Sofradex user manual
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Composition and form of release
Medicinal drops Sofradex have different indications for use, are used in otolaryngology and ophthalmology. They include several ingredients with anti-inflammatory and antibacterial properties:
gramicidin;
dexamethasone;
framycetin sulfate.
Among the excipients that enhance the effect of the antibiotic, the manufacturer indicates: phenylethyl and ethyl alcohol, purified water for the base, lithium chloride and sodium citrate. Citric acid acts as a preservative, preserving the properties of hormonal components.
The drops have a characteristic alcoholic smell, a light yellow tint. For treatment, they are available in 5 ml tinted glass vials. The drip tip makes it easy to use at home.
Pharmacological properties of the components
Ear drops Sofradex are a combined remedy, contain several active substances:
Framycetin sulfate. An antibiotic from the aminoglycoside group acts on many groups of bacteria: streptococci, staphylococci, gram-positive pathogens, E. coli and Pseudomonas aeruginosa.
Gramicidin. A broad-spectrum antibiotic that destroys Staphylococcus aureus, causative agents of dysentery, anaerobic viruses.
Dexamethasone. The synthetic hormonal component in Sofradex drops is responsible for the tone of the blood vessels, normalizes the outflow of blood and lymph, restores the nutrition of the hearing organ by suppressing the allergic reaction. When instilled in the ears, it relieves discomfort, burning, itching.
The medicinal compounds are quickly absorbed into the epidermis of the ear canal, affect the nerve endings, blood vessels. Antibiotics act on pathogenic microflora, destroying infectious agents in otitis media.
Drops relieve burning, itching, irritation, preventing the accumulation of inflammatory exudate in the middle ear.
Indications
Ear solution based on broad spectrum antibiotics and glucocorticosteroid hormone for the treatment of otitis externa caused by the following bacteria:
Klebsiella;
Staphylococcus aureus;
proteuses;
streptococci;
Pseudomonas aeruginosa.
The drops can be used to treat catarrhal otitis media, if the patient does not have a damaged eardrum. The drug is used in the complex therapy of eye diseases: blepharitis, barley, iridocyclitis, iritis. Recent clinical studies have proven an effective effect on inflamed adenoids, polyps in the nasal passage.
Instructions for use
The drops should be used only after examination and consultation with an otolaryngologist. The instructions for use contain the following dosage instructions:
When treating otitis media in children, it is necessary to instill 2 drops 3-4 times a day. After the procedure, you can close the ear canal with a cotton swab.
Adult patients are recommended 3 drops 3 times a day every 4 hours. The course of treatment lasts up to 7 days.
Babies can insert cotton turunda soaked in drops of Sofradex into the ear canal, leaving it for 15-30 minutes.
The drug contains potent antibiotics and dexamethasone, so do not exceed the dosage, be sure to visit an otolaryngologist to monitor the condition of the tympanic membrane.
When used in ophthalmology, Sofradex drops are carefully injected into the conjunctival sac. Before the procedure, you should wash your hands with soap and water, wipe the dispenser with an antiseptic to eliminate bacteria. In case of inflammation, allergies or keratitis, the medicine is used 3-5 times a day, 1 drop in each eye. With barley, it is recommended to apply cotton compresses soaked in the drug.
According to the appointment of an otolaryngologist, Sofradex drops are allowed to be used to reduce inflammation in the nasopharynx. With the complex therapy of adenoids, 5 drops are dropped into the nasal passage. Treatment lasts from 5 to 7 days, combined with taking antibiotics in tablets or injections.
Contraindications
In the treatment of otitis media and inflammation in the ear canal, there are the following contraindications that prohibit Sofradex drops with the following complications:
fungal infections;
viral diseases;
intolerance to one of the components of the drug;
purulent abscesses;
tuberculosis;
pregnancy;
lactation.
The components of Sofradex drops are distinguished by their ototoxicity, therefore, the use of a ruptured eardrum can lead to hearing loss and dangerous complications. Therefore, during the course of treatment, patients are advised to visit a doctor in 2–3 days for examination.
When using drops of Sofradex for the treatment of eye diseases, contraindications are: viral pathologies, thinning of the cornea, open wounds on the sclera. They are not used after surgery on the lens, for ulcers on the mucous membranes.
No less dangerous is the use of drops in case of exacerbation of herpes infection. The hormonal component stimulates the activity of the virus, provokes its reproduction and division. With long-term treatment, bacterial resistance often develops, the patient's condition worsens.
Overdose and side effects
In rare cases, the patient has a negative reaction to an overdose of Sofradex drops. It manifests itself in the following symptoms:
herpesvirus infection worsens;
the condition with ear dermatitis worsens;
itching and burning intensifies;
puffiness occurs.
The components of the drug can penetrate into the blood, therefore, in rare cases, there are signs of an overdose: increased blood pressure, a decrease in the level of hormones produced by the adrenal glands, general weakness and drowsiness. After the cancellation of treatment, the functions are restored in full.
Side effects often become a consequence of an allergy to the components of the drug or the effect of a synthetic hormone on the patient's internal organs. Symptoms of intolerance to Sofradex:
hives;
breathing disorder;
redness of the skin;
the development of dermatitis.
In rare cases, the drug Sofradex provokes the activity of viruses and pathogenic fungi. The patient develops a secondary infection of the ear canal and needs an antibiotic replacement.
Features of using Sofradex
The ear preparation must be used as directed by the attending physician, do not exceed the duration of treatment. Otherwise, the risk of developing superinfection and complications increases. During clinical observations, doctors noted a slight thinning of the mucous membranes while taking the corticosteroid dexamethasone. When antibiotics get into open wounds or fistulous passages, an ototoxic effect occurs.
Dexamethasone passes through the bloodstream to the adrenal glands, so overdose increases the risk of disrupting the production of certain hormones. In rare cases, organ dysfunction occurs in patients with kidney and thyroid diseases.
Use of the drug in pregnant and lactating patients
The manufacturer of Sofradex drops Aventis Pharma has not conducted clinical trials to prove the safety of the solution for pregnant women. It should not be forgotten that hormones negatively affect the work of the adrenal glands, can cause pathology in the development of internal organs in the embryo. Toxic effects, deterioration of blood circulation in the placenta are not excluded.
Sofradex is not used during lactation treatment. At any dosage, the minimum amount of the drug enters the bloodstream and breast milk, is passed on to the baby. This increases the risk of damage to the endocrine system, the adrenal glands of the newborn.
Drug interactions
Drops of Sofradex contain an antibiotic of the aminoglycoside series, therefore, simultaneous use with drugs based on gentamicin, monomycin and streptomycin is not recommended. This interaction enhances the toxic effect, disrupts the blood supply to soft tissues, mucous membranes.
When instilling ears during an exacerbation of otitis media, the drug can be combined with analgesic and anti-inflammatory compounds. But it is necessary to maintain a time interval of 20-30 minutes so that the active substances are absorbed into the epithelium of the ear canal.
Reviews
Victoria, 26 years old
Otitis media in my little son became a real test for me. The doctor recommended Sofradex drops to reduce inflammation, suppress bacterial infection. I was confused by the presence of 2 antibiotics and a hormone in the composition, but I decided to try the treatment according to the prescribed scheme. I noticed improvements after the second instillation, additionally put in cotton swabs with medicine. There were no side effects, the child underwent the procedure without allergies or complaints.
Maria, 31 years old
I have chronic otitis media, which appears after each hypothermia or ARVI. I use Sofradex drops at the first signs of inflammation, I drip it 3 times a day. This helps me avoid complications, relieves puffiness and discomfort. I think the only drawback is the high cost and the need to use the medicine 30 days after opening.
Yuri, 42 years old
On vacation I started having otitis media with severe pains, congestion of the ear. It was impossible to chew and sleep, the temperature rose. At a local hospital, an ENT doctor recommended Sofradex drops. He buried the sore ear 4 times a day, 2 drops. A day later, the condition improved significantly, painful swelling decreased. The drug is not cheap, but I can recommend it as a quality and proven remedy.
Terms of sell
You don't need a prescription to buy Sofradex.