Sparflo - description of the drug, instructions for use, reviews

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Active ingredients

• Sparfloxacin

Disease class

• Gardeolum and chalazion
• Conjunctivitis
• Blepharoconjunctivitis
• Keratitis
• Purulent endophthalmitis
• Purulent and unspecified otitis media
• Otitis media, unspecified
• Otitis media in bacterial diseases classified elsewhere
• Acute sinusitis
• Pneumonia caused by Streptococcus pneumoniae
• Pneumonia caused by Haemophilus influenzae [Afanasyev-Pfeffer bacillus]
• Pneumonia caused by Klebsiella pneumoniae
• Pneumonia caused by staphylococcus
• Pneumonia caused by other aerobic gram-negative bacteria
• Pneumonia caused by Mycoplasma pneumoniae
• Pneumonia caused by chlamydia
• Other chronic obstructive pulmonary disease
• Skin abscess, boil and carbuncle
• Pyoderma
• Local infection of skin and subcutaneous tissue, unspecified
• Biliary tract disease, unspecified
• Infectious dermatitis
• Other salmonella infections
• Shigelosis
• Respiratory tuberculosis of unspecified localization without mention of bacteriological or histological confirmation
• Leprosy, unspecified
• Gonococcal infection
• Chlamydial lymphogranuloma (venereal)
• Other chlamydial sexually transmitted diseases
• Other diseases caused by chlamydia
• Disease caused by the human immunodeficiency virus [HIV], appearing as infectious and parasitic diseases
• Cystitis
• Urethritis and urethral syndrome
• Inflammatory diseases of the prostate gland
• Salpingitis and oophoritis

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Antimicrobial
• Antibacterial
• Bactericidal

Pharmacological group

• Quinolones/fluoroquinolones

Pharmacological properties of the drug Sparflo

cparfloxacin (5-amino-1-cyclopropyl-7-(cis-3,5-dimethyl-1-piperazinyl)-6,8-difluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid) - antimicrobial drug a class of fluoroquinolones, the mechanism of action of which is associated with the inhibition of DNA gyrase, the enzyme responsible for the replication of bacterial DNA. Sparfloxacin has bactericidal activity against most gram-negative and gram-positive microorganisms, chlamydia, mycoplasma, including those relatively resistant to β-lactam antibiotics. Despite the existing resistance to other fluoroquinolones, some microorganisms resistant to them are sensitive to sparfloxacin. Sparfloxacin is active against Mycobacterium tuberculosis , including multi-resistant strains. Sparfloxacin is absorbed relatively slowly from the digestive tract after oral administration, the maximum concentration in the blood serum is reached after 3-6 hours and is 1.2-1.6 mg/l. Absolute bioavailability is 92%. The maximum bactericidal titer of blood serum after taking 400 mg of sparfloxacin is 1.3 ± 0.2 mg/ml. Sparfloxacin binds to plasma proteins, mainly albumin, by 45%. Sparfloxacin has a very large volume of distribution - 3.9±0.8 l/kg. Penetrates well into various organs, tissues and biological fluids (saliva, tear fluid, sweat, nasal secretions, mucous membrane of the bronchi and sinuses, pleural fluid, exudate, etc.), in many cases exceeding the concentration in blood serum. Sparfloxacin penetrates the BBB. It is slowly eliminated from the body, mainly via the extrarenal route. The half-life is 16–30 hours. Patients with moderate and severe renal failure require dose adjustment. Elderly patients and patients with impaired liver function do not require dose adjustment. Food intake does not affect the absorption of the drug and its pharmacokinetics.

Sparflo 200 mg 6 pcs. film-coated tablets

Composition and release form Sparflo 200 mg 6 pcs. film-coated tablets

Film-coated tablets - 1 tablet. sparfloxacin - 200 mg excipients: corn starch; MCC; crospovidone; colloidal silicon dioxide; talc; magnesium stearate hydroxypropyl methylcellulose; propylene glycol; titanium dioxide; quinoline yellow shell: hypromellose; propylene glycol; titanium dioxide; talc; quinoline yellow dye in a blister 6 pcs.; 1 blister in a cardboard pack.

Directions for use and doses

Orally, for adults, regardless of food intake, without chewing, with a sufficient amount of liquid. The duration 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 Cl creatinine

Pharmacodynamics

An antimicrobial agent, a fluoroquinolone derivative, inhibits bacterial DNA gyrase, which despirals sections of chromosomal DNA. Low toxicity for the cells of the macroorganism is explained by the absence of gyrases in them. It is a broad-spectrum bactericidal antimicrobial drug against both gram-positive and gram-negative flora. The advantage of the drug is its greater activity against gram-positive cocci and anaerobes compared to fluoroquinolones of previous generations. In relation to gram-negative flora, it exhibits activity close to aminoglycosides. It has a bactericidal effect on gram-positive microorganisms only during the period of division, on gram-negative organisms - and during the dormant period, since it affects not only DNA gyrase, but also causes lysis of the cell wall. Prevents the transcription of the genetic material of bacteria, leading to a rapid decrease in the ability of bacteria to divide. As a result of its action, there is no parallel development of resistance to other antibiotics that do not belong to the group of gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines 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. Sparfloxacin is characterized by high activity against Mycobacterium tuberculosis, including multi-resistant strains of Enterococcus faecalis, Ureaplasma urealyticum, Nocardia asteroides, which are usually sensitive to sparfloxacin. The following microorganisms are moderately susceptible: Gardnerella spp., Flavobacterium spp., Alcaligenes spp., Streptococcus agalactiae, Enterococcus faecalis, Streptococcus pyogenes, Streptococcus viridans, Mycoplasma hominis, Mycobacterium fortuitum. With some exceptions, anaerobic microorganisms are moderately sensitive (Peptococcus spp., Peptostreptococcus spp.) or resistant (Bacteroides spp.). Sparfloxacin is not effective against Treponema pallidum. Resistance to sparfloxacin develops extremely slowly, since, on the one hand, after its action there are practically no persistent microorganisms left, and on the other hand, bacterial cells do not have enzymes that inactivate it. No cross-resistance to other antimicrobial drugs was observed. In relation to Pseudomonas aeruginosa and other gram-negative bacilli, the activity is inferior to ciprofloxacin. It has a post-antibiotic effect: microorganisms do not multiply within 0.5-4 hours after the drug disappears from the plasma.

Pharmacokinetics

Absorption after oral administration is about 90%. The degree of absorption does not change when taking the drug with food or milk. Food slows down the rate of absorption, but does not change the degree of absorption, so that the maximum concentration of sparfloxacin is observed approximately 30 minutes later than when taken on an empty stomach. Well distributed in body tissues (excluding fat-rich tissue, including nervous tissue), the concentration in the tissues and fluids of the lower respiratory tract exceeds the concentration in plasma. Found in high concentrations in alveolar macrophages. Therapeutic concentrations are achieved in saliva, bile, intestines, abdominal and pelvic organs, kidneys and urinary organs, lung tissue, bronchial secretions, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. 10% of the drug concentration in plasma is found in the cerebrospinal and intraocular fluid. The drug has a large volume of distribution - (3.9±0.8) l/kg, exceeding this figure for other fluoroquinolones. Binding to plasma proteins (mainly albumin) is about 45%. The time to reach Cmax after oral administration of 400 mg is 3-6 hours, 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 dose taken. Activity decreases slightly at acidic pH values. Metabolized in the liver, excreted in feces (30-50%) and urine (tubular filtration and tubular secretion) - of which, unchanged, about 10% of the orally taken dose. T1/2 - 16-30 hours, in patients with renal failure the half-life is prolonged. In chronic renal failure, the percentage of the drug excreted through the kidneys decreases, but when creatinine Cl is above 20 ml/min, its accumulation in the body does not occur, since in parallel there is an increase in metabolism and excretion in feces.

Indications for use Sparflo 200 mg 6 pcs. film-coated tablets

Infectious and inflammatory diseases caused by sensitive microflora: respiratory tract infections: pneumonia, chronic obstructive pulmonary diseases in the acute stage caused by Streptococcus pneumoniae, Staphylococcus spp., Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Klebsiella pneumoniae, Enterobacter cloacae, Moraxella catarrhalis, Mycoplasma pneumoniae, 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; kidney and urinary tract infections (cystitis, non-gonococcal urethritis, pyelitis); genital infections (including adnexitis, prostatitis); abdominal infections (bacterial infections of the gastrointestinal tract, including those caused by Shigella and Salmonella, biliary tract); infections of the skin and soft tissues (abscess, pyoderma, furunculosis, infectious dermatitis); infections of bones and joints (including osteomyelitis); infections due to immunodeficiency, incl. during treatment with immunosuppressive drugs or in patients with neutropenia; sexually transmitted diseases (gonorrhea, chlamydia); pulmonary tuberculosis (for the treatment of drug-resistant tuberculosis or in case of intolerance to 1st line therapy); leprosy.

Contraindications

hypersensitivity to the components of the drug; epilepsy; age up to 18 years (incomplete process of skeletal formation); prolonged QT interval 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; breastfeeding period. With caution: cerebral atherosclerosis; cerebrovascular accident; epileptic syndrome; living conditions (professional activities) that do not allow limiting insolation; chronic renal failure.

Application of Sparflo 200 mg 6 pcs. film-coated tablets during pregnancy and breastfeeding

Contraindicated during pregnancy. Breastfeeding should be stopped during treatment.

Overdose

Treatment: specific antidote is unknown. Symptomatic therapy, if necessary - hemodialysis and peritoneal dialysis.

Side effects Sparflo 200 mg 6 pcs. film-coated tablets

From the cardiovascular system: prolongation of the QT interval, tachycardia, thrombosis of cerebral arteries. From the digestive system: loss of appetite, nausea, vomiting, dyspepsia, abdominal pain, flatulence, diarrhea, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis. From the respiratory system: shortness of breath. From the nervous system: dizziness, headache, increased fatigue, drowsiness, anxiety, tremor, peripheral paralgesia (anomaly in the perception of pain), increased sweating, increased intracranial pressure, nightmares, confusion, depression, hallucinations, psychotic reactions, fainting states. From the senses: disturbances of taste and smell, visual impairment (for example, diplopia, changes in color vision), tinnitus, hearing loss. From the urinary system: hematuria, crystalluria (primarily with alkaline urine and low diuresis). From the musculoskeletal system: arthralgia, asthenia, myalgia, tendovaginitis. Allergic reactions: itching, drug fever, pinpoint hemorrhages (petechiae), erythema nodosum, swelling of the face, blood vessels or larynx, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome). From laboratory parameters: eosinophilia, leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia, increased activity of liver transaminases and alkaline phosphatase, hypoprothrombinemia, hypercreatinemia, hyperbilirubinemia, hyperglycemia. Other: photosensitivity, “flushes” of blood to the face.

Drug interactions

It has virtually no effect on the concentration of theophylline, oral hypoglycemic drugs, or indirect anticoagulants. NSAIDs (excluding acetylsalicylic acid) increase the risk of seizures. Oral administration together with iron-containing preparations, sucralfate and antacid preparations containing magnesium, aluminum, calcium, zinc, as well as iron salts, leads to a decrease in the absorption of sparfloxacin (it should be prescribed either 1-2 hours before or at least 4 hours later). after). Metoclopramide accelerates the absorption of sparfloxacin, which leads to a decrease in the time to reach its maximum concentration in plasma. Since sparfloxacin may prolong the QT interval, concomitant use with drugs that have the same effect is not recommended: class Ia and III antiarrhythmics, terfenadine, bepridil, erythromycin, astemizole, cisapride, pentamidine, tricyclic antidepressants and phenothiazine. When combined with other antimicrobial drugs, synergism is usually observed (beta-lactams, aminoglycosides, clindamycin, metronidazole); sparfloxacin can be successfully used in combination with azlocillin and ceftazidime for infections caused by Pseudomonas spp.; with mezlocillin, azlocillin and other beta-lactam antibiotics - for streptococcal infections; with beta-lactamase-resistant penicillins and vancomycin for staphylococcal infections; with metronidazole and clindamycin - for anaerobic infections. With simultaneous use of sparfloxacin with cyclosporine, an increase in serum creatinine is observed, so in such patients it is necessary to monitor this indicator 2 times a week.

Indications for use of the drug Sparflo

Uncomplicated and complicated infections caused by pathogens sensitive to the drug:

• respiratory infections: pneumonia, exacerbation of COPD, otitis media, sinusitis;
• gastrointestinal infections: salmonellosis, shigellosis;
• sexually transmitted diseases: gonorrhea, chlamydia;
• infections of the genitourinary system: urethritis, cystitis, pyelitis;
• infections of the skin and soft tissues: infected wounds, abscesses, pyoderma, furunculosis, infectious dermatitis;
• surgical infections.

Release form and composition

Sparflo is produced in the form of film-coated tablets: oval, light yellow or white, with “200” embossed on one side and a line on the other side (6 pieces in blisters; 1 blister in a cardboard box).

1 tablet contains:

• Active ingredient: sparfloxacin – 0.2 g;
• Auxiliary components: magnesium stearate, talc, colloidal silicon dioxide, crospovidone, microcrystalline cellulose, corn starch;
• Shell: quinoline yellow dye (E104), talc, titanium dioxide (E171), propylene glycol, hypromellose.

Drug interactions Sparflo

The simultaneous use of Sparflo and antacid drugs that contain aluminum or magnesium hydroxide, as well as ferrous sulfate and sucralfate, reduces the absorption of Sparflo. In this regard, Sparflo should be taken 1–2 hours before or at least 4 hours after taking these drugs. Unlike other fluoroquinolones, Sparflo has virtually no effect on the pharmacokinetics of theophylline. Sparflo increases the concentration of digoxin in the blood serum; careful monitoring is required when taking these drugs simultaneously. It is not recommended to use Sparflo simultaneously with drugs that can cause prolongation of the QT (terfenadine, astemizole, erythromycin, class Ia and III antiarrhythmic drugs). Cisapride accelerates the absorption of sparfloxacin, but does not affect its bioavailability. Cimetidine does not affect the distribution of sparfloxacin.

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before you start using Sparflo, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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Contraindications

Absolute:

• Severe renal failure;
• Glucose-6-phosphate dehydrogenase deficiency;
• Prolonged QT interval or other factors contributing to the development of arrhythmias: atrial fibrillation, congestive heart failure, severe bradycardia, hypokalemia;
• Epilepsy;
• Concomitant therapy with drugs that prolong the QT interval: phenothiazine, tricyclic antidepressants, pentamidine, cisapride, class I A and III antiarrhythmic drugs, erythromycin, astemizole, bepridil, terfenadine;
• Children and adolescents up to 18 years of age;
• Pregnancy;
• Breastfeeding period;
• Hypersensitivity to the components of the drug.

Relative (must be used with caution, as there is a high likelihood of complications):

• Atherosclerosis of cerebral vessels;
• Cerebrovascular accidents;
• Convulsive syndrome;
• Chronic renal failure;
• Living or professional conditions that do not allow limiting insolation.

special instructions

During the period of use of the drug and for 3 days after the end of therapy, it is important to avoid ultraviolet radiation.

In isolated cases, taking fluoroquinolones was accompanied by tendon ruptures; such complaints are grounds for discontinuation of therapy.

To avoid the development of crystalluria, it is unacceptable to exceed the recommended daily doses of the drug. Patients should be ensured that their urine is acidic and that they consume sufficient fluids.

During therapy, you should refrain from engaging in potentially hazardous activities, including driving vehicles, that require increased attention and speed of psychomotor reactions.

Directions for use and dosage

The tablets are taken orally, regardless of food intake: swallowed whole (do not chew), washed down with a sufficient amount of liquid.

The duration of therapy is determined individually and depends on the results of bacteriological examination, the severity and clinical course of the disease.

Sparflo tablets are recommended to be taken in the following doses:

• Pneumonia, exacerbation of chronic bronchitis: on the first day – 2 pcs. once, then - 1 pc. per day for 10 days. Patients with creatinine clearance <50 ml per minute on the first day are prescribed 2 pcs. once, then - 1 pc. every 48 hours;
• Infections of the ENT organs (including sinusitis): on the first day – 2 pcs. once, then - 1 pc. per day for 10 days;
• Pulmonary tuberculosis (in combination with anti-tuberculosis drugs): on the first day - 2 pcs. once, then - 1 pc. per day for 30 days;
• Urinary tract infections: on the first day – 1 pc. once, then - ½ pcs. per day for 10-14 days;
• Acute gonorrheal urethritis: on the first day – 2 pcs. once, then after 24 hours, 1 pc. Course dose – 3 pcs.;
• Non-gonococcal urethritis: on the first day – 1 pc. once, then - ½ pcs. 1 time per day for 6 days;
• Bacterial prostatitis, chlamydial infections: on the first day – 2 pcs. once, then - 1 pc. per day for 10-14 days;
• Skin and soft tissue infections: on the first day – 2 pcs. once, then - 1 pc. 1 time per day for 3-9 days;
• Leprosy: 1 pc. 1 time per day for 84 days.