Neminos

Netilmicin.

Each mL contains: Netilmicin Sulfate equivalent to Netilmicin 100 mg or 200 mg.

Pharmacology: Netilmicin is an aminoglycoside antibiotic that active against many strains of gram-negative and gram-positive bacteria. It showed a synergistic effect with beta lactam on some organisms.
Netilmicin is an antibiotic that has broad-spectrum bactericidal properties. Mechanism of action by inhibiting normal protein synthesis in susceptible microorganisms. These microorganisms include Citrobacter, Enterobacter, Escherichia coli, Klebsiella species, Proteus mirabilis, Pseudomonas aeruginosa, Salmonella species, Shigella species, and Staphylococcus species (strains that are resistant to Penicillin and Methicillin). Netilmicin is also active against several isolates from Acinetobacter and Neisseria species, indole positive for Proteus species, Pseudomonas, and Serratia species. Nocardia asteroides and some Nocardia species are sensitive to Netilmicin. All gram-positive anaerobic bacteria are microorganisms that are resistant to Netilmicin. Netilmicin cannot be absorbed by mouth and is usually given intramuscularly or intravenously. In the treatment of severe infections, often combined with other drugs as appropriate as with a beta lactam antibiotic.

NEMINOS 100 or 200 injection is indicated for short-term treatment of patients of all ages, including neonates, infants, and children with serious or life-threatening infections caused by susceptible strains of microorganisms in the disease as follows: Urinary tract infections with complication; Septicemia; Skin and skin structure infections; Intra-abdominal infections include peritonitis and intraabdominal abscess; Lower respiratory tract infections.
If not an antibiotic group as the first line, NEMINOS 100 or 200 can be considered for the treatment of serious staphylococcal infections, if Penicillin or other lower-toxic drugs are contraindicated and bacterial susceptibility testing and clinical considerations support their use. Also consider mixed infections caused by susceptible strains of Staphylococcus and gram-negative organisms. NEMINOS 100 or 200 can also be considered as a starting therapy for infections that are suspected or confirmed by gram negative.
In serious infections if the causative organism is unknown, NEMINOS 100 or 200 can be administered as initial treatment concomitantly with penicillin or cephalosporins before the results of the susceptibility test are obtained.
In neonates suspected of sepsis, it is usually given concomitantly with Penicillin. If an anaerobic organism is suspected as a cause, can be given with appropriate antimicrobial therapy. NEMINOS 100 or 200 injection can be used in concomitantly with Carbenicillin or Ticarcillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa.

NEMINOS 100 or 200 injection can be given intramuscularly or intravenously (both are identical). The dose of Netilmicin Sulfate is stated in equivalency of the amount of Netilmicin. Weight the body mass prior the treatment to get the appropriate dose. Aminoglycoside doses for patients with obesity are based on clean body mass.
Do not mix physically with other drugs, but give them separately according to the recommended route and dose schedule. Usually given intramuscularly in doses equivalent to Netilmicin 4-6 mg/kg/day as a single dose, alternatively can be given in same dose every 8 or 12 hours. For life-threatening infections, doses up to 7.5 mg/kg/day are given in divided dose every 8 hours. The recommended dose for urinary tract infections is a single dose of 150 mg daily or 3-4 mg/kg/day in divided dose every 12 hours. The same dose can be given by intravenous injection 3-5 minutes. Treatment with Netilmicin is usually given for 7 to 14 days.
The recommended dosage for infants and children is slightly different.
For infants and neonates aged more than 1 week 7.5-9 mg/kg/day in divided dose every 8 hours.
For children 6-7 mg/kg/day in divided dose every 8 hours. Premature infants and neonates aged less than 1 week can be given 6 mg/kg/day in divided dose 3 mg/kg every 12 hours. Alternative administration for neonates aged less than 6 weeks 4-6.5 mg/kg/day in divided dose every 12 hours, in infants and children 5.5-8 mg/kg/day in divided dose every 8 or 12 hours.
It is recommended that administration to all patients should be regulated based on plasma Netilmicin concentration. This is important because factors such as age, kidney damage or dosage can give a tendency towards toxicity or a risk of subtherapeutic concentration.
Dosage for renal impairment: Dosage must be adjusted. If possible the level of Netilmicin in the serum is monitored. When no serum level is present and kidney function is stable, creatinine is the most reliable indicator of the level of kidney damage that is easily provided as a guideline for dose adjustment to increase the interval between usual doses. Because creatinine levels in serum have a high correlation with Netilmicin half-life in serum, this laboratory test can provide guidelines for administration interval adjustment. The interval between administration (in hours) can be estimated by multiplying serum creatinine levels (mg/100 mL) by 8. In patients with serious systemic infection and renal impairment, antibiotics can be given more often with reduced doses. In these patients, measure the level of Netilmicin in the serum.
The recommended method is: 1. After the initial or usual loading dose, the guidelines for determining dose reduction at 8-hour intervals are to divide the recommended dose normally with serum creatinine levels.
2. If the creatinine clearance rate is known, the maintenance dose given every 8 hours is calculated using the following formula: see equation.


Click on icon to see table/diagram/image


The initial dose or loading is the same as recommended for patients with normal renal function. Worsening kidney function can require a larger dose reduction than mentioned for patients with stable renal impairment.
Hemodialysis: Recommended dose: 2 mg/kg at the end of each dialysis period.
In children, a dose of 2-2.5 mg/kg can be given depending on the severity of the infection.

Hypersensitivity to Netilmicin or other aminoglycosides.

Patients treated with aminoglycosides must be carefully observed clinically because of the potential toxicity associated with the use of these drugs. Netilmicin has the potential as a strong neuromuscular blocker. The possibility of phenomena occurring in humans should be considered if aminoglycosides are given to patients receiving neuromuscular blocking agents such as succinylcholine, tubocurarine or decamethonium or receiving massive blood transfusions containing citric anticoagulants. As with other aminoglycosides, injection of Netilmicin sulfate is potentially nephrotoxic. This risk is greater in patients with impaired kidney function, patients who receive high doses or long-term therapy and elderly patients.
Neurotoxicity is manifested by ototoxicity, both vestibular dysfunction and hearing, can occur especially in patients with history of renal impairment and patients who are treated with larger doses or longer than recommended.
Aminoglycoside-induced ototoxicity is usually irreversible.
Renal function and eighth cranial nerve should be monitored, especially in patients who are known or suspected of having impaired kidney function at the start of therapy or during therapy. Urine should be examined for an increase in protein excretion, weight loss and presence of cells or cast.
Creatinine serum concentration or blood urea nitrogen must be determined periodically. The dose of Netilmicin needs to be reduced or discontinued if it is proven to be ototoxicity or nephrotoxicity. Aminoglycoside concentrations in serum need to be monitored if possible, to ensure adequate levels and avoid toxic levels. Avoid concomitant use with potentially neurotoxic or nephrotoxic drugs such as: Cephaloridine, Amphotericin B, Streptomycin, Kanamycin, Acyclovir, Gentamicin, Tobramycin, Amikacin, Neomycin, Vancomycin, Bacitracin, Polymyxin B, Colistin, Promomycin, Viomycin or Cisplatin. Also avoid combination with strong diuretics such as ethacrynic acid or furosemide, because it causes ototoxicity.
Use carefully in patients with a history of hypersensitivity or serious toxic reactions to other aminoglycosides, because cross-sensitivity of drugs in same class has been reported.
Aminoglycosides should be used cautiously in patients with neuromuscular disorders such as myasthenia gravis and infant botulism, because these muscles exacerbate muscle weakness due to their effects which have potential such as curare on the neuromuscular junction. Elderly patients may have decreased kidney function which cannot be proven in routine screening tests such as BUN (blood urea nitrogen) and serum creatinine levels. Monitoring renal function during treatment with Netilmicin, especially important in such patients. Syndromes such as Fanconi with aminoaciduria and metabolic acidosis were reported in some adults and infants receiving injections of Netilmicin. Patients must be well hydrated during treatment.
Treatment with Netilmicin Sulfate can cause excessive growth of non-susceptible organisms, if this happens, appropriate therapy is recommended.
A small amount of Netilmicin is excreted in breast feeding mother so it needs to be decided whether to stop giving milk or stop using the drug.
Aminoglycosides must be used cautiously in premature and neonatal because in these patients the kidney is not fully developed and the longer half-life of the drug.
Products containing metabisulfite sodium can cause allergy-type reactions which include anaphylactic and life-threatening symptoms or asthmatic episodes that are less severe in certain vulnerable patients. Sensitivity is difficult to find more often in patient with asthma than non-asthmatic patients.
Safety of use during pregnancy has not been established.

Nephrotoxicity: It is rare, mild and reversible, usually in elderly people, patients with a history of renal impairment, patients who are treated for a long time or a dose greater than recommended.
Ototoxicity: Unlike other aminoglycosides, the incidence of vestibular and cochlear toxicity is very low. Damage to vestibular function is temporary due to the compensation mechanism.
Usually irreversible cochlear damage is rarely reported. This effect occurs mainly in patients treated with high doses or for the long term therapy.
Other factors also increase the risk of aminoglycoside-induced ototoxicity. Symptoms of aminoglycoside-induced ototoxicity are often transient and can include dizziness, vertigo, tinnitus, hearing noises and hearing loss, the latter usually manifested by reduced sharpness to high pitch.
Rarely reported reactions: headache, lethargy, visual disturbances, disorientation, tachycardia, hypotension, palpitations, thrombocytosis, paresthesia, fluid retention, rash, chills, fever, vomiting, diarrhea.
Possible reactions related to Netilmicin: increased blood sugar, alkaline phosphatase, SGOT or SGPT, bilirubin, other abnormal liver function tests, increased potassium, reduced hemoglobin, white blood cells and platelets, eosinophilia, anemia and increased prothrombin time.
Symptomatic effect: Local reactions such as pain in the administration site, phlebitis and skin reactions. Hypersensitivity reactions such as urticaria and maculopapular rash.

Store between 2°C and 8°C. Do not freeze.
Away from light.
Before used, store below 30°C for 1 hour.

Aminoglycosides

J01GB07 - netilmicin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections.

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