The instruction for medical use
of MAKSITROL medicine
the Trade name
Maksitrol
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
Sterile ophthalmologic ointment of 3.5 g
Structure
1 g contains
active agents: dexamethasone of 1 mg
of Neomycinum sulfate of 3500 PIECES
of polymyxin In sulfate of 6000 PIECES,
excipients: methylparaben of 0.05%, propylparaben of 0.01%, anhydrous liquid lanolin, white vaseline.
The description
Fat, homogeneous ointment from white till yellowish color without lumps
Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Dexamethasone in combination with antimicrobial drugs.
The code of automatic telephone exchange S01CA01
the Pharmacological
Pharmacokinetics Maximum Concentration properties of dexamethasone in watery moisture of an eye, a component approximately 30ng/ml, is reached within two hours, subsequently decreases during of half an hour till 3 o'clock.
Dexamethasone to be removed with urine. About 60% of a dose are found in urine in a look 6-β-гидроксидексаметазона.
Neomycinum is soaked up badly, at topical administration absorption insignificant. Sulfate polymyxin B absorption through cellular membranes lies in the range from very weak and insignificant before absolute not penetration.
A pharmacodynamics
Maksitrol – a dexamethasone 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. Vibrio 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.
Dexamethasone – glyukortikosteroid, actively suppresses inflammatory processes, oppressing emission by eosinophils of mediators of inflammation, migration of mast cells and reducing permeability of capillaries, and also has the antiallergic and desensibilizing effect.
The dexamethasone combination with an antibacterial component (Neomycinum and polymyxin B) allows to reduce risk of development of infectious process.
Indications
- sharp and chronic bacterial blefarit
- conjunctivitis
- a keratitis (without injury of an epithelium)
- iridocyclites
- prevention of postoperative inflammation of front department of an eye.
The route of administration and doses
an ointment Strip 1-1.5sm is put by length for a lower eyelid of the affected eye 3-4 times a day or in addition to drops before going to bed.
It is necessary to be careful at the premature termination of therapy.
It is not necessary to touch with a tuba tip tip eyes or any other surface to avoid pollution of contents of a tuba.
At local use of several ophthalmologic drugs, it is necessary to observe an interval between use of drugs from 10 to 15 minutes. Ointment to be applied in the last turn.
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 prolonged use 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 viral 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
At local use of several ophthalmologic drugs, it is necessary to observe an interval between use of drugs from 10 to 15 minutes.
Special instructions
At use of steroids within 10 days and more intraocular pressure has to be controlled and checked regularly at children and at the patients who are not visiting the doctor. In case of glaucoma, intraocular pressure has to be checked weekly.
Long use can suppress an immune response of an organism of the patient and, thus, increase danger of development of consecutive eye infections.
Pregnancy
Maksitrol has to be appointed only when the efficiency of treatment justifies possible risk for a fruit.
Contact lenses
for treatment by Maksitrol ointment it is necessary to refrain from carrying soft (hydrophilic) contact lenses, or to delete them during drawing. Lenses can be carried in breaks between use of drug and to insert not earlier than in 15 minutes after ointment use. 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 drawing can arise temporary illegibility of sight or other visual concerns that 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
it is not known of cases of overdose of this drug.
Some patients can have similar to signs of undesirable reactions clinically defined signs or symptoms of overdose of Maksitrol (dot keratitis, an erythema, increase in dacryagogue, the Eden and naggers of a century).
At overdose the treatment has to be symptomatic and supporting, it is necessary to wash out eyes/a eyes plentiful amount of warm water.
A form of release and packing
the Aluminium tuba on 3.5 g covered epoxide - a phenolic covering with a polyethylene tip and a polyethylene cover.
Each tuba together with the instruction for use is packed into a cardboard box.
To Store storage conditions at a temperature from +80 to + 300C.
To store in places inaccessible for children!
4 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
of MAKSITROL medicine
the Trade name
Maksitrol
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
Sterile ophthalmologic ointment of 3.5 g
Structure
1 g contains
active agents: dexamethasone of 1 mg
of Neomycinum sulfate of 3500 PIECES
of polymyxin In sulfate of 6000 PIECES,
excipients: methylparaben of 0.05%, propylparaben of 0.01%, anhydrous liquid lanolin, white vaseline.
The description
Fat, homogeneous ointment from white till yellowish color without lumps
Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Dexamethasone in combination with antimicrobial drugs.
The code of automatic telephone exchange S01CA01
the Pharmacological
Pharmacokinetics Maximum Concentration properties of dexamethasone in watery moisture of an eye, a component approximately 30ng/ml, is reached within two hours, subsequently decreases during of half an hour till 3 o'clock.
Dexamethasone to be removed with urine. About 60% of a dose are found in urine in a look 6-β-гидроксидексаметазона.
Neomycinum is soaked up badly, at topical administration absorption insignificant. Sulfate polymyxin B absorption through cellular membranes lies in the range from very weak and insignificant before absolute not penetration.
A pharmacodynamics
Maksitrol – a dexamethasone 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. Vibrio 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.
Dexamethasone – glyukortikosteroid, actively suppresses inflammatory processes, oppressing emission by eosinophils of mediators of inflammation, migration of mast cells and reducing permeability of capillaries, and also has the antiallergic and desensibilizing effect.
The dexamethasone combination with an antibacterial component (Neomycinum and polymyxin B) allows to reduce risk of development of infectious process.
Indications
- sharp and chronic bacterial blefarit
- conjunctivitis
- a keratitis (without injury of an epithelium)
- iridocyclites
- prevention of postoperative inflammation of front department of an eye.
The route of administration and doses
an ointment Strip 1-1.5sm is put by length for a lower eyelid of the affected eye 3-4 times a day or in addition to drops before going to bed.
It is necessary to be careful at the premature termination of therapy.
It is not necessary to touch with a tuba tip tip eyes or any other surface to avoid pollution of contents of a tuba.
At local use of several ophthalmologic drugs, it is necessary to observe an interval between use of drugs from 10 to 15 minutes. Ointment to be applied in the last turn.
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 prolonged use 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 viral 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
At local use of several ophthalmologic drugs, it is necessary to observe an interval between use of drugs from 10 to 15 minutes.
Special instructions
At use of steroids within 10 days and more intraocular pressure has to be controlled and checked regularly at children and at the patients who are not visiting the doctor. In case of glaucoma, intraocular pressure has to be checked weekly.
Long use can suppress an immune response of an organism of the patient and, thus, increase danger of development of consecutive eye infections.
Pregnancy
Maksitrol has to be appointed only when the efficiency of treatment justifies possible risk for a fruit.
Contact lenses
for treatment by Maksitrol ointment it is necessary to refrain from carrying soft (hydrophilic) contact lenses, or to delete them during drawing. Lenses can be carried in breaks between use of drug and to insert not earlier than in 15 minutes after ointment use. 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 drawing can arise temporary illegibility of sight or other visual concerns that 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
it is not known of cases of overdose of this drug.
Some patients can have similar to signs of undesirable reactions clinically defined signs or symptoms of overdose of Maksitrol (dot keratitis, an erythema, increase in dacryagogue, the Eden and naggers of a century).
At overdose the treatment has to be symptomatic and supporting, it is necessary to wash out eyes/a eyes plentiful amount of warm water.
A form of release and packing
the Aluminium tuba on 3.5 g covered epoxide - a phenolic covering with a polyethylene tip and a polyethylene cover.
Each tuba together with the instruction for use is packed into a cardboard box.
To Store storage conditions at a temperature from +80 to + 300C.
To store in places inaccessible for children!
4 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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