Cefotaxim Sandoz - instructions for use, dose, side effects, contraindications

Cefotaxime is usually sensitive: Aeromonas hydrophila; Bacillus subtilis; Bordetella pertussis, Barrelia burgdorferi; Moraxella catarrhalis; Citrobacter diversus*; Cilrobacter freundii *; Clostridium perfringens; Corenybacterium diphtheriae; Escherichia coli; Enterobacter spp. *; Erysipelotlirix insidiosa; Eubacterium spp .; Haemophilus spp. (penicillinase-producing and non-producing penicillinase strains, including ampicillin-resistant strains); Klebsiella pneumoniae; Klebsiella oxytocci; Staphylococcus spp. (methicillin-sensitive, including penicillinase-producing and non-producing penicillinase strains); Morganella morganii; Neisseria gonorrhoea (including producing and non-producing penicillin inazu strains); Neisseria meningitidis, Propionibactrerium spp.; Proteus mirabilis; Proteus vulgaris; Providencia spp.; Streptococcus spp. (including Streptococcus pneumoniae); Salmonella spp.; Serratia spp.*; Shigella spp.; Veillonella spp.; Yersinia spp.*; Pseudomonas spp. (Besides Pseudomonas aeruginosa, Pseudomonas cepacia).

* sensitivity depends on epidemiological data and on the level of sustainability in each country. Cefotaxime is stable: Acinetobacter baumanii; Bacteroides fragilis; Clostridium difficile; Enterococcus spp.; gram-negative anaerobes; Listeria monocytogenes; Staphylococcus spp. (methicillin-resistant strains); Pseudomonas aeruginosa; Pseudomonas cepacia; Stenotrophomonas maltophilia.

Pharmacokinetics:

After a single intravenous injection of 0.5, 1 and 2 g, the maximum concentration (C_max) is achieved after 5 minutes and is 39 μg / ml, 100 μg / ml and 214 μg / ml, respectively. After w / m 0.5 and 1 g of C_max is achieved after 0.5 h and is 11 and 21 mcg / ml, respectively. The connection with plasma proteins is 25-40%. Creates therapeutic concentrations most tissues (myocardium, bones, gallbladder, skin, soft tissues) and liquids (synovial, nericardial, pleural, sputum, bile, urine, cerebrospinal fluid) of the body. The volume of distribution is 0.25-0.39 l / kg.

The half-life (T₁_/2) - 1 hour with intravenous administration and 1-1.5 hours - with intramuscular injection. About 90% of the administered dose is excreted by the kidneys: 50% in unchanged form, about 15-25% in the form of deacetylcefotaxime metabolite and 15-30% in the form of inactive metabolites (M2 + M3). 10% of the administered dose is excreted by the intestine.

In chronic renal disease insufficiency (KHPI) and in the elderly T₁_/2 increases by 2 times. T₁_/2 in newborns - 0.75-1.5 h, in preterm newborns it increases to 4.6 h. For repeated intravenous injections, a dose of 1 g every 6 hours during 14 days of cumulation is not observed. Penetrates into breast milk.

Indications:Bacterial infections of the severe course caused by susceptible microorganisms: infections of the central nervous system (meningitis), respiratory tract and LOP organs, urinary tract, bones, joints, skin and soft tissues, pelvic organs, chlamydia, gonorrhea, infected wounds and burns, peritonitis , sepsis, abdominal infections, endocarditis, Lyme disease (borreliosis), salmonellosis, infection against immunodeficiency, prevention of infections after surgical operations (including urological, obstetric-gynecological, gastrointestinal antiplaque tract).

Contraindications:

- Hypersensitivity to cefotaxime and other cephalosporins;

- In case of dissolution of the drug with 1% lidocaine solution: hypersensitivity to lidocaine or other local anesthetic of the amide type; intracardiac blockade without an established pacemaker; severe heart failure; intravenous administration (in / in); children under the age of 2.5 years (intramuscular injection).

Carefully:

Patients with a history of allergy to penicillins (risk of developing cross-allergic reactions); with simultaneous application of with aminoglycosides; with renal failure.

Pregnancy and lactation:

The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

Cefotaxime excreted in breast milk, so if you need to prescribe the drug during lactation should stop breastfeeding.

Dosing and Administration:

Intravenous or intramuscular. The dose, method and frequency of administration should be determined by the severity of the infection, the sensitivity of the pathogen and the patient's condition. Treatment can be initiated before the results of the sensitivity test are obtained.

Adults and children over 12 years of age and weighing 50 kg or more:

For infections of mild to moderate severity - 1 g every 12 h. The dose may vary depending on the severity of the infection, the sensitivity of the pathogen and the patient's condition. In severe infections, the dose can be increased to 12 g per day, divided into 3 or 4 injections. For infections caused by Pseudomonas spp., The daily dose should be more than 6 g.

Children under 12 years of age and weighing up to 50 kg:

The usual dose is 100-150 mg / kg / day, divided into 2-4 injections. In very severe infections, the dose can be increased to 200 mg / kg / day.

Newborns:

50 mg / kg / day, divided into 2-4 injections. In severe infections, a dose of 150-200 mg / kg / day, divided into 2-4 injections.

With gonorrhea:

1 g once intravenously or intramuscularly.

In order to prevent infections before surgery:

For 30-90 minutes before the operation, 1 g of the drug is administered intramuscularly or intravenously.

When performing cesarean section at the time of application of the clamps to the umbilical vein, 1 g of the drug is intravenously injected, then 6 g and 12 h are re-introduced 1 g intravenously or intramuscularly.

With renal insufficiency:

In cases where the creatinine clearance is less than 10 ml / min, the dose should be reduced. After the introduction of the initial single dose, the daily dose should be halved without changing the frequency of administration, i.e. instead of 1 g every 12 hours - 0.5 g every 12 hours, instead of 1 g every 8h- 0.5 g every 8 h, instead of 2 g every 8 h - 1 g every 8 h, etc. A further dose adjustment may be required depending on the course of the infection and the general condition of the patient.

Rules for the preparation of solutions: For intravenous injection, water for injection is used as a solvent (500 mg diluted in 2 ml of solvent, 1 g in 4 ml); with intravenous injection the solution should be introduced within 3 to 5 minutes.For intravenous infusion, 0.9% sodium chloride solution or 5% dextrose solution is used as the solvent (1-2 g diluted in 40-100 ml of the solvent). Ringer's lactate solution can also be used. The duration of the infusion is 20-60 min. For intramuscular injection water for injection or 1% solution of lidocaine (500 mg in 2 ml, 1 g in 4 ml) is used.

Side effects:

According to the World Health Organization (WHO), undesirable effects are classified according to their frequency of development as follows: very often (> 1/10), often (>1/100, <1/10), infrequently (>1/1000. <1/100), rarely (>1/10000, <1/1000) and very rarely (<1/10000); frequency is unknown (the frequency of occurrence of phenomena can not be determined on the basis of available data).

From the side of the blood and lymphatic system

infrequently: leukopenia, eosinophilia, thrombocytopenia;

frequency unknown: agranulocytosis, neutropenia, hemolytic anemia, bone marrow hematopoiesis deficiency, pancytopenia.

From the nervous system

infrequently: convulsions;

frequency is unknown: headache, increased fatigue, encephalopathy (eg, impaired consciousness, motor disorders), dizziness.

From the side of the cardiovascular system

frequency unknown: arrhythmia with rapid introduction through the central venous catheter.

From the digestive system

infrequently: diarrhea, increased activity "liver" enzymes (alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase) and / or concentration of bilirubin (these laboratory abnormalities (which can also be explained by the presence of infections), in rare cases, exceed the upper limit of normal in 2 times and pa indicate liver damage and cholestasis manifested often asymptomatic);

frequency unknownNausea, vomiting, abdominal pain, pseudomembranous colitis, hepatitis (sometimes with jaundice).

From the skin and subcutaneous tissues

infrequently: skin rash, itching, hives.

frequency is unknown (can not be estimated from available data): exfoliative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis.

From the genitourinary system

infrequently: decreased kidney function (high urea and creatinine in the blood);

frequency is unknown: acute renal insufficiency, interstitial nephritis.

From the immune system:

infrequently: the Yarisch-Gerxheimer reaction. As with the application of other antibiotics, in the treatment of borreliosis in during the first days it is possible to develop the Yarisch-Gerxheimer reaction. There are

messages about the occurrence of one or several symptoms after a few week treatment of borreliosis: skin rash, itching, fever, lakopenia, increased activity of "liver" enzymes, difficulty breathing, discomfort in area of joints.

frequency is unknown: anaphylactic reactions, angioedema, bronchospasm,

anaphylactic shock.

General disorders and disorders in place of introduction

Often: pain at the injection site (when intramuscular injection);

infrequently: inflammatory reactions in place Introduction, including phlebitis / thrombophlebitis, fever.

Other

frequency unknown: superinfection, excessive growth of organisms insensitive to cefotaxime. When intramuscular introduction, if the solvent used lidocaine, it is possible to develop systemic reactions associated with lidocaine.

Overdose:

Symptoms: cramps.reversible encephalopathy (in the case of the administration of large doses, especially in patients with renal insufficiency), tremor, increased neuromuscular

excitability.

Treatment: symptomatic therapy. There is no specific antidote.

It is excreted in peritoneal dialysis or hemodialysis.

Interaction:

Increases the risk of bleeding when combined with antiaggregants, non-steroidal anti-inflammatory drugs.

Does not lead to the development of disulfiram-like reactions when combined with ethanol.

The probability of kidney damage increases with simultaneous administration with aminoglycosides, polymyxin B and "loop" diuretics.

Drugs that block tubular secretion, increase plasma concentrations of cefotaxime and slow its elimination.

Pharmaceutically incompatible with solutions of other antibiotics in one syringe or dropper.

Special instructions:

Diarrhea (especially severe and persistent), developed during treatment and in the first weeks after completion of therapy, may be a manifestation of Clostridium difficile associated diarrhea (the most severe form - pseudomembranous colitis).In case of suspicion of pseudomembranous colitis, the use of cefotaxime should be stopped immediately and specific antibacterial therapy (for example, vancomycin or metronidazole). In this condition, preparations that inhibit peristalsis are contraindicated. Before prescribing the drug, you need to collect an allergic medical history, especially with regard to beta-lactam antibiotics. If a patient develops a hypersensitivity reaction, then the drug treatment should be discontinued. It is necessary to control the rate of drug administration. Disorders of hematopoiesis: during treatment with cefotaxime, leukopenia, neutropenia, and, more rarely, bone marrow failure hematopoiesis, pancytopenia and agranulocytosis. With a duration of treatment more than 10 days should be monitored the number of blood cells. If the deviation from the norm of these blood levels should be canceled drug.

As cefotaxime excreted mainly through the kidneys, patients with impaired renal function require monitoring of kidney function, as well as correction of the dosing regimen.The rapid administration of cefotaxime through a central venous catheter can lead to arrhythmia. When determining glucose in the urine by a non-enzymatic method (for example, by the method of Benedict), false positive results are possible. When using the drug Cefotaxime Sandoz® possible false positive reaction of Coombs (direct antiglobulin test). When using high doses of beta-lactam antibiotics, including cefotaxime, especially in patients with impaired renal function, the risk of encephalopathy increases. It is necessary to take into account the sodium content in the preparation Cefotaxime Sandoz® (24.1 mg sodium in the dosage form 0.5 g cefotaxime, 48.2 mg sodium in the dosage form 1 g cefotaxime) with the appointment of cefotaxime to patients who need to limit sodium intake.

There is no need for special precautions when destroying an unused preparation.

Effect on the ability to drive transp. cf. and fur:In the case of the development of such a side effect as dizziness, the ability to concentrate attention and reactions may be impaired. In this case, patients should refrain from driving vehicles and working with mechanisms.

Form release / dosage:Powder for solution for intravenous and intramuscular injection 0.5 g and 1.0 g.

Packaging:Powder for solution for intravenous and intramuscular injection 0.5 g and 1.0 g in a vial of colorless glass type III Heb. Pharm., Corked with a rubber stopper and crimped with an aluminum cap with a protective plastic cover. The bottle is placed in a pack of cardboard along with instructions for use. For hospitals, 50 vials of the drug, together with instructions for use, are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C, in a dry, dark place.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007706/08

Date of registration:25.09.2008

Date of cancellation:2017-02-10

The owner of the registration certificate:Sandoz GmbHSandoz GmbH Austria

Manufacturer: & nbsp

SANDOZ, GmbH Austria

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp10.02.2017

Illustrated instructions

Instructions

Cefotaxim Sandoz® (Cefotaxim Sandoz®)