Ceftriaxone . 1gr. 10 vials

Ceftriaxone . 1gr. 10 vials
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Ceftriaxone was administered for the treatment of severe infections caused by susceptible microorganisms Ceftriaxone:
Respiratory tract infections - acute and chronic bronchitis, bronchopneumonia, lung abscess, infected bronchiectasis, postoperative pulmonary infections and others., Bacterial endocarditis, ear-nose-throat infections;
Meningit;

Ceftriaxone . 1gr. 10 vials
 
CLINICAL DATA
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Ceftriaxone was administered for the treatment of severe infections caused by susceptible microorganisms Ceftriaxone :
Respiratory tract infections - acute and chronic bronchitis, bronchopneumonia , lung abscess , infected bronchiectasis , postoperative pulmonary infections and others. , Bacterial endocarditis , ear-nose - throat infections ;
Meningit ;
IAI - peritonitis , infections of the biliary tract and gastrointestinal tract - salmonellosis , shigellosis ;
Infections of the kidney and urinary tract (where aminoglycosides are unsuitable ) Genital - soft chancre ( chancroid ) , gonorrhea , syphilis (primary, secondary , latent ), septicemia ;
Lyme disease;
Infections of skin and skin structures , bones, joints , soft tissue, infected wounds ;
Infections in patients with immunodeficiency .
Perioperative prophylaxis in surgery.
 
Dosage and method of administration

Ceftriaxone was administered deep intramuscular or intravenous injection such as direct or infusion.
Adults and children over 12 years
The usual dose is 1-2 g per day once or twice, and in life-threatening infections , for 12 h . The maximum daily dose should not exceed 4 g.
For the treatment of uncomplicated gonococcal infections recommended single intramuscular injection of 250 mg.
Prophylaxis in surgical interventions recommended single iv injection of 1 g eftriakson 0.5 to 2 hrs before surgery.
Children under 12 years
The usual dose is 50-75 mg / kg once daily. The maximum daily dose should not exceed 2 g.
In premature and newborn babies - 20-50 mg / kg once daily.
In meningitis, ceftriaxone may be administered in a dose of 100 mg / kg once daily or in two equal doses every 12 hours . The maximum daily dose should not exceed 4 g. The usual duration of treatment is 7-14 days. Ceftriaxone should be administered at least two days after the disappearance of symptoms of the infection. In complicated infections possible lengthening of the duration of therapy .
In patients with impaired renal or hepatic function does not need dose adjustment . Only in cases with advanced renal failure, creatinine clearance <10 ml / min, the dose should not exceed 2 g daily. In cases of simultaneous presence of severe renal functional impairment and ernodrobni appropriate control of the plasma concentration of Ceftriaxone at specified intervals.
Duration of treatment with ceftriaxone depends on the progress of the disease and usually lasts from 4 to 14 days and should last at least 2-3 days after the resolution of clinical symptoms or following a negative microbiological examination . In the treatment of infections caused by Streptococcus pyogenes , therapy should be continued for at least 10 days. Complicated infections require prolonged therapy .
Dialysis patients do not need additional dose after dialysable. In such patients require monitoring of plasma concentrations of the antibiotic and dosage adjustment .
Contraindications
Known hypersensitivity to penicillin and cephalosporin antibiotics.
Special precautions for use
Ceftriaxone was administered at a proven susceptibility of pathogens as determined by a diffusion test or by dilution using standard media .
Before any new course of treatment with ceftriaxone , the patient should be carefully examined to identify previous hypersensitivity reactions to cephalosporins , penicillins, or other drugs.
Caution is advised and medical surveillance after the first injection in patients hypersensitive to penicillin, penicillamine and grizeofulfin ( cross-allergy ) and in patients with some form of allergy , especially IgE -mediated .
If there is no history of allergy is made skarifikatsionna skin sample with a solution of the product. In a history of allergy to begin with A patch is done and if it is negative proceed to skarifikatsionna sample. Samples were read after 30 minutes.
In case of onset of severe acute hypersensitivity require application of 0,5 -1 mg adrenalin s.c. , intravenous infusion of antihistamine ( parenteral ) novphylline and selective beta- adrenergic agents in bronchospasm oxygen ventilation and, if necessary , intubation .
In patients with renal impairment do not require a change in the usual dose. Periodic monitoring of serum concentrations of the product and where there is evidence of accumulation dose should be reduced accordingly .
In patients with impaired liver function is not necessary to reduce the dose, but in the presence of underlying renal disease , it should not exceed 2 g, except under strict control of serum concentrations.
As can be observed Prolongation of prothrombin time is necessary to control it, particularly in patients with impaired production facilities and low vitamin K in chronic liver diseases and malnutrition . If necessary, it can be administered vitamin K ( 10 mg weekly ) .
Ceftriaxone should be prescribed with caution in patients with a history of gastrointestinal disease , particularly colitis.
Like all antibacterial agents and Ceftriaxone can change the normal intestinal flora and develop pseudomembranous colitis. Therefore, caution should be exercised in patients with diarrhea occurring after administration.
In the diagnosis of pseudomembranous colitis should take appropriate therapeutic measures . Mild cases are handled with discontinuation of treatment, and the average and worst - with the application of more fluids , electrolytes , proteins and oral antibacterial agents against Clostridium difficile.
Treatment with ceftriaxone should be discontinued in patients developing symptoms of gallbladder disease ( jaundice and biliary colic ) .
In patients with granulocytopenia , ceftriaxone , and other third generation cephalosporins , should be administered in combination with an aminoglycoside antibiotic .
Prolonged use of ceftriaxone may result in the overgrowth of Candida sp., Enterococcus sp., Resistant strains of Staphylococcus aureus and others. In the presence of secondary infection during treatment must take appropriate measures.
Due to the high plasma protein binding , ceftriaxone should be used with caution in neonates with hyperbilirubinemia and in patients receiving verapamil long time .
With prolonged use of Ceftriaxone blood counts should be monitored periodically.
During treatment possible false positive reaction for glucose in the urine using the method of reduction of copper , therefore a determination be made at least 4 hours after administration of the product or by glucose oxidase method.
Possible false positive test of Coombs.
Ceftriaxone is not recommended to apply for prophylaxis in neurosurgery .
To take account of the quantity of sodium content of the product ( ~ 70 mg / g) in patients on diets with sodium restriction .
Intramuscular injection of ceftriaxone without lidocaine painful . When using solvent lidocaine must make sample hypersensitivity to it. It is unacceptable lidocaine solutions to ceftriaxone intravenously
It is always recommended after pricking with intramuscular injections to pull the plunger (no blood appears ) to ensure that the needle does not hit a blood vessel.
It is recommended to use freshly prepared solutions !
Ceftriaxone solutions have a characteristic light yellow to amber color , depending on concentration , which is not related to the activity , efficacy and tolerability, and they remain stable for 24 hours at refrigerated (2-8 ° C).
It is desirable solutions to inlay immediately after preparation .
Interactions

Was observed additive and synergistic effect between Ceftriaxone and aminoglycoside antibiotics against gram -negative microorganisms including Pseudomonas aeruginosa and Streptococcus faecalis.
In cases where it is applied with Ceftriaxone aminoglycosides is essentially intramuscular administration of antibiotics can be performed at various locations and can not be mixed in the same syringe for injection or infusion solutions , as they are inactivated .
Ceftriaxone is incompatible with vancomycin.
Coadministration oral anticoagulants may result in potentiation of the effect of the latter, due to the suppression of the synthesis of vitamins . K.
Use during pregnancy and lactation

Although not teratogenic and mutagenic effects is not recommended ceftriaxone in pregnant women ( especially during the first three months) unless absolutely displayed.
Ceftriaxone is excreted in low concentrations in breast milk , which requires caution in its application to nursing women .
Effects on ability to drive and use machines
Ceftriaxone does not affect the ability to drive and use machines.
Undesirable effects
Ceftriaxone is usually well tolerated. Sometimes it can be observed :
Allergic skin rashes and fever (fever ) , rarely anaphylactic shock ;
Gastrointestinal disorders - nausea , vomiting , diarrhea, initial symptoms of pseudomembranous colitis;
Reversible hematologic reactions - eosinophilia , thrombocytosis , leukopenia, less anemia, hemolytic anemia , neutropenia , lymphopenia , thrombocytopenia , changes in some laboratory blood tests - prothrombin time , transient elevations of serum transaminases ;
Superinfection - Candida, Enterococcus, Pseudomonas aeruginosa;
Jaundice and biliary colic , hyperbilirubinemia , in rare cases can be observed ultrasound identified sediment in the gallbladder , which, whether or not accompanied by clinical symptoms are reversible after discontinuation of the application ;
Changes in intestinal flora due to the elimination of Ceftriaxone primarily via the bile ;
CNS - with high doses of beta-lactam antibiotics , especially in patients with renal insufficiency may occur headaches and dizziness was observed renal function during treatment with beta-lactam antibiotics , especially when co-administered with aminoglycosides or loop diuretics , others - oliguria , pain at the injection site , phlebitis .
Overdose.
There are no reports of overdose with Ceftriaxone .
Pharmacological
Pharmacokinetic properties:

After intramuscular administration of 0,500 g and 1g Ceftriaxone maximum plasma concentration of 43-80 ?g / ml is reached after about 2 hours. Bactericidal concentrations were maintained about 24 hours. Due to the high degree of reversible binding to plasma proteins (about 83-96%) Ceftriaxone exhibits nonlinear dose- dependent pharmacokinetics , depending on their plasma concentration.
In the application of large doses of the product once daily , protein spot is filled and connect a relatively small percentage of applications Ceftriaxone. Ceftriaxone is therefore recommended to be administered in a large single dose , rather than divided into smaller volumes. The biological half-life of Ceftriaxone is independent of dose and ranged from 6 to 9 hours, but may be prolonged in patients with severe renal impairment accompanied by hepatic impairment and in infants.
Ceftriaxone penetrates well into the body fluids and tissues - peritoneal , synovial , amniotic . Therapeutic concentrations are achieved in the cerebrospinal fluid of inflamed meninges . Crosses the placenta and at low concentrations detected in the milk of nursing mothers. High concentrations are achieved in bile.
About 40-65 % of the administered dose Ceftriaxone is excreted unchanged in the active form in the urine, mainly by glomerular filtration and the remaining 30-60% is excreted in the bile and is found in the faeces unchanged active form and an inactive metabolite .
In patients with impaired renal function increases the broadcast via the bile and back, in patients with impaired liver function is increased in the urine .
Pharmacodynamic properties:
Pharmacotherapeutic group: Anti-infective agents for systemic use . Antibacterials for systemic use . Other antibakterialni.Treta generation cephalosporins.
formulations
Powder for solution for injection
Qualitative and quantitative composition
The drug substance in a vial:
Ceftriaxone sodium eq. 500 mg, 1g or 2g Ceftriaxone.

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