Tarivid

General characteristics. Structure:

Active agent: - ofloxacin of 200 mg.

Excipients: lactose, starch, hypro rod (hydroxypropyl cellulose), karmelloza (carboxymethylcellulose), magnesium stearate, gipromelloz (gidroksipropilmetiltsellyuloz), macrogoal (polyethyleneglycol) 8000, titanium dioxide (E171), talc.

Pharmacological properties:

Pharmacodynamics. Antimicrobic drug from group of ftorkhinolon of a broad spectrum of activity. Works bakteritsidno. The mechanism of action of an ofloksatsin is connected with blockade of DNK-girazy enzyme in bacterial cells.

It is highly active concerning the majority of gram-negative and some gram-positive microorganisms: Aeromonas hydrophila, Branhamella catarrhalis, Brucella spp., Clostridium perfringens, Esherichia coli, Salmonella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae and parainfluenzae, Haemophilus ducreyi, Plesiomonas, Legionella, Shigella spp., Proteus spp., including Proteus mirabilis, Proteus vulgaris (indole + and indole-), Moraxella morganii, Klebsiella spp., including Klebsiella pneumoniae, Helicobacter pylori, Mycoplasma spp., Vibrio spp., Gardnerella vaginalis. Neisseria gonorrhoeae, Neisseria meningitidis, Chlamydia trachomatis, Staphylococcus aureus methi-S, Staphylococcus coagulase negative. Are moderately sensitive to Acinetobacter spp ofloksatsin., Ureaplasma urealyticum, Bacteroides fragilis, Mycobacterium tuberculosis, Mycobacterium leprae, Chlamidia psittaci, anaerobic gram-positive cocci, Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp, Streptococcus spp. (especially beta and hemolitic).

To an ofloksatsin Acinetobacter braumanmii, Clostridium difficile, Enterococci, Listeria monocytogenes, Staphylococci methi-R, Nocardia spp are insensitive.

Ofloxacin is inactive concerning Treponema pallidum.

Pharmacokinetics. After intake ofloxacin quickly and almost is completely absorbed from a GIT. The Biodostupost makes nearly 100%. Cmax of an ofloksatsin in a blood plasma after reception of a single dose of 200 mg makes 2.5-3 mkg/ml and is reached in 1 h. Linkng with proteins of plasma makes 25%. About 5% ofloksatsina.t1/2 - 6-7 h Vd about 120 l are metabolized. To 90% of an ofloksatsin about 4% with bile are removed by kidneys in not changed look.

Indications to use:

Treatment of the infectious and inflammatory diseases caused by microorganisms, sensitive to an ofloksatsin:

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

— infections of an ear, a throat, a nose (except for cases of acute tonsillitis);

— infections of an abdominal cavity and biliary tract;

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

— infections of bodies of a small pelvis;

— infections of bones and joints;

— infections of skin and soft tissues;

— prevention of infections at patients with disturbance of the immune status (including at a neutropenia).

Route of administration and doses:

Inside.

The dose of an ofloksatsin and duration of treatment depend on weight and a type of an infection, the general condition of the patient and function of kidneys.

Average daily dose for adults - from 200 mg to 600 mg. Duration of treatment is-7-10 days.

It is possible to appoint a dose to 400 mg/days in 1 reception, it is preferable in the morning. Doses over 400 mg/days should be divided into 2 receptions with an equal period. A pill should be taken entirely, washing down them with water both to, and during food. It is necessary to avoid a concomitant use together with antacids.

At heavy infections or at treatment of patients with an excess weight the daily dose can be increased to 800 mg.

At uncomplicated infections of lower parts of urinary tract drug appoint in a dose 200 mg/days within 3-5 days.

At gonorrhea appoint 400 mg once.

At patients with renal failures the dose has to be reduced depending on clearance of creatinine:

Clearance of creatinine	Single dose	Interval between doses
50-20 ml/min.	100-200 mg	24 hours
less than 20 ml/min. or hemodialysis	100 mg	24 hours
hemodialysis less than 20 ml/min. or hemodialysis	200 mg	48 hours

Features of use:

Renal failure. Because ofloxacin is removed generally through kidneys, at patients with a renal failure dose adjustment of an ofloksatsin is necessary.

Prevention of a photosensitization. During treatment ofloksatsiny, in connection with risk of emergence of a photosensitization, it is necessary to avoid impact of a bright sunlight and ultraviolet rays.

Consecutive infection. As well as at treatment by other antibiotics, reception of an ofloksatsin, especially long, can cause the consecutive infection connected with growth of microorganisms, steady against drug. Repeated assessment of a condition of the patient is necessary. If consecutive infection arises during therapy, it is necessary to take the appropriate measures.

Pseudomembranous colitis. Emergence of diarrhea, especially in a severe form, persistent and/or with blood impurity, in time or after treatment ofloksatsiny can be display of pseudomembranous colitis. At suspicion on development of pseudomembranous colitis treatment ofloksatsiny has to be immediately stopped, and the corresponding specific antibacterial therapy (for example, ваякомицин inside, тейкопланин inside or metronidazole) has to be appointed urgently. In this clinical situation the drugs suppressing an intestines peristaltics are contraindicated.

The patients predisposed to developing of epileptic seizures. As well as other hinolona, ofloxacin it has to be appointed with extra care the patient predisposed to development of epileptic seizures (the patients with damage of TsNS to the anamnesis accepting фенбуфен and the similar non-steroidal anti-inflammatory drugs or drugs lowering a threshold of convulsive activity, for example, theophylline).

Tendinitis. The tendinitis arising very seldom can sometimes lead to a rupture of sinews, is preferential the Achilles tendon, especially at elderly patients. In case of signs of a tendinitis (a sinew inflammation), it is recommended to stop immediately treatment, to make an immobilization of the Achilles tendon and to provide consultation of the orthopedist.

Lengthening of an interval of QT. A certain care at reception of ftorkhinolon is necessary, including ofloxacin, patients with the known risk factors have lengthenings of an interval of QT, such as:

— advanced age;

— not adjusted imbalance of electrolytes (for example, a hypopotassemia, a hypomagnesiemia);

— inborn lengthening of an interval of QT;

— diseases of cardiovascular system (heart failure, myocardial infarction, bradycardia)

— a concomitant use of the drugs extending QT interval (IA and the III classes of antiarrhytmic drugs, tricyclic antidepressants, macroleads).

Myasthenia. Ofloxacin can lead to deterioration in a current of a myasthenia.

Porphyria. Increase of attacks of a porphyria is possible. During treatment ofloksatsiny emergence of false positive results when determining opiates and porphyrines in urine is possible.

Other. Ofloxacin interferes with Mycobacterium tuberculosis allocation, resulting in false-negative results at bacteriological diagnosis of tuberculosis.

Also during treatment it is not recommended to use ethanol.

At drug use Tarivid to women is not recommended to use hygienic tampons from communication with the increased risk of development of the milkwoman.

Ofloxacin is not choice drug at the pneumonia caused by pneumococci.

It is not shown at treatment of acute tonsillitis.

Influence on ability to driving of motor transport and to control of mechanisms

Some side reactions, for example: dizziness, drowsiness and visual disturbances can reduce reaction and ability to concentration and in this regard to increase risk in situations in which existence of these abilities is especially important (for example when driving or other mechanisms).

Side effects:

From the alimentary system: gastralgia, loss of appetite, nausea, vomiting, diarrhea, lock, meteorism, abdominal pain, increase in activity of "hepatic" transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous colitis, dryness of a mucous membrane of an oral cavity, pharyngitis.

From a nervous system: headache, dizziness, uncertainty of movements, tremor, spasms, numbness and paresthesias of extremities, intensive dreams, "dreadful" dreams, psychotic reactions, uneasiness, condition of excitement, phobia, depression, confusion of consciousness, hallucination, increase in intracranial pressure, sleeplessness, nervousness.

From a musculoskeletal system: the tendinitis, mialgiya, arthralgias, tendosinovit, a rupture of a sinew, extremity pain.

From sense bodys: disturbance of color perception, diplopia, disturbances of taste, sense of smell, hearing and balance.

From CCC: tachycardia, increase or decrease in the ABP, a collapse (at in introduction; at sharp decrease in the ABP introduction is stopped).

Allergic reactions: skin rash, itch, small tortoiseshell, allergic pneumonitis, allergic nephrite, eosinophilia, fever, Quincke's disease, bronchospasm; a multiformny exudative erythema (including Stephens-Johnson's syndrome) and a toxic epidermal necrolysis (Lyell's disease), a photosensitization, a vasculitis, an acute anaphylaxis, an itch of external genitals at women.

From integuments: dot hemorrhages (petechias), violent hemorrhagic dermatitis, papular rash with a crust, testimonial of defeat of vessels (vasculitis).

From bodies of a hemopoiesis: leukopenia, agranulocytosis, anemia (including. Aplastic and hemolitic), thrombocytopenia, pancytopenia.

From an urinary system: acute intersticial nephrite, renal failure, giperkreatininemiya, increase in concentration of urea, dysuria, ischuria.

Others: an intestinal dysbiosis, superinfection, a hypoglycemia (at patients with a diabetes mellitus), a vaginitis, a stethalgia, fatigue, an adynamy, the general weakness, allocations from a vagina, nasal bleeding, thirst, decrease in body weight.

Local reactions: pain, a hyperemia in an injection site, thrombophlebitis (at in introduction).

Interaction with other medicines:

The antacids containing aluminum hydroxides (including сукральфат) and magnesium, aluminum phosphate, zinc, iron reduce absorption of an ofloksatsin. At reception of antacids and an ofloksatsina between their reception it is necessary to observe approximately two-hour interval.

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

Ofloxacin can slightly increase serumal concentration of Glibenclamidum at simultaneous use.

In case of use of high doses of an ofloksatsin and other medicines which are removed by means of renal tubular secretion such as пробеницид, Cimetidinum, furosemide or a methotrexate, increase in concentration of an ofloksatsin in blood serum is possible.

In clinical trials pharmacokinetic interaction of an ofloksatsin with theophylline is not revealed. However, noticeable reduction of the threshold of convulsive activity could be observed at purpose of hinolon in combination with theophylline, fenbufeny or other non-steroidal anti-inflammatory drugs, and also other drugs, lowering a threshold of convulsive activity.

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

At co-administration with glucocorticosteroids the risk of a rupture of sinews, especially at elderly people increases.

At joint appointment with drugs as QT extending an interval (IA and the III classes of antiarrhytmic drugs, tricyclic antidepressants, macroleads) the risk of lengthening of an interval of QT increases.

At Tarivid's appointment with the medicines alkalizing urine (karboangidraza inhibitors, citrates, Natrii hydrocarbonas) the risk of a crystalluria and nephrotoxic effects increases.

Contraindications:

 — epilepsy;

— damages of the central nervous system with the lowered convulsive threshold (after a craniocereberal injury, a stroke, inflammatory processes in the central nervous system (CNS);

— damages of sinews at earlier carried out treatment of a hinolonama;

— age up to 18 years;

— pregnancy and period of a lactation;

— hypersensitivity to an ofloksatsin, other hinolona or components of drug Tarivid.

With care: patients with atherosclerosis of vessels of a brain, disturbance have blood circulations (in the anamnesis), a chronic renal failure, organic lesions of TsNS, with lengthening of an interval of QT.

Overdose:

The most important symptoms of overdose are symptoms from TsNS: dizziness, confusion of consciousness, block, a disorientation, drowsiness, and also reactions from digestive tract: vomiting.

In case of overdose it is recommended to carry out a gastric lavage (treats tablets) and symptomatic therapy. The specific antidote does not exist.

Storage conditions:

At a temperature not above 25 °C in dry protected from light and the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, 200 mg.

White with a yellowish shade oblong, biconvex, with a dividing groove and an engraving of "M" on the left side and "XI" on the right side from a groove on both sides of a tablet.

10 pieces in 1 planimetric strip packaging are placed in a cardboard pack.