Sofradex storage. Sofradex drops: instructions for use. Among analogues of Sofradex ear drops, there are drugs with similar composition and indications

Sofradex is a combined drug with anti-inflammatory and antiseptic effects, intended for local use in ophthalmic practice. For readers of “Popular about Health”, let’s look at what the instructions for use say about the drug Sofradex.

Instructions for use Sofradex

What is the composition and release form of Sofradex??

The active ingredients in the drug Sofradex: framycetin sulfate - 5 milligrams, dexamethasone - 500 micrograms and gramicidin - 50 mcg. Sofradex contains auxiliary components: water for injection, phenylethanol, ethanol 995%, lithium chloride, polysorbate 80, sodium citrate, citric acid monohydrate.

The drug Sofradex is available in a clear solution, with a characteristic odor of phenylethyl alcohol, sold in 5 ml bottles. The delivery set includes a special dropper pipette. Sales are by prescription.

What is the effect of Sofradex??

A combined drug that includes the glucocorticosteroid hormone dexamethasone and two antibacterial components: framycetin sulfate and gramicidin. All active substances of the drug have a powerful anti-inflammatory and antiseptic effect directed against most pathogens in ophthalmology and ENT practice.

Framycetin sulfate is an antibiotic that has a bactericidal effect against a significant number of pathogenic microorganisms. The principle of its action is based on suppressing the reactions of synthesis of the most important components of the cell wall.
The following bacteria are susceptible to the drug: Shigella spp., Streptococcus spp., Salmonella spp., Enterobacter spp., Klebsiella spp., Proteus spp., Staphylococcus spp. Fungi, anaerobic microorganisms and viruses are not sensitive to framycetin.

Gramicidin disrupts bacterial division processes, which leads to a decrease in the population of pathogenic bacteria. In addition, this substance helps to increase the susceptibility of pathogens to framycetin. The action of the drug is directed primarily against staphylococci.

Dexamethasone is a powerful anti-inflammatory component that is part of the group of glucocorticosteroids. The effect of the drug is very multifaceted. Suppression of the manifestations of the inflammatory reaction is based on inhibition of the reactions of synthesis of inflammatory mediators, as well as the processes of migration of mast cells.

The local action of Sofradex helps eliminate signs of inflammatory ophthalmological pathology: redness of the eyes, burning, dryness, soreness, lacrimation, photophobia, and so on.

When applied topically, adsorption from the surface of the eye is minimal. However, in the presence of damage to the integument, this figure may increase. Some of the components of the drug that enter the systemic circulation are excreted from the body in the urine. The half-life is no more than 3 hours.

What are Sofradex's indications for use??

Indications for Sofradex according to the annotation are as follows:

Conjunctivitis;
Blepharitis (inflammation of the eyelids);
Iridocyclitis (inflammation of the iris);
Scleritis;
Keratitis;
Otitis externa;
Eczema.

The use of the drug must be approved by a specialist. The use of Sofradex without adequate supervision by the attending physician may be unsafe.

What are the contraindications for use of Sofradex??

Contraindications for Sofradex according to the annotation are as follows:

Viral and fungal etiology of diseases;
Violation of the integrity of the epithelium;
Perforation of the eardrum;
Pregnancy and lactation (breastfeeding);
Intolerance to the components of the solution.

In addition, the patient's infancy.

What are the uses and dosage of Sofradex??

For ophthalmological pathology, Sofradex solution is instilled into each eye, 1 - 2 drops, every 4 hours. If the infectious process is severe, instillation should be repeated every 2 hours. As inflammatory reactions subside, the frequency of use should be reduced. The attending physician should answer all questions more accurately.

For ENT diseases, the solution is instilled into the ear canal only on the affected side. The dosage of Sofradex is 1 – 2 drops. The frequency of use is 1 time every 4 hours. The duration of treatment is determined by the dynamics of the symptoms of the disease.

What are the side effects of Sofradex??

Local side effects of Sofradex: dermatitis, itching, soreness, increased intraocular pressure, decreased visual acuity, thinning or perforation of the sclera (the membrane of the eye), the appearance of a secondary infection (mycosis), headaches.

special instructions

During treatment, it is strongly recommended not to wear contact lenses. Firstly, such vision correction contributes to additional trauma to the epithelium of the eyeball. Secondly, a cloudy deposit may appear on the lens material, which will blur the outlines of objects.

Instillation of the solution into the eyes is sometimes accompanied by distortion of visual perception. For this reason, during treatment it is better to refrain from driving vehicles or other dangerous mechanisms.

How to replace Sofradex, what analogs to use?

There are no analogues of Sofradex.

Conclusion

Diseases of the visual organs are very dangerous and, without proper control by an experienced ophthalmologist, can lead to decreased visual acuity or even complete blindness. Do not self-medicate.

Sofradex: instructions for use and reviews

Latin name: Sofradex

ATX code: S01CA01

Active substance: Gramicidin S + Dexamethasone + Framycetin

Manufacturer: Aventis Pharma, Ltd. (Aventis Pharma, Ltd.) (India); Sanofi India Limited (India)

Updating the description and photo: 27.08.2019

Sofradex refers to drugs with antibacterial and anti-inflammatory effects for topical use in ophthalmology and ENT practice. It comes in the form of drops (eye and ear) in the form of a clear, almost colorless solution, with the smell of phenylethyl alcohol.

The product is intended for the treatment of infectious diseases of the ear, nose and eyes simultaneously. Since Sofradex contains antibacterial and hormonal components, it should be used only as prescribed by a doctor.

The active (active) components of this dosage form are: framycetin sulfate, dexamethasone (sodium metasulfobenzoate) and gramicidin.

Framycetin sulfate (content 5 mg per 1 ml of drug) is a broad-spectrum amino-glycoside antibiotic exhibiting bactericidal properties. The substance is active against gram-positive microorganisms, including Staphylococcus aureus, and most clinically significant gram-negative microorganisms (Escherichia coli, dysentery bacillus, Proteus, etc.).

Dexamethasone (content 500 mcg/1 ml) is a glucocorticoid (a synthetic analogue of the adrenal hormone that has a direct effect on carbohydrate and protein metabolism), exhibits anti-inflammatory, antiallergic and antipruritic effects, and expands the spectrum of antimicrobial activity of framycetin. When applied topically in ophthalmology, it reduces pain, burning of mucous membranes, photophobia and lacrimation.

Gramicidin is produced by Bacillus brevis Dubos (content 50 μg/1 ml). The substance can have bacteriostatic and bactericidal effects. Due to its activity against staphylococci, it significantly expands the spectrum of antimicrobial effects of framycetin.

The medicinal composition, penetrating into the mucous membrane of the eye, has the following effects:

1. Antibacterial.
2. Decongestant.
3. Anti-inflammatory.
4. Antihistamine.
5. Anesthetic.

Indications for use Sofradex

Sofradex eye and ear drops are used externally only. Doctors prescribe the drug in complex therapy for the following pathological conditions of the body:

• Otitis in external form (acute and chronic stage of the pathological process).
• Blepharitis is an inflammatory process on the eyelids in the areas where eyelashes grow.
• A purulent formation in the sac of the hair follicle of the eyelash (colloquially this problem is called stye).
• Conjunctivitis, including allergic origin.
• Other infections in the eyes, ears and nasal cavity caused by pathogenic bacteria sensitive to the components of Sofradex and having pronounced inflammatory or allergic external manifestations: keratitis (without damage to the epithelium), iridocyclitis, scleritis and even infectious eczema of the skin on the eyelids.
• Long-term rhinitis.
• Adenoids.

Instructions for use of Sofradex, dosage

For children over 7 years of age and adults for ear treatment: apply 2-3 drops 3-4 times a day.

For eye treatment: 1-2 drops every hour.

In emergency cases, use the drug 2 times an hour for 2-3 days, gradually reducing the dose to 1-2 drops 3-4 times a day.

The duration of treatment should not exceed 7 days.

For ear diseases

Instill 2-3 drops 3-4 times a day; a gauze swab moistened with Sofradex solution can be placed in the external auditory canal.

The duration of use 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 Sofradex contributes to the development of resistant flora).

Sofradex for conjunctivitis

Use eye drops according to the following dosage: drop 1 or 2 drops into each eye 3 to 7 times a day. Treatment should be carried out for no more than 5 days. As inflammation decreases, the frequency of drug instillations decreases.

Features of application

Patients who use Sofradex for the treatment of vision organs, due to possible blurring of the eyes, should refrain from driving vehicles or working with equipment and mechanisms that require increased visual attention.

Particular care should be taken when prescribing medication in large doses to infants and young children. A long-term intensive course of local treatment can have a general systemic effect on a fragile child’s body.

Side effects and contraindications Sofradex

Reviews of Sofradex say that the use of the drug may be accompanied by such side effects as: cataracts (a disease that leads to clouding of the lens of the eye), burning, itching, inflammation of the skin; with long-term use of Sofradex, a gradual decrease in the thickness of the membranes of the eye (thinning of the cornea) and an increase in intraocular pressure are possible.

When using Sofradex ear drops, side effects may occur, which, as a rule, are a consequence of failure to comply with contraindications for taking this drug. For example, itching, burning or redness may appear in the external auditory canal. The possibility of developing dermatitis cannot be ruled out.

Contraindications:

• viral or fungal infections, tuberculosis, purulent inflammation of the eyes, trachoma;
• increased individual sensitivity to any of the components of the drug;
• violation of the integrity of the corneal epithelium and thinning of the sclera;
• herpetic keratitis (tree-like ulcer of the cornea), in this situation it is possible to increase the size of the ulcer and significant deterioration of vision);
• glaucoma;
• perforation of the eardrum (penetration of the drug into the middle ear can lead to the development of ototoxicity);
• infants.

The drug Sofradex is contraindicated during pregnancy and lactation.

Analogues of Sofradex, list of drugs

Analogs of Sofradex in terms of areas of application and indications are the following drugs:

1. Otium,
2. Claritsin,
3. Garazon,
4. Zanotsin,
5. Brotinum,
6. Microflox,
7. Oxamp.
8. Otipax

There are quite a lot of drugs that are considered analogues of Sofradex and have similar pharmacological effects. However, only an otolaryngologist or ophthalmologist can prescribe them.

It should be understood that the instructions for use of Sofradex, price and reviews do not apply to analogues and cannot be used as instructions or a guide to action. All prescriptions, including dosage and replacement of Sofradex with an analogue, must be carried out by the attending physician. This instruction is not intended for self-medication.

Sofradex drops are a drug with a combined effect against various infections and inflammations of the eyes and ears. The medicine is intended for local use in ophthalmology and otorhinolaryngology.

Pharmacological action and group

Sofradex drops include three active ingredients that have a bactericidal and bacteriostatic effect against the development of harmful bacteria that cause acute infection in the eyes or ears. The pharmacological group of this medicine is S03C (corticosteroids in combination with antimicrobials for the treatment of ophthalmological and ear diseases).

• The antibiotic "framycetin sulfate" has an antibacterial and anti-inflammatory effect on the affected area of ​​the eye or ear. Framycetin sulfate belongs to the group of aminoglycosides. Effective against many known gram-negative microorganisms. The substance helps to defeat E. coli bacteria, Proteus, dysentery and Staphylococcus aureus. The antibiotic is not active against streptococci, pathogenic fungi, anaerobic flora and viruses. Immunity of harmful organisms to this substance manifests itself slowly.
• Gramicidin enhances the spectrum of action of framycetin sulfate and has the same bacteriostatic effect. These two substances are effective in combination against staphylococci.
• Dexamethasone (GCS) is an antimicrobial component of the drug. Has an anti-inflammatory effect. GCS stops inflammatory processes, reduces capillary permeability and improves systemic blood flow.

Sofradex contains antibacterial and hormonal components, so it should be used only under the instructions of a doctor. Dexamethasone is a hormonal medication (a synthetic analogue of the adrenal hormone) that affects protein and carbohydrate metabolism.

In relation to the INN (international nonproprietary name), the drug does not have a name. ATX classification: S03CA01 (Dexamethasone in combination with antimicrobials).

Release form and composition

Eye and ear drops are sold in a yellow transparent glass bottle with a sealed rubber stopper, which is covered with an aluminum cap and a plastic lid.

Description of Sofradex: Colorless medicinal solution with the odor of phenylethyl alcohol. Available in dark yellow glass bottles with a 5 ml dropper applicator in a cardboard package.

Main components:

• framycetin sulfate;
• gramicidin;
• dexamethasone.

Excipients of the drug:

• lithium chloride;
• sodium citrate;
• citric acid monohydrate;
• phenylethanol;
• ethanol denatured 95%;
• polysorbate 80;
• distilled water.

Sofradex is available on prescription from an ENT doctor or ophthalmologist as drops, cream or ointment.

Indications for use

In ophthalmology, Sofradex eye and ear drops are prescribed for various bacterial infections of the anterior ocular segment and for ear diseases. Drops are suitable for external use only. Experts prescribe them for complex therapy for pathological conditions:

• for inhalation for prolonged rhinitis;
• with adenoids;
• redness and otitis media of the external ear (in acute and chronic stages);
• infected eczema of the skin of the eyelids
• blepharitis;
• conjunctivitis, including allergic origin;
• keratitis (when the epithelium is not damaged)
• with inflammation of the ears;
• scleritis and episcleritis;
• iridocyclitis;
• for other infectious and inflammatory diseases in the eyes, ears and nasal cavity;
• infectious eczema, burning, pain, itching and dermatitis of the skin of the eyelids.

Instructions for use

Note on the use of the drug:

• the medicine is used only for local purposes, use inside the body is not allowed;
• suitable for insertion into the external auditory canal or for instillation into the conjunctival sac;
• The maximum period of use of the medicine is 7 days, otherwise addiction to the antibiotics in the composition may develop.

Official guidelines for the use of Sofradex for adults:

1. For the treatment of mild diseases of the conjunctiva, 1-2 drops are dripped into the eyes with a break of 4 hours. In case of severe inflammation, the drug is administered 1-2 drops every hour.
2. For otitis media, 2-3 drops are instilled into each ear 3 to 4 times daily. It is recommended to cover the ear canal with cotton wool after insertion. If this causes pain, you can roll up small turundas from gauze, dip them in the solution and insert them into the ear canal. Turundas need to be replaced with new ones 3-4 times a day.
3. For acute laryngitis, you can breathe with a nebulizer drug, 5-10 drops per container.
4. Sofradex is prescribed by specialists after eyelid blepharoplasty, 2 drops in both eyes before instilling other medications.

Side effects and contraindications

As a side effect, an allergic reaction to Sofradex may occur. Allergies can be recognized by symptoms such as itching, severe burning, dermatitis, and pain.

A course of treatment of more than 7 days in rare cases can cause:

• increased intraocular pressure;
• development of fungal infection;
• posterior subcapsular cataract
• thinning and subsequent perforation of the cornea or sclera.

You should not use drops if:

• sensitivity to the components of the drug;
• purulent inflammation of the eyes;
• thinning of the sclera;
• dendritic ulcer of the cornea (herpetic keratitis)
• glaucoma;
• perforation of the eardrum;
• tuberculosis;
• fungal infections;
• pregnancy and lactation.

Sofradex should be used with extreme caution to treat young children, since large doses of the drug can impair the functioning of the adrenal cortex.

Interaction with other drugs

There are no particularly significant interactions with other drugs during treatment with Sofradex. The drug is used in combination with other medications (Dexamethasone, Actovegin) as home therapy after blepharoplasty.

Use in children

Drops are used in the treatment of otitis media and infectious eye inflammation in children. For a young child or infant, the drug should be instilled carefully and at a precise time for a course of no more than 5 days. The manufacturer does not recommend using drops for infants, but doctors allow the use of the drug in the absence of contraindications for use.

Before using the drops, you must first show the child to the doctor, since the product is a strong antibiotic. In children, Sofradex is used to treat runny nose, sinusitis, prevent otitis media, adenoids, and infectious and inflammatory diseases of the nasopharynx.

Children's dosage of drops:

• 2-3 drops in the ear 3-4 times a day;
• 1-2 drops into the eye sac for 3 to 7 instillations daily;
• 2-4 drops in each nostril 3 or 4 times a day.

Use during pregnancy

Pregnant women and during breastfeeding are not recommended to use Sofradex drops. The active substances of the drug can penetrate into breast milk and negatively affect the health and development of the fetus. During lactation and feeding the mother, it is recommended to pay attention to more gentle drugs.

Storage conditions and shelf life

The shelf life of the drops is 2 years. The bottle can be stored for 1 month after opening.

Analogs

Sofradex can be replaced with pharmaceutical analogues that have similar therapeutic effects. Preparations with other active ingredients similar to Sofradex:

• Otipax;
• Anauran;
• Polydex;
• Otinum;
• Candibiotic;
• Signicef;
• Solutab;
• Otofa;
• Tobradex.

There are a lot of analogue drugs, but only an ENT doctor or an ophthalmologist can prescribe them.

Price and reviews

Sofradex (5 ml volume) can be purchased at a pharmacy at a price of 140 to 200 rubles, depending on the region of residence. When purchasing, pay attention to the safety of the packaging and the expiration date; it should not exceed 2 years. Drops can be purchased with a doctor's prescription.

In ophthalmology and otorhinolaryngology, Sofradex drops are considered a highly effective remedy against various diseases of the ears and eyes. The reviews are often contradictory. Experts believe that this phenomenon is associated with neglected treatment. If you start dripping the medicine during the initial illness, the positive effect will appear quickly.

Many people are satisfied with the drug Sofradex, but there are negative reviews about complications after treatment: not everyone knows that the medicine is not suitable for a long course of treatment. The disadvantages include the shelf life of the bottle after opening - only 1 month.

In general, one can observe positive reviews about the medicinal properties of Sofradex. For many people, the drug helps cope with infectious diseases of the eyes and ears. Those who followed all the doctor’s instructions and precautions were satisfied with the drug.

Sofradex drops are considered an effective remedy for eye and ear diseases, but they contain antibiotics and hormonal substances. It is worth remembering that patient comments cannot be an indication for the use of the medicine. The attending physician can prescribe the medicine after a preliminary medical examination.

Ear drops are the first necessity when otitis occurs, because it is unbearably difficult to endure severe, throbbing pain in the ear for a long time, and it is not necessary. Any pharmacy provides a wide selection of medications for this disease, but the drug 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. There is no need for a longer treatment period - 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 have been recommending the drug Sofradex to their patients for almost any inflammation of the mucous membranes. These ear drops can rightfully be called eye drops and even nasal drops, although the instructions do not suggest such use. In reality, they cope not only with otitis of the external ear, but also with conjunctivitis, keratitis, eczema of the outer eyelid, adenoids and other diseases of the eyes, ears and nasopharynx.

The price of the drops allows everyone to purchase them, and the instructions describe in detail the method of application.

Active substances

Naturally, all the benefits of the medication are due to its balanced and thoroughly researched composition, which is confirmed by 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 ingredients of the drug:

The instructions for the drug describe all these substances and say that Sofradex drops provide bactericidal, bacteriostatic, antimicrobial, antistaphylococcal, anti-inflammatory, antiallergic and desensitizing effects. These are exactly the beneficial properties of the medication that are needed to relieve symptoms and treat acute inflammation of the ears and eyes.

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 although the drops are effective, they are not suitable for everyone, and they must be used strictly, as the instructions say, and not intuitively. Since the price of ear drops is affordable, they can help anyone if they have a clear indication for use.

To treat acute otitis of the external ear, you just need to instill 2-3 drops into the sore ear up to 3-4 times a day. Once opened, the bottle can be stored for no longer than a month in a dark place. It is important that in case of purulent otitis, ear drops are strictly prohibited, because the discharge of pus is a clear sign of perforation of the eardrum. If droplets enter the middle ear, they can damage the auditory nerve and lead to hearing loss. Therefore, if severe pain is felt after instillation, then treatment with Saphrodex must be stopped immediately.

The instructions indicate the possibility of another method of use, which is praised by reviews - using a cotton wool... It must be soaked in the preparation and replaced with a new one 4 times a day. The price of the drug allows its repeated purchase. During treatment with Safrodex, other antibiotics with ototoxic or nephrotoxic effects should not be used. The use of Safrodex for longer than 7 days is possible only if there are clearly pronounced positive dynamics in difficult cases. The reason for this is that long-term use can provoke an increase in the resistance of the microflora and hide other inflammatory processes.

Caution, dangerous: contraindications

The instructions for any drug contain contraindications, but, unfortunately, few people pay attention to them. And this is very in vain: a prohibited use can lead to the most unexpected consequences. Negative reviews are based precisely on incorrect application. The price of Sofradex is its clear advantage, but if a person has one of the diseases described below, then it is necessary to choose another medicine. 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 pregnant women should refrain from using these ear drops. The instructions also inform you that side effects are possible when treating the eyes. Ingestion of the drug is prohibited, but swallowing a bottle of up to 5 ml does not require any treatment - side effects will not be pronounced.