Name:
Floxal eye drops 3mg/ml in vial 5ml in pack No.1
Description:
Plastic bottle (5 ml) with dropper and screw cap. The main active ingredient Ofloxacin Release form Drops Dosage 3 mg / ml Pharmacological properties Pharmacodynamics Mechanism of action: A quinolonic acid derivative (ofloxacin) is a fluorine-substituted quinolone (gyrase inhibitor) with a bactericidal effect. Control points: The primary classification of bacteria according to their susceptibility or resistance was based on the recommendations set out in document 1 DIN 58940-4 (2004): ofloxacin (susceptibility < 1 mg/l, resistance > 2 mg/l). Antibacterial Spectrum: Ofloxacin’s spectrum of activity includes obligate anaerobes, facultative anaerobes, aerobes, and other pathogens such as Chlamydia. With topical application of ofloxacin, partial adsorption is possible, but this does not lead to any clinical or pathological changes. The distribution of acquired resistance in individual species may change geographically and over time. Therefore, case-by-case information on resistance is very important in order to respond to serious infections in a timely manner. If, due to local resistance, the use of ofloxacin is called into question, at least for some types of infections, appropriate studies should be carried out. Microbiological examination, including identification of the pathogen and its susceptibility to ofloxacin, is desirable, especially in the presence of serious infections or therapeutic error. The information below is from 35 German centers and is based on resistance studies including 1470 individual cases. The aerobic bacteria mentioned here provide a clear picture of the pathogens that can and should be considered as a source of eye infections in Germany. It can be assumed that the number of bacterial species that cause ophthalmic infections in other countries is, if not identical, then similar. Therefore, the pathogens mentioned below are the most common causative agents of bacterial infections of the external eye in these countries as well. Resistance data are based on the above breakpoints, which are related to systemic use. When applied topically to the eye, a much higher concentration of the antibiotic is achieved. Therefore, clinical efficacy is noticeable even in relation to those pathogens that are considered resistant in the laboratory. Species with normal susceptibility (<10% resistance) Gram-positive aerobes Staphylococcus aureus (MSSA) Bacillus spp Gram-negative aerobes Acinetobacter baumannii Acinetobacter Iwoffii Enterobacter cloacae Escherichia coli Haemophilus influenzae Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae Moraxella catarrhcenalis Proteus miracesbilis for use (resistance > 10%) Gram-positive aerobes Corynebacterium spp. Enterococcus faecalis Staphylococcus aureus (MRSA) Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative aerobes Pseudomonas aeruginosa Stenotrophomonas maltophilia Species resistant to Enterococcus spp ciliary body and anterior chamber of the eye. Repeated application also induces therapeutic concentrations in the vitreous. The application of Floxal five times at 5-minute intervals causes a concentration of ofloxacin in human aqueous humor of 1.2-1.7 pg/ml after 60-120 minutes. This value decreases to 0.8 pg/ml after three hours. Depending on the frequency of application, the concentration of the active substance in the aqueous liquid decreases to zero after 5-6 hours. Based on the results of animal studies, it can be assumed that the remaining tissues of the eye contain higher concentrations of the drug than the aqueous humor. Since ofloxacin can bind to melaninated tissues, a delayed elimination of the substance from these tissues should be expected. Systemically adsorbed ofloxacin exhibits a plasma half-life of 3.5 to 6.7 hours. Preclinical safety data No toxicological effects have been observed with topical application of ofloxacin. The local persistence of Floxal was good to very good even after frequent use at short intervals and over long periods of use. Numerous in vitro and in vivo tests conducted to induce gene and chromosome mutations have shown negative results. Animal studies to evaluate carcinogenic potential have not been conducted. There was no evidence of a cataractogenic or cocataractogenic effect. Ofloxacin does not reduce fertility, does not affect perinatal and postpartum development, and is not teratogenic. After the systemic use of ofloxacin, degenerative changes in the articular cartilage were found in laboratory animals. Articular cartilage damage was dose and age dependent. (The younger the animals were, the more obvious the damage was.) Excipients Benzalkonium chloride, sodium chloride, hydrochloric acid and sodium hydroxide solution (to create the required pH value), water for injection. Indications for useInfections of the anterior part of the eye caused by microorganisms sensitive to ofloxacin: chronic conjunctivitis, keratitis, corneal ulcer and chlamydia. Dosage and administration Unless otherwise indicated, apply 1 drop 2-4 times a day. For ophthalmic use. Treatment with Floxal eye drops should not exceed two weeks. Please note: When using Floxal with other eye drops/eye ointments, a 15-minute interval must be observed, and Floxal should be used last. Use during pregnancy and lactation There is no evidence of the harmful effects of ofloxacin on the fetus, but it is not recommended to use the drug during pregnancy and lactation. Precautions It is not recommended to wear soft contact lenses during the use of the drug. Benzalkonium chloride may cause eye irritation. Benzalkonium chloride may cause discoloration of soft contact lenses. It is recommended to remove contact lenses before using Floxal. It is possible to put on contact lenses again no less than 15 minutes after using the drug. Interaction with other drugs. Other forms of interaction Drug interaction of the drug is not described. Interaction with other drugs Not described Contraindications Not specified Composition 1 ml of solution contains 3.0 mg ofloxacin Single dose (1 drop) contains 0.10 mg ofloxacin Excipients: benzalkonium chloride Overdose Cases of overdose are not known. Side effect Hypersensitivity reactions; hyperemia of the conjunctiva, burning sensation, discomfort in the eyes, itching and dryness of the conjunctiva, photophobia, lacrimation. In most cases, these symptoms are short-lived. In isolated cases, systemic hypersensitivity reactions have been recorded. Rare: Corneal deposits may form under appropriate conditions. Storage conditionsKeep in a place protected from light, at a temperature not exceeding 25°C. Buy Floksal eye drops 3mg/ml 5ml №1 Price for Floksal eye drops 3mg/ml 5ml №1Instruction for use for Floksal eye drops 3mg/ml 5ml №1
Floksal eye drops 3mg/ml 5ml №1
$32.00
SKU: 43054
Category: Medicines for diseases of the eyes and ears
INN | OFLOXACIN |
---|---|
The code | 43 054 |
Barcode | 4 029 835 000 111 |
Dosage | 0.3% 5ml |
Active substance | Ofloxacin |
Manufacturer | Dr. Gerhard Mann Kem.-Pharm. Fabrik GmbH, Germany |
Importer | Closed Joint Stock Company "BAUSH HEALTH", 220073, Minsk, st. Olshevsky, 22, room 22 |
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