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

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.

Pefloxacin is usually sensitive:

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

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

To the drug are resistant:

Gram-negative anaerobic bacteria, Bacteroides spp. (with the exception of B. fragilis), Spirochaetaceae, Mycobacterium tuberculosis.

Pharmacokinetics:

After intravenous administration, the maximum concentration of pefloxacin in serum is reached within 60 minutes. The elimination half-life is between 7.2 and 13 hours after a single dose. After repeated administration, the elimination half-life is 14 to 15 hours. Pefloxacin well penetrates into the tissues of the body (bronchial mucosa, bones, heart, spinal fluid, sputum, urine, secret prostate, 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 stool in an unchanged form and in the form of metabolites.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to pefloxacin:

- respiratory tract;

- lower respiratory tract and ENT organs;

- kidney and urinary tract;

- Digestive system (including 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.

Contraindications:

- pregnancy;

- lactation period (breastfeeding);

- children and adolescence - up to 18 years;

- 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 CNS lesions, 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.

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

Patients with impaired renal function (creatinine clearance at least 20ml / min) single dose should be 50% of the medium dose at a multiplicity of destination 2 times a day, or full single dose is administered 1 time per 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 effects:

From the nervous system: depression, headache, dizziness, fatigue, insomnia, increased convulsive readiness, 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, liver necrosis.

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: the specific antidote is unknown. Symptomatic therapy, with necessity - hemodialysis and peritoneal dialysis.

Interaction:

Cimetidine and other microsomal oxidation inhibitors increase T1 / 2, 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).

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

The simultaneous use of beta-lactam antibiotics can prevent the development of resistance during the periodtreatment 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.

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.

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;

To 100 ml in a plastic bottle with a protective white plastic cap and a ring - holder at the bottom of the bottle.

For 1 bottle in a cellophane wrapper along with instructions for use in a cardboard pack.

Packaging:(1) - plastic bottles (1) - packs cardboard

Storage conditions:

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 expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012529 / 02

Date of registration:13.02.2008

The owner of the registration certificate:Unik Pharmaceutical Laboratories Unik Pharmaceutical Laboratories India

Manufacturer: & nbsp

UNIQUE PHARMACEUTICAL Laboratories India

Representation: & nbsp"UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")""UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")"India

Information update date: & nbsp30.08.2015

Illustrated instructions

Instructions

Unicpef® (Unikpef®)