Product name: Siprol 500
Active substance (INN): Ciprofloxacin (in the form of ciprofloxacin hydrochloride).
Dosage form: Tablets film-coated, 500 mg
Pharmacotherapeutic group: Antibacterial synthetic drugs (fluoroquinolones).
Storage: In a dry, dark place at a temperature not higher than 25°C.
Shelf life: 3 Years
Conditions of supply of pharmacies: With recipe
Antimicrobial wide spectrum of action of the fluoroquinolones. It has a bactericidal effect on microorganisms which are in the reproductive phase and a rest phase. The mechanism of action is associated with inhibition of the enzyme DNA – gyrase, which plays an important role in the process segment despiralization and helix chromosomes during bacterial growth. Highly active against most Gram-negative and Gram-positive microorganisms: Pseudomonas aeruginosa, Haemophilus influenzae and E. coli, Shigella, Salmonella, meningococcus, gonococcus, many strains of staphylococci (producing and not producing penicillinase, methicillin), some species of enterococci and campylobacter, Legionella, Chlamydia, mycobacteria. It is active against organisms that produce beta-lactamase. Highly effective against bacteria resistant to aminoglycosides, penicillins, third-generation cephalosporins, tetracyclines and other antibiotics. Resistance to a drug is produced slowly (multi-type). For drug resistant: Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides, Streptococcus faecum, Treponema pallidum.
The drug is rapidly and well absorbed from the gastrointestinal tract. Time after dosing before it is detected (Cmax) in blood is usually less than 30 minutes. The time to reach maximum blood concentration of from 1 to 1.5 hours. The bioavailability of the drug is about 70-80%. Plasma protein binding is 30-40%. Easily into the organs and tissues, passes the blood-brain barrier, partially (15-30%) is biotransformation in the liver. The half-life (T1 / 2) 3-5 hours. With significant renal dysfunction may increase this figure (up to 12 hours).
It provided mainly unaltered mainly kidneys, and through the intestine.
Infections of the kidneys and urinary tract infections (acute or chronic pyelonephritis, obstructive litiaz, cystitis, complicated or recurrent urinary tract infections, prostatitis, epididymitis), respiratory tract infections (pneumonia, bronchopneumonia, infected pleurisy, lung abscess, infected bronchiectasis, exacerbation of chronic bronchitis) infections of skin and soft tissue (infected ulcers, wound infections, abscesses, cellulitis, otitis externa, infected burns), infections of the gastrointestinal tract (typhoid fever, bacterial diarrhea and OE), an infection of the abdominal cavity (peritonitis, intra-abdominal abscess, cholangitis, cholecystitis, empyema of the gall bladder), eye infections, middle ear and paranasal sinuses, bones and joints, the pelvic organs, gonorrhea, meningitis, endocarditis, bacteremia, sepsis and other inflammatory processes.
Prevention and treatment of infections in patients with reduced immunity.
Dosing and Administration
Inside. The tablets should be swallowed whole, on an empty stomach or after a meal with a small amount of liquid. The dose is determined individually, depending on the location and severity of the infection and the sensitivity of the microorganism. In patients with moderate and severe renal impairment require a correction mode (for example, when creatinine clearance (CC) of less than 20ml / min, single dose should be 50% of the average dose in the multiplicity of destination 2 times daily or usual single dose is administered 1 time day). the dose should be reduced (typically 3.1) for elderly patients.
In uncomplicated kidney infections and urinary tract appoint 0,25-0,5g twice a day; complications at 500-750 mg twice daily, 7-10 days treatment. In uncomplicated gonorrhea 0,25-0,5g once; when combined gonococcal infection with Chlamydia and Mycoplasma appoint 0,75g every 12 hours for 7-9 days. When meningokokovom nasopharyngeal carriage of prescribed a single dose of 0.5 g or 0,75g. In chronic carriers of salmonelll appoint 0.25 g 4 times a day. When pneumonia, osteomyelitis appoint 0,75g 2 times a day for 7-14 days. For infections of the gastro-intestinal tract caused by Staphylococcus aureus, 0,75g designate every 12 hours for 7-28 days.
Gastro-Intestinal tract and liver: nausea, vomiting, dyspepsia, diarrhea, abdominal pain, flatulence, loss of appetite, jaundice, cholestatic hepatitis.
From the nervous system: dizziness, headaches, migraines, fatigue, weakness, insomnia, agitation, tremor, peripheral neuralgia, paraesthesia, sweating, incoordination, convulsions, a state of anxiety, depression, hallucinations, nightmares (these reactions require discontinuation of the drug ).
Skin: itching, rash, photosensitivity, redness.
Cardio-vascular system: tachycardia, syncope, hypertension, angina pectoris, myocardial infarction, cerebral thrombosis.
From the side of blood and its components: eosinophilia, leukopenia, leukocytosis, anemia, hemolytic anemia, thrombocytopenia, thrombocytosis.
From the urinary system: glomerulonephritis, dysuria, polyuria, crystalluria, albuminuria, urethral bleeding, dysfunction until the development of transient renal failure.
From the senses: taste and smell disorders, visual disturbances (diplopia, hromatopsiya), tinnitus, temporary hearing loss (particularly high-pitched sounds).
Allergic and immunopathological reactions: skin rash, drug fever, rarely – angioedema, bronchospasm, arthralgia, very rarely – anaphylactic shock, petechiae, hemorrhagic vesicles, myalgia, vasculitis, Stevens – Johnson syndrome, toxic epidermal necrolysis.
When concomitant administration is not revealed to reducing other antibiotics or antibacterial agents except fluoroquinolones. Simultaneous oral iron, sucralfate, antacids containing aluminum hydroxide, magnesium or calcium causes a decrease in absorption of the drug, so the time interval between administration of these medications must be at least 4 hours. Simultaneous treatment with theophylline enhances its side effects, which may require dose reduction of theophylline. In an application with warfarin increases the effects of the latter. Co-administration of the drug with probenecid increases the effects of the drug.
Precautions (only for health reasons) given to patients with severe cerebral atherosclerosis, stroke, epilepsy, seizures seizures in history, with severe impaired hepatic elderly kidney function. During treatment, patients should receive plenty of fluids. The drug can cause a decrease in the rate of reaction (especially with simultaneous use of alcohol), it is necessary to take into account those professions that require attention and increased reaction (eg transport drivers). In the event of severe and prolonged diarrhea need to exclude the diagnosis of pseudomembranous colitis, which requires immediate discontinuation of the drug and appropriate treatment. Against the background of treatment with possible changes in some laboratory parameters: the appearance of the sediment in the urine, a temporary increase in the concentration of creatinine, urea, bilirubin, liver transaminases in blood serum; in some cases – hyperglycaemia, crystalluria or haematuria, changes in rates of prothrombin.
Keep out of the reach of children, and it should not be used after the expiration date.
Symptoms: transitory kidney damage.
Treatment: Induce vomiting, stomach wash, the appointment of preparations neutralizing gastric juice. It is necessary to provide sufficient fluid flow in the body. ciprofloxacin minor amount (less than 10%) can be derived by dialysis.
Hypersensitivity to ciprofloxacin or any hinonolonovym drugs, the age of 15 years (younger can cause damage to the cartilage), old age, pregnancy and lactation.