Tsefogram
Producer: Orchid Healthcare (Orkhid Helskea) India
Code of automatic telephone exchange: J01DD04
Release form: Liquid dosage forms. Powder for preparation of solution for injections.
General characteristics. Structure:
Active ingredient: 250 mg, 500 mg or 1000 mg of a tseftriakson (in the form of sodium salt).
Pharmacological properties:
Pharmacodynamics. Generation cephalosporin III. Tseftriakson acts bakteritsidno, inhibiting synthesis of mukopeptid of a cell wall of bacteria in a mitosis phase.
Possesses a broad spectrum of activity. It is steady against action of the majority β-лактамаз.
Tseftriakson is active concerning gram-positive microorganisms: streptococci of groups A, B, C and G, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, Staphylococcus aureus, Staphylococcus epidermidis; gram-negative microorganisms: Aeromonas hydrophila, Bacillus subtilis, Borrelia burgdorferi, Morganella morganii, Citrobacter diversus, Clostridium perfringens, Corynebacterium diphtheriae, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Enterobacter spp., Haemophilus influenzae, Moraxella catarrhalis, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Eubacterium spp., Shigella spp., Salmonella spp., Yersinia spp.
Pharmacokinetics. Absorption. Later in/in administrations of drug in a dose of 1 g of Cmax makes 150 mkg/ml. Bioavailability of drug at introduction in oil makes 100%.
Distribution. Linkng with proteins of plasma makes 85-95%.
Later in/in introductions цефтриаксон quickly gets into an interintercellular lymph where during more than a day its bactericidal concentration concerning sensitive microorganisms is maintained.
At meningitis at children (including newborns) drug gets through the inflamed meninx, at the same time in cerebrospinal fluid sufficient bactericidal concentration is created.
At adults in 2 h after introduction of a tseftriakson in a dose of 50 mg/kg of body weight concentration of drug in cerebrospinal fluid many times over surpasses MPK for the most widespread causative agents of meningitis.
Removal. T1/2 makes 8 h 60% of drug 40% — with bile are removed by kidneys.
Pharmacokinetics in special clinical situations. At babies, patients of advanced age of patients with a serious illness of a liver and kidneys of T1/2 increases twice.
Indications to use:
— respiratory infections (including pneumonia, abscess of lungs, pleura empyema);
— infections of urinary tract (including pyelonephritis);
— infections of abdominal organs (including peritonitis);
— infections of bones and joints;
— infections of skin and soft tissues;
— sepsis;
— meningitis;
— prevention of infectious and inflammatory complications at surgical interventions on a GIT, in urological and obstetric and gynecologic practice.
Route of administration and doses:
To adults and children 12 years drug are more senior appoint 1-2 g 1 time/days in a dose. The maximum daily dose for adults makes 4 g.
The newborn drug appoint 20-50 mg/kg of body weight of 1 times/days in a dose.
To children from 3rd week of life to 12 years drug appoint 20-100 mg/kg of body weight of 1 times/days in a dose.
At patients with a liver and renal failure of heavy degree at KK less than 10 ml/min. a daily dose of drug should be reduced twice.
Rules of preparation and administration of solutions. For preparation of solution for in/in jet introductions as solvent use water for injections. For a dose of 500 mg use 5 ml of solvent, for a dose of 1 g - 10 ml. The drug is administered in/in slowly within 2-4 min.
For preparation of solution for in/in drop introductions as solvent apply water to injections, 5% or 10% dextrose solutions. For a dose of 1-2 g and more use 50-100 ml of solvent. Enter in/in kapelno slowly within 30 min.
For preparation of solution for introduction in oil as solvent apply water to injections or 1% lidocaine solution. For a dose of 500 mg use 2 ml of solvent, for a dose of 1 g - 4 ml. It is recommended to enter no more than 1 g into one buttock.
Features of use:
Use at pregnancy and feeding by a breast. Use of drug at pregnancy is possible only in that case when the estimated advantage for mother surpasses potential risk for a fruit.
In need of use of drug in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.
Use at abnormal liver functions. At patients with a liver failure of heavy degree the daily dose of drug is reduced twice.
Use at renal failures. At patients with a renal failure of heavy degree at KK less than 10 ml/min. a daily dose of drug should be reduced twice.
Special instructions. At prolonged use of drug it is recommended to carry out clinical blood test periodically.
At Tsefogram's appointment the patient, being on a hemodialysis, it is necessary to control concentration of drug in a blood plasma, considering possible reduction of speed of its removal at such patients.
Use in pediatrics. Newborn children should appoint drug with care with a hyperbilirubinemia (especially premature).
Influence on ability to driving of motor transport and to control of mechanisms. Tsefogram does not cause drowsiness and does not influence ability to driving of motor transport and control of the mechanisms requiring special attention and speed of psychomotor reactions.
Side effects:
From the alimentary system: nausea, vomiting, diarrhea, dysbacteriosis, tranzitorny increase in activity of hepatic transaminases, pseudomembranous colitis.
From system of a hemopoiesis: reversible leukopenia, neutropenia, thrombocytopenia, eosinophilia.
From coagulant system of blood: hemorrhages, nasal bleedings.
Allergic reactions: urticaria, skin itch, Quincke's edema, acute anaphylaxis.
Local reactions: morbidity in the place in oil of an injection.
Others: fever, arthralgias, renal failure, candidiasis.
Interaction with other medicines:
At co-administration of Tsefogram and antibiotics from group of aminoglycosides an action synergism concerning gram-negative bacteria is shown.
Pharmaceutical interaction. Pharmaceutical it is incompatible with the solutions containing other antibiotics or with the solutions containing calcium ions.
Contraindications:
— bleedings in the anamnesis;
— coloenterites in the anamnesis;
— hypersensitivity to cephalosporins and another beta лактамным to antibiotics.
Overdose:
Symptoms: development of reversible encephalopathy is possible.
Treatment: symptomatic therapy. There is no specific antidote. Tseftriakson is not brought by a hemodialysis or peritoneal dialysis.
Storage conditions:
Drug should be stored in dry, protected from light, the place, unavailable to children, at a temperature not above 25 °C. A period of validity — 3 years. Drug cannot be used on expiry date.
Issue conditions:
According to the recipe
Packaging:
Bottles glass (1) - boxes cardboard.