about the product
The drug CEFOTAXIME + SULBACTAM is a powder for the preparation of a solution for intravenous and intramuscular administration, which outwardly is a white or brown powder with a yellowish tinge.
Specifications
Name
CEFOTAXIME+SULBACTAM
Dosage form
POWDER FOR SOLUTION PREPARATION FOR INTRAVENOUS AND INTRAMUSCULAR ADMINISTRATION
Nosological classification
Antibacterial drugs of systemic action
INN
Cefotaxime+[Sulbactam]
Dosages
1000 mg + 500 mg
ATC code
J01DD51
Active substance
cefotaxime and sulbactam.
Pharmacotherapeutic group
Antibacterial
use
Always use the drug in full accordance with the recommendations of the attending physician.
If in doubt, consult your doctor.
Doses are given in terms of cefotaxime.
Recommended dose
The doctor will determine the dose for you individually, depending on the diagnosis and severity of the disease.
Dosage regimen
The dose, method, and frequency of administration should be determined by the severity of the infection, the sensitivity of the pathogen, and the patient's condition. Treatment can be initiated before receiving the results of a sensitivity test.
Doses are given in terms of cefotaxime.
Adults and children over 12 years of age with a body weight of 50 kg or more: for infections of mild and moderate severity - 1000 mg every 12 hours. The dose may be changed by the doctor depending on the severity of the infection, the sensitivity of the pathogen and the patient's condition. In severe infections, the dose can be increased to 12 g per day, divided into 3-4 injections. For infections caused by Pseudomonas spp, the daily dose should be more than 6 g.
The maximum daily dose of sulbactam is 4 g. If necessary, more than 12 g of the drug is administered (with a ratio of the main components cefotaxime + sulbactam 2:1) an increase in the dose is achieved due to the additional administration of cefotaxime.
Children under 12 years of age with a body weight of up to 50 kg: the usual dose is 100-150 mg / kg / day, divided into 2-4 injections. For very severe infections, the dose can be increased to 200 mg/ kg per day.
Newborns: the dose is 50 mg / kg per day, divided into 2-4 injections. For severe infections, the dose is 150-200 mg / kg per day, divided into 2-4 injections. The maximum daily dose of sulbactam in children should not exceed 80 mg/kg/day. For gonorrhea: 1000 mg once intravenously or intramuscularly.
In order to prevent the development of infections before surgery (ot 30 1o 90 minutes before the operation), 1000 mg is administered intravenously or intramuscularly.
During cesarean section (At the moment of clamping the umbilical vein) - 1000 mg intravenously, then 6 and 12 hours after the first dose, 1000 mg each.
Special patient groups
Patients with renal insufficiency
If the creatinine clearance (KK) is less than 10 ml / min, the daily dose of cefotaxime is reduced. After the initial single dose is administered, the daily dose should be reduced by 2 times without changing the frequency of administration, i.e. instead of 1000 mg every 12 hours — 500 mg every 12 hours, instead of 1000 mg every 8 hours — 500 mg every 8 hours, instead of 2000 mg every 8 hours — 1000 mg every 8 hours, etc.D. Further dose adjustment may be required depending on the course of the infection and the general condition of the patient. In patients with a creatinine clearance of 15-30 ml/min, the maximum daily dose of sulbactam is 2000 mg, and in patients with a creatinine clearance of less than 15 ml/min, the maximum daily dose of sulbactam is 1000 mg. In severe infections, additional administration of cefotaxime may be required.
The way and method of administration
You will receive CEFOTAXIME+SULBACTAM intravenously (jet, drip) or intramuscularly.
Lidocaine-containing solutions should not be administered intravenously!
Intravenously, the drug is injected slowly for 3-5 minutes. The duration of intravenous drip infusion is 20-60 minutes. With intramuscular administration, a solution of CEFOTAXIME + SULBACTAM is injected deep into a relatively large muscle .
Doses are given in terms of cefotaxime.
Recommended dose
The doctor will determine the dose for you individually, depending on the diagnosis and severity of the disease.
Dosage regimen
The dose, method, and frequency of administration should be determined by the severity of the infection, the sensitivity of the pathogen, and the patient's condition. Treatment can be initiated before receiving the results of a sensitivity test.
Doses are given in terms of cefotaxime.
Adults and children over 12 years of age with a body weight of 50 kg or more: for infections of mild and moderate severity - 1000 mg every 12 hours. The dose may be changed by the doctor depending on the severity of the infection, the sensitivity of the pathogen and the patient's condition. In severe infections, the dose can be increased to 12 g per day, divided into 3-4 injections. For infections caused by Pseudomonas spp, the daily dose should be more than 6 g.
The maximum daily dose of sulbactam is 4 g. If necessary, more than 12 g of the drug is administered (with a ratio of the main components cefotaxime + sulbactam 2:1) an increase in the dose is achieved due to the additional administration of cefotaxime.
Children under 12 years of age with a body weight of up to 50 kg: the usual dose is 100-150 mg / kg / day, divided into 2-4 injections. For very severe infections, the dose can be increased to 200 mg/ kg per day.
Newborns: the dose is 50 mg / kg per day, divided into 2-4 injections. For severe infections, the dose is 150-200 mg / kg per day, divided into 2-4 injections. The maximum daily dose of sulbactam in children should not exceed 80 mg/kg/day. For gonorrhea: 1000 mg once intravenously or intramuscularly.
In order to prevent the development of infections before surgery (ot 30 1o 90 minutes before the operation), 1000 mg is administered intravenously or intramuscularly.
During cesarean section (At the moment of clamping the umbilical vein) - 1000 mg intravenously, then 6 and 12 hours after the first dose, 1000 mg each.
Special patient groups
Patients with renal insufficiency
If the creatinine clearance (KK) is less than 10 ml / min, the daily dose of cefotaxime is reduced. After the initial single dose is administered, the daily dose should be reduced by 2 times without changing the frequency of administration, i.e. instead of 1000 mg every 12 hours — 500 mg every 12 hours, instead of 1000 mg every 8 hours — 500 mg every 8 hours, instead of 2000 mg every 8 hours — 1000 mg every 8 hours, etc.D. Further dose adjustment may be required depending on the course of the infection and the general condition of the patient. In patients with a creatinine clearance of 15-30 ml/min, the maximum daily dose of sulbactam is 2000 mg, and in patients with a creatinine clearance of less than 15 ml/min, the maximum daily dose of sulbactam is 1000 mg. In severe infections, additional administration of cefotaxime may be required.
The way and method of administration
You will receive CEFOTAXIME+SULBACTAM intravenously (jet, drip) or intramuscularly.
Lidocaine-containing solutions should not be administered intravenously!
Intravenously, the drug is injected slowly for 3-5 minutes. The duration of intravenous drip infusion is 20-60 minutes. With intramuscular administration, a solution of CEFOTAXIME + SULBACTAM is injected deep into a relatively large muscle .
Help
Package leaflet
- Infectious and inflammatory diseases caused by microorganisms sensitive to the combination of cefotaxime with sulbactam: infections of the central nervous system (including meningitis, except listeriosis), lower respiratory tract and ENT organs, urinary tract, bones, joints, skin and soft tissues (including infected wounds and burns), pelvic organs gonorrhea, peritonitis, sepsis, intra-abdominal infections are a wide range of infectious processes that usually develop when exposed to microorganisms that infect the gastrointestinal tract (GIT) and penetrate into other, usually sterile areas of the abdominal cavity, endocarditis (inflammation of the inner lining of the heart), Lyme disease (borreliosis), infections associated with immunodeficiency.
- Prevention of infections before and after surgical operations (including urological, obstetric and gynecological, on the gastrointestinal tract).
Possible symptoms of overdose: seizures, encephalopathy (In case of high doses, especially in patients with renal insufficiency), tremor, neuromuscular excitability. Treatment: symptomatic. There is no specific antidote.
Like all medications, CEFOTAXIME+ SULBACTAM can cause undesirable reactions, but they do not occur in everyone. It is important that you inform your doctor about any adverse reactions that occur so that he can take appropriate measures (for example, temporarily suspend or cancel treatment, change the dose and duration of the drug, or prescribe additional therapy).
For more information about all possible adverse reactions and the frequency of their occurrence, see the instructions in the leaflet.
Do not use CEFOTAXIME+SULBACTAM in the following cases:
— if you are allergic to cefotaxime, sulbactam, other cephalosporin antibiotics or any other components of the drug listed in section 6 of the leaflet.
For forms containing lidocaine as a solvent:
— if you are allergic to lidocaine or other local anesthetics of the amide type (drugs used for anesthesia);
— if you have intracardiac blockages (impaired conduction of an electrical impulse in the atria, more often to the left atrium from the right) without a pacemaker installed;
— if you have severe heart failure;
— it is not used for intravenous administration;
— it is not used intramuscularly in children under 2.5 years of age.
Tell your doctor that you are taking, have recently taken, or may start taking any other medications.
Your doctor needs to know about the medications you are taking in order to take into account possible adverse reactions that may develop due to the interaction of various medications with CEFOTAXIME+ SULBACTAM, and possibly adjust the doses of the medications you are taking.
Be sure to tell your doctor if you need to take medications containing aminoglycosides or polymyxin B or loop diuretics at the same time as CEFOTAXIME+SULBACTAM, as the likelihood of kidney damage increases with simultaneous administration.
Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
An organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro
Store at temperatures below 25 °C. Store in the original packaging (pack/box).
When using the drug, adverse reactions such as dizziness may develop, and the ability to concentrate and react may be impaired. Take care when driving vehicles and working with mechanisms during treatment with the drug.
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