Project Description

Gentamycin sulfate

solution 0,3% (eye drops) – Solutio Gentamicini sulfatis 0,3% (guttae ophthalmicae)

international nonproprietary name

Gentamycin. – Gentamicin.

Ref

BP-0058

Pharmacotherapeutic group

Antibiotic of aminoglycosides class.

Composition of the preparation

1 ml of sterile solution (eye drops) contains 3 mg of gentamycin sulfate.

Pharmacological action

Pharmacodynamics

Gentamycin is characterized by a wide range of antimicrobial activity. Active against the majority of gram-negative bacteria: Escherichia Coli, Klebsiella spp., indole-positive and indole-negative Proteus spp., Enterobacter spp., Providencia stuartii, Salmonella spp., Shigella spp., Acinetobacter spp.; anaerobic gram-positive cocci: Staphylococcus spp. (including penicillin-resistant). Resistance of microorganisms to gentamicin develops slowly, however strains neomycin- and kanamycin-resistant strains are also resistant to gentamicin.

Pharmacokinetics

It practically does not absorb into blood after instillation into the conjunctival pouch. Penetrates into the humor of anterior chamber of the eye, vitreous humor and cornea tissue, not detected in the lens. Peak gentamicin levels are observed in 30 minutes after injection, the concentration decreases, mainly due to the elution with lacrimal liquid, maintaining at therapeutic levels for 6 hours.

Indications 

The eye drops are intended for the treatment of acute and chronic conjunctivitis, corneal ulcer, keratitis, keratoconjunctivitis, acute and chronic iritis, acute and chronic blepharitis, dacryocystitis and other infectious-inflammatory eyes diseases, as well for the prophylaxis treatment of suppurative complication after eye surgery.

special indication

Not established

special warning

Not established

Dosage and method of administration

1-2 eye drops are instilled into the conjunctival pouch 3-4 times a day . The duration of treatment is up to 14 days.

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

Preparation should be administered with caution in patients with hypersensitivity to aminoglycosides. During long-term treatment renal and hearing organs functions should be monitored.

Side effects

Burning sensations and eye irritation, flushing of conjunctiva can occur. In rare cases allergic reactions can be observed.

Contraindications

Hypersensitivity to the preparation, severe impairment of renal function. The preparation is contraindicated during auditory nerve, vestibular organ diseases and during pregnancy.

Interactions with other medicinal preparations

Preparation should not be administered with other antibiotics, exhibiting oto- or nephrotoxic effects. Can be administered concomitantly with corticosteroids.

The activity of antibiotic is decreased in the presence of sodium, potassium, calcium, magnesium kations, as several anions (sulphates, phosphates, nitrates).

The form of release

Gentamycin sulfate 0.3% solution (eye drops) in 1 ml tube-droppers.