Form of production of medicine. Tablets, film coated.
Farmakoterapevtichesky group. Antimicrobic means for system use. Ftorkhinolona. Code of automatic telephone exchange J01M A01.
Effect of the medicine.
Pharmacodynamics. Bactericidal action of an ofloksatsin, as well as other ftorkhinolon, it is caused by its ability to block bacterial DNK-girazu enzyme owing to what the DNA function of bacteria is broken. Drug is active against the majority of aerobic gram-negative microorganisms: Echerichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella pneumoniae, Legionella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Haemophilus influenzae, Neisseeria gonorrhoeae, Neisseria meningitidis, Providencia spp., Mycoplasma spp., Acinetobacter spp., Chlamydia spp., Helicobacter pylori and aerobic gram-positive bacteria – stafilokokk, including strains which produce a penicillinase (strains, resistant to Methicillinum), streptococci (including Streptococcus pneumoniae), Listeria monocytogenes, Corynebacterium spp. Drug is also active against Chlamidia trachomatis, Mycobacterium leprae, Mycobacterium tuberculosis and some other types of Mycobacterium. It is established synergy action of an ofloksatsin and rifabutin against Mycobacterium leprae. To drug anaerobic bacteria (except B. ureоliticus), Treponema pallidum (a pale spirochete), viruses, mushrooms and protozoa are insensitive.
Pharmacokinetics. Ofloxacin is well and quickly soaked up from a food path. The food significantly does not influence absorption. Bioavailability of drug at oral administration - nearly 100%. The maximum concentration in blood serum is reached in 1 - 2 hour after reception. The elimination half-life makes 5 - 8 hour. At the therapeutic level concentration of drug keeps within 8 - 12 hour. Linkng with proteins of a blood plasma makes 25%. Ofloxacin well gets into biological liquids and body tissues and it is found in therapeutic concentration in a phlegm, bile, saliva, cerebrospinal fluid, a bone tissue, mucous membranes, to pass through a placental barrier and into breast milk. 65 - 80% of the entered ofloksatsin are excreted with urine in an invariable look within 24 - 48 hour. Less than 5% of the accepted dose are removed with urine in the form of metabolites - dismetilovy and N-oxidic forms of an ofloksatsin which have moderate antibacterial activity. From 4 to 8% of the administered drug can be allocated with a stake.
Indications for use. Treatment of the infections caused by microorganisms, sensitive to drug:
- persistent and recurrent infections of an ear, throat, nose, including otitis, sinusitis;
- respiratory infections: pneumonia and bronchial pneumonia, pleurisy, an empyema of a pleura, infection at an illness bronkhoyektatichniya, an exacerbation of chronic bronchitis, pulmonary abscesses;
- infections of soft tissues and skin;
- infections of an abdominal cavity, including infections of a small pelvis, bacterial diarrhea;
- infections of urinogenital ways: acute and chronic pyelonephritis, prostatitis, urethritis, cystitis, epididymite, surgical infections of uric ways;
- the diseases of an urethra, a neck of uterus, a rectum caused resistant to gonokokama penicillin, the chlamydias and other microorganisms sensitive to an ofloksatsin;
- other infectious diseases: typhoid, salmonellosis, shigellosis, infections of bilious ways, osteomyelitis;
- for prevention of infections (including by the selection intestinal disinfecting) at patients at states with a neutropenia.
In complex therapy of a septicaemia, an endocarditis, osteomyelitis, mikobakterialny infections, leprosies, for preoperative prevention or postoperative treatment of surgical infections.
Way of use and dose. The dose of drug depends on a look and weight of an infection, a species of microorganism, age, body weight and function of kidneys of the patient.
Treatment duration. Depends on a look and weight of an infection. It is in most cases recommended to continue treatment during at least 3 days after decrease in body temperature and the diseases weakened symptoms.
At acute infections is reasonable treatments within 7 - 10 days. The usual duration of treatment makes 7 - 8 days at salmonelloses, 4 - 5 days - at a shigellosis 3 days - at the intestinal infections caused by Escherichia coli.
At not complicated infections of the lower urinary tract is ordinary sufficient treatments ofloksatsiny in a dose of 200 mg within 3 days. For treatment to not complicated gonorrhea 2 tablets of OFLOTAD are enough 200 – 400 mg.
At infections of bones duration of treatment makes 3 - 4 weeks, in some cases even longer.
Treatment of the infections caused by beta and hemolitic staphylococcus at a certain sensitivity of the activator to an ofloksatsin should be carried out within 10 days to be saved from late effects of an illness, such as rheumatism or a glomerulonephritis. Treatment of such infections demands confirmation of sensitivity of microorganisms to an ofloksatsin in each separate case.
It is recommended not to exceed the 2-month duration of therapy.
OFLOTAD 200 it is necessary to accept, without chewing, together with enough liquid (0, 5 - 1 glass of water) as on an empty stomach, and during reception of food.
The single dose can make up to 400 mg of an ofloksatsin which is accepted mainly in the morning.
The daily dose is ordinary divided into two identical doses and accepted in the morning and in the evening. It is important that periods between receptions were approximately identical.
The maximum daily dose – 800 mg.
Dosage at normal function of kidneys
Single and daily doses
Respiratory infections, and also fish soup, throats, nose
100 mg of an ofloksatsin twice a day
Infections of skin and soft tissues
200 mg of an ofloksatsin twice a day
Infections of an abdominal cavity (including the diarrhea caused by bacteria)
200 mg of an ofloksatsin twice a day
Infections of kidneys, urinary tract and generative organs
200 mg of an ofloksatsin twice a day
Not complicated infections of the lower urinary tract
400 mg of an ofloksatsin of 1 times a day as disposable a dose
Infections of bones
200 mg of an ofloksatsin twice a day
In some cases, for example in the presence of pathogenic microorganisms with various sensitivity, at insufficient sensitivity of the patient to drug, at infections of bones the dose can be increased to 400 mg of an ofloksatsin twice a day.
For prevention by the patient it is recommended to appoint ofloxacin in a dose of 400 - 600 mg a day to a neutropenia.
Dosage at a renal failure
For patients with moderate or heavy disturbance of renal function which is defined behind changes of level of creatinine in blood serum and clearance of creatinine appoint such doses of drug. Tickling the dose is similar to same at patients with normal function of kidneys respectively to type and disease severity.
The maintenance dose is defined depending on clearance of creatinine in such way:
Side effect. Symptoms in general arise seldom and quickly disappear after drug withdrawal.
Digestive tract. Complaints to an abdominal pain, lack of appetite, nausea, vomiting and diarrhea. Very seldom pseudomembranous colitis can be observed.
Liver and bilious channels. Level of liver enzymes increases and bilirubin level increases. Very seldom cholestatic jaundice, hepatitis or signs of a hepatotoxic develop.
Nervous system. Complaints on a headache, dizziness, a sleep disorder, concern, misting of consciousness, a tremor, uncertain gait. Very seldom - paresthesia and a hyperesthesia, drowsiness, are intensive dreams (up to dreadful), a condition of alarm, a depression and hallucination. Cardiovascular system. There can be tachycardia and short-term hypotension.
Picture of blood and hemogenesis. Anemia, a leukopenia, an agranulocytosis, a thrombopenia or a pancytopenia take place. In isolated cases hemolitic anemia can develop.
Lungs. The renal failure with increase in creatinine of blood serum and acute intersticial nephrite is very seldom observed.
Skin and mucous membranes. There can be an itch and a dieback, is very rare – the passing erythema, Stephens-Johnson's syndrome or a Lyell's disease, a vasculitis which can strike also internal bodies.
Increase of a photosensitivity. Very seldom it can be observed the skin photosensitivity therefore patients who accept OFLOTAD 200 have to avoid influence of a sunlight and radiation by UF-light (a solar lamp, sunbeds) is raised.
Anaphylactic or anaphylactoid reactions. Are observed very seldom in the form of burning-down eye pain, the angry cough or allocated from a nose, a cutaneous dropsy and mucous membranes, the person, language and a throat. In the most hard cases asthma can take place, it is caused bronkhzospazmy, and/or shock. In such cases of use of drug immediately stop and carry out antishock therapy.
Tendinitis. Meets very seldom and hour from an initiation of treatment takes place within the 48th.
Other side effects. In isolated cases can take place muscle pain or weakness that is especially important for patients on a myasthenia. Very seldom there can be a hypoglycemia or a hyperglycemia, especially at patients with a diabetes mellitus.
In cases of development of side effect drug should be cancelled immediately.
Contraindications. Do not appoint to children and teenagers till 18 flyings, to pregnant women and in the period of a lactation, the patient with epilepsy, at defeat of the central nervous system with a reduced convulsive threshold, at liver diseases, hepatitis, at diseases/injury of the sinews caused by preliminary therapy of a hinolonama at hypersensitivity to hinolona and ftorkhinolon.
Overdose. The most important symptoms that can take place at acute overdose, disturbance from the central nervous system is, such, including as misting and depression of consciousness, dizziness, a headache, vomiting, abdominal pains, diarrhea, erosion of a mucous membrane of a digestive tract.
Treatment. There is no specific antidote; the recommended general means of acute management: a gastric lavage, reception of adsorbents and magnesium sulfate (if it is possible – within the first 30 minutes), antacids for protection of a mucous membrane of a stomach. If there are spasms, reasonable is calming therapy with diazepam use. The hemodialysis and a peritoneal dialysis an insignificant measure reduce concentration of an ofloksatsin in blood.
Features of use. Drug is not appointed at pneumonia which caused by pneumocooks, for treatment of acute tonsillitis.
At patients with abnormal liver functions or kidneys necessary control of concentration of an ofloksatsin in plasma. At a heavy renal and liver failure the risk of development of toxic effects increases (it is necessary lowering dose adjustment).
At drug use women are not recommended to apply sanitarily tampons in connection with the increased risk of development of the milkwoman.
During treatment not to take alcoholic beverages.
Influence on laboratory indicators. Definition of opiates or to porphyrine in urine can yield lozhnopozitivny result during treatment using Oflotadu 200.
Influence on ability to steer the car and to use mechanisms. Some side effects (dizziness, a headache, depression of consciousness) can worsen ability of the patient of a zoseredzhuvata and reduce its reactivity and thus increase risk when driving by transport or service of mechanisms. During therapy ofloksatsiny it is forbidden to steer vehicles, to work with potentially unsafe mechanisms, to take alcohol.
Interaction with other medicines. Simultaneous introduction of inorganic antiacid means, a sukralfata, drugs which contain ions of metals (aluminum, iron, magnesium, zinc) for example of vitamins C microelements, reduces effect of an ofloksatsin therefore drug should be accepted approximately in 2 hours prior to reception of such drugs.
At a concomitant use of an ofloksatsin and some non-steroidal anti-inflammatory drugs for example of a fenbufen) or theophylline the probability of emergence of spasms increases.
At simultaneous use to medicines which are emitted with renal tubules (probenetsid, Cimetidinum, furosemide, a methotrexate) there can be a mutual inhibition their allocation that can lead to increase of levels in serum and to increase in side effects. Hinolona can strengthen effect of derivatives of coumarin therefore at patients it is necessary to control koagulogramma indicators regularly.
At simultaneous use with peroral antidiabetic drugs it is necessary to carry out detailed monitoring of sugar of blood through ability of an ofloksatsin to increase serumal levels of Glibenclamidum.
Conditions and periods of storage. To store in the unavailable to children, dry, protected from light place at a temperature not above 25 °C. A period of validity - 5 years.