Name:
Tobrom eye drops 0.3% in vial-cap. 5 ml in pack No. 1
Description:
Transparent solution without visible particles. The main active ingredient Tobramycin Release form eye drops Dosage 0.3% 5 ml Patients who temporarily lose their vision after the application are not recommended to drive a car or work with complex equipment immediately after instillation of the drug. Pharmacological actionMeans used in ophthalmology. Antibiotics. ATX drug code: S01AA12. Pharmacodynamics Mechanism of action Tobramycin is a broad-spectrum bactericidal amine glycoside antibiotic. The main effect on bacterial cells is manifested through inhibition of the assembly and synthesis of the polypeptide on the ribosome. Mechanism of resistance Tobramycin resistance develops through a variety of mechanisms, which include alteration of the ribosome subunit within the bacterial cell; violation of the transport of tobramycin into the cell; inactivation of tobramycin by adenylation, phosphorylation and acetylation by enzymes. Genetic information about the formation of inactivating enzymes can be carried by bacterial chromosomes or plasmids. Cross-resistance with other aminoglycosides is possible. The incidence of acquired resistance in some strains may vary depending on place and time, so it is desirable to have local information on microbial resistance, especially in the treatment of severe infections where expert advice is needed, and local microbial resistance is such that the efficacy of tobramycin is at least with some types of infections, is doubtful. Susceptible strains of aerobic gram-positive microorganisms: Bacillus megaterium, Bacillus pumilus, Corynebacterium accolens, Corynebacterium bovis, Corynebacterium macginleyi, Corynebacterium pseudodiphtheriticum, Kocuria kristinae, Staphylococcus aureus (methicillin-sensitive – MSSA), Staphylococcus haemolyticus (methicillin-sensitive microorganisms). : Acinetobacter junii, Acinetobacter ursingii, Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, Moraxella oslonensis, Morganella morganii, Neisseria perflava, Proteus mirabillis, Pseudomonas aeruginosa, Serratia liquifaciens, Bacillus bauciens. cereus, Bacillus thuringiensis, Kocuria rhizophila, Staphylococcus aureus (methicillin resistant – MRSA), Staphylococcus epidermidis, Staphylococcus haemolyticus (methicillin resistant – MRSH, resistance >50%), Staphylo coccus, other coagulase-negative species, Serratia marcescens. Microorganisms with intrinsic resistance aerobic gram-positive microorganisms: Enterococci faecalis, Streptococcus mitis, Streptococcus pneumonia, Streptococcus pyogenes, Streptococcus sanguis. aerobic gram-negative microorganisms: Chryseobactefium indologenes, Haemophilus influenzae, Stenotrophomonas maltophilia patients. in which tobramycin-containing eye drops or eye ointment was used to treat bacterial conjunctivitis, blepharitis, or blepharoconjunctivitis, more than 60 pediatric patients participated. The age of the patients ranged from 1 to 18 years. In general, the safety profile for pediatric patients did not differ from that for adult patients. For children under the age of one year, there are no dosage recommendations due to the lack of relevant data. Pharmacokinetics Tobramycin poorly penetrates the cornea and conjunctiva and undergoes minimal absorption by the tissues of the eye after topical application. Indications for use The drug is used to treat superficial bacterial eye infections such as conjunctivitis, keratitis and corneal ulcers caused by microorganisms susceptible to tobramycin. Dosage and administrationAdults: For mild illnesses: 1 or 2 drops in the eye(s) every 4 hours. For more severe infections: 2 drops in eye(s) every hour. When improvement is achieved, the frequency of instillations should be reduced. The duration of treatment depends on the severity of the infection and can vary from several days to several weeks. To prevent contamination of the dropper, avoid touching the tip to the eyelids, adjacent edges or other surfaces. After each use, the vial must be tightly closed. When taking several topical drugs at the same time, 5-10 minutes should elapse between doses. Systemic absorption of the drug can be reduced by pressing on the lacrimal ducts. Children and adolescents: the drug can be used in children and adolescents (aged 1 year and older) at the same dose as in adults. Use during pregnancy and lactation There are limited data on the use of tobramycin in pregnant women. Animal studies have shown reproductive toxicity. It is not recommended to use Tobrom during pregnancy. Tobramycin probably does not pass into breast milk, but a possible risk to the baby cannot be ruled out. The physician must decide whether to stop breastfeeding or stop/withhold the use of Tobroma, based on the ratio of the benefit of breastfeeding to the child and the benefit of therapy to the woman. Precautions Tobrom is for topical use only (not for injection). Prolonged use of eye drops Tobrom, as in the case of the use of other antibiotics, can lead to increased growth of non-susceptible microorganisms (including fungi). It is recommended to do culture after the end of treatment if the clinical result is unsatisfactory. With the development of superinfection, it is necessary to prescribe appropriate therapy. It is not recommended to wear contact lenses during the treatment of an ophthalmic infection. Therefore, patients should be advised not to wear contact lenses during treatment with this medicinal product. In addition, Tobrom contains benzalkonium chloride, which can cause eye irritation and discolour soft contact lenses. Patients using contact lenses, despite the recommendations, should use eye drops only with the lenses removed. Lenses can be installed 15 minutes after instillation of the drug. With the development of allergic reactions, the use of the drug should be discontinued. Interaction with other drugs No interaction studies have been conducted with other medicinal products. The simultaneous use of aminoglycosides (tobramycin) and other systemic, oral or topical drugs with neurotoxic, ototoxic or nephrotoxic effects may increase the toxicity of the drug, so this use should be avoided. Attention should be paid to the use of: aminoglycosides, for internal use. The total plasma concentration should be checked; diuretics; drugs containing amphotericin B or cephalothin. Interaction with these drugs may increase the risk of nephrotoxic and ototoxic effects. Preparations belonging to the group of tetracyclines for topical use in ophthalmology should not be used simultaneously with Tobrom, because tyloxapol, one of the components of this drug, is chemically incompatible with tetracyclines. With the simultaneous use of topical corticosteroids in combination with tobramycin, they can mask the clinical manifestations of a bacterial, fungal or viral infection, as well as suppress hypersensitivity reactions. Contraindications Hypersensitivity to tobramycin, gentamicin or to any of the components of the drug. Composition Active ingredient: tobramycin 3 mg/ml; excipients: benzalkonium chloride, anhydrous sodium sulfate, boric acid, sodium chloride, tyloxapol, 0.5M sulfuric acid solution or 1M sodium hydroxide solution, purified water. Overdose Symptoms: punctate keratitis, erythema, increased lacrimation, itching and swelling of the eyelid. In case of an overdose of tobramycin when applied topically, it is recommended to rinse the eye(s) with warm water. Side effects The most common adverse reactions are symptoms of local toxic effects and hypersensitivity, including itching and swelling in the eyelids, redness of the eyes, itching of the eyes and increased lacrimation. The following adverse reactions are classified according to the frequency of manifestation: very often (?1/10), often (?1/100 to <1/10), rarely (?1/1000 to <1/100), rarely (?1/10000 to <1/1000), very rare (<1/10000), or not known (cannot be estimated from the available data). In each group, adverse reactions are presented in descending order of severity. The list of adverse reactions has been established based on the results of clinical studies and post-registration spontaneous reports. The following adverse reactions have been reported: Ophthalmic disorders Common: ocular allergy, ocular itching, eyelid itching, eyelid edema, eye hyperemia, increased lacrimation. Uncommon: Eyelid erythema, eye discharge, eyelid disease, conjunctival edema, eye discomfort, eye irritation. Not known: keratitis, eye pain, foreign body sensation in the eyes, blurred vision. Skin and subcutaneous tissue disorders Not known: rash, urticaria, erythema.
Tobrom eye drops 0.3% 5ml №1
$20.00
SKU: 17761
Category: Medicines for diseases of the eyes and ears
INN | tobramycin |
---|---|
The code | 17 761 |
Barcode | 5 944 728 000 186 |
Dosage | 0.3% 5ml |
Active substance | Tobramycin |
Amount in a package | 25 |
Manufacturer | Rompharm company S.R.L., Romania |
Importer | "VitPharmMarket" LLC Vitebsk, Republic of Belarus, 210004 Vitebsk, 5th Kooperativnaya st., 8; Limited Liability Company "PHARMPROEKT", 220037, Minsk, 1st Solid Lane, 7, room 107; Komfarm LLC, Minsk, 220131 Minsk, Sosnovy Bor st., 4, room 1 |
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