Signicef, eye drops 0.5% 5 ml

The main active ingredient of the drug is levofloxacin, which is the L-isomer of the antibacterial agent of the II generation of fluoroquinolones group of Ofloxacin.

The drug is active against Gram-negative (Branhamella catarrhalis, Neisseria gonorrhoeae, Haemophilus influenzae, Pseudomonas aeruginosa) and Gram-positive (Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus pyogenes) anaerobes. Another microflora sensitive to levofloxacin is Chlamydia trachomatis. The maximum concentration of levofloxacin achieved with the use of eye drops exceeds the values of the minimum inhibitory concentration of this active substance for sensitive microorganisms by more than a hundred times.

After instillation directly into the eye, levofloxacin is able to retain well in the tear film, causing persistent therapeutic action.

Pharmacokinetics

Levofloxacin is well maintained in the tear film after instillation into the eye. The concentration of levofloxacin in the tear fluid after a single dose (1 drop) quickly reaches high values and is maintained above the MIC for most sensitive ocular pathogens (less than or equal to 2 µg/ml) for at least 6 hours.

In studies on healthy volunteers, 5 of 6 subjects were shown to have levofloxacin concentrations of 2 µg/mL or higher 4 h after instillation. In 4 of 6 subjects this concentration was maintained 6 hours after instillation.

The mean plasma concentration of levofloxacin 1 h after administration ranged from 0.86 ng/ml in the first day to 2.05 ng/ml. Cmax of levofloxacin in plasma equal to 2.25 ng/ml was detected on the fourth day after two days of using the drug every 2 hours up to 8 times a day.

The Cmax of levofloxacin achieved on day 15 is more than 1,000 times lower than concentrations observed after oral administration of standard doses of levofloxacin.

Indications

Active ingredient

Composition

1 ml – levofloxacin (in hemihydrate form) 5 mg.

Auxiliary substances:

benzalkonium chloride,

hypromellose,

sodium chloride,

sodium hydroxide,

hydrochloric acid,

d/i water.

How to take, the dosage

Topically, in the affected eye.

1-2 drops in the affected eye(s) every two hours up to 8 times a day while awake for the first 2 days, then four times a day from day 3 to day 5. The duration of treatment is determined by the doctor, usually 5 days.

Interaction

Special studies on the interaction of Signif 0.5% eye drops have not been conducted.

Because the maximum plasma concentration of levofloxacin after topical application in the eye is at least 1000 times lower than after standard oral doses, the interaction with other drugs typical for systemic use is clinically insignificant.

Special Instructions

Signicef should not be instilled subconjunctivally or into the anterior chamber of the eye.

If other ophthalmologic agents are used at the same time with this drug, the interval between instillations should be at least 15 min. Signicef should not be administered simultaneously with antacids, the interval between the use of these drugs should be at least 2 hours.

When wearing soft hydrophilic lenses SIGNITZEF is not recommended due to the presence of benzalkonium chloride in the drug. This preservative is able to be absorbed by the contact lenses, causing adverse effects on the eyes and discoloration of the lenses themselves.

In order to avoid contaminating the tip of the dropper or solution, refrain from touching the eye during placement.

Contraindications

In children and adolescents under 18 years of age, the drug is prescribed with caution.

Side effects

Side effects may occur in about 10% of patients. Frequent side effects (1-10% of patients) are decreased visual acuity and mucous clots.

Rare side effects (0.1-1% of patients) – blepharitis, chemosis, papillary growths on conjunctiva, edema of eyelids, discomfort in the eye, burning and itching in the eye, visual impairment, pain in the eye, conjunctival hyperemia, mucous discharge, conjunctival folliculosis, “dry eye” syndrome, erythema of eyelids, contact dermatitis, photophobia and allergic reactions, headache, rhinitis.

Overdose

The total amount of levofloxacin contained in one bottle of eye drops is too low to cause toxic reactions even after accidental ingestion.

Symptoms: there may be increased side effects.

Treatment: After topical application of excessive doses of Signif 0.5% eye drops, the eyes should be rinsed with clean water at room temperature.

Pregnancy use

It is contraindicated in pregnancy and lactation, children under 1 year of age.

The drug should be used with caution in children and adolescents under 18 years of age.

Similarities