Instructions for use of GENTAMICIN SULFAT

Nosological classification (ICD-10)

• A09 Diarrhea and gastroenteritis of presumably infectious origin (dysentery, bacterial diarrhea)
• A41.9 Septicemia, unspecified
• J06 Acute upper respiratory tract infections of multiple and unspecified localization
• J18 Pneumonia without specifying the pathogen
• J22 Acute respiratory infection of the lower respiratory tract, unspecified
• J40 Bronchitis, not specified as acute or chronic
• J85 Abscess of the lung and mediastinum
• J86 Pyothorax
• K65 Peritonitis
• L00-L08 Infections of the skin and subcutaneous tissue
• L02 Skin abscess, boil and carbuncle
• L08.0 Pyoderma
• M00-M03 Infectious arthropathy
• M60.0 Infectious myositis
• M65.0 Tendon sheath abscess
• M65.1 Other infectious tenosynovitis
• M71.0 Abscess of bursa
• M71.1 Other infectious bursitis
• M86 Osteomyelitis
• N15 Other tubulointerstitial kidney diseases
• N39.0 Urinary tract infection without established location
• O85 Puerperal sepsis
• O86 Other postpartum infections
• R09.1 Pleurisy
• R78.8.0* Bacteremia
• T79.3 Post-traumatic wound infection, not elsewhere classified

Gentamicin sulfate 4%, 100 ml

DESCRIPTION

Gentamicin sulfate is an aminoglycoside antibiotic with bactericidal action. In appearance it is a colorless or slightly yellow transparent solution for injection.

COMPOUND

Quincy Promes In appearance it is a colorless or slightly yellow transparent solution for injection. The drug is packaged in 100 ml glass bottles.

PHARMACOLOGICAL PROPERTIES

Gentamicin has a broad spectrum of antimicrobial action. Active against most gram-negative and gram-positive microorganisms, including Proteus, Escherichia, Salmonella and Staphylococcus. The antibiotic does not act on anaerobic bacteria, fungi, viruses and protozoa.

When administered intramuscularly, the drug penetrates well into many organs and tissues. The maximum concentration in the blood is achieved 1 hour after administration. After a single injection, the therapeutic concentration of the antibiotic in the body remains for 8 to 12 hours after administration. When administered orally, the drug is practically not absorbed from the gastrointestinal tract and exerts its effect only in the intestines for 12 hours. With parenteral administration of gentamicin, the antibiotic is excreted from the body unchanged mainly in the urine, and with oral administration - with feces.

INDICATIONS

Prescribed to cattle, horses, pigs, dogs and cats for the treatment of gastrointestinal, respiratory diseases, sepsis, peritonitis, meningitis, pyelonephritis and other diseases caused by antibiotic-sensitive microorganisms.

APPLICATION

Gentamicin solution is used intramuscularly or orally twice a day with an interval of 10 - 12 hours in the following doses:

The maximum volume of the drug for administration to one site should not exceed 15 ml for cattle and horses, 10 ml for pigs, 5 ml for sheep, 2.5 ml for dogs and cats.

SIDE EVENTS

With increased individual sensitivity of the animal to the drug, the following are possible: refusal to feed, vomiting, and impaired coordination of movements. In these cases, the use of the drug is stopped, and the animal is prescribed desensitizing therapy. In rare cases, the animal may develop edema at the injection site, which spontaneously resolves within 1 to 2 days and does not require treatment.

Slaughter of animals for meat is permitted no earlier than 21 days after the last use of the drug. The meat of animals forcedly killed before the expiration of the specified period can be used as feed for fur-bearing animals. Milk obtained from animals treated with gentamicin should not be used for food purposes during the treatment period and for 72 hours after the last administration of the drug.

CONTRAINDICATIONS

Increased individual sensitivity of animals to gentamicin sulfate. The drug should not be prescribed with antibiotics of the penicillin, streptomycin, kanamycin and neomycin group, or mixed in the same syringe with other drugs. The drug should not be used in cases of severe renal impairment.

STORAGE

Store in sealed manufacturer's packaging, in a dry place, protected from light, out of reach of children and animals, separately from food and feed at a temperature from plus 5°C to plus 25°C. Shelf life, subject to storage conditions, is 2 years from the date of production.

PACKING

The drug is produced packaged in 100 ml glass bottles.

TOXICOLOGY

Gentamicin injection solution affects vestibular and renal functions in animals and humans.

Chronic administration of 5 mg/kg for 50 days in dogs, 10 mg/kg for 40 days in cats, and 20 mg/kg for 24 days in rats resulted in moderate toxicity in some animals studied. Higher toxic doses result in renal and vestibular damage that appears to be dose related. In humans, the only serious side effect to date has been damage to the eighth cranial nerve, predominantly the vestibular branch. When the dose of gentamicin was exceeded, the animals developed proteinuria, an increase in the content of urea nitrogen and creatinine in the blood serum. These results usually returned to normal after discontinuation of the drug.

Gentamicin toxicity was not observed in neonatal pigs that were administered gentamicin at three times the recommended dose for 15 days. During clinical studies in piglets under three days of age, no side effects were observed.

The LD50 of gentamicin for one-day-old turkey poults is calculated to be 27.8 mg per male and 40.5 mg per female.

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Clinical pharmacology of gentamicin in animals

When gentamicin is administered intramuscularly, peak serum concentrations bactericidal to susceptible bacteria occur between 30 and 90 minutes after injection: effective concentrations persist for six to eight hours.

Gentamicin is poorly absorbed in animals after oral administration. Therefore, oral administration is not recommended for the treatment of systemic infections. About 25-30% of the administered dose of gentamicin is bound to serum protein: it is released when the drug is excreted from the body.

Gentamicin in animals is excreted mainly in the urine by glomerular filtration.

Gentamicin was detected in the cerebrospinal fluid after intramuscular injection: however, concentrations were low and may be insufficient for the treatment of some central nervous system infections.

Gentamicin was also detected in sputum, pleural and peritoneal fluid. Gentamicin in animals penetrates the peritoneal and placental membranes.

Indications

An antibacterial drug for the treatment of diseases of cattle, poultry, bees, domestic animals, used in calves, piglets, young farm birds for therapeutic and prophylactic purposes and for therapeutic purposes in diseases of the gastrointestinal tract of bacterial etiology, for the treatment of respiratory tract infections in calves. Gentamicin for cows is used to treat mastitis during lactation. The dosage of gentamicin for animals is calculated depending on the type, route of administration, age and weight of the animal.

CONTRAINDICATIONS

A history of hypersensitivity or toxic reactions to gentamicin in an animal is a contraindication to its use.

WARNING: Do not mix with other drugs. Pregnancy. Although studies in pregnant animals have not shown teratogenic effects, caution should be exercised.

Ototoxicity: Gentamicin, along with the antibiotics streptomycin, neomycin and kanamycin, causes ototoxicity in experimental animals and humans

. The reversibility of this adverse reaction often depends on early detection of this complication.

Nephrotoxicity: Nephrotoxicity, manifested by increased blood urea or serum creatinine levels or decreased creatinine clearance, may occur with the administration of gentamicin. In most cases, these changes were reversible after discontinuation of the drug. Administration of other potentially nephrotoxic agents prior to or in combination with gentamicin injection may increase the risk of nephrotoxicity.

Neuromuscular blockade: Neuromuscular blockade and respiratory paralysis have been reported in a cat receiving high doses (40 mg/kg) of gentamicin. The possibility of these effects should be considered if gentamicin is administered to animals receiving general anesthesia using neuromuscular blocking drugs such as succinylcholine or tubocurarine. The neuromuscular blocking effect of gentamicin in animals can be reduced by neostigmine or calcium.

Superinfections: As with other antibiotics, treatment with gentamicin can sometimes result in overgrowth of nonsusceptible organisms. If superinfection develops, appropriate measures should be taken.

Medications

As of 05.2020, 23 gentamicin drugs were registered in the Russian Federation, for example:

• Eye drops IRIS
  - (Produced by NVC Agrovetzashchita LLC, Moscow, Russia, 129329) - a single drug of gentamicin sulfate in the form of eye drops at a concentration of 4 mg/ml. Used in dogs and cats for therapeutic and treatment-and-prophylactic purposes for acute and chronic conjunctivitis, keratitis, keratoconjunctivitis, ulcers and erosions of the cornea, meibomitis, blepharitis, and iridocyclitis (uveitis), as well as to reduce the risk of eye infections when a foreign body gets into the eye and other irritating agents.
• Mastomycin
  - (Produced by NITA-PHARM LLC, 410010, Saratov) - a combined preparation of gentamicin sulfate, clindamycin hydrochloride and lidocaine hydrochloride in the form of a gel for intracisternal administration with a concentration of gentamicin sulfate 15 mg/ml. It is used to treat various forms of mastitis of bacterial etiology in cows during lactation.
• Oxybactocide plates
  - (Produced by JSC Agrobioprom, 105064, Russia, Moscow) - a combined preparation of gentamicin sulfate and oxytetracycline hydrochloride in the form of a veterinary plate at a concentration of gentamicin 20 mg per plate. It is used for therapeutic and prophylactic purposes for foulbrood diseases of bees in the spring before the main honey harvest or in the summer, after pumping out commercial honey. It is prohibited to use the drug less than 14 days before the start of the main honey collection to avoid the components of the drug getting into commercial honey.
• Gentamicin sulfate 4% solution
  - (Produced by JSC "Mosagrogen", 142000, Moscow region, Domodedovo) - a single preparation of gentamicin sulfate at a concentration of 40 mg/ml (in terms of base) in the form of an injection solution. Used to treat cattle, pigs, horses, dogs and cats with bacterial diseases; respiratory and gastrointestinal diseases, sepsis, peritonitis, meningitis, pyelonephritis and other animal diseases caused by antibiotic-sensitive microorganisms.
• Polygen
  - (Produced by JSC Mosagrogen, 142000, Moscow region, Domodedovo) - a combined preparation of gentamicin sulfate at a concentration of 0.15 g or 0.3 g per bottle and colistin sulfate in the form of a lyophilisate for the preparation of a solution for sanitation. Used for the sanitation of sperm and embryos of farm animals. Polygen is not recommended for use when the biological quality of sperm is low. The drug is stored at a temperature not exceeding 25°C.
• Suprimycin
  - (Produced by JSC Mosagrogen, 142000, Moscow region, Domodedovo) - a combined preparation of gentamicin sulfate at a concentration of 20 mg/ml (in terms of base), sulfadimethoxine and trimethoprim in the form of an injection solution. Prescribed for large and small cattle, pigs, dogs and cats for bacterial respiratory tract infections (pneumonia, bronchopneumonia, bronchitis), dysentery, colibacillosis, enteritis, septicemia, metritis and endometritis, mastitis, mumps, pyelitis, pyelonephritis, cystitis, urethritis, pasteurellosis , skin infections, actinomycosis, purulent abscesses, etc. Suprimycin is not recommended for use in renal failure.
• Cyprogen
  - (Produced by Belfarmacom LLC, 308024, Russia, Belgorod) - a combined preparation of gentamicin sulfate at a concentration of 25 mg/ml and ciprofloxacin hydrochloride in the form of a solution for oral use. Gentamicin is used for broiler chickens and replacement young chickens for therapeutic and prophylactic purposes, for pigs - for therapeutic purposes in case of infectious diseases of the gastrointestinal tract, salmonellosis, streptococcosis, necrotic enteritis, dysentery in pigs, atrophic rhinitis, mixed infections, secondary infections in viral infections and etc.

It is prohibited to use Cyprogen in animals with significant disturbances in the development of cartilage tissue, with lesions of the nervous system accompanied by convulsions, with severe damage to the liver and kidneys. During the treatment period, prolonged exposure of animals to direct sunlight should be avoided. It is prohibited to use the drug in laying hens and replacement chickens less than 2 weeks before the start of laying, due to the accumulation of the active substance in the eggs. The use of the drug by pregnant and lactating sows is prohibited.

Description

Solution for injection gentamicin sulfate

, is a water-soluble (bactericidal) aminoglycoside antibiotic derived from Micromonospora purpurea, an actinomycete. GENTOCIN solution for injection 100 mg/ml is a sterile aqueous solution. Ingredients: Each ml contains: Drug Ingredient: Gentamicin (as Sulfate USP) 100 mg; Non-medicinal ingredients: 10 mg benzyl alcohol as a preservative, 2.4 mg sodium metabisulfite, 0.8 mg anhydrous sodium sulfite and 0.1 mg disodium edetate.