Dexatobropt eye drops 5ml

Instruction for Dexatobropt

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Composition and form of release

Eye drops Dexatobropt contains 2 main components: tobramycin, dexamethasone. They look like a white suspension. May have a precipitate that dissolves quickly if the bottle is shaken. In addition to the main substances that endow the drug with medicinal properties, the composition contains additional components:
    purified water;
    tyloxapol;
    hypromellose;
    disodium edetate dihydrate;
    sodium chloride;
    sodium hydroxide solution;
    benzalkonium chloride.
The suspension is poured into 5 ml vials made of polymeric material. Vials are sealed in cardboard packaging with instructions for use. The drug is produced by the Romanian company "Rompharm".

Pharmacological action of Dexatobropt drops

Eye drops are a combined preparation that has anti-inflammatory, antibacterial effects. Tobramycin is a broad-spectrum antibacterial agent. It belongs to aminoglycosides by group. The mechanism of action in violation of the permeability of the cytoplasmic membrane of a pathogenic microorganism, violation of protein synthesis. They have a detrimental effect on many gram-positive, gram-negative pathogens, such as streptococci, staphylococci, including strains that do not respond to penicillin. The antibiotic also destroys:
    escherichia;
    pseudomonas;
    klebsiella;
    enterobacteria;
    morganella, etc.
Dexamethasone is the second active ingredient in drops. Glucocorticosteroid, which has anti-inflammatory, desensitizing, anti-allergic effects. It is a derivative of fluorine-prednisolone. Anti-inflammatory action is associated with:
    inhibition of the synthesis and release of inflammatory mediators into the blood;
    a decrease in the number of mast cells;
    a decrease in the permeability of the walls of blood vessels;
    by stimulating the release of lipocortins.
In case of inflammation, it acts on all stages of its development. The antiallergic effect is due to the suppression of the synthesis, the release of substances involved in allergic reactions. And also a decrease in the level of biologically active substances, basophils, mast cells, etc. Dexamethasone has no mineralocorticoid activity.

Pharmacokinetics

After instillation, dexamethasone enters the systemic circulation in extremely small quantities. Its maximum level in the liquid part of the blood when instilled in 1 drop 4 times a day for 48 hours is no more than 888 pg / ml. Approximately 80% of the glucocorticosteroid that enters the bloodstream binds to plasma proteins. About 60% is excreted from the body by the kidneys in the urine in 3-4 hours.
After instillations, tobramycin also enters the general bloodstream in a small amount. Its level in the liquid part of the blood after instilling 1 drop into each eye 4 times a day for 48 hours was below the level that can be detected - 247 pg / ml. This level is below the threshold that causes nephrotoxicity. Tobramycin is excreted by the kidneys in the urine, does not form metabolites, therefore it is excreted unchanged.

Indications for the use of Dexatobropt drops

The drug is prescribed for inflammatory processes in the organ of vision, including its appendages for diseases associated with flora sensitive to active substances:
    conjunctivitis;
    keratoconjunctivitis;
    keratitis;
    iridocyclitis;
    blepharoconjunctivitis;
    blepharitis.
The suspension can be instilled to prevent inflammatory processes after surgical procedures for cataracts.

Instructions for use, dosage

Before using drops, shake the bottle, as a precipitate may form. After each use, close the bottle tightly so that the suspension does not get dirty. It is not recommended to touch the drop dispenser to eyelashes, eyelids, skin or touch it with your hands so that pathogenic flora does not get into the solution.
Before use, it is advisable to warm the suspension in your hands in order to eliminate the discomfort from the instillation of a cold solution. The active components of the drug enter the systemic circulation. To reduce the likelihood of systemic side effects, it is recommended to apply light pressure to the area of ​​the lacrimal sacs - the inner corner of the eye. Press down for 1-2 minutes.
The standard dosage for adults, adolescents over 15 years old is 1-2 drops into the conjunctival sac of the sore eye (under the eyelid), repeat the procedure after 4-6 hours. In the first 2 days of treatment, it is allowed to drip 2 drops every 2 hours until the symptoms of acute inflammation subside, as the severity of symptoms decreases, the number of instillations is reduced to a standard rate.

Dosage for severe infectious processes

Instill 1-2 drops every hour, as the acute symptoms subside, they switch to repeating the procedures every 2 hours. The dosage is usually reduced by 3-4 days of treatment. On days 5-8, instillation is repeated every 4 hours. The duration of the course of treatment is determined by the doctor.

Application after surgery

After cataract extraction, the drug is started to be instilled a day before surgery 4 times a day, 1 drop, on the day of surgery 1 drop a day, after surgery, also 1 drop 4 times a day for three weeks. On the recommendation of a doctor, the number of drops, the frequency can be increased

Contraindications to the use of Dexatobropt drops

Ophthalmic suspension has a number of restrictions on its use:
    superficial forms of keratitis, including treelike;
    vaccination;
    viral infections of the cornea, conjunctiva;
    mycobacterial infections of the organ of vision;
    parasitic diseases affecting the eyes;
    age under 15;
    fungal eye diseases;
    increased susceptibility, intolerance to the components in the suspension;
    breast-feeding;
    acute purulent processes in the organ of vision without concomitant treatment;
    defects of the corneal epithelium, including the condition after removal of a foreign body.
During pregnancy, deep stromal keratitis, the drug is used with caution.

Side effects

Negative manifestations while taking the drug have been found in people taking the drug and during research. Possible side effects from the eyes:
    pain, itching, irritation;
    feelings of discomfort when blinking;
    increased intraocular pressure;
    blurred vision or blurred vision;
    dry eyes;
    redness, swelling of the conjunctiva;
    swelling, erythema of the eyelids,
    lacrimation;
    dilated pupil.
Side effects from other organs and systems can be:
    headache;
    dizziness;
    an increase in the amount of discharge from the nasal cavity ;;
    nausea;
    discomfort in the stomach;
    skin rash;
    swelling of the face;
    itchy skin;
    laryngeal spasm.
Negative manifestations from the immune system can manifest as hypersensitive, anaphylactic reactions.

Overdose

The appearance of symptoms of an overdose, signs of intoxication with local use is extremely rare. The likelihood of their occurrence is small even with accidental drinking of the drug. Symptoms can manifest as side effects of varying severity. If an excess amount of drops has been dropped into the conjunctival sac, it is necessary to rinse the eyes with plain water. When swallowed, therapeutic measures, a group of drugs depend on the side symptoms and their severity.

Application in pregnant women, lactating

High dosages of antibiotics from the aminoglycoside group, to which the active ingredient of Dexatobropt drops belongs, can have a negative effect on the hearing organ. When applied locally - by instillation in the eyes, the systemic concentration of the drug is extremely low, and does not show a toxic effect on reproductive function. In studies on pregnant animals, it was concluded that fetal malformation is possible, but the percentage of probability has not been established.
In a study on animals, data were obtained that with the local application of drops, the development of cardiovascular diseases, metabolic disorders, mental, physical development is possible. There is no data on the effect of the drug during pregnancy in humans. Therefore, the drug is prescribed with extreme caution.
It is known that tobramycin passes into breast milk when taken orally, there is no information about dexamethasone.
There is no exact data confirming the entry of active ingredients into breast milk after instillation into the eyes. But it is impossible to completely exclude the risk for the baby, therefore, when treating with drops from breastfeeding, it is better to refuse and transfer the newborn to artificial feeding, to express milk, to preserve lactation. Resume feeding after the end of the course of instillations.

Special instructions

As part of the drug, dexamethasone, banned by the World Anti-Doping Agency, as it can give a positive reaction to doping. This fact must be taken into account by athletes who use Dexatobropt before competition. The drug is intended for instillation into the eyes, you cannot drink. When using the product for more than 10 days, it is necessary to control the intraocular pressure.
When used together with systemic aminoglycosides, it is necessary to control the level of tobramycin in the blood serum. In case of side effects, stop using the drug. The composition contains a preservative in the form of benzalkonium chloride, which can irritate the eyes and negatively affect soft lenses. Before use, any lenses are removed before instillation, put on after 20 minutes.
During the period of treatment, it is not forbidden to drive vehicles, to perform work that requires clear vision. However, after instillation, a temporary decrease in vision clarity is possible. If there is thinning of the cornea, caution is needed, the use of glucocorticosteroids may cause its perforation. It is necessary to monitor the state of the cornea during long-term treatment.

Additional Information

Before instillation, you must read the instructions, the dosage of the drug, and consult a doctor.

Drug interaction

If you combine Dexatobropt with ophthalmic non-steroidal anti-inflammatory drugs, it is possible to increase the negative effect on the healing processes of corneal tissues. With concomitant administration of Ritonavir, the level of dexamethasone may increase in the liquid part of the blood. The manufacturer indicates that there have been cases of severe side effects, including toxic effects on the hearing organ, kidneys, brain with systemic use of aminoglycosides (which include tobramycin in the composition), this must be taken into account when they are used simultaneously.
Experts recommend observing the interval between instillations of 20 minutes if complex treatment is prescribed using other drops. When using eye ointments, they are laid last, as they form a film on the eye, which prevents the absorption of solutions.

Storage conditions

You can buy drops at the pharmacy only with a doctor's prescription. Store drops at a temperature not exceeding 25 ° C, away from children, direct sunlight. The duration of the preservation of the therapeutic effect is 3 years from the date of issue indicated on the package. After its completion, Dexatobropt must be disposed of. After opening the bottle, instillations can be carried out within 1 month.

Reviews

Matvey, 32 years old
The optometrist prescribed Dexatobropt drops for blepharitis of the left eye. What is the reason for the inflammation, I do not know, the eye began to turn red, the eyelid was swollen, it hurt. In the morning it was hard to open the eye due to puffiness, purulent discharge that glued the eye. I dripped on the first day every 2 hours, then after 4. By the end of the week, the swelling almost subsided, the amount of discharge decreased markedly. The signs of the disease disappeared in 2 weeks.
Alexander, 29 years old
At work, dirt got into the eyes, there was no time to rinse them right away. In the evening I washed my eyes with chamomile, in the morning they turned red, were very watery, washed again with chamomile. After 2 days, some yellowish liquid began to stand out, pain appeared. The ophthalmologist said bacterial conjunctivitis, prescribed Dexatobropt, drip for 1.5 weeks. Redness, the amount of discharge from the eye decreased on the third day. The conjunctivitis cleared up in 12 days.

Terms of sell

You don't need a prescription to buy Dexatobropt.