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Composition:


active ingredients: imipenem and cilastatin;


1 bottle contains imipenem monohydrate in terms of imipenem anhydrous 500 mg, cilastatin sodium in terms of cilastatin 500 mg;


excipient: sodium bicarbonate.


Dosage form. Powder for infusion solution.


Basic physical and chemical properties: White to light yellow powder.


Pharmacotherapeutic group.


Antibacterial agents for systemic use. Imipenem and cilastatin.


ATX code J01D H51.


Pharmacological properties.


Pharmacodynamics.


Imifors consists of two components: imipenem, the first representative of a new class of b-lactam antibiotics – thienamycin, and cilastatin sodium, a special enzyme inhibitor that blocks the metabolism of imipenem in the kidneys and significantly increases the concentration of unchanged imipenem in the urinary tract. The weight ratio of imipenem and cilastatin sodium in the preparation is 1:1.


The class of thienamycin antibiotics, to which imipenem belongs, is characterized by a wider spectrum of powerful bactericidal action than that provided by any of the antibiotics studied.


Imifors is indicated for the treatment of mixed infections caused by sensitive strains of aerobic and anaerobic bacteria. The drug is effective in the treatment of many infections caused by aerobic and anaerobic gram-positive and Gram-negative bacteria resistant to cephalosporins, including cefazolin, cefoperazone, cephalotin, cefoxitin, cefotaxime, moxalactam, cefamandol, ceftazidime and ceftriaxone. A large number of infections caused by pathogens resistant to aminoglycosides (gentamicin, amikacin, tobramycin) and/or penicillins (ampicillin, carbenicillin, penicillin-G, ticarcillin, piperacillin, azlocillin, meslocillin) can also be treated with the drug.


Imifors is not indicated for the treatment of meningitis.


Imifors is a powerful inhibitor of bacterial cell wall synthesis and has a bactericidal effect against a wide range of Gram-positive and Gram-negative, aerobic and anaerobic pathogenic microorganisms.


Imifors, together with the latest cephalosporins and penicillins, has a broad spectrum of action against Gram-negative species, but its distinctive feature is its high activity against Gram-positive species, which was previously observed only in narrow-spectrum B-lactam antibiotics. The spectrum of activity of the drug covers Pseudomonas aeruginosa, Staphylococcus aureus, Enterococcus faecalis and Bacteroides fragilis, a diverse and clinically problematic group of pathogens, usually resistant to other antibiotics.


Imifors is effective against a large number of microorganisms, such as Pseudomonas aeruginosa, Serratia and Enterobacter species, which are naturally resistant to most B-lactam antibiotics.

Children


Mean clearance and volume of distribution for imipenem were approximately 45% higher in children (aged 3 months to 14 years) compared to adults. The AUC for imipenem after a dose of imipenem/cilastatin 15/15 mg/kg body weight in children was approximately 30% higher than in adults who received a dose of 500 mg/500 mg. At a higher dose, exposure after imipenem/cilastatin 25/25 mg/kg in children was 9% higher compared to exposure in adults who received a dose of 1000 mg/1000 mg.


Elderly patients


In healthy elderly volunteers (aged 65 to 75 years with normal renal function for their age), the pharmacokinetics of a single intravenous dose of 500 mg/500 mg administered for 20 minutes were consistent with the expected results in patients with minor renal insufficiency, for whom any dose changes are considered unnecessary. The average plasma half-lives of imipenem and cilastatin were 91±7 minutes and 69±15 minutes, respectively. Multiple doses did not affect the pharmacokinetics of imipenem or cilastatin, and no accumulation of imipenem/cilastatin was observed.


Clinical characteristics.


Indications.


Treatment of infections in adults and children over 1 year of age caused by microorganisms sensitive to the drug:


- intra-abdominal infections;


- lower respiratory tract infections (severe pneumonia, including hospital-acquired and ventilator-associated pneumonia);


- intranatal and postpartum infections;


- infections of the genitourinary system;


- skin and soft tissue infections;


- infections of bones and joints;


- septicemia;


- endocarditis.


Imifors can be used in the treatment of patients with neutropenia, accompanied by fever, the probable cause of which is a bacterial infection.


Treatment of patients with bacteremia Associated or likely associated with any of the above infections.


Contraindications.


Hypersensitivity to any of the components of the drug, to other carbapenem preparations, other b-lactam antibiotics (for example, to penicillin or cephalosporins).


Interactions with other drugs and other types of interactions.


Generalized seizures were reported in patients treated with Ganciclovir together with imipenem/cilastatin for intravenous administration. These drugs can only be used together if the expected benefit of the use outweighs the possible risk.


During post-marketing studies, a decrease in the level of valproic acid in blood plasma was recorded when combined with carbapenems, in some cases ‒ sudden seizures. Therefore, concomitant use of imipenem and valproic acid/sodium valproate is not recommended.


Concomitant use of antibiotics with warfarin may increase its anticoagulant effects. The risk may vary depending on the type of infection, age, and general status of the patient. Frequent monitoring of the international normalized ratio (INR) is recommended during and after concomitant use of antibiotics with oral anticoagulants.


Concomitant use of imipenem/cilastatin and probenecid resulted in a minimal increase in the plasma concentration of imipenem and the plasma half-life of imipenem. Urinary excretion of active (undigested) imipenem decreased to approximately 60% of the dose when the drug was used with probenecid. Concomitant administration of imipenem/cilastatin and probenecid doubled plasma cilastatin levels and the Half-Life of cilastatin, but had no effect on urinary excretion of cilastatin.


Application features.


There are some clinical and laboratory data that indicate partial cross-allergenicity of the drug and other B-lactam antibiotics, penicillins and cephalosporins. Severe reactions (including anaphylaxis) are observed with most B-lactam antibiotics. Before starting therapy with the drug, the patient's medical history should be carefully studied for a hypersensitivity reaction to b-lactam antibiotics. If an allergic reaction develops during the use of the drug, the drug should be discontinued and appropriate measures should be taken. Serious anaphylactic reactions require urgent treatment.


During treatment with imipenem/cilastatin, liver function should be carefully monitored due to the risk of hepatic toxicity (increased transaminase levels, liver failure, and lightning-fast hepatitis).


Patients with pre-existing liver disease should be monitored for liver function during treatment with imipenem/cilastatin. There is no need to adjust the dose.


During treatment with imipenem/cilastatin, a positive direct or indirect Coombs test is possible.


The antibacterial spectrum of imipenem/cilastatin should be considered before any empirical treatment, especially in life-threatening conditions. In addition, caution should be exercised due to the limited sensitivity of certain pathogens (associated, for example, with bacterial infections of the skin and soft tissues) to imipenem/cilastatin. The use of imipenem/cilastatin is appropriate for the treatment of these types of infections if a particular pathogen has already been documented and is known to be sensitive, or when there are very strong reasons to believe that the most likely pathogen is suitable for such treatment. Concomitant use of this agent against methicillin-resistant Staphylococcus aureus (MRSA) may be indicated when the involvement of MRSA infections is suspected or proven with approved indications. Concomitant use of aminoglycoside may be indicated when Pseudomonas aeruginosa infections are suspected or proven to be involved with approved indications.


The development of pseudomembranous colitis has been recorded as a complication with the use of almost all antibiotics; its forms can range from mild to life-threatening. Because of this, antibiotics should be prescribed with caution to patients with a history of gastrointestinal diseases, especially colitis. It is important to keep in mind the possibility of developing pseudomembranous colitis, when a patient develops diarrhea during antibiotic treatment. Discontinuation of imipenem/cilastatin therapy and the use of specific Clostridium difficile treatment should be considered. Do not prescribe medications that inhibit peristalsis.


Imiforce is not recommended for the treatment of meningitis.


As with other beta-lactam antibiotics, CNS side effects such as myoclonia, confusion, or seizures have been described with imipenem/cilastatin, especially in cases where the recommended doses were exceeded depending on renal function and body weight. Usually, such disorders were observed in patients with CNS damage (brain injuries or seizures in the Anamnesis) and/or in patients with impaired renal function, in which accumulation of the drug in the body is possible. In this regard, especially for such patients, it is extremely necessary to strictly adhere to the recommended doses and treatment regimen. Anticonvulsant therapy should be continued in patients with a history of seizures.


Special attention should be paid to neurological symptoms or seizures in children with known risk factors for seizures or who are receiving concomitant treatment with medications to reduce the intensity of seizures.


If focal tremor, myoclonia, or seizures occur during treatment with the drug, patients should undergo a neurological examination with the appointment of anticonvulsant therapy, if it has not been prescribed before. If the symptoms of CNS disorders persist, then the dose of Imiforce should be reduced or the drug should be discontinued altogether.


Imifors is not indicated for the treatment of patients with CrCl £5 mL/min/1.73 m2, except when hemodialysis is performed after 48 hours. For patients undergoing hemodialysis, Imifors is recommended only when positive treatment results outweigh the potential risk of seizures.


The drug contains 37.6 mg of sodium (1.6 mg-EQ.), which should be considered when using it in patients who are on a controlled sodium (salt-free) diet.


Use during pregnancy or lactation.

Vagitnist.


Zastosuvannya preparation for likuvannya vagitnih zhinok nalezhnim rank not vivchen, that priznachati yogo pid hour vagitnosti mozhna tilki u razi, yaksho ochikuvana korist for the mother perevischuya mogliviy rizik for the fetus.


Period goduvannya gruddyu.


Imipenem and cilastatin are prescribed in small amounts in breast milk. U razi neobhidnosti zastosuvannya drug goduvannya gruddyu slid pripiniti.


Zdatnist vplivati na shvidkist reaktsii pri keruvanni motor transport abo inshimi mechanizmami.


Vrahovuyuchi rizik viniknennya such pobichnih yavishch, yak miokloniya, hallucinacii, splutanist svidomosti i sudomi, slid unikati keruvannya motor transport ta roboti zinshih mekhanizmami pri zastosuvanni drug.


Sposib zastosuvannya ta dozi.


Recommendations of doses for the drug Imifors stosuetsya kylkosti imipenem/cilastatin, yaka bude zastosovuvatysya.


Dobovu dose of the drug Imifors viznachayut, beruchi to uvagi type ta stupin severity of infection, vidilenogo (- their) pathogen (- ib); dose rozpodilyayut on decilka rivnih vveden, vrahovuuchi stan functioni nirok i masu tila.


Dorosli patsienti z normalnoyu funktsiyu nirok


Dose for patients with normal niroc function (CrCl >70 ml/xb/1.73 m2) i weight not less than 70 kg:


- 500 mg/500 mg via kozhni 6 godin abo


- 1000 mg/1000 mg via kozhni 8 godin abo via kozhni 6 godin.


For the most severe infections, the most severe infections (for example, in neutropenic patients with iz gariachkoyu), the most severe infections (for example, in neutropenic patients with iz gariachkoyu) are recommended to be treated with a dose of 1000 mg/1000 mg through the skin 6 years.


The dose of slid znizhuvati for the patient is CrCl £70 ml / xb/1.73 m2 ta/abo z masoyu tila less than 70 kg. Zmenshennya dozi zalezhno vid masi tila osoblivo vazhlive for patsiyontiv zi znachno menshoyu for 70 kg masoyu tila ta/abo pomirnoyu/tyazhkoyu formoyu porushennya funktsii nirok.


The dose for the patients, masa tila yakikh less than 70 kg, viznachayut for the additional formula:


Actual weight (kg) * standard dose


70 (kg)


The maximum dobova dose is not guilty of perevishchuvati 4000 mg/4000 mg per day.

Overdose.


Symptoms of overdose that may occur are consistent with the profile of adverse reactions; these may include seizures, confusion, tremors, nausea, vomiting, hypotension, and bradycardia.


There is no specific information regarding the treatment of overdose with the drug. The drug is removed by hemodialysis. However, the effectiveness of this procedure for overdose has not been established. Treatment is symptomatic.


Adverse reactions.


In clinical trials involving 1,723 patients treated intravenously with imipenem/cilastatin, the following most common systemic adverse reactions that may have been associated with treatment were reported: nausea (2.0%), diarrhea (1.8%), vomiting (1.5%), rash (0.9%), fever (0.5%), hypotension (0.4%), convulsions (0.4%), dizziness (0.3%), pruritus (0.3%), urticaria (0.2%), drowsiness (0.2 %); local adverse reactions were: phlebitis/thrombophlebitis (3.1%), pain at the injection site (0.7%), erythema at the injection site (0.4 %) and vein induration (0.2 %); there was also an increase in serum transaminase and alkaline phosphatase levels.


Adverse reactions and their frequency were determined based on the results of clinical studies and post-marketing experience. Adverse events were divided into organ system classes and frequency: very common (>1/10), often (>1/100 to >1/1000 to >1/10000 to


Infections and infestations: rarely ‒ pseudomembranous colitis, candidiasis; very rarely – gastroenteritis.


From the blood and lymphatic system: often-eosinophilia; infrequently – pancytopenia, neutropenia, leukopenia, thrombocytopenia, thrombocytosis; rarely - agranulocytosis; very rarely-hemolytic anemia, suppression of bone marrow function.


Immune system disorders: rarely-anaphylactic reactions.


From the side of the psyche: infrequently ‒ mental disorders, including hallucinations and states of confusion.


From the nervous system: infrequently ‒ convulsions, myoclonic activity, dizziness, drowsiness; rarely - encephalopathy, paresthesia, focal tremor, taste distortion; very rarely - deterioration of severe myasthenia gravis, headache.


From the side of the organs of hearing and Labyrinth: rarely ‒ hearing loss; very rarely ‒ dizziness, tinnitus.


Cardiac disorders: very rarely-cyanosis, tachycardia, strong heartbeat.


Vascular disorders: often-thrombophlebitis; infrequently – hypotension; very rarely-hot flashes.


From the respiratory system, chest and mediastinal organs: very rarely ‒ dyspnoea, hyperventilation, pharyngeal pain.


From the digestive tract: often-diarrhea, vomiting, nausea. Drug-related nausea and/or vomiting are more common in patients with granulocytopenia than in patients without granulocytopenia treated with the drug. Rarely - discoloration of the teeth and/or tongue; very rarely ‒ hemorrhagic colitis, abdominal pain, heartburn, glossitis, hypertrophy of the papillae of the tongue, increased salivation.


Hepatobiliary disorders: rarely-liver failure, hepatitis; very rarely-lightning-fast hepatitis.


From the skin and subcutaneous tissue: often ‒ rashes (for example, exanthematous); infrequently ‒ urticaria, pruritus; rarely ‒ toxic epidermal necrolysis, Quincke's disease, Stevens‒Johnson syndrome, polymorphic erythema, exfoliative dermatitis; very rarely ‒ hyperhidrosis, changes in skin structure.


From the musculoskeletal system and connective tissue: very rarely ‒ polyarthritis, pain in the thoracic spine.


From the kidneys and urinary system: rarely ‒ acute renal failure, oliguria/anuria, polyuria, discoloration of urine (safe, not to be confused with hematuria). The role of the drug in changes in renal function is difficult to assess, since there were usually factors that cause a tendency to prerenal azotemia or to deterioration of renal function.


From the reproductive system and mammary glands: very rarely ‒ genital pruritus.


General disorders and conditions at the site of application: infrequently ‒ fever, local pain and induration at the injection site, erythema at the injection site; very rarely ‒ chest discomfort, asthenia/weakness.


Studies: often-increased serum transaminase levels, increased serum alkaline phosphatase levels; infrequently ‒ positive direct Coombs test, prolongation of prothrombin time, decreased hemoglobin, increased serum bilirubin levels, increased serum creatinine levels, increased blood urea nitrogen levels.


Adverse reactions similar to those observed in adult patients were reported in studies involving 178 children aged >3 months.


Expiration date. 2 years.


Storage conditions.


Store in the original packaging at a temperature not exceeding 25 ° C. Keep out of reach of children.


Reconstituted solutions of the drug should not be frozen.


The shelf life of reconstituted solutions is given in the section "dosage and administration".


Incompatibility.


The drug is chemically incompatible with lactates (lactic acid salts), so it should not be diluted with the solvents that they are part of. Despite this, the drug can be administered through the same intravenous system through which lactate solutions are infused.


The drug is not allowed to be mixed with other antibiotics.

Tags: Imipenem, Cilastatin