Oftaquix eye drops 5mg/ml 5ml №1

Name:
Oftakviks solution (to-li ch.) 5mgml in vial 5ml with a drip tip in pack No. 1
Description:
Transparent from light yellow to light greenish-yellow color solution that does not contain visible inclusions. The main active ingredient Levofloxacin Release formSolution/eye drops 5 mg/ml. 0.3 ml solution in a dropper tube for a single use. 10 dropper tubes soldered in the form of a plastic tape are put into three-layer laminated paper bags. 1 package together with instructions for use is placed in a cardboard box. Dosage 5 mg / 1 ml 5 ml Special instructions In the event of any transient visual impairment, patients should be advised to wait until vision is restored, and only then drive a car or operate mechanical equipment. Pharmacological action Antimicrobial drug from the group of fluoroquinolones. Levofloxacin is the L-isomer of the racemic drug substance ofloxacin. The antibacterial activity of ofloxacin relates mainly to the L-isomer. Levofloxacin blocks DNA gyrase and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall, and membranes. Active against gram-negative aerobes: Branchamella (Moraxella) cataralis, Haemophilus influenzae, Neisseria gonorrhoeae, Pseudomonas aeruginosa; gram-positive aerobes: Staphyloccocus aureus, Streptococcus pneumoniae, Streptococcus pyogenes. Pharmacokinetics After instillation into the eye, levofloxacin is well preserved in the tear film. In studies on healthy volunteers, it was shown that the average concentrations of levofloxacin in the tear film, measured 4 and 6 hours after topical application, were 17 μg / ml and 6.6 μg / ml, respectively. In five of the six subjects, levofloxacin concentrations were 2 µg/ml or higher 4 hours after instillation. In four out of six subjects, this concentration was maintained 6 hours after instillation. The average concentration of levofloxacin when using Oftaquix eye drops in aqueous humor is statistically significantly (p=0.0008) higher than the average concentration of ofloxacin (1139.9±717.1 ng/ml and 621.7±368.7 ng/ml, respectively). The average concentration of levofloxacin in plasma 1 hour after administration is from 0.86 ng/ml to 2.05 ng/ml. Cmax of levofloxacin in plasma, equal to 2.25 ng / ml, was detected on the fourth day after 2 days of using the drug every 2 hours up to 8 times / day. The Cmax of levofloxacin reached on the fifteenth day was more than 1000 times lower than the concentration observed after oral administration of standard doses of levofloxacin. Indications for use Topical treatment of superficial bacterial infections of the eye caused by microorganisms sensitive to levofloxacin in adults and children aged 1 year and older. Official guidance on the appropriate use of antibacterial agents should be taken into account. Oftaquix is indicated for use in adults, children aged 1 to 12 years and adolescents aged 12 to 18 years. Dosage and administration Locally, instilled into the affected eye. During the first two days during wakefulness – every 2 hours, 1-2 drops in the affected eye, up to 8 times / day. From the 3rd to the 5th day of treatment – 1-2 drops in the affected eye 4 times / day. The duration of the course of treatment is determined by the doctor and is usually 5 days. Use during pregnancy and lactation Pregnancy: There are no adequate data on the use of levofloxacin in pregnant women. Conducted animal studies are insufficient with regard to effects on pregnancy, embryonic development and the fetus, as well as on childbirth and postpartum development of the newborn. The potential risk of the drug to humans is unknown. Oftakviks® eye drops, 5 mg/ml, can be used during pregnancy if the expected benefit to the mother outweighs the possible risk to the fetus. Breast-feeding: Levofloxacin passes into breast milk. However, when using Oftaquix® at therapeutic doses, no effects on the infant are expected. Oftaquix® eye drops, 5 mg/ml, may be used during breastfeeding if the potential benefit to the mother outweighs the potential risk to the nursing infant. Precautions: Oftaquix® eye drops, 5 mg/ml, must not be administered subconjunctivally or directly into the anterior chamber of the eye. Fluoroquinolones for systemic use can cause allergic reactions even after a single use. If an allergic reaction to levofloxacin occurs, the use of eye drops should be discontinued. As with other antimicrobial agents, prolonged use of the drug may lead to the growth of resistant strains of microorganisms, including fungi. If there is a worsening of infectious manifestations or after a certain period of clinical improvement is not observed, it is necessary to stop using the drug and prescribe an alternative therapy. With the simultaneous use of other ophthalmic agents, the interval between instillations should be at least 15 minutes. If symptoms of a superficial bacterial eye infection are present, patients should not wear contact lenses. To avoid contamination of the dropper tip and solution, do not touch the eyelids and tissues around the eye with the dropper tip. Interaction with other drugs: Special studies on the interaction of Oftaquix eye drops have not been conducted. Since the maximum plasma concentration of levofloxacin after topical application in the eye is at least 1000 times lower than after standard oral doses, interactions with other drugs that are characteristic of systemic use are most likely not clinically significant. Contraindications Hypersensitivity to the active substance – levofloxacin, other quinolones or any excipient. Composition 1 ml of eye drops contains: Active substance: 5.12 mg of levofloxacin hemihydrate, equivalent to 5.0 mg of levofloxacin. Excipients: Sodium chloride, hydrochloric acid or sodium hydroxide, water for injection. Overdose The total amount of levofloxacin contained in one bottle of eye drops is too small to cause toxic reactions even after accidental ingestion. After topical application of an overdose of Oftaquix eye drops, the eyes should be rinsed with clean (tap) water at room temperature. Side effects Side effects may occur in approximately 10% of patients. Often (1-10%): burning sensation in the eye, decreased visual acuity, the appearance of mucous cords. Rare (0.1-1%): blepharitis, chemosis, papillary growths on the conjunctiva, eyelid edema, discomfort in the eye, itching in the eye, pain in the eye, conjunctival hyperemia, the appearance of follicles on the conjunctiva, dry eye syndrome, erythema of the eyelids, eye irritation , contact dermatitis, photophobia and allergic reactions. Other: during clinical trials – headache, rhinitis. Storage conditions Store below 25°C. Keep out of the reach of children. Buy Oftaquix eye drops 5mg/ml 5ml №1