Brimo 5 ml of eye drops
- $20.80
The Ministries of Health
The Republic of Kazakhstan
from' ____' __________ 2011
No. _________________
Istruktion
on medical use
of Brimo Torgovoye medicine
Brimo
Mezhdunarodnoye's name the unlicensed
name Brimonidin Lekarstvennaya
the Drop form eye, 5 ml
Structure is APPROVED By the order of the Chairman of the Committee of control of medical and pharmaceutical activity
One ml of drug contains:
active agent - a brimonidina tartrate of 2 mg,
excipients: a benzalkoniya chloride, sodium citrate, citric acid monohydrate, sodium chloride, polyvinyl alcohol, sodium hydroxide 1M or acid of chlorohydrogen 1 M, water for injections.
The description
Transparent, slightly yellowish color the solution free from foreign particles.
The pharmacotherapeutic group
Sympathomimetics for treatment of glaucoma
of SO1EA05
the Pharmacological
Pharmacokinetics At properties topical administration of a brimonidin tartrate quickly gets through a cornea. In insignificant quantities gets to a system blood stream by absorption through vessels of a conjunctiva, mucous a nose and a plaintive path. After the 10th day use of eye drops the concentration of a brimonidin of tartrate in blood plasma did not exceed 0.06ng/ml, in this regard systemic action of drug is very low. After drug use elimination half-life of a brimonidin tartrate makes about 3 hours of blood plasma.
The pharmacodynamics
Active agent of the drug Brimo – a brimonidin tartrate is agonist α2-адренорецепторов, shows the greatest selectivity to α2-адренорецепторам, than to α1-адренорецепторам. As a result of selective effect on α2-адренорецепторы drug does not cause a mydriasis and vasoconstriction of the microvessels associated with retina heterografts at people.
Topical administration of a brimonidin of tartrate causes decrease in intraocular pressure in people at insignificant influence on a cardiovascular and respiratory system.
Information on clinical trials concerning safe use of drug for patients with bronchial asthma are limited.
Intraocular pressure begins to decrease quickly after drug use, and its maximum decrease is noted in 2 h Brimonidin reduces intraocular pressure due to reduction of intraocular liquid and insignificant increase in its uveoskleralny outflow.
Indications
For decrease in the increased intraocular pressure at patients with an open angle glaucoma or intraocular hypertensia:
- as monotherapy at patients to whom drugs of beta-blockers in eye drops are contraindicated
- as auxiliary therapy at patients at whom adequate decrease in intraocular pressure at monotherapy is not reached by other protivoglaukomny drugs.
Route of administration and doses
Adult and elderly: on 1 drop in the affected eye two times a day every 12 hours.
Elderly people do not need correction of a dosage of drug when assigning.
For decrease in possible system absorption it is recommended after burying it is necessary to press an internal corner of eyes within one minute.
Side effect
- is very frequent: dryness in a mouth, hyperaemia of eyes, burning/pricking of eyes which are tranzitorny, headaches, drowsiness, irritation of mucous membranes of eyes (including allergic reactions – hyperaemia, burning, pricking, an itching, feeling of a foreign body, conjunctivitis), the obscured sight, weakness (feeling of fatigue)
- is frequent: the food faddism, dizziness, local reactions of irritation (hyperaemia the century, blepharitis, a chemosis, pain to an eye also swelled), a photophobia, an erosion and colourings of a cornea, xerophthalmus, a disorder of vision, an asthenia
- is rare: increase of pulse, arrhythmia (including bradycardia and tachycardia), xeromycteria, dispny, a depression
- is very rare: to a syncope, iritis (front uveitis), miosis, hypertensia, hypotension, insomnia.
-
Contraindications
- newborns and children up to 18 years
- hypersensitivity to a bromonidin to tartrate and other compound substances of drug
- simultaneous use with inhibitors of a monoaminooxidase or other antidepressants which have effect through release of noradrenaline (tricyclic antidepressants)
Medicinal interactions
is possible interaction with the drugs and substances oppressing the central nervous system (alcohol, barbiturates, opiates, sedative drugs and anesthetics).
It is necessary to appoint with care to the patients taking medicines which can affect metabolism and the return neuronalny capture of amines (Chlorpromazinum, methylphenidate, reserpine) though there are no data on the level of catecholamines in the blood course after use of eye drops with bromonidiny.
It is necessary to be careful at co-administration of eye drops with bromonidiny and antihypertensive drugs, cardiac glycosides.
Bromonidin can interact with alpha adrenoblockers.
Special instructions
of Brimo it has to be used with caution at patients with a depression, disturbance of cerebral or coronary circulation and orthostatic hypotension.
Patients with the diagnosis Intraocular pressure at treatment with the drug Brimo have to check intraocular pressure regularly.
Pediatrics
the Clinical trials confirming safety and efficiency of eye drops with bromodipin tartrate at children aged up to 18 years were not carried out.
Pregnancy and a lactation
Use of drug during pregnancy can be considered only at absolute indications taking into account advantage/risk for the pregnant woman and a fruit.
During chest feeding the use of drug is contraindicated.
Influence on ability to run transport and other mechanisms
It is necessary to be careful in connection with a possibility of development of side effects from the central nervous system and disturbance of visual acuity.
Overdose
of Data on overdose there is no drug.
Symptoms at accidental intake: development of systemic side effects.
Treatment: symptomatic therapy.
The form of release and packing
On 5 ml place in plastic bottles with the screwing-up cover with control of the first opening. On 1 bottle together with the instruction for use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the place protected from light, at a temperature from 15 of 0C up to 25 0C
to Store out of children's reach!
2 years
After opening of a bottle a period of storage of 28 days
not to apply a period of storage after the expiration date specified on packing
Prescription status
According to the prescription
the Producer
by Jamjoom Pharmaceuticals Co. Ltd, Jeddah, Saudi Arabia
Saudi Arabia, Mr. Zhedakh, Industrialnaya Square phase 5,
ph./fax +966 2 6081111 / +966 2 6081222
e-mail: www.jamjoompharma.com, salmanhussain@jamjoompharma.co
Name and country of the owner of the registration certificate
Jamjoom Pharmaceuticals Co. Ltd, Saudi Arabia
Name and country organization of the packer
Jamjoom Pharmaceuticals Co. Ltd, Saudi Arabia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Republic of Kazakhstan, city of Almaty, Al-Farabi Avenue, 15 of the Centre Party of Finland of 'Nurla Tau', block 4'B', office No. 18.
Phone number: 251 98 22, 8702 198 65 74
E-mail address: pharmacovigilance@jamjoompharma.com
The Republic of Kazakhstan
from' ____' __________ 2011
No. _________________
Istruktion
on medical use
of Brimo Torgovoye medicine
Brimo
Mezhdunarodnoye's name the unlicensed
name Brimonidin Lekarstvennaya
the Drop form eye, 5 ml
Structure is APPROVED By the order of the Chairman of the Committee of control of medical and pharmaceutical activity
One ml of drug contains:
active agent - a brimonidina tartrate of 2 mg,
excipients: a benzalkoniya chloride, sodium citrate, citric acid monohydrate, sodium chloride, polyvinyl alcohol, sodium hydroxide 1M or acid of chlorohydrogen 1 M, water for injections.
The description
Transparent, slightly yellowish color the solution free from foreign particles.
The pharmacotherapeutic group
Sympathomimetics for treatment of glaucoma
of SO1EA05
the Pharmacological
Pharmacokinetics At properties topical administration of a brimonidin tartrate quickly gets through a cornea. In insignificant quantities gets to a system blood stream by absorption through vessels of a conjunctiva, mucous a nose and a plaintive path. After the 10th day use of eye drops the concentration of a brimonidin of tartrate in blood plasma did not exceed 0.06ng/ml, in this regard systemic action of drug is very low. After drug use elimination half-life of a brimonidin tartrate makes about 3 hours of blood plasma.
The pharmacodynamics
Active agent of the drug Brimo – a brimonidin tartrate is agonist α2-адренорецепторов, shows the greatest selectivity to α2-адренорецепторам, than to α1-адренорецепторам. As a result of selective effect on α2-адренорецепторы drug does not cause a mydriasis and vasoconstriction of the microvessels associated with retina heterografts at people.
Topical administration of a brimonidin of tartrate causes decrease in intraocular pressure in people at insignificant influence on a cardiovascular and respiratory system.
Information on clinical trials concerning safe use of drug for patients with bronchial asthma are limited.
Intraocular pressure begins to decrease quickly after drug use, and its maximum decrease is noted in 2 h Brimonidin reduces intraocular pressure due to reduction of intraocular liquid and insignificant increase in its uveoskleralny outflow.
Indications
For decrease in the increased intraocular pressure at patients with an open angle glaucoma or intraocular hypertensia:
- as monotherapy at patients to whom drugs of beta-blockers in eye drops are contraindicated
- as auxiliary therapy at patients at whom adequate decrease in intraocular pressure at monotherapy is not reached by other protivoglaukomny drugs.
Route of administration and doses
Adult and elderly: on 1 drop in the affected eye two times a day every 12 hours.
Elderly people do not need correction of a dosage of drug when assigning.
For decrease in possible system absorption it is recommended after burying it is necessary to press an internal corner of eyes within one minute.
Side effect
- is very frequent: dryness in a mouth, hyperaemia of eyes, burning/pricking of eyes which are tranzitorny, headaches, drowsiness, irritation of mucous membranes of eyes (including allergic reactions – hyperaemia, burning, pricking, an itching, feeling of a foreign body, conjunctivitis), the obscured sight, weakness (feeling of fatigue)
- is frequent: the food faddism, dizziness, local reactions of irritation (hyperaemia the century, blepharitis, a chemosis, pain to an eye also swelled), a photophobia, an erosion and colourings of a cornea, xerophthalmus, a disorder of vision, an asthenia
- is rare: increase of pulse, arrhythmia (including bradycardia and tachycardia), xeromycteria, dispny, a depression
- is very rare: to a syncope, iritis (front uveitis), miosis, hypertensia, hypotension, insomnia.
-
Contraindications
- newborns and children up to 18 years
- hypersensitivity to a bromonidin to tartrate and other compound substances of drug
- simultaneous use with inhibitors of a monoaminooxidase or other antidepressants which have effect through release of noradrenaline (tricyclic antidepressants)
Medicinal interactions
is possible interaction with the drugs and substances oppressing the central nervous system (alcohol, barbiturates, opiates, sedative drugs and anesthetics).
It is necessary to appoint with care to the patients taking medicines which can affect metabolism and the return neuronalny capture of amines (Chlorpromazinum, methylphenidate, reserpine) though there are no data on the level of catecholamines in the blood course after use of eye drops with bromonidiny.
It is necessary to be careful at co-administration of eye drops with bromonidiny and antihypertensive drugs, cardiac glycosides.
Bromonidin can interact with alpha adrenoblockers.
Special instructions
of Brimo it has to be used with caution at patients with a depression, disturbance of cerebral or coronary circulation and orthostatic hypotension.
Patients with the diagnosis Intraocular pressure at treatment with the drug Brimo have to check intraocular pressure regularly.
Pediatrics
the Clinical trials confirming safety and efficiency of eye drops with bromodipin tartrate at children aged up to 18 years were not carried out.
Pregnancy and a lactation
Use of drug during pregnancy can be considered only at absolute indications taking into account advantage/risk for the pregnant woman and a fruit.
During chest feeding the use of drug is contraindicated.
Influence on ability to run transport and other mechanisms
It is necessary to be careful in connection with a possibility of development of side effects from the central nervous system and disturbance of visual acuity.
Overdose
of Data on overdose there is no drug.
Symptoms at accidental intake: development of systemic side effects.
Treatment: symptomatic therapy.
The form of release and packing
On 5 ml place in plastic bottles with the screwing-up cover with control of the first opening. On 1 bottle together with the instruction for use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the place protected from light, at a temperature from 15 of 0C up to 25 0C
to Store out of children's reach!
2 years
After opening of a bottle a period of storage of 28 days
not to apply a period of storage after the expiration date specified on packing
Prescription status
According to the prescription
the Producer
by Jamjoom Pharmaceuticals Co. Ltd, Jeddah, Saudi Arabia
Saudi Arabia, Mr. Zhedakh, Industrialnaya Square phase 5,
ph./fax +966 2 6081111 / +966 2 6081222
e-mail: www.jamjoompharma.com, salmanhussain@jamjoompharma.co
Name and country of the owner of the registration certificate
Jamjoom Pharmaceuticals Co. Ltd, Saudi Arabia
Name and country organization of the packer
Jamjoom Pharmaceuticals Co. Ltd, Saudi Arabia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Republic of Kazakhstan, city of Almaty, Al-Farabi Avenue, 15 of the Centre Party of Finland of 'Nurla Tau', block 4'B', office No. 18.
Phone number: 251 98 22, 8702 198 65 74
E-mail address: pharmacovigilance@jamjoompharma.com
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