Tulixon (ceftriaxone, sulbactam) powder for solution for injections vial №1

Description

Tulixon (ceftriaxone, sulbactam) powder for solution for injections vial №1

Composition

active substances: ceftriaxone, sulbactam;

1 vial contains ceftriaxone sodium equivalent to ceftriaxone 1 g and sulbactam sodium equivalent to sulbactam 500 mg.

Dosage form

Powder for solution for injection.

Basic physical and chemical properties: white or almost white powder.

Pharmacotherapeutic group

Antibacterial agents for systemic use, other b-lactam antibiotics. Ceftriaxone, combinations.
ATX code J01D.

Tulixon is a combination of ceftriaxone and sulbactam sodium.

Ceftriaxone is a parenteral cephalosporin antibiotic of the third generation with prolonged action. The bactericidal activity of ceftriaxone is due to inhibition of cell membrane synthesis. Ceftriaxone is active in vitro against most gram-negative and gram-positive microorganisms. Ceftriaxone is characterized by very high resistance to most b-lactamases (both penicillinases and cephalosporinases) of gram-positive and gram-negative bacteria.
Ceftriaxone is active against the following microorganisms in vitro and in clinical infections:

• Gram-positive aerobes: Staphylococcus aureus (methicillin-sensitive), coagulase-negative staphylococci, Streptococcus pyogenes (β-hemolytic, group A), Streptococcus agalactiae (β-hemolytic, group B), Streptococcus pneumococci,
• Gram-negative aerobes: Acinetobacter lwoffi, Acinetobacter anitratus (mainly A. baumanii), Aeromonas hydrophila, Alcaligenes faecalis, Alcaligenes odorans, alkagen-like bacteria, Borrelia burgdorferi, Capnocytopamarus, Citnocytopamaroca C., including Capnocytopamaro s. , Escherichia coli, Enterobacter aerogenes, Enterobacter cloacae, Enterobacter spp. (others), Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Hafnia alvei, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis (formerly Branhamella catarrhalis), Moraxella oslaenspp, Moraxella. (others), Morganella morganii, Neisseria gonorrhoea, Neisseria meningitidis, Pasteurella multocida, Plesiomonas shigelloides, Proteus mirabilis, Proteus penneri, Proteus vulgaris, Proteus vulgaris, Pseudomonas fluorescens, Pseudomonas spp. (others), Providentia rettgeri, Providentia spp. (others), Salmonella typhi, Salmonella spp. (non-typhoid), Serratia marcescens, Serratia spp. (others), Shigella spp., Vibrio spp., Yersinia enterocolitica, Yersinia spp. (others).
• Anaerobes: Bacteroides spp. (sensitive to bile), Clostridium spp. (except C. difficile), Fusobacterium nucleatum, Fusobacterium spp. (others), Gaffkia anaerobica (formerly called Peptococcus), Peptostreptococcus spp.

Indication:

• lower respiratory tract infections;
• acute bacterial otitis media;
• soft tissue and skin infections;
• kidney and urinary tract infections;
• infections of bones, joints;
• septicemia;
• infections of the abdominal cavity (peritonitis, infections of the biliary tract and digestive tract);
• meningitis;
• gonorrhea;
• prevention of infections in surgery.

Contraindication

Hypersensitivity to ceftriaxone or to any other cephalosporin. Presence of a history of severe hypersensitivity reactions (eg, anaphylactic reactions) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems); renal and / or hepatic insufficiency; History of gastrointestinal disease, especially non-specific ulcerative colitis, enteritis or colitis associated with the use of antibacterial drugs.

Ceftriaxone is contraindicated:

1) Premature infants ≤ 41 weeks, taking into account the period of fetal development (gestational age + age after birth);

2) Full-term newborns (age ≤ 28 days):

• with hyperbilirubinemia, jaundice, hypoalbuminemia or acidosis, as bilirubin binding is likely to be impaired in such conditions;
• who require (or are expected to require) intravenous calcium supplements or infusions of calcium-containing solutions as there is a risk of ceftriaxone calcium salt precipitates forming.

Method of application and dosage

When prescribing Tulixon, it is necessary to follow the official recommendations for antibiotic therapy and in particular the recommendations for the prevention of antibiotic resistance.

Prepare solutions immediately before use. After adding the solvent, you need to visually assess the completeness of the dissolution. Tulixon can be administered intravenously or intramuscularly.

1) Adults and children over 12 years of age: usually prescribe 1-2 g (in terms of ceftriaxone) of Tulixon 1 time per day (every 24 hours). In severe infections or infections whose pathogens are only moderately sensitive to the drug, the daily dose can be increased to 4 g (in terms of ceftriaxone).

2) Newborns, infants and children under 12 years

• Newborns (up to 2 weeks): 20-50 mg / kg body weight (calculated on ceftriaxone) 1 time per day. Due to the underdevelopment of the enzyme system, the daily dose should not exceed 50 mg / kg body weight. Doses of the drug for full-term and premature infants do not differ.
• Tulixon is contraindicated in neonates ≤ 28 days of age when necessary (or expected to be) treated with intravenous calcium-containing solutions, including intravenous calcium-containing infusions such as parenteral nutrition, due to the risk of ceftriaxone calcium salt precipitates.

3) Newborns and children aged 15 days to 12 years: 20-80 mg / kg body weight (calculated on ceftriaxone) 1 time per day.

4) Doses for adults weighing more than 50 kg should be prescribed for adults.

The total daily dose for children should not exceed 2 g (in terms of ceftriaxone).

Intravenous doses of 50 mg / kg (calculated on ceftriaxone) or higher should be infused slowly over 30-60 minutes.

Children

In newborns and premature infants, cases of precipitates in the lungs and kidneys have been reported, which have been fatal with concomitant administration of ceftriaxone and calcium supplements. In some of these cases, the same infusion systems were used for intravenous Tulixon and calcium-containing solutions, and precipitates were observed in some intravenous infusion systems.

Overdose:

• Symptoms: There is limited information on overdose in humans.
  In case of overdose, nausea, vomiting, diarrhea may occur. High concentrations of b-lactam antibiotics in the cerebrospinal fluid can cause neurological reactions, including seizures.
• Treatment: Plasma ceftriaxone concentrations cannot be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote. Symptomatic treatment is recommended for the treatment of overdose.

Side effects:

• infections and infestations: candidiasis, genital mycosis, secondary fungal infections and infections caused by resistant microorganisms, superinfections;
• from the blood and lymphatic system: eosinophilia, neutropenia (associated with long-term use, reversible), leukopenia, leukocytosis, lymphopenia, granulocytopenia, anemia, including hemolytic anemia, thrombocytopenia, thrombocytosis;
• from the gastrointestinal tract: loose stools, diarrhea, nausea, vomiting, flatulence, stomatitis, taste disturbances, glossitis;
• from the hepatobiliary system: pseudocholelithiasis of the gallbladder, precipitates of the calcium salt of ceftriaxone in the gallbladder with corresponding symptoms in children, reversible cholelithiasis in children, increased activity of hepatic transaminases and alkaline phosphatase, hyperbilirubinemia, nuclear;
• from the skin and subcutaneous tissue: skin rash, allergic dermatitis, itching, urticaria;
• from the kidneys and urinary system: increased concentrations of urea and creatinine in the blood, oliguria, hematuria, glucosuria;
• neurological disorders: headache, dizziness, tremor, convulsions;
• cardiac disorders: increase or decrease in blood pressure, palpitations;
• from the respiratory system, chest and mediastinum: shortness of breath, bronchospasm;
• from the immune system: anaphylactic or anaphylactoid reactions, anaphylactic shock, hypersensitivity;
• from the organs of hearing and balance: vertigo;
• general disorders: fever, chills, serum sickness, edema, nosebleeds, weakness;
• local reactions: when administered intravenously – phlebitis, soreness, tightness along the vein.