Tienam - instructions for use, reviews, analogs and forms of release (injections in ampoules for injections and infusions of antibiotics) drugs for the treatment of infections in adults, children and pregnancy

In this article, you can read the instructions for using the drug Tienam. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of antibiotic Tienam in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Tienam in the presence of existing structural analogues. Use to treat infectious diseases of various locations in adults, children, as well as during pregnancy and lactation.

Tienam - an antibiotic with a wide spectrum of action, consisting of two components.

Imipenem (the active substance of the preparation Tienam) - a derivative of tienamycin - is the first representative of a new class of beta-lactam antibiotics - carbapenems.

Imipenem inhibits the synthesis of the bacterial cell wall and has a bactericidal effect against a wide range of gram-positive and gram-negative pathogens, aerobic and anaerobic. Imipenem is active against those Gram-positive species in which only beta-lactam antibiotics of a narrow spectrum of action have been active before.

Cilastatin sodium is a specific enzyme that inhibits the metabolism of imipenem in the kidneys and significantly increases the concentration of unchanged imipenem in the urinary tract.

The spectrum of action of Tienam includes Pseudomonas aeruginosa, Staphylococcus aureus (Staphylococcus), Enterococcus faecalis (Enterococcus) and Bacteroides fragilis, a diverse group of problem pathogenic microorganisms, usually resistant to other antibiotics.

Thienam is resistant to degradation by bacterial beta-lactamase, which makes it effective against many microorganisms, such as Pseudomonas aeruginosa, Serratia spp.and Enterobacter spp., which are resistant to most beta-lactam antibiotics.

The antimicrobial spectrum of Tienam includes virtually all clinically relevant pathogens. Tienam is active against aerobic gram-negative and gram-positive bacteria, anaerobic gram-negative and gram-positive bacteria, as well as Mycobacterium fortuitum, Mycobacterium smegmatis.

Tienamu is resistant to Xanthomonas maltophilia (formerly Pseudomonas maltophilia) and some strains of Pseudomonas cepacia, as well as Streptococcus faecium and methicillin-resistant staphylococci.

Tests show that Tienam acts synergistically with antibiotics from the aminoglycoside group against certain Pseudomonas aeruginosa isolates.

The effectiveness of Tienam against such a wide range of pathogenic microorganisms makes it particularly useful in the treatment of polymicrobial and mixed aerobic / anaerobic infections, as well as for primary therapy before determining bacterial pathogens.

Composition

Imipenema monohydrate + Cilastatin sodium + excipients.

Indications

Treatment of infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

• infections of the abdominal cavity;
• infections of the lower respiratory tract;
• gynecological infections;
• septicemia (application of the drug in the dosage form for the / m administration is not recommended);
• infection of the genitourinary system;
• infection of bones and joints;
• infections of the skin and soft tissues;
• infectious endocarditis (application of the drug in the drug form for the / m administration is not recommended);
• mixed infections (including those caused by Bacteroides fragilis).

Tienam is not indicated for the treatment of meningitis.

Tienam is indicated for the prevention of some postoperative infections in patients with a high probability of postoperative infection.

Forms of release

Powder for the preparation of solution for intramuscular injection (injections in ampoules for injection).

Powder for solution for infusion.

There are no other dosage forms, be it pills or capsules.

Instructions for use and dosage

The average daily dose of Tienam and the method of administration are determined depending on the severity of the infection and are divided into several equal methods, taking into account the degree of sensitivity of microorganisms, kidney function and body weight.

It should be taken into account that the form for intramuscular administration can not be administered intravenously.

Intravenous route of drug administration is preferable to use in the initial stages of therapy of bacterial sepsis, endocarditis or other severe and life-threatening infections, including. lower respiratory tract infections caused by Pseudomonas aeruginosa, and in the case of severe complications such as shock.

For adults, the average therapeutic dose for intravenous infusion is 1-2 g per day (based on imipenem) divided by 3-4 infusions. The maximum daily dose is 4 g or 50 mg / kg of body weight, whichever is less. However, patients with cystic fibrosis with normal renal function were treated with Tienam at doses up to 90 mg / kg per day in several administrations, with a total dose not exceeding 4 grams per day.

For the prevention of postoperative infections, the drug should be administered intravenously at a dose of 1 g for anesthesia and 1 g in 3 hours. In case of high-risk surgical intervention (for example, surgery on the large intestine), 500 mg after 8 and 16 h after anesthesia.

Children older than 3 months with a body weight of less than 40 kg of the drug prescribed in a dose of 15 mg / kg every 6 hours.The total daily dose should not exceed 2 g. Enter by IV infusion. With a body weight of 40 kg or more, the drug is administered in the same doses as for adults.

Preparation of a solution for intravenous infusion

In a vial of powder, add 100 ml of solvent. As the solvent can be used: isotonic sodium chloride solution; 5% aqueous solution of dextrose; 10% aqueous solution of dextrose; 5% Dextrose solution and 0.9% sodium chloride; 5% dextrose solution and 0.45% sodium chloride; 5% dextrose solution and 0.225% sodium chloride; 5% dextrose solution and 0.15% potassium chloride; 5% and 10% mannitol solution. The resulting solution (concentration of imipenem 5 mg / ml) should be shaken until a clear liquid forms. Differences in the color of the solution from yellow to colorless do not affect the activity of the preparation.

To prepare a solution of Tienam, solvents containing a lactic acid salt (lactate) are not used.

The intramuscular route of administration can be used as an alternative for the treatment of infections in which the IM is preferable.

Intramuscularly, the drug is prescribed in a dose of 500-750 mg (calculated on imipenem) every 12 hours (depending on the severity of the infection, the sensitivity of pathogens and the patient's condition); the maximum daily dose is 1.5 g.If it is necessary to prescribe the drug in high doses, you should use the IV route.

For the treatment of urethritis and cervicitis caused by Neisseria gonorrhoeae, Tienam is injected once / at a dose of 500 mg.

In / m injection Tienam should be carried deep into the large muscles.

The safety and efficacy of intravenous administration of Tienam in patients with SC less than 20 ml / min / 1.73 m2 and in children have not been studied.

Preparation of solution for intramuscular injection

The powder is mixed with 2 ml of a 1% solution of Lidocaine hydrochloride (without epinephrine) or water for injection or saline until a uniform suspension is formed. The prepared solution has a white or slightly yellowish color.

Side effect

• erythema, pain and infiltration at the injection site;
• thrombophlebitis;
• rash;
• itching;
• hives;
• fever;
• anaphylactic reactions;
• erythema multiforme;
• angioedema;
• exfoliative dermatitis;
• toxic epidermal necrolysis;
• nausea, vomiting;
• diarrhea;
• dyeing of teeth;
• pseudomembranous colitis;
• hepatitis;
• eosinophilia, leukopenia, neutropenia (including agranulocytosis), thrombocytopenia, thrombocytosis, lowering of the hemoglobin level;
• direct positive Coombs test;
• oliguria / anuria;
• polyuria;
• acute renal insufficiency;
• change of color of urine (this phenomenon is safe and it should not be confused with hematuria);
• cases of myoclonia, mental disorders, including hallucinations, confusion, epileptic seizures;
• violation of taste.

Thienam is usually well tolerated. In controlled clinical trials, Tienam showed the same tolerability as with cefazolin, cephalothin and cefotaxime. Side effects rarely require discontinuation of therapy and are usually mild and transient; severe side effects are rare.

Local reactions in the field of injection are the most common side effects of Tienam.

Contraindications

• hypersensitivity to any of the components of the drug.

Application in pregnancy and lactation

The safety of Tienam use during pregnancy has not been studied. Therefore, Tienam is prescribed only if the intended benefit to the mother exceeds the potential risk to the fetus.

It is not known whether active substances of the drug are excreted in mother's milk.If you need to use Tienam during lactation, breastfeeding should be stopped.

Use in children

Tienam in the form of infusion (for intravenous injection) can be used to treat children with sepsis. The duration of therapy is not limited if there is no suspicion of meningitis.

Clinical data are insufficient to recommendations for use of the drug in children under the age of 3 months as well as in children with impaired renal function (serum creatinine 2 mg / dL).

The safety and effectiveness of intramuscular use of Tienam in children have not been studied.

special instructions

Tienam demonstrated efficacy against many infectious diseases caused by bacteria resistant to cephalosporins, including cefazolin, cefoperazone, cephalothin, ceftazidime, cefoxitin, cefotaxime, moxalactam, cefamandole and ceftriaxone. Many infectious diseases caused by organisms resistant to aminoglycosides (gentamicin, amikacin, tobramycin) and / or to penicillins (ampicillin, carbenicillin, penicillin-G, ticarcillin, piperacillin, azlocillin, mezlocillin), also responded to treatment tienama.

Tienam was successfully used for monotherapy in cancer patients with weakened immunity in the case of confirmed or suspected infections such as sepsis.

There are some clinical and laboratory data on partial cross-allergy when using Tienam and other beta-lactam antibiotics, penicillins and cephalosporins. Severe reactions (including anaphylaxis) have been reported with most antibiotics of the beta-lactam group. Before the start of therapy, Tienam should have a thorough history of previous allergic reactions to beta-lactam antibiotics. If an allergic reaction occurs during treatment, the drug should be discontinued and appropriate therapy prescribed.

Pseudomembranous colitis has been described as a complication in the treatment of virtually all antibiotics; Its severity can range from mild forms to severe and life threatening conditions. Therefore, people who have a history of GIT disease, especially colitis, Tienam should be administered with caution. It is especially important to consider the possibility of developing pseudomembranous colitis in cases when diabetic appears on the background of treatment with antibiotics.All possible options should be considered in cases where studies show that the primary cause of antibiotic-associated colitis is toxins produced by Clostridium difficile. It is necessary to take into account other reasons.

Side effects from the CNS during the period of Tienam administration were more often observed when recommended doses, depending on kidney function and body weight, were exceeded. Similar disorders were usually described in patients with CNS lesions (brain injuries or seizures in the anamnesis) and / or in patients at risk due to impaired renal function, in which accumulation of the drug is possible. Therefore, it is extremely necessary to strictly adhere to the recommended dosing regimen, especially in such patients. Therapy with anticonvulsant drugs should be preserved in patients with indications of seizures in the anamnesis.

If central tremor, myoclonia or seizures occur during therapy, patients should undergo a neurological examination with the appointment of anticonvulsant therapy if it has not been prescribed earlier.If symptoms of CNS dysfunction persist, the dose of Tienam should be reduced or the drug should be withdrawn.

If suspected of having meningitis, appropriate antibiotics should be prescribed.

Patients on hemodialysis, especially those with CNS diseases, can be prescribed Tienam only in cases where the intended benefit of therapy exceeds the potential risk of increasing renal failure.

Drug Interactions

Pharmaceutical interaction

The solution of Tienam for intravenous administration has a chemical incompatibility with the lactic acid salt (lactate), it should not be prepared on the basis of solvents containing a lactic acid salt.

Tienam solution for intravenous administration can not be mixed or added to solutions of other antibiotics.

Analogues of the drug Tienam

Structural analogs for the active substance:

• Grimipenem;
• Imipenem and Cilastatin Jodas;
• Imipenem and Cilastatin Spencer;
• Imipenem with cilastatin;
• Cilapenem;
• Cilaspion.

Analogues for the pharmacological group (carbapenem antibiotics):

• Grimipenem;
• Jenham;
• Doriprex;
• Invenza;
• Merexide;
• Meronem;
• Meronoxol;
• Meropenabol;
• Meropenem;
• Let us propinem;
• Cyronome.

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