Sofradex description. Sofradex drops - relieve inflammation and pain in the ear. Cross-drug interactions
Infectious inflammatory lesions - otitis - can occur in the middle, inner and outer ear. Treatment in this case (regardless of the type of pathology) is complex. An important component of combination therapy are medicines, the range of which is quite extensive today. But preference is given, as a rule, One of these drugs is the drug "Sofradex" (ear drops). Its price in pharmacies is about 140 rubles.
Composition and mechanism of action
Means "Sofradex" (ear drops) - a combined synthetic medication. It contains framecitin sulfate, dexamethasone, gramicidin. The first component has bactericidal activity. The substance affects staphylococci and streptococci, as well as other anaerobic bacteria. Dexamethasone is a glucocorticoid hormone. This component has an anti-inflammatory and anti-allergic effect. Gramicidin prevents the reproduction of bacteria, destroys gram-positive pathogenic microflora. Due to the beneficial properties of substances, the drug has a complex anti-inflammatory, anti-allergic and antibacterial effect. Additionally, it contains water for injection, phenylethanol, citric acid, sodium citrate, lithium chloride, and ethanol. When instilled into the external auditory canal, pathogenic microflora is destroyed, which leads to the elimination of the inflammatory process. The use of the drug helps to alleviate the manifestations that accompany the lesion. In particular, pain, burning, itching in the external auditory canal, swelling and redness of the skin, a feeling of congestion in the ear are eliminated.
Purpose
The antibacterial agent "Sofradex" (ear drops) is recommended both in otolaryngological and ophthalmic practice. Indications include infected eyelid eczema, barley, blepharitis, chronic or acute otitis externa. Prescribe medication for keratitis, allergic conjunctivitis. In some cases, the drug is indicated for sinusitis (with intranasal administration).
The drug "Sofradex" (ear drops). Instructions for use
Experts warn that the use of the drug is allowed only after consulting a doctor and establishing an accurate diagnosis. The examination should exclude the possibility of a fungal or viral infection. The agent is injected into the external auditory canal in two or three drops. The frequency of instillations is three or four times a day. Bury the solution gradually, drop by drop. In some cases, after instillation, it is allowed to put a cotton swab soaked in medicine into the ear. The duration of the use of the antibiotic "Sofradex" (ear drops) is set by the doctor personally. This takes into account the severity of the course of the disease, the intensity of symptoms. Usually the duration of therapy does not exceed seven days.
Adverse reactions
When using the drug, increased soreness, burning, irritation is likely. On the basis of hypersensitivity to the components, an allergic reaction of a local nature may develop. If these symptoms occur, as well as in the absence of a therapeutic effect when using the medication, you should visit a doctor, stopping treatment.
Contraindications to the use of the drug "Sofradex"
Ear drops are not prescribed for perforation in the eardrum, in order to avoid the occurrence of hearing impairment and the development of partial or complete deafness. Contraindications include periods of pregnancy and lactation, infectious lesions of a viral or fungal nature. Treatment is not recommended for persons with hepatic or renal insufficiency, tuberculosis. Do not prescribe medication for hypersensitivity to the components.
Analogues
Medicines with a similar mechanism of action include the drug Pledrex. However, dexamethasone and
chloramphenicol. Indications for the use of the drug "Pledrex" are somewhat wider than those of the drug "Sofradex". There are differences in the list of side effects and restrictions on use. Experts warn that changing the treatment regimen, self-replacing one remedy with another is highly discouraged.
Additional information about the drug "Sofradex"
Intranasal (in the nose) administration or instillation into the eyes is carried out only on the recommendation of a doctor. With prolonged use of the solution, the development of superinfection provoked by pathogens (including fungi) that are resistant to active components is likely. After each instillation, it is necessary to tightly close the vial with the solution. After opening the package, the drug is allowed to be used for a month. When instilled into the eyes, a short blurred vision is likely.
One ml contains:
Active ingredients:
framycetin sulfate - 5.00 mg,
gramicidin - 0.05 mg,
dexamethasone (as sodium metasulfobenzoate) - 0.50 mg.
Excipients: lithium chloride, sodium citrate (E331), citric acid monohydrate (E33O), phenylethanol (phenylethyl alcohol), ethanol 99.5%, polysorbate 80 (E433), water for injection
Farmacotherapeutic group
Means for the treatment of diseases in ophthalmology and otology. Combinations of corticosteroids and anti-infective agents.
ATC code: S03CA01.
Pharmacological properties
Pharmacodynamics
Framycetin sulfate is an antibiotic from the group of aminoglycosides, it acts bactericidal. It has a wide spectrum of antibacterial activity, is active against gram-positive (staphylococci, pneumococci, etc.) and gram-negative microorganisms (E. coli, dysentery bacillus, Proteus, etc.). Ineffective against streptococci. Does not affect pathogenic fungi, viruses, anaerobic flora. The resistance of microorganisms to framycetin sulfate develops slowly.
Gramicidin is an antibacterial cyclic polypeptide. It has a bactericidal and bacteriostatic effect, is active against streptococci, staphylococci, pathogens of anaerobic infections and other microorganisms.
Dexamethasone is a synthetic glucocorticosteroid. It has properties in common with other corticosteroids.
Pharmacokinetics
When applied topically, systemic absorption is low.
Indications for use
Inflammatory diseases of the anterior segment of the eye of bacterial origin, for which the use of glucocorticosteroids is indicated:
Blepharitis; conjunctivitis; keratitis (without damage to the epithelium); scleritis, episcleritis.
Infected eczema of the skin of the eyelids.
Otitis externa.
Dosage and administration
For eye diseases: with a mild course of the infectious process, 1-2 drops of the drug are instilled into the conjunctival sac of the eye every 4 hours. In the case of the development of a severe infectious process, the drug is instilled every hour. As inflammation decreases, the frequency of drug instillations decreases.
For diseases of the ear: 2-3 drops are instilled 3-4 times a day, a gauze swab moistened with a solution can be placed in the external auditory canal.
The duration of the drug should not exceed 7 days.
Side effecte
Allergic reactions:
Irritation, burning, pain, itching, dermatitis.
With prolonged use of the drug is possible:
From the side of the organ of vision:
Increased intraocular pressure with the development of a symptom complex of glaucoma (when using drugs containing glucocorticosteroids, intraocular pressure should be measured regularly for more than 7 days); development of posterior capsular cataract; thinning and perforation of the cornea; chorioretinopathy - frequency unknown;
Blurred vision - frequency unknown.
From the side of the placeApplications:
Accession of a secondary (fungal) infection.
If any of the listed adverse reactions or a reaction not mentioned in the leaflet occurs e- leaflet, you need to see a doctor!
Contraindications
increased individual sensitivity to any of the components of the drug; viral (including herpetic) or fungal infections, tuberculosis, purulent inflammation of the eyes, trachoma; violation of the integrity of the corneal epithelium and thinning of the sclera; glaucoma perforation of the eardrum (risk of ototoxicity); pregnancy and breastfeeding period.
Overdose
Long-term topical treatment may have a general systemic effect. Treatment is symptomatic.
Precautionary measures
Framycetin sulfate, which is part of the preparation, is an antibiotic from the aminoglycoside group, which is characterized by nephro- and ototoxicity, especially when used in high doses and in patients with renal or hepatic insufficiency. Antibiotics from the aminoglycoside class can cause partial or complete irreversible deafness when applied topically to open wounds or damaged skin surfaces. This effect is exacerbated by renal or hepatic insufficiency, as well as a long duration of therapy. Do not use the drug after the disappearance of symptoms.
Visual impairment may be associated with systemic topical use of corticosteroids. If the patient has symptoms such as blurred vision or other visual disturbances, they should see an ophthalmologist for a possible diagnosis, which may be cataracts, glaucoma, or rare disorders such as central serous chorioretinopathy.
The duration of admission should not exceed 7 days, except in cases of obvious positive dynamics of the disease, since long-term use of the glucocorticosteroid, which is part of the composition, can mask latent infections, and long-term use of antimicrobial components can contribute to the emergence of stable microflora.
Systemic treatment with glucocorticoids can lead to chorioretinopathy, which can lead to visual impairment, including loss of vision. Long-term use of systemic glucocorticoids, even at low doses, can cause chorioretinopathy.
Do not use Sofradex (eye and ear drops) for red eye syndrome.
Treatment with corticosteroid drugs should not be prolonged or re-administered without regular ophthalmological examination, necessary to exclude an increase in intraocular pressure, the development of cataracts, corneal ulcers, or infection.
Caution should be exercised when prescribing the drug to children. Prolonged use of the drug may lead to a risk of adrenal suppression in young children. Although the ototoxic effect of aminoglycosides has not been reported after use in the form of eye drops, its possibility should be considered when using high doses of the drug in infants and young children.
The bottle must be closed after each use. Do not touch the tip of the pipette to the eye.
Use during pregnancy and lactation
Pregnancy
The safety of the drug during pregnancy and lactation has not been established. There is insufficient evidence for the safety of use in pregnancy. Topical application of corticosteroids in pregnant animals can cause fetal abnormalities, including cleft palate and intrauterine growth retardation. Therefore, there is a very small risk of such consequences for the human fetus. There is a risk of fetal ototoxicity with the use of aminoglycoside antibiotics during pregnancy.
Therefore, Sofradex® should not be used during pregnancy.
Lactation
Since there is not enough experience in the use of the drug in lactating women, Sofradex® should not be used during lactation.
Interaction with other drugs
Framycetin sulfate should not be used together with other antibiotics that have ototoxic and nephrotoxic effects (streptomycin, monomycin, kanamycin, gentamicin).
Package
Is it possible to instill drops of "Sofradex" in the nose of a child? Manufacturers do not recommend the use of this medication for the treatment of newborns. This is due to the fact that it can have a toxic effect on their body. Moreover, the drug "Sofradex" (drops) is intended for the treatment of eye and ear diseases. Although doctors often prescribe it for a prolonged runny nose or sinusitis.
Description, composition, packaging
In what form can the Sofradex solution be purchased? Reviews of experts report that this medication goes on sale in the form of ear and eye drops. They are available as a clear and almost colorless liquid with a phenethyl alcohol odor.
The active components of this drug are framycetin sulfate, dexamethasone (sodium metasulfobenzoate) and gramicidin.
Also, the composition of the drops includes such auxiliary ingredients as lithium chloride, citric acid monohydrate, sodium citrate, phenylethanol, denatured 95% ethanol (or methylated industrial alcohol) and distilled water.
You can buy a medicinal solution "Sofradex" (drops) in dark glass bottles (volume 5 ml) with a dropper dispenser (placed in cardboard packaging).
Pharmacological characteristics
The effective action of the drug in question is due to its composition.
Framycetin sulfate is an antibiotic substance belonging to the group of aminoglycosides. It has bactericidal properties and has a fairly wide spectrum of antibacterial action. Also, this element is active against gram-positive bacteria, including Staphylococcus aureus, and most gram-negative microorganisms (including E. coli, Proteus, dysentery bacillus, etc.).
It is impossible not to say that Sofradex drops (ear and eye) are ineffective for streptococcus. They also do not act against pathogenic fungi, viruses and anaerobic flora.
Bacterial resistance to framycetin sulfate develops very slowly.
Dexamethasone is called GCS, which has a pronounced desensitizing, anti-inflammatory and anti-allergic effect.
This component is able to suppress inflammatory processes. It inhibits the migration of mast cells and the release of inflammatory mediators, and also reduces capillary permeability.
After instillation of the drug into the eyes, dexamethasone reduces pain, lacrimation, burning sensation and photophobia. When instilled into the ears, this component eliminates all symptoms of otitis externa (including redness of the skin, sensation of pain, burning in the external auditory canal and itching).
What role does gramicidin play in Sofradex? Reviews of experts report that this ingredient is able to provide bacteriostatic and bactericidal effects. Due to its activity against staphylococci, it significantly expands the spectrum of antimicrobial effects of framycetin.
Pharmacokinetic indicators
Are Sofradex drops absorbed? Reviews of doctors say that when used topically, the systemic absorption of this drug is very low. However, in the presence of inflamed skin or open wounds, this medication can still be absorbed into the bloodstream. In this case, it is rapidly excreted (in unchanged form) by the kidneys. The half-life of framycetin sulfate is 120-180 minutes.
When taking dexamethasone orally, it is able to be instantly absorbed from the gastrointestinal tract. In this case, the half-life of the drug is 3 hours.
Indications
According to the instructions, drops "Sofradex" with otitis externa help very well. They are also used for:
- blepharitis;
- keratitis (without damage to the epithelium);
- conjunctivitis;
- scleritis, episcleritis;
- iridocyclitis;
- infected eczema of the skin of the eyelids.
Contraindications
Ear and eye drops "Sofradex", the price of which is indicated below, should not be prescribed for:
It cannot be said that this medication is prescribed with caution to young children (especially in large doses and for a long time), since there is a risk of suppression of adrenal function and the development of systemic side effects.
Application methods
How should Sofradex drops be used? Reviews of experts say that only a doctor should prescribe this solution.
In case of eye diseases with a mild course of the infectious process, the drug is instilled in 2 drops every 4 hours. In the event of a severe infection, the medication is used every 60 minutes. As the inflammatory reactions decrease, the frequency of instillations is reduced.
For ear diseases, the medication is instilled into the external auditory canal, 3 drops four times a day. In some cases, a gauze swab pre-soaked in a solution is placed in the ear.
The duration of the use of this remedy should not be more than a week, except in cases of pronounced positive dynamics of the disease. It should be borne in mind that corticosteroids can mask ongoing infections, and long-term use of antimicrobials can contribute to the emergence of resistant flora.
Drops "Sofradex" in the nose of a child
Despite the fact that the drug in question is intended for the treatment of eye and ear diseases, it is often prescribed to children with a prolonged runny nose in order to prevent the development of otitis media. In addition, nasal drops can be used to treat allergic rhinitis. Also, the solution is used in the complex treatment of otitis media.
For the correct use of the drug, the child is placed on his back and his head is thrown back. In this position, 2-5 drops are applied to each nostril and the patient is left for several minutes so that the medication penetrates to the site of the inflammatory process.
In the treatment of otitis media, drops are pre-diluted with saline (1: 1) and injected into the nose.
For the treatment of a prolonged runny nose, the drug can be used both in pure and diluted form. In this case, appoint 3 drops in each nostril three times a day for a week.
It is forbidden to inject more than 5 drops into the nose at the same time.
Sofradex (fl. 5 ml. drops. ear, eye) India Aventis Pharma
Composition and form of release: 1 ml of drops contains framycetin 5 mg, gramicidin 0.05 mg and dexamethasone 0.5 mg; in vials of 5 ml.
1 g of cream contains framycetin 10 mg and dexamethasone 1 mg; in tubes of 15 and 20 g.
Pharmachologic effect: Anti-inflammatory, antiallergic, antibacterial, antipruritic .
Pharmacodynamics: It has a broad spectrum antibacterial bactericidal effect, is active against various gram-positive and gram-negative microorganisms (due to famicetin and gramicidin), including Staphylococcus epidermidis, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus faecalis, Streptococcus pneumoniae, Proteus spp., Pseudomonas spp., Escherichia coli, Klebsiella spp. etc. It has anti-inflammatory, antiallergic and antipruritic properties (glucocorticoid dexamethasone). When instilled into the eye, it reduces pain, burning, photophobia and lacrimation, which are characteristic of the corresponding pathological processes. With external skin application, it reduces the symptoms of inflammation (pain, hyperemia, exudation, itching).
Indications: Superficial bacterial infections of the eyes, accompanied by a pronounced inflammatory or allergic component; blepharitis, infected eyelid eczema, stye, allergic conjunctivitis, rosacea keratitis, scleritis, episcleritis, iridocyclitis, iritis, acute and chronic otitis externa.
Contraindications: Hypersensitivity, viral (including herpetic) or fungal infections, tuberculosis, purulent inflammation of the eyes, glaucoma, perforation of the eardrum (for use in ENT practice).
Use during pregnancy and lactation: The safety of the drug during pregnancy and lactation has not been established.
Side effects: Irritation, burning, pain, itching, dermatitis at the site of application, increased intraocular pressure, subcapsular cataract (with prolonged use), thinning of the cornea (with diseases of the cornea or sclera, accompanied by a decrease in the thickness of these membranes).
Precautions: It is necessary to apply only after establishing an accurate diagnosis and excluding lesions of viral and fungal origin. The duration of treatment should not exceed 7 days (except in cases of obvious positive dynamics of the disease), because. long-term use of the glucocorticoid, which is part of the drug, can mask latent infections; and antimicrobial components - to promote the emergence of stable microflora. The course should not be repeated without a doctor's prescription in order to avoid an increase in intraocular pressure, the formation of cataracts or the occurrence of eye infections. At the time of treatment, it is recommended to refrain from driving a car or working with mechanisms that require increased visual attention.
Ear drops are the first necessity in the event of otitis media, because it is unbearably difficult to endure a strong, throbbing pain in the ear for a long time, and it is not necessary. Any pharmacy provides a wide selection of medicines for this disease, but Sofradex deserves special attention among them.
These ear drops have been on the market for a long time, their price is quite affordable, but their action and effectiveness have already saved hundreds of people from a painful and unpleasant illness. A longer treatment period is not needed - the reviews confirm that Sofradex ear drops act quickly and effectively - the symptoms of the disease disappear the very next day.
Sofradex drops - a panacea for any inflammation
Recently, doctors recommend Sofradex to their patients for almost any inflammation of the mucous membranes. These ear drops can rightly be called eye drops, and even nasal ones, although the instructions do not imply such use. In reality, they cope not only with otitis media, but also with conjunctivitis, keratitis, eczema of the outer eyelid, adenoids and other diseases of the eyes, ears and nasopharynx.
The price of drops allows everyone to purchase them, and the instructions describe in detail the method of application.
Active substances
Naturally, all the benefits of the drug are due to its balanced and carefully researched composition, which is confirmed by the reviews. The substances contained in ear drops have long been known to medicine, and their actions complement each other, making the drug combined. As a result of this, Sofradex ear drops have such a wide spectrum of action. So, the active substances of the drug:
The instructions for the drug describe all these substances and say that Sofradex drops provide bactericidal, bacteriostatic, antimicrobial, anti-staphylococcal, anti-inflammatory, anti-allergic and desensitizing effects. These are exactly the beneficial properties of the drug that are needed to relieve symptoms and treat acute inflammation of the ears and eyes.
An invaluable effect on the body: how to use drops correctly
The drug Sofradex is sold by prescription, which means that in order to buy it, you still need to visit a doctor. This is true, because drops, although they have an effective effect, are not suitable for everyone, and they must be applied strictly, as the instructions say, and not intuitively. Since the price of ear drops is affordable, they can help anyone if he has a clear indication for use.
For the treatment of acute otitis externa, it is only necessary to instill the diseased ear up to 3-4 times a day, 2-3 drops each. Once opened, the bottle can be stored for no longer than a month in a dark place. It is important that with purulent otitis, ear drops are strictly prohibited, because the release of pus is a clear sign of perforation of the eardrum. If drops enter the middle ear, they can damage the auditory nerve and cause hearing loss. Therefore, if severe pain is felt after instillation, then treatment with Safrodex should be stopped immediately.
The instruction indicates the possibility of another method of application, which is praised by reviews - with the help of cotton turunda ... It must be moistened in the preparation and changed to a new one 4 times a day. The price of the drug allows its repeated purchase. During treatment with Saphrodex, other antibiotics with ototoxic or nephrotoxic effects should not be used. The use of Saphrodex for longer than 7 days is possible only if there is a pronounced positive trend in difficult cases. The reason for this is that long-term use can provoke an increase in the stability of the microflora and hide other inflammatory processes.
Caution, dangerous: contraindications
The instruction of any drug contains contraindications, but, unfortunately, few people pay attention to them. And this is very in vain: a forbidden technique can lead to the most unexpected consequences. Negative reviews are based just on the wrong application. The price of Sofradex is its clear advantage, but if a person has one of the diseases described below, then another medicine must be chosen. Contraindications:
- tuberculosis;
- purulent, viral or fungal infections;
- perforation of the eardrum;
- glaucoma and herpetic keratitis (in the treatment of eye diseases);
- age up to 3 years.
The effect of the drug during pregnancy and lactation has not been studied, but it is better for pregnant women to refrain from using these ear drops. Also, the instruction informs that side effects are possible in the treatment of eyes. The use of the drug inside is prohibited, but swallowing a bottle up to 5 ml does not require any treatment - side effects will not be expressed.