TSYPROBAY

Active material: Ciprofloxacin
When ATH: J01MA02
CCF: Fluoroquinolone antibacterial drug
When CSF: 06.17.02.01
Manufacturer: BAYER HealthCare AG (Germany)

DOSAGE FORM, STRUCTURE AND PACKAGING

100 ml – bottles (1) – packs cardboard.

10 PC. – blisters (1) – packs cardboard.

10 PC. – blisters (1) – packs cardboard.

Pharmacological action

Ciprobai (Ciprofloxacin) is a synthetic broad-spectrum antibacterial drug for oral and parenteral administration. Ciprofloxacin belongs to the group of quinolones, also known as gyrase inhibitors. Microbiology Ciprofloxacin has extremely high activity against a wide range of bacteria. Ciprofloxacin disrupts the transcription of bacterial chromosomes, necessary for their normal metabolism, the result is a rapid decrease in the ability of bacteria to divide. A characteristic feature of ciprofloxacin is the fact, that during its use parallel resistance of pathogens to antibiotics is not developed, not belonging to the group of gyrase inhibitors. Ciprofloxacin is highly effective against bacteria, resistant, eg, k aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics.

Pharmacokinetics

The absolute bioavailability of ciprofloxacin is 70-80 %. The maximum concentration in the blood is achieved after 60-90 minutes after oral administration. The half-life of ciprofloxacin ranges from 3 to 5 hours. Ciprofloxacin reaches its highest concentrations in areas where the infection is localized., for example in liquid media and tissues.

Testimony

Uncomplicated and complicated infections, caused by pathogens sensitive to ciprofloxacin.

Infection

• respiratory. For outpatient treatment of patients, suffering from pneumonia, caused by bacteria of the genus Pneumococcus, ciprofloxacin should not be used, as a drug of first choice. Ciprofloxacin is recommended for use in pneumonia, caused by Klebsiella, Enterobacter, Proteus, IS. coli, Pseudomonas, Haemophilias, Branham, Legionella and Staphylococcus.
• middle ear (otitis media), paranasal sinuses (sinusitis), especially if these infections are caused by gram-negative microorganisms, including Pseudomonas and Staphylococcus.
• eye
• kidneys and/or urinary tract – genital, including adnexitis, gonorrhea and prostatitis
• abdomen (eg, bacterial infections of the gastrointestinal tract, biliary tract, peritonitis)
• skin and soft tissue – bone and joints

Sepsis

• Infections or prevention of infections in immunocompromised patients (eg, patients, taking immunosuppressants or suffering from neutropenia).
• Selective enteric decontamination in immunocompromised patients.

According to the results of in-vitro studies, The following pathogenic microorganisms are sensitive to ciprofloxacin: IS. coli, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia, Hafnia, Edwardsiella, Proteus (indole-positive and indole-negative), Providence, Morga-nella, Yersinia; Vibrio, Aeromonas, Plesiomonas, Pasteurella, Hemo-philus, Campylobacter, Pseudomonas, Legionella, Neisseria, Mor-axella, Acinetobacter, Brucella; Staphylococcus, Listeria, Corynebacterium, Chlamydia.

The following microorganisms have varying sensitivity to ciprofloxacin: Gardnerella, Flavobacterium, Alcaligenes, Streptococcus agalactiae, Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae, Viridans group of streptococci, Mycoplasma hominis, Mycobacterium tuberculosis and Mycobacterium fortuitum.

The following microorganisms are considered resistant to ciprofloxacin: Enterococcus faecium, Ureaplasma urealyticum, Nocardia asteroids. With some exceptions, anaerobic microorganisms are moderately sensitive (eg, Peptocccus, Peptostreptococ-cus) or resistant to ciprofloxacin (eg, Bacteroides). Ciprofloxacin is not effective against Treponema pallidum

Dosage regimen

In the absence of other prescriptions, it is recommended to follow the following dosage regimen:

Testimony / Single/daily dose for adults (Ciprofloxacin, mg) Oral administration

• Respiratory tract infections* depending on the severity of the infection and the patient’s condition / 2 x 250 – 500
• Urinary tract infections - acute, uncomplicated - cystitis in women (before menopause) -complicated / from 2 x 125 to 1-2 x 250 single dose of 250 2 x 250 – 500
• Gonorrhea – extragenital – acute, uncomplicated / 2 x 125 single dose of 250
• Diarrhea 1-2×500
• Other infections* (cm. section Indications*) / 2×500
• * Particularly heavy, life-threatening infections, incl. – Streptococcal pneumonia – Recurrent infections in cystic fibrosis – Bone and joint infections – Septicemia – Peritonitis 2 x 750

– especially in the presence of Pseudomonas, Staphylococcus или Streptococcus

For urinary tract infections, caused by chlamydia, The daily dose of ciprofloxacin, if necessary, can be increased to 2 x 750 mg.

When treating elderly patients, the lowest possible doses of ciprofloxacin should be used., based on disease severity and creatinine clearance.

Tsiprobay tablets are taken regardless of the entire meal., drinking a small amount of liquid. When taken on an empty stomach, ciprofloxacin is absorbed faster.

Etcduration of use

The duration of therapy depends on the severity of the disease and its clinical and bacteriological course.. It is very important to continue treatment systematically for at least 3 days after the disappearance of fever or other clinical symptoms. The average duration of treatment: 1 day for acute uncomplicated gonorrhea and cystitis, to 7 days for kidney infections, urinary tract and abdomen, the entire period of neutropenia in immunocompromised patients, max. 2 months for osteomyelitis, 7 – 14 days for other infections.

When infections, caused by streptococci, due to the risk of late complications, treatment should continue for at least 10 days.

When infections, caused by chlamydia, therapy should also be continued for at least 10 days.

Side effect

Along with what you want, main action, medications can also have undesirable effects, so-called side effect.

Side effects are described below, observed in some patients during the use of ciprofloxacin.

From the gastrointestinal tract:

Nausea, diarrhea, vomiting, dyspepsia, abdominal pain, flatulence, decreased appetite. If severe, prolonged diarrhea occurs during or after treatment, you should consult your doctor., since this symptom may hide a serious intestinal disease (psevdomembranoznыy colitis), which requires immediate treatment. In such cases, ciprofloxacin should be stopped and appropriate treatment initiated. (eg, Vancomycin oral, 250 mg x 4 once a day). In this case, the use of drugs is contraindicated, suppressing peristalsis. –

From the nervous system:

Dizziness, headache, fatigue, anxiety, tremor; rarely: insomnia, peripheral paralgezija, Sweating, unsteady gait, convulsions, intracranial hypertension, anxiety states, nightmares, confusion, depression, hallucinations, in some cases psychotic reactions (occasionally progressive to States, in which the patient may cause harm).

Sometimes these reactions appear after the first dose of ciprofloxacin. In such cases, you should stop taking the drug and consult a doctor immediately.

From the senses:

Rarely: disorders of taste and smell, visual disturbances (eg, diplopia, change of color), noise in ears, temporary hearing impairment.

Hypersensitivity reactions:

Sometimes the reactions listed below occur after the first dose of ciprofloxacin. In such cases, you should stop taking the drug and consult a doctor immediately.

Skin reactions, eg: rash, itch, drug fever.

Rarely: Pinpoint skin hemorrhages (petechiae), Blisters, accompanied by bleeding (hemorrhagic bullae), papules with crusting, vasculitis. Erythema nodosum, exudative polymorphic erythema (small forms).

Stevens-Johnson syndrome (malignant exudative erythema), Lyell's syndrome.

Interstitial nephritis, hepatitis, liver tissue necrosis, in rare cases, progressing to life-threatening liver failure.

Anaphylactic/anaphylactoid reactions (eg, swelling of the face or larynx; breathlessness, progressing to life-threatening shock), sometimes appearing after the first dose of the drug. In such cases, Ciprofloxacin should be discontinued and appropriate treatment should be sought. (eg, for the treatment of anaphylactic shock).

Cardio-vascular system:

Tachycardia; rarely: paroxysmal feeling of heat, migraine, swoon.

Other side effects: Pain in the joints, swelling of joints; rarely: generalized weakness, muscle aches, tendinitis, increased light sensitivity, transient renal dysfunction, including kidney failure.

In isolated cases, achillotendinitis was observed during the use of ciprofloxacin.. At the same time, isolated cases of partial or complete rupture of the Achilles tendon were noted, primarily, elderly patients, previously received systemic treatment with glucocorticoids. Concerning, if any symptoms of achilles tendonitis appear (eg, painful swelling), you should stop taking ciprofloxacin and consult a doctor.

Long-term or repeated use of ciprofloxacin may lead to the development of superinfection, caused by resistant microorganisms or yeast-like fungi.

From the hematopoietic system:

Eozinofiliya, leukopenia, granulocytopenia, anemia, thrombocytopenia; rarely: leukocytosis, thrombocytosis, gemoliticheskaya anemia, changes in the level of prothrombin.

By the laboratory parameters:

There may be a temporary increase in transaminase and alkaline phosphatase levels or cholestatic jaundice, especially in patients with a history of liver disease; possible temporary increase in urea levels, serum creatinine or bilirubin; in some cases: giperglikemiâ, crystalluria or hematuria.

Photosensitivity

Ciprofloxacin has potential phototoxicity. Patients, Those taking ciprofloxacin should avoid direct sunlight and intense ultraviolet radiation. If photosensitivity occurs (the appearance of burn-like skin reactions), the drug should be discontinued.

Note for drivers:

Even when used as prescribed, this drug can reduce the reaction rate to such an extent, that it will adversely affect the ability to drive a car or operate automated systems. This negative effect is aggravated when alcohol is consumed concomitantly with therapy..

Contraindications

Contraindications are diseases or conditions, in which the use of certain medications is contraindicated at all or is possible only after a thorough medical examination, since in such cases the possible negative effect generally dominates the predicted positive effect. For, so that the doctor can identify the presence of possible contraindications, he must be informed about all the patient’s previous major and concomitant diseases, about any concurrent therapy, as well as the specifics of the patient’s lifestyle and habits. The presence of contraindications is sometimes detected after the start of therapy; in this case, it is also necessary to inform the attending physician about this.

Ciprobay should not be used if you have hypersensitivity to ciprofloxacin or other quinolones..

Ciprofloxacin is contraindicated in children, adolescents and women during pregnancy and lactation, since there is no data yet on the safety of the drug in these groups of patients. Besides, Experiments on animals did not allow us to completely exclude the possibility of the damaging effects of ciprofloxacin on the cartilage tissue of the fetus or growing organism., although teratogenic effect (malformations) was not identified.

Precautions

When treating patients, those suffering from epilepsy and those who have had central nervous system diseases (eg, lowering the seizure threshold, history of seizures, cerebrovascular accidents, organic brain damage or stroke), ciprofloxacin should only be used in cases, when the expected clinical effect outweighs the possible risk of side effects of the drug on the central nervous system.

Pregnancy and lactation

These are not represented.

Cautions

Not disclosed.

Overdose

In cases of severe oral overdose, reversible toxic effects on the renal parenchyma have been observed in several cases.. Therefore, in case of overdose, in addition to performing standard tests, It is also recommended to monitor kidney function. Antacids reduce the absorption of ciprofloxacin, containing magnesium and calcium.

Only small amounts of ciprofloxacin are removed by hemodialysis or peritoneal dialysis (<10%).

Drug Interactions

The effect of some drugs in most cases is affected to varying degrees by the simultaneous use of others.. Thus, if the patient constantly takes, have recently taken or are planning to take any medications at the same time as ciprofloxacin, he needs to consult with his doctor. Врач должен определить, следует ли в данном случае опасаться лекарственной несовместимости или прибегать к особым мерам, eg, к изменению дозировки.

Одновременный прием таблетированных форм ципрофлоксацина и железосодержащих препаратов, сукралфата или антацидов, а также препаратов с большой буферной ёмкостью (eg, антиретровирусных препаратов), содержащих магний, алюминий или кальций, reduces the absorption of ciprofloxacin. В таких случаях Ципробай следует принимать либо за 1-2 часа до, or via 4 часа после приёма этих препаратов. Это ограничение не относится к антацидам, принадлежащим к классу блокаторов Н2 рецепторов.

Одновременное применение ципрофлоксацина и теофиллина может вызвать нежелательное повышение концентрации теофиллина в плазме крови, что может привести к усугублению его побочного действия. Если одновременное применение этих двух препаратов неизбежно, необходим постоянный контроль концентрации теофиллина в плазме крови вплоть до соответственного снижения его дозировки. Animal studies have shown, что сочетание очень высоких доз хинолонов (ингибиторов гиразы) и некоторых нестероидных противовоспалительных препаратов (excluding acetylsalicylic acid) может вызвать судороги. При одновременной терапии ципрофлоксацином и циклоспорином наблюдалось кратковременное повышение концентрации креатинина в плазме крови. В связи с этим в таких случаях необходимо два раза в неделю определять уровень содержания креатинина в крови.

Одновременное применение ципрофлоксацина и варфарина может усилить действие последнего.

В отдельных случаях одновременное применение ципрофлоксацина и глибенкламида может усилить действие глибенкламида (gipoglikemiâ).

Пробенецид замедляет скорость выведения ципрофлоксацина почками. Одновременное применение пробенецида и ципрофлоксацина повышает концентрацию ципрофлоксацина в плазме крови.

Metoclopramide accelerates the absorption of ciprofloxacin, сокращая период времени, необходимый для достижения его максимальной концентрации в плазме крови. При этом биодоступность ципрофлоксацина не изменяется.

Conditions and terms

Store in a dry, dark place at a temperature no higher than 25 ° C.

Хранить в месте, out of reach of children.

Срок годности 5лет.

Do not use after the expiry date, on the package.