Tsifran OD tablets 1000mg, No. 10

CifranЃ OD is indicated for the treatment of the following infectious 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 complicated);
- chronic bacterial prostatitis;
- gonorrhea;
- intra-abdominal infections (including peritonitis, intra-abdominal abscesses, cholangitis, cholecystitis, empyema of the gallbladder) is used in combination with metronidazole
- infectious diseases of the skin;
- infectious diseases of bones and joints (including acute and chronic osteomyelitis);
- diarrhea of ??infectious origin - incl. Travelers' diarrhea;
- typhoid fever;
- anthrax.

Inside.
Do not crush, chew, or otherwise destroy the tablets. The tablets should be taken orally after meals whole with plenty of water.
The use of CifranЃ OD should be continued for at least 2 more days after the symptoms of the disease have completely disappeared.

Acute sinusitis 1000mg, every 24h -10 days;

Infectious and inflammatory diseases of the lower respiratory tract:

Mild degree - 1000 mg, every 24 hours - 10 days;

Severe / Complicated 1500mg, every 24 hours, 7-14 days.

Urinary tract infections:

Acute uncomplicated - 500 mg, every 24 hours - 3 days

Mild / Medium - 500 mg, every 24 hours - 7-14 days

Severe / Complicated -1000 mg every 24 hours for 7-14 days.

Chronic bacterial prostatitis:

Mild / Moderate - 1000 mg every 24 hours for 28 days

Gonorrhea:

Acute uncomplicated - 500 mg once a day

Complicated - 500 mg, every 24 hours for 3-5 days

Intra-abdominal infections *:

Complicated 1000 mg every 24 hours for 7-14 days

Infectious diseases of the skin:

Mild / Medium - 1000 mg every 24 hours for 7-14 days

Severe / Complicated - 1500 mg, every 24 hours for 7-14 days

Infectious diseases of bones and joints

Mild / Medium - 1000 mg every 24 hours for 4-6 weeks

Severe / Complicated - 1500 mg every 24 hours> 4-6 weeks

Diarrhea of ??infectious origin - incl. Traveler's diarrhea

Mild / Moderate / Severe - 1000 mg every 24 hours for 5-7 days

Typhoid fever

Mild / Medium - 1000 mg every 24 hours for 10 days

anthrax

Prevention and Treatment - 1000 mg, every 24 hours for 60 days

* used in combination with metronidazole;

Active ingredient: ciprofloxacin - 500 mg; 1000 mg.

Excipients: sodium alginate (Keltone LVCR), hypromellose, sodium bicarbonate, crospovidone (CLM), magnesium stearate, colloidal silicon dioxide (200), talc.

- Pseudomembranous colitis;
- age up to 18 years;
- pregnancy;
- lactation period;
- hypersensitivity to ciprofloxacin or other drugs from the fluoroquinolone group;
- concomitant use of tizanidine (risk of a pronounced decrease in blood pressure, drowsiness);
- chronic renal failure (creatinine clearance less than 29 ml / min, including patients on hemodialysis).

Carefully:

- pronounced atherosclerosis of the vessels of the brain; violation of cerebral circulation; mental illness;
- epilepsy;
- renal failure (creatinine clearance 35-50 ml / min);
- severe liver failure, advanced age;
- Damage to the tendons with previous treatment with fluoroquinolones.

Pharmacological properties
Pharmacodynamics:

The bactericidal effect of fluoroquinolones is due to the inhibition of a bacterial enzyme - topoisomerase II (DNA gyrase). Topoisomerase II is required for the normal replication of bacterial DNA. This ATP-dependent process in the absence of topoisomerase II leads to uncontrolled replication of damaged DNA, and, consequently, to disruption of the synthesis of normal proteins in the bacterial cell.
Antibacterial spectrum:
Ciprofloxacin has a pronounced in vitro activity against a wide range of gram-negative and gram-positive bacteria. Ciprofloxacin acts both on multiplying microorganisms and on those at rest. Ciprofloxacin has been shown to be active against most microorganisms in in vitro studies and clinical applications.

Pharmacokinetics:

- absorption: after oral administration, ciprofloxacin is rapidly absorbed from the gastrointestinal tract. CifranЃ OD tablets provide a long, uniform release of ciprofloxacin, while the drug is taken only once a day. One dose of CifranЃ OD 500 mg and CifranЃ OD 1000 mg are able to maintain the required concentration of ciprofloxacin, which in other cases is provided by two-fold use of conventional ciprofloxacin 250 mg or 500 mg, respectively

-distribution: after the administration of a single dose, the maximum plasma concentrations (Cmax) are reached within 6 hours and are 1.3 ± 0.4 ?g / ml and 2.4 ± 0.7 ?g / ml for CifranЃ OD 500 mg and CifranЃ OD 1000 mg, respectively.
The corresponding values ??of the Area under the pharmacokinetic curve (AUC0-t) are 83 ± 2.1 and 18.9 ± 4.6 ?g * ml / h. Plasma protein binding from 20% to 40%.
Ciprofloxacin penetrates well into tissues and body fluids: lungs, skin, adipose tissue, muscles, cartilage and bone tissue, prostate gland, saliva, nasal and bronchial mucosa secretions, sperm, lymph, peritoneal fluid and prostate secretions.

-metabolism: ciprofloxacin is partially metabolized in the liver.

-excretion: about 50% of the dose taken orally is excreted by the kidneys unchanged and about 15% in the form of active metabolites. Approximately 20-35% of the dose taken is excreted by the intestines. The half-life (T1 / 2) of CyfranЃ OD is about 6.5-7.5 hours. T1 / 2 can be lengthened with severe renal failure and in the elderly.
Special groups of patients
With impaired renal function: In patients with slightly impaired renal function, the half-life of ciprofloxacin may slightly increase. In this case, it is necessary to correct the dosage regimen (see 'Dosage and Administration').
In case of impaired liver function: In preliminary studies in patients with a stable course of liver cirrhosis, there were no significant changes in the pharmacokinetics of ciprofloxacin. However, studies on the kinetics of ciprofloxacin in patients with acute hepatic failure have not been conducted.

Application during pregnancy and during breastfeeding:

It is not recommended to use CifranЃ OD during pregnancy.
Ciprofloxacin is excreted in breast milk, therefore, during lactation, if the use of CifranЃ OD is necessary, then, based on the degree of importance of its use for the mother, it should be decided whether to stop taking the drug or breastfeeding.

Side effect:

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis.
From the nervous system: dizziness, photophobia, insomnia, paresthesia, irritability, headache, increased fatigue, anxiety, tremors, '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 states in which the patient can harm himself), migraine, fainting, cerebral artery thrombosis.
From the senses: disturbances in taste and smell, visual impairment (diplopia, change in color perception), tinnitus, hearing loss.
From the side of the cardiovascular system: tachycardia, cardiac arrhythmias, decreased blood pressure, Уhot flushesФ 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 urine reaction and low urine output), acute interstitial nephritis (with possible development of acute renal failure), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, decreased nitrogen excretion ...
Allergic reactions: pruritus, urticaria, blistering accompanied by bleeding, and the appearance of small nodules that form scabs, drug fever, punctate hemorrhages on the skin (petechiae), edema of the face or larynx, shortness of breath, 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.
Others: increased sweating, photosensitivity, general weakness, superinfections (candidiasis, pseudomembranous colitis).

Overdose:

Possible reversible kidney toxicity;
There is no specific antidote, so it is necessary to induce vomiting or to wash the stomach and carry out symptomatic therapy:
- to take measures for adequate hydration of the body (infusion therapy);
- carrying out supportive therapy.
Only small amounts of ciprofloxacin (<10%) can be removed with hemo- and peritoneal dialysis.

Interaction with other medicinal products:

Due to inhibition of microsomal enzymes in the liver, it increases the concentration and lengthens T1 / 2 of theophylline and other xanthines (eg, caffeine), oral hypoglycemic drugs (eg, glibenclamide), indirect anticoagulants (eg, warfarin and its derivatives). If it is necessary to jointly use with drugs of these groups, it is necessary to control the concentration of the drug in the blood and adjust the dosage regimen accordingly.
In the presence of antacids containing magnesium hydroxide or aluminum hydroxide, the absorption of ciprofloxacin decreases. Thus, the simultaneous use of these drugs should be excluded. In such cases, ciprofloxacin should be taken either 1Ц2 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 used together with probenecid and other drugs that block tubular secretion, the renal excretion of ciprofloxacin decreases.
Metoclopramide accelerates the absorption of the drug, which leads to a decrease in the time to reach its Cmax.
The joint appointment of uricosuric drugs leads to a slowdown in excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin.
When combined with other antimicrobial drugs (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 mezlocillin, azlocillin and other beta-lactam antibiotics - for streptococcal infections; with isoxazolylpenicillins and vancomycin - for staphylococcal infections; with metronidazole and clindamycin - for anaerobic infections.
Ciprofloxacin enhances the nephrotoxic effect of cyclosporin. There is an increase in the concentration of serum creatinine. In such patients, it is necessary to monitor this indicator 2 times a week.
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, there was a variability (decrease or increase) in the concentration of phenytoin in blood plasma.
Concomitant use with non-steroidal anti-inflammatory drugs (NSAIDs) increases the likelihood of developing side effects of ciprofloxacin from the central nervous system (the risk of seizures).
The absorption of ciprofloxacin when administered orally decreases after cytotoxic therapy with antineoplastic and immunosuppressive drugs.

Special instructions:

Photosensitivity reactions were 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 CifranЃ OD is a drug with a possible reversible toxic effect on the kidneys, it is not recommended to use it in patients with impaired renal function, with creatinine clearance <29 ml / min, or in patients on hemodialysis or peritoneal dialysis.
With the use of almost all antimicrobial drugs, including CifranЃ OD, it is possible to develop pseudomembranous colitis, ranging in severity from mild to life-threatening. If severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.
In order to avoid the development of crystalluria, it is unacceptable to exceed the recommended daily dose; it is also necessary to have sufficient fluid intake and maintain an acidic urine reaction.
Patients with epilepsy, a history of seizures, vascular diseases and organic lesions of the brain, due to the threat of adverse reactions from the central nervous system, CifranЃ OD should be prescribed only for УvitalФ indications.
If pain in the tendons appears or when the first signs of tendovarinitis appear, treatment should be discontinued (individual cases of inflammation and even rupture of tendons during treatment with fluoroquinolones are described).
During treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and speed of mental and motor reactions.