Unicpef

The drug Unikpef belongs to the antibacterial drugs of the fluoroquinolone group.

Indications Unicpef

Unikpef is used to treat infectious pathologies whose pathogens are sensitive to the action of this drug:

• infectious pathologies of the urinary, digestive system, liver and biliary system;
• infectious diseases of the reproductive organs, musculoskeletal and respiratory systems, otolaryngological and ophthalmological inflammatory processes;
• intra-abdominal abscesses;
• inflammation of the abdominal cavity (peritonitis);
• septic conditions and septicemia;
• inflammatory processes in cardiac tissue;
• meningitis and encephalitis;
• osteomyelitis;
• genital infections;
• post-surgical and hospital-acquired infectious complications;
• as a preventive measure against infectious pathologies and their consequences.

Release form

Unikpef is a light-colored, capsule-shaped film-coated tablet with a notch on one side for easy dosing.

The active ingredient of Unikpef is pefloxacin mesylate dihydrate.

Additional components include corn starch, MCC, carboxymethyl starch, silicon dioxide, magnesium stearate, dye, talc.

Tablets in the amount of 10 pieces are sealed in a blister. The cardboard package may contain two or ten blisters (which corresponds to 20 or 100 tablets).

Pharmacodynamics

Unikpef is a fluoroquinolone antibacterial agent. Accordingly, it is a bactericidal drug, inhibits the action of bacterial DNA gyrase, suppresses RNA and the production of microbial proteins.

It acts on gram (-) microorganisms in the division or resting phase, as well as on gram (+) microorganisms in the division stage. The active component exhibits activity against aerobic microbes, as well as against bacteria resistant to other antimicrobial agents.

Unikpef acts:

• on the causative agent of aeromonosis;
• campylobacter;
• citrobacter;
• enterobacteria;
• Escherichia;
• Hemophilus;
• Klebsiella;
• legionella;
• moraxellas;
• morganella;
• Neisseria;
• pasturella;
• Proteus;
• providence;
• salmonella;
• shigella;
• serratia;
• staphylococci;
• ureaplasma;
• yersinia.

Less sensitive are pseudomonads, clostridia, chlamydia, mycoplasma. Gram (-) anaerobes, pale treponema, tuberculosis mycobacteria are resistant to the action of the drug.

Pharmacokinetics

The absorption of the drug is quite good: 20 minutes after oral administration of a single amount of Unikpef, up to 90% is absorbed.

The maximum amount of the active component in the blood is detected after 90-120 minutes. The therapeutic content of Unikpef is determined over a period of 12 to 15 hours.

If Unikpef has entered the body multiple times, its maximum amount in the blood serum can be 10 mcg/ml, in bronchial secretions – 5 mcg/ml, and the ratio of the amount of the drug in the mucous membranes and bloodstream is 100%.

Plasma protein binding ranges from 25 to 30%.

The active ingredient freely enters liquid media and tissues, including bones, cerebrospinal fluid, prostate, and lung tissue. The content in cerebrospinal fluid after three doses of the drug in a standard dose is 4.5 mcg/ml, in an overdose – 9.8 mcg/ml. The amount in the blood serum and cerebrospinal fluid is 89%.

Contents 12 hours after taking Unikpef:

• in the thyroid gland – 11.4 mcg/g;
• in salivary fluid – 2.2 mcg/g;
• in the skin – 7.6 mcg/g;
• in the nasopharyngeal mucosa – 6 mcg/g;
• in the pharyngeal tonsils – 9 mcg/g;
• in muscle tissue – 5.6 mcg/g.

Metabolism occurs in the liver. The main metabolite is dimethylpefloxacin, which is further oxidized to form pefloxacin glucuronide.

The half-life is 8 to 10 hours, with repeated entry into the body - 12 to 13 hours. Excretion is 60% through the urinary system, 30% through the liver.

The amount of unchanged drug in urine 60-100 minutes after administration can be 25 mcg/ml, and after 24 hours – up to 15 mcg/ml.

The unchanged active component and its metabolic products can be detected in urine for 84 hours after the end of treatment with the drug.

It is practically not amenable to hemodialysis.

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Dosing and administration

The medicine is used for internal use, always before meals.

The dosage and treatment regimen are determined individually - this may depend on the specific disease and the complexity of the infectious process, as well as on the type of pathogen and its sensitivity to the drug.

In case of uncomplicated infectious disease, 0.4 g of the medicine is usually taken twice a day. The average amount of Unikpef per day is 0.8 g twice a day. The tablet should be swallowed without chewing or crushing, with a sufficient amount of liquid.

Patients with functional liver disorders require dosage adjustment:

• for minor disorders, take 400 mg per day;
• for moderate disorders, take 400 mg once every 36 hours;
• For severe disorders, 400 mg of Unikpef is prescribed once every 48 hours.

The duration of the course of therapy is no more than one month.

In case of renal dysfunction (creatinine clearance less than 20 ml per minute), half the average amount of Unikpef is taken at one time.

For elderly patients, the dosage is reduced by approximately a third.

Use Unicpef during pregnancy

Unikpef is not prescribed to pregnant and lactating women, since there is a risk of developing erosive damage to cartilage tissue in the unborn child.

Contraindications

• Epileptic seizures;
• hemolytic anemia;
• glucose-6-phosphate dehydrogenase deficiency;
• the period of bearing and feeding a child;
• tendency to allergies to the ingredients of the drug;
• not used in pediatrics (only from 18 years of age).

There are also some conditions in which taking Unikpef is possible, but only under constant medical supervision:

• atherosclerotic changes in the blood vessels of the brain;
• cerebrovascular accident;
• convulsions, unspecified;
• severe liver and kidney damage.

Side effects Unicpef

In most cases, Unikpef is tolerated without any additional undesirable symptoms. However, sometimes they do occur:

• pain in the epigastrium, increased gas formation, attacks of nausea and vomiting, diarrhea, colitis, jaundice, liver damage;
• urinary disorder;
• sleep disturbances, headaches, apathy or nervousness, depression, tremors in the muscles of the arms and legs, convulsions;
• muscle pain, joint pain, vascular inflammation (with intravascular injections);
• blood test: decreased number of leukocytes, platelets, increased level of eosinophils;
• manifestations of allergies (skin rashes, itching, redness, swelling);
• increased heart rate;
• fungal infections (candida).

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Overdose

Signs of overdose include increased side effects. In more severe cases, confusion and convulsions are possible.

Treatment consists of gastric lavage, taking sorbents (activated carbon, enterosgel). Symptomatic drugs may be prescribed.

There is no special agent that neutralizes the effect of pefloxacin.

Hemodialysis and peritoneal dialysis procedures are practically ineffective.

Interactions with other drugs

The active ingredient of the drug acts simultaneously with beta-lactam antimicrobial drugs. Unikpef is prescribed in combination with metronidazole and vancomycin.

Combination with rifampicin gives a greater effect against staphylococcal infection. The same can be said about the combined administration with aminoglycosides, ceftazidine - such treatment mutually enhances the antimicrobial action of drugs.

The active component increases the level of theophylline in the blood serum and central nervous system, therefore, when combining these drugs, the dosage of theophylline is usually adjusted to avoid overdose and the development of side effects.

When used in combination with tetracycline or chloramphenicol, Unikpef has the opposite effect.

In combination with indirect anticoagulants, Unikpef may provoke a decrease in the prothrombin index.

Unikpef is incompatible with drugs containing heparin.

If urine testing is performed during treatment with the drug, methods without the use of copper sulfate reagent should be used, since in this case an erroneous result is possible.

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Storage conditions

The medicine is stored in the original packaging, at a temperature of no more than +30°C. The medicine should not be frozen under any circumstances.

Keep out of reach of children.

Shelf life

The shelf life is up to 3 years, after which the medication is prohibited from being used.

The medicine Unikpef is permitted to be dispensed in pharmacies only with a doctor's prescription.