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Pharmacological properties

The drug acts locally, the systemic effect is minimal. It is practically not absorbed through the conjunctival mucosa and does not bind to proteins (0-10%). Well distributed in organs and tissues of the body. Distributed in extracellular fluid (including blood serum), abscess fluid, pleural effusion, ascitic, pericardial, synovial, lymphatic and peritoneal fluids, urine. High concentrations are created in the kidneys, liver, lungs; low – in bone and adipose tissue. Does not penetrate through intact BBB. Penetrates through the placenta and into breast milk. Volume of distribution in adults – 0.26 l/kg, in children – 0.2-0.4 l/kg, newborns less than 1 week old and weighing less than 1500 g – up to 0.68 l/kg, less than 1 week old and body weight more than 1500g - up to 0.58 l/kg, patients with cystic fibrosis - 0.3-0.39 l/kg. Not metabolized. It is excreted by the kidneys (93% in 24 hours) mainly unchanged. T1/2 with normal renal function – 2-4 hours; in newborns - 5-8 hours, in older children - 2-4 hours. Final T1/2 - more than 100 hours (release from intracellular depots). In patients with renal failure, T1/2 varies depending on the degree of failure - up to 100 hours, in patients with cystic fibrosis - 1-2 hours, in patients with burns and hyperthermia it may be shorter than the average due to increased clearance. Hemodialysis removes 25-70% of the administered dose.

Pharmacodynamics

The active ingredient of Tobrom, tobramycin, is a broad-spectrum antibiotic from the group of aminoglycosides. At low concentrations it acts bacteriostatically (blocks the 30S subunit of ribosomes and disrupts protein synthesis), and at higher concentrations it acts bactericidal (disrupts the function of cytoplasmic membranes, causing the death of microbial cells). Highly active against Staphylococcus spp. (including Staphylococcus aureus, Staphylococcus epidermidis /coagulase-negative and coagulase-positive/, as well as strains resistant to penicillin); Streptococcus spp. (including ab-hemolytic species, some non-hemolytic species, Streptococcus pneumoniae); Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis (indole-negative) and indole-positive species Proteus spp., Haemophilus influenzae, Haemophilus aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus (Herelleavaginacola), some species of Neisseria spp. (including Neisseria gonorrhoeae). The spectrum of action of Tobramycin is similar to the spectrum of action of gentamicin, however, it is active against a number of strains of bacteria resistant to gentamicin; can also be used in case of low effectiveness of eye drops containing neomycin. Compared to other antibiotics, the effect of the drug is more pronounced in infections caused by Pseudomonas.

Indications for use

Infectious eye diseases caused by microorganisms sensitive to the drug:

blepharitis, conjunctivitis, keratoconjunctivitis, blepharoconjunctivitis, keratitis

iridocyclitis, endophthalmitis

prevention of postoperative complications in ophthalmology.

Directions for use and doses

In case of a mild infectious process, the drug is instilled 1-2 drops into the conjunctival sac of the affected eye (or eyes) every 4 hours. In the case of an acute severe infectious process (endophthalmitis), the drug is instilled every 30-60 minutes; as the inflammation decreases, the frequency of instillations of the drug is reduced.

The bottle must be closed after each use. Do not touch the tip of the pipette to the eye to maintain the sterility of the solution.

The course of treatment is 7-10 days.

Side effects

- allergic reactions: itching and swelling of the eyelids, conjunctival hyperemia

- blurred vision

Contraindications

hypersensitivity to aminoglycoside antibiotics and other components of the drug.

Drug interactions

In the case of simultaneous administration of Tobrom eye drops with systemic antibiotics from the group of aminoglycosides, systemic side effects (nephrotoxic, ototoxic, disturbances of mineral metabolism and hematopoiesis) may be increased.

special instructions

Tobrom is for topical use only (not for injection).

Long-term use of Tobrom eye drops, as in the case of the use of other antibiotics, can lead to increased growth of resistant microorganisms (including fungi). It is recommended to perform a culture after completion of treatment if the clinical result is unsatisfactory.

Patients who wear contact lenses should only use eye drops when the lenses are removed. Lenses can be installed 15 minutes after instillation of the drug.

If allergic reactions develop, use of the drug should be discontinued.

Before use, shake the contents of the bottle.

Use in pediatrics

There is no sufficient experience in using Tobrom eye drops in children. The drug can be used in children if the expected therapeutic effect exceeds the potential risk of side effects.

Pregnancy and lactation

There is no sufficient experience with the use of the drug during pregnancy and lactation (breastfeeding). It is possible to use Tobrom eye drops in pregnant women for health reasons. During treatment, breastfeeding should be stopped.

Features of the effect of the drug on the ability to drive a vehicle and potentially dangerous mechanisms

The use of Tobrom does not cause increased fatigue and visual impairment, and therefore does not affect the ability to drive vehicles or operate machinery. After instillation, blurred vision may occur.

Overdose

Symptoms: punctate keratitis, erythema, increased lacrimation, itching and swelling of the eyelid.

Treatment: perform symptomatic therapy

Release form and packaging

5 ml in opaque white polymer bottles, with a dropper cap and a screw cap.

1 bottle, along with instructions for use in the state and Russian languages, is placed in a cardboard pack.

Storage conditions

Store at temperatures from +15ºС to +25 0С, in the original packaging.

Keep out of the reach of children!

Shelf life

3 years

After opening the bottle - 4 weeks

Do not use the drug after the expiration date indicated on the package.

Vacation conditions

from pharmacies

According to the recipe
Attention! The description of the drug on this page is simplified. Before purchasing and using the drug, consult your doctor or pharmacist, and also read the instructions approved by the manufacturer. Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. ATTENTION! This section is provided for informational purposes only and is not a catalog or price list of our company. To obtain information about the availability of drugs, call + 99871 202 0999 Pharmacy Network Helpline 999.

Tobrom eye drops 0.3% 5ml No. 1

Name

Tobrom eye drops. 0.3% in 5ml bottle in pack No. 1

Description

Transparent solution without visible particles.

Main active ingredient

Tobramycin

Release form

eye drops

Dosage

0.3% 5 ml

special instructions

The use of Tobrom does not cause increased fatigue and visual impairment, and therefore does not affect the ability to drive vehicles or operate machinery. Patients who temporarily lose clarity of vision after application are not recommended to drive a car or operate complex equipment immediately after instilling the drug.

pharmachologic effect

Drugs 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 through inhibition of polypeptide assembly and synthesis on the ribosome. Mechanism of Resistance Resistance to tobramycin develops through various mechanisms, which include changes in the ribosomal subunit within the bacterial cell; disruption of tobramycin transport 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 frequency of acquired resistance of some strains may vary depending on place and time, so it is advisable to have local information on the resistance of microorganisms, especially in the treatment of severe infections where expert advice is necessary and the resistance of microorganisms in the locality is such that the use of tobramycin is at least effective for some types of infections, it is doubtful. Susceptible strains

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 - MSSH).
aerobic gram-negative 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.

Stamps that can acquire resistance Acinetobacter baumanii, bacillus cereus, bacillus thuringiensis, kocuria rhizophila, staphylococcus aureus (resistant to methicillin - mrsa), staphylococcus epidermidis, Staphylococcus haemolyticus (resistant to methycillin - MRSH, resistance> 50%), Staphylococcus, other coagulazoid species, Serratia marcescens. Microorganisms with their own resistance

aerobic gram-positive microorganisms: Enterococci faecalis, Streptococcus mitis, Streptococcus pneumonia, Streptococcus pyogenes, Streptococcus sanguis.
aerobic gram-negative microorganisms: Chryseobacterium indologenes, Haemophilus influenzae, Stenotrophomonas maltophilia.
anaerobic microorganisms: Propionibacterium acnes.

Pediatric Patients More than 60 pediatric patients were enrolled in 10 clinical studies in which tobramycin-containing eye drops or ophthalmic ointment were used to treat bacterial conjunctivitis, blepharitis, or blepharoconjunctivitis. The age of the patients ranged from 1 year to 18 years. Overall, the safety profile for pediatric patients did not differ from that for adult patients. There are no dosage recommendations for children under one year of age due to lack of relevant data.

Pharmacokinetics

Tobramycin penetrates poorly through the cornea and conjunctiva and undergoes minimal absorption into ocular tissues after topical application.

Indications for use

The drug is used to treat superficial bacterial infections of the eyes, such as conjunctivitis, keratitis and corneal ulcers caused by microorganisms sensitive to tobramycin.

Directions for use and doses

Adults: For mild illnesses: 1 or 2 drops in the eye(s) every 4 hours. For more severe infections: 2 drops in the 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 infectious process 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 bottle should be tightly closed. When taking several topical medications at the same time, 5-10 minutes should elapse between doses. Systemic absorption of the drug can be reduced by pressing on the tear ducts. Children and adolescents: the medicine can be used in children and adolescents (1 year of age 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 show 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/abstain from using Tobrom based on the balance between the benefits of breastfeeding for the baby and the benefits of therapy for the woman.

Precautionary measures

Tobrom is for topical use only (not for injection). Long-term use of Tobr eye drops, as in the case of the use of other antibiotics, can lead to increased growth of resistant microorganisms (including fungi). It is recommended to perform a culture after completion of treatment if the clinical result is unsatisfactory. If superinfection develops, appropriate therapy must be prescribed. During the treatment of an ophthalmic infection, wearing contact lenses is not recommended. Therefore, patients should be advised not to wear contact lenses during treatment with this drug. In addition, Tobrom contains benzalkonium chloride, which can cause eye irritation and discolor soft contact lenses. Patients who wear contact lenses, despite recommendations, should use eye drops only with the lenses removed. Lenses can be installed 15 minutes after instillation of the drug. If allergic reactions develop, use of the drug should be discontinued.

Interaction with other drugs

No interaction studies have been conducted with other drugs. The simultaneous use of aminoglycosides (tobramycin) and other systemic, oral or local drugs that have neurotoxic, ototoxic or nephrotoxic effects may increase the toxicity of the drug, so such use should be avoided. Please pay attention to the use of:

aminoglycosides, for internal use. Total plasma concentrations should be checked;
diuretics;
medicines containing amphotericin B or cephalothin.

Interactions with these drugs may increase the risk of nephrotoxicity and ototoxicity. Drugs belonging to the tetracycline group 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. When used concomitantly with topical corticosteroids in combination with tobramycin, they can mask the clinical manifestations of bacterial, fungal or viral infections, as well as suppress hypersensitivity reactions.

Contraindications

hypersensitivity to tobramycin, gentamicin or any of the components of the drug.

Compound

Active ingredient: tobramycin 3 mg/ml; excipients: benzalkonium chloride, anhydrous sodium sulfate, boric acid, sodium chloride, tyloxapol, 0.5 M sulfuric acid solution or 1 M sodium hydroxide solution, purified water.

Overdose

Symptoms: punctate keratitis, erythema, increased lacrimation, itching and swelling of the eyelid. In case of overdose of topical tobramycin, it is recommended to rinse the eye(s) with warm water.

Side effect

The most common adverse reactions are symptoms of local toxicity and hypersensitivity, including itching and swelling in the eyelids, eye hyperemia, itchy eyes and increased lacrimation. The following adverse reactions are classified by frequency of occurrence: very often (?1/10), often (?1/100 to

some patients may experience sensitivity to topically applied aminoglycosides;
If tobramycin is used topically in combination with oral aminoglycoside antibiotics, their total serum levels should be monitored.

Storage conditions

Store in the manufacturer's packaging at a temperature of 15–25 °C. Keep out of the reach of children.