TOBRALIV D [Tobramycin + Dexamethasone] 3 + 1 mg Eye ointment
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instructions for the medical use of the medicinal
product
TOBRALIV D
Tradename: Tobraliv D, Тобралив Д
International non-proprietary name or generic name: dexamethasone + tobramycin, дексаметазон+тобрамицин
Dosage form: eye ointment.
1 g of the medicine
contains:
active
substances: tobramycin 3 mg, dexamethasone 1 mg;
excipients: anhydrous lanolin, chlorobutanol,
soft yellow paraffin.
Pharmacotherapeutic group: Glucocorticosteroid for
topical use + aminoglycoside antibiotic.
Pharmacological
properties
Pharmacodynamics
Combination drug.
Tobramycin is a broad-spectrum antibiotic of the
aminoglycoside group. It disrupts protein synthesis, structure, and
permeability of the cytoplasmic membrane of microbial cells. It is active
against gram-positive and gram-negative microorganisms: staphylococci
(including Staphylococcus aureus and Staphylococcus epidermidis), including
methicillin-resistant strains; streptococci, including some beta-hemolytic
group A species, non-hemolytic species, and some Streptococcus pneumoniae;
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter
spp., Proteus mirabilis, Morganella morganii, Citrobacter spp., Haemophilus
influenzae, Moraxella spp., Acinetobacter spp., and Serratia marcescens.
Dexamethasone is a synthetic fluorinated glucocorticosteroid
(GCS) without mineralocorticoid activity. It has pronounced anti-inflammatory,
antiallergic, and desensitizing effects. Dexamethasone actively suppresses
inflammation by inhibiting the release of inflammatory mediators by
eosinophils, mast cell migration, and reducing capillary permeability and
vasodilation.
Combining GCS with an antibiotic (tobramycin) can
reduce the risk of infection.
Pharmacokinetics
With topical administration, systemic absorption of
dexamethasone is low. The peak plasma concentration of dexamethasone ranges
from 220 to 888 pg/mL. Approximately 77-84% of dexamethasone entering the
systemic circulation is bound to plasma proteins. The half-life is on average
3-4 hours. It is eliminated by metabolism, approximately 60% as 6-β-hydroxydexamethasone
in the urine.
With topical administration, systemic absorption of
tobramycin is low. Plasma tobramycin concentrations are low. The peak plasma
concentration of tobramycin was 247 ng/mL, which is 8 times lower than the
threshold concentration associated with nephrotoxicity. It is excreted by the
kidneys, primarily unchanged.
Indications for use
Inflammatory diseases of the eye and its appendages
caused by pathogens sensitive to the drug:
• blepharitis;
• conjunctivitis;
• keratoconjunctivitis;
• blepharoconjunctivitis;
• keratitis;
• iridocyclitis.
Prevention and treatment of inflammation in the
postoperative period after cataract extraction.
Contraindications
• Viral eye
diseases (including Herpes simplex keratitis, chickenpox);
• Mycobacterial
eye infections;
• Fungal eye
diseases;
• Purulent eye
diseases;
• Conditions
following corneal foreign body removal;
• Children and adolescents
under 18 years of age;
• Individual
hypersensitivity to any of the drug's components
Use with caution
during pregnancy and lactation.
Method of administration and dosage
Topical application. Place a 1.5 cm
strip of ointment into the lower conjunctival sac 3-4 times daily, decreasing
the frequency as inflammation subsides.
Instructions for use
Wash your hands thoroughly before
applying the ointment. To apply the ointment, gently pull down the lower eyelid
and, using gentle pressure on the tube, insert a strip of ointment into the
conjunctival sac. Then slowly release the eyelid and apply pressure with a
cotton swab or cotton ball for 1-2 minutes. Close your eyes for 1-2 minutes.
Special instructions and
precautions
Consult
a physician before using this medication.
If
therapy lasts longer than 2 weeks, corneal function should be monitored.
If
tobramycin is administered topically concurrently with systemic aminoglycoside
antibiotics, a complete blood count should be monitored.
Avoid
touching the tip of the tube to any surface to avoid contamination of the tip
and contents. The tube must be closed after each use.
Influence
on the ability to drive vehicles and mechanisms
If
the patient experiences temporary visual impairment after using the medication,
it is recommended not to drive or engage in activities requiring increased
alertness until visual impairment is restored.
Influence
on the ability to drive vehicles and mechanisms
After
using eye drops, visual acuity may be reduced. Therefore, driving or engaging
in activities requiring increased alertness and rapid psychomotor reactions is
not recommended immediately after instillation.
Side effect
Local reactions: eye discomfort, eye
pain and irritation, hypersensitivity and allergic reactions, increased
intraocular pressure, keratitis (including punctate), conjunctival hyperemia,
itching, eyelid erythema, blurred vision, foreign body sensation, eyelid and
conjunctival edema, dry eye syndrome, increased lacrimation, development of
glaucoma, cataracts, decreased visual acuity, mydriasis, photophobia.
Systemic reactions: headache, dysgeusia,
laryngospasm, rhinorrhea. With prolonged use (more than 24 days) or increased
frequency of steroid instillations, the following may occur: increased
intraocular pressure with possible subsequent development of steroid glaucoma;
posterior subcapsular cataract; delayed wound healing (in diseases causing
corneal thinning, corneal perforation is possible).
Secondary infection. A secondary bacterial
infection may occur as a result of the local immunosuppressant effect of
glucocorticosteroids. Fungal corneal infections tend to occur especially
frequently with long-term use of glucocorticosteroids. The development of
non-healing corneal ulcers after prolonged treatment with glucocorticosteroids
may indicate the development of a fungal infection. In acute purulent eye
infections, glucocorticosteroids may mask or exacerbate an existing infection.
If any of the side effects listed
in the instructions worsen, or you notice any other side effects not listed in
the instructions, notify your doctor.
Interaction with other
medicinal products
In case of
combined use with other local ophthalmic drugs, the interval between their use should
be at least 5 minutes, and eye ointments should be used last.
Symptoms: conjunctival hyperemia, punctate keratitis, erythema, increased
lacrimation, swelling, and itching of the eyelids.
Treatment: Rinse eyes with warm water; treatment is symptomatic.
Storage conditions
Store at temperatures below 30°C.
Keep out of reach of children!
Shelf life
2 years. Do not use after the expiration date printed
on the package.
Vacation conditions
By prescription.
Release form
5 g of ointment in a tube together with instructions for use are packed in a cardboard box.