Garamycinum

Garamycinum – antibacterial agent of a broad spectrum of activity from group of aminoglycosides.

Form of release and structure

• Solution for injections (on 1 and 2 ml in ampoules, on 10 ampoules in packaging);
• Cream (on 15 g in tubas);
• Ointment (on 15 g in tubas).

Active agent – Gentamycini sulfas:

• 1 ml of solution – 0,04 g;
• 1 g of cream – 0,001 g;
• 1 g of ointment – 0,001 g.

Indications to use

For injection solution:

• Sepsis of newborns;
• Bacteremia;
• Septicaemia;
• Respiratory infections;
• Digestive tract infections;
• Infections of urinogenital ways and kidneys;
• Infections of the central nervous system, including meningitis;
• Intraperitoneal infections, including peritonitis;
• Infections of organs of sight;
• Infections of bones, soft tissues and skin, including contaminated wounds and burns;
• Gonorrhea;
• Perioperatsionny prevention of an infection.

Cream and ointment are applied to treatment of bacterial damages of skin.

Contraindications

Absolute:

• Heavy chronic renal failure with uraemia and an azotemia;
• Neuritis of an acoustical nerve;
• Hypersensitivity to drug or other aminoglycosides in the anamnesis.

Relative (because of risk of development of complications it is necessary to be careful):

• Botulism;
• Parkinsonism;
• Myasthenia;
• Renal failure;
• Dehydration;
• Prematurity of children;
• Neonatality period;
• Advanced age.

During pregnancy and feeding by a breast use of drug is possible only in the presence of vital indications.

Route of administration and dosage

Cream and ointment

Cream and ointment apply Garamycinum outwardly: apply with a thin layer on the struck surfaces of skin 3-4 times a day. If there is a need means can be used under a bandage.

Solution for injections

Solution for injections Garamycinum is intended for intramuscular and intravenous administration.

Intravenously the drug is administered kapelno within 1,5-2 hours in 5% solution of a dextrose or 0,9% chloride sodium solution, the entered volume – from 50 to 300 ml. For children the volume of the entered liquid is reduced (concentration should not exceed 0,1%=1 mg/ml).

At moderately severe diseases appoint adult with normal function of kidneys 3 mg/kg a day with frequency rate of introduction 2 or 3 times a day, respectively two equal portions in 12 hours or three equal portions in 8 hours.

At a severe disease with high risk of a lethal outcome the daily dose is increased to 5 mg/kg with frequency rate by 3-4 times, after clinical improvement of a state the dose is reduced to 3 mg/kg/days. A course of treatment – no more than 7-10 days.

At infectious and inflammatory diseases of urinary tract to patients with normal function of kidneys the drug is administered intramusculary in a dose of 120-160 mg of 1 times a day within 7-10 days, at gonorrhea – intramusculary once in a dose of 240-280 mg. About 1/2 doses are intramusculary recommended to enter into each buttock.

Doses for children:

• Newborns (before the 7th birthday) and premature – on 2,5-3 mg/kg each 12 hours;
• Babies are more senior than 7 days and children till 1 year – on 2,5 mg/kg each 8 hours;
• Children are more senior than 1 year – on 2-2,5 mg/kg each 8 hours.

To elderly people and patients with disturbances of secretory function of kidneys, and also at a serious burn disease the dose of Garamycinum is defined depending on concentration of gentamycin in a blood plasma. The interval between introductions of average doses is determined by a formula: an interval (in hours) = concentration of creatinine (mg / 100 ml) x 8.

At heavy infectious processes introduction of smaller doses with a bigger frequency is recommended. At the same time the single dose has to be picked up so that the maximum concentration of gentamycin did not exceed 0,012 mg/ml.

At obesity, ascites and hypostases the dose is determined by Sukhoi and "ideal" body weight.

At renal failures and carrying out a hemodialysis after the session administration of drug in a dose is recommended: adult – 1-1,7 mg/kg, to children – 2-2,5 mg/kg depending on weight of an infection.

Side effects

• Alimentary system: nausea, vomiting, hyperbilirubinemia, increase in activity of hepatic transaminases;
• Bodies of a hemopoiesis: granulocytopenia, leukopenia, thrombocytopenia, anemia;
• Nervous system: feeling of numbness, paresthesia, twitching of muscles, drowsiness, headache, epileptic seizures; children have a psychosis;
• Urinary system: renal failure (microhematuria, proteinuria, oliguria); in some cases – a renal tubular necrosis;
• Sense bodys: labyrinth and vestibular disturbances, decrease in hearing, sonitus, irreversible deafness;
• Allergic reactions: fever, skin rash, itch, eosinophilia, Quincke's disease;
• Others: fever, superinfection;
• Laboratory indicators: children have a hypopotassemia, a hypocalcemia, a hypomagnesiemia.

Special instructions

During treatment it is necessary to control concentration of gentamycin in blood serum and clearance of creatinine, especially at elderly people.

The risk of development of nephrotoxicity is higher at patients with renal failures, and also at use of drug in high doses or during the long period. For this reason it is necessary to control function of kidneys regularly: 1-2 times a week, and at the patients receiving high doses or being on treatment more than 10 days – daily.

Not to allow development of a hearing disorder it is necessary periodically (1-2 times a week) to investigate vestibular function for definition of a hearing loss at high frequencies. In case of unsatisfactory audiometric tests it is necessary to lower a dose or to cancel drug.

Patients with infectious and inflammatory diseases during treatment are recommended to use the increased amount of liquid.

It is necessary to consider probability of development of resistance of microorganisms. In this case it is necessary to cancel Garamycinum and to appoint the corresponding treatment, based on data of an antibiotikogramma.

It must be kept in mind probability of neuromuscular blockade and paralysis of breath.

Medicinal interaction

• Kurarepodobny drugs: their myorelaxation action amplifies;
• Anti-myasthenic means: their efficiency decreases;
• Loopback diuretics, Cisplatinum, others from - and nefrotoksichny drugs: also ototoxicity of gentamycin amplifies nefro-;
• Antibiotics of a penicillinic row (for example, карбенициллин, ampicillin): antimicrobic effect of gentamycin increases;
• Indometacin parenterally: the risk of development of toxic actions of Garamycinum increases;
• Metoksifluran, polymyxins for parenteral administration and other drugs blocking neuromuscular transmission (narcotic analgetics, halogenated hydrocarbons as means for inhalation anesthesia, transfusion of large amounts of blood with citrate preservatives): the risk of development of nephrotoxic action and an apnoea owing to strengthening of neuromuscular blockade increases.

In the form of solution Garamycinum pharmaceutical is incompatible with any other medicines therefore they cannot be mixed in one syringe.

Terms and storage conditions

To store at a temperature from 2 to 30 ºС in the place, unavailable to children.

Period of validity – 5 years.