Universal reference book for medicines
Product name: ABAKTAL ® (ABAKTAL ® )

Active substance: pefloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: LEK dd (Slovenia)
Composition, form of production and packaging
The tablets covered with a film membrane
from white to slightly yellowish color, oval, biconcave.

1 tab.

pefloxacin mesylate dihydrate 558.5 mg,

which corresponds to the content of pefloxacin 400 mg

Excipients: lactose monohydrate - 79.5 mg, corn starch - 32 mg, povidone - 32 mg, sodium carboxymethyl starch - 32 mg, talc - 27 mg, silicon dioxide colloidal anhydrous - 2 mg, magnesium stearate - 7 mg.

The composition of the membrane: hypromellose 13.166 mg, titanium dioxide 2.09 mg, talc 854 μg, macrogol 400 1.79 mg, carnauba wax 100 μg.

10 pieces.
- blisters (1) - packs of cardboard.
Concentrate for the preparation of a solution for intravenous administration is transparent, from light yellow to yellow.

1 ml of 1 amp.

pefloxacin (in the form of mesylate) 80 mg 400 mg

Excipients: ascorbic acid, sodium metabisulphite, disodium edetate, benzyl alcohol, sodium bicarbonate, water d / u.

5 ml - ampoules (10) - pallets (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Synthetic antibacterial drug from the group of fluoroquinolones.
Has a bactericidal effect, inhibiting the replication of bacterial DNA at the level of DNA-gyrase.
Abactal is active against Staphylococcus aureus, Escherichia coli, Klebsiella spp., Enterobacter spp., Serratia spp., Proteus mirabilis, indole-positive strains of Proteus spp., Citrobacter spp., Salmonella spp., Shigella spp., Haemophilus influenzae, Neisseria gonorrhoeae .

The drug is moderately sensitive to Streptococcus spp.
(including Streptococcus pneumoniae), Pseudomonas spp., Acinetobacter spp., Clostridium perfringens, Mycoplasma spp., Chlamydia spp.
The drug is resistant to gram-negative anaerobes, Spirochaeta spp., Mycobacterium tuberculosis.

PHARMACOKINETICS

Suction

After ingestion pefloxacin is well absorbed from the digestive tract.
C max is reached after 1-1.5 hours after administration. Bioavailability is about 100%.
Distribution

The degree of binding to plasma proteins is 25-30%.
V d - 1.7 l / kg. Pefloxacin rapidly penetrates into tissues, organs and body fluids (aortic valves, mitral valve, cardiac muscle, bones, abdominal cavity, peritoneal fluid, gall bladder, prostate gland, saliva, sputum). The concentration of pefloxacin in these liquids and tissues is higher than the concentration in the blood plasma.
Metabolism and excretion

Biotransformatsya in the liver.
T 1/2 is approximately 10.5 hours. With normal liver and kidney function, approximately half of the administered dose is excreted in the urine unchanged and in the form of metabolites for 48 hours. About 20-30% of pefloxacin is excreted with bile.
Pharmacokinetics in special clinical cases

If the renal function is impaired, the plasma concentration of pefloxacin and T 1/2 does not change.

If there is a violation of liver function, the plasma clearance of pefloxacin is significantly reduced, and T 1/2 is correspondingly increased.

INDICATIONS

Treatment of infectious diseases caused by microorganisms sensitive to the preparation:

- infections of the kidneys and urinary tract;

- infections of the pelvic organs (including adnexitis, prostatitis);

- infections of the lower respiratory tract;

- infections of the ENT organs (including chronic sinusitis, severe external otitis media);

- severe bacterial infections of the gastrointestinal tract (including salmonellosis, typhoid fever);

- infections of the liver and biliary tract;

- infections of the abdominal cavity (intra-abdominal abscesses, peritonitis);

- infections of bones, joints and connective tissue (including osteomyelitis);

- infections of the skin and soft tissues (including those caused by staphylococcus, resistant to penicillin);

- meningeal infections;

- sepsis;

- bacterial endocarditis;

- Gonorrhea.

It is used as a monotherapy or in combination with other antimicrobial drugs.

The drug is effective in the prevention of infections in patients with immunodeficiency.

DOSING MODE

The average dose for oral administration is 800 mg / day.
The drug is prescribed for 400 mg (1 tab.) 2 times / day, every 12 hours. The maximum daily dose is 1.2 g.
In the treatment of certain infections of the genitourinary system , Abaktal may be administered at a dose of 400 mg (1 tab.) 1 time / day in the morning or evening.

For treatment of uncomplicated gonorrhea in men and women appoint the drug once in a dose of 800 mg.

With severe hepatic insufficiency, it is recommended to prescribe the drug at a dose of 400 mg / day (every 24-48 hours).

Tablets should be taken with meals to avoid abnormalities on the part of the gastrointestinal tract.

In / in the drug is prescribed as an infusion at a dose of 400 mg every 12 hours;
duration of infusion is 1 hour. Preliminary, the contents of one ampoule (400 mg) are diluted with 250 ml of a 5% solution of dextrose (glucose). Abaktal can not be diluted with a solution of sodium chloride or any solvent containing chlorine ions.
For faster achievement of therapeutic concentrations, administration in the first dose of 800 mg is allowed.
The maximum daily dose is 1.2 g.
For the prevention of infectious complications in surgery, iv administration of the drug in a dose of 400-800 mg per hour is recommended before the operation.

For patients with liver disease, a single dose for intravenous drip administration is 8 mg / kg body weight;
duration of infusion is 1 hour. The frequency of infusion is in patients with jaundice 1 time per 24 hours; in patients with ascites - 1 time per 36 hours; in patients with jaundice and ascites - 1 time in 48 hours.
In elderly patients, especially with concomitant disorders of kidney function, the dose should be reduced both when taken orally, and with iv introduction.

SIDE EFFECT

On the part of the digestive system: loss of appetite, dyspepsia, diarrhea, nausea, taste change, vomiting, transient increase in hepatic enzyme activity, alkaline phosphatase and bilirubin level;
very rarely - pseudomembranous colitis.
From the side of the central nervous system: headache, anxiety, dizziness, a state of heightened mental arousal, depression, insomnia, visual impairment, confusion, hallucinations, tremor;
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, itching, hives, redness of the skin;
rarely - bronchospasm, photosensitivity.
Other: transient changes in the pattern of peripheral blood.

CONTRAINDICATIONS

- Pregnancy;

- lactation (breastfeeding);

- age up to 18 years;

- Hypersensitivity to quinolones.

With caution appoint a drug for violations of the central nervous system (including epileptic syndrome of unknown etiology), combined renal and hepatic insufficiency, with severe hepatic insufficiency.

PREGNANCY AND LACTATION

Abaktal is contraindicated in pregnancy.

If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution appoint a drug with combined renal and hepatic insufficiency.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution appoint a drug with combined renal-hepatic failure, with severe hepatic failure.

For patients with liver disease, a single dose for intravenous drip administration is 8 mg / kg body weight;
duration of infusion is 1 hour. The frequency of infusion is in patients with jaundice 1 time per 24 hours; in patients with ascites - 1 time per 36 hours; in patients with jaundice and ascites - 1 time in 48 hours.
APPLICATION FOR CHILDREN

Contraindicated: age to 18 years.

APPLICATION IN ELDERLY PATIENTS

In elderly patients, especially with concomitant disorders of kidney function, the dose should be reduced both when taken orally, and with iv introduction.

SPECIAL INSTRUCTIONS

Solution for injection is used only in a hospital.

Due to possible photosensitization during the treatment with Abaktal, UV irradiation and direct sunlight should be avoided within 6 days after discontinuation of therapy.

If there is an allergic reaction or changes from the side of the central nervous system, as well as when suspicion of tendonitis should immediately cancel the drug.

Risk factors for the development of tendonitis on the background of fluoroquinolone therapy include: age over 60 years, renal failure, dialysis, concomitant therapy with GCS, dyslipidemia.
The patient should be warned about the need to cancel the drug at the appearance of the initial signs of tendonitis, exclude the load on the affected limb and consult a doctor.
There may be false-positive results in the determination of glucose in urine by the copper reduction method (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.

Caution should be exercised with the simultaneous administration of pefloxacin and isoniazid.

Impact on the ability to drive vehicles and manage mechanisms

Against the background of Abaktal use caution should be exercised when dealing with potentially dangerous activities requiring 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 charcoal.
It is necessary to provide medical control of the patient's condition, sufficient supply of liquid to the patient's body; if necessary, conduct symptomatic therapy. Hemodialysis is not an effective method of removing quinolone derivatives from the body.
DRUG INTERACTION

Absorption of pefloxacin is slowed down by simultaneous administration with antacids containing aluminum hydroxide and magnesium hydroxide (the interval between doses should be at least 2 h).

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 CNS.

With the simultaneous use of Abaktal and indirect anticoagulants, it is possible to enhance the effect of the latter.

With the combined use of fluoroquinolones and cyclosporine, an increase in the concentration of cyclosporine and the level of creatinine in the blood is possible.

The combination of pefloxacin with tetracyclines and chloramphenicol has an antagonistic effect.

Pharmaceutical interaction

Pefloxacin should not be mixed with solutions containing chlorine ions, to avoid precipitation.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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