Tsiprofarm

General characteristics. Structure:

Active ingredient: ciprofloxacin;

1 ml of drug contains ciprofloxacin of a hydrochloride 3 mg in terms of ciprofloxacin;

excipients: benzalkoniya chloride; sodium dihydrophosphate, dihydrate; sorbite   (Е 420); water for injections.

Pharmacological properties:

Pharmacodynamics. Antimicrobic broad-spectrum agent of group of ftorkhinolon. Possesses bactericidal action which mechanism is caused by oppression DNK-girazy of bacteria with disturbance of synthesis of DNA, growth and cell fission.

Possesses a wide range of antimicrobic action with the greatest activity concerning gram-negative bacteria and less expressed influence on anaerobe bacterias. Highly active concerning the majority of gram-negative bacteria: Pseudomonas aeruginosa, Haemophilus influenzae, Escherichia coli, Shigella spp., Salmonella spp., Neisseria meningitidis, N. gonorrhoeae. It is active concerning many strains of Staphylococcus spp. (producing or not producing a penicillinase, metitsilin-resistant), some strains of Enterococcus spp., and also Campylobacter spp., Legionella spp., Mycoplasma spp., Chlamidia spp., Mycobacterium spp. Ciprofloxacin is active concerning the bacteria producing beta lactamelements.

Pharmacokinetics. At topical administration of drug therapeutic concentration of active ingredient is reached in fabrics and biological liquids of an eye or tissues of an ear.

Pharmaceutical characteristics

 

Main physical and chemical properties: transparent slightly yellowish-greenish liquid.

Incompatibility. The Tsiprofarm is incompatible with alkaline solutions (bases).

Indications to use:

Helcomas and superficial infections of an eye (eyes) and its appendages caused by the strains of bacteria sensitive to ciprofloxacin.

Acute otitis of an outside ear, and also acute otitis of a middle ear with drenazhy through a timpanostomichesky tube, caused by strains of the bacteria sensitive to ciprofloxacin.

Route of administration and doses:

Use in ophthalmology

Use for adults, including patients of advanced age.

Helcoma:

The Tsiprofarm should be applied within a day with such intervals, including night time:

1st day: to dig in 2 drops in a sore eye each 15 minutes within the first 6 hours, then on 2 drops each 30 minutes within the first days.

2nd day: to dig in 2 drops in a sore eye hourly.

From the 3rd to the 14th day to dig in 2 drops in a sore eye each 4 hours. If it is necessary to continue treatment more, than 14 days, the scheme of dosing is defined by the doctor.

At a helcoma treatment can continue more than 14 days, the scheme of dosing and duration of treatment are defined by the doctor.

Bacterial superficial infections of an eye and its appendages.

The standard dose makes 1-2 drops in a conjunctival sac of each affected eye 4 times a day. At heavy infections the dose can make 1-2 drops each 2 hours in the first 2 days in the afternoon. Usually treatment continues 7-14 days.

After instillation dense closing a century or lacrimonasal occlusion is recommended. It reduces system absorption of the medicine entered into an eye that reduces probability of system side effects.

In case of the accompanying therapy by other local ophthalmologic drugs it is necessary to observe an interval 10-15 minutes between their use.

Children. Dosing is same, as well as for adults.

For treatment of bacterial conjunctivitis at children 1 years Tsiprofarm are more senior apply 1-2 drops 3-4 times a day for 4 days.

To prevent pollution of a tip of a bottle and solution, it is necessary to be careful and not to touch centuries, adjacent sites or other surfaces a bottle tip.

Use in otology

Adults, including people of advanced age. The dose makes 4 drops of drug Tsiprofarm in acoustical pass twice a day. For adult patients who need use of earplugs the dose can be doubled only at the first use (i.e. 8 drops).

Generally, duration of treatment should not exceed 5-10 days. In certain cases treatment can be prolonged, but in that case it is necessary to check sensitivity of local microflora.

In case of the accompanying therapy by other local medicines it is necessary to observe an interval between their receptions 10-15 minutes.

Children. Safety and efficiency of ciprofloxacin, a thaw of eye/ear 3 mg/ml, at use in otology is established only for children 1 years are more senior. The drug dose Tsiprofarm makes 3 drops in acoustical pass twice a day. For children who need use of earplugs the dose can be doubled only at the first use (i.e. 6 drops).

To prevent pollution of a tip of a bottle and solution, it is necessary to be careful and not to touch an auricle or acoustical pass, adjacent body parts or other surfaces a bottle tip.

It is necessary to clean external acoustical pass carefully. To prevent vestibular stimulation, it is recommended to enter solution of room temperature or body temperature. The patient has to lie on an opposite side of rather sore ear. It is desirable to be in such situation within 5-10 minutes. Also after local clarification it is possible to enter the moistened tampon from a gauze into acoustical pass or from hydroscopic cotton wool for 1-2 days, but it needs to be moistened for saturation with drug 2 times a day.

Features of use:

It is necessary to stop drug use Tsiprofarm at emergence of the first symptoms of rash on skin or other signs of hypersensitivity reaction.

It was reported about serious, and sometimes and lethal cases of reaction of hypersensitivity (anaphylactic reactions) at patients who applied hinolona systemically, and at some patients after the first dose. Some reactions were followed by a cardiovascular collapse, a loss of consciousness, a pricking, hypostasis of a throat or person, диспноэ, urticaria and an itch. Heavy anaphylactic reactions demand urgent treatment using Epinephrinum and other resuscitation actions, including oxygen therapy, intravenous injections, intravenous administration of antihistaminic drugs, corticosteroids, the amines narrowing vessels, artificial ventilation of the lungs according to clinical indications.

Phototoxic action from average to heavy degree in the form of heavy sunblisters at patients who were affected by direct sunshine during system use of medicines of a class of hinolon was revealed. It is necessary to avoid excessive impact of sunlight. In case of phototoxicity treatment needs to be stopped.

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

At emergence of superinfection it is necessary to carry out the corresponding treatment.

Eye/ear drops Tsiprofarm contain a benzalkoniya chloride as preservative which can cause irritation. It is also known that this preservative can decolour soft contact lenses therefore before drug use Tsiprofarm patients have to remove contact lenses and wait 15 minutes after drug instillation Tsiprofarm before again putting on contact lenses.

According to the standard rule, use of contact lenses in the presence of an infection of eyes is undesirable.

At drug use the Tsiprofarm for treatment of otitis is recommended to conduct medical examination of patients for timely establishment of need of use of other therapeutic actions (system use of antibiotics, surgical treatment).

Ability to influence speed of response at control of motor transport or work with other mechanisms

 

As well as in case of use of other eye drops, the temporary illegibility of sight or other vision disorders can influence ability to manage motor transport or work with other mechanisms. If the illegibility of sight takes place, the patient needs to wait until sight is recovered before managing motor transport or other mechanisms.

After drug use Tsiprofarm in an ear it was not reported about any effects which influence ability to manage motor transport or to work with other mechanisms.

Side effects:

Disturbances from organs of sight: often – a sensation of discomfort, a white plaque (it was observed at patients with a helcoma and at frequent use of drug. The plaque appeared, as a rule, during the period from 24 hours to 7 days after an initiation of treatment and disappeared or at once, or for 13 days after the beginning of therapy), feeling of a foreign body, formation of scales / кристалликов, a hyperemia of a conjunctiva and an itch; in isolated cases – coloring of a cornea, a keratopathy/keratitis, allergic reactions, the century, dacryagogue, a photophobia, infiltration of a cornea and decrease in visual acuity swelled.

Disturbances from acoustic organs: often – an itch in an ear; in isolated cases – a ring in an ear.

Disturbance from skin: dermatitis.

Others: unpleasant smack in a mouth, nausea, a headache.

Interaction with other medicines:

There are data that simultaneous use of some system quinolines leads to increase in concentration of theophylline in a blood plasma, influences metabolism of caffeine and strengthens effect of peroral anticoagulants, such as warfarin and its derivatives.

In blood serum at patients who accepted cyclosporine together with system ciprofloxacin creatinine level temporarily increased. The Tsiprofarm is incompatible with alkaline solutions (bases).

Contraindications:

Hypersensitivity to hinolona or to auxiliary ingredients of solution. Viral and fungus diseases of an eye (eyes).

Overdose:

In case of drug overdose Tsiprofarm at topical administration in an eye it is necessary to wash up excess of drug from an eye (eyes) warm water.

In case of overdose of drug at topical administration in an ear the patient has to lay down, turn sideways and wait until excess of liquid flows out from an ear.

Use during pregnancy or feeding by a breast

 

As controlled researches with participation of pregnant women were not conducted, the Tsiprofarm should be applied during pregnancy only when the expected advantage for mother prevails over potential risk for a fruit.

There are no data on whether ciprofloxacin gets into breast milk after topical administration. Therefore mothers who nurse should be careful at Tsiprofarm appointment.

Children

 

Efficiency and safety at drug use are not established to children till 1 year.

Drug is used for treatment of children 1 years are more senior.

Storage conditions:

Period of validity. 3 years. A period of validity after opening of a bottle – 28 days. Not to use drug after the termination of the period of validity specified on packaging. To store in the place protected from light at a temperature from 8 ˚С to 25 ˚С. To store in the place, unavailable to children. Not to freeze.

Issue conditions:

According to the recipe

Packaging:

On 5 or 10 ml in a bottle. On 1 bottle enclosed in a pack.