use of Cifran® OD is necessary, based on the degree of importance of its use to the mother, a decision should be made whether to stop taking the drug or breastfeeding.

Similarities