Sparflo® (Sparflo)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSparfloxacinSparfloxacin
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  • Sparflo®
    pills inwards 
    Dr. Reddy's Laboratories Ltd.     India
  • Sparfloxacin
    pills inwards 
    AVVA RUS, OJSC     Russia
    • Dosage form: & nbspcoated tablets
    Composition:

    Each tablet contains:

    Active substance:

    sparfloxacin - 200 mg.

    Excipients:

    corn starch 15 mg, cellulose microcrystalline 65 mg, crospovidone 5 mg, silicon dioxide colloid 6 mg, talc 3 mg, magnesium stearate 6 mg;

    shell: hypromellose 5.36 mg, propylene glycol 1.32 mg, titanium dioxide (E171) 2.19 mg, talc 1.11 mg, quinoline yellow dye (E104) 0.03 mg.

    Description:

    almost white or light yellow oval tablets, covered with a coating, on one side - risk, on another stamping "200".

    Pharmacotherapeutic group:antimicrobial agent, fluoroquinolone
    ATX: & nbsp

    J.01.M.A   Fluoroquinolones

    J.01.M.A.09   Sparfloxacin

    Pharmacodynamics:

    The antimicrobial agent, the derivative of fluoroquiolone, inhibits bacterial DNA-gyrase, the x-ray region of chromosomal DNA.

    Low toxicity for macroorganism cells is explained by the absence of girazes in them. It is a bactericidal antimicrobial drug of a wide spectrum of action, both for gram-positive and gram-negative flora.The advantage of the drug is a greater activity against Gram-positive cocci and anaerobes compared to the fluoroquinolones of previous generations. In a relationship 1The ramotrictal flora exhibits activity close to aminoglycosides.

    On gramp-positive microorganisms have a bactericidal effect only in the period of division, on gram-negative organisms - and at rest, because it affects not only DNA-gyrase, but also causes lysis of the cell wall.

    Prevents transcription of the genetic material of bacteria required for their normal metabolism, which leads to a rapid decrease in the ability of bacteria to division. As a result of its action, there is no parallel development of resistance to other antibiotics that do not belong to the group of intrinsic inhibitors. which makes it highly effective against bacteria that are resistant, for example to aminoglycosides, penicillins, iesfalosporins, tetranilins and many other antibiotics.

    The following pathogenic microorganisms are highly sensitive to sparfloxacin: Escherichia coli, Shigella spp., Salmonella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Serratia spp., Hafnia spp., Edwardsiella spp., Proteus spp. (indole-positive and indole-negative), Providencia spp .. Morganella spp. Yersinia spp .; Vibrio spp., Aeromonas spp. Plesiomonas spp., Pasteurella spp., Haemophilus spp., Campylobacter spp., Pseudomonas cepacia. Pseudomonas aeruginosa, Legionella spp. Neisseria spp., Moraxella spp., Acinetobacter spp., Brucella spp .; Staphylococcus spp., Streptococcus pneumoniae, Mycoplasma pneumoniae. Listeria spp., Corynebacterium spp., Chlamydia spp., Xanthomonas maltophilia.

    Sparflox is characterized by high activity in relation to Mycobacterium tuberculosis, including multiple resistant strains.

    Enterococcus faecium, Ureaplasma urealyticum, Nocardia asteroides, as a rule, sensitive to sparfloxacin.

    The following microorganisms have a moderate sensitivity: Gcirdnerella spp., Flavobacterium spp., Alcaligenes spp., Streptococcus agalacliae, Enterococcus faecalis, Streptococcus pyogenes, Streptococcus viridans, Mycoplasma hominis, Mycobacterium fortuitum.

    With some exceptions, anaerobic microorganisms are moderately sensitive (Peptococcus spp., Pcptostreplococcus spp.) or stable (Bacteroides spp.). Sparfloxacin is not effective against Treponema pallidum.

    Resistance to sparfloxacin develops extremely slowly, because, on the one hand, after its action, there is almost no persistent microorganisms, and on the other hand - bacterial cells do not have enzymes that inactivate it.

    No cross-resistance to other antimicrobials has been observed.

    In a relationship Pseudomonas aeruginosa and other gram-negative bacilli by activity is inferior to ciprofloxacin.

    Has a post-antibiotic effect: microorganisms do not reproduce within 0.5-4 h after the drug disappeared from the plasma.

    Pharmacokinetics:

    Absorption after oral administration - about .90%.The degree of absorption of ns varies with the intake of the drug along with food or milk. The food slows the rate of absorption, however, nc changes the degree of absorption, so that the maximum concentration of sparfloxacid is observed approximately 30 minutes later than when administered on an empty stomach.

    It is well distributed in body tissues (excluding fat-rich tissue, including nerve tissue), the concentration in the tissues and fluids of the lower respiratory tract exceeds the concentration in the plasma. It is found in high concentrations in alveolar macrophages. Therapeutic concentrations are achieved in saliva, bile, intestines, abdominal and pelvic organs, kidneys and urinary organs, pulmonary tissue, bronchial secretion, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. In spinal and intraocular fluid is detected in 10% of the concentration of the drug in the plasma.

    The drug has a large volume of distribution - 3.9 + 0.8 l / kg, exceeding this figure for other fluoroquilolones. The connection with plasma proteins (mainly albumins) is about 45%.

    Time to reach the maximum concentration after ingestion 400 mg - 3-6 h,the concentration in tissues is 2-12 times higher than in plasma. The concentration of the drug in the blood serum has a linear dependence on the value of the dose taken.

    The activity decreases slightly at acidic pH values.

    It is meta-ozed in the liver, excreted with fecal masses (30-50%) and urine (tubular filtration and tubular secretion) - of them, unchanged, about 10% of the orally taken dose. The half-life is 16-30 hours, in patients with renal insufficiency the half-life is prolonged.

    In chronic renal failure, the percentage of the drug excreted through the kidneys decreases, but with creatinine clearance above 20 ml / min, no cumulation takes place in the body, because in parallel, there is an increase in metabolism and excretion with calves.

    Indications:

    Infectious-inflammatory diseases caused by sensitive microflora:

    • infections of the respiratory tract: pneumonia, chronic obstructive pulmonary disease in the acute stage, caused by Streptococcus pneumonia, Staphylococcus spp., Haemophilus influenzae, Haemophilus parainfluenzac, Moraxella calarrhalis, Klebsiella pneumonia, Enterobacter cloacae, Moraxella calarrhalis, Mycoplasma pneumonia. Chlamydia pneumoniae;

    • infections of the middle ear, paranasal sinuses, especially if they are caused by gram-negative pathogens, including Pseudomonas spp., or Staphylococcus spp. ',

    • eye infections;

    • infection of the kidneys and urinary tract (cystitis, pegonococcal urethritis, pyelitis);

    • infection of the genitals (including adnexitis, prostatitis);

    • infection of the abdominal cavity (bacterial infections of the gastrointestinal tract, including those caused by shigella and salmonella, bile ducts);

    • infections of the skin and soft tissues (abscess, pyoderma, furunculosis, infectious dermatitis),

    • infection of bones and joints (including osteomyelitis);

    • infection against the background of immunodeficiency, including on the background of treatment with immunosuppressive agents or in patients with neutropenia;

    • Sexually transmitted diseases: gonorrhea, chlamydia;

    • tuberculosis of the lungs (for treatment of drug-resistant tuberculosis or intolerance of first-line therapy);

    • leprosy.

    Contraindications:

    Hypersensitivity to drug components, epilepsy, age to 18 years (incomplete process of skeleton formation), extended interval Q-T or other factors contributing to the development of arrhythmias (hypokalemia, severe bradycardia, chronic heart failure, atrial fibrillation), deficiency of glucose-6-phosphate dehydrogenase, severe renal failure; pregnancy, lactation.

    Carefully:

    Atherosclerosis of cerebral vessels, cerebral circulation, epileptic syndrome, conditions of life (professional activity), which do not allow to limit insolation, chronic renal failure.

    Dosing and Administration:
    Dosing and Administration
    Adults, inside, regardless of food intake (without chewing, drinking with a sufficient amount of liquid). The length of the course of treatment depends on the nature and severity of the disease and the type of pathogen.
    Pneumonia, exacerbation of chronic bronchitis - on the first day 400 mg once, then 200 mg / day for 10 days; patients with creatinine clearance less than 50 ml / min - on the first day 400 mg once, then 200 mg every 48 hours.
    Infections of ENT organs, sinusitis - on the first day 400 mg once, then 200 mg per day for 10 days.
    When pulmonary tuberculosis is used as part of complex therapy with anti-TB drugs - on the first day 400 mg once, then 200 mg per day for 30 days.
    Urinary tract infections: on the first day, 200 mg once, then 100 mg once a day for 10-14 days.
    Acute gonorrhea urethritis: at
    the first day 400 mg once, then strictly after 24 hours - 1 tablet (200 mg), the course dose of 600 mg.
    Non-gonococcal urethritis - on the first day 200 mg once, then 100 mg once a day for 6 days. Bacterial prostatitis - on the first day 400 mg once, then 200 mg per day for 10-14 days. Chlamydial infections - in the first day 400 mg, then 200 mg in for 10-14 days.

    Infections of the skin and soft tissues - in the first day 400 mg once, then 200 mg once a day for 3-9 days.

    Leprosy: 200 mg once a day in for 12 weeks.


    Side effects:

    From the cardiovascular system: interval spar Q-T, tachycardia, thrombosis of the cerebral arteries;

    From the digestive system: loss of appetite, nausea, vomiting, dyspepsia, abdominal pain, flatulence, diarrhea, yellow holestatichsskaya \ ha (especially in patients with prior liver disease), hepatitis, gepatonekroz:

    From the respiratory system: dyspnea;

    From the nervous system: dizziness, headache, fatigue, drowsiness, anxiety, tremor, peripheral paralgeziya (anomaly perception feelings of pain), increased sweating, increased intracranial pressure, "nightmarish" dream, confusion, depression, hallucinations, psychotic reactions, fainting;

    From the sense organs: disorders of taste and smell, visual impairment (eg diplopia, change in color perception), tinnitus, hearing loss;

    From the urinary system: hematuria; crystalluria (especially with alkaline urine and low diuresis);

    From the musculoskeletal system: arthralgia, asthenia, myalgia, tendovaginitis; Lycurgical reactions: itching, drug fever, pinpoint hemorrhage (p? stychi); nodal erythema, edema of the face, vessels or larynx, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome);

    From the laboratory indicators: eosinophilia, leukopenia, grapulocytopedy, anemia, thrombocytopenia; leukocytosis, thrombocytosis, hemolytic anemia, increased activity of "hepatic" transampase and alkaline phosphatase, hypoprothrombemnemia, hypercortexia, gynerbilirubinemia, hyperglycemia;

    Other: photosensitization, "tides" of blood to the face.

    Overdose:

    Treatment: a specific antidote is unknown. Symptomatic therapy, with

    necessity - hemodialysis and peritoneal dialysis.

    Interaction:

    Virtually does not affect the concentration of theophylline, a pen: - '; hypoglycemic drugs, non-steroidal anticoagulants.

    Non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increase the risk of seizures.

    Oral administration together with iron-containing preparations, sucralfate and antacid preparations containing magnesium, aluminum, calcium, zinc, and also iron salts, leads to a decrease in absorption of sparfloxacin (it should be administered either as a 1-

    1. hours before, or, not less than 4 hours after).

    Metoclopramide accelerates the absorption of sparfloxacin. which leads to a decrease in the time to reach its maximum concentration in the plasma.

    Since sparfloxanin may increase the duration of the interval Q-T. It is not recommended simultaneous reception with drugs that have the same effect: with actarhythmic drugs of the class Ia and III, terfenadine, bepridilom, erythromycin. atemisol, cisapride, pentamidine. tricyclic antidepressants and phenothiazine.

    When combined with other antimicrobials, synergy is usually observed (beta-lactams, aminoglycosides, clindamycin, metronidazole); sparfloxanin can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp .; with mezlocillin, azlocillin and other beta-lactam antibiotics - with streptococcal infections; with peyitsillinami, resistant to the action of betalactamases, and vancomycin - with staphylococcal infections; with metropidazole and klippamation - with anaerobic infections.

    With the simultaneous use of sparfloxacin with cyclosporine, there is an increase in serum creatinine, so these patients need control of this indicator 2 times a week.

    Special instructions:

    Avoid ultraviolet irradiation during treatment with sparfloxacin and within 3 days after its termination.

    In order to avoid the development of kristururii, it is inadmissible to exceed the recommended daily dose, sufficient fluid intake and maintenance of acid urine reaction is necessary. There are isolated reports that the use of fluoroquinolones is accompanied by ruptures of tendons of the shoulder, hands and Achilles tendon. When complaints arise, treatment should be discontinued.

    During treatment with sparfloxacin, one should refrain from engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions.

    Form release / dosage:

    The tablets covered with a cover, on 200 mg. For 6 tablets per blister, together with the Instruction for the use of the drug is placed in a pack of cardboard.

    Packaging:The tablets covered with a cover, on 200 mg. For 6 tablets per blister, together with the Instruction for the use of the drug is placed in a pack of cardboard.
    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 of the year.

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N011913 / 01
    Date of registration:07.08.2007
    The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India
    Information update date: & nbsp18.08.2015
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