Zanocin - instructions for use, dose, side effects, contraindications

Excipients: microcrystalline cellulose - 40,00 mg, corn starch - 20,00 mg, lactose - 100,00 mg, magnesium stearate - 8,00 mg, polysorbate 80 - 5,00 mg, talc purified - 4,00 mg, silicon dioxide colloid - 3.00 mg, sodium carboxymethyl starch - 24 mg.

Film sheath: hypromellose - 5.84 mg, macrogol - 400 (polyethylene oxide) - 1.35 mg, titanium dioxide-2.50 mg, talc purified-0.31 mg.

Description:

White or almost white, biconvex, round tablets, film-coated, engraved "ZNT" on one side and "200" on the other side and with a partial risk.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

S.01.A.E.01 Ofloxacin

J.01.M.A.01 Ofloxacin

Pharmacodynamics:

The broad-spectrum antimicrobial agent from the group of fluoroquinolones acts on the bacterial DNA-gyrase enzyme, which provides super-convolution and thus the stability of bacterial DNA (the destabilization of DNA chains leads to their death). Has a bactericidal effect.

The antimicrobial spectrum includes Gram-positive aerobes: Staphylococcus aureus (methicillin-sensitive), Staphylococcus epidermidis (methicillin-sensitive), Staphylococcus saprophyticus, Streptococcus pneumoniae (penicillinsensitive), Streptococcus pyogenes. Gram-negative aerobes: Acinetobacter Calcoaceticus, Bordetella pertussis, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Klebsiella oxytoca, Moraxella catarrhalis, Morganella morganii, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa (quickly develop resistance), Serratia marcescens. Anaerobes: Clostridium perfringens. Other: Chlamydia trachomatis, Chlamydia pneumoniae, Gardnerella vaginalis, Legionella pneumophila, Mycoplasma hominis, Mycoplasma pneumoniae, Ureaplasma urealyticum. In most cases insensitive: Nocardia asteroides, anaerobic bacteria (incl. Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile), Enterococcus spp., most Streptococcus spp., does not apply to Treponema pallidum.

Pharmacokinetics:

Absorption after oral administration is rapid and complete (95%). Bioavailability is more than 96%, the connection with plasma proteins is 25%, the time to reach the maximum concentration (TCmOh) when administered orally admission - 1-2 hours, the maximum concentration (Cmax) after taking a dose of 200 mg, 400 mg and 600 mg, it is 2.5 μg / ml, 5 μg / ml and 6.9 mg / l, respectively.

Food can slow absorption, but does not have a significant effect on bioavailability.

Apparent volume of distribution - 100 liters. Distribution: cells (leukocytes, alveolar macrophages), skin, soft tissues, bone, abdominal and pelvic organs, respiratory system, urine, saliva, bile, the secretion of the prostate gland, well, penetrates, through the blood-brain barrier (GEB), the placental barrier, is secreted with the mother's milk. Penetrates into spinal fluid (14-60%).

Metabolised in the liver (about 5%) with the formation ofloxacin-N-oxide and demethylofloxacin. The half-life (T1 / 2) is 4.5-7 hours (regardless of dose).

It is excreted by the kidneys - 75-90% (in unchanged form), about 4% - with bile. Non-adrenal clearance less than 20%.

After a single application at a dose of 200 mg in urine is detected within 20-24 hours.

With renal / hepatic failure, excretion can be slowed down. Do not cumulate. With hemodialysis, 10-30% of the drug is removed.

Indications:

Respiratory tract infections (bronchitis, pneumonia), LOP-organ (sinusitis, pharyngitis, otitis media, laryngitis), skin, soft tissues, bones, joints, infectious-inflammatory diseases of the abdominal cavity and bile ducts (except for bacterial enteritis), kidneys (pyelonephritis), urinary tract (cystitis, urethritis), pelvic 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 to ofloxacin and other fluoroquinolones, epilepsy (including in the anamnesis), reduction of the convulsive threshold (including after cerebrospinal trauma, stroke or inflammatory processes in the central nervous system); defeat of tendons with previous treatment with fluoroquinolones; lactose intolerance, lactase deficiency, glucose-galactose malabsorption, age 18 years (until the skeleton has been completed), pregnancy, lactation, creatinine clearance less than 20 ml / min.

Carefully:Cerebral atherosclerosis, cerebrovascular disease (disorder), chronic renal failure, hepatic failure, organic central nervous system disorders, predisposition to convulsive reactions, myasthenia, hepatic porphyria, deficiency of glucose-6-phosphate dehydrogenase, diabetes, congenital long interval syndrome QT, heart disease (heart failure, myocardial infarction, bradycardia), psychoses and other mental disorders in the anamnesis, simultaneous, taking medications that extend the interval QT (antiarrhythmic IA and III classes, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungal, imidazole derivatives, some antihistamines, including antihistamines. astemizole, terfenadine, ebastine), for general anesthesia from the barbiturate group, drugs that reduce blood pressure, and elderly age.

Pregnancy and lactation:Contraindicated.

Dosing and Administration:

Inside. Doses are selected individually depending on the localization and severity of the infection, as well as 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 course of treatment - 7-10 days, 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 100-200 mg with a multiplicity of 1 appointment per day. When creatinine clearance less than 20 ml / min single dose - 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 take whole before or during meals, washed down with water. The duration of the course of treatment 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 digestive system: gastralegia, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, increased activity of "hepatic" 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, rising intracranial pressure, insomnia, nervousness.

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 cardio-vascular system: tachycardia, lowering of arterial pressure, vasculitis, collapse, lengthening of the intervalQT.

Allergic reactions: skin rash, itching, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, Quincke's edema, bronchospasm, Stevens-Johnson syndrome, photosensitivity, erythema multiforme exudative, anaphylactic shock, toxic epidermal necrolysis (Lyell's syndrome), vasculitis, anaphylactic shock, itching external genitalia in women. From the skin: point hemorrhages (petechiae), dermatitis bullous hemorrhagic, papular rash with a cortex, indicating the defeat of blood vessels (vasculitis).

Co hematopoiesis side: leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.

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

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

Overdose:

Symptoms: dizziness, confusion, inhibition, disorientation, drowsiness, vomiting, lengthening of the interval QT.

Treatment: gastric lavage, symptomatic therapy. With hemodialysis, 10-30% of the drug is removed.

In connection with the possible lengthening of the interval QT, ECG monitoring should be performed.

Interaction:

Food products, antacids containing A13 +, Ca2 +, Mg2+ or iron salts are reduced. 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.

Use with caution in combination with drugs that cause lengthening of the interval QT (for example: antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, neuroleptics).

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 two 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 tendonitis should immediately stop treatment, makeimmobileLisathe Achilles tendon and consult an orthopedist.

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

Against the background of treatment may worsen the flow of myasthenia, an increase in seizures porphyria in predisposed patients.

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

In patients with impaired hepatic or renal function, concentration control is necessary ofloxacin in plasma. In severe renal and hepatic insufficiency, the risk of toxic effects increases (correction is required dose).

Children are only used in case of a life threat, taking into account the expected benefit 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 is 15 mg / kg.

Some caution is needed when taking Zanocin® in patients with known risk factors for lengthening the interval QT, such as advanced 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 use of drugs that extend the interval QT (IA and III classes of antiarrhythmic drugs, tricyclic antidepressants, macrolides).

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 potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions. You can not use ethanol.

Form release / dosage:

Film coated tablets 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:

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:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011425 / 01

Date of registration:11.07.2011

Expiration Date:Unlimited

The owner of the registration certificate:Ranbaxy Irland Ltd.Ranbaxy Irland Ltd. Ireland

Manufacturer: & nbsp

RANBAXY IRELAND, Ltd. Ireland

Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED

Information update date: & nbsp10.10.2017

Illustrated instructions

Instructions

Zanocin® (Zanocin®)