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  • Сіз мындасыз:  

цифрофлоксацин

CYPROFLOXACIN-DF

eye drops 0.3%, 10 ml

Dispensing conditions: PRESCRIPTION ONLY

 

Фарм.тобы: Medications for eye diseases

THERAPEUTIC INDICATIONS:

  • Infectious and inflammatory eye diseases caused by pathogens sensitive to the product:

  • infections of the eye(s) and its appendages: conjunctivitis, keratitis, corneal ulcer;

  • prevention of postoperative infectious complications in ophthalmology.

dwldDownload instructions for use

 

Composition

1 ml of the solution contains

  • active substance - ciprofloxacin hydrochloride 3.33 mg (equivalent to 3.00 mg of ciprofloxacin)  
  • excipients: benzalkonium chloride, sodium dihydrophosphate dihydrate, sorbitol, water for injection.

Pharmaceutical form

Eye drops 0.3%, 10 ml

Pharmacotherapeutic group

Sense organs. Medications for ophthalmologic and otologic diseases. Antimicrobials. Ciprofloxacin.

ATC code S03АА07

Indications

  • Infectious and inflammatory eye diseases caused by pathogens sensitive to the product:
  • infections of the eye(s) and its appendages: conjunctivitis, keratitis, corneal ulcer;
  • prevention of postoperative infectious complications in ophthalmology.

The use of the medicine should be guided by the proper use of antibacterial agents.

Contraindications

  • hypersensitivity to quinolones or excipients of the solution;
  • viral and fungal eye diseases;
  • children under 8 years of age.

Posology and method of administration

Elderly.

Corneal ulcer:

  • Day 1: instill 1 drop in the affected eye every 15 minutes for the first 6 hours, then 1 drop every 30 minutes during waking hours.
  • Day 2: instill 1 drop in the affected eye hourly during waking hours.
  • Day 3 to 14, instill 1 drop in the affected eye every 4 hours of waking time.

If it is necessary to continue treatment for more than 14 days, the dosing regimen is determined by the doctor.

Infections of the eye(s) and its appendages:

The standard dose is 1-2 drops in the conjunctival sac of each affected eye 4 times a day. In severe infections, the dose may be 1-2 drops every 2 hours. After the condition improves, the dose and frequency of instillations are reduced. The duration of treatment should not exceed 5-10 days.

After instillation, a tight eyelid closure or nasolacrimal occlusion is recommended. This reduces the systemic absorption of the product instilled into the eye, which reduces the likelihood of systemic side effects.

In case of concomitant therapy with other topical ophthalmic drugs it is necessary to observe an interval of 10-15 minutes between their application.

Pediatric population. Dosing for children over 8 years of age is the same as for adults.

To prevent contamination of the bottle tip and solution, be careful not to touch the eyelids, adjoining areas or other surfaces with the bottle tip.

Adverse reactions

Eye disorders

Common:

  • feeling of discomfort, white plaque (observed in patients with corneal ulcer if the product is used frequently);
  • The plaque usually appeared within 24 hours to 7 days after the start of treatment and disappeared either immediately or within 13 days after the start of therapy.
  • feeling of a foreign body, formation of scales/crystals;
  • itching, burning, mild soreness, and hyperemia of the conjunctiva.

In individual cases:

  • corneal staining, keratopathy/keratitis;
  • allergic reactions;
  • eyelid swelling, lacrimation, photophobia, corneal infiltration, and decreased visual acuity.

Other:

  • unpleasant taste in the mouth, nausea, headache;
  • dermatitis;
  • development of superinfection.

Overdose

In case of overdose of Ciprofloxacin-DF when applied topically to the eye, the eye(s) should be flushed with warm water.

Use during pregnancy or breastfeeding

Since no controlled studies have been conducted in pregnant women, Ciprofloxacin-DF should be used during pregnancy only when the expected benefit to the mother outweighs the potential risk to the fetus.

There is no information about whether ciprofloxacin penetrates into breast milk after topical administration. Therefore, caution should be exercised when prescribing Ciprofloxacin-DF to lactating mothers.

Pediatric population

Do not use in children under 8 years of age.

Special warnings

The solution in the form of eye drops is not intended for intraocular injections. If other ophthalmic drugs are used, the interval between instillations should be at least 5 minutes.

Ciprofloxacin-DF should be discontinued if the first signs of a skin rash or other signs of a hypersensitivity reaction appear.

Serious and sometimes fatal hypersensitivity reactions (anaphylactic reactions) have been reported in patients who have used quinolones systemically, and in some patients after the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, swelling of the throat or face, dyspnea, urticaria, or itching. Severe anaphylactic reactions require immediate treatment with epinephrine and other resuscitation measures, including oxygen therapy, intravenous infusions, intravenous administration of antihistamines, corticosteroids, vasoconstrictor amines, artificial pulmonary ventilation according to clinical indications.

A moderate to severe phototoxic effect in the form of severe sunburn has been found in patients who were exposed to direct sunlight during systemic administration of quinolone class drugs. Excessive exposure to sunlight should be avoided. If phototoxicity occurs, treatment should be stopped.

Prolonged use of ciprofloxacin, as well as any other antibacterial drugs, may lead to activation of growth of microorganisms insensitive to it, including fungi.

If superinfection occurs, appropriate treatment should be given.

Ciprofloxacin-DF eye drops contain benzalkonium chloride as a preservative, which may cause irritation. It is also known that this preservative may discolor soft contact lenses, so patients should remove their contact lenses and wait 15 minutes after instillation of Ciprofloxacin-DF before putting contact lenses back on.

As a general rule, it is undesirable to use contact lenses if you have an eye infection.

Effects on ability to drive and use machines

As with other drops, temporary blurred vision or other visual impairment may affect your ability to drive or operate machinery. If there is blurred vision, the patient should wait until vision is restored before driving motor vehicles or other machinery.

Presentation and package

10 ml of the product in plastic dropper bottles, sealed with tamper-proof caps. A bottle with instructions for use in the state and Russian languages are placed in a carton pack.

Storage conditions

Store in a place protected from light, at a temperature below 25°С.

Do not freeze.

Keep out of the reach of children.

Shelf life

3 years

The period of use of the product after opening the bottle is 28 days.

Manufacturer

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan, tel.: (727) 253-03-88.

Marketing authorization holder

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan.

Name, address, contact information of the organization accepting claims (proposals) against quality of products from consumers in the territory of the Republic of Kazakhstan, which is responsible for post-authorization safety surveillance of the medicine:

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan,

Tel./Fax: (727) 253-07-07, 253-03-88, e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра.

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