Tsipromed 5 ml of 0.3% eye drops

The instruction
for medical use


of TsIPROMED medicine
the Trade name
Tsipromed

Mezhdunarodnoye the unlicensed


name Ciprofloxacin Dosage Form
of the Drop eye 0.3%

Structure
of 1 ml of drug contains
active agent - ciprofloxacin (in the form of hydrochloride ciprofloxacin) – 3 mg,
excipients: a benzalkoniya chloride, dinatrium edetat, sodium chloride, sodium hydroxide, acid chlorohydrogen, water for injections.

The description
Transparent solution from colourless till light yellow color.

Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Antimicrobial drugs others. Ciprofloxacin.
The ATX S01AX13 code

the Pharmacological

Pharmacokinetics Ciprofloxacin properties at topical administration in the form of eye drops well gets into eye tissues. After single instillation its concentration in moisture of an anterior chamber of an eye in 10 minutes makes 0.1 mg/ml. The maximum concentration in moisture of an anterior chamber defined in 1 hour also makes 0.19 mg/ml. After 2 hours the concentration begins to decrease, however its antibacterial action in fabrics of a cornea remains till 6 o'clock, in moisture of an anterior chamber till 4 o'clock. At treatment within 7 days, on average, 4 times a day in both eyes, average concentration makes less than 2 ng/ml.
After instillation the system absorption of drug is possible.
Elimination half-life at topical administration makes 4-5 hours of blood serum. Drug is removed through kidneys mainly (up to 50%) in not changed look and up to 10% in the form of metabolites, about 15% are removed through intestines, at the nursing mothers - is partially removed with breast milk.
The pharmacodynamics
Ciprofloxacin - antibacterial drug from group of ftorkhinolon, possesses a wide range of antibacterial action, renders bactericidal effect. Drug inhibits DNK-girazu enzyme of bacteria owing to what DNA replication and synthesis of cellular proteins of bacteria is broken. Ciprofloxacin affects both the breeding microorganisms, and on being in a rest stage.
The range of antibacterial effect of ciprofloxacin includes gram-negative microorganisms: Esherichia coli, Salmonella spp., Shigella spp., Proteus spp. (indolpositive and indolnegative), Morganella morganii, Citrobacter spp., Klebsiella spp., Enterobacter spp., Vibrio spp., Campylobacter spp., Hafnia spp., Providencia stuartii, Haemophilus influenzae, Pasteurella multocida, Pseudomonas spp., Gardnerella spp., Legionella pneumophila, Neisseria spp., Moraxella catarrhalis, Acinetobacterspp., Brucella spp., Chlamidia spp.
Also gram-positive microorganisms are sensitive to ciprofloxacin:
Staphylococcus spp., Streptococcus pyogenes, St. Agalactiae, Corynebacterium diphtheriae, Listeria monocitogenes. Drug malotoksichen.

Indications
Bacterial inflammatory diseases of an eye and its appendages
- acute and subacute conjunctivitis
- a keratitis
- a front uveitis
- blepharitis and other inflammatory diseases a century
- a dacryocystitis
- prevention and treatment of infectious complications after wounds of an eye and its appendages and at eyeball surgeries

the Route of administration and doses
Locally. Drug is dug in on 1-2 drops in a conjunctival sac. Frequency of instillations depends on weight of inflammatory process.
In acute bacterial conjunctivitis, simple, scaly and ulcer blefarita Tsipromed appoint from 4th to 8 times a day depending on disease severity. Course of treatment from 5 to 14 days.
In a keratitis drug is appointed on 1 drop not less than 6 times a day, with positive effect the maximum course of treatment depending on weight of defeat of a cornea makes 2-4 weeks.
At defeat of a cornea a pyocyanic stick Tsipromed appoint as often as possible - not less than 8-12 times a day on 1 drop. The course of treatment depends on the course of the disease and usually makes about 2-3 weeks.
In front uveites drug is dug in by 8-12 times a day on 1 drop.
In acute dacryocystites and canaliculites Tsipromed appoint 6-12 times a day, at chronic - 4-8 times a day on 1 drop.
In wounds of an eye and its appendages for prevention of consecutive infection Tsipromed appoint within 1-2 weeks on 1 drop of 4-8 times a day.
For prevention of inflammatory diseases after surgical interventions with perforation of an eyeball Tsipromed appoint 4-6 times a day on 1 drop to all term of the postoperative period, usually from 5 days to 1 month.

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
- the keratitis, a keratopathy, coloring of a cornea
- an eye allergy
- decrease in visual acuity, misting of sight, a photophobia
- swelled centuries
- 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 components of drug or to other hinolona
- children's age up to 8 years

Medicinal interactions
Solution of ciprofloxacin is incompatible with medicines with value rn 3-4 which physically or are chemically unstable.

The special
instructions Drug for topical ophthalmologic administration not to use for injections or intake.
It is necessary to stop drop drug Tsipromed 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 eye Tsipromed has to be stopped at the first signs of inflammation of sinews.
Pregnancy and the period of a lactation
Tsipromed should be applied during pregnancy only in case the potential advantage for mother exceeds possible risk for a fruit.
At use of drug during breastfeeding it is necessary to stop feeding by a breast.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Right after burying drug decrease in clearness of sight and delay of mental reactions is possible that can reduce ability to active participation in traffic, service of cars or to performance of work without support. In a bigger degree it takes place at simultaneous use of drug with alcohol.

Overdose
Symptoms: At accidental reception of Tsipromed inside specific symptoms are absent. Nausea, vomiting, diarrhea, a headache, a faint, feeling of alarm are possible.
Treatment: it is plentiful to wash out under clear flowing water. If necessary carry out symptomatic therapy.

Form of release and packing
of the Drop eye 0.3%.
On 5 ml of drug in plastic bottles droppers.
On 1 bottle dropper together with the screw-on cap in which there is a device for opening of a bottle and with the instruction for medical use in the state and Russian languages place in a cardboard pack.


To Store storage conditions in the place protected from light at a temperature not above 25 °C.
Not to freeze.
To store out of children's reach!

A period of storage
2 years
the use Period after opening of a bottle 1 month.
Not to use after the expiry date specified on packing!

Prescription status
According to the prescription


of Proizvoditel SENTISS FARM Pvt. Ltd.
212/D-1, Greene Park, New Delhi, India
At the plant: Villidzh Khera Nikhla, Tekhsil Nalagarkh, Region of Solan, Himachal Pradesh 174,101, India

Name and country of the owner of the registration certificate
of SENTISS FARMA of Pvt. Ltd., India

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Republic of Kazakhstan, 050000, Almaty, Bogenbay St. of the Batyr 132, office 309
Ph./fax: +7 (7272) 96-45-99
Email:

To Develop sentiss_kz@land.ru