Gentamycin sulfat-Darnitsa, solution for and 4% on 2 ml No. 10
Producer: CJSC Pharmaceutical Firm Darnitsa Ukraine
Code of automatic telephone exchange: J01GB03
Release form: Liquid dosage forms. Solution for injections.
General characteristics. Structure:
international name: Gentamicinum;
main physical and chemical properties: transparent, colourless liquid;
structure: 1 ml of solution contains Gentamycini sulfas in terms of gentamycin and anhydrous substance - 0,04 g;
excipients: sodium pyrosulphite technical, sodium эдетат, water for injections.
Pharmacological properties:
Gentamycin - a bactericidal antibiotic of a broad spectrum of activity from group of aminoglycosides. Active concerning gram-positive bacteria: Staphylococcus (koagulazopolozhitelny, koagulazootritsatelny and some penitsilinazoprodutsiruyushchy strains), Streptococcus (group A a-hemolitic and b-hemolitic), Mycobacterium spp and gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Esherichia coli, Proteus spp., Klebsiella spp., Serratia spp., Shigella spp., Citrobacter spp., Providentia spp., Yersinia spp. More often than a rezistentna to Streptococcus pneumoniae gentamycin.
Drug does not work on anaerobe bacterias, mushrooms, viruses, the elementary. Resistance of microbes to drug arises slowly and the strains steady against it, in this case rezistentna also to Neomycinum and Kanamycinum.
Pharmacokinetics. Drug is quickly soaked up at intramuscular introduction. The maximum concentration of drug in a blood plasma after parenteral administration is observed in 30-60 min. Gentamycin sulfat-Darnitsa badly contacts proteins of plasma. Therapeutic concentration is maintained stable throughout the entire period of treatment. Well gets into fabrics, serous cavities, cerebrospinal fluid, passes through a blood-brain barrier, a placenta. In therapeutic concentration active agent is defined in a wound, pus, granulations.
Gentamycin sulfat-Darnitsa is practically not metabolized in an organism. It is removed by kidneys in high concentration in not changed look. It creates concentration in urine considerably the highest, than in a blood plasma. An elimination half-life - 2-3 hours.
Indications to use:
Gentamycin sulfat-Darnitsa apply at sepsis, meningitis, peritonitis, a septic endocarditis, infectious and inflammatory diseases of a respiratory organs (pneumonia, a pleura empyema, abscess of lungs), infections of kidneys and urinary tract (pyelonephritis, cystitis, an urethritis), the prostatitis infected the burns and other diseases caused by preferential gram-negative microorganisms steady against other antibiotics, or associations of gram-positive and gram-negative activators (multi-infection).
The indication for Gentamycin use sulfata-Darnitsa are it is also purulent - the septic diseases arising at patients with leukoses and malignant new growths against the background of the carried-out cytostatic radiation therapy and at use of immunodepresant.
Drug appoint at infections of skin and soft tissues (contagious impetigo, superficial folliculites, a furunculosis, a pyoderma, dermatitis and eczema, pustular an acne, ulcers, including varicose), frostbites, burns, wounds, grazes, etc. Important aspect of appointment of Getamitsin sulfata-Darnitsa are not only multi-infections, but also situations when the infestant is not established. In treatment planning of the last the antibiotic is applied together with semi-synthetic penicillin - karbenitsilliny, ampicillin.
Route of administration and doses:
Drug is used intramusculary and intravenously (kapelno).
At heavy infections (sepsis, peritonitis, abscess of lungs, meningitis, etc.) the single dose for adults and children is more senior than 14 years makes 0,8-1 mg/kg of body weight, daily-2,4-3,2 mg/kg of body weight. The maximum daily dose is equal to 5 mg/kg of body weight. To children of early age drug is appointed only according to vital indications at heavy infections. The daily dose for newborns and children of chest age is equal to 2-5 mg/kg of body weight, 1-5 years - 1,5-3 mg/kg of body weight, 6-14 years - 3 mg/kg of body weight. The maximum daily dose for children irrespective of age makes 5 mg/kg of body weight. The daily dose is entered into 2-3 receptions. Intravenous injections carry out for 2-3 days, and then pass to intramuscular introduction. The average duration of treatment - 7-10 days. At infections of urinary ways the single dose for adults and children is more senior than 14 years makes 0,4 mg/kg of body weight, daily - 0,8-1,2 mg/kg of body weight. The daily dose can be increased by the patient with the heavy course of an infectious disease to 3 mg/kg of body weight.
Features of use:
With care appoint to patients with Parkinson's disease or a myasthenia, to people of advanced age. At long treatment it is necessary to control function of kidneys and acoustic organs periodically. During treatment it is necessary to use a large amount of liquid. Gentamycin sulfat-Darnitsa cannot be mixed in one syringe with other medicines.
Side effects:
Gentamycin sulfat-Darnitsa at parenteral administration can have ototoksichesky and nephrotoxic action which, as a rule, has reverse character. Therefore drug is recommended to use under control of function of kidneys, a vestibular mechanism and hearing (at least 1 time a week), and also to define concentration it in blood. Concentration of Gentamycin sulfata-Darnitsa in blood should not exceed 8 mkg/ml.
Sometimes at parenteral administration of Gentamycin sulfata-Darnitsa such complication as blockade of neuromuscular conductivity and respiratory depression meets. In such cases use antikholinesterazny drugs, in particular прозерин, and also calcium drugs intravenously.
Allergic reactions (skin rash, itch, hypostasis) can seldom be noted. In that case drug is cancelled and appoint the desensibilizing therapy.
Interaction with other medicines:
Toxic effects of Gentamycin sulfata-Darnitsa amplify at simultaneous use with the drugs possessing ototoksichesky, nephrotoxic action, and also influencing neuromuscular conductivity:
diuretics (furosemide, Acidum etacrynicum);
antibiotics (cephalosporins, цепорин, Methicillinum, Vancomycinum);
from ulfanilamida;
quinine derivatives;
salicylates;
synthetic antineoplastic drugs (Cisplatinum);
cardiac glycosides (digoxin).
Contraindications:
Hypersensitivity to drug, heavy renal failures, first of all at patients with uraemia. At insignificant renal failures drug is appointed with care. Drug is contraindicated at the expressed azotemia, diseases of an acoustical nerve, vestibular mechanism, a myasthenia, during pregnancy if it is not caused by vital indications.
Overdose:
Symptoms: nausea, vomiting, nephrotoxic and ototoksichesky action.
Treatment: symptomatic therapy. Acceleration of removal from an organism by means of a hemodialysis and peritoneal dialysis.
Storage conditions:
To store in protected from light and the place, unavailable to children, at a temperature of 15-25 °C.
Period of validity - 3 years.
Issue conditions:
According to the recipe
Packaging:
On 2 ml of 4% of solution in ampoules; on 10 ampoules in packaging.