about the product
The
drug CEFTRIAXONE+ SULBACTAM is a powder for the preparation of a solution for intravenous and intramuscular administration, externally it is a white or white crystalline powder with a yellowish tinge.
Solvent Lidocaine solution for injection 10 mg/ml is a clear, colorless to light yellow solution.
Solvent Water for injection solvent for the preparation of dosage forms for injection is a colorless, transparent, odorless liquid.
Solvent Lidocaine solution for injection 10 mg/ml is a clear, colorless to light yellow solution.
Solvent Water for injection solvent for the preparation of dosage forms for injection is a colorless, transparent, odorless liquid.
Specifications
Name
CEFTRIAXONE+SULBACTAM
Dosage form
POWDER FOR SOLUTION PREPARATION FOR INTRAVENOUS AND INTRAMUSCULAR ADMINISTRATION
Nosological classification
Antibacterial drugs of systemic action
INN
CEFTRIAXONE+[SULBACTAM]
Dosages
1000 mg + 500 mg
ATC code
J01DD63
Active substance
ceftriaxone and sulbactam.
Pharmacotherapeutic group
Antibacterial
use
Always take the drug in full accordance with the recommendations of your doctor.
If in doubt, consult your doctor.
Recommended dose
Adults
The usual dose is 1-2 g of ceftriaxone (0.5—1 g of sulbactam) once a day or divided into two injections (every 12 hours). In severe cases or in infections whose pathogens have only moderate sensitivity to ceftriaxone, the daily dose can be increased to 4 g. The maximum daily dose of sulbactam is 4 g. Use in children
Children over 12 years old
The dosage regimen is the same as for adults.
Children under 12 years old
When using the drug once a day, it is recommended to adhere to the following dosage regimens: Newborns (up to 2 weeks)
20-50 mg/kg body weight of ceftriaxone (10-25 mg/kg of sulbactam) once a day. The daily dose of ceftriaxone should not exceed 50 mg / kg body weight.
Newborns, infants, and young children (from 15 days to 12 years old)
The recommended daily dose of ceftriaxone is 20-80 mg / kg (10-40 mg / kg sulbactam) once a day or divided into 2 doses (every 12 hours). The total daily dose of ceftriaxone in children should not exceed 2 g; the maximum daily dose of sulbactam should not exceed 80 mg / kg. A dose of 50 mg / kg body weight or more (ceftriaxone) should be administered as an intravenous infusion for 30 minutes. In the treatment of acute otitis media in children, a single intramuscular injection at a dose of 50 mg / kg (but not more than 1 g) is recommended. In children with a body weight of 50 kg or more, adult doses are used.
The way and method of administration
You will receive CEFTRIAXONE+SULBACTAM parenterally: intramuscularly or intravenously.
Recommended dose
Adults
The usual dose is 1-2 g of ceftriaxone (0.5—1 g of sulbactam) once a day or divided into two injections (every 12 hours). In severe cases or in infections whose pathogens have only moderate sensitivity to ceftriaxone, the daily dose can be increased to 4 g. The maximum daily dose of sulbactam is 4 g. Use in children
Children over 12 years old
The dosage regimen is the same as for adults.
Children under 12 years old
When using the drug once a day, it is recommended to adhere to the following dosage regimens: Newborns (up to 2 weeks)
20-50 mg/kg body weight of ceftriaxone (10-25 mg/kg of sulbactam) once a day. The daily dose of ceftriaxone should not exceed 50 mg / kg body weight.
Newborns, infants, and young children (from 15 days to 12 years old)
The recommended daily dose of ceftriaxone is 20-80 mg / kg (10-40 mg / kg sulbactam) once a day or divided into 2 doses (every 12 hours). The total daily dose of ceftriaxone in children should not exceed 2 g; the maximum daily dose of sulbactam should not exceed 80 mg / kg. A dose of 50 mg / kg body weight or more (ceftriaxone) should be administered as an intravenous infusion for 30 minutes. In the treatment of acute otitis media in children, a single intramuscular injection at a dose of 50 mg / kg (but not more than 1 g) is recommended. In children with a body weight of 50 kg or more, adult doses are used.
The way and method of administration
You will receive CEFTRIAXONE+SULBACTAM parenterally: intramuscularly or intravenously.
Help
Package leaflet
The drug is used to treat infectious and inflammatory diseases caused by pathogens sensitive to the combination of ceftriaxone with sulbactam in adults and children:
Symptoms of overdose
Nausea and vomiting, diarrhea, neurological disorders, including seizures.
Treatment
Overdose treatment is symptomatic. There is no specific antidote.
Like all medications, CEFTRIAXONE+ 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, and 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 take CEFTRIAXONE+SULBACTAM:
- if you are allergic to sulbactam and ceftriaxone, as well as to other cephalosporins, penicillins, beta-lactam antibiotics, or any other components of the drug listed in section 6 of the leaflet;
- if your full-term newborn baby (under the age of 28 days) has hyperbilirubinemia, hypoalbuminemia, jaundice or acidosis;
- if your newborn baby has not reached the "estimated" age of 41 weeks (including the period of intrauterine development and age);
- If your full-term newborn baby (under the age of 28 days) has been prescribed or is scheduled to receive intravenous calcium-containing solutions.
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 CEFTRIAXONE+ SULBACTAM, and possibly adjust the doses of the medications you are taking.
This applies, among other things, to any herbal preparations or medications that you bought without a doctor's prescription, as well as to vaccines.
Bacteriostatic antibiotics reduce the bactericidal effect of ceftriaxone+sulbactam, antagonism with chloramphenicol in vitro.
The formation of precipitates of calcium salts of ceftriaxone can also occur when mixing the drug and calcium-containing solutions using a single venous access. When using vitamin K antagonists during therapy with CEFTRIAXONE+ SULBACTAM, the risk of bleeding increases. Your doctor will constantly monitor blood clotting parameters and, if necessary, adjust the dose of the anticoagulant both during and after therapy with CEFTRIAXONE+SULBACTAM.
Ceftriaxone and aminoglycosides enhance each other's action against many gram-negative bacteria. Although the increased effectiveness of such combinations is not always predictable, it should be borne in mind in severe, life-threatening infections such as those caused by Pseudomonas aeruginosa.
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).
Store at temperatures below 25 °C. Store in the original packaging (pack).
Store at temperatures below 25 °C. Store in the original packaging (pack). Do not freeze.
Use caution when driving vehicles and operating machinery during treatment with CEFTRIAXONE+ SULBACTAM. Be sure to consult with your doctor if you want to follow these steps.
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