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

Active substance: pefloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: UNIQUE PHARMACEUTICAL Laboratories (India) JB Chemicals & Pharmaceuticals (India)
Composition, form of production and packaging
The solution for infusions is
transparent, from colorless to light yellow color.

1 ml of 1 fl.

pefloxacin mesylate dihydrate 5.59 mg 559 mg,

which corresponds to the content of pefloxacin 4 mg 400 mg

Excipients: dextrose anhydrous, disodium edetate, water d / u.

100 ml - plastic bottles (1) - cellophane wrappers (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Antimicrobial preparation of a broad spectrum of action from the group of fluoroquinolones.
It is bactericidal. The drug inhibits the DNA enzyme enzyme of bacteria, as a result of which DNA replication and the synthesis of bacterial cell proteins are disturbed.
Gram-negative aerobic bacteria are usually sensitive to pefloxacin : Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Neisseria gonorrhoeae;
intracellular pathogens: Chlamydia spp., Mycoplasma spp .; Gram-positive aerobic bacteria: Streptococcus spp., Clostridium perfringens.
Moderately sensitive: Acinetobacter spp.

The drug is resistant gram-negative anaerobic bacteria Bacteroides spp.
(with the exception of B. fragilis), Spirochaetaceae, Mycobacterium tuberculosis.
PHARMACOKINETICS

After intravenous administration of C max pefloxacin in the blood serum is achieved within 60 min.
T 1/2 - from 7.2 to 13 hours after a single dose. After repeated injections, T 1/2 is 14-15 hours. Pefloxacin penetrates well into the body tissues (bronchial mucosa, bones, heart, spinal fluid, sputum, urine, secretion of the prostate, bile, peritonial fluid). Metabolised in the liver.
With normal liver and kidney function, about half of the injected drug is excreted by the kidneys in unchanged form or in the form of metabolites.
About 30% is found in the stool in unchanged form and in the form of metabolites.
INDICATIONS

Infectious-inflammatory diseases caused by microorganisms sensitive to pefloxacin:

- upper and lower respiratory tract and ENT organs;

- kidney and urinary tract;

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

- Gallbladder and bile ducts;

- skin, mucous membranes and soft tissues;

- musculoskeletal system;

- abdominal cavity and pelvic organs;

- gonorrhea, chlamydia, prostatitis;

- surgical and nosocomial infections;

- severe systemic infections: septicemia, bacteremia, endocarditis, meningoencephalitis, osteomyelitis.

DOSING MODE

The dosage regimen is set individually, depending on the localization and severity of the infection, as well as the sensitivity of the microorganism.
In severe infections, the drug is given IV infusion (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.
Patients with impaired renal function (with creatinine clearance less than 20 ml / min) single dose should be 50% of the average dose with a multiplicity of appointment 2 times / day or a full single dose administered 1 time / day.

In patients with impaired liver function , correction of the dosing regimen is required: with minor violations, the drug is prescribed at a dose of 0.4 g / day;
with more severe violations - every 36 hours; with severe liver pathology, the interval between administrations is extended to 2 days. The course of treatment - no more than 30 days.
For elderly people, the dose of the drug is reduced by about 1/3.

SIDE EFFECT

From the nervous system: depression, headache, dizziness, fatigue, insomnia, increased convulsive alertness, anxiety, agitation, tremor;
rarely convulsions.
On the part of the digestive system: nausea, vomiting, diarrhea, abdominal pain, anorexia, flatulence, pseudomembranous colitis, transient increase in hepatic transaminases, cholestatic jaundice, hepatitis, liver necrosis.

From the urinary system: crystalluria;
rarely glomerulonephritis, dysuria.
Allergic reactions: skin rash, skin itching, 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.

CONTRAINDICATIONS

- epilepsy;

- deficiency of glucose-6-phosphate dehydrogenase.

- Pregnancy;

- lactation period (breastfeeding);

- children and adolescence under 18;

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

With caution: atherosclerosis of cerebral vessels, cerebral circulation, organic lesions of the central nervous system, convulsive syndrome of unknown etiology, renal and / or hepatic insufficiency.

PREGNANCY AND LACTATION

Contraindicated.

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function (with creatinine clearance less than 20 ml / min) single dose should be 50% of the average dose with a multiplicity of appointment 2 times / day or a full single dose administered 1 time / day.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with impaired liver function , correction of the dosing regimen is required: with minor violations, the drug is prescribed at a dose of 0.4 g / day;
with more severe violations - every 36 hours; with severe liver pathology, the interval between administrations is extended to 2 days. The course of treatment - no more than 30 days.
APPLICATION FOR CHILDREN

Contraindicated in children under 18 years.

APPLICATION IN ELDERLY PATIENTS

For elderly people, the dose of the drug is reduced by about 1/3.

SPECIAL INSTRUCTIONS

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).

During treatment with pefloxacin, avoid direct exposure to sunlight.

Impact on the ability to drive vehicles and manage mechanisms

Patients receiving the drug should not engage in activities that require concentration and speed of psychomotor reactions.

OVERDOSE

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

Cimetidine and microsomal oxidation inhibitors increase T 1/2 , reduce overall clearance, but do not affect V d 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).

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

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).

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.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Store in a dark place at a temperature of no higher than 30 ° C.
Do not freeze. Keep out of the reach of children. Shelf life - 3 years. Do not use after the expiration date printed on the package.
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