Active substanceOfloxacinOfloxacin
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  • Dosage form: & nbsp

    tablets, film-coated prolonged action

    Composition:

    Each film-coated, sustained-release tablet contains:

    Zanocin® OD 400 mg

    Active substance: ofloxacin 400 mg. Excipients: crospovidone

    89.5 mg, sodium hydrogen carbonate 99.8 mg, hypromellose 6.2 mg, purified water *, sodium alginate 5 mg, xanthan gum 15 mg, carbomer 30 mg, lactose monohydrate 100 mg, magnesium stearate 14 mg, silicon dioxide colloid 0 , 5 mg.

    Film Sheath:

    Foam white 31B58910 7 mg (hypromellose 35%, lactose monohydrate 40%, titanium dioxide 15%, macrogol 10%), purified water *, isopropanol *.

    Inks for inscriptions:

    Opacode S-1-17823 black (shellac 45% (20% esterified) in SD-45 alcohol 44,467%, ferric oxide black oxide 23,409%, n-butanol 2,242%, propylene glycol 2,000%, isopropanol 26.882%, ammonium hydroxide 28% 1,000%), isopropanol *.

    Zanocin® OD 800 mg

    Active substance: ofloxacin 800 mg.


    Excipients: crospovidone * 136.2 mg, sodium hydrogen carbonate 80 mg, hypromellose 5 mg, purified water *, sodium alginate 8 mg, xanthan gum 24 mg, carbomer 38.8 mg, magnesium stearate 17 mg, silicon dioxide colloid 1 mg. Film Sheath:

    Fold white 31B58910 11 mg

    (hypromellose 35%, lactose monohydrate 40%, titanium dioxide 15%, macrogol 10%), purified water *, isopropanol *.

    Inks for writing:

    Opacode S-1-17823 black (shellac 45% (20% esterified) in SD-45 alcohol 44.467%, ferric oxide black oxide 23.409%, n-butanol 2.242%, propylene glycol 2,000%, isopropanol 26.882%, ammonium hydroxide 28% 1,000%), isopropanol *.

    * - evaporates in the production process


    Description:

    Tablets "Zanocin® OD 400 mg":

    Biconvex tablets of oval form, film-coated, from white to almost white, with printed black food ink on one side of the ZNT OD with an arrow intersecting the inscription OD, and smooth to 400 another.

    Tablets "Zanotsin® OD 800 mg ":

    Biconvex tablets of oval form, film-coated, from white to almost white, with printed black food ink on one side ZNT OD with an arrow crossing the inscription OD, and smooth on 800 another.

    Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone
    ATX: & nbsp

    S.01.A.E.01   Ofloxacin

    J.01.M.A.01   Ofloxacin

    Pharmacodynamics:

    The antibacterial effect of ofloxacin is effected by suppressing the action of the topoisomerase II (DNA-gyrase) enzyme in bacterial cells. Topoisomerases are responsible for the introduction of negative nucleotide rings in DNA. Fluoroquinolones reduce the introduction of negative rings in DNA and cause rapid disruption of DNA replication.

    Zanocin® OD tablets are able to release for a long time ofloxacin, which makes the use of the drug (once a day) more convenient. A single application of Zanocin® OD 400 mg tablets and Zanocin® OD 800 mg is equivalent to the amount of ofloxacin released using conventional tablets of ofloxacin 200 mg and 400 mg twice daily.

    Antibacterial spectrum:

    Ofloxacin is active against the following microorganisms:

    Aerobic Gram-positive microorganisms:

    Staphylococcus aureus (methicillin-sensitive strains); Streptococcus pneumoniae (penicillin-sensitive strains); Streptococcus pyogenes.

    Aerobic Gram-negative microorganisms:

    Citrobacter (diversus) koseri; Enterobacter aerogenes; Escherichia coli; Haemophilus influenzae; Klebsiella pneumoniae; Neisseria gonorrhoeae; Proteus mirabilis; Pseudomonas aeruginosa.

    Other microorganisms:

    Chlamydia trachomatis

    In vitro Ofloksacin minimum inhibitory concentration is 2 μg / ml or less for most (90%) strains of the following microorganisms:

    Aerobic Gram-positive microorganisms:

    Staphylococcus epidermidis (methicillin-sensitive strains); Streptococcus pneumoniae (penicillin-resistant strains); Staphylococcus saprophyticus.

    Aerobic Gram-negative microorganisms:

    Acinetobacter calcoaceticus; Bordetella pertussis; Citrobacter freundii; Enterobacter cloacae; Haemophilus ducreyi; Klebsiella oxytoca; Moraxella catarrhalis; Morganella morganii; Proteus vulgaris; Providencia rettgeri; Providencia stuartii; Serratia marcescen. Anaerobic microorganisms:

    Clostridium perfringens Other microorganisms:

    Chlamydia pneumoniae; Gardnerella vaginalis; Legionella pneumophila; Mycoplasma hominis; Mycoplasma pneumoniae; Ureaplasma urealyticum.

    Ofloxacin does not have activity against Treponema pallidum. Many strains Streptococcus and Enterococcus, as well as anaerobic microorganisms are resistant to ofloxacin.

    Pharmacokinetics:

    When administered orally ofloxacin quickly absorbed. Absorption after ingestion is rapid and complete (95%). Bioavailability is over 96%. Food can slow absorption, but does not have a significant effect on bioavailability. After a single application of Zanocin® OD 400 mg tablets and Zanocin® OD 800 mg, peak plasma concentrations are achieved within 6-8 hours and are 2.09 ± 0.46 μg / ml and 5.15 ± 1.07 μg / ml, respectively, and the rate and degree of absorption are comparable with those with a double intake of conventional tablets of ofloxacin 200 mg and 400 mg. When using ofloxacin together with food, the time to reach the maximum concentration of the drug in the plasma is prolonged,the level of maximum plasma concentration in the plasma and the area under the pharmacokinetic curve do not change. Apparent volume of distribution - 100 liters. Distribution: cells (leukocytes, alveolar macrophages), skin, soft tissues, bones, abdominal and pelvic organs, respiratory system, urine, saliva, bile, the secretion of the prostate gland, penetrates well through the blood-brain barrier (GEB), the placental barrier, is secreted with the mother's milk. Penetrates into the cerebrospinal fluid (CSF) (14-60%). Metabolised in the liver (about 5%). 25% ofloxacin is bound by plasma proteins. The half-life of taking tablets is 6-8 hours. Ofloxacin is excreted mainly by the kidneys: about 70-90% of the drug is unchanged in kidney and less than 5% in the form of metabolites, including dimethyl- or Noxide-ofloxacin.

    The clearance of ofloxacin is lower in patients with impaired renal function (creatinine clearance <50 mL / min), such patients need correction of the regime

    dosing.

    With hemodialysis, 10-30% of the drug is removed.

    Indications:

    Zanocin® OD is indicated for the following infectious-inflammatory diseases caused by susceptible microorganisms:

    Lower parts of the respiratory tract, including pneumonia, caused by H. influenzae and Streptococcus pneumoniae and exacerbation of chronic bronchitis. Genitourinary system, including: acute, uncomplicated or complicated, urethral or cervical forms of gonorrhea; urethritis and cervicitis caused by Chlamydia trachomatis; mixed urethral and cervical infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae; prostatitis.

    Infections of the skin and soft tissues.

    Pelvic organs: endometritis, oophoritis, parametritis.

    Contraindications:

    Hypersensitivity to ofloxacin or other drugs of the fluoroquinolones group.

    - Deficiency of glucose-6-phosphate dehydrogenase.

    - Epilepsy (including in the anamnesis).

    Decreased convulsive threshold (including after traumatic brain injury, stroke or inflammatory processes in the central nervous system (CNS)).

    Age to 18 years (until the skeleton has been completed).

    - Pregnancy.

    Lactation period.

    Creatinine clearance (CK) is less than 20 ml / min.

    Carefully:

    - Atherosclerosis of cerebral vessels.

    Disorders of cerebral circulation (in the anamnesis).

    Chronic renal failure.

    Organic lesions of the central nervous system.

    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    Inside the whole after eating, squeezed with enough water. Tablets can not be broken or chewed!

    Recommended dosages for adults:

    Infections

    Daily

    dose

    The frequency of application of Zanocin® OD

    Duration

    applications

    Urinary tract infections:

    - cystitis caused by E.coli or K.pneumoniae

    400 mg

    Every 24 hours

    3 days

    - Cystitis caused by other microorganisms

    400 mg

    Every 24 hours

    7 days

    - complicated urinary tract infections

    400 mg

    Every 24 hours

    10 days

    Infections of the skin and soft tissues

    800 mg

    Every 24 hours

    10 days

    Pneumonia or exacerbation of chronic bronchitis

    800 mg

    Every 24 hours

    10 days

    Sexually Transmitted Infections:

    uncomplicated gonorrhea

    400 mg

    Once

    1 day

    - non-gonococcal urethritis and cervicitis

    800 mg

    Every 24 hours

    7-10 days

    - mixed urethral and cervical infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae.

    800 mg

    Every 24 hours

    7-14 days

    Prostatitis

    400 mg

    Every 24 hours

    up to 6 weeks

    Acute inflammatory diseases of the pelvic organs

    800 mg

    Every 24 hours

    10 - 14 days

    Dosing regimen in patients with impaired renal function:

    After the initial normal dose, the dosage regimen should be adjusted according to the following scheme:


    Creatinine clearance (ml / min)

    Dose maintenance and dosing frequency

    20-50

    In infections of the skin and soft tissues, pneumonia or exacerbation of chronic bronchitis, as well as acute inflammatory diseases of the pelvic organs, chlamydia infection


    a dose of Zanocin® OD 400 mg is recommended - 1 tablet every 24 hours.

    If only the concentration of creatinine in plasma is known, the calculation of creatinine clearance is carried out according to the following formula:

    Men:

    Weight (kg) х (140-age)

    Creatinine clearance (ml / min)= -------------------------------

    72 x creatinine in plasma (mg%)

    Women: 0.85 x value, calculated for men Use in patients with impaired liver function:

    In patients with severe impairment of liver function, as well as in the case of cirrhosis or ascites, there may be a slight decrease in the rate of elimination of ofloxacin. Therefore, do not exceed the maximum dose of ofloxacin 400 mg per day. Application in elderly patients

    In this group of patients, there are no restrictions on the use of fluoroquinolones. However, in elderly patients with a decreased excretory function of the kidneys, it is necessary to correct the dosage regimen of the drug (see "Dosage regimen in patients with impaired renal function").

    Side effects:

    Below are the side effects, the frequency of which was estimated as follows: often - more than 1 case for 100 appointments; infrequently - less than 1 case per 100 appointments; rarely - less than 1 case per 1000 appointments.

    From the gastrointestinal tract and the hepatobiliary system:

    Often: nausea, vomiting, diarrhea, abdominal pain, gastralgia, flatulence. Diarrhea can be a symptom of enterocolitis (which in some cases can be hemorrhagic).

    Infrequently: loss of appetite, increased indices of "liver" transaminases and / or bilirubin.

    Rarely: possibly development of cholestatitic jaundice, hepatitis, or severe impaired liver function. A rare form of enterocolitis that occurs when using antibiotics is pseudomembranous colitis (in most cases caused by Clostridium difficile). If pseudomembrane colitis is suspected, ofloxacin should be discontinued. Do not use drugs that reduce intestinal peristalsis.

    From the central nervous system (CNS):

    Often: headache, dizziness, fatigue.

    Infrequently: uncertainty of movements, convulsions,psychomotor agitation, phobias, increased intracranial pressure, confusion, disturbed balance, nightmares, anxiety, depression, hallucinations and psychotic reactions, insomnia, unsteady gait and tremor (as a result of muscle coordination disorders), neuropathy, numbness and paresthesia or hyperesthesia.

    From the sense organs:

    Infrequently: impaired vision, violation of color perception, diplopia, violation of taste and smell (in rare cases, temporary loss of function).

    Rarely: hearing loss (including hearing loss). If these reactions were observed in patients after the first dose of ofloxacin, then the course of therapy should be discontinued.

    From the side of the cardiovascular system:

    Tachycardia and temporary lowering of blood pressure.

    Infrequently: a circulatory collapse (as a result of a rapid decrease in blood pressure).

    From the hematopoiesis:

    Rarely: anemia, leukopenia (including agranulocytosis), thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.

    From the urinary system:

    Infrequently: impaired renal function.

    Rarely: acute interstitial nephritis, or acute renal failure with a progressive increase in serum creatinine concentration. Increase in the content of urea.

    Allergic reactions:

    Often: skin rash, itching.

    Infrequently: photodermatitis, exudative erythema, Stevens-Johnson syndrome, Lyell's syndrome and vasculitis.

    Rarely: fever, allergic pneumonitis, allergic nephritis,

    bronchospasm, dyspnoea, shock, angioedema, vasculitis-like reactions, eosinophilia, eosinophilic pneumonia.

    From the musculoskeletal system:

    Rarely: tendonitis, myalgia, arthralgia, tendosinovitis, tendovaginitis, tendon rupture, pain in the muscles and joints (in rare cases, it may be a sign of rhabdomyolysis).

    Other side effects:

    Rarely: hyper- or hypoglycemia (in patients with diabetes mellitus), weakness, intestinal dysbacteriosis, superinfection, vaginitis.

    In some patients (with a particular predisposition), the use of ofloxacin can provoke an attack of porphyria.

    Laboratory indicators:

    Increased activity of alkaline phosphatase, aspartate aminotransferase, glutamine transaminase and lactate dehydrogenase.

    Overdose:

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

    Treatment:

    There is no specific antidote for ofloxacin. In case of an overdose, treatment should be symptomatic and supportive, and should include the following measures:

    gastric lavage;

    maintenance of adequate hydration of the body; maintenance therapy.

    Ofloxacin is not removed during hemodialysis or peritoneal dialysis.
    Interaction:

    Theophylline:

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

    Antacid preparations, sucralfate, metal cations, multivitamins, food products:

    Reduce the absorption of fluoroquinolones, so their combined use with ofloxacin should be avoided (the interval between the appointment of these drugs should be at least 2 hours).

    Non-steroidal anti-inflammatory drugs (NSAIDs):

    Joint use with the drugs of this group increases the side effects of fluoroquinolones on the central nervous system.

    Cyclosporine:

    With the combined use of cyclosporine with certain fluoroquinolones,an increase in the concentration of cyclosporine in plasma was noted. Reactions of drug interaction between cyclosporine and ofloxacin have not been studied.


    Drugs metabolized cytochrome P450:

    Most fluoroquinolones suppress the activity of cytochrome P450. When combined with fluoroquinolones, an increase in the half-life of drugs that are also metabolized by cytochrome P450 (for example, ciclosporin, theophylline / methylxanthine, warfarin etc). The degree of inhibition among the various fluoroquinolones is variable.

    Wapfarin:

    Fluoroquinolones enhance the effects of oral anticoagulant warfarin and its derivatives. With the joint application of these drugs should closely monitor the parameters of the blood coagulation system.

    Cimetidine:

    Cimetidine changes the rate of excretion of certain fluoroquinolones, leading to a significant increase in the pharmacokinetic area under the curve. Hypoglycemic agents:

    In patients receiving both fluoroquinolones and antidiabetics, there are violations of the concentration of glucose in the blood plasma, including hypo- and hyperglycemia.

    At simultaneous reception with antagonists of vitamin K it is necessary to control the coagulation system of blood.

    At simultaneous appointment with glucocorticosteroids (GCS), 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.

    Special instructions:

    Some patients receiving fluoroquinolones exhibit phototoxicity reactions. Avoid prolonged exposure to direct sunlight. It should stop using the drug when signs of phototoxicity appear. In the joint use of ofloxacin with antidiabetic agents, careful monitoring of the concentration of glucose in the blood plasma is recommended. Ofloxacin It is not a drug of choice for pneumonia caused by pneumococci.

    Not indicated in the treatment of acute tonsillitis.

    In case of side effects from the central nervous system, allergic reactions, it is necessary to cancel the drug.

    When using the drug, it is possible to develop pseudomembranous colitis, which can range from mild to life-threatening.Therefore, in the first place, it is necessary to exclude the possibility of this disease in patients with diarrhea that has arisen against the use of antibacterial drugs.

    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 tendinitis, it is necessary to immediately stop treatment, to make an immobilization of the Achilles tendon and consult an orthopedist. When using the drug, women are not recommended to use tampons such as Tampax, 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 bacteriological diagnosis of tuberculosis (prevents 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 correction is required).


    You can not use ethanol.

    During the period of application of Zanocin® OD, false-positive results are possible when determining opiates and porphyrins in urine.

    Data on the use of ofloxacin in children, adolescents (less than 18 years of age), pregnant women and lactating mothers are not sufficient to predict its safety in these groups.

    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.
    Form release / dosage:

    Tablets, coated with a film membrane prolonged action of 400 mg, 800 mg.


    Packaging:5 tablets in a blister of aluminum foil and PVC film; 1 or 2 blisters with instructions for medical use in a cardboard bundle.
    Storage conditions:

    List B.

    Store in a dry place at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015180 / 01
    Date of registration:17.06.2008
    The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India
    Manufacturer: & nbsp
    Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED
    Information update date: & nbsp11.09.2012
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