Project Description
Gentamycin sulphate
solution eye drops 0,3% – Solutio Gentamicini sulfatis 0,3% (guttae ophthalmicae)
international nonproprietary name
Gentamycin. – Gentamicin.
Ref
BP-0056
Pharmacotherapeutic group
Antibiotic of aminoglycosides
Composition of the preparation
1 ml sterile solution (eye drops) contains 3 mg of gentamycin sulphate.
Pharmacological action
Pharmacodynamics Gentamycin is characterized of vast gamma of antibacterial actions. It is active to the majority of gram-negative: Escherichia coli, Klebsiella spp., indole-positive and indole-negative Proteus spp., Enterobacter spp., Providencia stuartii, Salmonella spp., Shigella spp., Acinetobacter spp.; anaerobic gram-positive coccus: Staphylococcus spp. (resistant to penicillin inclusive). Bacterium resistance t o gentamycin develops slowly still the strains resistant to neomycin and canamycin, are resistant also to gentamycin. Pharmacokinetics Practically not absorbed in blood under instillation in conjunctival sac. Absorbed in the humid front chamber of eye, vitreous body and cornea tissue, no absorption to lens. Max.level of gentamycin is detected in 30 minutes, then the concentration falls mainly due to elution by lacrimal liquid and is maintained at the therapeutic level during 6 h.
Indications
Eye drops are administered in acute and chronic conjunctivitis, cornea ulcer, keratitis, keratoconjunctivitis, acute and chronic iritis, acute and chronic blepharitis, dacriocystitis and other infection-inflammatory eye diseases as well as to prevent and treat purulent complication in post operative period.
Special indication
Not established
Special warning
Not established
Dosage and method of administration
Instill 1-2 drops in conjunctival sac 3-4 times a day. The period of treatment up to 14 days.
Overdosage
Multiinstillation (more than 5) daily within a week causes edematic chemosis of stroma of cornea.
Safety measures
Administer with care to patients with hypersensitivity to aminoglycosides. In long treatment control renal function and organs of hearing.
Side effects
Possible burning and irritation in eyes, hyperemia of conjunctive. Rare possible allergic reaction.
Contraindications
Hypersensitivity to preparation, grave renal dysfunction. Prohibited in patients with auditory nerve disease, vestibular apparatus and pregnancy.
Interactions with other medicinal preparations
Forbidden concurrent administration with antibiotics of oto- or nephrotoxic action. Possible co-administration with corticosteroids. Antibiotic activity is inhibited by cations of sodium, calcium, magnesium, and anion series (sulphate, phosphate, nitrate).
The form of release
Gentamycin sulphate solution 0,3% (eye drops) in tube-dropper 1 ml.