Abaktal tablets 400mg, No. 10

Infectious and inflammatory diseases caused by microorganisms sensitive to pefloxacin: infections of the kidneys and urinary tract; Gastrointestinal tract (including salmonellosis, typhoid fever); mouth, teeth, jaws; infections of the gallbladder and biliary tract (cholecystitis, cholangitis, empyema of the gallbladder); infections of the pelvic organs (including adnexitis and prostatitis); bones, joints, skin and soft tissues, infections of the lower respiratory tract and ENT organs (middle ear, paranasal sinuses, pharynx, larynx); eye infections; intra-abdominal abscesses, peritonitis, sepsis, septicemia; endocarditis; meningoencephalitis; osteomyelitis; gonorrhea, chlamydia, epididymitis, chancre; surgical and nosocomial infections; prevention of surgical infection.

Inside, on an empty stomach. The tablets are swallowed without chewing and drinking plenty of water. Doses are selected individually, depending on the location and severity of the infection, the sensitivity of microorganisms. For uncomplicated infections - 400 mg 2 times a day, the average daily dose is 800 mg in 2 divided doses.

Intravenous drip (for infective endocarditis, sepsis, osteomyelitis, for severe infections), 1st dose - 800 mg; then - 400 mg every 12 hours. The infusion is carried out for 1 hour; the contents of the ampoule are dissolved in 250 ml of 5% glucose solution. The course of treatment is 1-2 weeks (no more).

In case of impaired liver function, correction of the dosage regimen is necessary: ??with minor violations, the drug is prescribed at a dose of 400 mg / day, with more pronounced disorders - every 36 hours, with severe liver pathology, the interval between injections is increased to 2 days. The course of treatment is no more than 30 days.

For patients with impaired renal function (with Cl creatinine below 20 ml / min), a single dose is 50% of the average (with a frequency of administration 2 times a day) or a full single dose once a day. For the elderly, the dose of the drug is reduced by 1/3.

in a contour acheikova packing 10 pcs .; in a pack of cardboard 1 or 2 packages.

in ampoules of dark glass, 5 ml each, complete with an ampoule knife; in a pack of cardboard 10 pcs.

Hypersensitivity, epilepsy, hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, pregnancy, lactation, children (up to 18 years).

With caution - atherosclerosis of the vessels of the brain, cerebrovascular accident, organic lesions of the central nervous system, convulsive syndrome of unknown etiology.

pharmachologic effect

Synthetic antibacterial drug from the group of fluoroquinolones. It has a bactericidal effect, inhibiting the replication of bacterial DNA at the level of DNA gyrase. Abaktal is active against Staphylococcus aureus, Escherichia coli, Klebsiella spp., Enterobacter spp., Serratia spp., Proteus mirabilis, indole-positive Proteus spp., Citrobacter spp., Salmonella spp., Shigella spp., Haemophilusus ... Streptococcus spp. Are moderately susceptible to the drug. (including Streptococcus pneumoniae), Pseudomonas spp., Acinetobacter spp., Clostridium perfringens, Mycoplasma spp., Chlamydia spp. Gram-negative anaerobes, Spirochaeta spp., Mycobacterium tuberculosis are resistant to the drug. Pharmacokinetics

Suction

After oral administration, pefloxacin is well absorbed from the gastrointestinal tract. Cmax is reached within 1-1.5 hours after administration. Bioavailability is about 100%. Distribution The degree of plasma protein binding is 25-30%. Vd - 1.7 l / kg. Pefloxacin quickly penetrates into tissues, organs and body fluids (aortic valves, mitral valve, heart muscle, bones, abdominal cavity, peritoneal fluid, gallbladder, prostate gland, saliva, sputum). The concentration of pefloxacin in the listed fluids and tissues is higher than the concentration in blood plasma. Metabolism and excretion Biotransformed in the liver. T1 / 2 is approximately 10.5 hours. With normal liver and kidney function, about half of the administered dose is excreted in the urine unchanged and in the form of metabolites within 48 hours. About 20-30% of pefloxacin is excreted in the bile.

Pharmacokinetics in special clinical situations

In case of impaired renal function, the plasma concentration of pefloxacin and T1 / 2 do not change.

In case of impaired liver function, the plasma clearance of pefloxacin is significantly reduced, and T1 / 2, respectively, increases.

Side effect

On the part of the digestive system: loss of appetite, dyspepsia, diarrhea, nausea, change in taste, vomiting, transient increase in the activity of liver enzymes, alkaline phosphatase and bilirubin levels; very rarely - pseudomembranous colitis. From the side of the central nervous system: headache, anxiety, dizziness, a state of increased mental agitation, depression, insomnia, visual disturbances, confusion, hallucinations, tremors; rarely - convulsions. From the urinary system: crystalluria; rarely - hematuria, interstitial nephritis. From the musculoskeletal system: myalgia, arthralgia, tendonitis; in very rare cases, rupture of the Achilles tendon. Local reactions: phlebitis. Allergic reactions: skin rash, pruritus, urticaria, redness of the skin; rarely - bronchospasm, photosensitization. Others: transient changes in the picture of peripheral blood.Application during pregnancy and lactation

Abaktal is contraindicated for use during pregnancy. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be resolved.

Application for violations of liver function

The drug is prescribed with caution in case of combined renal-hepatic insufficiency, with severe hepatic insufficiency. For patients with liver disease, a single dose for intravenous drip is 8 mg / kg of body weight; the duration of the infusion is 1 hour. The frequency of infusion in patients with jaundice is 1 time per 24 hours; in patients with ascites - once every 36 hours; in patients with jaundice and ascites - once every 48 hours.

Application for impaired renal function

The drug is prescribed with caution in case of concomitant renal-hepatic insufficiency. Application in children

Contraindicated: under 18 years of age.

In elderly patients, especially with concomitant impaired renal function, the dose should be reduced both for oral administration and for intravenous administration.

special instructions

Solution for injection is used only in a hospital setting. Due to possible photosensitization during treatment with Abaktal, UV radiation and direct sunlight should be avoided for 6 days after stopping therapy. If an allergic reaction or changes in the central nervous system occurs, or if tendonitis is suspected, the drug should be discontinued immediately. Risk factors for the development of tendinitis during therapy with fluoroquinolones include: age over 60 years, renal failure, dialysis, concomitant GCS therapy, dyslipidemia. The patient should be warned about the need to cancel the drug when the initial signs of tendinitis appear, exclude the load on the affected limb and consult a doctor.False positive results can occur when determining urine glucose by copper reduction (using copper sulfate), therefore, enzymatic methods of analysis should be used. The drug can be used in combination with beta-lactam antibiotics, metronidazole, vancomycin and rifampicin. Care must be taken with the simultaneous appointment of pefloxacin and isoniazid. Influence on the ability to drive vehicles and control mechanisms Against the background of the use of Abaktal, care should be taken when engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.vancomycin and rifampicin. Care must be taken with the simultaneous appointment of pefloxacin and isoniazid. Influence on the ability to drive vehicles and control mechanisms Against the background of the use of Abaktal, caution should be exercised when engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.vancomycin and rifampicin. Care must be taken with the simultaneous appointment of pefloxacin and isoniazid. Influence on the ability to drive vehicles and control mechanisms Against the background of the use of Abaktal, caution should be exercised when engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms: nausea, vomiting, confusion, mental agitation; in severe cases - loss of consciousness, convulsions. Treatment: gastric lavage, activated carbon. It is necessary to ensure medical monitoring of the patient's condition, sufficient fluid intake into the patient's body; if necessary, symptomatic therapy is carried out. Hemodialysis is not an effective method for removing quinolone derivatives from the body.

Drug interactions

The absorption of pefloxacin is slowed down when taken simultaneously with antacids containing aluminum hydroxide and magnesium hydroxide (the interval between doses should be at least 2 hours). The simultaneous administration of Abaktal with cimetidine and ranitidine leads to an increase in T1 / 2 of pefloxacin. Pefloxacin reduces the metabolism of theophylline and NSAIDs in the liver, which leads to an increase in their concentration in the blood plasma and central nervous system. With the simultaneous use of Abaktal and indirect anticoagulants, it is possible to enhance the action of the latter. With the combined use of fluoroquinolones and cyclosporine, it is possible to increase the concentration of cyclosporine and the level of creatinine in the blood. The combination of pefloxacin with tetracyclines and chloramphenicol has an antagonistic effect. Pharmaceutical interactions Pefloxacin must not be mixed with solutions containing chlorine ions,to avoid precipitation.