Pefloxacin - instructions for use, dose, side effects, contraindications

Excipients: dextrose (glucose) in terms of anhydrous, disodium edetate dihydrate (disodium ethylenediamine-N, N, N salt¹,N¹ - tetraacetic acid 2-water (Trilon B)), water for injection.

Description:Transparent colorless or yellowish liquid

Pharmacotherapeutic group:antimicrobial agent-fluoroquinolone

ATX: & nbsp

J.01.M.A.03 Pefloxacin

Pharmacodynamics:

Antimicrobial preparation of a broad spectrum of action from the group of fluoroquinolones. It is bactericidal. Inhibits the DNA enzyme of the bacterial DNA, as a result of which DNA replication and the synthesis of bacterial cell proteins are disturbed.

Pefloxacin is usually sensitive:

Gram-negative aerobic bacteria: Escherichia coli, Klebsiella spp., Proteus vulgaris., Proteus mirabilis, Enterobacter spp., Neisseria gonorrhoeae, Serratia marcescens, Citrobacter spp., Salmonella spp., Shigella spp.

Some intracellular pathogens: Chlamydia spp., Mycoplasma spp. Gram-positive aerobic bacteria: Streptococcus spp., Clostridium perfringens. Moderately sensitive microorganisms: Acinetobacter spp.

To the drug are resistant: gram-negative anaerobic bacteria, Mycobacterium tuberculosis, Bacteroides spp. (3a exclusion Bacteroides fragilis), Spirochaetaceae.

Pharmacokinetics:

After intravenous administration, the maximum serum concentration of the drug is reached within 60 minutes. The half-life is between 7.2 and 13 hours after a single dose. After repeated administration, the elimination half-life is 14-15 hours. Pefloxacin penetrates well into the tissues of the body (bronchial mucosa, bones, heart, spinal fluid, sputum, urine, secretion of the prostate gland, bile, peritoneal fluid). Metabolised in the liver.

With normal liver and kidney function, about half of the injected drug is excreted through the kidneys in an unchanged form or in the form of metabolites. About 30% is found in the intestines in an unchanged form and in the form of metabolites.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to pefloxacin:

- lower respiratory tract and ENT organs;

- kidneys and urinary tract;

- digestive system (including mouth, teeth, jaws);

-zhelchnogo bubble and biliary tract;

- Skin covers, mucous membranes and soft tissues;

- musculoskeletal system;

- the abdominal cavity and pelvic organs;

-gonorrhea, chlamydia, prostatitis;

- surgical and nosocomial infections;

Heavy systemic infections: septicemia, bacteremia, endocarditis, meningoencephalitis, osteomyelitis.

Contraindications:

pregnancy;

-period of lactation (breastfeeding);

-Children and adolescents-18 years of age;

-increased sensitivity to pefloxacin or other drugs from the group of fluoroquinolones;

-epilepsy;

deficiency of glucose-6-phosphate dehydrogenase.

Carefully:

Atherosclerosis of cerebral vessels, cerebral circulation disorder, organic lesions of the central nervous system, convulsive syndrome of unknown etiology, renal and / or hepatic insufficiency

Pregnancy and lactation:contraindicated

Dosing and Administration:

The dosage regimen is set individually, depending on the localization and severity of the infection, as well as the sensitivity of the microorganism.

With infections of severe course, the drug is administered intravenously, drip (in 250 ml of 5% glucose solution, for 1 hour): the first dose is 800 mg; then - 400 mg every 12 hours. The average course duration is not more than 1-2 weeks.

In patients with impaired liver function, correction of the dosing regimen is required: for minor violations, the drug is prescribed at a dose of 0.4 g / day; with more severe violations - every 36 hours; with severe liver disease, the interval between administrations is extended to 2 days.

For elderly people, the dose of the drug is reduced by about 1/3. Patients with impaired renal function (with creatinine clearance below 20 ml / min) single dose should be 50% of the average dose with a multiplicity of appointment 2 times a day or a full single dose administered once a day.

Side effects:

From the nervous system: depression, headache, dizziness, fatigue, insomnia, increased convulsive alertness, anxiety, agitation, tremor, rarely - convulsions.

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, anorexia, flatulence, pseudomembranous colitis, transient increase in "liver" transaminases, cholestatic jaundice, hepatitis, and necrosis of the liver.

From the urinary system: crystalluria, rarely glomerulonephritis, dysuria.

Allergic reactions: skin rash, skin itch, urticaria, skin hyperemia, photosensitivity, rarely - Quincke's edema, bronchospasm, arthralgia.

From the hematopoietic system: leukopenia, neutropenia, thrombocytopenia (at doses of 1600 mg / day), agranulocytosis, eosinophilia.

Local reactions: phlebitis.

Other: tachycardia, myalgia, tendonitis, candidiasis.

Overdose:

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

Interaction:

Cimetidine and other microsomal oxidation inhibitors increase half-life, reduce overall clearance, but do not affect the volume of distribution and renal clearance.

Pefloxacin reduces the metabolism of theophylline in the liver, which leads to an increase in the concentration of theophylline in the plasma and the central nervous system (in order to avoid the development of intoxication the dose of theophylline should be reduced).

The simultaneous use of beta-lactam antibiotics can prevent the development of resistance during the treatment of staphylococcal infection. Aminoglycosides, piperacillin, azlocillin, ceftazidime increase the antibacterial effect (including infection with Pseudomonas aeruginosa).

Significantly reduces the prothrombin index (in patients taking indirect anticoagulants, continuous monitoring of the blood picture is necessary).

Drugs that block tubular secretion, slow the excretion of pefloxacin.

Pharmaceutically incompatible with heparin.

Do not dilute with sodium chloride solution or any solvent containing chlorine ions.

Special instructions:

With mixed infections, perforated processes in the abdominal cavity, with infections of the pelvic organs are combined with drugs active against anaerobes (metronidazole, clindamycin). If pelefloxacin occurs during or after treatment with severe and prolonged diarrhea, the development of pseudomembranous colitis should be ruled out (immediate withdrawal of the drug and the appropriate treatment).

In renal and hepatic insufficiency, a single dose and the frequency of administration (in proportion to the degree of damage to the function) should be reduced.

During treatment with pefloxacin, patients should receive a large amount of fluid (to prevent crystalluria).

Avoid contact with direct sunlight.

Effect on the ability to drive transp. cf. and fur:Patients receiving the drug should not engage in activities that require concentration and speed of psychomotor reactions.

Form release / dosage:

Solution for infusion 4 mg / ml.

100 ml in glass bottles. A bottle with the instruction for use is placed in an individual pack.

For hospitals: 48 bottles without packs with 5 instructions for use in a box of corrugated cardboard.

Packaging:(1) - bottles
(1) - bottles (1) - packs of cardboard
(1) - bottles (48) - cardboard boxes

Storage conditions:

List B. In the dark place at a temperature of 10 ° C to 25 ° C. Freezing is not allowed. Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002513/07

Date of registration:31.08.2007

The owner of the registration certificate:KRASFARMA, JSC KRASFARMA, JSC Russia

Manufacturer: & nbsp

KRASFARMA, JSC Russia

Information update date: & nbsp30.08.2015

Illustrated instructions

Instructions

Pefloxacin (Pefloxacin)