Ceftriaxone

Alvobac powder is intended for the treatment of the following infections in adults and children, including full-term newborns (from birth):

• bacterial meningitis;
• community-acquired pneumonia;
• hospital pneumonia;
• acute otitis media;
• intraperitoneal infections;
• complicated urinary tract infections (including pyelonephritis);
• infections of bones and joints;
• complicated infections of the skin and soft tissues;
• gonorrhea;
• syphilis;
• bacterial endocarditis.

Alvobac can be used for:

• treatment of acute complications of chronic obstructive pulmonary disease in adults;
• for the treatment of disseminated Lyme borreliosis (early (II stage) and late (III stage)) in adults and children, including newborns from the age of 15 days;
• preoperative prevention of infections at the site of surgical intervention;
• for the management of patients with neutropenia who develop a fever with suspected bacterial infection;
• for the treatment of patients with bacteremia that has arisen in connection with any of the above infections or if there is a suspicion of any of the above infections.

Structure

Active ingredient: ceftriaxone;

1 vial contains ceftriaxone sodium equivalent to ceftriaxone - 1 g.

Contraindications

Hypersensitivity to ceftriaxone or to any other cephalosporin. The presence of a history of severe hypersensitivity reactions (for example, anaphylactic reactions) to any other type of beta-lactam antibacterial agents (penicillins, monobactams and carbapenems).

Ceftriaxone is contraindicated in premature infants aged ≤ 41 weeks, taking into account the term of intrauterine development (gestational age + age after birth).

Full-term newborns (aged ≤ 28 days):

• with hyperbilirubinemia, jaundice, hypoalbuminemia or acidosis, since bilirubin binding is probably impaired in such conditions;
• requiring (or expected to require) intravenous administration of calcium preparations or infusions of calcium-containing solutions, since there is a risk of the formation of ceftriaxone calcium salt precipitates.

Ceftriaxone solutions containing lidocaine should never be administered intravenously.

Mode of application

The dose of the drug depends on the severity, sensitivity, location and type of infection, as well as on the age and function of the liver and kidneys of the patient.

The following doses are generally accepted recommended for these indications. In severe cases, the highest dose should be used from the recommended range.

Adults and children over 12 years old (≥ 50 kg).

1-2 g once a day:

• Community-acquired pneumonia.
• An acute complication of chronic obstructive pulmonary disease.
• Intra-abdominal infections.
• Complicated urinary tract infections (including pyelonephritis).

2 g once a day:

• Hospital pneumonia
• Complicated infections of the skin and soft tissues.
• Infections of bones and joints.

2-4 g once a day:

• Management of patients with neutropenia who have developed fever and are suspected of having a bacterial infection.
• Bacterial endocarditis.
• bacterial meningitis.

Newborns, infants and children aged 15 days to 12 years (<50 kg).

50-80 mg / kg once a day:

• Intra-abdominal infections.
• Complicated urinary tract infections (including pyelonephritis).
• Community-acquired pneumonia.
• Hospital pneumonia

50-100 mg / kg (maximum - 4 g) once a day:

• Complicated infections of the skin and soft tissues.
• Infections of bones and joints.
• Management of patients with neutropenia who have developed fever and are suspected of having a bacterial infection.

80-100 mg / kg (maximum - 4 g) once a day: bacterial meningitis.

100 mg / kg (maximum 4 g) once daily: bacterial endocarditis.

Newborns 0-14 days.

20-50 mg / kg once a day:

• Intra-abdominal infections.
• Complicated infections of the skin and soft tissues.
• Complicated urinary tract infections (including pyelonephritis).
• Community-acquired pneumonia.
• Hospital pneumonia
• Infections of bones and joints.
• Management of patients with neutropenia who have developed fever and are suspected of having a bacterial infection.

50 mg / kg once a day:

• Bacterial meningitis.
• Bacterial endocarditis.

Application features

Pregnant women

Ceftriaxone crosses the placental barrier. Limited data are available on the use of ceftriaxone in pregnant women. Animal studies do not indicate a direct or indirect harmful effect on the embryo / fetus, and postnatal development. During pregnancy, especially in the first trimester, ceftriaxone can be used only if the benefit outweighs the risk.

Children

The safety and effectiveness of the drug Alvobac in newborns, infants and children have been established for the doses described in the section "Method of use". Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from its association with serum albumin.

Alvobac is contraindicated in premature and full-term infants who are at risk of developing bilirubin encephalopathy.

Drivers

During treatment with ceftriaxone, adverse reactions such as dizziness can occur, which can affect the ability to drive vehicles or work with complex mechanisms. Patients should be careful when driving or working with other mechanisms.

Overdose

In case of an overdose, hemodialysis or peritoneal dialysis will not reduce excessive plasma concentrations of the drug. In case of an overdose, nausea, vomiting, diarrhea can be observed. There is no specific antidote. Overdose treatment is symptomatic.

Side effects

Adverse reactions were most often observed with the use of ceftriaxone: eosinophilia, leukopenia, thrombocytopenia, diarrhea, rash and increased levels of liver enzymes.

Interaction

Solvents containing calcium, such as Ringers solution or Hartmanns solution, should not be used to reconstitute Alvobac in vials or to further dilute reconstituted solution for intravenous administration, since precipitate may form. Ceftriaxone calcium salt precipitates can also be formed by mixing ceftriaxone with calcium-containing solutions in a single infusion system. Ceftriaxone cannot be administered simultaneously with intravenous solutions containing calcium, including calcium-containing solutions for long-term infusions, such as solutions for parenteral nutrition, using the Y-shaped system. However, other patients, except newborns, ceftriaxone and calcium-containing solutions can be administered sequentially, after each other, if the system is thoroughly flushed with a compatible liquid between infusions.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Store the prepared solution in a dark place for 6 hours at room temperature or for 24 hours at a temperature of 2-8 ° C.

Shelf life is 2 years.