Ifitsipro

General characteristics. Structure:

Active agent: ciprofloxacin the hydrochloride corresponds to ciprofloxacin of 250 mg, 500 mg. Excipients: cellulose microcrystallic, starch corn, starch (for paste of 20%), magnesium stearate, talc, silicon dioxide colloid, starch sodium glycollate, Opadry dye white 33G28707.

Pharmacological properties:

Pharmacodynamics. Ciprofloxacin is effective antimicrobic drug from group of ftorkhinolon. Bactericidal effect of drug is caused by inhibition of the DNK-girazy enzyme of bacteria controlling structure and the DNA function. Antibacterial activity is caused also by influence on RNA bacteria and synthesis of bacterial proteins, on stability of membranes and on other vital processes of bacterial cells. Has bactericidal effect on the bacteria which are both in a reproduction phase, and in a resting phase. 

Ifitsipro is highly active concerning almost all aerobic gram-negative bacteria: E.coli, Klebsiella spp., an indole - positive and an indole - negative Proteus spp., Enterobacter spp., Morganella morganii, Providencia stuartii, Providencia spp., Citrobacter spp., Salmonella spp., Shigella spp., Yersinia enterocolitica, Vibrio cholerae, Vibrio parahaemolyticus, Neiserii gonorrhoeae, Neiserii meningitidis, Haemophilus influenzae, Pseudomonas aeruginosa, Acinetobacter anitratus, Moraxella catarrhalis, Pasteurella multocida, Campylobacter spp., Hafnia spp.; aerobic grampolozhitelnykhbakteriya: Staphylococcus spp., (including, producing and not producing a penicillinase and metitsillinrezistentny), Streptococcus pyogenes, Streptococcus agalactiae, Corynebacterium diphtheriae, Listeria monocytogenes, intracellular bacteria: Legionella pneumophila, Brucella spp., Chlamidia spp. and also concerning the bacteria developing beta lactamelements. 

Have various sensitivity: Serratia spp., Gardnerelle vaginalis, Gardnerelle spp., Flavobacterium, Alcaligenes, Enterococcus faecalis, Streptococcus pneumoniae, Mycoplasma hominis, Mycobacterium spp., Mycobacterium fortuitum 

To rezistentna drug: Streptococcus faecium, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides, Treponema pallidum, Bacteroides. 

Ifitsipro is effective against microorganisms, resistant to Acidum nalidixicum (Nevigramonum, Negramum); it can be applied to treatment of the infections caused by the organisms steady against aminoglycosides, penicillin, streptocides, tetracyclines and cephalosporins. Resistance to drug is developed slowly and gradually. 

Pharmacokinetics. After intake ciprofloxacin is quickly soaked up from digestive tract. The maximum concentration in a blood plasma is observed in 1-2 h after intake and in 30 minutes after intravenous administration. Bioavailability of drug makes about 70-80%. 

As linkng of ciprofloxacin with proteins of a blood plasma is insignificant (20-30%), and substance is in plasma preferential in not ionized form, almost all amount of the administered drug can freely diffuse in ekstravazalny space. In this regard concentration of ciprofloxacin in some fabrics and liquids (a phlegm, bones, peritoneal liquid, a prostate and bodies of a small pelvis) can exceed considerably appropriate level in serum, in particular high concentration of ciprofloxacin in bile is noted (several times exceeding its concentration in plasma). 

About 40% of the accepted dose are allocated generally with kidneys in an invariable look within 24 hours and about 15% - in the form of metabolites. Renal clearance - 3-5 ml/min.; the general clearance makes 8-10 ml/min. The elimination half-life, both after peroral, and after intravenous administration, makes 3-5 hours. At a renal failure increase in this indicator up to 12 h is possible. 

Indications to use:

Ifitsipro is recommended for treatment of the infections caused by microorganisms, sensitive to drug: 

- respiratory infections; 

- infections of a middle ear and adnexal bosoms of a nose, throat and throat; 

- infections of eyes; 

- infections of skin and soft tissues; 

- infections of kidneys and urinary tract; 

- digestive tract infections, including the infections caused by Salmonella spp., Shigella spp., Campylobacter spp, etc.; 

- infections of a gall bladder and biliary tract; 

- infections of bodies of a small pelvis (including an adnexitis and prostatitis); 

- infections of bones and joints; 

- peritonitis; 

- sepsis; 

- gonorrhea. 

Route of administration and doses:

Doses of drug are selected individually depending on localization and weight of a course of an infection, and also sensitivity of a microorganism. 

At uncomplicated infections of uric ways on 0,125 g 2 times a day; at the complicated infections of uric ways and respiratory infections – on 0,25-0,5 g 2 times a day, and in more hard cases – to 0,75 g 2 times a day (if it is not carried out parenteral treatment).  Course of treatment usually 5-10 days. 

At acute gonorrhea appoint ciprofloxacin once inside in a dose of 250-500 mg. 

For the majority of infections treatment should be continued before disappearance of symptoms of a disease and in the next 48 hours. Usually course of treatment of 7-10 days. In uncomplicated cases the course of treatment can be less long. At patients with reduced immunity treatment is carried out during the entire period of a neutropenia. At the infections caused by streptococci and chlamydias, it is necessary to continue treatment not less than 10 days. 

Features of use:

It is necessary to be careful at purpose of drug to patients with attacks of spasms in the anamnesis, vascular diseases of a brain, organic lesions of TsNS. Ifitsipro in these cases should appoint only according to vital indications; at emergence in time or after Ifitsipro's treatment of heavy and long diarrhea it is necessary to exclude the diagnosis of pseudomembranous colitis which demands immediate drug withdrawal and purpose of the corresponding treatment; at use of ftorkhinolon it is not necessary to be treated to action of ultraviolet rays because of a possible photosensitization of skin; at course treatment change of some laboratory indicators is possible: emergence of a deposit in urine; temporary increase in concentration of urea, creatinine, bilirubin, hepatic transaminases in serum; in certain cases – a hyperglycemia, a crystalluria or a hamaturia; change of indicators of a prothrombin. 

The patients accepting Ifitsipro should be careful during the driving of the car and occupations other types of activity demanding speed of mental and motor reactions; at patients with abnormal liver functions or kidneys control of concentration of ciprofloxacin in a blood plasma is necessary. 

Side effects:

From cardiovascular system: tachycardia; very seldom – feeling of inflows, migraine, an unconscious state; from digestive tract: nausea, vomiting, diarrhea, abdominal pains, lack of appetite, meteorism. From a liver: tranzitorny increase in transaminases, cholestatic jaundice, hepatitis, necrosis of cells of a liver. From the central nervous system: headache, dizziness, depression, feeling of concern, frustration of a dream, excitement, tremor; seldom: spasms, vision disorder, perceptions of a smell and taste, sweating strengthening, instability of gait, increase in intracranial pressure, sensation of fear, confusions, nightmares, hallucinations. (These reactions demand immediate drug withdrawal). From an urinary system: a crystalluria, it is rare – a glomerulonephritis, a dysuria; overdevelopment of fungal flora of a vagina (candidiases). Allergic and immunopathological reactions: skin rash, itch, small tortoiseshell; seldom - a Quincke's edema, a bronchospasm, arthralgias; very seldom – an acute anaphylaxis, hemorrhagic bubbles, mialgiya, papules with crusting as a vasculitis sign; Stephens-Johnson's syndrome, Lyell's disease. From the hemopoietic system: leukopenia, agranulocytosis, eosinophilia, thrombocytopenia. Dermatological reactions: the phenomena connected with a photosensitization. Local reactions: phlebitis. 

Interaction with other medicines:

Simultaneous use of Ciprofloxacin and iron preparations, sukralfat or antiacid means containing magnesium, aluminum, calcium reduces intensity of absorption of Ciprofloxacin therefore time interval between purpose of these drugs has to be not less than 4 hours. 

Theophylline. Combined use of high doses of ciprofloxacin and theophylline leads to undesirable increase in concentration of theophylline in a blood plasma, and to lengthening of the period of its semi-removal therefore in avoidance of emergence of teofillinovy toxicity the dose of theophylline needs to be reduced. 

Cyclosporine. The concomitant use of cyclosporine and ciprofloxacin leads to increase in level of creatinine in a blood plasma, in this regard control of this indicator is necessary (2 times a week). 

At simultaneous use of Ciprofloxacin and warfarin strengthening of effect of warfarin is possible. 

Contraindications:

• pregnancy, lactation;
• hypersensitivity to ciprofloxacin or other  derivatives    of ftorkhinolon;
• children's and teenage age

Overdose:

The specific antidote is unknown. Usual measures of acute management are recommended; it is in addition possible to carry out a hemodialysis and peritoneal dialysis. 

Storage conditions:

To store tablets at the room temperature, in the place protected from light. Not to freeze. 

 

Issue conditions:

According to the recipe

Packaging:

Tablets - the blister strips on 10 tablets; 100 tablets in packaging.