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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 12.03.2022
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Changfu TianXin
Netilmicin
Bacteremia, septicemia (including neonatal sepsis), severe infectious diseases of the respiratory tract, infections of the kidneys and genitourinary system, skin, soft tissues, bones and joints, burns, wounds, postoperative infections, intraperitoneal infections (including peritonitis), gastrointestinal infections, gonorrhea.
Indications for use: treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- sepsis (including newborns),
- severe infections of the respiratory tract,
- infections of the kidneys and genitourinary tract, including acute uncomplicated gonococcal infection in men (urethra, rectum) and in women (urethra, cervix, rectum) with normal kidney function,
- skin and soft tissue infections,
- bone and joint infections,
- burns, wounds, postoperative infection (including preventive treatment),
- abdominal infections (including peritonitis),
infection of the gastrointestinal tract.
V/v or in/m.
The recommended doses for intravenous and intravenous administration are identical. Intravenous administration can be particularly useful in the treatment of patients with septicemia or in shock, as well as patients with congestive heart failure, hematological disorders, severe burns or reduced muscle mass.
To calculate the correct dose, the patient's body weight should be determined before starting therapy. Doses of aminoglycosides for patients with increased body weight are calculated for the ideal body weight (i.e., without taking into account the excess weight of subcutaneous fat).
The average duration of therapy is 7-14 days, with severe infections with complications, a longer course of treatment may be required.
Adults with normal kidney function the recommended dose Changfu Tappa® for injections with urinary tract infections or systemic infections of moderate severity-4.0-6.0 mg/kg / day, divided into 3 equal injections every 8 hours or 2 injections every 12 hours, or 1 administration per day. In this case, the dose should be adjusted depending on the severity of the infection and the patient's condition. Adults weighing 50-90 kg, the drug is administered at a dose of 150 mg every 12 hours or 100 mg every 8 hours for Adult patients with varying body mass determine dose rate of 1 mg/kg of ideal body weight.
In severe, life-threatening infections, the drug can be prescribed at a dose of up to 7.5 mg / kg / day, divided into 3 injections every 8 hours. The dose is reduced to 6 mg/kg/day (usually after 48 hours) in accordance with the clinical situation.
In gonorrhea in men and women is recommended that a single in/m introduction Changfu Tappa® at a dose of 300 mg. The injection (using a solution with a concentration of 100 mg / ml) should be done deep into the upper outer quadrant of the gluteal muscle, injecting half of the dose into each buttock. For patients with more or less body weight, it is recommended to recalculate the dose based on the ideal body weight.
In uncomplicated urinary tract infections, especially chronic or recurrent and without signs of renal failure, the drug can be administered intravenously once a day at a dose of 3 mg / kg for 7-10 days.
For children the drug is prescribed depending on the age. Newborns (including premature infants) at the age of 1 week or less, the dose is set at the rate of 6 mg / kg/day (3 mg/kg / administered every 12 hours). Children aged from 1 week to 1 year — from 7.5 to 9.0 mg / kg / day (2.5-3.0 mg / kg is administered every 8 hours). Children over 1 year old - from 6.0 to 7.5 mg / kg / day (2.0-2.5 mg/kg is administered every 8 hours).
When combined with other antibiotics, do not change the dose of the drug recommended for patients with normal or impaired renal function.
In patients with impaired renal function to correct the dosage regimen, it is necessary to monitor the concentration of netilmycin in the blood serum. If this is not possible, and the kidney condition is stable, the most reliable way to adjust the dose is to focus on the creatinine clearance (CC) and serum creatinine content.
One way to correct the dosage regimen is to increase the interval between injections at the average recommended doses. To do this, the interval between injections (in hours) is determined by multiplying the serum creatinine level (mg/100 ml) by 8.
In patients with severe infections and impaired renal function, more frequent administration of the antibiotic may be required, but at a reduced dose.
After the introduction of the average initial or loading dose to determine the reduced dose when administered every 8 hours, you can divide the value of the average dose by the value of creatinine in the blood serum (see Table.)
If the CC is known, the maintenance dose administered every 8 hours is determined by the formula:
Maintenance Dose = Observed CC/Normal CC × Standard Maintenance Dose.
The initial or loading dose corresponds to the recommended dose for patients with normal renal function.
Table
| Serum creatinine level, mg/100 ml | Approximate KK value, mg / min/1.73 m2 | Percentage of standard dose |
| ≤1 | >100 | 100 |
| 1,1–1,3 | 70–100 | 80 |
| 1,4–1,6 | 55–70 | 65 |
| 1,7–1,9 | 45–55 | 55 |
| 2,0–2,2 | 40–45 | 50 |
| 2,3–2,5 | 35–40 | 40 |
| 2,6–3,0 | 30–35 | 35 |
| 3,1–3,5 | 25-30 | 30 |
| 3,6–4,0 | 20–25 | 25 |
| 4,1–5,1 | 15–20 | 20 |
| 5,2–6,6 | 10–15 | 15 |
| 6,7–8,0 | <10 | 10 |
The above dosage regimens are indicative and are used in cases where it is not possible to determine the level of netilmycin in the blood serum.
If the renal function deteriorates during the therapy, an additional dose reduction may be required.
When performing hemodialysis, the recommended dose of the drug for administration at the end of the dialysis procedure is 2 mg/kg, for children - from 2 to 2.5 mg/kg, depending on the severity of the infection.
Rules for the preparation and administration of the solution for intravenous administration
For intravenous administration to adults, the required dose of the drug is diluted in 50-200 ml of a sterile 0.9% sodium chloride solution or 5% aqueous dextrose solution, for children and infants, the volume of the solvent depends on the patient's need for fluid. The resulting solution is administered drip for 0.5-2 hours. In some cases, it is allowed to inject the solution into a vein or into a venous catheter slowly for 3-5 minutes.
Hypersensitivity.
From the nervous system and sensory organs: headache, malaise,disorientation, paresthesia, visual impairment, vestibular and cochlear function.
From the cardiovascular system and blood (hematopoiesis, hemostasis): tachycardia, hypotension, palpitations, thrombocytosis, leukocytopenia, thrombocytopenia, anemia, increased prothrombin time.
From the gastrointestinal tract: vomiting, diarrhea, impaired liver function, hyperglycemia.
Other: rash, chills, fever, impaired kidney function, fluid retention, hyperkalemia, pain at the injection site, allergic reactions.
Highly active against Gram-negative microorganisms: Escherichia coli, Klebsiella spp., Enterobacter spp., Serratia spp., Shigella spp., Salmonella spp., Proteus spp., Citrobacter sp., Proteus spp. (indole-positive and indole-negative), Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Pseudomonas aeruginosa and Neisseria gonorrhoeae and some Gram-positive microorganisms, in particular Staphylococcus spp. (strains that produce and do not produce penicillinase, as well as methicillin-resistant strains).
- Aminoglycosides
Nephrotoxicity and ototoxicity are enhanced by others. drugs that affect the kidneys (for example, cephalosporins) and the auditory vestibular apparatus (for example, ethacric acid, furosemide). Muscle relaxants and anesthetics increase the risk of neuromuscular blockage and respiratory paralysis.
