Project Description

Gentamycin

ointment 0.1% – Unguentum Gentamycini 0.1%

international nonproprietary name

Gentamycin. – Gentamicin.

Ref

BP-0057

Pharmacotherapeutic group

Antibiotic of aminoglycoside group for topical use.

Composition of the preparation

1 g of ointment contains 1 mg of gentamycin sulfate.

Pharmacological action

Pharmacodynamics

Gentamycin is characterized by a wide range of antimicrobial activity. It is active against the majority of gram-negative and gram-positive microorganisms: Pseudomonas aeruginosa, Escherichia coli, Proteus spp., Klebsiella spp., Serratia spp., Salmonella spp., Shigella spp., Staphylococcus spp., including multiple resistant strains. The preparation is active against anaerobic bacteria, fungi, viruses.

Exhibits bactericidal action. Actively penetrating through bacterial cell membranes it binds with 30S subunit of bacterial ribosome and inhibits the synthesis of causative agent protein.

Pharmacokinetics

Gentamycin poorly penetrates through intact skin and mucosa due to this when used topically in the form of ointment the preparation virtually does not exhibit a resorptive effect. The duration of the effect following single dose is 8-12 hours. When applied on damaged skin it is readily absorbed. Gentamycin is excreted via kidneys in unchanged form, predominantly as a result of glomerular filtration.

Indications 

Gentamycin ointment is used in surgery for topic treatment of wounds (during the second stage of wound process) with the view of prophylaxis of pyogenic complications; for the treatment of burns of II-IIIA degree (during the second stage of wound process) and frostbites; for the treatment of pyoderma, superficial folliculitis, furunculosis, infected seborrheic dermatitis, infected acne, eczema, secondary bacterial infection during mycotic and viral skin lesions, infected varicose ulcer, household lesions (for the treatment of small wounds and cuts).

special indication

Not established

special warning

Not established

Dosage and method of administration

Gentamycin ointment is used topically.

The preparation in thin layer is applied on the affected skin area after the removal of pus and necrotic masses, 2-3 times daily, for the treatment of burns – 2-3 times a week. In vast burn injury the daily dose of the ointment should not increase  200 g (200 mg of antibiotic). The duration of treatment depends on the form and severity of the disease and usually lasts 7-14 days.

For the treatment of dermatologic diseases the preparation is applied in thin layer on the affected area 2-3 times daily, or applied on the gauze bandage with followed by the application on the damaged skin area. Duration of treatment  7-14 days.

When exudate is present wounds and erosions are preliminary washed by the solutions of furacilin (1:5000), hydrogen peroxide (3%) or boric acid (1-2%).

overdosage

When administered for a prolonged period of time at doses increasing the recommended ones nephrotoxic effects (proteinuria, azotemia and other) and ototoxic effects (vestibular disorders, rarely – decrease of hearing), hyperbilirubinemia, increase of hepatic transaminase activity, change of peripheral blood cell composition can occur.

safety measures

Not established

Side effects

During treatment with gentamycin ointment local irritation (redness, pruritus) & allergic reactions (skin rash, pruritus, hives) can occur. If case of appearance of allergic reactions the preparation should be withdrawn and desensitizing therapy should be applied.

Contraindications

The administration of the preparation is contraindicated in case of individual hypersensitivity to gentamycin.

Interactions with other medicinal preparations

The preparation should not be used concomitantly with other antibiotics, having oto- and nephrotoxic effects (streptomycin, kanamycin, florimycin, monomycin, ristomycin), with furosemide. The activity of gentamycin decreases in presence of Na+, K+, Ca++, MG++ ions, as well as several anions (sulphates, phosphate, nitrates and others). There is data about synergism in the combinations of gentamycin with dioxidin and about the increase of therapeutic efficacy when administered concomitantly with corticosteroids.

The form of release

Ointment 0.1% in tubes and jars of  25 g.