Ofloks - instructions for use, doses, side effects, contraindications

Film sheath: ready water-soluble film shell - 15 mg. (Shell composition: hydroxypropylmethylcellulose (hypromellose) - 3,75mg, copovidone (kopolividon) -3.375, polyethylene glycol 6000 (Macrogol 6000) - 1,425mg, glyceryl kaprilokaprat - 0,45mg, polydextrose -2,25mg, titanium dioxide - 3,75mg.

Description:The tablets covered with a covering, white or white with a yellowish or grayish shade of color, the round form, biconcave.

Pharmacotherapeutic group:Antimicrobial agent-fluoroquinolone

ATX: & nbsp

S.01.A.E.01 Ofloxacin

J.01.M.A.01 Ofloxacin

Pharmacodynamics:

Antimicrobial preparation of a broad spectrum of action from the group of fluoroquinolones. It is bactericidal. Inhibits DNA-gyrase (topoisomerase II and IV), disrupts the process of supercoiling and cross-linking DNA breaks, depresses cell division, causes structural changes in the cytoplasm and death of microorganisms. Has a wide range of activities. It affects mainly gram-negative and some gram-positive microorganisms. Effective against microorganisms producing beta-lactamase and fast-growing atypical mycobacteria. Possible cross-resistance of bacteria to ofloxacin and other fluoroquinolones. The spectrum of action includes: Escherichia coli, Salmonella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Haemophilis influenzae, Haemophilis ducreyi, Proteus mirabilis, Proteus vulgaris, Pseudomonas spp., including Pseudomonas aeruginosa, Aeromonas hydrophila, Bordetella parapertussis, Bordetella pertussis, Klebsiella spp., including Klebsiella pneumoniae, Moraxella (Branhamella) catarrhalis, Morganella morganii, Providencia spp., Neisseria meningitidis, Shigella sonnei, Helicobacter pyroli, Mycoplasma spp., Ureaplasma urealyticum, Vibrio spp., Gardnerella vaginalis, Chlamydia spp., Legionella pneumophila, Staphylococcus spp. Propionibacterium acnes.

Different sensitivity to the drug has: Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans, Serratio marcescens, Pseudomonas aeruginosa, Acinetobacter spp., Mycoplasma hominis, Mycobacterium pneumoniae, Mycobacterium tuberculosis, and Mycobacterium fortuim, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis.

In most cases, they are insensitive: Nocardia asteroides, anaerobic bacteria (for example, Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile). He acts on Treponema pallidum.

Pharmacokinetics:

Completely absorbed in the gastrointestinal tract (about 95%), bioavailability - 96%. The maximum concentration is achieved after 1-2 hours, depending on the dose: after oral administration of 100, 300 or 600 mg, it is 1, 3.4 and 6.9 mg / l. About 25% are associated with plasma proteins. Apparent volume of distribution - 100 liters. Distribution: cells (leukocytes, alveolar macrophages), skin, soft tissues, bones, abdominal and pelvic organs, respiratory system, urine, saliva, bile, the secret of the prostate gland, penetrates well through the blood-brain barrier, the placental barrier, is secreted with the mother's milk. Penetrates into cerebrospinal fluid with inflamed and non-inflamed meninges (14-60%).

Metabolized in the liver (about 5%) with formation NOxygen ofloxacin and demethylfloxacin. It is excreted mainly by the kidneys in the unmodified form (80-90%); a small part is allocated with bile (about 4%), breast milk (the extra-neural clearance is less than 20%).The half-life (regardless of the dose) is 4.5-7 hours. After a single administration of 200 mg in urine is detected within 20-24 hours. In diseases of the liver and / or kidneys, excretion can be slowed down. Re-appointment does not result in cumulation.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin: respiratory tract infections (bronchitis, pneumonia), ENT organs (sinusitis, pharyngitis, otitis media, laryngitis); skin, soft tissues; bones, joints; Infectious and inflammatory diseases of the abdominal cavity and bile ducts (with the exception of bacterial enteritis); kidneys (pyelonephritis), urinary tract (cystitis, urethritis); small pelvis organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis); genital organs (colpitis, orchitis, epididymitis), gonorrhea, chlamydia; prevention of infections in patients with impaired immune status (including neutropenia).

Contraindications:

Hypersensitivity, deficiency of glucose-6-phosphate dehydrogenase, epilepsy (including in the anamnesis), reduction of convulsive threshold (including after craniocerebral trauma, stroke or inflammatory processes in the central nervous system); age to 18 years (until the growth of the skeleton is completed), pregnancy, lactation.

Carefully:Atherosclerosis of cerebral vessels, cerebral circulatory disorders (in the anamnesis), chronic renal failure, organic lesions of the central nervous system.

Pregnancy and lactation:Contraindicated.

Dosing and Administration:

Inside. Doses are selected individually depending on the location and severity of the infection. And also the sensitivity of microorganisms, the general condition of the patient and the function of the liver and kidneys.

Adults - 200-800 mg per day, the frequency of application - 2 times a day. A dose of up to 400 mg per day can be given in one session, preferably in the morning. With gonorrhea - 400 mg once.

In patients with impaired renal function (with a creatinine clearance of 50-20 ml / min), a single dose should be 50% of the average dose with a multiplicity of 2 times per day, or a full single dose administered once a day. When creatinine clearance is less than 20 ml / min - a single dose of 200 mg, then - 100 mg per day every other day.

With hemodialysis and peritoneal dialysis - 100 mg every 24 hours. The maximum daily dose for liver failure is 400 mg / day.

Tablets are taken whole, washed down with water before or during meals. Duration of the coursetreatment is determined by the sensitivity of the pathogen and the clinical picture; treatment should continue for at least 3 more days after the disappearance of the symptoms of the disease and complete normalization of temperature. In the treatment of salmonellosis treatment course - 7-8 days, with uncomplicated infections of the lower urinary tract treatment course - 3-5 days.

Side effects:

From the gastrointestinal tract: gastralgia, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, increased activity of "liver" transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis.

From the nervous system: headache, dizziness, motion uncertainty, tremor, convulsions, numbness and paresthesia of the limbs, intense dreams, nightmarish dreams, psychotic reactions, anxiety, arousal, phobias, depression, confusion, hallucinations, increased intracranial pressure.

From the side of the musculoskeletal system: tendonitis, myalgia, arthralgia, tendosynovitis, tendon rupture.

From the sense organs: violation of color perception, diplopia, violation of taste, smell, hearing and balance.

From the side of the cardiovascular system: tachycardia, lowering blood pressure.

Allergic reactions: skin rash, itching, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, Quincke's edema, bronchospasm, Stevens-Johnson and Lyell syndromes, photosensitivity, multiform exudative erythema, anaphylactic shock.

From the skin: pinpoint hemorrhages (petechiae), dermatitis bullous hemorrhagic, papular rash with cortex, indicating the defeat of blood vessels (vasculitis).

On the part of the organs of hematopoiesis: leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.

From the urinary system: acute interstitial nephritis, impaired renal function, hypercreatininaemia, increased urea levels.

Other: dysbacteriosis, superinfection, hypoglycemia (in patients with diabetes mellitus), vaginitis.

Overdose:

Symptoms: dizziness, confusion, inhibition, disorientation, drowsiness, vomiting. Treatment: gastric lavage, symptomatic therapy. With hemodialysis, 10-30% of the drug is removed.

Interaction:

Foods, antacids containing aluminum, calcium, magnesium or iron salts, reduce the absorption of ofloxacin, forming insoluble complexes (the time interval between the appointment of these drugs should be at least 2 hours).

Reduces the clearance of theophylline by 25% (with simultaneous use should reduce the dose of theophylline).

Cimetidine, furosemide, methotrexate and drugs that block tubular secretion - increase the concentration of ofloxacin in plasma.

Increases the concentration of glibenclamide in plasma.

At simultaneous admission with antagonists of vitamin K, it is necessary to control the blood coagulation system.

When administered with non-steroidal anti-inflammatory drugs, derivatives of nitroimidazole and methylxanthines, the risk of neurotoxic effects increases.

At simultaneous appointment with glucocorticosteroids, the risk of rupture of tendons increases, especially in the elderly.

When administered with drugs that alkalinize urine (inhibitors of carbonic anhydrase, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects increases.

Special instructions:

It is not a drug of choice for pneumonia caused by pneumococci.Not indicated in the treatment of acute tonsillitis.

It is not recommended to use more than 2 months, exposed to sunlight, ultraviolet rays (mercury-quartz lamps, solarium).

In the event of side effects from the central nervous system, allergic reactions, pseudomembranous colitis, drug withdrawal is necessary. With pseudomembranous colitis, confirmed colonoscopically and / or histologically, oral administration of vancomycin and metronidazole is indicated.

Rarely developing tendonitis can lead to rupture of tendons (mainly Achilles tendon), especially in elderly patients. In case of signs of tendinitis, it is necessary to immediately stop treatment, to make an immobilization of the Achilles tendon and consult an orthopedist.

When using the drug, women are not recommended to use tampons, due to the increased risk of thrush development.

Against the backdrop of treatment, myasthenia flow may worsen, and porphyria attacks may be more frequent in predisposed patients.

Can lead to false-negative results in the bacteriological diagnosis of tuberculosis (prevents the isolation Mycobacterium tuberculosis).

In patients with impaired liver or kidney function, it is necessary to monitor the concentration of ofloxacin in plasma. In severe renal and hepatic insufficiency, the risk of toxic effects increases (dose adjustment is required).

Effect on the ability to drive transp. cf. and fur:During the period of treatment it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions, one should not use ethanol.

Form release / dosage:

Tablets, film-coated, 200 mg.

Packaging:

By 5 or 10 tablets in a planar cell packaging made of a polyvinyl chloride film and aluminum foil printed lacquered. By 1 or 5 contour mesh packages together with instructions for use in a pack of cardboard. By 50 or 100 tablets (for hospitals) in a package of polyethylene for medicines. The package together with instructions for use in a can of polyethylene with a lid of polyethylene.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:4 years.Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000076/08

Date of registration:18.01.2008 / 15.02.2016

Expiration Date:Unlimited

The owner of the registration certificate:FARMASINTEZ, JSC (Irkutsk) FARMASINTEZ, JSC (Irkutsk) Russia

Manufacturer: & nbsp

FARMASINTEZ, JSC (Irkutsk) Russia

Representation: & nbspPharmasynthesis, JSCPharmasynthesis, JSC

Information update date: & nbsp16.06.2017

Illustrated instructions

Instructions

Oflox (Oflox)