Sifloks 10s 500 mg coated tablets

The instruction for use
of medicine for experts
of Sifloks ®
the Trade name
of Sifloks ®

the International unlicensed


name Ciprofloxacin Dosage Form
of the Tablet, film coated
Structure
One tablet contains
active substance-ciprofloxacin a hydrochloride of 500 mg
excipients: corn starch, cellulose microcrystalline, krospovidon, magnesium stearate, silicon dioxide colloidal
structure of a cover: a hydroksipropilmetiltsellyuloza, polyethyleneglycol 4000, the titan dioxide

the Description
of the Tablet, coated, an oval form, white or yellowish color with dividing cutting on one party
Pharmacotherapeutic group
Antibacterial drugs derivatives of a hinolon. Ftorkhinolona.
The code of automatic telephone exchange J01MA02
the Pharmacological


Pharmacokinetics Absorption At properties oral administration of Sifloks is quickly soaked up from digestive tract. The bioavailability of drug leaves 50-85%. The maximum concentration in serum at healthy people at use to food is reached in 0.5-1.5 hours.
The maximum concentration in serum at oral administration of 250,500,750 and 1000 mg of drug make 0,76, 1,6, 2,5 3.4mkg/ml. Orally accepted ciprofloxacin widely is distributed in fabrics and liquids of an organism and creates high concentrations in bile, lungs, kidneys, a liver, a gall bladder, a uterus, semen, prostate tissue, tonsils, endometrium, fallopian pipes and ovaries. Concentration of a tsiprofloksan in these fabrics is higher, than in serum. Besides tsiprofoksatsin well gets into bones, eye liquid, bronchial slime, saliva, skin, muscles, fatty and cartilaginous tissues, a pleura, a peritoneum, astsitny liquid and a lymph. Concentration in neutrophils high, is 2-7 times higher, than in serum. Distribution volume in an organism is 2-3.5 l/kg.
Ciprofloxacin gets into likvorny liquid in a small amount. Concentration in likvorny liquid makes 6-10% of concentration in serum. Extent of linking of a tsiprofloksain with proteins of plasma makes about 30%.
Removal
At patients with normal function of kidneys elimination half-life makes 3-5 hours, and at patients with impaired renal function it is extended. Drug, is generally removed from an organism by kidneys (50-70% with urine, and 15-30% with excrement). Patients with a heavy renal failure (the clearance of creatinine is lower than 20 ml/min. / 1.73 m) need to apply a half of a daily dose.
The pharmacodynamics
the Main mechanism of action consists in suppression of bacterial DNA of a giraza.
Antibacterial action
Sensitive bacteria (MIC is lower 1mkg/ml):E.coli, Klebsiella, Enterobacter, Serratia, Proteus(indol+), Proteus(indol-), Citrobacter, Shigella, Salmonella, Pseudomonas aeruginosa, Haemophilus, Staphilococcus, Neisseria gonorrhoeae, Providencia, Morganella, Yersinia, Vibrio, Aeromonas, Pasteurella, Gardnerella, Campylobacter, Legionella, Corynebacterium.
Bacteria of average degree of sensitivity:
Acinetobacter, Streptococcus (Strept.Pneumoniae, Strept. Faecalis), Fusobacterium, Peptococcus, Clostridium, Actiinomyces, Veillonella, Chlamediae, Mycoplazma, Mycobacterium tuberculosis, Listeria.
The bacteria which are difficult giving in to drug influence:
Gram negative anaerobic bacteria (Bacteroides), spirochetes.
Tests of sensitivity
Some cations (such as magnesium) which are contained in composition of the used culture medium rn can influence assessment of the received results. rn Wednesday is considered optimum in an interval 6-8. If rn lower than 6, then received vedichina of MIC are 4-16 times higher.
When using a method of disk diffusion of Kurbi-Bauyer the 5th mikrogramovy disks of ciprofloxacin are applied. Bacteria with a zone of inhibition of 15 mm and less reckon as steady, with a zone of inhibition of 21 mm and more - sensitive.
Indications
- gonorrhea and not gonococcal urethritis
- pneumonia, bronchitis, etc.
- infections of skin and soft tissues (a postoperative wound fever, infections against the background of diabetes infected decubituses, etc.)
- osteomyelitis, septic arthritis, etc.
- an adnexitis and prostatitis
- infections of bilious ways
- infections in obstetrics and gynecology
- digestive tract infections
- infections of a middle ear and adnexal bosoms of a nose
- an infection of eyes
- peritonitis
- sepsis
- prevention and treatment of infections at patients with reduced immunity, including against the background of treatment by immunodepressants and at a neutropenia.

The route of administration and doses
Is established individually depending on localization and weight of an infection and also sensitivity of the activator.
- in simple infections of urinary tract-2 of time a day on 250 mg
- in heavy infections of urinary tract - 2 times a day on 500 mg
- in heavy respiratory infections, osteomyelitis: 2 times a day on 750 mg
- in other infections of a heavy course: 2 times a day on 500 mg
- in acute gonorrhea - 250 mg once
the Course of treatment prepraty are appointed by individually attending physician.
If the clearance of creatinine in cases of a renal failure is lower 20mg/mines, then it is necessary to apply a half of a dose. Usually treatment continues within 72 hours after clinical and bacteriological recovery.
Side effects
- nausea, vomiting, diarrhea, lack of appetite
- dizziness, a headache, insomnia, concern
- rash, an itching, a paraglossa
- an eosinophilia, a leukocytosis
Very seldom
- parksizmalny tachycardia, migraine
- thrombocytopenia, changes of indicators of a prothrombin
- pains of joints and light sensitivity
- increase in hepatic transaminases and alkaline phosphatase
of the Contraindication
- hypersensitivity to drug and also children before end of a growth period
- children's age up to 15 years
- pregnancies and the period of a lactation

Medicinal interactions
the Antacids containing magnesium and aluminum slow down drug absorption process. Ciprofloxacin should be accepted in two hours prior to or in two hours after reception of antacids.
At simultaneous use of ciprofloxacin and theophylline the increase in concentration in blood of the last is possible. In such cases it is necessary to korregirovat a theophylline dose.

Special instructions
At patients with attacks of spasms in the anamnesis ciprofloxacin should be accepted after a proyevedeniye of the corresponding anticonvulsant therapy.
During drug treatment the patients have to receive enough liquid. At reception next the heart process of absorption accelerates.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Ciprofloxacin can cause an olableniye of attention and reactions therefore the patients accepting ciprofloxacin should limit the activity connected with need of fast concentration of attention and high reactionary ability. Alcohol can strengthen influence of adverse factors.

Overdose
Symptoms: strengthening of side effects
Treatment: symptomatic

the Form of release and packing
On 10 tablets in blister strip packaging from a film of the polyvinylchloride and aluminum foil varnished.
Blister strip packaging together with the instruction for use in the state and Russian languages is enclosed in a cardboard box.


To Store storage conditions in dry, protected from light, the place at a temperature from +18 °C to +25 °C.
To store out of children's reach!

An expiration date
4 years
it is impossible to use Drug after the expiration date specified on packing.

Prescription status
According to the prescription


Edzhzadzhibasha Saglik Yugyunleri's Producer Sang.ve
of Tidzharet A.Sh. Kyuchyukkarishtiran
of 39780 Lyuleburgaz Kirklareli-Turkey
of Eczacibasi Saglik Urunleri San.ve Tic.A.S.

Kucukkaristiran 39780 Luleburgaz-Kirklareli-Tyrkey