Gentamicin 80 mg. 10 ampoules

SOPHARMA
Gentamicin 80 mg. 10 ampoules
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Solution for injection
 
 
4. Clinical data
4.1. Indications
 
For the treatment of acute and chronic acute infections caused by susceptible microorganisms drug urinary tract (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, hydro and pionefroza and infected nephrolithiasis), sepsis, pulmonary infections, infected burns, shigellosis, salmonellosis , nonspecific meningitis, peritonitis, biliary tract infections, osteomyelitis and skin infections.
 
4.2. Dosage and method of administration
 
The product is administered parenterally (intravenously or intramu cheekbones)
In adult normal renal function c 2 to 5 mg / kg body weight daily for 8 or 12 hours intramuscularly. Should not be administered a higher dose of 8 mg / kg body weight per day. In adults with impaired renal function is necessary to reduce the dose according to the creatinine klirans.Prilozhenata table provides indicative figures for the determination of Gentamicin depending on the degree of renal insufficiency. Gentamicin can be applied once daily intravenously at a dose of 3 mg / kg body weight. This method is recommended because better therapeutic efficacy and lower nephrotoxicity. A single dose should be dissolved in 50 to 200 ml of physiological saline or 5% dextrose for slow venous infusion, the infusion should have a duration of 1.5 to 2 hours.
In newborn (within 2 weeks of age) are administered intramuscularly or intravenously as 2,5 mg / kg body weight per 12 hours.
In older infants and children 2-2,5 mg / kg of body weight every 8 or 12 hours.
The recommended maximum daily dose for children is up to 7,5 mg / kg weight.
A course of treatment usually lasts 7-10 days.
 
 
4.3. Contraindications
Hypersensitivity to constituents or previous allergic reactions to other aminoglycoside antibiotics; pregnancy; myasthenia gravis; botulism; parkinsonism; in severe kidney disease; dysfunction of the auditory nerve.
 
 
4.4. Special precautions for use.
Because of the risk of ototoxicity and nephrotoxicity is necessary to monitor individual dosage for each patient, so as not to allow maximum plasma concentrations above 10-12 mg / l. This is especially important in children and elderly patients receiving high doses for a long course of treatment.
Recommended before treatment to make skin sample chuvstvitelnost.Produktat contain as excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergy. Usually these are delayed reactions. Rarely cause immediate reaction with urticaria and bronchospasm.
The product contains the excipient sodium sulphite. May cause allergic-type reactions including anaphylactic symptoms and bronchospasm in susceptible people, especially those with a history of asthma or allergy.
 
 
4.5. Drug Interactions
Concomitant administration of gentamicin and other aminoglycoside antibiotics (kanamycin, streptomycin, neomycin, polymyxin, cephalosporins), ethacrynic acid and furosemide, amplified ototoxic risk.
Gentamicin potentiate the effects of muscle relaxants (succinylcholine and tubocurarine), with the result that can intensify and prolong neuromuscular block.
 
 
4.6. Pregnancy and lactation
Not recommended its implementation in pregnant because it may harm the eighth brain nerve of the fetus. Gentamicin is excreted in small amounts in milk. Due to the potentially serious adverse effects on the infant should be weighed against the benefit / risk whether to apply to nursing women or discontinue breastfeeding.
 
 
4.7. Effects on ability to drive and use machines.
Gentamicin not affect the ability to drive and use machines
 
 
4.8. Undesirable effects
The most common and most serious are damage to the eighth cranial nerve, resulting in ototoxicity, especially in patients with chronic diseases of the ear, the elderly and prolonged course of therapy. Occurrence of ototoxicity occurs with dizziness, nausea, tinnitus and hearing loss.
Another serious side effect is nephrotoxicity, especially in patients with impaired renal function or prior treatment with other aminoglycoside antibiotics. Nephrotoxicity is expressed by an increase in blood urea, residual nitrogen, serum creatinine, and reduce diurezata.Mogat be observed especially in susceptible patients and in the elderly and young children: itching, hives, numbness, muscle twitching or muscle weakness, difficulty in breathing, seizures, headache, changes in leukocyte formula, increases in serum transaminases and bilirubin.
 
4.9. Overdose
Gentamicin overdose is characterized by vestibular and hearing disorders, toxic encephalopathy, renal and haematological disorders. In toxic doses Gentamicin can block mionevralnite synapses and depress respiration. In overdose and removal of the toxic effects of Gentamicin blood can be performed by hemodialysis or peritoneal dialysis treatment, applying and symptomatic agents.
 
 
5. Pharmacological
5.1. Pharmacodynamics
 
Gentamicin belongs to the group of aminoglycoside antibiotics. It exerts a bactericidal effect on gram-negative infections caused by Pseudomonas sp., E.Coli, Proteus sp., Enterobacter sp., KlebsieUa, Proteus and the like. From Gram-positive organisms many strains of Staphylococcus aureus exhibit high sensitivity to Gentamicin. Some activity of gentamycin was demonstrated in terms of. Neisseria, Listeria monocytogenes, some actinomycetes, mycoplasma and others.
Sensitive bacterial cells take antibiotics by active transport processes that inhibit anaerobic and acidic hiperosmatichna environment. The antibiotic binding to the 30s subunit of the bacterial ribosome inhibiting protein synthesis and transcription of the genetic code.
 
 
5.2. Pharmacokinetics
Gentamicin and other aminoglycoside antibiotics are poorly absorbed in the digestive tract, but very rapidly absorbed after parenteral administration. The maximum plasma concentration (about 4 rag / ml) is reached in patients with normal renal function from 30 to 60 minutes after intramuscular injection. Similar concentrations were also observed following intravenous injection, some patients are possible individual variations. Gentamicin binds weakly to plasma proteins. Gentamicin has a plasma half-life of about 2-3 hours of it may be prolonged in patients with impaired renal function. Gentamicin is not metabolized in the body and is excreted unchanged in the urine by glomerular filtration. Less than 70% of the administered dose of gentamicin can be detected in urine after 24 hours, its concentration there may be up to 100 mg / ml.
Gentamicin may accumulate in renal failure.
Gentamicin was detected in the cerebrospinal fluid, u passes the placental barrier and is found in breast milk.
 
 
5.3. Preclinical safety data
In experimental toxicology studies in mice and rats it has been shown that gentamicin is less toxic than neomycin, but is more toxic than kanamycin. LD50 in mice was 484 mg / kg body weight; LD50 in rats is 1100 mg / kg weight of intramuscular administration, whereas intraperitoneal administration LD50 is 924 mg / kg body weight.
In subchronic and chronic toxicity studies showed that, at doses much higher than therapeutic concentrations of the antibiotic were observed relatively low toxic effects, mainly by the kidneys and liver with transient harakter.Aminoglikozidite cross the placenta and there are reports of irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. It has not been proven whether gentamicin can cause birth defects or reproduction in humans.
 
 
6. Pharmaceutical data
 
6.1. Excipients and their amounts in mg:
Content of a vial 10 mg / ml-lml 20mg / ml-lml 40mg / ml-lml 80mg / ml-2ml
 
Methyl parahydroxybenzoate
/ Methyl parahydroxybenzoate / 1,5 1,5 1,5 3,0
 
Propylparahydroxybenzoate
/ Propyl parahydroxybensoate / 0,10 0 1 0 0 1 0 0.20
 
Disodium edetate
/ Disodium edetate / 0,10 0,10 0,10 0,20
 
Sodium sulfite anhydrous
/ Sodium sulphite, anhydrous 0,15 0,22 0,30 0,60
 
Water for injections
/ Water for injectifhs / to 1ml 1ml 1ml 2ml
 
 
6.2. Incompatibilities
Proven incompatibility between gentamicin and beta-lactam antibiotics.
 
 
6.3. Shelf life
4 (four) years from date of manufacture.
 
6.4. Special precautions for storage
Protected from light, at a temperature below 25 ° C. Do not freeze!
6.5. Packaging Data
The product was filled in colorless ampoules of 1 ml and 2 ml glass 1st hydrolytic class. Ten vials were placed in a blister pack of a solid PVC foil. One or ten blister packs are placed in an embossed box unilaterally pigment coated cardboard. In each box placed leaflet on how to use Emery and control number, and when there is a mark on the upper part of the ampoule in the form of a colored dot or ring, do not enjoy Emery opening the ampoule.
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