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Description
The instruction for medical use
of MAKSITROL® medicine
the Trade name
of Maksitrol®
the International unlicensed name
Is not present
the Dosage form
of the Drop eye 5 ml, suspension
Structure
of 1 ml contains
active agents: dexamethasone of 1 mg
of Neomycinum sulfate of 3500 PIECES
of polymyxin In sulfate of 6000 PIECES,
excipients: a benzalkoniya chloride (preservative), sodium chloride, polysorbate 20, a hydroksipropilmetiltsellyuloza of 0.5%, Acidum hydrochloricum and/or sodium hydroxide (for adjustment rn), purified water.
The description
Suspension of white color
Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Dexamethasone in combination with antimicrobial drugs.
The code of automatic telephone exchange S01CA01
the Pharmacological
Kortikoida’s Pharmacokinetics properties are soaked up in watery moisture, a cornea, an iris of the eye, an eye choroid, a ciliary body and a retina. System absorption can arise only in case of use of high doses or at long treatment.
The maximum concentration in watery moisture, a component approximately 30ng/ml, is reached within two hours which decreases during of half an hour till 3 o’clock subsequently.
The pharmacokinetics of Neomycinum is similar to the same antibiotics aminoglycosides. Sulfate polymyxin B absorption through cellular membranes lies in the range from very weak and insignificant before absolute not penetration.
The pharmacodynamics
Dexamethasone renders expressed the anti-inflammatory, antiallergic and desensibilizing action. Dexamethasone – glyukortikosteroid, actively suppresses inflammatory processes, oppressing emission by eosinophils of mediators of inflammation, migration of mast cells and reducing permeability of capillaries. Макситрол® – a dexamethasone combination in combination with antimicrobial drugs.
Neomycinum – an antibiotic from group of aminoglycosides. Neomycinum has bactericidal effect, breaking synthesis of protein in a microbic cell. Possesses a wide range of antibacterial action, it is active concerning gram-positive and gram-negative microorganisms, including St. Aureus, Streptococcus pneumoniae, Escherichia coli, Proteus, Shigella. It is a little effective concerning streptococci and P. Aeruginosa. Does not affect a pathogenic fungi, viruses, anaerobic flora. Resistance of microorganisms to Neomycinum develops slowly and in small degree.
Polymyxin B – an antibiotic of polypeptide structure. The mechanism of action is caused by ability to contact phospholipids of membranes of microbic cells that leads to their destruction. Shigella, Enterobacter, Klebsiella spp., Haemophilus influenzae, Salmonella, Bordetella pertussis is active concerning the majority of gram-negative microorganisms, including Escherichia coli, is especially active concerning P. Aeruginosa, is not active concerning Proteus, Nesseria spp., strict anaerobes and gram-positive bacteria. Virbo cholerae (except for the eltor subtype) and also Coccidioides immitis is sensitive to polymyxin, but generally mushrooms show resistance to this antibiotic. It is one of the most active antibiotics against Pseudomonas aeruginosa.
The dexamethasone combination with antibacterial components (Neomycinum and polymyxin B) allows to reduce risk of development of infectious process.
Indications
– acute and chronic bacterial blepharitis
– conjunctivitis
– a keratitis (without injury of an epithelium)
– iridocyclites
– prevention of postoperative inflammation of front department of an eye.
A route of administration and doses
to Stir up a bottle before the use!
In slow diseases to dig in 1 or 2 drops of drug locally in a konyyuktivalny bag each 4-6 hours. In acute diseases of a drop it is possible to apply each hour, in process of reduction of inflammation to reduce the frequency of instillations to an absolute recovery. It is necessary to be careful at the premature termination of therapy. The course of treatment is defined by the attending physician.
It is not necessary to touch with a pipette tip eyes or any other surface to avoid pollution of contents of a bottle.
After burying the pressing of the lacrimonasal channel or cover is recommended a century. It reduces system absorption and an adverse effect of the medicine which is applied locally through eye tissues.
When using several ophthalmologic drugs of topical administration, it is necessary to observe an interval between burying at least 5 minutes.
Side effects
– allergic reactions
– misting of sight, passing discomfort
– feeling of a foreign body in an eye
– hyperaemia
– the dot keratitis
– lachrymation, an itching
– swelled a century or conjunctivas
At absorption in rare instances can be noted:
– increase in intraocular pressure with the subsequent development of glaucoma, damage of an optic nerve and a field of vision, formation of a back subkapsulyarny cataract.
– delay of process of healing of wounds (in the diseases causing thinning of a cornea or sclera the perforation of a fibrous cover at topical administration of steroid drugs is possible).
– development of consecutive infection, a fungal infection of a cornea at prolonged use of steroids.
Contraindications
– hypersensitivity to any component of drug
– the keratitis caused by the causative agent of herpes
– a treelike keratitis
– a vaccinia
– chicken pox
– fungus diseases of eyes
– tuberculosis of eyes
– uncomplicated removal of a foreign body from a cornea
– the lactation period.
Medicinal interactions
When assigning Maksitrola® together with other local ophthalmologic drugs it is necessary to observe an interval between burying, at least, 5 minutes.
Special instructions
At use of steroids within 10 days and more intraocular pressure has to be controlled and checked by the attending physician regularly. In case of glaucoma, intraocular pressure has to be checked weekly.
Long use of drug can suppress immunity of the patient and, thus, increase danger of developing of consecutive eye infections.
Use in pediatric practice
Currently safety and efficiency of use of drug for children are not established. Need of use of drug for children is defined by the attending physician.
Pregnancy
of Maksitrol® it has to be appointed only when the efficiency of treatment justifies possible risk for a fruit.
Contact lenses
As Maksitrol® contains chloride a benzalkoniya, it is necessary to refrain from carrying soft (hydrophilic) contact lenses, or to delete them during burying. Lenses can be carried in breaks between use of drug and to insert not earlier than in 15 minutes after burying. It is impossible to apply Maksitrol® over contact lenses.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
After burying the temporary illegibility of sight or other visual concerns is possible that it can negatively affect ability to drive the car or other potentially dangerous mechanisms. In this case it is necessary to wait some time before recovery of sight.
Overdose
overdose Cases are not known for this drug.
Clinically defined signs or symptoms of overdose of Maksitrola® (dot keratitis, an erythema, increase in lachrymation, the Eden and naggers of a century) can be similar to signs of undesirable reactions at some patients. At overdose it is necessary to wash out eyes/a eyes plentiful amount of warm water, with further symptomatic treatment at the ophthalmologist.
A form of release and packing
Eye drops of 5 ml, suspension, in bottles from white opaque plastic with Drop-Tainer™ dropper doser. Each bottle together with the instruction for use is packed into a cardboard box.
To Store storage conditions in vertical position at a temperature from +80 to + 300C. To store in places inaccessible for children!
2 years
not to apply a period of storage after an expiration date.
An expiration date after the first opening – 4 weeks at a temperature from +80 to + 300C.
Prescription status
According to the prescription
the Producer
Alcon-Couvreur
of Rijksweg 14, B-2870 Puurs, Belgium
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