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

Excipients: Lactose, starch, giproloza (hydroxypropyl cellulose), carmellose (carboxymethylcellulose), magnesium stearate, hypromellose (hydroxypropylmethyl cellulose), Macrogol (polyethylene glycol) 8000, titanium dioxide (E 171), talc.

Description:

white with a yellowish tinge oblong, biconvex film-coated tablets with a dividing notch and an engraved "M" on the left side and "the XI" on the right side of the grooves on both sides of the tablet.

Pharmacotherapeutic group:antimicrobial agent-fluoroquinolone

ATX: & nbsp

S.01.A.E.01 Ofloxacin

J.01.M.A.01 Ofloxacin

Pharmacodynamics:

Antimicrobial drug from the group of fluoroquinolones of broad spectrum of action. It is bactericidal.The mechanism of the action of ofloxacin is associated with the blockade of the DNA-gyrase enzyme in bacterial cells.

Highly active against most 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.

Moderately sensitive to ofloxacin Acinetobacter spp., Ureaplasma urealyticum, Bacteroides fragilis, Mycobacterium tuberculosis, Mycobacterium leprae, Chlamidia psittaci, Anaerobic Gram positive cocci, Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp, Streptococcus spp. (especially β hemolytic).

To ofloxacin insensitive Acinetobacter braumanmii, Clostridium difficile, Enterococci, Listeria monocytogenes, Staphylococci methi-R, Nocardia spp., Ofloxacin is inactive with respect to Treponema pallidum.

Pharmacokinetics:

After oral administration ofloxacin quickly and almost completely absorbed from the gastrointestinal tract. Biodostupity is almost 100%. The maximum concentration of ofloxacin in the blood plasma after administration of a single 200 mg dose of 2.5 - 3 mg / ml achieved after 1 h Plasma protein binding is 25%.. Metabolized about 5% ofloxacin. The half-life is 6-7 hours. The volume of distribution is approximately 120 liters. Up to 90% of ofloxacin excreted by the kidneys in unchanged form, about 4% bile.

Indications:

Treatment of infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin:

-infection of the respiratory tract (with the exception of cases of pneumococcal infection); -infection of the ear, throat, nose (except for cases of acute tonsillitis);

-infections of the abdominal cavity and biliary tract;

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

-infection of the pelvic organs;

- infection of bones and joints;

-infection of the skin and soft tissues.

-prophylaxis of infections in patients with impaired immune status (including neutropenia).

Contraindications:

-increased sensitivity to ofloxacin, other quinolones or components of the drug;

-epilepsy;

- the central nervous system with a lower convulsive threshold (after traumatic brain injury, stroke, inflammatory processes in the central nervous system (CNS);

- the damage of tendons during the previous treatment with quinolones;

-About 18 years of age;

- pregnancy and lactation;

Carefully:

in patients with atherosclerosis of cerebral vessels, blood circulation disorder (in the anamnesis), chronic renal insufficiency, organic lesions of the central nervous system, with lengthening of the interval QT.

Pregnancy and lactation:contraindicated

Dosing and Administration:

Inside.

The dose of ofloxacin and the duration of treatment depend on the severity and type of infection, the general condition of the patient and the function of the kidneys.

The average daily intake for adults is from 200 mg to 600 mg. The duration of treatment is 7-10 days.

A dose of up to 400 mg / day can be given in one session, preferably in the morning. Doses over 400 mg / day should be divided into 2 divided doses with an equal period of time. Tablets should be taken whole, washed down with water before and during meals. It is necessary to avoid simultaneous reception together with antacids.

In severe infections or in the treatment of patients with overweight, the daily dose can be increased to 800 mg.

In uncomplicated infections of the lower urinary tract, the drug is prescribed at a dose of 200 mg / day for 3-5 days. With gonorrhea prescribed 400 mg once.

In patients with impaired renal function the dose should be reduced depending on the creatinine clearance:

Creatinine clearance	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

Have patients with hepatic insufficiency it is not recommended to exceed the maximum daily dose of 400 mg.

Initiated iv treatment withloxacin can be continued with the tablet form of the drug at the same dose (with improvement of the patient's condition).

Side effects:

The information below is based on clinical trials and on a broad post-marketing experience with the drug.

The following frequency rating of side effects was used;

Very widespread: 10%

Widespread: 1% -10%

Uncommon: 0.1% -1%

Rare: 0.01% -0.1%

Very rare: less than 0.01%

Individual cases:

- Anaphylactic / anaphylactoid reactions, reactions from the skin and mucous membranes

Infrequent Symptoms such as: itching, rashes, burning in the eyes, dry cough,

occurring: rhinitis.

Rare: Anaphylactic / anaphylactoid reactions such as:

urticaria, angioedema, choking / bronchospasm; hyperemia, sweating, papular rash.

Very rare: Anaphylactic / anaphylactic shock,multiform exudative erythema, toxic epidermal necrolysis, photosensitivity, persistent drug rash, vascular purpura, bullous hemorrhagic dermatitis, pinpoint hemorrhages, vasculitis,which in exceptional cases can lead to skin necrosis.

Separate Stevens-Johnson Syndrome, severe suffocation, allergic

cases: pneumonitis, allergic nephritis.

- From the gastrointestinal tract

Infrequently Abdominal pain, diarrhea, nausea, vomiting, decreased appetite.

meeting:

Rare: Anorexia, flatulence, enterocolitis, which can in individual

cases of being hemorrhagic.

Very rare: Pseudomembranous colitis.

Neurological

Infrequently

meeting: Excitation, dizziness, headache, sleep disturbance / insomnia.

Rare: Psychotic reactions (for example, hallucinations), anxiety, confusion, intense or "nightmarish" dreams, depression, drowsiness, peripheral sensitivity disorders such as paresthesia, taste and smell disturbances, color dysfunction, diplopia.

Very rare:OnInterstitial nephritis.hearing impairment, such as tinnitus or hearing loss, epileptic seizures, extrapyramidal disorders or other disorders of muscle coordination, hypoesthesia, tremor, convulsions.

Separate

cases: Psychotic reactions accompanied by dangerous behavior for the patient, including suicidal tendencies, increased intracranial pressure.

- Cardiovascular

Rare: Decrease in blood pressure, tachycardia.

- Locomotorium

Rare: Tendonitis.

Very rarely: Arthralgia, myalgia.

Tendon tendon rupture (i.e. Achilles tendon); as with the use of other fluoroquinolones, this side effect can be observed within 48 hours after the initiation of treatment and may be bilateral.

Individual rhabdomyolysis (acute necrosis of skeletal muscles) and / or myopathy.

Cases: Muscular weakness, which may be particularly important

value in patients with severe pseudo-paralytic myasthenia gravis.

- From the side of the liver

Rare: Increased hepatic enzymes (ACT, ALT, LDH, GGT and / or

alkaline phosphatase) and / or bilirubin.

Very rare: Cholestatic jaundice.

Individual Hepatitis, which can be severe,

cases:

- From the urinary system

Rare: Hypercreatinemia, increased urea concentration.

Very rare: Acute renal failure.

Individual Interstitial nephritis.

cases:

- From the urinary system

Rare: Hypercreatinemia, increased urea concentration.

Very rare: Acute renal failure.

Separate

cases:Interstitial nephritis.

- From the peripheral blood

Very rare: Anemia, hemolytic anemia, leukopenia, eosinophilia, thrombocytopenia.

Agranulocytosis, pancytopenia, oppression of bone marrow hematopoiesis.

Individual cases:

- Other

Uncommon: Development of secondary infection caused by drug-resistant microorganisms and fungi.

Individual cases: Acute attacks of porphyria in patients with porphyria, vaginitis, intestinal dysbiosis, hypoglycemia in patients with diabetes treated with hypoglycemic drugs.

Overdose:

The most important symptoms of an overdose are symptoms from the side of the central nervous system: dizziness, confusion, inhibition, disorientation, drowsiness, as well as reactions from the gastrointestinal tract: vomiting.

In case of an overdose, it is recommended to perform gastric lavage (refers to tablets) and symptomatic therapy. There is no specific antidote.

Interaction:

Antacids containing aluminum hydroxide (including sucralfate) and magnesium, aluminum phosphate, zinc, iron reduce the absorption of ofloxacin. When taking antacids and ofloxacin between their intake should be observed approximately two-hour interval.

With the simultaneous use of vitamin K antagonists, control over the blood coagulation system is necessary.

Ofloxacin may slightly increase the serum concentrations of glibenclamide when used concomitantly.

In the case of using high doses of ofloxacin and other drugs released by renal tubular secretion, such as probenicide, cimetidine, furosemide or methotrexate, it is possible to increase the concentration of ofloxacin in the blood serum.

In clinical studies no pharmacokinetic interaction of ofloxacin with theophylline has been revealed. However, a noticeable decrease in the threshold of convulsive activity could be observed with the administration of quinolones in combination with theophylline,
fenbufen or other non-steroidal anti-inflammatory drugs, as well as other drugs that lower the threshold of convulsive activity.

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

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

When co-administered with drugs, the lengthening interval QT (IA and III classes of antiarrhythmic drugs, tricyclic antidepressants, macrolides) increases the risk of lengthening the interval QT.

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

Special instructions:

- Renal insufficiency

Due to ofloxacin is excreted mainly through the kidneys, patients with renal insufficiency need a dose adjustment of ofloxacin.

- Prevent photosensitivity

During the treatment with ofloxacin, due to the risk of photosensitization, exposure to bright sunlight and ultraviolet rays should be avoided.

- Secondary infection

As with other antibiotics, taking ofloxacin, especially prolonged, can cause a secondary infection associated with the growth of resistant to the drug microorganisms. A reassessment of the patient's condition is necessary.If a secondary infection occurs during therapy, appropriate measures must be taken.

- Pseudomembranous colitis

The appearance of diarrhea, especially in severe, persistent and / or mixed with blood, during or after treatment with ofloxacin may be a manifestation of pseudomembranous colitis. If suspected to develop pseudomembranous colitis, ofloxacin should be stopped immediately, and appropriate specific antibiotic therapy (for example, vancomycin inside, teicoplanin inside or metronidazole) must be appointed without delay. In this clinical situation, drugs that suppress the intestinal peristalsis are contraindicated.

- Patients who are prone to epileptic seizures

Like other quinolones, ofloxacin should be given special care to patients who are predisposed to develop epileptic seizures (patients with a history of central nervous system history who take fenbufen and similar non-steroidal anti-inflammatory drugs or drugs that lower the threshold of seizure activity, for example, theophylline). (See "Interaction").

- Tendonitis

Tendinitis, which occurs very rarely, can sometimes lead to the rupture of tendons, mainly Achilles tendon, especially in elderly patients. In case of signs of tendinitis (inflammation of the tendon), it is recommended to immediately stop the treatment, immobilize the Achilles tendon and provide orthopedic consultation.

- Interval lengthening QT

Some caution is needed when taking fluoroquinolones, including ofloxacin, in patients with known risk factors for lengthening the interval QT, such as:

- elderly age;

- uncorrectable imbalance of electrolytes (eg, hypokalemia, hypomagnesemia);

- congenital lengthening of the interval QT;

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

- simultaneous reception of drugs that extend the interval QT (IA and III classes of antiarrhythmic drugs, tricyclic antidepressants, macrolides).

- Myasthenia gravis

Ofloxacin can lead to a worsening of myasthenia flow.

- Porphyria

Perhaps more frequent attacks of porphyria. During the treatment with ofloxacin, false-positive results may appear in the determination of opiates and porphyrins in the urine.

- Other

Ofloxacin prevents the release of Mycobacterium tuberculosis, leading to false-negative results in the bacteriological diagnosis of tuberculosis. Also during the period of treatment is not recommended to use ethanol. When using the drug, women are not recommended to use hygiene tampons due to the increased risk of thrush development. Ofloxacin It is not a drug of choice for pneumonia caused by pneumococci. Not indicated in the treatment of acute tonsillitis.

Effect on the ability to drive transp. cf. and fur:

Some adverse reactions, for example: dizziness, drowsiness, and visual impairments can reduce the reaction and the ability to concentrate, and therefore increase the risk in situations in which the availability of these abilities is particularly important (for example, when driving or using other mechanisms).

Form release / dosage:

Tablets, film-coated 200 mg.

Packaging:For 10 tablets in a blister of PVC / aluminum foil. 1 blister with instructions for use in a cardboard box.

Storage conditions:

At a temperature not higher than + 30 ° C in the dark place.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011520 / 01

Date of registration:02.04.2008

The owner of the registration certificate:Aventis Pharma Deutschland GmbHAventis Pharma Deutschland GmbH Germany

Manufacturer: & nbsp

SANOFI-AVENTIS Deutschland, GmbH Germany

Representation: & nbspAventis Pharma Co., Ltd.Aventis Pharma Co., Ltd.India

Information update date: & nbsp02.04.2008

Illustrated instructions

Instructions

Tarivid® (Tarivid®)