Sofradex eye ear drops 5ml
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Active ingredients
Gramicidin C + Dexamethasone + Framycetin
Release form
Drops
Composition
Active ingredient: framycetin sulfate 5 mg, gramicidin 50 μg, dexamethasone (in the form of sodium metasulfobenzoate) 500 μg. Auxiliary substances: lithium chloride, sodium citrate, citric acid monohydrate, phenylethanol, ethanol 99. 5%, polysorbate 80, water d / i. Concentration active ingredient (mcg): 5550 mcg
Pharmacological effect
Framycetin sulfate is an antibiotic from the group of aminoglycosides, bactericidal. It has a broad spectrum of antibacterial action, is active against gram-positive microorganisms, including Staphylococcus aureus, and the majority of clinically significant gram-negative microorganisms (E. coli, Dysterium bacillus, Proteus, etc.). Ineffective against steptococci. Does not affect pathogenic fungi, viruses, anaerobic flora. The resistance of microorganisms to framycetin sulfate develops slowly. Gramicidin - has a bactericidal and bacteriostatic effect, expands the spectrum of the antimicrobial action of framycetin due to its activity against staphylococci, since it also has an anti-staphylococcal effect. Dexamethasone is a GCS that has a pronounced anti-inflammatory, antiallergic and desensitizing effect. Dexamethasone inhibits inflammation by inhibiting the release of inflammatory mediators, the migration of mast cells and reducing capillary permeability. When instilled into the eyes, pain, burning, tearing, photophobia will be reduced. When instilled into the ears, it reduces the symptoms of otitis media in the outer ear (redness of the skin, pain, itching, burning sensation in the external auditory canal, feeling of ear congestion).
Pharmacokinetics
When applied topically, systemic absorption is low. Framicetin sulfate can be absorbed through inflamed skin or open wounds. When it enters the systemic circulation, it is rapidly excreted by the kidneys in unchanged form. T1 / 2 framycetin sulfate is 2-3 hours. When taken orally, dexamethasone can quickly be absorbed from the gastrointestinal tract. T1 / 2 is 190 minutes.
Indications
Bacterial diseases of the anterior segment of the eye. - blepharitis; - conjunctivitis; - keratitis (without damage to the epithelium); - iridocyclitis; - sclerites, episclerites; - infected skin eczema of the eyelids; - otitis of the outer ear.
Contraindications
- increased individual sensitivity to any of the components of the drug; - viral or fungal infections, tuberculosis, purulent eye inflammation, trachoma; - violation of the integrity of the corneal epithelium and thinning of the sclera; - Herpetic keratitis (corneal tree ulcer) (possibly increasing the size of the ulcer and significant visual impairment); - glaucoma; - perforation of the eardrum (penetration of the drug into the middle ear can lead to the development of an ototoxic effect); - pregnancy and lactation period; - infants. With caution: young children (especially with the appointment of the drug in large doses and for a long time - the risk of developing systemic effects and suppressing adrenal function).
Precautionary measures
With caution: young children (especially with the appointment of the drug in large doses and for a long time - the risk of developing systemic effects and suppressing adrenal function).
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and lactation.
Dosage and administration
In case of eye diseases: in case of mild infection, 1-2 drops of the drug are instilled into the conjunctival sac of the eye every 4 hours. In case of a serious infection, the preparation is instilled every hour. As the inflammation decreases, the frequency of drug instillations decreases. In case of ear diseases: 2-3 drops are instilled 3-4 times a day, a gauze pad moistened with a solution can be put into the external auditory canal. The duration of the drug should not exceed 7 days, except in cases of obvious positive dynamics of the disease (GCS can mask hidden infections, and long-term use of the antimicrobial components of the drug contribute to the development of a sustainable flora).
Side effects
Allergic reactions are usually of a delayed type, manifested by irritation, burning, pain, itching, dermatitis. With long-term use of local corticosteroids, it is possible: an increase in intraocular pressure with the development of a symptom complex of glaucoma (damage to the optic nerve, reduced visual acuity and the appearance of defects in the visual fields); development of posterior supapsular cataracts (especially with frequent instillation); thinning of the cornea or sclera, which can lead to perforation; joining a secondary (fungal) infection.
Overdose
Prolonged and intensive local use can lead to systemic effects. Symptomatic treatment. If one vial is swallowed (up to 10 ml of solution), serious side effects are unlikely.
Interaction with other drugs
Framycetin sulfate should not be used with other antibiotics that have ototoxic and nephrotoxic effects (streptomycin, monomitsin, kanamycin, gentamicin).
special instructions
With long-term use of the drug, as well as with the long-term use of other antimicrobial agents, the development of superinfections caused by drug-resistant microorganisms, including fungi, is possible. A prolonged instillation of the eye preparation 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 long-term without regular monitoring of intraocular pressure, eye examinations for cataracts or secondary infections. Local GCS should never be used in patients with hyperemia of an unspecified eliology, because inappropriate use of the drug can lead to a significant deterioration in vision. Part of the drug framycetin sulfate is an antibiotic from the group of aminoglycosides, which are characterized by the development of nephro and ototoxic effects during systemic application or local application to an open wound or damaged skin. These effects depend on the dose and increase and renal or hepatic insufficiency. Although the development of these effects was not observed when boiling the drug in the eye, the possibility of their occurrence in the case of local application of high doses of the drug in children should be taken into account. The duration of use of the drug should not exceed 7 days, except in cases of obvious positive dynamics of the disease, because long-term use of the GCS, which is part of it, can mask latent infections, and long-term use of antimicrobial components can contribute to the development of sustainable flora. The effect on the ability to drive vehicles and control mechanisms. Patientsin which, after instillation into the eye of the drug, the clarity of vision is temporarily lost, it is not recommended immediately after the instillation of the drug to drive a car or work with complex equipment, machines or any other complex equipment that requires a clear view. The bottle must be closed after each use. Do not touch the eye with a pipette tip. After opening the bottle, the drug should be used within 1 month.