for medical use
of OFTAKVIKS® medicine
the Trade name
the International unlicensed
name Levofloxacin Dosage Form
of the Drop eye 5mg/ml
of 1 ml of solution contains
active agent – a levofloksatsin gemigidrat – 5.12 mg (5.0 mg of a levofloksatsin are equivalent),
excipients: sodium chloride, acid chlorohydrogen, sodium hydroxide, water for injections.
Transparent solution from light yellow till light-chartreuse color without mechanical inclusions.
Drugs for treatment of diseases of eyes. Antimicrobial drugs. Levofloxacin.
The ATX S01AX19 code
Pharmacokinetics Later properties of instillation in an eye levofloxacin well remains in a plaintive film. Average concentration of a levofloksatsin in a plaintive film in 4 and 6
hours after topical administration makes 17.0 mkg/ml and 6.6 mkg/ml respectively.
Average concentration of a levofloksatsin of eye drops of Oftakviks® in watery moisture is approximately twice higher, than average concentration of an ofloksatsin (1139.9 ± 717.1 ng/ml and 621.7 ± 368.7 ng/ml respectively).
Average concentration of a levofloksatsin in blood plasma in 1 hour after use – from 0.86 ng/ml in the 1st day up to 2.05 ng/ml for 15 day. The maximum concentration of a levofloksatsin in plasma, equal 2.25 ng/ml, is revealed for the 4th day after two days of use of drug each 2 hours up to 8 times a day. The maximum concentration of a levofloksatsin increased from 0.94 ng/ml in the 1st day up to 2.15 ng/ml for the 15th day that is 1000 times lower, than its concentration after intake of standard doses of a levofloksatsin. Bioabsorption high – from 60 do100%.
of Oftakviks® whose active ingredient is levofloxacin is left-handed isomer of racemic substance of an ofloksatsin. The antibacterial activity of an ofloksatsin is mainly caused by left-handed isomer.
The action mechanism
As antibacterial drug of a class of ftorkhinolon, levofloxacin selectively inhibits bacterial II topoisomerase – DNK-girazu and topoisomerase IV. Preferable targets of a levofloksatsin in gram-negative bacteria is DNK-giraza, and in gram-positive topoisomerase IV. It is effective concerning the following microorganisms:
Aerobic gram-positive: Staphylococcus aureus (MSSA) *, Staphylococcus pneumoniae, Staphylococcus pyogenes, Viridans group streptococci
Aerobic gram-negative: Escherichia coli, Branhamella (Moraxella) catarrhalis, Haemophilus influenzae, Pseudomonas aeruginosa (local cultures)
of Chlamydia trachomatis (treatment of patients with chlamydial conjunctivitis demands the accompanying system antimicrobic therapy)
Vida .dlya which the acquired stability can be a problem
Aerobic gram-positive microorganisms: Staphylococcus aureus (MRSA) **, Staphylococcus epidermidis
Aerobic gram-negative microorganisms: Pseudomonas aeruginosa (hospital strains)
* MSSA = Methicillinum – sensitive strains of Staphylococcus aureus
** MRSA = Methicillinum – resistant strains of Staphylococcus aureus
– treatment of superficial bacterial infections
– prevention of complications after surgical and laser eye surgeries
the Route of administration and doses
Locally – on 1-2 drop in one or both struck eyes each 2 hours up to 8 times a day within the first 2 days, then 4 times a day within the next 3-5 days. Usually duration of treatment is 5 days. Increase in a course of treatment up to 2 weeks is in certain cases possible.
At simultaneous use of other ophthalmologic means the interval between instillations has to be at least 15 minutes.
To avoid solution pollution, it is not necessary to touch with a tip of a dropper by centuries and fabrics around an eye.
One tube dropper is enough contents for instillation in both eyes.
Side effects can arise approximately at 10% of patients. Side effects, as a rule, are shown in an easy or moderate form, have passing character and are usually limited to ophthalmologic symptoms.
The general (³1/100 & lt, 1/10)
– burning sensation in eyes
– decrease in visual acuity
– emergence of slime in the form of tyazhy
Rare (³1/1.000 & lt, 1/100)
– blepharitis, hemoz, conjunctival papillary reaction, swelled centuries, discomfort, an itching and eye pain, conjunctiva hyperaemia, conjunctiva follicles, xerophthalmus, an erythema a century, photophobia
– a headache
Very rare (³1/10.000, & lt, 1/1.000)
– extraocular allergic reactions, including skin rash
Extremely rare (& lt, 1/10.000), (including separate messages)
– an anaphylaxis
the Contraindication laryngeal edema
– hypersensitivity to active agent — a levofloksatsin, other hinolona or any filler
– children’s age till 1 year
are not established
Eye drops of Oftakviks®, 5 mg/ml cannot be entered subkonjyunktivalno. Eye drops should not be instillirovat directly in an anterior chamber of an eye.
Ftorkhinolona for system use can cause allergic reactions even after single use. At emergence of allergic reaction to levofloxacin it is necessary to stop use of eye drops.
As concerning all antimicrobic means, prolonged use of Oftakviksa® can lead to growth of resistant microorganisms, including fungi. If there is a deterioration in infectious manifestations or later a certain period of clinical improvement is not observed, it is necessary to stop use of drug and to appoint alternative therapy.
In the presence of symptoms of a superficial bacterial infection of eyes the patients should not use contact lenses.
Safety and efficiency of drug at treatment of a helcoma and gonococcal conjunctivitis of newborns are not studied.
Use for elderly: Change of a dosage is not required.
Pregnancy and the period of a lactation
Eye drops of Oftakviks®, 5 mg/ml it is possible to apply during pregnancy and feeding by a breast if the potential advantage for mother exceeds possible risk for the baby and a fruit.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
in case of any passing disorders of vision to the patient should recommend to be waited while the sight is not normalized, and only then to drive the car or to operate the mechanical equipment.
the Total number of a levofloksatsin which is contained in one tube dropper of eye drops is not enough to cause toxic reactions after accidental intake. After topical administration of an excess dose of eye drops of Oftakviks®, 5 mg/ml of eyes can be washed with clear water of room temperature.
A form of release and packing
On 0.5 ml of solution in a disposable polyethylene tube dropper with the screw-on cap. On the 10th tube droppers place in a package from aluminum foil. On 1 package together with the instruction for medical
use in the state and Russian languages place in a cardboard box.
To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!
After the first opening of a package about a tube droppers to use a period of storage within 3 months.
Not to use after the expiration date specified on packing.
According to the prescription
JSC Santen Producer, Finland, Tampere, 33720 Niittyhaankatu, 20 according to the license of Daychi Sankio Co. Ltd., Japan
the Name and the country of the owner of the registration certificate
of JSC Santen, Finland
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Representative office of JSC Canten in
Kazakhstan Almaty, Zheltoksan St., 129/65 quarter
56 Phone number –
250-39-17 Fax number – 250-39-17
E-mail address: email@example.com