Ciprolet 3 mg / ml 5 ml of eye drops
- $4.90
The instruction for medical use
of TSIPROLET® medicine
the Trade name
of Tsiprolet®
the International unlicensed
name Ciprofloxacin Dosage Form
of the Drop eye 3 mg/ml
Structure
One ml of solution contains
active agent: ciprofloxacin of a hydrochloride of 3.49 mg, it is equivalent to ciprofloxacin of 3.00 mg
excipients: sodium chloride, sodium EDTA salt, a benzalkoniya chloride solution of 50%, water for injections.
The description
Transparent from colourless till pale yellow color the solution free from
mechanical impurity.
Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Other antimicrobial drugs. Ciprofloxacin.
The ATX S01AX13 code
The pharmacological
Pharmacokinetics System Absorption properties of ciprofloxacin after topical administration in eyes low. Ciprofloxacin levels in plasma after 7-day topical administration in eyes varied from not measured (& lt, 1.25 ng/ml) up to 4.7 ng/ml. The average peak value of level of ciprofloxacin in plasma after topical administration in eyes is about 450 times less than the values observed after oral administration of 250 mg of ciprofloxacin.
Distribution volume in an equilibrium state is 1.7-2.7 l/kg. The connected protein of serum makes 16-43%. Elimination half-life of ciprofloxacin makes 3-5 hours of plasma. Both ciprofloxacin and four of its of the main of a metabolite are removed with urine and a stake. The renal clearance of ciprofloxacin usually is 300-479 ml/min. About 20-40% of a dose are removed with a stake in an invariable look and in the form of metabolites within 5 days.
The maximum concentration (Cmax) of ciprofloxacin in blood plasma when using eye drops makes less than 5 ng/ml. Average concentration – is lower than 2.5 ng/ml.
The pharmacodynamics
of Tsiprolet® – antimicrobial drug of a broad spectrum of activity, derivative a ftorkhinolona, suppresses bacterial DNK-girazu (topoisomerases II and IV responsible for process of superspiralling of chromosomal DNA around nuclear RNA that is necessary for reading of genetic information), breaks DNA synthesis, growth and division of bacteria, causes the significant morphological changes (including a cell wall and membranes) and fast death of a bacterial cell.
The spectrum of action of ciprofloxacin includes the following species of microorganisms: E.coli, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia, Hafnia, Edwardsiella, Proteus, Providencia, Morganella, Yersinia, Vibrio, Aeromonas, Plesiomonas, Pasteurella, Haemophilus, Campylobacter, Pseudomonas, Legionella, Neisseria, Moraxella, Branhamella, Acinetobacter, Brucella, Staphylococcus, Sreptococcus agalactiae, Listeria, Corynebacterium, Chlamydia.
The indications
of the Infection of an eye and its appendages caused by the strains susceptible to ciprofloxacin:
- a helcoma
- a keratitis
- conjunctivitis
Treatment and prevention of infectious complications after injuries (with or without foreign bodys) an eyeball and its adnexal device.
Prevention of postoperative infectious complications in ophthalmology.
Route of administration and doses
of the Helcoma:
Ципролет® drops eye it has to be applied in the following periods, even at night:
- the first day on 2 drops in a conjunctival sac of the injured eye each 15 minutes within the first six hours, and then on 2 drops in a conjunctival sac of the affected eye each 30 minutes until the end of day.
- in second day on 2 drops in a conjunctival sac of the affected eye each hour
- from the third to the fourteenth day on two drops in a conjunctival sac of the affected eye each 4 hours.
Duration of treatment of helcomas can be more than 14 days, the dosage and duration of treatment are regulated by the attending physician.
Superficial infections of an eye and its appendages:
A usual dose 1 or 2 drops in a conjunctival sac of the affected eye 4 times a day. In case of serious infections, the dose in the first two days makes 1-2 drops each 2 hours in hours of wakefulness.
The usual duration of treatment is 7-14 days.
After burying the easy cover a century or pressing of the lacrimonasal channel is recommended. It reduces system absorption of the medicine administered through tissues of an eye and serves as prevention of development of system side effects.
In case of joint therapy with other local ophthalmologic medicines, it is recommended to observe an interval between drugs of about 10-15 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:
Often
- an itching of an eye, irritation of an eye
- discomfort in an eye, feeling of a foreign body in an eye, abnormal feelings in an eye
- formation of crusts on an edge of the lid
- conjunctiva hyperaemia, eye hyperaemia
- residue of drug
Infrequently
- a keratitis, a keratopathy, coloring of a cornea
- an eye allergy
- decrease in visual acuity, misting of sight, a photophobia
- hypostasis of a century
- infiltration of a cornea
- eye pain
- increase in lachrymation
System:
Often
- a food faddism
Infrequently
- a post-nasal syndrome
- nausea
- dermatitis
- a herpetic keratitis, a herpes simplex of an optic nerve, barley
- hypersensitivity
-
the Contraindication headache
- hypersensitivity to ciprofloxacin and other drugs of group of hinolon
- pregnancy and the period of a lactation
- children's age up to 18 years.
Medicinal interactions
At simultaneous use of Tsiprolet® eye drops with other drugs of clinically significant medicinal interaction it is not established.
The special
instructions Drug for topical ophthalmologic administration not to use for injections or intake.
It is necessary to stop drop drug Tsiprolet® use eye at the first manifestations of skin rash or any other sign of hypersensitivity.
Lethal hypersensitivity reactions (anaphylactic reactions) serious in certain cases, sometimes after the first dose, were observed at the patients accepting system hinolona. Some reactions were followed by cardiovascular insufficiency, a loss of consciousness, pricking, edema of laryngeal or face, an asthma, a small tortoiseshell and an itching. Serious acute reactions of hypersensitivity demand immediate emergency treatment by epinephrine (adrenaline) and other measures of resuscitation, including intake of oxygen, intravenous solutions, intravenous antihistamines, kortikoid, vasoconstrictive factors and artificial ventilation of the lungs, in case of clinical need.
It is known of manifestation cases from the phototoxicity moderated to heavy degree in the form of reactions of a sunblister at the patients who were under direct sunshine during system reception of some representatives of a class of hinolon. It is necessary to avoid excessive sunlight. At manifestation of cases of phototoxicity it is necessary to stop treatment.
As well as with other antibacterial drugs, prolonged use can result in excess quantity of irresponsive bacterial strains or fungi. In case of superinfection it is necessary to begin the corresponding therapy.
At system treatment of a ftorkhinolonama, including ciprofloxacin, especially at elderly patients and at patients corticosteroids, possible cases of inflammation and the ruptures of sinews accepting in common. Therefore treatment by drops has to be stopped by eye Tsiprolet® at the first signs of inflammation of sinews.
Pregnancy
there Are no adequate data on drop drug Tsiprolet® use eye at pregnant women. Drop drug Tsiprolet® use eye during pregnancy is not recommended.
The lactation
At oral administration ciprofloxacin is found in breast milk. There are no reliable data about penetration of ciprofloxacin into breast milk at topical administration in eyes. As the majority of medicines is distinguished in breast milk, it is necessary to make the weighed decision on interruption of breastfeeding or termination/abstention of the Tsiprolet® drug treatment of a drop eye, considering advantages of breastfeeding to the child and advantage of treatment to the woman. At use of drug during breastfeeding it is necessary to stop feeding by a breast.
Contact lenses
of Tsiprolet® of a drop eye the benzalkoniya contains in quality of preservative chloride which can cause irritation of eyes and decolouration of soft contact lenses. Carrying contact lenses is not recommended during treatment of infections of eyes. Carrying contact lenses is not recommended to patients during treatment by eye drops of Tsiprolet®.
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.
Overdose
Symptoms: conjunctiva hyperaemia, pain
Treatment: it is plentiful to wash out under clear flowing water. If necessary carry out symptomatic therapy.
A form of release and packing
the Plastic bottle containing 5 ml of solution of ciprofloxacin in concentration of 3 mg/ml, completed with a kopachkom-dropper is placed in a cardboard box together with the instruction for use in the state and fair-haired languages.
To Store storage conditions in the dry, protected from light place at a temperature not over 25 of 0C.
To store in the places inaccessible for children!
2 years
After opening of a bottle drug to store a period of storage no more than 14 days!
After an expiration date not to apply.
Prescription status According to the prescription
"Dr. of Reddi's Laboratoris Ltd" Producer
India, Andhra Pradesh,
Mr. Hayderabad Adres of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
050057, Almaty, Dzhandosov St., 21,
post office box No. 7 ph./fax: (7272) 245-71-88
Name of the owner of the Registration certificate:
"The Dr. of Reddi's Laboratoris Limited", India
Adres of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
Representative office "Dr. of Reddi's Laboratoris Limited" in Republic of Kazakhstan, 050057 Almaty, 22nd Line St., 45,
a post office box 7, mobile phone number +77017633805, ph. 8 (727) 3941688, fax: 8 (727) 3941294
To develop
of TSIPROLET® medicine
the Trade name
of Tsiprolet®
the International unlicensed
name Ciprofloxacin Dosage Form
of the Drop eye 3 mg/ml
Structure
One ml of solution contains
active agent: ciprofloxacin of a hydrochloride of 3.49 mg, it is equivalent to ciprofloxacin of 3.00 mg
excipients: sodium chloride, sodium EDTA salt, a benzalkoniya chloride solution of 50%, water for injections.
The description
Transparent from colourless till pale yellow color the solution free from
mechanical impurity.
Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Other antimicrobial drugs. Ciprofloxacin.
The ATX S01AX13 code
The pharmacological
Pharmacokinetics System Absorption properties of ciprofloxacin after topical administration in eyes low. Ciprofloxacin levels in plasma after 7-day topical administration in eyes varied from not measured (& lt, 1.25 ng/ml) up to 4.7 ng/ml. The average peak value of level of ciprofloxacin in plasma after topical administration in eyes is about 450 times less than the values observed after oral administration of 250 mg of ciprofloxacin.
Distribution volume in an equilibrium state is 1.7-2.7 l/kg. The connected protein of serum makes 16-43%. Elimination half-life of ciprofloxacin makes 3-5 hours of plasma. Both ciprofloxacin and four of its of the main of a metabolite are removed with urine and a stake. The renal clearance of ciprofloxacin usually is 300-479 ml/min. About 20-40% of a dose are removed with a stake in an invariable look and in the form of metabolites within 5 days.
The maximum concentration (Cmax) of ciprofloxacin in blood plasma when using eye drops makes less than 5 ng/ml. Average concentration – is lower than 2.5 ng/ml.
The pharmacodynamics
of Tsiprolet® – antimicrobial drug of a broad spectrum of activity, derivative a ftorkhinolona, suppresses bacterial DNK-girazu (topoisomerases II and IV responsible for process of superspiralling of chromosomal DNA around nuclear RNA that is necessary for reading of genetic information), breaks DNA synthesis, growth and division of bacteria, causes the significant morphological changes (including a cell wall and membranes) and fast death of a bacterial cell.
The spectrum of action of ciprofloxacin includes the following species of microorganisms: E.coli, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia, Hafnia, Edwardsiella, Proteus, Providencia, Morganella, Yersinia, Vibrio, Aeromonas, Plesiomonas, Pasteurella, Haemophilus, Campylobacter, Pseudomonas, Legionella, Neisseria, Moraxella, Branhamella, Acinetobacter, Brucella, Staphylococcus, Sreptococcus agalactiae, Listeria, Corynebacterium, Chlamydia.
The indications
of the Infection of an eye and its appendages caused by the strains susceptible to ciprofloxacin:
- a helcoma
- a keratitis
- conjunctivitis
Treatment and prevention of infectious complications after injuries (with or without foreign bodys) an eyeball and its adnexal device.
Prevention of postoperative infectious complications in ophthalmology.
Route of administration and doses
of the Helcoma:
Ципролет® drops eye it has to be applied in the following periods, even at night:
- the first day on 2 drops in a conjunctival sac of the injured eye each 15 minutes within the first six hours, and then on 2 drops in a conjunctival sac of the affected eye each 30 minutes until the end of day.
- in second day on 2 drops in a conjunctival sac of the affected eye each hour
- from the third to the fourteenth day on two drops in a conjunctival sac of the affected eye each 4 hours.
Duration of treatment of helcomas can be more than 14 days, the dosage and duration of treatment are regulated by the attending physician.
Superficial infections of an eye and its appendages:
A usual dose 1 or 2 drops in a conjunctival sac of the affected eye 4 times a day. In case of serious infections, the dose in the first two days makes 1-2 drops each 2 hours in hours of wakefulness.
The usual duration of treatment is 7-14 days.
After burying the easy cover a century or pressing of the lacrimonasal channel is recommended. It reduces system absorption of the medicine administered through tissues of an eye and serves as prevention of development of system side effects.
In case of joint therapy with other local ophthalmologic medicines, it is recommended to observe an interval between drugs of about 10-15 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:
Often
- an itching of an eye, irritation of an eye
- discomfort in an eye, feeling of a foreign body in an eye, abnormal feelings in an eye
- formation of crusts on an edge of the lid
- conjunctiva hyperaemia, eye hyperaemia
- residue of drug
Infrequently
- a keratitis, a keratopathy, coloring of a cornea
- an eye allergy
- decrease in visual acuity, misting of sight, a photophobia
- hypostasis of a century
- infiltration of a cornea
- eye pain
- increase in lachrymation
System:
Often
- a food faddism
Infrequently
- a post-nasal syndrome
- nausea
- dermatitis
- a herpetic keratitis, a herpes simplex of an optic nerve, barley
- hypersensitivity
-
the Contraindication headache
- hypersensitivity to ciprofloxacin and other drugs of group of hinolon
- pregnancy and the period of a lactation
- children's age up to 18 years.
Medicinal interactions
At simultaneous use of Tsiprolet® eye drops with other drugs of clinically significant medicinal interaction it is not established.
The special
instructions Drug for topical ophthalmologic administration not to use for injections or intake.
It is necessary to stop drop drug Tsiprolet® use eye at the first manifestations of skin rash or any other sign of hypersensitivity.
Lethal hypersensitivity reactions (anaphylactic reactions) serious in certain cases, sometimes after the first dose, were observed at the patients accepting system hinolona. Some reactions were followed by cardiovascular insufficiency, a loss of consciousness, pricking, edema of laryngeal or face, an asthma, a small tortoiseshell and an itching. Serious acute reactions of hypersensitivity demand immediate emergency treatment by epinephrine (adrenaline) and other measures of resuscitation, including intake of oxygen, intravenous solutions, intravenous antihistamines, kortikoid, vasoconstrictive factors and artificial ventilation of the lungs, in case of clinical need.
It is known of manifestation cases from the phototoxicity moderated to heavy degree in the form of reactions of a sunblister at the patients who were under direct sunshine during system reception of some representatives of a class of hinolon. It is necessary to avoid excessive sunlight. At manifestation of cases of phototoxicity it is necessary to stop treatment.
As well as with other antibacterial drugs, prolonged use can result in excess quantity of irresponsive bacterial strains or fungi. In case of superinfection it is necessary to begin the corresponding therapy.
At system treatment of a ftorkhinolonama, including ciprofloxacin, especially at elderly patients and at patients corticosteroids, possible cases of inflammation and the ruptures of sinews accepting in common. Therefore treatment by drops has to be stopped by eye Tsiprolet® at the first signs of inflammation of sinews.
Pregnancy
there Are no adequate data on drop drug Tsiprolet® use eye at pregnant women. Drop drug Tsiprolet® use eye during pregnancy is not recommended.
The lactation
At oral administration ciprofloxacin is found in breast milk. There are no reliable data about penetration of ciprofloxacin into breast milk at topical administration in eyes. As the majority of medicines is distinguished in breast milk, it is necessary to make the weighed decision on interruption of breastfeeding or termination/abstention of the Tsiprolet® drug treatment of a drop eye, considering advantages of breastfeeding to the child and advantage of treatment to the woman. At use of drug during breastfeeding it is necessary to stop feeding by a breast.
Contact lenses
of Tsiprolet® of a drop eye the benzalkoniya contains in quality of preservative chloride which can cause irritation of eyes and decolouration of soft contact lenses. Carrying contact lenses is not recommended during treatment of infections of eyes. Carrying contact lenses is not recommended to patients during treatment by eye drops of Tsiprolet®.
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.
Overdose
Symptoms: conjunctiva hyperaemia, pain
Treatment: it is plentiful to wash out under clear flowing water. If necessary carry out symptomatic therapy.
A form of release and packing
the Plastic bottle containing 5 ml of solution of ciprofloxacin in concentration of 3 mg/ml, completed with a kopachkom-dropper is placed in a cardboard box together with the instruction for use in the state and fair-haired languages.
To Store storage conditions in the dry, protected from light place at a temperature not over 25 of 0C.
To store in the places inaccessible for children!
2 years
After opening of a bottle drug to store a period of storage no more than 14 days!
After an expiration date not to apply.
Prescription status According to the prescription
"Dr. of Reddi's Laboratoris Ltd" Producer
India, Andhra Pradesh,
Mr. Hayderabad Adres of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
050057, Almaty, Dzhandosov St., 21,
post office box No. 7 ph./fax: (7272) 245-71-88
Name of the owner of the Registration certificate:
"The Dr. of Reddi's Laboratoris Limited", India
Adres of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
Representative office "Dr. of Reddi's Laboratoris Limited" in Republic of Kazakhstan, 050057 Almaty, 22nd Line St., 45,
a post office box 7, mobile phone number +77017633805, ph. 8 (727) 3941688, fax: 8 (727) 3941294
To develop
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