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Tobradex eye drops 5ml

Compound

Active ingredients: tobramycin - 3 mg, dexamethasone - 1 mg. Excipients: benzalkonium chloride, disodium edetate, sodium chloride, sodium sulfate anhydrous, tyloxapol, hydroxyethylcellulose, sodium hydroxide or sulfuric acid (to maintain pH level), purified water.

Pharmacokinetics

When Tobradex® is applied topically, systemic absorption of dexamethasone is low. The maximum concentration (Cmax) of dexamethasone in blood plasma ranges from 220 to 888 pg/ml (about 555 ± 217 pg/ml) after using 1 drop of Tobradex® in each eye 4 times a day for 2 days. About 77-84% of dexamethasone entering the systemic circulation is bound to plasma proteins. T1/2 averages 3-4 hours. It is excreted by metabolism, about 60% in the form of 6-β-hydroxydexamethasone in the urine.

When Tobradex® is applied topically, systemic absorption of tobramycin is low. The concentration of tobramycin in the blood plasma after using 1 drop of Tobradex® in each eye 4 times a day for 2 days was below the detection limit in 9 of 12 patients. The maximum measurable concentration (Cmax) of tobramycin in plasma was 247 ng/ml, which is eight times lower than the concentration threshold associated with nephrotoxicity. It is excreted by the kidneys, mainly unchanged.

Indications for use

prevention of postoperative infectious complications;
blepharitis;
conjunctivitis;
keratitis (without damage to the epithelium).

Contraindications

viral diseases of the cornea and conjunctiva (including keratitis caused by Herpes simplex, chicken pox);
mycobacterial eye infection;
fungal eye diseases;
conditions after removal of a corneal foreign body;
hypersensitivity to any component of the drug.

Directions for use and doses

Locally. Shake the bottle before use.

For children over 12 years of age and adults, instill 1-2 drops into the conjunctival sac every 4-6 hours.

In the first 24-48 hours, the dose can be increased to 1-2 drops into the conjunctival sac every 2 hours, followed by a decrease in the frequency of drug instillations as inflammation decreases.

In case of acute severe infectious process: 1-2 drops into the conjunctival sac every 60 minutes until the severity of the condition decreases. Then reduce the frequency of drug instillations to 1-2 drops into the conjunctival sac every 2 hours for 3 days. Then 1-2 drops into the conjunctival sac every 4 hours for 5-8 days. If necessary, continue instillation: 1-2 drops into the conjunctival sac for 5-8 days.

For the prevention of inflammatory phenomena in the postoperative period: 1 drop into the conjunctival sac 4 times a day, starting from the day of surgery until 24 days. Therapy can be started before surgery: 1 drop into the conjunctival sac 4 times a day 1 day before surgery, 1 drop on the day of surgery, then 1 drop into the conjunctival sac 4 times a day for 23 days. If necessary, the frequency of drug instillations can be increased to 1-2 drops into the conjunctival sac every 2 hours during the first 2 days after surgery.

After using the drug, to reduce the risk of developing systemic side effects, it is recommended to apply light pressure with a finger on the projection area of the lacrimal sacs at the inner corner of the eye for 1-2 minutes after instillation of the drug - this reduces the systemic absorption of the drug.

You can combine the use of ointment and Tobradex® drops: ointment - in the evening before bed, drops - during the day (while maintaining the frequency of use of the drug 3-4 times a day).

Storage conditions

The drug should be stored out of the reach of children at a temperature of 8° to 27°C. The Drop Tainer dropper bottle should be stored upright.

Best before date

2 years. Do not use after the expiration date stated on the package.

Use within 4 weeks after opening the bottle.

special instructions

When prescribing Tobradex simultaneously with aminoglycoside antibiotics for systemic use, peripheral blood patterns should be monitored.

When using Tobradex simultaneously with other eye drops or ointments, the interval between their applications should be at least 5 minutes.

The bottle must be closed after each use. Shake the contents of the bottle before use. When instilling, do not touch the tip of the pipette to the eye.

Description

A drug with antibacterial and anti-inflammatory effects for topical use in ophthalmology.

Dosage form

Eye drops in the form of a suspension from white to almost white.

Use in children

Contraindicated under the age of 12 years.

Action

A combined drug with antibacterial and anti-inflammatory effects for local use in ophthalmology.

Tobramycin

– a broad-spectrum antibiotic from the group of aminoglycosides. Active against gram-positive and gram-negative microorganisms: Staphylococcus spp. (including Staphylococcus aureus, Staphylococcus epidermidis /including strains resistant to penicillin/), Streptococcus spp. (including some β-hemolytic species of group A, some non-hemolytic species and some strains of Streptococcus pneumoniae), Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, Proteus vulgaris, Haemophilus influenzae, Haemophilus aegyptius , Moraxella lacunata, Acinetobacter calcoaceticus, as well as some strains of Neisseria spp.

Dexamethasone

– GKS. It has a pronounced anti-inflammatory, antiallergic and desensitizing effect. Has an antiexudative effect.

Side effects

Allergic reactions: itching and swelling of the eyelids, redness of the conjunctiva.

On the part of the organ of vision (due to dexamethasone): increased intraocular pressure, formation of posterior subcapsular cataracts, slowdown in the healing process of wounds.

Other: development of secondary infection (including bacterial), as a result of suppression of the patient’s protective reaction. The appearance of non-healing ulcers on the cornea after long-term treatment with corticosteroids may indicate the development of a fungal infection.

Use during pregnancy and breastfeeding

There is no sufficient experience with the use of the drug during pregnancy and lactation (breastfeeding).

It is possible to use Tobradex in pregnant women when the expected therapeutic effect outweighs the potential risk of side effects.

The drug should not be used during breastfeeding.

Interaction

In case of simultaneous administration of Tobradex eye drops with systemic antibiotics from the aminoglycoside group, systemic side effects may increase.

Overdose

Symptoms: irritation of the mucous membrane of the eye, itching, lacrimation, swelling of the eyelids, conjunctival hyperemia.

Treatment: rinse eyes with warm water, symptomatic therapy.

Impact on the ability to drive vehicles and operate machinery

If the patient's vision is temporarily reduced after using the drug, it is not recommended to drive a car or engage in activities that require increased attention until it is restored.

Tobradex

Tobradex (tobramycin + dexamethasone) is a combination drug with antimicrobial and anti-inflammatory effects for local use in ophthalmic practice. Tobramycin is an antibiotic belonging to the aminoglycoside group. It actively interferes with the synthesis of proteins in bacterial cells and radically changes the structure and permeability of their cytoplasmic membranes. Tobramycin affects both gram-positive and gram-negative microorganisms: Staphylococcus aureus, Staphylococcus epidermidis (including methicillin-resistant strains), Streptococcus spp. (including beta-hemolytic and non-hemolytic species, as well as Streptococcus pneumoniae), Acinetobacter spp., Citrobacter spp., Escherichia coli, Enterobacter spp., Haemophilus influenzae, Klebsiella pneumoniae, Morganella morganii, Moraxella spp., Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens. Dexamethasone is a synthetic glucocorticosteroid. It does not have mineralocorticosteroid activity (the ability to retain sodium and water in the body). Shows a strong anti-inflammatory, anti-allergic and desensitizing effect. Suppresses the progression of inflammatory processes, inhibiting the release of inflammatory mediators by zosinophils, preventing the migration of mast cells and reducing the permeability of the walls of small blood vessels and their lumen. In addition, the combination of tobramycin with dexamethasone can reduce the risk of infection, exhibiting preventive properties. When Tobradex is used topically, dexamethasone is only slightly absorbed into the systemic circulation. About 78-85% of the substance that has undergone systemic absorption is bound to blood plasma proteins. The half-life of dexamethasone is approximately 3.5 hours. This glucocorticosteroid is excreted for the most part (about 60%) in the form of metabolites along with urine. Tobramycin, like dexamethasone, practically does not enter the systemic circulation when applied topically. Thus, the maximum concentration of this antibiotic in the blood when using Tobradex is only 247 ng/ml, which is an order of magnitude lower than the threshold concentration associated with nephrotoxicity.

It is excreted unchanged in the urine.

Tobradex is available in two dosage forms: eye drops and ointment. It is used exclusively locally. The ointment is placed in the space between the eyeball and the lower eyelid 3-4 times a day, with the frequency of use decreasing as the inflammation symptoms regress. It is possible to combine both forms of Tobradex with each other, using drops during the day and ointment in the evening before bed while maintaining the frequency of use of the drug 3-4 times a day. To avoid contamination of the contents of the tube, you should not touch its tip to any surfaces other than the conjunctival sac. After applying the ointment, the tube should only be kept closed. When using eye drops, 1-2 drops are instilled every 4-6 hours. In the first 1-2 days, the frequency of instillation can be doubled. The bottle with drops should be closed immediately after instillation. To make the solution homogeneous, the bottle must be shaken before each use. When instilling, a certain distance should be maintained between the tip of the pipette and the eye to avoid their involuntary contact. Pregnancy is not a direct contraindication to the use of Tobradex, however, special caution should be exercised in such patients, carefully weighing the benefits and potential risks to the fetus. Preclinical studies have demonstrated the toxic effects of tobramycin and dexamethasone on the fetus when administered in high doses. When using Tobradex for more than 2 weeks, it is necessary to monitor the condition of the cornea. The combined use of the drug together with aminoglycoside antibiotics of systemic action determines the need to monitor the general blood picture. When using Tobradex together with other eye drops or ointments, the time interval between their use should be at least 5 minutes.