SofraDex® (Sofradex®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceGramicidin C + Dexamethasone + FramicetinGramicidin C + Dexamethasone + Framicetin
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  • SofraDex®
    drops d / eye tion. 
    Sanofi India Limited     India
    • Dosage form: & nbspdrops eye and ear
    Composition:

    1 ml of the solution contains:

    active ingredients: framicetin sulfate 5.00 mg, gramicidin 0.05 mg, dexamethasone (as sodium metasulfobenzoate) 0.50 mg;

    Excipients: lithium chloride, sodium citrate, citric acid monohydrate, phenylethanol (phenylethyl alcohol), ethanol 99.5%, polysorbate 80, water for injection.

    Description:

    Transparent, almost colorless solution with the smell of alcohol phenylethyl.

    Pharmacotherapeutic group:glucocorticosteroid for topical use + antibiotics (aminoglycoside and cyclic polypeptide)
    ATX: & nbsp

    S.03.C.A.01   Dexamethasone in combination with antimicrobials

    Pharmacodynamics:

    Framicetin Sulfate - antibiotic from the group of aminoglycosides, it acts bactericidal. It has a wide spectrum of antibacterial action, is active against gram-positive microorganisms, including Staphylococcus aureus and most clinically significant Gram-negative microorganisms (Escherichia coli, dysentery rods, Proteus, etc.). It is not effective for streptococci. Does not affect pathogenic fungi, viruses, anaerobic flora.Stability of microorganisms to ferricetin sulfate develops slowly.

    Gramicidin - has a bactericidal and bacteriostatic effect, expands the spectrum of the antimicrobial action of Framicetin due to its activity against streptococci and anaerobic microorganisms. It enhances the effects of Framicetin against staphylococci, since it also has an anti-staphylococcal effect.

    Dexamethasone - Glucocorticosteroid, which has a pronounced anti-inflammatory, antiallergic and desensitizing effect. Dexamethasone suppresses inflammatory processes, inhibiting the release of mediators of inflammation, the migration of mast cells and reducing the permeability of capillaries.

    When instilled in the eyes reduces pain, burning, lacrimation, photophobia.

    When instilled in the ears reduces the symptoms of otitis externa ear (reddening of the skin, pain, itching, burning in the external ear canal, a feeling of stuffiness of the ear).

    Pharmacokinetics:

    With topical application, systemic absorption is low.

    Framicetin sulfate can be absorbed through inflamed skin or open wounds. When entering the systemic bloodstream, it is quickly excreted by the kidneys unchanged.The half-life of Framicetin sulfate is 2-3 hours.

    Ingestion dexamethasone can quickly be absorbed from the gastrointestinal tract. The half-life is 190 minutes.

    Indications:

    Bacterial diseases of the anterior part of the eye:

    - blepharitis;

    - conjunctivitis;

    - keratitis (without damage to the epithelium);

    - Iridocyclitis;

    - Sclerites, episclerites.

    Infected eczema of the skin of the eyelids.

    Otitis of the external ear.

    Contraindications:

    - Increased individual sensitivity to any of the components of the drug;

    - viral or fungal infections, tuberculosis, purulent inflammation of the eyes, trachoma;

    - corneal epithelial integrity and thinning of sclera

    - Herpetic keratitis (dendritic corneal ulcer) (possibly an increase in the size of the ulcer and a significant deterioration in vision);

    - glaucoma;

    - perforation of the tympanic membrane (penetration of the medication into the middle ear can lead to the development of ototoxic action);

    - pregnancy and the period of breastfeeding;

    - infants.

    Carefully:

    To children of younger age (especially at purpose or appointment of a preparation in the big doses and it is long - risk of development of system effects and suppression of function of adrenals).

    Dosing and Administration:

    In case of eye diseases: at a light current of an infectious process instill 1-2 drops of a preparation in a conjunctival bag of an eye every 4 hours. In the case of a serious infectious process, the drug is instilled every hour. As the inflammatory phenomena decrease, the frequency of instillations of the drug decreases.

    In case of ear diseases: Bury 2-3 drops 3-4 times a day in the external auditory meatus; You can put a gauze swab moistened with a solution.

    The duration of the drug should not exceed 7 days, except in cases of obvious positive dynamics of the disease (the glucocorticoid can mask hidden infections, and long-term use of antimicrobial components of the drug - to promote the development of a stable flora).

    Side effects:

    Allergic reactions are usually delayed type, manifested by irritation, burning, pain, itching, dermatitis.

    With prolonged use of topical corticosteroids, it is possible:

    - increased intraocular pressure with the development of the glaucoma symptom complex (optic nerve damage, reduced visual acuity and visual field defects), therefore, intraocular pressure should be measured regularly for more than 7-day use of glucocorticosteroid-containing preparations;

    - development of posterior subcapsular cataract (especially with frequent instillation);

    - thinning of the cornea or sclera, which can lead to perforation;

    - attachment of secondary (fungal) infection.

    Overdose:

    Long and intensive local use can lead to systemic effects. Treatment is symptomatic.

    When swallowing the contents of one bottle (up to 10 ml of solution), it is unlikely that serious side effects will develop.

    Interaction:

    Do not use framicetin sulfate along with other antibiotics that have ototoxic and nephrotoxic effects (streptomycin, monomycin, kanamycin, gentamicin).

    Special instructions:

    With long-term use of the drug, as with the long-term use of other antimicrobial agents, it is possible to develop superinfections caused by microorganisms resistant to the preparation, including fungi.

    Continuous instillation of the drug in the eyes can lead to thinning of the cornea with the development of its perforation, as well as an increase in intraocular pressure.

    Treatment with drugs containing corticosteroids,should not be repeated or prolonged without regular monitoring of intraocular pressure, eye examination for cataracts or secondary infections.

    Local corticosteroids should never be used in patients with eye hyperemia of unknown etiology, as inappropriate use of the drug may lead to significant visual impairment (see "Contraindications").

    Framicetin sulfate, which is part of the drug, is an antibiotic from the aminoglycoside group, which is characterized by the development of nephro- and ototoxic effects in systemic application or local application to open wounds or damaged skin. These effects depend on the dose and increase with renal or hepatic insufficiency. Although the development of these effects has not been observed with instillation of the drug in the eye, it should be taken into account the possibility of their occurrence in the case of topical application of high doses of the drug in children.

    The duration of the drug should not exceed 7 days, except in cases of obvious positive dynamics of the disease, since the long-term use of the glucocorticosteroid, which is part of its composition,can mask hidden infections, and long-term use of antimicrobial agents - contribute to the emergence of a stable microflora.

    The bottle must be closed after each use. Do not touch the tip of the pipette to the eye.

    After opening the vial, the drug should be used within 1 month.

    Effect on the ability to drive transp. cf. and fur:Patients who, after instillation into the eye of the drug, temporarily lose visual clarity, it is not recommended immediately after the instillation of the drug to drive a car or work with complex equipment, machines or some other complex equipment that requires clear vision.
    Form release / dosage:Eye and ear drops.
    Packaging:

    To 5 ml in a bottle of transparent glass of yellow, ukuporenny rubber stopper, covered with an aluminum cap with a plastic lid.

    One bottle together with a dropper of polyethylene and instructions for medical use in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013871 / 01
    Date of registration:29.10.2008
    The owner of the registration certificate:Sanofi India LimitedSanofi India Limited India
    Manufacturer: & nbsp
    Representation: & nbspSanofi Aventis GroupSanofi Aventis Group
    Information update date: & nbsp25.12.2015
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