Claforan

Klaforan is a semisynthetic antibiotic drug of the cephalosporins group.

Release form and composition

Klaforan is produced in the form of a powder for preparing a solution for injections (intravenous and intramuscular) - yellowish-white or white, crystalline, in colorless glass vials, 1 bottle in carton packs.

The composition of 1 bottle contains the active substance: cefotaxime - 1 g.

Indications for use

Klaforan is prescribed for the treatment of inflammatory-infectious diseases caused by microorganisms sensitive to the action of the active substance:

• Infections of the respiratory and urinary tract;
• Infections of the joints and bones;
• Bacteremia;
• Septicemia;
• Intraabdominal infections (including peritonitis);
• Infections of soft tissue and skin;
• Endocarditis;
• Infections of the central nervous system, including meningitis (except listeriosis).

Also, the drug is indicated for the prevention of infectious complications after obstetric-gynecological and urological operations, as well as operations on the organs of the gastrointestinal tract.

Contraindications

Hypersensitivity to cephalosporins.

If lidocaine is used as a solvent, intramuscular injections should take into account the following contraindications:

• Severe heart failure;
• Intracardiac blockade without a pacemaker installed;
• Intravenous drug;
• Children's age up to 2.5 years;
• Hypersensitivity to lidocaine or other local anesthetics amide type.

Claforan is not recommended for pregnant and lactating women.

Dosing and Administration

Klaforan can be administered intramuscularly or intravenously (as an infusion or slow injection).

In the treatment of uncomplicated gonorrhea in adults with normal kidney function, Claforan is administered intramuscularly once in a dose of 0.5-1 g.

For uncomplicated infections, characterized by a moderate degree of severity, the drug should be administered intramuscularly or intravenously in a single dose of 1-2 g with an interval of 8-12 hours. Daily dose - 2-6 g.

In the treatment of severe infections, Klaforan should be administered intravenously in a single dose of 2 g with an interval of 6-8 hours. Daily dose - 6-8 g.

If the infection is caused by strains that are not sensitive enough to the action of Claforan, the only way to confirm its effectiveness is to conduct a test.

In cases of impaired renal function (creatinine clearance (CK) - 10 ml per minute and less), the adult single dose should be reduced by 2 times, keeping the interval between injections. If QC cannot be measured, it is calculated by the level of serum creatinine using the Cockroft formula.

Depending on the severity of the infection, 1-2 g of Claforan per day is prescribed for patients on hemodialysis. On the day of dialysis, the solution must be injected after the end of the procedure.

The daily dose of antibiotic in prematurely born children is:

• Up to 7 days of life - 50-100 mg / kg, divided into 2 intravenous administrations with an interval of 12 hours;
• 1-4 weeks of life - 75-150 mg / kg, divided into 3 intravenous administration with an interval of 8 hours.

For children whose body weight is less than 50 kg, Claforan is prescribed in a daily dose of 50-100 mg / kg. The drug is administered with an interval of 6-8 hours intravenously or intramuscularly. The maximum daily dose - 2 g. In severe infections, including meningitis, you can increase the daily dose by 2 times.

Children with a body weight of 50 kg of the drug is prescribed in an adult dose.

Intramuscular administration of Claforan with 1% lidocaine solution is strictly contraindicated in children under 2.5 years of age.

To prevent the occurrence of postoperative infections before surgery during induction of anesthesia, the solution can be administered intramuscularly or intravenously at a dose of 1 g with repeated administration after surgery after 6-12 hours.

When a caesarean section is performed during the application of clips to the umbilical vein, Klaforan is administered intravenously at a dose of 1 g, after 6-12 hours, the drug is re-administered at the same dose (intramuscularly or intravenously).

The duration of therapy is determined by the doctor individually.

To prepare the solution of Klafaran for intramuscular injection, the powder must be dissolved with sterile water for injection: 2 g in 10 ml, 1 g in 4 ml. As a solvent for intramuscular injection, you can use a 1% solution of lidocaine (intravenous administration in this case is strictly contraindicated).

When preparing a solution for intravenous administration, the powder (1 g or 2 g) is dissolved in 40-100 ml of an infusion solution or sterile water for injection. The injection is carried out within 3-5 minutes slowly (due to the high probability of occurrence of life-threatening arrhythmias, with the introduction of Claforan through the central venous catheter). For infusion, you can use (concentration - 1 g / 250 ml): sodium lactate solution, 0.9% sodium chloride solution, water for injection, 5% glucose solution (dextrose), Ringer's solution, as well as solutions of yonosteril, tufuzin B, hemaccel , reomacrodex 12%, macrodex 6%.

It is necessary to observe aseptic conditions during the preparation of solutions for injection, especially in cases where the drug will not be used immediately after dilution.

Side effects

During therapy may develop disorders of some body systems:

• The digestive system: vomiting, nausea, increased activity of liver enzymes or bilirubin, abdominal pain, diarrhea (can be a symptom of enterocolitis, which is sometimes accompanied by the appearance of blood in the feces. A special form of enterocolitis is pseudomembranous colitis);
• Hematopoietic system: neutropenia; rarely - thrombocytopenia, eosinophilia, agranulocytosis; in some cases - hemolytic anemia;
• Urinary system: deterioration of kidney function (increase in creatinine level), especially when used simultaneously with aminoglycosides; very rarely, interstitial nephritis;
• Cardiovascular system: in some cases - arrhythmias (with bolus administration through a central venous catheter);
• Central nervous system: encephalopathy (when using high doses), especially in patients with renal insufficiency;
• In the treatment of borreliosis: Yarish-Herxheimer's reaction (in the first days of therapy), leukopenia, skin rash, fever, difficulty breathing, itching, discomfort in the joints, increased levels of liver enzymes;
• Allergic reactions: bronchospasm, angioedema, rash, urticaria, skin redness; very rarely - erythema multiforme, anaphylactic shock, toxic epidermal necrolysis, Stevens-Johnson syndrome;
• Local reactions: inflammation at the injection site;
• Other: superinfection, fever, weakness.

special instructions

Before starting to use Claforan, it is necessary to collect an allergic history, this especially applies to allergic diathesis, hypersensitivity reactions to beta-lactam antibiotics.

In 5-10% of cases, cross-allergy between cephalosporins and penicillins occurs. In patients with a history of allergic reactions to penicillin, Claforan should be used with extreme caution.

The use of the drug is strictly contraindicated in patients with a history of hypersensitivity to immediate cephalosporins. In case of any doubts, the presence of a doctor at the first injection of Claforan is obligatory (due to the possible development of an anaphylactic reaction).

If hypersensitivity reactions occur, the drug should be withdrawn.

In the first weeks of therapy, pseudomembranous colitis may develop, manifested by prolonged, severe diarrhea. The diagnosis is confirmed by histological examination and / or colonoscopy. Since this complication is regarded as quite serious, the drug should be immediately discontinued and adequate treatment prescribed (including oral administration of metronidazole or vancomycin).

When Clarafan is used together with potentially nephrotoxic drugs (diuretics, aminoglycoside antibiotics), it is necessary to control kidney function, which is associated with the danger of nephrotoxic action.

Patients who need to limit sodium intake should take into account the sodium content of cefotaxime sodium salt (48.2 mg / g).

During therapy, a Coombs false positive test is possible.

It is necessary to control the rate of Claforan injection

With the duration of the treatment course longer than 10 days, the picture of peripheral blood should be monitored. With the development of neutropenia, therapy is stopped.

During treatment, to avoid the development of false-positive results when using non-specific reagents, it is recommended to use glucose-oxidase methods for determining the level of glucose in the blood.

Drug interaction

Klaforan can potentiate the nephrotoxic effect of drugs that have a nephrotoxic effect.

Probenecid when combined with Claforan increases plasma concentrations of cefotaxime and retards excretion.

Klaforan is incompatible with solutions of other antibiotics, including aminoglycosides, in a single infusion solution or syringe.

Terms and conditions of storage

Store in a dark, out of reach of children at a temperature up to 25 ° C.

Shelf life - 2 years.

The solution for intramuscular administration, prepared using a 0.5% or 1% solution of lidocaine hydrochloride or water for injection, maintains chemical stability for 8 hours when stored at room temperature up to 25 ° C or for 24 hours when stored at 2- 8 ° C in a dark place.

The solution for infusion or injection, prepared using water for injection, is chemically stable for 12 hours when stored at room temperature up to 25 ° C or for 24 hours when stored at 2-8 ° C in the dark place. Light yellow shade of the drug does not indicate a decrease in its activity.

The solution for infusions, which was prepared on the basis of infusion solutions, retains chemical stability for 8 hours after dilution in a solution of tutofusin, yonosteril, hemacel, or for 6 hours after dilution in 10% glucose solution (dextrose), reomacrodex or macrodex.