Abaktal – instructions for using the medicine, structure, Contraindications

Registration certificate holder: SANDOZ, d.d. (Slovenia)

ATX code: J01MA03 (Pefloxacin)

Active material: pefloxacin (pefloxacin) WHO registered

Pharmaceutical form

Abaktal®

Tab., cover. film-coated, 400 mg: 10 PC. reg. №: P N008768 / 02 from 18.08.10 – IndefinitelyDate of re-registration: 15.08.19

Product form, packaging and composition of Abaktal®

Pills, film-coated from white to slightly yellowish, Oval, lenticular.

Excipients: lactose monohydrate – 79.5 mg, corn starch – 32 mg, povidone – 32 mg, sodium carboxymethyl starch – 32 mg, talc – 27 mg, Colloidal anhydrous silica – 2 mg, magnesium stearate – 7 mg.

The composition of the shell: gipromelloza – 13.166 mg, Titanium dioxide – 2.09 mg, talc – 854 g, macrogol 400 – 1.79 mg, carnauba wax – 100 g.

10 PC. – blisters (1) – packs cardboard.

Clinical and pharmacological group: Fluoroquinolone antibacterial drug

Pharmaco-therapeutic group: Antimicrobial agent, fluoroquinolone

Abaktal: pharmachologic effect

Broad-spectrum antimicrobial agent of the fluoroquinolone group. It has bactericidal activity, inhibiting bacterial DNA replication at the level of DNA gyrase, also has an effect on RNA and protein synthesis of bacteria.

Effective against Gram-negative bacteria, in the process of dividing (growth phase), and at rest. In relation to gram-positive strains, it acts only on cells, in the process of mitotic division. Shows activity against intracellular pathogens.

Active against gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus saprophyticus; Gram negative bacteria: Escherichia coli, Klebsiella spp., Enterobacter spp., Serratia spp., Proteus is wonderful, Proteus vulgaris, Citrobacter spp., Salmonella spp., Shigella spp., Haemophilus ducreyi, Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Aeromonas spp., Campylobacter spp., Legionella spp., Moraxella spp., Morganella spp., Pasteurella spp., Providencia spp., Pseudomonas aeruginosa, Yersinia spp., Ureaplasma urealyticum.

Moderately sensitive to pefloxacin: Acinetobacter spp., Gardnerella vaginalis, Mycoplasma spp., Chlamydia spp; weakly sensitive: Streptococcus spp. (incl. Streptococcus pneumoniae), Enterococcus spp.

Abaktal: pharmacokinetics

After a single dose infusion 400 mg Cmax of pefloxacin is 4 mcg/ml and maintained for 12-15 no. After IV infusion, pharmacokinetic parameters are the same, as after ingestion. AUC for both methods of application is the same, indicating complete absorption of pefloxacin.

After oral administration, pefloxacin is rapidly absorbed from the gastrointestinal tract.. After a single oral 400 mg of pefloxacin through 20 min absorbed 90% dose, while Cmax is reached through 1-2 h and is through 1.5 no 4 ug / ml. Bioavailability - approx. 100%.

Plasma protein binding is 25-30%. Vd – 1.5-1.8 l / kg. Pefloxacin quickly penetrates tissues, organs and body fluids (aortic valves, mitral valve, cardiac muscle, bones, abdomen, peritoneal fluid, gallbladder, prostate, saliva, wetness, pancreatic tissue / including. necrotic/). The concentration of pefloxacin in the listed fluids and tissues is higher than the concentration in blood plasma.

T1/2 is approximately 8-10 no, repeated administration – 12-13 no. Write mainly with urine (60% during 72 no). 30% excreted in bile unchanged, partly as metabolites: NOR, pefloxacin-N-oxide and pefloxacin-glucuronide. The content of unchanged pefloxacin in the urine through 1-2 h after admission - 25 ug / ml, through 12-24 h - 15 mcg / ml. Unchanged pefloxacin and its metabolites are found in the urine for 84 h after the last injection of the drug. Extraction ratio of pefloxacin in hemodialysis -23%.

Indications of the active substances of the drug Abaktal®

Treatment of infectious and inflammatory diseases, caused by microorganisms sensitive to pefloxacin: liver and biliary tract infections; sepsis and bacterial endocarditis; staphylococcal meningitis and meningitis, caused by gram-negative flora; bone and joint infections; infections of the lower respiratory tract; infection of upper respiratory tract; urinary tract infection; infection of the abdominal cavity; gynecological infections; infections of skin and soft tissue; disease, sexually transmitted.

Treatment and prevention of infectious complications after surgical interventions.

Abaktal: dosing regimen

The method of application and dosing regimen of a particular drug depends on its form of release and other factors.. The optimal dosing regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed..

Establish individually, Depending on the location and severity of the current infection, as well as the sensitivity of the microorganism.

If ingestion is the average dose is 800 mg / day 2 admission.

For severe infections, it is administered intravenously: the first dose – 800 mg, then – by 400 mg every 12 no. In case of impaired renal function of a mild degree, it is administered by 400 mg every 24 no, with more severe disorders – every 36 no.

For patients with liver disease, with intravenous drip, a single dose is 8 mg / kg; duration of infusion – 1 no. The frequency of infusions is in patients with jaundice 1 once every 24 no; in patients with ascites – 1 once every 36 no; in patients with jaundice and ascites – 1 once every 48 no.

The maximum daily dose is 1.2 g / day.

Abaktal: side effects

From the digestive system: nausea, vomiting, diarrhea, stomach ache.

CNS: headache, insomnia.

On the part of the musculoskeletal system: myalgia, arthralgia.

From the hematopoietic system: thrombocytopenia (at an application rate 1.6 g / day).

Dermatological reactions: photosensitivity.

Allergic reactions: itching, hives.

Abaktal: contraindications for use

Deficiency of glucose-6-fosfatdegidrogenazы, pregnancy, lactation (breast-feeding), childhood and adolescence up 15 years, hypersensitivity to pefloxacin and other fluoroquinolones.

Abaktal: use during pregnancy and lactation

Pefloxacin is contraindicated for use during pregnancy and lactation. (breast-feeding).

In experimental studies, the toxic effect of monofluoroquinolones on cartilage tissue has been established..

Abaktal: use for violations of liver function

Use with caution in patients with severe hepatic impairment.

Abaktal: use for impaired renal function

Application is possible according to the dosing regimen.

Abaktal: use in children

Contraindicated in childhood and adolescence 15 years.

Abaktal6 special instructions

Use with caution in patients with cerebral atherosclerosis, disorders of cerebral circulation, epilepsy, convulsive syndrome of unknown etiology, with severe liver dysfunction.

During the treatment period, ultraviolet radiation should be avoided..

Perhaps the combined use of pefloxacin with beta-lactam antibiotics and rifampicin in order to prevent the development of bacterial resistance to the latter.

Abaktal: drug interaction

With the simultaneous use of pefloxacin and aminoglycosides, synergism is noted in relation to Pseudomonas aeruginosa; with indirect anticoagulants – may increase their activities.

Absorption of pefloxacin slows down when taken with antacids, containing aluminum hydroxide and magnesium hydroxide.

Simultaneous administration of pefloxacin and cimetidine leads to a decrease in total clearance and an increase in T1 / 2 of pefloxacin.

Pefloxacin inhibits microsomal oxidation in liver cells, acting on the enzymes of the cytochrome P450 system. Therefore, pefloxacin slows down the metabolism of theophylline in the liver., which leads to an increase in the concentration of theophylline in plasma.

Pefloxacin must not be mixed with solutions, containing chloride ions, to avoid precipitation.