Trade name

Ceftribak-NOVO

 

Active substances

ACeftriaxone and sulbactam (as sodium salt)

 

Code ATC:

 

Pharmaceutical form

Powder for solution for injection 0.75 g and 1.5 g vials

 

Ingredients for one bottle

Ceftriaxone sodium based on ceftriaxone - 0.500 g or 1.0 g
Sulbactam sodium in terms of sulbactam - 0,250 g or 0.5 g

 

Pharmacotherapeutic group

Antibiotics (cephalosporins group)

 

Pharmacological properties

The drug is a combination of sulbactam sodium and ceftriaxone sodium.
Ceftriaxone sodium is a semisynthetic cephalosporin antibiotic of broad-spectrum intravenous (I / O) and intramuscular (i / m) administration.
Ceftriaxone has a broad spectrum of action: is active against aerobic gram-positive microorganisms: facultative anaerobes - Staphylococcus aureus (including penicillin generators strains), Staphylococcus epidermidis, Streptococcus pneumoniae-b, hemolytic group A streptococci (S.pyogenes), group B streptococci (S.agalactiae ), Streptococcus viridans, Streptococcus bovis, Streptococcus non-enterococcal group D; Gram-negative microorganisms: Escherichia coli, Haemophilus influenzae, H.rarainfluenzae, species Klebsiella (including Kb. pneumoniae), Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia, Salmonella (including S.typhy), Serratia spp. (including S.marcescens), Shigella, Versinia (including Y.enterocolitica); microaerophiles - Treponema pallidum; aerobic - Neisseria gonorrheae (includingpenicillin generators strain), Neisse-ria meningitides, Pseudomonas aeruginosa; obligate anaerobes, Bacteroides species (including some strains B.Fragilis), Clostridium (C. difficile strains but most is resistant), Peptococcus, Peptostreptococcus, Fusobacterium (including F.mortiferum and F.varium).
Sulbactam sodium is a derivative of the basic penicillin nucleus.
Sulbactam has no clinically significant antibiotic activity. Studies have shown that it is an irreversible inhibitor of the most basic β-lactamases produced by microorganisms which are resistant to β-lactam antibiotics.
Sulbactam binds to penicillin some proteins, so the combination of ceftriaxone / sulbactam often has a more pronounced effect on the sensitive strains than one ceftriaxone.

 

Pharmacokinetics

After intramuscular administration of the drug, the maximum concentration (Cmax) in plasma ceftriaxone and sulbactam determined between 15 minutes and 2 hours. Ceftriaxone plasma Cmax after a single intramuscular dose of 1.0 g is about 81 mg / l and is determined within 2-3 hours after dosing, while the concentration of sulbactam sodium is 6-24 mg / ml and is determined for 1 hour after dosing.
After intravenous administration at the recommended dose of ceftriaxone sodium is well distributed in the tissue of the body. Germicidal concentrations are maintained for 24 hours. Ceftriaxone reversibly binds albumin, and binding decreases as the concentration increases, e.g., from 95% binding at plasma concentrations> 100 mg / l to 85% the binding at 300 mg / l. Because of the low levels of albumin, the proportion of free tseftriak Thomson in tissue fluid, respectively higher than in plasma.
The volume of distribution (Vd) of ceftriaxone sodium is 7-12 l and sulbactam is -18-27,6 l. Both are widely distributed in the amniotic fluid. It is also determined in the milk. In young healthy adult volunteers and purification of plasma factor is 10-22 ml / min. Hepatic purification of 5-12 ml / min. Approximately 75-85% and 50-80% of sulbactam ceftriaxone is excreted unchanged by the kidneys, while the remainder dose is excreted in the bile.
Mean plasma half-life time of 8 hours of ceftriaxone in healthy young adult volunteers. In neonates, urinary recovery calculations are about 70% of the dose. By children younger than eight days, and by the elderly over 75 years, the average half-life increases typically 2-3 times higher than in young healthy people. Mean plasma half-life time of about 1 hour sulbactam.
Hemodialysis half-time changes, the overall recovery of the body, and Vd sulbactam.
Study conducted in pediatric patients had no significant changes in the pharmacokinetics of ceftriaxone components when administered in combination form.

 

Indications for use

Ceftribak-NOVO prescribed for the treatment of the following infections caused by microorganisms sensitive to it:
• Infections of the upper and lower respiratory tract;
• Acute bacterial otitis media;
• Infections of the skin and soft tissues;
• Urinary tract infections (complicated and uncomplicated);
• Infections of the pelvic organs;
• Bacterial sepsis;
• Infections of bones and joints;
• Infections of the gastrointestinal tract;
• Meningitis;
• Infections indulging sexually;
• Prevention of infection in surgery
Preoperative use of the drug may reduce the incidence of postoperative infections in patients undergoing surgical procedures.

 

Dosing and administration

May be introduced into / in or / m after dissolution in sterile water for injection
It is recommended to use the solution immediately after dissolution.
Number of vials of the drug and the recommended amount of water for injection to dissolve the drug

 

Preparation The volume
of one ampoule
The recommended amount of sterile water
for injection to dissolve the drug
For i / m injection For in / injection
Сeftribak-NOVO 1.5g 10 ml 5 ml 10-20 ml
Сeftribak-NOVO 0,75 g 5 ml 2-3 ml 5 ml

 

Adults
A typical daily dose for an adult (in the case of ceftriaxone) is 1-2 g, which is administered 1 time per day (or equally divided doses twice per day), depending on the severity of the infection. The maximum daily dose should not exceed 4 years
In patients with severe renal impairment (creatinine clearance 15-30 ml / min) maximum dose formulations that is 1 g every 12 hours (maximum daily dose of sulbactam - 2 g), and in patients with creatinine clearance less than 15 ml / min maximum dose of sulbactam 0.5 g every 12 hours (maximum daily dose of sulbactam - 1 g).

Pediatric patients:
For infections of the skin and soft tissues of the skin recommended daily dose (in the case of ceftriaxone) is 50-75 mg / kg, which is administered one time per day (or in equally divided doses twice a day). The maximum daily dose should not exceed 1 year for the treatment of acute bacterial otitis media: single / m dose (in the case of ceftriaxone) recommended 250 mg / kg (not to exceed 1 g).
For the treatment of severe infections mixed except meningitis recommended daily dose in the case of ceftriaxone 50-75 mg / kg, which is given in divided doses every 12 hours. The maximum daily dose (in the case of ceftriaxone) should not exceed 2 g.
For the treatment of meningitis recommended initial therapeutic dose designation (if ceftriaxone) was 100 mg / kg (not to exceed 4 g.) A daily dose (for ceftriaxone) may be administered one time per day (or equally divided doses every 12 hours). Typically, the duration of therapy is 7-14 days. Ceftriaxone therapy must be to continue for at least 2 days after the infection signs and symptoms disappear. Conventional therapy lasts 4-14 days. In complicated infections may require longer therapy.
In the treatment of infections caused by streptococcus anti-pyrogenic treatment should continue for at least 10 days.

 

Adverse effects

Using drugs can appear allergic reaction (hives, itching, eosinophilia, serum sickness, erythema multiforme exudative, anaphylactic reactions, in rare cases, anaphylactic shock); stomatitis, glossitis, and from the digestive tract may include nausea, vomiting, loss of taste, abdominal pain, goiter, superinfection, pseudomembranous colitis.
Possible changes in the peripheral blood neutropenia, lymphopenia, thrombocytopenia, hemolytic anemia rarely, in some cases, reduced levels of serum factors fiery (II, VII, IX, X), the prothrombin time is prolonged; observed nosebleeds, develops cholestatic jaundice, increases in urine creatinine levels appear cylinders; oliguria, anuria, biochemical changes (increase in liver transaminases and bilirubin in blood plasma), possible acute renal failure, arrhythmias, headache, or infiltration at the injection site, in some cases, phlebitis or thrombophlebitis with intravenous administration.

 

Contraindications

The drug is contraindicated in patients with known allergy to penicillin or to any of its components, as well as (intramuscular administration) to lidocaine, with liver and kidney failure, diseases of the gastrointestinal tract (in history), ulcerative colitis or nonspecific enteritis, during pregnancy and lactation.

 

Interactions

At simultaneous application cephalosporins and cyclosporine may increase levels in blood plasma and the toxicity of the latter.
When used in combination with an aminoglycoside efficacy due to synergism increased with respect to Gram-negative microorganisms, however, requires the choice of optimal doses. Non-steroidal anti-inflammatory drugs, antiplatelet agents increase the chances of bleeding, loop diuretics and nephrotoxic drugs (aminoglycosides, polymyxin B) cause renal dysfunction.
In a joint application diclofenac stimulates secretion of ceftriaxone in bile and reduces the total clearance in the urine.
Acetazolamide increases the concentration of ceftriaxone in the stomach contents.
Solutions of ceftriaxone should not be mixed or administered simultaneously with other antimicrobials.
Ceftriaxone must not be mixed with solutions containing calcium.

 

Special instructions

In severe anaphylactic reactions is necessary urgent administration of epinephrine (ad-renalina). Glucocorticosteroids are injected intravenously, including intubation.
In severe biliary obstruction, severe liver disease, and renal impairment may require correction dosing regimen of the drug.
Patients who are violating liver function and concomitant renal impairment need monitoring of serum concentration of ceftriaxone and correction dose if necessary. If the regular monitoring of serum concentration of ceftriaxone in such cases is not carried out, its daily dose should not exceed 2 g
For intramuscular administration in order to eliminate pain at the injection site dissolve in a 1% solution of lidocaine in the following ratio: The contents of the vial with 0.5 g dissolve in 1 ml of 2% lidocaine with 1 g - 3.5 ml.
With long-term treatment of drug (and other antibiotics) may experience excessive growth of non-susceptible organisms. Patients should be carefully monitored during treatment.
With long-term drug therapy is recommended to periodically monitor the performance of the functions of internal organs, including the kidneys, liver, and hematopoietic system. This is especially important for newborns, especially premature and young children.

Pregnancy and lactation:
Pregnancy and lactation is possible only if the expected benefit to the mother outweighs the potential risk to the fetus and child.

Paediatric use:
The drug should not be administered to newborns with hyperbilirubinemia, especially born prematurely.

 

Overdose

Symptoms: increased side effects.
Treatment: symptomatic, hemodialysis or peritoneal dialysis is ineffective.

 

Storage conditions

In a dry protected from light place, at temperature not exceeding 25°C.

 

Expiration date

2years.

 

Terms of supply of pharmacies

By prescription.

Сeftribak-NOVO

Hepatoprotectors
Antibiotics
Local anaesthetic drugs
Nootropic drugs
Antihypertensive drugs
Drugs for a parenteral food
Medicines applied at poisonings and intoxications
Medicines for metabolic processes correction
Medicines for peripheric blood circulation
Mineral drugs, microcells
Salt solutions
Analgesic and antispasmodic drugs
Nonsteroidal anti-inflammatory drugs
Haemostatics