Biotraxon
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Biotraxone is a bactericidal drug. Third generation cephalosporin antibiotic.
Release form and composition
Biotraxon is available in the form of a powder for the preparation of a solution for intramuscular and intravenous administration, which has a white or white color with a yellowish tinge (1000 mg in vials, one vial in a cardboard box).
One bottle with the drug contains 1000 mg of ceftriaxone (in the form of ceftriaxone sodium trisesquihydrate).
Indications for use
Biotraxone is used for infections caused by pathogens sensitive to ceftriaxone:
- ENT infections;
- respiratory tract infections (including pneumonia);
- abdominal infections (including peritonitis);
- infections of the connective tissue, joints, bones and skin;
- urinary tract and kidney infections;
- urogenital infections (including gonorrhea);
- infections in immunocompromised patients;
- meningitis;
- sepsis.
The drug is also used to prevent infections in the period after surgery.
Contraindications
Absolute:
- jaundice or hyperbilirubinemia in term newborns;
- hypoalbuminemia and acidosis in term newborns;
- simultaneous intravenous administration of solutions containing calcium (in term newborns);
- prematurity [newborns who have not reached the age of 41 weeks (taking into account the period of intrauterine development and age)];
- pregnancy (first trimester);
- hypersensitivity to cephalosporin, penicillin, or carbapenem antibiotics.
Relative (Biotraxon is used with caution):
- nonspecific ulcerative colitis;
- colitis due to the use of antibacterial agents;
- enteritis;
- liver failure;
- renal failure;
- pregnancy (second and third trimesters);
- period of breastfeeding.
Method of administration and dosage
Biotraxone is intended for intravenous and intramuscular administration.
For intravenous administration, 1000 mg of the drug is diluted in 10 ml of water for injection, and then injected slowly intravenously over 2-4 minutes.
For intramuscular administration, 1000 mg of ceftriaxone is diluted in 3.5 ml of a 1% concentration lidocaine solution and injected deeply intramuscularly (into the gluteus muscle). It is not recommended to inject more than 1000 mg of the drug into one buttock. Lidocaine solution is not allowed to be administered intravenously.
For intravenous infusion, 2000 mg of Biotraxone is diluted in 40 ml of one of the calcium-free solutions (5% or 10% dextrose solution, 0.9% sodium chloride solution, 5% fructose solution). The duration of the infusion is at least 30 minutes.
The daily dose of ceftriaxone for children over 12 years of age and for adults is 1000–2000 mg once a day or 500–1000 mg every 12 hours. For infections caused by moderately sensitive microorganisms, as well as in severe cases, it is possible to increase the daily dose to 4000 mg.
For newborns (full-term or premature) under two weeks of age, the daily dose is 20-50 mg / kg body weight once a day. It is not recommended to use more than 50 mg / kg, since the enzyme system in newborns is immature.
For newborns (from the 15th day of life), infants and children under 12 years of age, the daily dose of Biotraxone is 20–80 mg / kg of body weight per day, once. Children weighing 50 kg or more are prescribed an adult dose. A dose of more than 50 mg / kg of body weight is administered as an intravenous infusion for at least 30 minutes.
In acute otitis media in children, the drug is administered intramuscularly once at a dose of 50 mg / kg body weight (but not more than 1000 mg).
The duration of the course of treatment depends on the course and severity of the disease.
The introduction of ceftriaxone is continued for another 48–72 hours after the temperature has returned to normal and the pathogen has been destroyed. For infections caused by Streptococcus pyogenes, the course of treatment is at least 10 days.
For gonorrhea, the recommended dose is 250 mg once intramuscularly.
For bacterial meningitis in children, including newborns, the initial dose of Biotraxone is 100 mg / kg body weight once a day (but not more than 4000 mg). When determining the type of pathogenic microorganism and its sensitivity, the dose of the drug should be reduced. The duration of therapy depends on the pathogen: Streptococcus pneumoniae - 7 days, Haemophilus influenzae - 6 days, Neisseria meningitidis - 4 days.
For the prevention of infections in the pre- and postoperative period, the drug is administered 30–90 minutes before surgery at a dose of 1000–2000 mg (depending on the risk of infection). For surgical interventions on the rectum and colon, additional administration of 5-nitroimidazoles is recommended.
With impaired renal function and normal liver function, as well as with impaired liver function and normal renal function, dose adjustment is not required. If creatinine clearance is less than 10 ml / min and in patients with renal-hepatic insufficiency, the daily dose of the drug should not exceed 2000 mg. Patients on hemodialysis do not need additional ceftriaxone after dialysis.
Biotraxone must not be mixed or administered simultaneously with solutions containing calcium.
Side effects
- digestive system: vomiting, bloating, diarrhea, abdominal pain, nausea, stomatitis, constipation, flatulence, taste disturbance, glossitis, liver dysfunction, dysbiosis, pseudocholelithiasis of the gallbladder, pseudomembranous colitis, pancreatitis, the formation of suspension or stagnation of bile in the bile;
- cardiovascular system: palpitations;
- hematopoietic system and blood coagulation system: lymphocytosis, agranulocytosis, thrombocytosis, leukocytosis, monocytosis, neutropenia, leukopenia, lymphopenia, thrombocytopenia, granulocytopenia, basophilia, hemolytic anemia, decrease or lengthening of prothrombin time, decrease in the concentration of plasma clotting factors;
- muscular system: cramps;
- organ of hearing and balance: vertigo;
- urinary system: increased blood urea, glucosuria, hematuria, azotemia, hypercreatininemia, cylindruria, nephrolithiasis, anuria, urine sediment, oliguria;
- allergic reactions: rash, allergic dermatitis, hives, swelling, itching, fever, or chills; rarely - eosinophilia, serum sickness, allergic pneumonitis, bronchospasm, Quincke's edema, toxic epidermal necrolysis, anaphylactic shock, exudative polymorphic erythema;
- local reactions: increased sweating, soreness along the vein, flushing, infiltration and soreness at the site of intramuscular injection, phlebitis;
- other reactions: nosebleeds, superinfection, dizziness, headache, vaginitis, candidiasis; rarely - the formation of precipitates of calcium ceftriaxone in the kidneys and lungs in full-term and premature infants less than 28 days old.
special instructions
If allergic reactions develop, Biotraxone should be discontinued immediately and appropriate treatment should be prescribed.
In newborns (especially premature infants) with hyperbilirubinemia, the drug should be used only under the strict supervision of a physician.
During treatment with Biotraxon, it is recommended to refrain from driving a car and operating other complex mechanisms.
Drug interactions
When used simultaneously with aminoglycosides, synergism is observed with respect to many gram-negative bacteria.
Biotraxone is incompatible with alcohol.
When used together with non-steroidal anti-inflammatory drugs and other inhibitors of platelet aggregation, the risk of bleeding increases.
Loop diuretics and other nephrotoxic drugs increase the likelihood of nephrotoxicity.
Ceftriaxone solutions should not be mixed or co-administered with other antimicrobial agents or solutions.
Terms and conditions of storage
Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
