The instruction for medical use
of DuoTrav medicine *
the Trade name
of DuoTrav *
the International unlicensed name
Is not present
the Dosage form
of the Drop eye 2.5 ml.
The structure
of 1 ml of drops contains:
active agents: travoprost - 0.04 mg, Timololum a maleate – 6.8 mg (it is equivalent to Timololum of 5.0 mg).
excipients: polikvaternium-1, Mannitolum, propylene glycol, castor oil the hydrogenated polyoxyethylene 40 (HCO-40), boric acid, sodium chloride, sodium hydroxide and/or acid chlorohydrogen for correction rn, the water purified.
The description
Transparent from colourless till light yellow color solution.
Pharmacotherapeutic group
Protivoglaukomny drugs and miotik. Beta blockers.
Timololum in a combination with other drugs.
The ATX S01ED51 code
the Pharmacological
Pharmacokinetics At properties topical administration of eye drops of DuoTrav *, travoprost and Timololum are soaked up through a cornea.
Free acid of the travoprost is defined in blood plasma within the first hour after use of eye drops of DuoTrav*. Timololum is defined in intraocular liquid right after its burying and in blood plasma in 12 hours after use of eye drops of DuoTrav*.
Free acid of the travoprost, Timololum and the formed metabolites generally are removed through kidneys. Two percent (2%) of a local dose of the travoprost are found in urine in the form of free acid, about 20% of a dose of Timololum are removed with urine in not changed look, other part is removed in the form of metabolites. Elimination half-life of Timololum makes 4 hours of blood plasma.
The pharmacodynamics
the Drug DuoTrav * drops eye contains two active agents: travoprost and Timololum maleate. These two components reduce intraocular pressure by the complementary mechanism of action and as a result of a combination give additional decrease in intraocular pressure. Travoprost - an analog of F2α prostaglandin, high-selection agonist which has high affinity with a receptor of FP prostaglandin and reduces intraocular pressure by increase in outflow of intraocular liquid through a retina and a uveoskleralny path. Decrease in intraocular pressure begins approximately in 2 hours after burying, the maximum effect is reached in 12 hours. Considerable decrease in intraocular pressure can be observed within 24 hours when using a single dose. Timololum is non-selective adrenoblocker which has no internal sympathomimetic, direct miokardiodepressivny or membrane stabilizing activity, action is mainly connected with reduction of secretion of intraocular liquid and small increase in outflow.
Indications
- the increased intraocular pressure at patients with an open-angle form of glaucoma which is not reacting to local action of beta-blockers or analogs of prostaglandins
- eye hypertensia of various etiology
the Route of administration and doses
of DuoTrav * eye dig in drops in a conjunctival sac on 1 drop in the affected eye(s), in the morning or in the evening, at the same time once a day.
After influence it is recommended to press the lacrimonasal channel or to carefully cover eyelids. It reduces system absorption of medicine and serves as prevention of development of adverse system reactions.
If the dose was passed, then treatment has to be continued with the following dose according to the schedule. The dose should not exceed 1 drop a day in the affected eye (eyes).
When replacing other protivoglaukomny drug, eye drops of DuoTrav *, it is necessary to stop intake of the replaced drug and to begin reception of eye drops of DuoTrav * next day. When using several ophthalmologic drugs of topical administration, it is necessary to observe an interval between burying, at least, 5 minutes.
It is not necessary to touch with a pipette tip eyes, or any other surface to avoid pollution of contents of a bottle.
Side effects
Local:
Very often
- discomfort in an eye
- hyperaemia
Often
- a dot keratitis
- eye pain, inflammations in an anterior chamber
- a photophobia
- puffiness of an eye, lachrymation
- eye hyperaemia, bleeding of a conjunctiva, an erythema of a century, blepharitis
- disorders of vision, decrease in visual acuity, ambiguity of sight,
- dryness in an eye, an itching of an eye, allergic conjunctivitis,
- an asthenopia
- growth of eyelashes
Infrequently
- conjunctivitis
- a keratitis, a cornea erosion
- meybomianit
- formation of crusts on an edge of the lid
Is rare
- irites
With an unknown frequency
- a macular oedema
- a ptosis of a century
- corneal disturbances
System:
Often
- nervousness
- dizziness, a headache
- disturbances of a warm rhythm, bradycardia
- increase in arterial blood pressure, a lowering of arterial pressure
- a bronchospasm
- an urtikariya
- a skin hyperpegmentation around eyes
- extremity pains
Infrequently
- arrhythmia
- fatigue, thirst
- short wind, cough, oropharyngeal pain, irritation of a throat, nasal discomfort, nasopharyngeal discharges
- hypersensitivity
- increase in aminotransferase of alanine, increase in aminotransferase of aspartate
- a hromatouriya
- the abnormal growth of hair
of the Contraindication
- hypersensitivity to any of drug components
- bronchial asthma
- a chronic obstructive disease of lungs of easy or heavy degree
- sinus bradycardia
- atrioventricular block of II and III degree
- cardiogenic shock
- the profound heart failure
- allergic rhinitis of heavy degree
- bronchial hyperactivity
- cornea dystrophy
- hypersensitivity to other β-blockers
Medicinal interactions
Timololum can interact with other medicines.
Impact on intraocular pressure or systemic action of β-blockers can be strongly eye drops of DuoTrav * if the patient besides eye drops receives β-blockers orally.
At use of eye drops of Timololum along with oral blockers of calcium channels, guanitidiny or β-blockers, antiarrhytmic drugs, cardiac glycosides or parasympathomimetic means, the additional effect at patients with hypotension and/or considerable bradycardia is observed.
The hypertensive reaction arising at sharp cancellation of a clonidine can be strengthened by use of β-blockers. β-blockers can enhance hypoglycemic effect of anti-diabetic drugs, and can also mask hypoglycemia symptoms.
Simultaneous use of two drugs from group of β-adrenoblockers and prostaglandins is not recommended.
Special instructions
At use of Timololum an adverse effect of a β-adrenergic component on respiratory and cardiovascular systems can be observed. Patients with cardiovascular diseases when prescribing Timololum have to be in the anamnesis under observation of the cardiologist or therapist for continuous monitoring of warm activity and pulse. At use of Timololum of a maleate can heavy reaction from respiratory and cardiovascular systems is observed, up to lethal, owing to a bronchospasm at patients with asthma, and less often owing to heart failure. β-adrenoblockers have to be appointed with care at patients with a spontaneous hypoglycemia or at diabetics (especially at patients with labile diabetes) as β-adrenoblockers can mask symptoms of a sharp hypoglycemia. Also, they can mask signs of a hypothyroidism, provoke Prinzmetal stenocardia attack, heavy disturbances of peripheral and central vascular circulation and hypotension.
Duotrav * eye propylene glycol which can cause irritation of skin contains drops.
Duotrav * eye the hydrogenated polyoxyethylene of castor oil 40 which can become the reason of skin reaction contains drops.
Influence on eyes
of Travoprost can change considerably color of an eye owing to increase in melonosom (pigmentary granules) in melanocytes.
Prior to treatment the patient has to be informed on continuous discoloration of an eye. As a result of unilateral treatment irreversible heterochromia is observed. Discoloration of an iris of the eye happens slowly and can be not noticeable within several months and years.
Use of the travoprost can cause darkening of a periorbital surface and/or an eyelid skin.
As a result of treatment travoprosty perhaps significant change from eyelashes that includes: increase in length, thickness, pigmentation and/or number of eyelashes.
Drug should be used with care at patients with an aphakia, with a psevdofakiya and a rupture of the back capsule of a crystalline lens or with a perednekamerny lens, in connection with increase in risk of developing macular hypostasis and cyst, iritis/uveitis.
Risk of development of anaphylactic reaction
At use of β-adrenoblockers for patients with an atopy and heavy anaphylactic reaction in the anamnesis can be observed resistance to the usual doses of adrenaline which are appointed at anaphylactic reaction.
* drops eye pregnant women are recommended to appoint pregnancy of DuoTrav only if the expected advantage of its use considerably exceeds potential risk for a fruit.
Prostaglandins and their analogs – biologically active materials which can get through skin. The pregnant or planning pregnancy women have to observe the appropriate measures of precaution for prevention of direct contact with bottle contents. In case of hit of solution on skin it is necessary to wash the place of contact with water well.
The lactation
of DuoTrav * eye is not recommended to accept drops to the women nursing.
The pediatrics
Safety and efficiency of eye drops of DuoTrav * at use for patients was not younger than 18 years is established thereof use of drug at patients more young is not recommended than 18 years.
Contact lenses
need to be deleted contact lenses from eyes before burying eye drops of DuoTrav*. The lens can be put on in 15 minutes after burying drug.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
After burying the temporary ambiguity 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.
The overdose
At topical administration overdose travoprosty is improbable. The most frequent symptoms of system overdose by Timololum are: bradycardia, hypotension, bronchospasm and heart failure.
Treatment: symptomatic. Timololum is not dialyzed. At hit in an eye of excess amount of drug it is necessary to wash out eyes plentiful amount of warm water.
The form of release and packing
On 2.5 ml of drug spill in oval bottles from white opaque polypropylene with a dropper doser and the screw-on cover. The bottle is placed in the foiled package.
On 1 bottle in the foiled package together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions at a temperature not above 30 °C.
To store out of children's reach!
A period of storage
24 months
the use Period after the first opening of a bottle - 4 weeks.
Not to apply after an expiration date.
Prescription status
According to the prescription
Puurs Alcon-Couvreur B-2870 Producer, Belgium.
Owner of the registration certificate
of Alcon-Couvreur, Belgium.
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representation "Alkon Pharmasyyutikals, Ltd."
Ph.: +7 727 374 35 79 / +7 727 374 35 86, Fax: +7 727 374 35 81
E-mail address:
To Develop phv.hotline@alcon.com
of DuoTrav medicine *
the Trade name
of DuoTrav *
the International unlicensed name
Is not present
the Dosage form
of the Drop eye 2.5 ml.
The structure
of 1 ml of drops contains:
active agents: travoprost - 0.04 mg, Timololum a maleate – 6.8 mg (it is equivalent to Timololum of 5.0 mg).
excipients: polikvaternium-1, Mannitolum, propylene glycol, castor oil the hydrogenated polyoxyethylene 40 (HCO-40), boric acid, sodium chloride, sodium hydroxide and/or acid chlorohydrogen for correction rn, the water purified.
The description
Transparent from colourless till light yellow color solution.
Pharmacotherapeutic group
Protivoglaukomny drugs and miotik. Beta blockers.
Timololum in a combination with other drugs.
The ATX S01ED51 code
the Pharmacological
Pharmacokinetics At properties topical administration of eye drops of DuoTrav *, travoprost and Timololum are soaked up through a cornea.
Free acid of the travoprost is defined in blood plasma within the first hour after use of eye drops of DuoTrav*. Timololum is defined in intraocular liquid right after its burying and in blood plasma in 12 hours after use of eye drops of DuoTrav*.
Free acid of the travoprost, Timololum and the formed metabolites generally are removed through kidneys. Two percent (2%) of a local dose of the travoprost are found in urine in the form of free acid, about 20% of a dose of Timololum are removed with urine in not changed look, other part is removed in the form of metabolites. Elimination half-life of Timololum makes 4 hours of blood plasma.
The pharmacodynamics
the Drug DuoTrav * drops eye contains two active agents: travoprost and Timololum maleate. These two components reduce intraocular pressure by the complementary mechanism of action and as a result of a combination give additional decrease in intraocular pressure. Travoprost - an analog of F2α prostaglandin, high-selection agonist which has high affinity with a receptor of FP prostaglandin and reduces intraocular pressure by increase in outflow of intraocular liquid through a retina and a uveoskleralny path. Decrease in intraocular pressure begins approximately in 2 hours after burying, the maximum effect is reached in 12 hours. Considerable decrease in intraocular pressure can be observed within 24 hours when using a single dose. Timololum is non-selective adrenoblocker which has no internal sympathomimetic, direct miokardiodepressivny or membrane stabilizing activity, action is mainly connected with reduction of secretion of intraocular liquid and small increase in outflow.
Indications
- the increased intraocular pressure at patients with an open-angle form of glaucoma which is not reacting to local action of beta-blockers or analogs of prostaglandins
- eye hypertensia of various etiology
the Route of administration and doses
of DuoTrav * eye dig in drops in a conjunctival sac on 1 drop in the affected eye(s), in the morning or in the evening, at the same time once a day.
After influence it is recommended to press the lacrimonasal channel or to carefully cover eyelids. It reduces system absorption of medicine and serves as prevention of development of adverse system reactions.
If the dose was passed, then treatment has to be continued with the following dose according to the schedule. The dose should not exceed 1 drop a day in the affected eye (eyes).
When replacing other protivoglaukomny drug, eye drops of DuoTrav *, it is necessary to stop intake of the replaced drug and to begin reception of eye drops of DuoTrav * next day. When using several ophthalmologic drugs of topical administration, it is necessary to observe an interval between burying, at least, 5 minutes.
It is not necessary to touch with a pipette tip eyes, or any other surface to avoid pollution of contents of a bottle.
Side effects
Local:
Very often
- discomfort in an eye
- hyperaemia
Often
- a dot keratitis
- eye pain, inflammations in an anterior chamber
- a photophobia
- puffiness of an eye, lachrymation
- eye hyperaemia, bleeding of a conjunctiva, an erythema of a century, blepharitis
- disorders of vision, decrease in visual acuity, ambiguity of sight,
- dryness in an eye, an itching of an eye, allergic conjunctivitis,
- an asthenopia
- growth of eyelashes
Infrequently
- conjunctivitis
- a keratitis, a cornea erosion
- meybomianit
- formation of crusts on an edge of the lid
Is rare
- irites
With an unknown frequency
- a macular oedema
- a ptosis of a century
- corneal disturbances
System:
Often
- nervousness
- dizziness, a headache
- disturbances of a warm rhythm, bradycardia
- increase in arterial blood pressure, a lowering of arterial pressure
- a bronchospasm
- an urtikariya
- a skin hyperpegmentation around eyes
- extremity pains
Infrequently
- arrhythmia
- fatigue, thirst
- short wind, cough, oropharyngeal pain, irritation of a throat, nasal discomfort, nasopharyngeal discharges
- hypersensitivity
- increase in aminotransferase of alanine, increase in aminotransferase of aspartate
- a hromatouriya
- the abnormal growth of hair
of the Contraindication
- hypersensitivity to any of drug components
- bronchial asthma
- a chronic obstructive disease of lungs of easy or heavy degree
- sinus bradycardia
- atrioventricular block of II and III degree
- cardiogenic shock
- the profound heart failure
- allergic rhinitis of heavy degree
- bronchial hyperactivity
- cornea dystrophy
- hypersensitivity to other β-blockers
Medicinal interactions
Timololum can interact with other medicines.
Impact on intraocular pressure or systemic action of β-blockers can be strongly eye drops of DuoTrav * if the patient besides eye drops receives β-blockers orally.
At use of eye drops of Timololum along with oral blockers of calcium channels, guanitidiny or β-blockers, antiarrhytmic drugs, cardiac glycosides or parasympathomimetic means, the additional effect at patients with hypotension and/or considerable bradycardia is observed.
The hypertensive reaction arising at sharp cancellation of a clonidine can be strengthened by use of β-blockers. β-blockers can enhance hypoglycemic effect of anti-diabetic drugs, and can also mask hypoglycemia symptoms.
Simultaneous use of two drugs from group of β-adrenoblockers and prostaglandins is not recommended.
Special instructions
At use of Timololum an adverse effect of a β-adrenergic component on respiratory and cardiovascular systems can be observed. Patients with cardiovascular diseases when prescribing Timololum have to be in the anamnesis under observation of the cardiologist or therapist for continuous monitoring of warm activity and pulse. At use of Timololum of a maleate can heavy reaction from respiratory and cardiovascular systems is observed, up to lethal, owing to a bronchospasm at patients with asthma, and less often owing to heart failure. β-adrenoblockers have to be appointed with care at patients with a spontaneous hypoglycemia or at diabetics (especially at patients with labile diabetes) as β-adrenoblockers can mask symptoms of a sharp hypoglycemia. Also, they can mask signs of a hypothyroidism, provoke Prinzmetal stenocardia attack, heavy disturbances of peripheral and central vascular circulation and hypotension.
Duotrav * eye propylene glycol which can cause irritation of skin contains drops.
Duotrav * eye the hydrogenated polyoxyethylene of castor oil 40 which can become the reason of skin reaction contains drops.
Influence on eyes
of Travoprost can change considerably color of an eye owing to increase in melonosom (pigmentary granules) in melanocytes.
Prior to treatment the patient has to be informed on continuous discoloration of an eye. As a result of unilateral treatment irreversible heterochromia is observed. Discoloration of an iris of the eye happens slowly and can be not noticeable within several months and years.
Use of the travoprost can cause darkening of a periorbital surface and/or an eyelid skin.
As a result of treatment travoprosty perhaps significant change from eyelashes that includes: increase in length, thickness, pigmentation and/or number of eyelashes.
Drug should be used with care at patients with an aphakia, with a psevdofakiya and a rupture of the back capsule of a crystalline lens or with a perednekamerny lens, in connection with increase in risk of developing macular hypostasis and cyst, iritis/uveitis.
Risk of development of anaphylactic reaction
At use of β-adrenoblockers for patients with an atopy and heavy anaphylactic reaction in the anamnesis can be observed resistance to the usual doses of adrenaline which are appointed at anaphylactic reaction.
* drops eye pregnant women are recommended to appoint pregnancy of DuoTrav only if the expected advantage of its use considerably exceeds potential risk for a fruit.
Prostaglandins and their analogs – biologically active materials which can get through skin. The pregnant or planning pregnancy women have to observe the appropriate measures of precaution for prevention of direct contact with bottle contents. In case of hit of solution on skin it is necessary to wash the place of contact with water well.
The lactation
of DuoTrav * eye is not recommended to accept drops to the women nursing.
The pediatrics
Safety and efficiency of eye drops of DuoTrav * at use for patients was not younger than 18 years is established thereof use of drug at patients more young is not recommended than 18 years.
Contact lenses
need to be deleted contact lenses from eyes before burying eye drops of DuoTrav*. The lens can be put on in 15 minutes after burying drug.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
After burying the temporary ambiguity 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.
The overdose
At topical administration overdose travoprosty is improbable. The most frequent symptoms of system overdose by Timololum are: bradycardia, hypotension, bronchospasm and heart failure.
Treatment: symptomatic. Timololum is not dialyzed. At hit in an eye of excess amount of drug it is necessary to wash out eyes plentiful amount of warm water.
The form of release and packing
On 2.5 ml of drug spill in oval bottles from white opaque polypropylene with a dropper doser and the screw-on cover. The bottle is placed in the foiled package.
On 1 bottle in the foiled package together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions at a temperature not above 30 °C.
To store out of children's reach!
A period of storage
24 months
the use Period after the first opening of a bottle - 4 weeks.
Not to apply after an expiration date.
Prescription status
According to the prescription
Puurs Alcon-Couvreur B-2870 Producer, Belgium.
Owner of the registration certificate
of Alcon-Couvreur, Belgium.
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representation "Alkon Pharmasyyutikals, Ltd."
Ph.: +7 727 374 35 79 / +7 727 374 35 86, Fax: +7 727 374 35 81
E-mail address:
To Develop phv.hotline@alcon.com
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