Tobrinext eye ointment 3 mg/g tube-cannula 5 g

Instructions Tobrinext eye ointment 3 mg/g tube-cannula 5 g

Composition

active ingredient: tobramycin;

1 g of ointment contains tobramycin sulfate, which is equivalent to tobramycin 3 mg;

excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), liquid paraffin, white soft paraffin.

Dosage form

Eye ointment.

Main physicochemical properties: ointment with a homogeneous consistency from white to pale yellow.

Pharmacotherapeutic group

Means used in ophthalmology. Antimicrobial agents. Antibiotics.

ATX code S01A A12.

Pharmacological properties

Pharmacodynamics.

Tobramycin is a fast-acting bactericidal antibiotic from the aminoglycoside group. It acts on bacterial cells by inhibiting the polypeptide complex and synthesis in ribosomes.

Resistance to tobramycin occurs through several different mechanisms, including alterations in the ribosomal subunits in the bacterial cell, impaired transport of tobramycin into the cell, and inactivation of tobramycin by a group of adenylating, phosphorylating, and acetylating enzymes. The genetic information for the production of inactivating enzymes can be carried in bacterial chromosomes or plasmids. Cross-resistance to other aminoglycosides is possible.

The following breakpoints and in vitro activity spectrum are based on systemic administration. These values may not be applicable when the medicinal product is administered topically to the eye, as higher concentrations are achieved with topical administration and local physical/chemical conditions may affect the activity of the medicinal product at the site of administration. According to the European Committee on Antibiotic Susceptibility Testing (EUCAST), the following breakpoints have been established for tobramycin:

Enterobacteriaceae S ≤ 2 mg/l, R > 4 mg/l,

Pseudomonas spp. S ≤ 4 mg/l, R > 4 mg/l,

Acinetobacter spp. S ≤ 4 mg/l, R > 4 mg/l,

Staphylococcus spp. S ≤ 1 mg/l, R > 1 mg/l,

Non-species-specific S ≤ 2 mg/l, R > 4 mg/l.

The information below provides an indication of whether microorganisms will be susceptible to tobramycin ophthalmic ointment. The instructions only list the types of bacteria that commonly cause external eye infections, such as conjunctivitis.

The prevalence of acquired resistance may vary geographically and over time for the relevant species of micro-organisms, therefore it is advisable to have local information on the resistance of microorganisms, especially when treating severe infections. As necessary, specialist advice should be sought if the local prevalence of resistance is such that the activity of tobramycin, at least against some species of infections, is questionable.

* resistance is more than 50%.

Children

Analysis of clinical trial data using tobramycin eye drops or ointment for the treatment of bacterial conjunctivitis, blepharitis, or blepharoconjunctivitis in children aged 1 to 18 years showed that the overall safety profile in children was similar to that in adults. It is not recommended for use in children under 1 year of age due to insufficient data.

Pharmacokinetics.

The absorption of tobramycin through the corneal and conjunctival tissues is quite low, so minimal amounts of tobramycin are absorbed into the eye after topical ophthalmic administration. Tobramycin is rapidly and extensively excreted in the urine by glomerular filtration, mainly unchanged. The plasma half-life is approximately 2 hours with a clearance of 0.04 L/h/kg and a volume of distribution of 0.26 L/kg. Plasma protein binding of tobramycin is negligible (less than 10%). Oral bioavailability of tobramycin is low (

Indication

Treatment of external infections of the eye and surrounding tissues caused by pathogenic microorganisms sensitive to tobramycin.

Contraindication

Hypersensitivity to the active substance or to any of the components of the drug.

Interaction with other medicinal products and other types of interactions

No appropriate interaction studies have been performed. There have been reports of interactions with other drugs following systemic administration of tobramycin. However, systemic absorption of tobramycin following topical administration is so low that the risk of any interaction is minimal.

In the case of simultaneous topical application of several ophthalmic drugs, an interval of at least 5 minutes must be observed between the use of drugs.

Eye ointments should be applied last.

Application features

The drug is intended for ophthalmic use only.

Some patients may develop sensitivity to topical aminoglycosides. The severity of the hypersensitivity reaction may range from local effects to generalized reactions such as erythema, pruritus, urticaria, skin rashes, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity occurs during treatment with this drug, the drug and other drugs being used should be discontinued.

Cross-sensitivity to other aminoglycosides may occur. It should also be considered that patients sensitive to topically administered tobramycin may also be sensitive to other topical and/or systemic aminoglycosides.

Serious adverse reactions, including neurotoxicity, ototoxicity, and nephrotoxicity, have occurred in patients receiving systemic tobramycin. Caution is advised when tobramycin is administered concomitantly with topical or systemic aminoglycosides.

As with other antibiotics, prolonged use of Tobrocym-Next may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.

It is not recommended to wear contact lenses during the treatment of infectious eye diseases.

Using eye ointment may slow the healing of corneal wounds.

This medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding

Reproductive function

Studies evaluating the effects of tobramycin on human reproductive function when used topically have not been conducted.

Pregnancy

There are no or very limited data from the use of topical ocular tobramycin in pregnant women.

Animal studies have shown toxic effects on reproductive function.

Tobrocym-Next is not recommended for use during pregnancy.

Breastfeeding period

It is not known whether tobramycin is excreted in human milk after topical administration. Tobramycin is excreted in human milk after systemic administration. It is unlikely that tobramycin will be excreted in human milk after topical administration or that it will cause clinical effects in the newborn. However, a risk to the breastfed infant cannot be excluded. Consideration should be given to temporarily discontinuing breast-feeding during treatment with tobramycin or to discontinuing/abstaining from therapy, taking into account the benefit/risk ratio.

Ability to influence reaction speed when driving vehicles or other mechanisms

There is no or negligible influence on the ability to drive or use machines during the use of Tobrocym-Next. Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs during the use of the ointment, the patient should wait until the vision clears before driving or using machines.

Method of administration and doses

Dosage

For mild to moderate disease, it is recommended to apply a small amount of the drug (a strip 1.5 cm long) into the conjunctival sac(s) of the affected eye(s) 2 or 3 times a day.

In severe cases, it is recommended to apply a small amount of the drug (a strip 1.5 cm long) into the conjunctival sac(s) of the affected eye(s) every 3-4 hours for the first 2 days and then 2-3 times a day until complete recovery.

As with other antibiotics, appropriate monitoring of bacterial susceptibility to the drug is necessary.

Treatment usually lasts 7–10 days.

It is recommended to carefully close the eyelids and lightly press on the nasolacrimal duct area; this will reduce the systemic absorption of medications administered into the eye, which reduces the likelihood of systemic side effects.

Patients with impaired liver and kidney function

There are no data on the use of ophthalmic preparations containing tobramycin in this group of patients. However, due to the low systemic absorption of tobramycin when the drug is applied topically, no dose adjustment is necessary.

Method of administration and doses.

To prevent contamination of the tip and contents of the tube, care should be taken not to touch the eyelids, surrounding areas, or other surfaces with the tip of the tube. The tube should be closed immediately after use.

Children.

Tobrocym-Next can be used in children aged 1 year and above at the same dosage as in adults. However, information on the use of the drug in pediatrics is limited (see section "Pharmacodynamics"). Safety and efficacy in children under 1 year of age have not been established.

Overdose

In case of overdose with the drug during topical application, wash the excess drug from the eye(s) with warm water.

Given the characteristics of this drug, no serious toxic reactions are expected in case of overdose after application to the eye(s) or in case of accidental ingestion of the contents of the tube.

Clinical manifestations of drug overdose resemble side effects observed in some patients: punctate keratitis, erythema, increased lacrimation, edema and itching of the eyelids.

Adverse reactions

The most common adverse reactions associated with the use of the drug are ocular hyperemia and ocular discomfort, which occurred in approximately 1.4% and 1.2% of patients, respectively.

Adverse reactions were classified as follows: very common (≥ 1/10), common (≥ 1/100,

Within each group, side effects are presented in order of decreasing severity.

The following additional adverse reactions have been identified during post-marketing surveillance. Based on the available data, it is not possible to estimate their frequency.

Description of some adverse reactions

Some patients may be sensitive to topical aminoglycosides (see section "Special warnings and precautions for use").

· Patients receiving systemic tobramycin have experienced serious adverse reactions, including neurotoxicity, ototoxicity, and nephrotoxicity (see section 4.4).

Expiration date

3 years.

After first opening, store for 28 days at a temperature not exceeding 25 ºС.

Storage conditions

Store in original packaging, protected from light, at a temperature not exceeding

25 °C. Keep out of reach of children.

Packaging

5 g of ointment in an aluminum foil tube with a cannula and a plastic screw cap; 1 tube in a cardboard box.

Vacation category

According to the recipe.

Producer

BALKANPHARMA-RAZGRAD AD/BALKANPHARMA-RAZGRAD AD.

Location of the manufacturer and address of its place of business

Blvd. Aprilsko vastanie 68, Razgrad 7200, Bulgaria/68 Aprilsko vastanie Blvd., Razgrad 7200, Bulgaria.