Oflo

General characteristics. Structure:

Active agent: ofloxacin of 200 mg and 400 mg;

excipients: corn starch, microcrystallic cellulose, methylhydroxysodium benzoate, magnesium stearate, the purified talc, colloid anhydrous silicon dioxide. 

Pharmacological properties:

Pharmacodynamics. Possesses bactericidal action, inhibiting the vital enzyme of a microbic cell – DNK-girazu, breaking thereby biosynthesis of DNA of microorganisms. 

Ofloxacin influences preferential gram-negative and some gram-positive aerobic bacteria. It is active concerning the microorganisms steady against the majority of antibiotics and sulfanamide drugs. 

Are highly sensitive to drug: E.coli, Klebsiella spp., including Klebsiella pneumonia, Proteus mirabilis, Proteus vulgaris, Serratia spp., Enterobacter spp., Providencia spp., Citrobacter spp., Salmonella spp., Shigella sonnei, Yersinia spp., Vibrio spp., Neiseria gonorrhoeae, Neiseria meningitidis, Haemophilis influenzae, Haemophilis ducreyi, Aeromonas hydrophila, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acnes, Staphylococcus spp., Staphylococcus aureus, Legionella spp., Brucella spp., Chlamidia trachomatis, Mycoplasma spp., fast-growing atypical mycobacteria, and also the bacteria developing beta lactamelements. 

Are moderately sensitive to Oflo: Acinetobacter spp., Enterococci, Streptococcus spp. (including pneumococci), Clostridium perfringens, Corynebacterium spp., Campylobacter spp., Helicobacter pilori, Listeria monocytogenes, Pseudomonas aeruginosa, Gardnerella vaginalis, Mycobacterium tuberculosis, Ureaplasma urealyticum. 

Anaerobic microorganisms are steady against drug (including the majority of types of bacteroids, clostridiums, actinomycetes, fuzobakteriya, enterococci, metitsillinorezistentny stafilokokk, nokardiya). 

Pharmacokinetics. After intake Ofloxacin quickly and almost is completely soaked up from a GIT (about 95%). The maximum concentration in a blood plasma at intake is reached in 1-2 hours and depends on a dose: after a single dose of 200 mg and 400 mg it makes 2,5 mkg/ml and 5,0 mkg/ml respectively. Food can slow down drug absorption, but has no significant effect on its bioavailability which makes nearly 100%. 5% of an ofloksatsin are metabolized in a liver. 

Linkng with proteins of a blood plasma insignificant - about 25%. Ofloxacin has the large volume of distribution therefore almost all amount of the administered drug can freely get in cells, creating high concentration in bodies, fabrics and liquids of an organism (lungs, a gall bladder, skin, ENT organs, bones, urinogenital bodies, a prostate). Gets through a blood-brain and placental barrier, it is allocated with breast milk. 

The elimination half-life of an ofloksatsin makes 6 - 7 hours. About 80 - 90% of the accepted dose are removed generally by kidneys in an invariable look; about 4% of an ofloksatsin are removed with a stake. 

Indications to use:

Oflo is recommended for treatment of the infectious and inflammatory diseases caused by microorganisms, sensitive to drug: 

- respiratory infections (except for cases of a pneumococcal infection);

- infections of an ear, throat, nose; 

- gynecologic infections (a colpitis, an adnexitis, a cervicitis, a salpingo-oophoritis, an endometritis, a parametritis (including caused gonokokky, chlamydias); 

- infections of kidneys, urinary tract, prostate, urethra (including gonococcal nature); 

- infections of an abdominal cavity and biliary tract (except for bacterial enteritis); 

- infections of skin, soft tissues, bones and joints; 

- septicaemia, meningitis. 

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 microorganisms, the general condition of the patient and function of a liver and kidneys. 

The average daily dose of Oflo for adults fluctuates from 200 mg to 800 mg. Frequency rate of use 2 times a day. Duration of a course of treatment makes 7-10 days. It is possible to appoint a dose to 400 mg a day in 1 reception, it is preferable in the morning. A pill of an ofloksatsin should be taken entirely, without chewing, washing down them with water, both to, and after meal. 

 

Features of use:

It is necessary to be careful at purpose of drug to patients with attacks of spasms in the anamnesis, the patient with vascular diseases of a brain, disturbance of cerebral circulation, organic lesions of the central nervous system. 

At emergence in time or after Oflo'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 patients with abnormal liver functions or kidneys control of concentration of an ofloksatsin in a blood plasma is necessary. At a heavy renal and liver failure the risk of development of toxic effects therefore doses of drug are subject to correction increases; increase of attacks of a porphyria at predisposed patients against the background of Oflo's treatment is possible. 

At Oflo's use it is not necessary to be treated to action of ultraviolet rays because of a possible photosensitization of skin.

Side effects:

From the central nervous system: headache, dizziness, depression, weakness, feeling of concern, frustration of a dream, excitement, tremor; seldom: muscular spasms, paresthesias in extremities, a hallucination. (These reactions demand immediate drug withdrawal); from sense bodys: diplopia, disturbance svetovospriyatiya, disturbance of taste, sense of smell, hearing and balance; from cardiovascular system: tachycardia, short-term arterial hypotension (at intravenous administration of drug); from digestive tract: nausea, vomiting, diarrhea, abdominal pains, lack of appetite, a meteorism, temporary increase in activity of hepatic transaminases and level of bilirubin in a blood plasma, pseudomembranous colitis; from an urinary system: a crystalluria, it is rare - acute intersticial nephrite and disturbance of azotovydelitelny function with some increase in content of urea and creatinine in a blood plasma; from the hemopoietic system: leukopenia, agranulocytosis, eosinophilia, thrombocytopenia; in isolated cases – hemolitic anemia, a pancytopenia; allergic reactions: skin rash, itch, small tortoiseshell, photosensitization, bronchospasm; seldom – a Quincke's disease, a Quincke's edema, arthralgias; very seldom – an acute anaphylaxis; others: arthralgias, mialgiya, tendinites, tenosinovita or ruptures of a sinew, a hypoglycemia (at patients with a diabetes mellitus); local reactions: pains and/or reddening in the place of infusion, thrombophlebitis. 

Interaction with other medicines:

Simultaneous use of an ofloksatsin with iron preparations, a sukralfat or antiacid means containing magnesium, aluminum, calcium leads to decrease in absorption of an ofloksatsin. Therefore time interval between purpose of these drugs has to be not less than 2-4 hours. 

At Oflo's use with the non-steroidal anti-inflammatory drugs derivative of a nitroimidazole and methylxanthines the risk of development of neurotoxic effects increases. 

At co-administration of Oflo with glucocorticoids the risk of ruptures of sinews, especially at elderly people increases. 

At Oflo's appointment with the drugs alkalizing urine (karboangidraza inhibitors, citrates, sodium bicarbonate) the risk of a crystalluria and nephrotoxic effects increases. 

The concomitant use with Cimetidinum, probenitsidy, furosemide or a methotrexate leads to increase in concentration of an ofloksatsin in a blood plasma. 

At simultaneous use of Oflo with antagonists of vitamin K control of coagulant system of blood is necessary. 

At co-administration of Oflo with peroral antidiabetic means, insulin perhaps a hypoglycemia or a hyperglycemia. 

Contraindications:

- hypersensitivity or intolerance of an ofloksatsin and other derivatives  of a ftorkhinolon; 

- deficit glyukozo-6-fosfatdegidrogenazy; 

- epilepsy; 

- defeats of TsNS with the lowered convulsive threshold (after a craniocereberal injury, a stroke, inflammatory diseases of a brain); 

- pregnancy, lactation; 

- children's and teenage age (up to 18 years). 

Overdose:

Symptoms: dizziness, confusion of consciousness, block, vomiting. 

Treatment: a gastric lavage, the disintoxication, desensibilizing and symptomatic therapy directed to correction of changes from internals. The specific antidote is unknown. 

Storage conditions:

To store at a temperature not above 25 °C, in protected from light and the place, unavailable to children. 

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated on 200 and 400 mg: blisters on 10 tablets. In packaging 1 blister (10 tablets).