SIPROMЕР eye drops

  • Trade name of the preparation: SIPROMER
  • Active ingredient (INN): ciprofloxacin
  • Dosage form: eye drops
  • Composition:
  • 1 ml solution contains:
  • active substance: ciprofloxacin (in the form of ciprofloxacin hydrochloride) – 3.0 mg;
  • excipients: benzalkonium chloride, disodium edetate, sodium chloride, hydrochloric acid, water for injection.
  • Description: clear liquid from colorless to light yellow.
  • Pharmacotherapeutic group: Agent primarily used in ophthalmology
  • ATX Code: S01AX13
Category:

Pharmacological properties 

A broad-spectrum antimicrobial agent, a derivative of fluoroquinolone. Ciprofloxacin inhibits bacterial DNA gyrase, disrupts DNA synthesis, growth and division of bacteria; causes pronounced morphological changes (including cell wall and membranes) and the rapid death of a bacterial cell.

It acts bactericidal on gram-negative microorganisms during dormancy and division (since it affects not only DNA gyrase, but also causes lysis of the cell wall), and gram-positive microorganisms only during the division period.

The low toxicity to macroorganism cells is explained by the absence of DNA gyrase in them. While taking ciprofloxacin, there is no parallel development of resistance to other antibiotics that do not belong to the group of gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics.

Gram-negative aerobic bacteria are susceptible to ciprofloxacin: enterobacteria (Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescensippa rfa, Haffa. , Morganella morganii, Vibrio spp., Yersinia spp.), Other gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campyunlobacterium. Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Corynebacterium diphtheriae; Gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae).

Most methicillin-resistant staphylococci are also resistant to ciprofloxacin. The sensitivity of Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium is moderate (high concentrations are required to suppress them).

Resistant to the drug: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides.

Resistance develops extremely slowly, because, on the one hand, after the action of ciprofloxacin there are practically no persistent microorganisms left, and on the other hand, bacterial cells have no enzymes that inactivate it.

The drug is ineffective against Treponema pallidum.

Pharmacokinetics                                                                                                                                   The registered maximum concentration of ciprofloxacin in blood plasma when using eye drops does not exceed 5 ng / ml, the average concentration is below 2.5 ng / ml.

Indications for use

– infectious and inflammatory eye diseases: acute and subacute conjunctivitis, blepharitis, blepharoconjunctivitis, keratitis, keratoconjunctivitis, bacterial corneal ulcer, chronic dacryocystitis, meibomite (barley);

– Infectious lesions of the eyes after injuries or foreign bodies;

– pre- and postoperative prevention of infectious complications in ophthalmic surgery.

Dosage and administration

For topical use only. The drug in the form of eye drops is not intended for intraocular injection. Before prescribing the drug, it is recommended to determine the sensitivity to microflora ciprofloxacin that caused the disease. For mild and moderately severe infections, 1-2 drops are instilled into the conjunctival sac of the affected eye every 2 hours for the first 2 days, then 1-2 drops every 4 hours for the next 5 days. After improvement, the dose and frequency of instillations are reduced. In case of bacterial corneal ulcer: 2 drops every 15 minutes for 6 hours into the affected eye, then 2 drops every 30 minutes during waking hours; on the 2nd day – 2 drops every hour; from 3 to 14 days – 2 drops every 4 hours during waking hours. If after 14 days of therapy epithelization has not occurred, treatment can be continued.

Side effects

Allergic reactions, itching, burning, mild soreness and conjunctival hyperemia are possible. Systemic side effects develop extremely rarely – dermatitis, nausea, taste disturbance.

Contraindications

– hypersensitivity to the components of the drug or to other drugs of the fluoroquinolone group;

– deficiency of glucose-6-phosphate dehydrogenase;

– age up to 18 years.

Drug interactions

The interaction of eye drops of ciprofloxacin with other drugs with simultaneous use was not detected.

Special instructions

The use of the drug should be discontinued if any signs of hypersensitivity appear. The drug should be prescribed with caution to patients with cerebral arteriosclerosis, cerebrovascular accident, convulsive syndrome. The patient should be informed that if, after prolonged use of the drug, conjunctival hyperemia continues or increases, its use should be discontinued and a doctor should be consulted. Wearing soft contact lenses is not recommended during treatment. When using hard contact lenses, they should be removed before using the drug and put on again after 15-20 minutes.

Pregnancy and lactation

The appointment of the drug during pregnancy is justified if the expected benefit to the mother is higher than the potential risk to the fetus. In order to avoid potential adverse effects on the newborn, breastfeeding during the treatment period should be discontinued.

Influence on the ability to drive vehicles and control mechanisms

The use of the drug can cause temporary visual impairment, therefore, it is recommended to abandon driving vehicles and control mechanisms immediately after using the drug.

Overdose

There are no data on an overdose of ciprofloxacin when used in the form of eye drops. In case of accidental use of the drug inside, the appearance of overdose symptoms is unlikely due to the low concentration of ciprofloxacin in the unit form of release relative to the maximum daily dose.

Release form

5 ml solution in plastic bottles.

1 bottle in a cardboard box or 50 bottles in a cardboard box, along with instructions for use in a cardboard box.

Storage conditions

Store in a dry, dark place at a temperature of no higher than 25 ° C.

The drug should be stored out of the reach of children.

Shelf life

2 years. Do not use after expiration date.

Pharmacy sales terms

On prescription.