Pharmacy No. 84. Delivery of medicines to your home and office.

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Instructions for use AXETINE

Before prescribing Aksetin, a thorough collection of the patient's medical history is necessary to identify hypersensitivity reactions to cephalosporins, penicillins and other drugs. Aksetin is prescribed with caution to patients with allergies to penicillin. Antibacterial drugs should be prescribed with caution to patients who are allergic to any medications. If allergic reactions to taking Aksetin develop, treatment should be stopped. Severe hypersensitivity reactions may require emergency treatment.

There are reports of Clostridium difficile associated diarrhea (CDAD) with the use of almost all antibacterial agents, including Aksetin, which can range from mild diarrhea to fatal colitis. Treatment with antibacterial agents of the normal microflora of the large intestine leads to excessively rapid growth of C. difficile. C. difficile produces toxins A and B, which contribute to the development of SDAD. Overproduction of C. difficile toxins leads to increased morbidity and mortality because this infection is resistant to antibiotic therapy and colectomy may be required. A diagnosis of SDBP should be considered in all patients who develop diarrhea after taking antibiotics. A thorough history taking is necessary, because SDBP can develop 2 months after the prescription of antibacterial drugs. If SDAD is suspected or this diagnosis is confirmed, further antibiotic therapy is not effective against C. difficile and requires discontinuation of the drug. Normalization of water and electrolyte balance, administration of protein preparations, antibacterial therapy for C. difficile, as well as surgical treatment if indicated are indicated. If there is no effect from the treatment, vancomycin is prescribed orally as the drug of choice for the treatment of antibiotic-associated pseudomembranous colitis caused by C. difficile. Axetine rarely has an effect on renal function, however, examination of the kidneys is necessary in patients with severe infectious processes and receiving maximum doses of the drug. Cephalosporins should be prescribed with caution to patients receiving concurrent diuretics due to the possible effect on renal function.

The total daily dose of Aksetin should be reduced in patients with renal failure due to the high concentration of the antibiotic in the blood plasma.

As with the prescription of other antibiotics, prolonged use of Axetine can lead to the growth of resistant flora. Careful examination of patients is necessary. If superinfection occurs during treatment, appropriate measures must be taken.

Broad-spectrum antibiotics should be prescribed with caution to patients with gastrointestinal diseases, especially a history of colitis. Concomitant use of aminoglycosides and cephalosporins leads to increased nephrotoxicity.

When treating meningitis in children with Aksetin, mild or moderate hearing loss was observed in some cases. The presence of microorganisms in the cerebrospinal fluid up to 18-36 hours during treatment with cefuroxime or in combination with other antibiotics was also revealed, however, the clinical significance of this is unknown. Cephalosporins can lead to a decrease in prothrombin activity. The risk group includes patients with renal or liver failure, malnutrition, who received a long course of antimicrobial therapy and took anticoagulants. In patients at risk, prothrombin time should be checked and prophylactic vitamin K prescribed.

Prescribing Aksetin for unconfirmed sensitivity of microorganisms or prophylactic prescription is not justified and leads to the emergence of strains of bacteria resistant to cephalosporins.

During treatment, a positive direct Coombs reaction and a false positive urine reaction to glucose with Benedict's or Fehling's solution are possible. There are no known cases of the drug affecting the ability to drive vehicles and machines.

Children under 3 months:

The safety and effectiveness of administration to children under 3 months has not been studied. There is evidence of the accumulation of cephalosporins in newborns with an increase in T1/2 of the drug.

Elderly patients:
There were no differences in the effectiveness and safety of the drug when prescribed to young and elderly patients. Renal dysfunction is common in elderly patients, so monitoring of renal function is necessary before prescribing Aksetin.

Aksetin tablets 500 mg, 10 pcs.

Absorption

After oral administration of cefuroxime, axetil is absorbed in the intestine, hydrolyzed on the mucous membrane and enters the bloodstream as cefuroxime.

The optimal level of absorption occurs immediately after eating. Cefuroxime maximum serum levels (2.9 mcg/mL for the 125 mg dose, 4.4 mcg/mL for the 250 mg dose, 7.7 mcg/mL for the 500 mg dose, and 13.6 mcg/mL for the 1000 mg dose ) is observed approximately 2-3 hours after taking the drug with food. The rate of absorption of cefuroxime when taken as a suspension is reduced compared to that when taken as tablets, which subsequently leads to lower maximum blood levels and reduced systemic bioavailability (4-17% less). Cefuroxime axetil oral suspension is not bioequivalent to cefuroxime axetil tablets as demonstrated in a study in healthy adult volunteers, and therefore are not interchangeable on a mg-for-mg basis. The pharmacokinetics of cefuroxime is linear in the dose range from 125 to 1000 mg when administered orally. Accumulation of cefuroxime did not occur after repeated oral doses of 250 to 500 mg.

Distribution

The level of protein binding is 33-50% depending on the determination method. Following administration of a single 500 mg dose of cefuroxime axetil tablets to 12 healthy volunteers, the apparent volume of distribution was 50 L (CV% = 28%). Concentrations of cefuroxime exceeding the MIC for most common pathogens are achieved in the tissues of the tonsils, sinuses, bronchial mucosa, bones, pleural fluid, joint fluid, synovial fluid, interstitial fluid, bile, sputum and aqueous humor of the eye chamber. Cefuroxime penetrates the blood-brain barrier during inflammation of the meninges.

Metabolism

Cefuroxime is not metabolized.

Conclusion

The half-life in serum is 1 to 1.5 hours. Cefuroxime is eliminated by glomerular filtration and tubular secretion. Renal clearance ranges from 125 to 148 ml/min/1.73 m2.

Special patient groups

Floor

There were no differences in the pharmacokinetics of cefuroxime in men and women.

Elderly patients

No special measures are required when using the drug in elderly patients with normal renal function at a dose up to a maximum of 1 g per day. Elderly patients are more likely to have reduced kidney function. Therefore, the dose should be adjusted according to renal function in such patients.

Children

From 3 months of age, the pharmacokinetics of cefuroxime are the same as in adults.

There is available clinical trial data on the use of cefuroxime axetil in children under 3 months of age.

Kidney failure

The safety and effectiveness of cefuroxime axetil in patients with renal impairment have not been established. Cefuroxime is mainly excreted by the kidneys. Therefore, as with all similar antibiotics, patients with impaired renal function (creatinine clearance <30 ml/min) are advised to reduce the dose of cefuroxime to compensate for the slow elimination. Cefuroxime is effectively eliminated by dialysis.

Aksetin® (Axetin®)

The drug is used intramuscularly and intravenously.

Adults: Cefuroxime is usually prescribed at a dose of 750 mg-1.5 g every 8 hours. The course of treatment is usually from 5 to 10 days.

Newborns are prescribed IV at a dose of 30-100 mg/kg/day, divided into 2-3 doses (in the first weeks of life, the half-life of cefuroxime in the blood serum of a newborn can be 3-5 times higher than in an adult).

Infants and children under 12 years of age are prescribed IV 30-100 mg/kg/day every 6-8 hours. For the treatment of most infections, the optimal daily dose is 60 mg/kg.

For pneumonia - prescribe 1.5 g IV or IM 2-3 times a day for 48-72 hours, and then switch to oral administration (use dosage forms for oral administration) 500 mg 2 times a day per within 7-10 days.

In case of exacerbation of chronic bronchitis, prescribe IM or IV 750 mg 2-3 times a day for 48-72 hours, then switch to oral administration (use dosage forms for oral administration) 500 mg 2 times a day in within 5-10 days.

For uncomplicated urinary tract infection, skin infection, disseminated gonococcal infection and uncomplicated pneumonia, 750 mg is prescribed every 8 hours. If necessary, the interval between doses can be reduced to 6 hours and the daily dose will be increased to 3-6 g. For severe or complicated infections Prescribe 1.5 g every 8 hours.

For bacterial meningitis - prescribed intravenously, 3.0 g every 8 hours; for younger and older children - IV 150-250 mg/kg/day in 3-4 doses. After 3 days, in case of clinical improvement, the dose can be reduced to 100 mg/kg/day. For newborns, the drug is prescribed intravenously at a dose of 100 mg/kg/day.

For gonorrhea - 1.5 g as an intramuscular injection once (in the form of 2 injections of 750 mg administered in different areas, for example, in both gluteal muscles).

For the purpose of prevention during surgical interventions:

- for operations on the abdominal cavity, pelvic organs and orthopedic operations - IV, 1.5 g during induction of anesthesia, then additionally - 750 mg IM, 8 hours and 16 hours after surgery;

- for operations on the heart, lungs, esophagus, blood vessels and orthopedic operations - intravenously, 1.5 g during induction of anesthesia, then intramuscularly, 750 mg 3 times a day over the next 24-48 hours;

- for complete joint replacement - 1.5 g of the drug is mixed dry with each packet of methyl methacrylate cement polymer before adding the liquid monomer.

In case of chronic renal failure, correction of the dosage regimen is necessary:

- if the creatinine clearance is 10-20 ml/min, 750 mg is prescribed IV or IM 2 times a day,

- with creatinine clearance less than 10 ml/min - 750 mg 1 time per day.

Patients on continuous hemodialysis using an arteriovenous shunt or on high-flow hemofiltration in intensive care units are prescribed 750 mg 2 times a day. Patients on low-rate hemofiltration are prescribed doses recommended for renal impairment.

Preparation of solutions for administration:

Solutions are prepared under aseptic conditions.

For intramuscular administration, add 6 ml of water for injection to a bottle containing 1.5 g of the drug and mix thoroughly.

For intravenous administration, add 15 ml of water for injection to a bottle containing 1.5 g and mix thoroughly.

For short-term intravenous infusions (no more than 30 minutes): 1.5 g of cefuroxime is dissolved in 50-100 ml of water for injection. These solutions are administered directly into a vein or indirectly using a solution infusion system.

For slow intravenous administration, additionally dissolve in 50 ml of 5% or 10% dextrose solution for injection, 0.9% sodium chloride solution for injection, Ringer's solution, Ringer's solution with lactate.

In accordance with good clinical practice, it is recommended that only freshly prepared solutions be used, but the solution remains stable for 24 hours when stored in the refrigerator (2-8°C).