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

Excipients: microcrystalline cellulose, potato starch, povidone, croscarmellose sodium, magnesium stearate, hypromellose (hydroxypropylmethylcellulose), macrogol (polyethylene glycol), glycerol (glycerin), talc, titanium dioxide, lactose (milk sugar).

Description:

The tablets covered with a film cover, round, biconcave, from white to white with kremovatym or grayish shade of color.

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. The mechanism of the action of ofloxacin is associated with the blockade of the DNA-gyrase enzyme in bacterial cells. It is bactericidal.

It is active against microorganisms that produce beta-lactamase and fast-growing atypical bacteria. Sensitive: Staphylococcus aureus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter, Klebsiella spp. (including Klebsiella pneumonia), Enterobacter spp., Hafnia, Proteus spp. (including Proteus mirabilis, Proteus vulgaris - indole-positive and indolotric), Salmonella spp., Shigella spp. (including Shigella sonnei, Yersinia enterocolitica, Campylobacter jejuni, Aeromonas hydrophila, Plesiomonas aeruginosa, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp., Serratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acne, Brucella spp. Different sensitivity to the drug has: Enterococcus faecalis, Streptococcus pyogenes, pneumoniae and viridans, Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium tectum, 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., Eubacter spp., Fusobacterium spp., Clostridium difficile). He acts on Treponema pallidum.

Pharmacokinetics:

Absorption after oral administration is rapid and complete (95%). Bioavailability is over 96%, the connection with plasma proteins is 25%. The maximum concentration after taking 100, 300 and 600 mg is 1, 3, 4 and 6.9 mg / L, respectively, and depends on the dose: after a single dose of 200 and 400 mg, it is 2.5 and 5 μg / ml, respectively.Food can slow absorption, but does not have a significant effect on bioavailability.

It is distributed: in cells (leukocytes, alveolar macrophages), skin, soft tissues, bones, organs of the abdominal cavity and small pelvis, respiratory system, urine, saliva, bile,

secretion of the prostate. Well penetrates the blood-brain barrier (GEB), the placental barrier, is secreted with the mother's milk. It penetrates into the cerebrospinal fluid (CSF) (14-60%).

Metabolized in the liver (about 5%) with formation Noxide ofloxacin and dimethylfloxacin. The half-life is 4,5-7 hours (regardless of the dose). It is excreted by the kidneys - 75-90% (unchanged), about 4% - with bile. The extrarenal clearance is less than 20%. After a single application in a dose of 200 mg in urine is detected within 20-24 hours. With renal or hepatic insufficiency, excretion can be slowed down. Do not cumulate. With hemodialysis, 10-30% of the drug is removed.

Indications:

Respiratory tract infections (bronchitis, pneumonia); infectionOP-organ (sinusitis, pharyngitis, otitis media, laryngitis); infection of the 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; meningitis; 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 (after traumatic brain injury, stroke, inflammatory processes in the central nervous system); age to 18 years (until the skeleton has been completed); pregnancy and 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. The dose of ofloxacin and the duration of treatment depend on the severity and type of infection, the sensitivity of microorganisms, the general condition of the patient and the kidney liver function. The average daily intake for adults is from 200 mg to 800 mg. The duration of treatment is 7-10 days.Multiplicity of application 2 times a day. A dose of up to 400 mg / 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), the dose should be 50% of the average dose with a multiplicity of 2 times a day or a complete 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.

Tablets are taken whole, washed down with water, before or during meals. Treatment should continue for at least 3 more days after the disappearance of the symptoms of the disease and complete normalization of body 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 digestive system: gastralgia, decreased appetite, nausea, vomiting, diarrhea, flatulence, abdominal pain, increased activity of "hepatic" transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis. From the nervous system: headaches, dizziness, motion uncertainty, tremors, convulsions, numbness and paresthesia of the limbs, intense dreams, nightmarish dreams, psychotic reactions, anxiety, arousal, phobias, depression, confusion, hallucinations, increased intracranial pressure. From 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 of blood pressure Allergic reactions: skin rash, itching, hives, allergic pneumonitis, allergic nephritis, eosinophilia, fever, angioedema, bronchospasm; multiforme exudative erythema (including Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell's syndrome), photosensitivity, vasculitis, anaphylactic shock.

From the skin: point hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash with a cortex, indicative of vascular lesions (vasculitis).

From the hematopoiesis: leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.

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

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

Overdose:

Symptoms: dizziness, confusion, inhibition, disorientation, drowsiness, vomiting.

Treatment: gastric lavage, symptomatic therapy.

Interaction:

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

Increases the concentration of glibenclamide in plasma.

Cimetidine, furosemide, methotrexate and drugs that block tubular secretion, increase the concentration of ofloxacin 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 carbohydrazine, citrates, sodium hydrogen carbonate), the risk of crystalluria and nephrotoxic effects increases.

Compatible with the following infusion solutions: 0.9% solution of sodium chloride, Ringer's solution, 5 % solution of fructose, 5 % solution of dextrose.

Do not mix with heparin (risk of precipitation).

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

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, be exposed to sunlight, ultraviolet rays (mercury quartz lamps, solarium).

In case of side effects from the central nervous system, allergic reactions, pseudodermatopharyngeal colitis is necessary to cancel the drug. 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 tendonitis, it is necessary immediately to stop treatment, to immobilize the Achilles tendon and consult an orthopedist.

During the period of treatment can not be consumed ethanol.

When using the drug, women are not recommended to use hygiene 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 (a decreasing dose adjustment is required).

Children are only used in case of a life threat, taking into account the expected clinical efficacy and the potential risk of side effects when it is impossible to use other, less toxic drugs. The average daily dose in this case is 7.5 mg / kg, the maximum - 15 mg / kg.

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

During the treatment period it is necessary to refrain from driving motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 200 mg.

Packaging:

For 10 tablets in a planar cell package.

For 1, 2, 3, 4 or 5 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

List B. In a dry, the dark place at a temperature of no higher than 25 ° C.

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:P N000391 / 01

Date of registration:19.12.2007

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp19.12.2007

Illustrated instructions

Instructions

Taricin® (Taricin®)