Pharmacy No. 84. Delivery of medicines to your home and office.

Medicines

my basket

Apteka84.kz is an online pharmacy that offers its customers medicines, medicinal and decorative cosmetics, dietary supplements, vitamins, baby food, intimate products for adults, medical equipment and thousands of other medical and cosmetic products at low prices. All data presented on the Apteka84.kz website is for informational purposes only and is not a substitute for professional medical care. Apteka84.kz strongly recommends that you carefully read the instructions for use contained in each package of medicines and other products. If you currently have any symptoms of the disease, you should seek help from a doctor. You should always tell your doctor or pharmacist about all the medicines you take. If you feel you need further help, please consult your local pharmacist or contact our GP online or by telephone.

Tobradex eye drops (3mg+1mg)/1ml 5ml No.1

Name

Tobradex.

Release forms

Drops.

INN

Dexamethasone + tobramycin.

FTG

Glucocorticosteroid for local use + aminoglycoside antibiotic.

Description

White or almost white suspension.

Compound

Each ml of the drug contains: active substances: tobramycin – 3.0 mg; dexamethasone – 1.0 mg; excipients: benzalkonium chloride; disodium edetate; sodium chloride; sodium sulfate anhydrous; tyloxapol; hydroxyethylcellulose; sulfuric acid and/or sodium hydroxide (to adjust pH); purified water.

Pharmacotherapeutic group

Drugs used in ophthalmology; a combination of corticosteroids and anti-infectives. ATX code: S01CA01.

Pharmacological properties

Pharmacodynamics Corticosteroids suppress the inflammatory response to a variety of agents and may delay or delay the healing process. Since corticosteroids can suppress the body's natural defense mechanisms against infection, there is a need for the simultaneous use of an antimicrobial agent. TOBRADEX is a combination of the powerful corticosteroid dexamethasone and the antibiotic tobramycin, active against a wide range of sensitive microorganisms. Although tobramycin and gentamicin are aminoglycoside antibiotics with a similar spectrum of action, tobramycin is significantly more active against Pseudomonas aeruginosa compared to gentamicin. In vitro studies have shown that tobramycin is active against sensitive strains of the following microorganisms: – Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Proteus myxofaciens, Morganella morgani and most strains of Proteus vulgaris, Haemophylus influenzae and H. aeqyptius, Moraxella lacunata, Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species; – Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains; – some Streptococci (resistant strains may occur). In studies of the sensitivity of pathogens, it has been established that in some cases microorganisms resistant to gentamicin are sensitive to tobramycin. A significant population of bacteria resistant to tobramycin has not yet been identified, but with long-term use of this antibiotic, the development of resistance is not excluded. Use in Pediatrics Extensive clinical experience shows that the use of TOBRADEX eye drops in children is safe and effective, but only limited studies have been conducted. During a clinical study using TOBRADEX suspension in the treatment of bacterial conjunctivitis, 29 patients aged 1 to 17 years were instilled with 1 or 2 drops of TOBRADEX every 4-6 hours for 5-7 days. There were no differences in the safety profile between adult and pediatric patients in this study. Pharmacokinetics: When applied topically, TOBRADEX eye drops suspension, systemic absorption of dexamethasone and tobramycin is low.

Indications for use

Adult patients and children aged 2 years and older with corticosteroid-sensitive inflammatory processes in ophthalmology, when the prescription of corticosteroids is indicated and when there is a bacterial eye infection or there is a risk of a bacterial eye infection due to tobramycin-sensitive microorganisms that are resistant to most other antibiotics, especially when infected with Pseudomonas aeruginosa. Corticosteroids in ophthalmology are indicated for inflammatory processes of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eyeball, when the risk of using corticosteroids in certain infectious conjunctivitis to reduce swelling and inflammation is acceptable. Corticosteroids are also indicated for the treatment of chronic anterior uveitis, chemical, radiation or thermal burns of the cornea, and foreign body penetration (taking into account contraindications). Corticosteroid eye drops should only be prescribed after an ophthalmological examination.

Contraindications

Hypersensitivity to the active substance or any of the excipients; herpetic keratitis (dendritic keratitis), vaccine disease, chicken pox and other viral diseases of the cornea and conjunctiva; mycobacterial infections of the eye, fungal diseases of the ocular structures, or untreated parasitic infections of the eyes. TOBRADEX should not be used after uncomplicated removal of a foreign body from the cornea, as well as in case of infections or damage to the surface layer of the corneal epithelium.

Directions for use and dosage

Dosage 1-2 drops into the conjunctival sac every 4 hours. In the first 24–48 hours, the dose can be increased to 1–2 drops every 2 hours. In severe cases, instill 1-2 drops every hour until the infection is controlled, and gradually reduce the frequency of instillations to 1-2 drops every 2 hours for 3 days, then 1-2 drops every 4 hours for 5-8 days and finally, if necessary, 1-2 drops every day for the next 5-8 days. Treatment should not be interrupted suddenly. If several ophthalmic medications are used simultaneously for treatment, an interval of 5 minutes should be observed between their use. If eye ointment is also used for treatment, it should be used last. Pediatric patients TOBRADEX eye drops suspension can be used in children aged 2 years and older in doses similar to adults. There are no data on the safety and effectiveness of the drug in children under 2 years of age. Directions for use: For local use in ophthalmology. After opening the bottle, before using the medicine, remove the tear-off ring, which ensures the first opening control. Shake thoroughly before use. To prevent contamination of the suspension and dropper tip, care should be taken not to touch the eyelids, surrounding areas, or any other surfaces with the dropper tip. After use, keep the bottle tightly closed. Compliance with the following recommendations will help when instilling the drug: WASH YOUR HANDS THOROUGHLY BEFORE INSTALLATION. TILT YOUR HEAD BACK. PULL YOUR LOWER EYELID DOWN AND LOOK UP. PLACE 1-2 DROPS INTO THE SPACE BETWEEN THE EYELID AND THE EYEBALL. DO NOT TOUCH THE TIP OF THE BOTTLE TO YOUR EYELIDS, EYELASHES OR YOUR HANDS. CLOSE YOUR EYE AND BLET IT WITH A DRY COTTON SWAMP. WITHOUT OPENING YOUR EYES, PRESS THE INNER CORNER LIGHTLY FOR 2 MINUTES. THIS WILL INCREASE THE EFFECTIVENESS OF THE DROPS AND REDUCE THE RISK OF SYSTEMIC ADVERSE REACTIONS.

Special warnings and special precautions

Initial prescription of the drug and re-prescription are possible only after examining the patient using ophthalmic instruments such as a slit lamp and, if necessary, fluorescein staining. Long-term and/or uncontrolled use of ophthalmic corticosteroids increases the risk of eye complications and may cause systemic side effects. If the condition caused by the inflammatory process does not improve within the appropriate time frame with therapeutic measures, then other treatment options should be used to reduce the risks. Some patients may develop hypersensitivity to topically applied aminoglycosides. The severity of hypersensitivity reactions can vary from local to general reactions such as erythema, pruritus, urticaria, skin rash, anaphylaxis, anaphylactoid or bullous reactions. If signs of hypersensitivity occur while using this drug, treatment should be discontinued. Topical application of corticosteroids may be accompanied by a decrease in urinary cortisol excretion, as well as a decrease in plasma cortisol concentrations. The use of corticosteroids is associated with suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, and slow growth in children, especially when the drug is used in large doses or during long-term treatment. Cushing's syndrome and adrenal suppression associated with systemic absorption of ophthalmic dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with ritonavir. In these cases, treatment should not be stopped suddenly, but gradually, reducing the dose. Long-term use of corticosteroids can cause increased intraocular pressure and/or the development of glaucoma with damage to the optic nerve, impaired visual acuity and visual field defects, and can also cause the formation of posterior subcapsular cataracts. Patients with a history or family history of glaucoma are at greater risk of increased intraocular pressure caused by corticosteroid use. If these drugs are used for 10 days or more, intraocular pressure should be monitored regularly, although this may be difficult in children and uncooperative patients. In patients with glaucoma, blood pressure should be monitored weekly. The use of corticosteroids can help reduce resistance to bacterial, fungal, viral and parasitic infections and mask their clinical manifestations. TOBRADEX should be used in cases of acute purulent eye infection only when treatment with corticosteroids in combination with an anti-inflammatory agent is necessary. Long-term use may suppress immune responses and thus increase the risk of developing secondary eye infections. The possibility of persistent fungal infection of the cornea after long-term use of corticosteroids must be taken into account. Patients using systemic or topical corticosteroids for other diseases may experience ocular manifestations of herpes simplex. The use of corticosteroids for the treatment of herpes simplex, except in cases of epithelial keratitis caused by the herpes simplex virus, in which they are contraindicated, should be used very carefully; Periodic examination with a slit lamp is necessary. There are known cases of thinning and perforation of the cornea and sclera when using topical corticosteroids. Treatment should not be stopped prematurely, as abrupt discontinuation of antibiotics or corticosteroids may worsen the infection or inflammatory condition. As with other antibiotics, long-term use of the drug can lead to excessive growth of resistant microorganisms. Cross-sensitivity to other aminoglycosides may develop. It is not recommended to wear contact lenses (hard or soft) while treating an eye infection or inflammation. TOBRADEX should not be instilled into eyes that contain contact lenses; Lenses can be put on 15 minutes after using TOBRADEX. In addition, the preservative benzalkonium chloride, which is part of the drug, can cause eye irritation and discolor soft contact lenses. To reduce systemic absorption of the drug after instillation, the following is recommended: • close the eyelids for 2 minutes; • press the inner corner of the eye with your finger for 2 minutes. Pediatric patients Frequent monitoring of intraocular pressure (IOP) is recommended. This is especially important for pediatric patients taking drugs containing dexamethasone, since the risk of increased intraocular pressure in children under 6 years of age due to steroid use is greater and the rate of increase in pressure is higher than in adults. Care should be taken in choosing the frequency and duration of such therapy, and IOP must be monitored from the very beginning of treatment, given that the risk of increased IOP when taking steroids in pediatric patients is higher and an increase in IOP develops earlier.

Interaction with other drugs

Interactions have been observed with systemic use of the active components. However, systemic absorption of torbamycin and dexamethasone when used in ophthalmology is low and the likelihood of interaction is minimal. In patients taking ritonavir, plasma concentrations of dexamethasone may increase.

Pregnancy, breastfeeding

Reproductive function No studies have been conducted on the effects of tobramycin on reproductive function in humans or animals. There are limited clinical data assessing the effects of dexamethasone on male and female reproductive function. Dexamethasone did not cause reproductive side effects in a human chorionic gonadotropin-sensitized rat study. Pregnancy: There are virtually no data on the topical ophthalmic use of tobramycin and dexamethasone in pregnant women. Tobramycin crosses the placental barrier after intravenous administration to pregnant women. Intrauterine ototoxicity caused by tobramycin is not expected. Long-term or repeated use of corticosteroids during pregnancy has been associated with an increased risk of intrauterine growth restriction. Infants born to mothers who received significant doses of corticosteroids during pregnancy should be carefully monitored for signs of hypoadrenalism. Animal studies have shown reproductive toxicity of tobramycin and dexamethasone when administered systemically and dexamethasone when administered topically. The use of TOBRADEX during pregnancy is not recommended. Breastfeeding Tobramycin is excreted into breast milk after systemic administration. There are no data on the excretion of dexamethasone into breast milk. It is unknown whether tobramycin and dexamethasone are excreted into breast milk following topical ophthalmic use. It is unlikely that significant amounts of tobramycin and dexamethasone will be found in breast milk and cause clinical effects in the newborn after topical use of this drug. Since a risk to the breastfeeding child cannot be ruled out, a decision to discontinue breastfeeding or discontinue/withhold treatment must be made taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the woman.

Impact on the ability to drive a vehicle and operate machinery

Like any eye drops, the drug can lead to a temporary decrease in visual acuity and affect the ability to drive a vehicle and operate machinery. If, after using the drug, the patient’s vision clarity is temporarily reduced, until it is restored, it is not recommended to drive a vehicle or engage in activities that require increased attention and reaction.

Adverse reactions

Adverse reactions can develop with the combined use of corticosteroids and antibiotics, and their occurrence may be associated with both the corticosteroid and the antibacterial component. The following adverse reactions are classified by frequency of occurrence: very often (≥1/10), often (≥1/100 to

Overdose

When applied topically, an overdose is unlikely. If excess amounts of TOBRADEX come into contact with the eyes, rinse the eye(s) with warm water. There is no danger of poisoning from accidental ingestion. Treatment for accidental ingestion should be symptomatic and supportive.

Release form

5 ml in a dropper bottle DROPTAINER® made of low-density polyethylene. 1 bottle along with instructions for medical use in a cardboard box.

Storage conditions

At a temperature not exceeding 25°C, out of the reach of children. Do not freeze! Store in an upright position.

Best before date

2 years. Do not use after the expiration date stated on the packaging. Use within 4 weeks after opening the bottle.

Conditions for dispensing from pharmacies

By doctor's prescription.

Buy Tobradex drops hl. susp. (3mg+1mg)/1ml in vial cap. 5ml per pack. No. 1 in pharmacy

Price for Tobradex drops hl. susp. (3mg+1mg)/1ml in vial cap. 5ml per pack. No. 1

Instructions for use for Tobradex drops hl. susp. (3mg+1mg)/1ml in vial cap. 5ml per pack. No. 1

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.