Description
Release form
Extended-release tablets, coated.
Packing
10 pcs.
Pharmacological action
Antimicrobial agent with a wide spectrum of action of the fluoroquinolone group. It has a bactericidal effect. Suppresses DNA gyrase 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 strains producing and not producing penicillinase, 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. The action against Treponema pallidum is not well understood.
Indications
Cifran ® OD is indicated for the treatment of the following infectious and inflammatory diseases caused by susceptible 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 complicated)
– chronic bacterial prostatitis srdlrdpp – including peritonitis, abdominal abscesses, cholangitis, cholecystitis, empyema of the gallbladder) is used in combination with metronidazole
– infectious diseases of the skin
– infectious diseases of the bones and joints (including acute and chronic osteomyelitis)
– diarrhea of the infectious .h. Travelers diarrhea
– typhoid fever
– anthrax.
Contraindications
– pseudomembranous colitis
– under 18 years of age
– pregnancy
– lactation period
– hypersensitivity to ciprofloxacin or other drugs from the fluoroquinolone group
– simultaneous arterial pressure (simultaneous hypertensive) insufficiency (creatinine clearance less than 29 ml / min, including patients on hemodialysis).
Caution:
– severe cerebral arteriosclerosis cerebrovascular accident mental illness
– epilepsy
– renal failure (creatinine clearance 35-50 ml / min)
– severe hepatic impairment, older age
– Tendon tendon lesion.
Use during pregnancy and lactation
Tsifran ® OD is not recommended for use during pregnancy.
Ciprofloxacin is excreted in breast milk, so during lactation, if you need to use Cifran ® OD, then, based on the importance of its use for the mother, you should decide whether to stop taking the drug or breastfeeding.
Special instructions
Photosensitivity reactions have been observed in some patients treated with fluoroquinolones. Excessive exposure to direct sunlight and UV radiation should be avoided. If a photosensitivity reaction occurs, it is recommended to stop using the drug. Since Cifran ® OD is a drug with possible reversible toxic effects on the kidneys, it is not recommended for use in patients with impaired renal function, with creatinine clearance <29 ml / min or in patients undergoing hemodialysis or peritoneal dialysis. When using almost all antimicrobials, including Cifran ® OD, pseudomembranous colitis may develop, ranging in severity from mild to life-threatening. If severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis, which requires immediate drug withdrawal and the appointment of appropriate treatment, should be excluded. In order to avoid the development of crystalluria, the recommended daily dose should not be exceeded, an adequate intake of fluid and the maintenance of an acidic reaction of the urine are also necessary. Patients with epilepsy, a history of seizures, vascular diseases and organic brain lesions, due to the threat of adverse reactions from the central nervous system, Tsifran ® OD should be prescribed only for “vital” indications. If there are pains in the tendons or when the first signs of tendovaritis appear, treatment should be discontinued (isolated cases of inflammation and even rupture of tendons during treatment with fluoroquinolones have been described). During treatment, you should refrain from engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions. Composition Active ingredient: ciprofloxacin – 500 mg. Excipients: sodium alginate (Keltone LVCR), hypromellose, sodium bicarbonate, crospovidone (CLM), magnesium stearate, colloidal silicon dioxide (200), talc. Film coating: white opadra 31B58910 *, talc, hypromellose, purified water, black ink for inscription (Opakod-Sl-17823 black). Dosage and Administration Individually. Inside – 250-750 mg 2 times / 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 / day, the duration of treatment is 1-2 weeks, if necessary more. It is possible to administer iv in a jet, but more preferably, droplet administration for 30 minutes. In case of local application, 1-2 drops are instilled into the lower conjunctival sac of the affected eye every 1-4 hours. After improvement, the intervals between instillations can be increased. The maximum daily dose for adults when taken orally is 1.5 g. Side effects of the digestive system: nausea, vomiting, diarrhea, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with liver disease), hepatitis, hepatonecrosis. From the nervous system: dizziness, photophobia, insomnia, paresthesia, irritability, headache, increased fatigue, anxiety, tremor, nightmares, peripheral paralgesia (anomaly in the perception of pain), increased intracranial pressure, confusion, depression, hallucinations as well as other manifestations of psychotic reactions (occasionally progressing to conditions in which the patient can harm himself), migraine, fainting, cerebral artery thrombosis. On the part of the sensory organs: impaired taste and smell, impaired vision (diplopia, color perception), tinnitus, hearing loss. From the cardiovascular system: tachycardia, cardiac arrhythmias, decreased blood pressure, flushing of blood to the skin of the face. From the hematopoietic system: eosinophilia, leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia. Laboratory indicators: hypoprothrombinemia, increased activity of hepatic transaminases, hypercreatininemia, hyperbilirubinemia, hyperglycemia, increased activity of alkaline phosphatase and lactate dehydrogenase. From the urinary system: hematuria, crystalluria (primarily with an alkaline reaction of the urine and low urine output), acute interstitial nephritis (with the possible development of acute renal failure), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, decrease in urethral bleeding, the kidneys. Allergic reactions: itching, hives, the formation of blisters accompanied by bleeding, and the appearance of small nodules forming scabs, drug fever, spot hemorrhages on the skin (petechiae), swelling of the face or larynx, dyspnea, vasculitis, erythema nodosum, erythema multiforme malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome). From the musculoskeletal system: arthralgia, arthritis, tendovaginitis, tendon ruptures, myalgia. Other: excessive sweating, photosensitivity, general weakness, superinfection (candidiasis, pseudomembranous colitis). Drug interaction Due to inhibition of microsomal enzymes in the liver, increases the concentration and prolongs T1 / 2 of theophylline and other xanthines (e.g. caffeine), oral hypoglycemic drugs (e.g. glibenclamide), indirect anticoagulants (e.g. warfarin and its derivatives). If necessary, joint use with drugs of these groups, it is necessary to control the concentration of the drug in the blood and accordingly adjust the dosage regimen. In the presence of antacids containing magnesium hydroxide or aluminum hydroxide, the absorption of ciprofloxacin decreases. Thus, the simultaneous administration of these drugs should be excluded. In such cases, ciprofloxacin should be taken either 1-2 hours before or 4 hours after taking these drugs. Didanosine reduces the 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. Metoclopramide accelerates the absorption of the drug, which leads to a decrease in the time it reaches Cmax. Co-administration of uricosuric drugs slows down excretion (up to 50%) and increases the plasma concentration of ciprofloxacin. When combined with other antimicrobials (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergism is usually observed can be successfully used in combination with azlocillin and ceftazidime for infections caused by Pseudomonas spp. with meslocillin, azlocillin and other beta-lactam antibiotics – for streptococcal infections with isoxazolylpenicillins and vancomycin – for staph infections with metronidazole and clindamycin – for anaerobic infections. Ciprofloxacin enhances the nephrotoxic effect of cyclosporine. An increase in the concentration of serum creatinine is noted. In such patients, control of this indicator 2 times a week is necessary. The simultaneous use of tizanidine with ciprofloxacin, which is an inhibitor of the isoenzyme CYP1A2, leads to a 10-fold increase in the AUC of tizanidine. The result of the combined use may be a clinically significant and prolonged decrease in blood pressure, leading to drowsiness, dizziness, inhibited psychomotor reactions. In patients Receiving therapy with ciprofloxacin and phenytoin, the variability (decrease or increase) in the concentration of phenytoin in the blood plasma was noted. Co-administration with non-steroidal anti-inflammatory drugs (NSAIDs) increases the likelihood of side effects of the central nervous system ciprofloxacin (risk of seizures). Absorption of ciprofloxacin when administered orally decreases after cytotoxic therapy with antitumor and immunosuppressive drugs. Overdose Reversible toxicity to the kidneys There is no specific antidote, therefore vomiting or gastric lavage and symptomatic therapy should be performed: – to carry out measures on an adequate hydration of an organism (infusion therapy) – carrying out maintenance therapy. Only minor amounts of ciprofloxacin (<10%) can be removed by hemo- and peritoneal dialysis. Storage conditions In a dry place at a temperature not exceeding 25 ° C. Keep out of the reach and sight of children. Shelf life 2 years. Deystvuyushtee substance Ciprofloxacin Dosage form tablets Possible product names DIGITAL OD 0.5 N10 TABLE PROLONG DIGITAL OD 0.5 N10 TABLE PROLONG P / O DIGITAL OD 500mg Tab. prolong. valid p / pl / rev X10 (R) Tsifran OD 500mg Tab. prolong. valid p / pl / rev X10 (R) /! Until 02.13g / Tsifran OD 500mg Tab. prolong. valid p / pl / rev X10 (R) /! Until 08. 12g / San Pharmaceutical Industries Ltd, India
