Rocephin Powder, 1 piece, 3.5 ml, 1 g, for solution preparation

Composition and release form

in bottles of 250, 500 mg or 1 g (with solvent in ampoules of 2 ml - for bottles of 250 and 500 mg and 3.5 ml - for bottles of 1 g); in a cardboard pack there is 1 bottle and 1 ampoule.

in bottles of 250, 500 mg or 1 g (with solvent in ampoules of 5 ml - for bottles of 250 and 500 mg and 10 ml - for bottles of 1 g); in a cardboard pack there is 1 bottle and 1 ampoule.

in bottles of 1 g; 1 bottle in a cardboard pack.

in bottles of 2 g; 1 bottle in a cardboard pack or 143 bottles in a cardboard box - for hospitals.

Rocephin®

Standard dosage regimen

Intravenously, intramuscularly.

Adults and children over 12 years of age ≥50 kg: 1-2 g once daily (every 24 hours). In severe cases or for infections whose pathogens are only moderately sensitive to ceftriaxone, the daily dose can be increased to 4 g.

The duration of treatment depends on the course of the disease. As always with antibiotic therapy, the administration of Rocephin® should be continued in patients for at least 48-72 hours after the temperature has normalized and eradication of the pathogen has been confirmed.

Usually the course of treatment is 4-14 days; for complicated infections, longer administration may be required.

The course of treatment for infections caused by Streptococcus pyogenes should be at least 10 days.

Introduction

The general rule should be to use solutions immediately after preparation. The prepared solutions retain their physical and chemical stability for 6 hours at room temperature (or for 24 hours at a temperature of 2-8 ° C). Depending on the concentration and duration of storage, the color of solutions can vary from pale yellow to amber. The color of the solution does not affect the effectiveness or tolerability of the drug.

For intramuscular injection, 250 mg or 500 mg of Rocephin® is dissolved in 2 ml, and 1 g in 3.5 ml of a 1% lidocaine solution and injected deep into a fairly large muscle (buttock). It is recommended to inject no more than 1 g into the same muscle. A solution containing lidocaine should not be administered intravenously.

For intravenous injection, dissolve 250 mg or 500 mg of Rocephin® in 5 ml, and 1 g in 10 ml of sterile water for injection; administered intravenously slowly over 5 minutes, preferably into a large vein.

The intravenous infusion should last at least 30 minutes. To prepare the solution, dilute 2 g of Rocephin® in 40 ml of one of the following infusion solutions that do not contain calcium ions: 0.9% sodium chloride solution, 0.45% sodium chloride solution + 2.5% dextrose solution, 5% dextrose solution , 10% dextrose solution, 6% dextran solution in 5% dextrose solution, 6-10% hydroxyethyl starch solution, water for injection. Solutions of Rocephin® should not be mixed or added to solutions containing other antimicrobials or other solvents other than those listed above due to possible incompatibility.

Solvents containing calcium, such as Ringer's solution or Hartmann's solution, should not be used to prepare solutions of Rocephin® for intravenous administration and their subsequent dilution due to the possible formation of precipitates. The formation of precipitates of calcium salts of ceftriaxone can also occur when mixing the drug Rocephin® and calcium-containing solutions when using the same venous access. Rocephin® should not be used simultaneously with calcium-containing solutions for intravenous administration, including long-term infusions of calcium-containing solutions, for example, with parenteral nutrition using a Y-connector. For all groups of patients, except newborns, sequential administration of Rocephin® and calcium-containing solutions is possible with thorough rinsing of the infusion systems between infusions with a compatible liquid (see section “Interaction with other drugs”).

There have been no reports of interactions between ceftriaxone and oral calcium-containing drugs or interactions between intramuscular ceftriaxone and calcium-containing drugs (intravenous or oral).

Dosing in special cases

Patients with liver dysfunction

In patients with impaired liver function, there is no need to reduce the dose, provided there is no impairment of renal function.

Patients with impaired renal function

In patients with impaired renal function, there is no need to reduce the dose, provided there is no impairment of liver function. The daily dose of Rocefin® should not exceed 2 g only in cases of renal failure with creatinine clearance less than 10 ml/min. Ceftriaxone is not eliminated during hemodialysis or peritoneal dialysis, so administration of an additional dose of Rocephin® to the patient after completion of dialysis is not required.

With a combination of severe renal and liver failure, the effectiveness and safety of the drug should be carefully monitored.

Elderly and senile patients

Usual dosages for adults, not adjusted for age, provided there is no severe renal or hepatic impairment.

Children

Newborns, infants and children under 12 years of age

When prescribing Rocephin® once daily, it is recommended to adhere to the following dosage regimens:

- newborns (up to 14 days): 20-50 mg/kg body weight once a day; the daily dose should not exceed 50 mg/kg body weight;

- newborns, infants and young children (from 15 days to 12 years): 20-80 mg/kg body weight once a day;

- Children weighing over 50 kg are prescribed doses for adults.

For premature infants up to 41 weeks of age inclusive (combined gestational and chronological age), the use of ceftriaxone is contraindicated. Rocephin® is contraindicated in neonates (≤28 days) who are already prescribed or are expected to be treated with intravenous calcium-containing solutions, including continuous calcium-containing infusions, for example, with parenteral nutrition due to the risk of the formation of precipitates of ceftriaxone calcium salts (see section "Contraindications").

In infants and children under 12 years of age, intravenous doses of 50 mg/kg or higher should be administered by drip over at least 30 minutes. In newborns, intravenous administration should be given over 60 minutes to reduce the potential risk of developing bilirubin encephalopathy.

Meningitis

For bacterial meningitis in infants and young children, treatment begins with a dose of 100 mg/kg (but not more than 4 g) once a day. Once the pathogen has been identified and its sensitivity determined, the dose can be reduced accordingly. The best results for meningococcal meningitis were achieved with a treatment duration of 4 days, for meningitis caused by Haemophilus influenzae - 6 days, Streptococcus pneumoniae - 7 days.

Lyme disease

50 mg/kg (highest daily dose - 2 g) for adults and children once a day for 14 days.

Gonorrhea (caused by penicillinase-forming and non-penicillinase-forming strains)

A single intramuscular injection of 250 mg of Rocephin® in adult patients and children over 12 years of age ≥50 kg.

Acute otitis media

When treating acute otitis media in children, a single intramuscular injection of 50 mg/kg (but not more than 1 g) is recommended.

For adults, a single intramuscular dose of 1-2 g is recommended. According to limited data, in severe cases or when previous therapy is ineffective, Rocephin® may be effective when administered intramuscularly at a dose of 1-2 g per day for 3 days.

Prevention of postoperative infections

Depending on the degree of infectious risk, 1-2 g of Rocephin® is administered once 30-90 minutes before the start of surgery. For operations on the colon and rectum, the simultaneous (but separate, see section “Dosage and Administration”) administration of the drug Rocephin® and one of the 5-nitroimidazoles, for example, ornidazole, has proven itself to be effective.

Directions for use and doses

IV and IM.

Standard dosage regimen

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

Newborns (up to 2 weeks): 20–50 mg/kg body weight 1 time per day. The daily dose should not exceed 50 mg/kg body weight. When determining the dose, there is no need to distinguish between full-term and premature infants.

Infants and young children (from 15 days to 12 years): 20–80 mg/kg body weight 1 time per day.

Children weighing over 50 kg are prescribed adult doses.

IV doses of 50 mg/kg or higher should be administered by drip over at least 30 minutes.

Elderly patients: usual doses for adults, not adjusted for age.

The duration of treatment depends on the course of the disease. As always with antibiotic therapy, the administration of Rocephin should be continued in patients for at least 48–72 hours after the temperature has normalized and eradication of the pathogen has been confirmed.

Combination therapy

The experiment showed synergism between Rocephin and aminoglycosides against many gram-negative bacteria. Although the increased effectiveness of such combinations is not always predictable, it should be considered in severe, life-threatening infections such as those due to Pseudomonas aeruginosa. Due to the physical incompatibility of ceftriaxone and aminoglycosides, they should be administered separately at their recommended doses.

Dosing in special cases

For bacterial meningitis in infants and young children, treatment begins with a dose of 100 mg/kg (but not more than 4 g) once a day. Once the pathogen has been identified and its sensitivity has been determined, the dose can be reduced accordingly. The best results for meningococcal meningitis were achieved with a treatment duration of 4 days, for meningitis caused by Haemophilus influenzae - 6 days, Streptococcus pneumoniae - 7 days.

Lyme borreliosis: 50 mg/kg (highest daily dose - 2 g) for adults and children, 1 time per day for 14 days.

Gonorrhea (caused by penicillinase-forming and penicillinase-non-forming strains): single intramuscular injection of 250 mg of Rocephin.

Prevention of postoperative infections: depending on the degree of infectious risk, 1–2 g of Rocephin is administered once 30–90 minutes before the start of surgery. During operations on the colon and rectum, the simultaneous (but separate) administration of Rocephin and one of the 5-nitroimidazoles, for example ornidazole, has worked well.

In patients with impaired renal function, there is no need to reduce the dose if liver function remains normal. The daily dose of Rocephin should not exceed 2 g only in cases of preterminal renal failure (Cl creatinine less than 10 ml/min). In patients with impaired liver function, there is no need to reduce the dose if renal function remains normal.

When severe renal and liver failure are combined, the plasma concentration of ceftriaxone should be regularly determined and its dose adjusted if necessary.

Patients on dialysis do not require additional administration of the drug after dialysis. However, serum ceftriaxone concentrations should be monitored for possible dosage adjustments as the elimination rate may be reduced in these patients.

Introduction

As a rule, drug solutions should be used immediately after preparation.

The prepared solutions retain their physical and chemical stability for 6 hours at room temperature (or for 24 hours at a temperature of 2–8 °C). However, the general rule should be to use solutions immediately after preparation. Depending on the concentration and duration of storage, the color of solutions can vary from pale yellow to amber. The color of the solution does not affect the effectiveness or tolerability of the drug.

For intramuscular injection, 250 or 500 mg of Rocephin is dissolved in 2 ml, and 1 g in 3.5 ml of a 1% lidocaine solution and injected deep into the gluteal muscle. It is recommended to inject no more than 1 g into one buttock. A solution containing lidocaine cannot be administered intravenously.

For intravenous injection, dissolve 250 or 500 mg of Rocephin in 5 ml, and 1 g in 10 ml of sterile water for injection; administered intravenously slowly over 2–4 minutes.

The IV infusion should last at least 30 minutes. To prepare the solution, dilute 2 g of Rocephin in 40 ml of one of the following infusion solutions that do not contain calcium ions: 0.9% sodium chloride, 0.45% sodium chloride + 2.5% glucose, 5% glucose, 10% glucose, 5 % fructose, 6% dextran in 5% glucose solution, 6–10% hydroxyethyl starch, water for injection. Rocephin solutions should not be mixed or added to solutions containing other antibiotics or other solvents other than those listed above due to possible incompatibility.

Rocephin Powder, 1 piece, 3.5 ml, 1 g, for solution preparation

Pharmacological properties

Third generation cephalosporin antibiotic for parenteral use. characterized by long-term action. The bactericidal activity of ceftriaxone is due to the suppression of the synthesis of cell membranes. in vitro, ceftriaxone has a broad spectrum of action against gram-negative and gram-positive microorganisms. it is highly resistant to most β-lactamases (both penicillinases and cephalosporinases) produced by gram-positive and gram-negative bacteria. It is active against the following microorganisms: gram-positive aerobes: staphylococcus aureus (methicillin-sensitive strains), coagulase-negative staphylococci, streptococcus pyogenes (β-hemolytic, group a), streptococcus agalactiae (β-hemolytic, group b), β-hemolytic streptococci (groups neither a nor b), streptococcus viridans, streptococcus pneumoniae. methicillin-resistant staphylococcus spp. resistant to cephalosporins, incl. to ceftriaxone. as a rule, enterococcus faecalis, enterococcus faecium and listeria monocytogenes are also resistant. gram-negative aerobes: acinetobacter lwoffi, acinetobacter anitratus (mainly a. baumanii)*, aeromonas hydrophila, alcaligenes faecalis, alcaligenes odorans, alkaligen-like bacteria, borrelia burgdorferi, capnocytophaga spp. , citrobacter diversus (including S. amalonaticus), citrobacter freundii*, escherichia coli, enterobacter spp.* (including enterobacter aerogenes*, enterobacter cloacae*), haemophilus ducreyi, haemophilus influenzae, haemophilus parainfluenzae, hafnia alvei, klebsiella oxytoca, klebsiella pneumoniae**, moraxella spp. (including moraxella catarrhalis, moraxella osloensis), morganella morganii, neisseria gonorrhoeae, neisseria meningitidis, pasteurella multocida, plesiomonas shigelloides, proteus mirabilis, proteus penneri*, proteus vulgaris*, pseudomonas spp. (including pseudomonas fluorescens*), providentia spp. (including providentia rettgeri*), salmonella spp. (including salmonella typhi), serratia spp.* (including serratia marcescens*), shigella spp., vibrio spp., yersinia spp. (including yersinia enterocolitica).* Some isolates of these species are resistant to ceftriaxone, mainly due to the production of chromosomally encoded β-lactamases.** Some isolates of these species are resistant due to the formation of a number of plasmid-mediated β-lactamases. Many strains of the above microorganisms, multiresistant to other antibiotics, such as aminopenicillins and ureidopenicillins, first and second generation cephalosporins and aminoglycosides, are sensitive to ceftriaxone. treponema pallidum is sensitive to ceftriaxone in vitro and in animal experiments. clinical trials show that ceftriaxone has good efficacy against primary and secondary syphilis. with very few exceptions, clinical isolates of p. aeruginosa are resistant to ceftriaxone. anaerobes: bacteroides spp. (bile-sensitive)*, clostridium spp. (except c. difficile), fusobacterium spp. (including fusobacterium nucleatum), gaffkia anaerobica (formerly called peptococcus), peptostreptococcus spp.* some isolates of these species are resistant to ceftriaxone due to the formation of β-lactamases. Many strains of β-lactamase-forming bacteroides spp. (in particular, b. fragilis) are resistant to cefriaxone. resistant and clostridium difficile. Susceptibility to ceftriaxone can be determined by the disk diffusion method or the serial dilution method on agar or broth using a standard procedure similar to that recommended by the National Committee of Clinical Laboratory Standards (NCLS). The NKCL has established the following criteria for assessing the test results for ceftriaxone: research method sensitive moderately sensitive stable dilution method inhibitory concentration, mg/l = 8 16-32 = 64 disc method (disc with 30 mcg ceftriaxone) diameter of the growth inhibition zone, mm = 21 20-41 = 13 to determine, you should take disks with ceftriaxone, because in vitro studies have shown that ceftriaxone is active against individual strains that exhibit resistance when using discs intended for the entire group of cephalosporins. Instead of NCLs standards, other well-standardized standards can be used to determine the sensitivity of microorganisms, for example, din and ics, which allow adequate interpret the state of sensitivity.

ROCEPHIN

Directions for use and doses

Standard dosage regimen
Intravenously, intramuscularly.

Adults and children over 12 years old >50 kg:

1-2 g once a day (every 24 hours).
In severe cases or for infections whose pathogens are only moderately sensitive to ceftriaxone, the daily dose can be increased to 4 g. The duration of treatment
depends on the course of the disease. As always with antibiotic therapy, the administration of Rocephin® should be continued in patients for at least 48-72 hours after the temperature has normalized and eradication of the pathogen has been confirmed.

Usually the course of treatment is 4-14 days; for complicated infections, longer administration may be required.

The course of treatment for infections caused by Streptococcus pyogenes,

must be at least 10 days.

Introduction

The general rule should be to use solutions immediately after preparation. The prepared solutions retain their physical and chemical stability for 6 hours at room temperature (or for 24 hours at a temperature of 2-8°C). Depending on the concentration and duration of storage, the color of solutions can vary from pale yellow to amber. The color of the solution does not affect the effectiveness or tolerability of the drug.

For intramuscular injection

250 mg or 500 mg of Rocephin® are dissolved in 2 ml, and 1 g in 3.5 ml of a 1% lidocaine solution and injected deep into a fairly large muscle (buttock). It is recommended to inject no more than 1 g into the same muscle. A solution containing lidocaine should not be administered intravenously.

For intravenous injection

dissolve 250 mg or 500 mg of Rocephin® in 5 ml, and 1 g in 10 ml of sterile water for injection; administered intravenously slowly over 5 minutes, preferably into a large vein.

Intravenous infusion

must last at least 30 minutes.
To prepare the solution, dilute 2 g of Rocephin® in 40 ml of one of the following infusion solutions that do not contain calcium ions: 0.9% sodium chloride solution, 0.45% sodium chloride solution + 2.5% dextrose solution, 5% dextrose solution, 10% dextrose solution, 6% dextran solution in 5% dextrose solution, 6-10% hydroxyethyl starch solution, water for injection. Solutions of Rocephin® should not be
mixed or added to solutions containing other antimicrobials or other solvents other than those listed above due to possible incompatibility.

Solvents containing calcium, such as Ringer's solution or Hartmann's solution, should not be used to prepare solutions of Rocephin® for intravenous administration and their subsequent dilution due to the possible formation of precipitates. The formation of precipitates of calcium salts of ceftriaxone can also occur when mixing the drug Rocephin® and calcium-containing solutions when using the same venous access. Rocephin® should not be used simultaneously with calcium-containing solutions for intravenous administration, including long-term infusions of calcium-containing solutions, for example, with parenteral nutrition using a Y-connector. For all groups of patients, except newborns, sequential administration of Rocephin® and calcium-containing solutions is possible with thorough rinsing of the infusion systems between infusions with a compatible liquid (see section “Interaction with other drugs”).

There have been no reports of interactions between ceftriaxone and oral calcium-containing drugs or interactions between intramuscular ceftriaxone and calcium-containing drugs (intravenous or oral).

Dosing in special cases

Patients with liver dysfunction

In patients with impaired liver function, there is no need to reduce the dose, provided there is no impairment of renal function.

Patients with impaired renal function

In patients with impaired renal function, there is no need to reduce the dose, provided there is no impairment of liver function. The daily dose of Rocefin® should not exceed 2 g only in cases of renal failure with creatinine clearance less than 10 ml/min. Ceftriaxone is not eliminated during hemodialysis or peritoneal dialysis, so administration of an additional dose of Rocephin® to the patient after completion of dialysis is not required.

With a combination of severe renal and liver failure

the effectiveness and safety of the drug should be carefully monitored.

Elderly and senile patients

Usual dosages for adults, not adjusted for age, provided there is no severe renal or hepatic impairment.

Children

Newborns, infants and children under 12 years of age

When prescribing Rocephin® once daily, it is recommended to adhere to the following dosage regimens:

- newborns (up to 14 days): 20-50 mg/kg body weight once a day; the daily dose should not exceed 50 mg/kg body weight;

- newborns, infants and young children (from 15 days to 12 years): 20-80 mg/kg body weight once a day;

- Children weighing over 50 kg are prescribed doses for adults.

For premature infants up to 41 weeks of age inclusive (combined gestational and chronological age), the use of ceftriaxone is contraindicated. Rocephin® is contraindicated in neonates (<28 days) who are already prescribed or are expected to be treated with intravenous calcium-containing solutions, including continuous calcium-containing infusions, for example, with parenteral nutrition due to the risk of precipitates of ceftriaxone calcium salts (see section "Contraindications").

In infants and children under 12 years of age, intravenous doses of 50 mg/kg or higher should be administered by drip over at least 30 minutes. In newborns, intravenous administration should be given over 60 minutes to reduce the potential risk of developing bilirubin encephalopathy.

Meningitis

For bacterial meningitis in infants and young children

treatment begins with a dose of 100 mg/kg (but not more than 4 g) once a day.
Once the pathogen has been identified and its sensitivity determined, the dose can be reduced accordingly. The best results for meningococcal meningitis were achieved with a treatment duration of 4 days, for meningitis caused by Haemophilus influenzae -
6 days,
Streptococcus pneumoniae
- 7 days.

Lyme disease

50 mg/kg (highest daily dose - 2 g) for adults and children once a day for 14 days.

Gonorrhea

(caused by penicillinase-forming and penicillinase-non-forming strains)

A single intramuscular injection of 250 mg of Rocephin® in adult patients and children over 12 years old >50 kg.

Acute otitis media

When treating acute otitis media in children, a single intramuscular injection of 50 mg/kg (but not more than 1 g) is recommended.

For adults, a single intramuscular dose of 1-2 g is recommended. According to limited data, in severe cases or when previous therapy is ineffective, Rocephin® may be effective when administered intramuscularly at a dose of 1-2 g per day for 3 days.

Prevention of postoperative infections

Depending on the degree of infectious risk, 1-2 g of Rocephin® is administered once 30-90 minutes before the start of surgery. For operations on the colon and rectum, the simultaneous (but separate, see section “Dosage and Administration”) administration of the drug Rocephin® and one of the 5-nitroimidazoles, for example, ornidazole, has proven itself to be effective.