Active substanceNorfloxacinNorfloxacin
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  • Dosage form: & nbspdrops eye and ear
    Composition:

    1 ml of drops contains:

    norfloxacin 3 mg

    Excipients: benzalkonium chloride, disodium edetate, sodium chloride, acetic acid, ice, water for injection.

    Description:

    A clear, colorless or slightly yellow solution that is free of any particles.

    Pharmacotherapeutic group:antimicrobial agent - fluoroquinolone
    ATX: & nbsp

    S.01.A.E.02   Norfloxacin

    Pharmacodynamics:

    Normax (norfloxacin) -antibacterial drug from the group of fluoroquinolones, has a broad spectrum of antibacterial action, has a bactericidal effect.The drug inhibits the DNA enzyme enzyme of bacteria, as a result of which DNA replication and the synthesis of bacterial cell proteins are disrupted. Normax acts on both reproducing microorganisms and those in rest. The spectrum of antibacterial action of Normax includes gram-negative microorganisms:

    Escherichia coli, Salmonella sp., Shigella spp, Proteus spp. (indol-positive and indolotric), Morganella morganii, Citrobacter spp., Klebsiella spp., Enterobacter spp., Yersinia enterocolitica, Vibrio spp., Campylobacter spp., Hafnia spp., Providencia stuartii, Haemophilus influenzae, Pasteurella multocida, Pseudomonas spp., Gardnerella spp., Legionella pneumophila, Neisseria spp., Moraxella catarrhalis, Acinetobacter spp., Brucella spp., Chlamidia spp.

    Gram-positive microorganisms are also sensitive to Normax: Staphylococcus spp., Streptococcus pyogenes, St. Agalactiae, Corynebacterium diphtheria, Listeria monocitogenes.

    The drug is low toxicity.

    Pharmacokinetics:

    Studies of the pharmacokinetics of the Normax preparation, droplets, were not carried out due to low systemic absorption.

    Indications:

    Normax is applied topically for the treatment of acute or chronic infectious diseases in ophthalmology and otorhinolaryngology, caused by microorganisms sensitive to norfloxacin.

    - Inflammation of the external auditory canal (external otitis media);

    - acute and chronic otitis media;

    - internal otitis and infectious inflammation of the Eustachian tube;

    - prevention of infectious otitis before and after surgery, with ear trauma, removal of a foreign body from the external auditory canal,accompanied by damage to the ear tissues.

    - conjunctivitis (including gonococcal);

    - keratitis,

    - keratoconjunctivitis;

    - corneal ulcer;

    - blepharitis;

    - blepharoconjunctivitis;

    - trachoma;

    Prevention of eye infections after removal of a foreign body from the cornea or conjunctiva, after damage by chemical or physical means, before and after surgical interventions.

    Contraindications:

    Normax is contraindicated in patients who are hypersensitive to the components of the drug or to other quinolones.

    Norfloxacin is not recommended for pregnant women, nursing mothers and children under 18 years of age.

    Dosing and Administration:

    Locally on 1-2 cap. in the affected eye or ear 4 times a day. Depending on the degree of infection, the dose on the first day can be increased to 1-2 cap. every 2 hours.

    Before using ear drops Normax, the external auditory canal should be sanitized (rinse and drain the external ear canal). Drops should be warm (have body temperature). It is necessary to lie sideways or throw back the head to facilitate burial. To drip into the external ear canal specified number of drops. Allow the drops to drain into the ear canal, pulling the earlobe down and back.Hold the head in the inverted position for about 2 minutes. You can put in the outer ear canal wool turunda. After the disappearance of the symptoms of the disease, the drug should be continued for the next 48 hours. Or as directed by a doctor. In acute and chronic trachoma, 2 drops are prescribed in each eye 2-4 times a day for 1-2 months.

    Side effects:

    From the digestive system: nausea, heartburn, anorexia, diarrhea; stomach ache.

    From the side of the central nervous system: headache, dizziness, tiredness, sleep disorders, irritability, anxiety.

    Allergic reactions: skin rash, itching, angioedema.

    Overdose:

    In case of accidental intake of Normox, no specific symptoms are present. Possible nausea, vomiting, diarrhea, headache, dizziness, a sense of anxiety. Treatment - the usual measures of emergency care, sufficient fluid intake into the body, the creation of an acid reaction of urine to prevent crystalluria. When using ear drops Normax in recommended doses of overdose phenomena was not observed.

    Interaction:

    The solution of norfloxacin is incompatible with drugs, with a pH value of 3-4,which are physically or chemically unstable.

    Special instructions:

    Normax is for local use only.

    To achieve a better therapeutic effect, Normax should be used in combination with systemic antimicrobial therapy (except for uncomplicated cases). It is necessary to protect the solution and dropper from contamination.

    Effect on the ability to drive transp. cf. and fur:

    Within 30 minutes after instillation of the drug in the eye should refrain from engaging in potentially hazardous activities that require increased attention.

    Form release / dosage:

    Drops eye and ear 0,3%.

    Packaging:For 5 ml of the drug in a plastic (low density polyethylene) bottle-dropper, with a screw cap. One bottle with instructions for use is placed in a cardboard box.
    Storage conditions:

    In dry, the dark place at a temperature below 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    2 years.

    After opening the bottle, the expiration date is 1 month.

    Do not use the product after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013963 / 02
    Date of registration:21.07.2008
    The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India
    Information update date: & nbsp10.08.2015
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