Сиспрес®

General characteristics. Structure:

Active ingredient: 291,51 mg and 583 mg of ciprofloxacin of a hydrochloride that 250 mg and 500 mg of ciprofloxacin respectively are equivalent.

Excipients: starch corn, cellulose microcrystallic PH 102, PVP K 30 polyvinylpirrolidone, silicon dioxide colloid (Aerosil), magnesium stearate, sodium of a kroskarmelloz, structure of a cover: hypro methyl cellulose, cellulose microcrystallic, stearic acid, titanium dioxide (Е 171).

Antibiotic of a broad spectrum of activity of a number of ftorkhinolon.

Pharmacological properties:

Pharmacodynamics. СИСПРЕС® is a microbicide. As other ftorkhinolonovy antibacterial substances, ciprofloxacin are inhibited by DNA-topoisomerase (DNK-girazu) of a microorganism, susceptible to drug. DNK-giraza it is necessary for a reproduction and some moments of a transcription, recovery, a recombination and transposition of bacterial DNA. A target of ciprofloxacin is the enzyme A-subunit. Ciprofloxacin can also interact with B-subunits of enzymes.

СИСПРЕС® has a broad spectrum of activity and it is highly active against the majority of gram-negative aerobic bacteria, including Enterobacteriaceae and Pseudomonas aeruginosa; Escherichia coli, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia, Hafnia, Edwardsiella, Proteus, Providencia, Morganella, Yersinia, Vibrio, Aeromonas, Plesiomonas, Pasteurella, Haemophilus, Gardnerella, Campylobacter, Pseudomonas, Logionella, Neisseria, Moraxella, Acinebacter, Flavobacterium, Alcaligenes, Brucella.

СИСПРЕС® it is also active against many gram-positive aerobic bacteria, including Staphylococcus aureus, koagulozo-negative strains of staphylococcus, Steptococcus pyogenes, Streprococcus pneumoniae, Listeria, Corynebacterium.

СИСПРЕС® it is active against the bacteria producing beta lactamazu.

СИСПРЕС® influences obligate anaerobic bacteria, such as Bacteroides, Fusobacterium Peptococcus, Clostridium, Eubacterium, Actinomyces veilonella a little.

СИСПРЕС®, tablets, film coated, are also active against Chlamydia, Mycoplasma, Micobacterium. Drug is less active against anaerobic bacteria, such as Ureaplasma and some strains of mycobacteria.

Pharmacokinetics. Drug after oral administration is quickly and well absorbed from the digestive tract (DT). Bioavailability makes 50-85%, the maximum concentration of drug in blood is reached within 0,5-2,5 hours. Ciprofloxacin for 16-43% contacts proteins of a blood plasma.
 
After reception ciprofloxacin is widely distributed in fabrics and liquids of an organism. High concentration of drug are observed in almonds, lungs, kidneys, a liver, bile and a gall bladder, semen, tissues of a prostate gland and its secret, an endometria, fallopian pipes and ovaries. The ciprofloxacin elimination half-life at adults with normally functioning kidneys makes 3-5 hours of plasma. Drug is partially metabolized in a liver with formation of 4 metabolites: diethylciprofloxacin, sulfociprofloxacin, oxociprofloxacin, N-formiltsiprofloksatsin.

Ciprofloxacin and its metabolites are removed from an organism with urine (50-70%) and a stake (15-30%). Not changed ciprofloxacin is emitted with urine, by means of glomerular filtering and canalicular secretion. At oral administration of a therapeutic dose of 15% - 50% of a dose are removed with urine within 5 days.

Indications to use:

The infectious and inflammatory diseases caused by microorganisms, sensitive to drug:

- ENT organs;

- respiratory bodies;

- intestinal infections (salmonellosis, shigellosis, cholera);

- typhoid;

- urinogenital bodies;

- skin and soft tissues;

- bone and joint system;

- infections, sexually transmitted;

- septicaemia;

- diseases and injuries of organs of sight;

- postoperative complications;

- prevention and treatments of infections at people with reduced immunity.

Route of administration and doses:

Drug should be accepted on an empty stomach, washing down with enough liquid.

The recommended dose for adults at infectious and inflammatory diseases of urinogenital system makes 250-500 mg each 12 hours.

At infections of other localization the recommended dose makes 500-750 mg each 12 hours.

For the majority of infectious and inflammatory diseases treatment has to continue at least 48 hours, after disappearance of symptoms. On average, the course of treatment makes 10 days.

If the clearance of creatinine makes 20 ml a minute or less, patients can receive a half of the recommended dosage.

The maximum single dose of drug - 750 mg; daily - 1500 mg.

Features of use:

СИСПРЕС® can cause serious reactions from the central nervous system (a spasm, increase in intracranial pressure, toxic psychoses with suicide tendencies, a depression, dizziness, confusion of consciousness, nervousness) therefore it is necessary to appoint carefully drug the patient at advanced age and the patient with disturbances of the central nervous system (epilepsy, attacks of spasms in the anamnesis, disturbance of cerebral circulation, paralysis, mental diseases).

The aggravation of symptoms of patients with a heavy liver failure is possible.

At patients with deficit of a glyukozo-6-phosphate-dehydrogenase purpose of the drug SISPRES® can become the reason of development of hemolitic anemia.

It is known that the first administration of drug can already cause serious reactions of hypersensitivity.

During treatment СИСПРЕСом®, in order to avoid development of a crystalluria, it is necessary to avoid urine alkalization. It is also necessary to provide reception of enough liquid (under control of a diuresis) for observance of a normal diuresis.

During treatment СИСПРЕСом® it is necessary to avoid direct sunshine and artificial sources of ultraviolet radiation as at the patients receiving hinolona photosensitivity can develop.

Administration of drug СИСПРЕС® can be connected with increase in resistance of microorganisms. In case of heavy and long diarrhea it is necessary to exclude the diagnosis pseudomembranous colitis. In this case treatment by the drug SISPRES® has to be stopped, and the appropriate measures are taken.

There are messages on isolated cases of a tendinitis or even a rupture of a sinew during treatment of a hinolonama, especially for elderly people who were treated also by glucocorticoids. It is recommended to stop treatment if pain along a sinew is observed or the first signs of a tendinitis are found. In time and right after treatment, patients have to avoid excessive physical exercises.

Patients should not take alcohol during treatment.

Features of influence of medicine on ability to manage the vehicle or potentially dangerous mechanisms. It is necessary to be careful during the driving of the car and occupations other potentially dangerous types of activity requiring special attention and speed of psychomotor reactions.

Side effects:

- nausea, vomiting, diarrhea, abdominal pains, increase in activity of alaninaminotranspherase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, bilirubin, prothrombinopenia;

- liver failure, cholestatic jaundice, hepatitis, гепатонекроз;

- the increased psychomotor activity / the raised psychomotor;

- excitement;

- headache, dizziness, feeling of fatigue, frustration of a dream, hallucination, faints, depression, migraine, thrombosis cerebral arteries, increase in intracranial pressure;

- crystalluria, albuminuria, hamaturia, dysuria, polyuria, passing increase in creatinine of blood;

- intersticial nephrite, tranzitorny renal failure;

- eosinophilia, leukopenia, neutropenia, thrombocytopenia, hemolitic anemia, granulocytopenia;

- tachycardia, disturbances of a rhythm, arterial hypotension;

- skin itch, small tortoiseshell, Quincke's edema, arthralgias, Stephens-Johnson's syndrome, acute anaphylaxis, toxic epidermal necrolysis, medicinal fever;

- candidiasis of mucous membranes;

- skeletal and muscular pain (for example, extremity pain, back pain, stethalgia), joint pain;

- tendovaginitis, rupture of sinews, myasthenia;

- a photodermatosis, "inflows" of blood to the person;

- superinfection, pseudomembranous colitis;

- disturbances of taste and sense of smell, vision disorder, diplopia, change of color perception, sonitus, decrease in hearing.

Interaction with other medicines:

The accompanying reception of aminoglycosides or beta лактамных antibiotics can cause additional or synergy effects.

At simultaneous use with warfarin the risk of bleeding increases.

Concomitant use СИСПРЕСа® and glucocorticosteroids can increase risk of emergence of a rupture of sinews.

Joint reception of ciprofloxacin with didanoziny reduces ciprofloxacin absorption, owing to formation of complexes of ciprofloxacin with the aluminum, magnesian salts which are contained in the didanozena.

The concomitant use of ciprofloxacin with theophylline can lead to increase in plasma concentration of theophylline and extension of its elimination half-life.

Probenetsid interferes with renal secretion of ciprofloxacin and promotes increase in level of ciprofloxacin in blood.

Reception of the antacids and drugs containing ions of iron, zinc, aluminum, magnesium reduces ciprofloxacin absorption therefore the interval between receptions of these drugs has to make not less than 4 hours.

At simultaneous use of ciprofloxacin and cyclosporine nephrotoxic effect of cyclosporine amplifies.

Non-steroidal anti-inflammatory drugs (except for acetylsalicylic acid) increase risk of development of spasms.

Contraindications:

- hypersensitivity to ciprofloxacin or other drugs from group of ftorkhinolon;

- epilepsy;

- pregnancy and period of a lactation;

- children's and teenage age up to 18 years;

- a concomitant use with tizanidiny.

Overdose:

Data on overdose of drug are absent.

Treatment: the specific antidote is unknown. It is necessary to control carefully a condition of the patient, to make a gastric lavage, to carry out usual measures of acute management, to provide sufficient intake of liquid. By means of haemo - or peritoneal dialysis the amount of drug can be removed only insignificant (less than 10%).

Storage conditions:

To store at a temperature not above 25 °C in the dry, protected from light place. To store in the place, unavailable to children! Period of storage 3 years.

Issue conditions:

According to the recipe

Packaging:

On 10 or 14 tablets (for a dosage of 250 mg) and on 5 or 7 tablets (for dosages of 500 mg) in a blister strip packaging from a film of polyvinyl chloride and printing aluminum foil.

On 1 for a dosage (250 mg) or 2 (for a dosage of 500 mg) blister strip packagings together with the instruction on a medical use in the state and Russian languages place in a cardboard pack with the hologram of firm – producer