Klaforan

Klaforan – semi-synthetic antibiotic medicine of group of cephalosporins for parenteral use.

Form of release and structure

Klaforan is issued in the form of powder for preparation of solution for intravenous and intramuscular administration: yellow-white or white color (in glass colourless bottles, on 1 bottle in a cardboard pack).

1 bottle contains active ingredient: tsefotaksy – 1 g (in the form of a tsefotaksim of sodium – 1,048 g).

Indications to use

Klaforan is appointed at therapy of the diseases of infectious and inflammatory character caused by microorganisms, sensitive to action of a tsefotaksim:

• Infections of respiratory and urinogenital system, soft tissues, skin, joints, bones, the central nervous system, including meningitis (except listeriozny);
• Intraabdominal (intra belly) infections, including peritonitis;
• Septicaemia;
• Endocarditises;
• Bacteremia.

For prevention of infectious complications drug is used when carrying out obstetric and gynecologic and urological operations and surgical interventions on digestive tract.

Contraindications

Klaforan's use contraindicated with hypersensitivity to cephalosporins.

At dissolution of powder of Klaforan the following contraindications to solution use exist lidocaine (intramuscular introduction):

• Intravenous administration;
• Endocardiac blockade without the established pacemaker;
• Heavy heart failure;
• Age up to 2,5 years (intramuscular introduction);
• Hypersensitivity to lidocaine or other local anestetichesky means of amide type.

It is not necessary to appoint Klaforan to pregnant women as there are no reliable data confirming its efficiency and safety. In need of performing therapy during a lactation breastfeeding is recommended to be interrupted.

Route of administration and dosage

Klaforan's solution is entered intramusculary or intravenously (as a slow injection or infusion).

At normal function of kidneys by the adult it is recommended to adhere to the following mode of dosing:

• Uncomplicated gonorrhea: once intramusculary 0,5-1 g;
• Uncomplicated infections of moderate severity: intramusculary or intravenously, a single dose – 1-2 g, daily – 2-6 g, an interval between introductions – 8-12 hours;
• Heavy infections: intravenously, a single dose – 2 g, daily – 6-8 g, an interval between introductions – 6-8 hours.

At insufficient sensitivity of strains of an infection to effect of drug the only means of confirmation of efficiency of Klaforan is the test of definition of sensitivity to it.

Adults at functional disturbances of kidneys (at the clearance of creatinine (CC) of 10 ml a minute and less) should lower a single dose twice, keeping break duration between introductions (the daily dose at the same time decreases twice).

At impossibility to measure KK it it is possible to calculate, based on serum creatinine level using Kokroft's formula for adults.

Men can apply one of two formulas:

• Body weight (kg) x (140 age)/72 x creatinine of serum (mg/dl);
• Body weight (kg) x (140 age)/0,814 x creatinine of serum (µmol/l).

Women to calculate KK should apply a formula: 0,85 x an indicator for men.

The patient who is on a hemodialysis Klaforan appoint 1-2 g in a daily dose (is defined by weight of an infection; solution is entered after the end of a procedure).

The recommended dosing mode for children:

• Prematurely been born children (up to 1 week of life): intravenously, a daily dose – 0,05-0,1 g/kg, divided into 2 introductions with a break of 12 hours;
• Prematurely been born children (1-4 weeks of life): intravenously, a daily dose – 0,075-0,15 g/kg, divided into 3 introductions with a break of 8 hours;
• Children with body weight to 50 kg: intravenously or intramusculary, a daily dose – 0,05-0,1 g/kg (it is entered with a break of 6-8 hours). It is not necessary to exceed a daily dose of 2 g. At heavy infections, including meningitis, increase in a daily dose is possible twice;
• Children with body weight from 50 kg: drug is used in adult doses.

To children up to 2,5 years strictly contraindicated intramuscular introduction of Klaforan dissolved by 1% lidocaine.

For the purpose of prevention of developing of postoperative infections before carrying out operation during an introduction anesthesia Klaforan enter intramusculary or intravenously in a dose of 1 g. Repeated introduction in the same dose is carried out in 6-12 hours after operation.

When imposing on an umbilical vein of clips during performing Cesarean section solution is entered intravenously in a dose of 1 g, in 6-12 hours repeatedly enter the same dose of drug (intramusculary or intravenously).

The doctor establishes therapy duration individually.

For preparation of solution for intramuscular introduction it is necessary to dissolve powder sterile water for injections: 4 ml for 1 g of powder and 10 ml for 2 g. As solvent it is possible to use 1% lidocaine solution (intravenous administration is strictly contraindicated).

For preparation of solution for intravenous administration of 1 g or 2 g of powder dissolve in 40-100 ml of infusion solution or sterile water for injections. The injection should be carried out slowly for 3-5 minutes (because of possible development of life-threatening arrhythmias at Klaforan's introduction through the central venous catheter). For infusions it is possible to use such solutions (concentration of a tsefotaksim of 1 g / 250 ml) as: water for injections, 0,9% sodium chloride solution, Ringer's solution, 5% solution of glucose (dextrose), sodium lactate solution, and also solutions yonosterit, гемакцель, 12% реомакродекс, 6% Macrodexum, тутофузин Century.

At dissolution of powder it is necessary to provide aseptic conditions, in particular if Klaforan's solution is entered not at once.

Side effects

• Cardiovascular system: in isolated cases – arrhythmias (when carrying out bolyusny introduction through the central venous catheter);
• Urinary system: deterioration in function of kidneys (increase in level of creatinine), in particular at simultaneous use with aminoglycosides; very seldom – intersticial nephrite;
• Alimentary system: are possible – vomiting, nausea, abdominal pains, increase in activity of liver enzymes (gamma глутамилтрансферазы, alaninaminotranspherases, lactate dehydrogenases, aspartate aminotransferases, an alkaline phosphatase) and/or bilirubin, diarrhea (can demonstrate to development of a coloenteritis that sometimes is followed by emergence in Calais of blood; a special form of a coloenteritis pseudomembranous colitis is);
• Central nervous system: encephalopathy (at introduction of high doses), in particular against the background of a renal failure;
• Hemopoietic system: neutropenia; seldom – an eosinophilia, thrombocytopenia, an agranulocytosis; in isolated cases – hemolitic anemia;
• Allergic reactions: small tortoiseshell, erubescence, Quincke's disease, rash, bronchospasm; very seldom – Stephens-Johnson's syndrome, a mnogoformny erythema, an acute anaphylaxis, a toxic epidermal necrolysis (Lyell's disease);
• Local reactions: an inflammation in a solution injection site;
• Others: fever, weakness, superinfection.

At therapy of borreliosis development of the following disturbances is possible: the complicated breath, skin rash, fever, an itch, Yarisha-Gerksgeymer's reaction (in the first days of therapy), increase in level of enzymes of a liver, a leukopenia, discomfort in joints.

Special instructions

Before Klaforan's use it is necessary to collect the allergological anamnesis, in particular concerning instructions on allergic diathesis, reaction of hypersensitivity to a beta laktamnym to antibiotic drugs. In 5-10% of cases there is a cross allergy between cephalosporins and penicillin. With extreme care Klaforan it is necessary to appoint the patient with instructions in the anamnesis to allergic reactions to penicillin.

Existence of anamnestic data on reactions of immediate hypersensitivity to cephalosporins is a strict contraindication to Klaforan's use. At any doubts at the first administration of solution presence of the doctor is necessary that is connected with probability of anaphylactic reactions.

At development of reactions of hypersensitivity Klaforan cancel.

In the first weeks of therapy development of pseudomembranous colitis which is shown by heavy long diarrhea is possible. The diagnosis is confirmed by a histologic research and/or a kolonoskopiya. This complication belongs to very serious therefore it is necessary to cancel immediately therapy and to appoint adequate treatment (including oral administration of metronidazole or Vancomycinum).

At co-administration of Klaforan with potentially nephrotoxic medicines (aminoglikozidny antibiotics, diuretics) it is necessary to control function of kidneys that is connected with danger of nephrotoxic action.

In need of restriction of consumption of sodium it is necessary to consider that in a tsefotaksim of sodium salt 48,2 mg/g of sodium contain.

At use of drug use of glyukozooksidazny methods of determination of level of glucose in blood is recommended that is connected with development of false positive results at use of nonspecific reactants.

During therapy emergence of false positive test of Koombs is possible.

It is necessary to control Klaforan rate of administering.

At long therapy (longer than 10 days) it is necessary to carry out control of a picture of peripheral blood. At development of a neutropenia drug is cancelled.

Medicinal interaction

At joint appointment of Klaforan with some medicines there can be following effects:

• Probenetsid: delay of excretion and increase in plasma concentration of a tsefotaksim;
• Drugs with nephrotoxic action: potentiation of their nephrotoxic effect.

Klaforan's solution cannot be mixed in one infusion solution or the syringe with solutions of other antibiotic drugs (including aminoglycosides).

Terms and storage conditions

To store in protected from light, the place, unavailable to children, at a temperature up to 25 °C.

Period of validity – 2 years.

Storage of the prepared solutions:

• The solution for intramuscular injections prepared using water for injections or 0,5% or 1% of solution of a hydrochloride of lidocaine: 8 hours (at the room temperature to 25 °C) or 24 hours (at storage at a temperature of 2-8 °C in the place protected from light);
• The solution for infusions prepared using infusion solutions: 8 hours (solution гемакцель, тутофузин or yonosterit) or 6 hours (10% solution of a dextrose (glucose), реомакродекс or Macrodexum);
• The solution for infusions or injections prepared using water for injections: 12 hours (at the room temperature to 25 °C) or 24 hours (at storage at a temperature of 2-8 °C in the place protected from light). Emergence of a pale yellow shade of decrease of the activity of drug does not mean.