Trade name
DeksaTobr
the International unlicensed name
Is not present
the Dosage form
Eye drops, the sterilnayasuspenziya
Structure
of 1 ml of drug contains
active agents: Tobramycinum of 3 mg
dexamethasone of 1 mg,
excipients: sodium edetat a dihydrate, a benzalkoniya chloride, natriyakhlorid, sodium sulfate anhydrous, tiloksapol, the hydroxyethylcellulose, sulphuric acid, water purified.
The description
Suspension, is possible presence of a deposit which quickly dissipates at a legkomvzbaltyvaniye
Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Dexamethasone in a combination with antimicrobial drug.
The code of automatic telephone exchange S01CA01
the Pharmacological
Pharmacokinetics Dexamethasone properties is quickly absorbed in an anterior chamber of an eye, including a cornea, a conjunctiva, watery moisture and a crystalline lens. Maksimalnoyedeystviye is reached through 10-20minut from the moment of instillyatsiioftalmologichesky solution, in 30 minutes dexamethasone is defined a blood vplazma, a gall bladder, a liver and kidneys, urine. System absorption of dexamethasone of posttopical administration of DeksaTobrom low. Level maximum koncentratsiiv to blood plasma fluctuates from 220 to 888 pg/ml (on average 555±217пг/мл) after instillation 1 drop of DeksaTobrom in each eye 4 razav day within 2 days. About 60% absorbed a dozydeksametazon are removed with urine in the form of 6-v-hydrogideksametazona. Not changed dexamethasone in urine is not revealed. Elimination half-life of an izplazma of blood rather short — 3–4 h Deksametazonpriblizitelno for 77–84% contacts blood plasma albumine. The clearance fluctuates from 0.111 to 0.225 l/h/kg, and an objemraspredeleniya — from 0.576 to 1.15 l/kg.
Tobramycinum passes vvodyanisty moisture in very small quantities, is systemically absorbed. System absorption to a tobramitsinaposla of topical ophthalmologic administration low. Levels of a koncentratsiitobramitsin in blood plasma did not give in to a quantitative opredeleniyu of 75% of patients to whom dug in eye drops of DeksaTobromv each eye 4 times a day within 2 days. Naivysshiyizmerenny level was 0.25 mkg/ml, what is 8 times lower, a chemkoncentration of 2 mkg/ml which is below limit of risk of a vozniknoveniyanefrotoksichnost. Slightly (less than 10%) contacts proteins of a plazmykrova.
ekskretiruyetsyav I wet Tobramycinum in not changed state by means of mainly glomerular filtration. Periodpoluvyvedeniya makes about 2 h of blood plasma (with klirensom0.04 l/h/kg and of distribution of 0.26 l/kg).
A pharmacodynamics
the Combined drug with antibacterial iprotivovospalitelny action for topical administration in ophthalmology.
Dexamethasone - a synthetic glucocorticosteroid which sostavmolekula include fluorine atom. Has the vyrazhennoyeprotivovospalitelny, antiallergic and desensibilizing effect, an atakzha antishock and anti-toxic action, possesses an immunodepressivnoyaktivnost. These effects are connected with oppression of release of eozinofilamimediator of inflammation, induction of formation of lipokortin and umensheniyakolichestvo of the mast cells producing hyaluronic acid from an umensheniyempronitsayemost of capillaries, stabilization of cellular membranes (osobennolizosomalny) and membranes of organellas. Immunosuppressive effect obuslovlentormozheniye of release of tsitokinin (interleukin 1.2, gamma interferon) of izlimfotsit and macrophages. The main influence on a metabolism is connected by a protein skatabolizm, increase in a gluconeogenesis in a liver and decrease in a utilizatsiiglyukoza peripheral fabrics. Slightly detains sodium and water in an organism. Not obladayetmineralokortikoidny activity.
Dexamethasone suppresses activity of vitamin D that leads to decrease in absorption of calcium an iuvelicheniya of its removal, also podavlyaetsintez and secretion of adrenocorticotropic hormone (AKTG) and again — sintezendogenny glucocorticosteroids.
Tobramycinum - an antibiotic of a broad spectrum of activity from gruppyaminoglikozid. It is active in the relation grampolozhitelnykhcorynebacterium, Listeria monocytogenes, Staphylococcus aureus and grammotritsatelnykhacinobacter, Branhamella, Campylobacter, Citrobacter freundii, C. koseri, Enterobacter aerogenes, Enterobacter cloacae, E. coli, H. influenzae, Klebsiella, Morganella morganii, proteus mirabilis, Proteusvulgaris, Pseudomonas aeruginosa, Salmonella, Serratia, Shigella, Yersiniabaktery and also some types of Neisseriaspp.
Indications
- infectious diseases of eyes, including conjunctivitis, blepharitis,
the keratitis (without injury of an epithelium)
treatment and prevention of postoperative infections of a voftalmokhirurgiya blefarokonjyunktivit.
The idose route of administration
Drug is intended only for an oftalmologicheskogoprimeneniye.
Before burying carefully wash up hands.
Before use the bottle should be stirred up well.
Use for teenagers and adults, including lyudeypozhily age.
Drug is dug in on 1-2 drops in conjunctival a meshokporazhenny eye (or an eye) in each 4-6 h. During the first 24–48 chdoza it is possible to raise to one or two drops each 2 h Chastotuprimeneniya of drug it is necessary to reduce gradually at improvement of a klinicheskoykartina. Duration of treatment is no more than 14 days.
For treatment and prevention of postoperative infektsiynaznachat on 1 drop 4 times a day, beginning from a dnyaoperation and continuing within 14 days.
After instillation it is recommended to close densely glaza to carry out occlusion of the lacrimonasal channel. It reduces system the absorbtsiyupreparat and risk of development of system side effects.
To prevent pollution of a tip of a kapelnitsya of suspension, it is necessary to avoid contact a century or others a bottle dropper poverkhnosteykonchik.
Close a bottle after the use.
When using the drug DeksaTobrom in a combination sdrugy ophthalmologic drops, keep the minimum interval of 15 minutmezhda burying.
If you forgot to dig one dose, its instilliruyta as mozhnobystry. Do not use a double dose of the dlyakompensation forgotten.
Side effects
local allergic reactions: hypostasis and an itching a century, a conjunctival erythema, hyperaemia of eyes, a dot keratitis, a povyshennoyeslezootdeleniye, temporary burning or pricking after burying
the increase in intraocular pressure (at a dlitelnomprimeneniya)
is possible: cornea mycoses at constant use in techeniyeboly 3 months
delay of processes of regeneration.
Contraindications
the epithelial keratitis caused by Herpes simplex (drevovidnyykeratit)
viral diseases of a cornea and conjunctiva (including in chicken pox)
mikobakterialny infections of eyes
fungus diseases of eyes
acute forms of purulent infections of eyes (at otsutstviiantibakterialny therapy)
hypersensitivity to any component of drug.
Drug is not appointed after uncomplicated removal of an inorodnogotel from a cornea.
Medicinal interactions
are not established.
The special
instructions DeksaTobrom it is intended only for topical administration.
At use of the drugs containing GKS (glucocorticosteroids), more than 10 days should be measured regularly a vnutriglaznoyedavleniye.
When prescribing the drug DeksaTobrom, along with an antibiotikamigruppa of aminoglycosides for system use, it is necessary to control a koncentratsiyutobramitsin in blood serum.
The benzalkoniya chloride (preservative) which can be laid for surfaces of soft contact lenses is a part of drug, poetomulinza need to be removed in 15 minutes prior to burying, their carrying perhaps not raneechy in 15 minutes after burying.
In the presence of diseases which privodyatk to thinning of a cornea or a sclera, topical administration steroidovmozht to cause perforation.
In a herpes simplex the rasprostraneniyeprocessa can be observed.
At development of allergic reactions the use preparatasledut to stop.
Use in pediatrics
At the moment safety and efficiency of the primeneniyapreparat at children are not established.
Pregnancy and lactation
of Sufficient experience on use of drug in a vremyaberemennost, a breast and children have no feeding. DeksaTobrom's use during pregnancy vozmozhnotolko on doctor's orders, if the prevyshayetpotentsialny risk expected effect of therapy for a fruit.
For the period of treatment it is necessary to stop a grudnoyevskarmlivaniye.
Influence of medicine on ability upravlyattransportny means or potentially dangerous mechanisms
to Patients who have after applique temporarily a sight teryaetsyachetkost is not recommended to drive or work with slozhnoytekhniky right after burying drug.
Overdose
Overdose at ophthalmologic an upotrebleniimaloveroyatna. Now about cases of overdose of the drug DeksaTobromne it was reported.
Overdose symptoms: strengthening collateral deystviypreparat.
Treatment: to wash eyes a large number with warm water.
Release form iupakovka
Eye drops, sterilnayasuspenziya of 0.1% of dexamethasone and 0.3% of Tobramycinum.
On 5 ml in a white bottle from polyethylene with a stopper dropper and the screwing-up protective cap supplied with a safety ring.
1 bottle together with the instruction for use in a kartonnoypachka.
To Store storage conditions at a temperature + 15-250C in original packing.
To store out of children's reach!
A period of storage
3 years
do not use drug after the expiry date specified on packing.
After opening the bottle should be stored in the fridge within 28 days.
Prescription status
According to the prescription
of Proizvoditel Romfarm Company of S.R. L.,
Romania Eroilor St. 1A, Otopen.
ph. +40 21 208 9743, +40 21 208 97 42, fax: +40 21 266 49 38
To develop
DeksaTobr
the International unlicensed name
Is not present
the Dosage form
Eye drops, the sterilnayasuspenziya
Structure
of 1 ml of drug contains
active agents: Tobramycinum of 3 mg
dexamethasone of 1 mg,
excipients: sodium edetat a dihydrate, a benzalkoniya chloride, natriyakhlorid, sodium sulfate anhydrous, tiloksapol, the hydroxyethylcellulose, sulphuric acid, water purified.
The description
Suspension, is possible presence of a deposit which quickly dissipates at a legkomvzbaltyvaniye
Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Dexamethasone in a combination with antimicrobial drug.
The code of automatic telephone exchange S01CA01
the Pharmacological
Pharmacokinetics Dexamethasone properties is quickly absorbed in an anterior chamber of an eye, including a cornea, a conjunctiva, watery moisture and a crystalline lens. Maksimalnoyedeystviye is reached through 10-20minut from the moment of instillyatsiioftalmologichesky solution, in 30 minutes dexamethasone is defined a blood vplazma, a gall bladder, a liver and kidneys, urine. System absorption of dexamethasone of posttopical administration of DeksaTobrom low. Level maximum koncentratsiiv to blood plasma fluctuates from 220 to 888 pg/ml (on average 555±217пг/мл) after instillation 1 drop of DeksaTobrom in each eye 4 razav day within 2 days. About 60% absorbed a dozydeksametazon are removed with urine in the form of 6-v-hydrogideksametazona. Not changed dexamethasone in urine is not revealed. Elimination half-life of an izplazma of blood rather short — 3–4 h Deksametazonpriblizitelno for 77–84% contacts blood plasma albumine. The clearance fluctuates from 0.111 to 0.225 l/h/kg, and an objemraspredeleniya — from 0.576 to 1.15 l/kg.
Tobramycinum passes vvodyanisty moisture in very small quantities, is systemically absorbed. System absorption to a tobramitsinaposla of topical ophthalmologic administration low. Levels of a koncentratsiitobramitsin in blood plasma did not give in to a quantitative opredeleniyu of 75% of patients to whom dug in eye drops of DeksaTobromv each eye 4 times a day within 2 days. Naivysshiyizmerenny level was 0.25 mkg/ml, what is 8 times lower, a chemkoncentration of 2 mkg/ml which is below limit of risk of a vozniknoveniyanefrotoksichnost. Slightly (less than 10%) contacts proteins of a plazmykrova.
ekskretiruyetsyav I wet Tobramycinum in not changed state by means of mainly glomerular filtration. Periodpoluvyvedeniya makes about 2 h of blood plasma (with klirensom0.04 l/h/kg and of distribution of 0.26 l/kg).
A pharmacodynamics
the Combined drug with antibacterial iprotivovospalitelny action for topical administration in ophthalmology.
Dexamethasone - a synthetic glucocorticosteroid which sostavmolekula include fluorine atom. Has the vyrazhennoyeprotivovospalitelny, antiallergic and desensibilizing effect, an atakzha antishock and anti-toxic action, possesses an immunodepressivnoyaktivnost. These effects are connected with oppression of release of eozinofilamimediator of inflammation, induction of formation of lipokortin and umensheniyakolichestvo of the mast cells producing hyaluronic acid from an umensheniyempronitsayemost of capillaries, stabilization of cellular membranes (osobennolizosomalny) and membranes of organellas. Immunosuppressive effect obuslovlentormozheniye of release of tsitokinin (interleukin 1.2, gamma interferon) of izlimfotsit and macrophages. The main influence on a metabolism is connected by a protein skatabolizm, increase in a gluconeogenesis in a liver and decrease in a utilizatsiiglyukoza peripheral fabrics. Slightly detains sodium and water in an organism. Not obladayetmineralokortikoidny activity.
Dexamethasone suppresses activity of vitamin D that leads to decrease in absorption of calcium an iuvelicheniya of its removal, also podavlyaetsintez and secretion of adrenocorticotropic hormone (AKTG) and again — sintezendogenny glucocorticosteroids.
Tobramycinum - an antibiotic of a broad spectrum of activity from gruppyaminoglikozid. It is active in the relation grampolozhitelnykhcorynebacterium, Listeria monocytogenes, Staphylococcus aureus and grammotritsatelnykhacinobacter, Branhamella, Campylobacter, Citrobacter freundii, C. koseri, Enterobacter aerogenes, Enterobacter cloacae, E. coli, H. influenzae, Klebsiella, Morganella morganii, proteus mirabilis, Proteusvulgaris, Pseudomonas aeruginosa, Salmonella, Serratia, Shigella, Yersiniabaktery and also some types of Neisseriaspp.
Indications
- infectious diseases of eyes, including conjunctivitis, blepharitis,
the keratitis (without injury of an epithelium)
treatment and prevention of postoperative infections of a voftalmokhirurgiya blefarokonjyunktivit.
The idose route of administration
Drug is intended only for an oftalmologicheskogoprimeneniye.
Before burying carefully wash up hands.
Before use the bottle should be stirred up well.
Use for teenagers and adults, including lyudeypozhily age.
Drug is dug in on 1-2 drops in conjunctival a meshokporazhenny eye (or an eye) in each 4-6 h. During the first 24–48 chdoza it is possible to raise to one or two drops each 2 h Chastotuprimeneniya of drug it is necessary to reduce gradually at improvement of a klinicheskoykartina. Duration of treatment is no more than 14 days.
For treatment and prevention of postoperative infektsiynaznachat on 1 drop 4 times a day, beginning from a dnyaoperation and continuing within 14 days.
After instillation it is recommended to close densely glaza to carry out occlusion of the lacrimonasal channel. It reduces system the absorbtsiyupreparat and risk of development of system side effects.
To prevent pollution of a tip of a kapelnitsya of suspension, it is necessary to avoid contact a century or others a bottle dropper poverkhnosteykonchik.
Close a bottle after the use.
When using the drug DeksaTobrom in a combination sdrugy ophthalmologic drops, keep the minimum interval of 15 minutmezhda burying.
If you forgot to dig one dose, its instilliruyta as mozhnobystry. Do not use a double dose of the dlyakompensation forgotten.
Side effects
local allergic reactions: hypostasis and an itching a century, a conjunctival erythema, hyperaemia of eyes, a dot keratitis, a povyshennoyeslezootdeleniye, temporary burning or pricking after burying
the increase in intraocular pressure (at a dlitelnomprimeneniya)
is possible: cornea mycoses at constant use in techeniyeboly 3 months
delay of processes of regeneration.
Contraindications
the epithelial keratitis caused by Herpes simplex (drevovidnyykeratit)
viral diseases of a cornea and conjunctiva (including in chicken pox)
mikobakterialny infections of eyes
fungus diseases of eyes
acute forms of purulent infections of eyes (at otsutstviiantibakterialny therapy)
hypersensitivity to any component of drug.
Drug is not appointed after uncomplicated removal of an inorodnogotel from a cornea.
Medicinal interactions
are not established.
The special
instructions DeksaTobrom it is intended only for topical administration.
At use of the drugs containing GKS (glucocorticosteroids), more than 10 days should be measured regularly a vnutriglaznoyedavleniye.
When prescribing the drug DeksaTobrom, along with an antibiotikamigruppa of aminoglycosides for system use, it is necessary to control a koncentratsiyutobramitsin in blood serum.
The benzalkoniya chloride (preservative) which can be laid for surfaces of soft contact lenses is a part of drug, poetomulinza need to be removed in 15 minutes prior to burying, their carrying perhaps not raneechy in 15 minutes after burying.
In the presence of diseases which privodyatk to thinning of a cornea or a sclera, topical administration steroidovmozht to cause perforation.
In a herpes simplex the rasprostraneniyeprocessa can be observed.
At development of allergic reactions the use preparatasledut to stop.
Use in pediatrics
At the moment safety and efficiency of the primeneniyapreparat at children are not established.
Pregnancy and lactation
of Sufficient experience on use of drug in a vremyaberemennost, a breast and children have no feeding. DeksaTobrom's use during pregnancy vozmozhnotolko on doctor's orders, if the prevyshayetpotentsialny risk expected effect of therapy for a fruit.
For the period of treatment it is necessary to stop a grudnoyevskarmlivaniye.
Influence of medicine on ability upravlyattransportny means or potentially dangerous mechanisms
to Patients who have after applique temporarily a sight teryaetsyachetkost is not recommended to drive or work with slozhnoytekhniky right after burying drug.
Overdose
Overdose at ophthalmologic an upotrebleniimaloveroyatna. Now about cases of overdose of the drug DeksaTobromne it was reported.
Overdose symptoms: strengthening collateral deystviypreparat.
Treatment: to wash eyes a large number with warm water.
Release form iupakovka
Eye drops, sterilnayasuspenziya of 0.1% of dexamethasone and 0.3% of Tobramycinum.
On 5 ml in a white bottle from polyethylene with a stopper dropper and the screwing-up protective cap supplied with a safety ring.
1 bottle together with the instruction for use in a kartonnoypachka.
To Store storage conditions at a temperature + 15-250C in original packing.
To store out of children's reach!
A period of storage
3 years
do not use drug after the expiry date specified on packing.
After opening the bottle should be stored in the fridge within 28 days.
Prescription status
According to the prescription
of Proizvoditel Romfarm Company of S.R. L.,
Romania Eroilor St. 1A, Otopen.
ph. +40 21 208 9743, +40 21 208 97 42, fax: +40 21 266 49 38
To develop
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