Sofradeks eye drops 5 ml / ear
- $9.80
Out Of Stock
The instruction for medical use
of Sofradeks medicine
the Trade name
of Sofradeks
the International unlicensed name
Is not present
the Dosage form
Eye/ear drops of 5 ml
Structure
1 ml of solution contains
active agents: Framycetinum sulfate of 5 mg, gramicidin of 0.05 mg, dexamethasone (in the form of metasulfobenzoate dexamethasone sodium) – 0.5 mg,
excipients: a lity chloride, sodium citrate, citric acid monohydrate, phenylethyl alcohol, absolute alcohol, polysorbate 80, water for injections.
The description
Transparent, almost colourless solution with a characteristic smell of phenylethyl alcohol
Pharmacotherapeutic group
Drugs for treatment of diseases of eyes.
Anti-inflammatory drugs in a combination with antimicrobial drugs. Glucocorticoids in a combination with antimicrobial drugs. Dexamethasone in a combination with the antimicrobial
drugs ATX S01CA01 Code Pharmacological Sulphate Framycetinum Absorption Properties is carried out from the inflamed skin and wounds. After absorption it is quickly removed from an organism by kidneys in an active form. It is registered that its elimination half-life makes 2-3 hours.
Gramicidin has the properties similar to tyrothricin and is too toxic to be applied systemically.
Dexamethasone is well soaked up from digestive tract. Its biological elimination half-life in plasma makes about 190 minutes.
The pharmacodynamics
Framycetinum sulfate is an aminoglikozidny antibiotic with the spectrum of action similar to Neomycinum range where Staph belongs. aureus and majority of clinically significant gram-negative microorganisms.
Gramicidin is the antimicrobic cyclic polypeptide showing activity of in vitro concerning many gram-positive bacteria. It is applied to topical treatment of the infections caused by microorganisms, sensitive to it, sometimes in a combination with other antimicrobic agents and is frequent - with corticosteroids.
Dexamethasone is a synthetic glucocorticoid and has properties, the general with other corticosteroids.
Indications
- for short-term treatment - dependent diseases of eyes when preventive antibiotic treatment after an exception of damages of fungal or virus origin is also required
- external otitis
the Route of administration and doses
to Apply steroid to ears and eyes.
A dosage
Adults (including advanced age) and children
In eyes: to put in each affected eye on one or two drops to six times a day or is more often if it is required.
In ears: to dig in in an ear two or three drops three or four times a day.
Treatment should be carried out by a short course (no more than 7 days).
A drug period of storage after opening of a bottle – 1 month.
Side effects
- can be observed the reactions of hypersensitivity, usually slowed down type leading to irritation, burning sensation, an acute pain, an itching and dermatitis
- steroids for topical administration can cause increase in the intraocular pressure leading to damage of an optic nerve, decrease in visual acuity and disturbance of fields of vision
- intensive or prolonged use of local corticosteroids can lead to forming of back subkapsulyarny cataracts
- in diseases which cause thinning of a cornea or sclera, of corticosteroids the thinning of an eyeball leading to perforation can be a consequence of therapy.
Contraindications
are viral, fungus, purulent diseases of eyes, eye tuberculosis
- presence of glaucoma, expected presence of a herpetic keratitis (the dentritic ulcer at use of local steroids can increase and lead to the significant deterioration in sight)
- external otitis, in case of perforation of a tympanic membrane (risk of ototoxicity)
- hypersensitivity to drug
- pregnancy and the period of a lactation
Medicinal interactions
At topical administration do not matter.
Local corticosteroids it is never necessary to appoint special instructions when reddening eyes of unspecified genesis as inappropriate use can lead to a blindness.
At disturbance of integrity of an epithelium of a cornea and thinning of a sclera, drug is not appointed, in connection with a possibility of perforation of covers of an eye.
It is not necessary to continue treatment by a combination of corticosteroids and antibiotics more than 7 days in the absence of any clinical improvement because prolonged use can lead to the hidden spread of infections, owing to the masking effect of steroid. Prolonged use can also bring into a sensitization of skin and to emergence of resistant microorganisms.
Prolonged use can increase risk of suppression of function of adrenal glands at children.
Treatment by corticosteroid drugs should not be repeated or prolonged without the regular control directed to an exception of the increased intraocular pressure, forming of a cataract or unexpected infections.
Aminoglikozidny antibiotics can cause irreversible, partial or full deafness if are applied systemically or locally on open wounds or the injured skin. This effect depends on a dose and amplifies in a renal failure or a liver. In spite of the fact that this effect was not registered at ophthalmologic use, such opportunity should be considered when to children or babies the high local dose is appointed.
Pregnancy and a lactation
Safety at use during pregnancy and a lactation is not established. Data on safety during pregnancy are insufficient. Topical administration of corticosteroids in preclinical trials can cause fetation pathology, including a wolf mouth and a delay of pre-natal development. Therefore, very small risk of rendering such effects and on a fruit of the person is possible.
There is a risk of ototoxicity for a fruit if drugs of aminoglikozidny antibiotics are used during pregnancy.
Temporary perception of visible objects in the form of indistinct contours can cause features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms At instillation in eyes, drug. Warn patients that at not clear sight they did not drive the car and did not work with the moving mechanisms posing a threat for health.
The overdose
Prolonged, frequent topical administration can make system impact. It is improbable that hit of contents of one bottle (up to 10 ml) in digestive tract caused serious undesirable reactions.
A form of release and packing
On 5 ml in bottles from dark glass corked by polyethylene traffic jams and the rolled-up aluminum caps. On 1 bottle and the polyethylene stopper dropper (packed hermetically into polyethylene) together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not above 25ºС.
To store out of children's reach!
2 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
the Producer
of Sanofi India Limited, India
the location Address: Aventis House, 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai - 400,093 India
the Owner of the registration certificate
of Sanofi India Limited, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. 187btelefon: +7 (727) 244-50-96факс: +7 (727) 258-25-96e-mail: quality.info@sanofi.com
of Sofradeks medicine
the Trade name
of Sofradeks
the International unlicensed name
Is not present
the Dosage form
Eye/ear drops of 5 ml
Structure
1 ml of solution contains
active agents: Framycetinum sulfate of 5 mg, gramicidin of 0.05 mg, dexamethasone (in the form of metasulfobenzoate dexamethasone sodium) – 0.5 mg,
excipients: a lity chloride, sodium citrate, citric acid monohydrate, phenylethyl alcohol, absolute alcohol, polysorbate 80, water for injections.
The description
Transparent, almost colourless solution with a characteristic smell of phenylethyl alcohol
Pharmacotherapeutic group
Drugs for treatment of diseases of eyes.
Anti-inflammatory drugs in a combination with antimicrobial drugs. Glucocorticoids in a combination with antimicrobial drugs. Dexamethasone in a combination with the antimicrobial
drugs ATX S01CA01 Code Pharmacological Sulphate Framycetinum Absorption Properties is carried out from the inflamed skin and wounds. After absorption it is quickly removed from an organism by kidneys in an active form. It is registered that its elimination half-life makes 2-3 hours.
Gramicidin has the properties similar to tyrothricin and is too toxic to be applied systemically.
Dexamethasone is well soaked up from digestive tract. Its biological elimination half-life in plasma makes about 190 minutes.
The pharmacodynamics
Framycetinum sulfate is an aminoglikozidny antibiotic with the spectrum of action similar to Neomycinum range where Staph belongs. aureus and majority of clinically significant gram-negative microorganisms.
Gramicidin is the antimicrobic cyclic polypeptide showing activity of in vitro concerning many gram-positive bacteria. It is applied to topical treatment of the infections caused by microorganisms, sensitive to it, sometimes in a combination with other antimicrobic agents and is frequent - with corticosteroids.
Dexamethasone is a synthetic glucocorticoid and has properties, the general with other corticosteroids.
Indications
- for short-term treatment - dependent diseases of eyes when preventive antibiotic treatment after an exception of damages of fungal or virus origin is also required
- external otitis
the Route of administration and doses
to Apply steroid to ears and eyes.
A dosage
Adults (including advanced age) and children
In eyes: to put in each affected eye on one or two drops to six times a day or is more often if it is required.
In ears: to dig in in an ear two or three drops three or four times a day.
Treatment should be carried out by a short course (no more than 7 days).
A drug period of storage after opening of a bottle – 1 month.
Side effects
- can be observed the reactions of hypersensitivity, usually slowed down type leading to irritation, burning sensation, an acute pain, an itching and dermatitis
- steroids for topical administration can cause increase in the intraocular pressure leading to damage of an optic nerve, decrease in visual acuity and disturbance of fields of vision
- intensive or prolonged use of local corticosteroids can lead to forming of back subkapsulyarny cataracts
- in diseases which cause thinning of a cornea or sclera, of corticosteroids the thinning of an eyeball leading to perforation can be a consequence of therapy.
Contraindications
are viral, fungus, purulent diseases of eyes, eye tuberculosis
- presence of glaucoma, expected presence of a herpetic keratitis (the dentritic ulcer at use of local steroids can increase and lead to the significant deterioration in sight)
- external otitis, in case of perforation of a tympanic membrane (risk of ototoxicity)
- hypersensitivity to drug
- pregnancy and the period of a lactation
Medicinal interactions
At topical administration do not matter.
Local corticosteroids it is never necessary to appoint special instructions when reddening eyes of unspecified genesis as inappropriate use can lead to a blindness.
At disturbance of integrity of an epithelium of a cornea and thinning of a sclera, drug is not appointed, in connection with a possibility of perforation of covers of an eye.
It is not necessary to continue treatment by a combination of corticosteroids and antibiotics more than 7 days in the absence of any clinical improvement because prolonged use can lead to the hidden spread of infections, owing to the masking effect of steroid. Prolonged use can also bring into a sensitization of skin and to emergence of resistant microorganisms.
Prolonged use can increase risk of suppression of function of adrenal glands at children.
Treatment by corticosteroid drugs should not be repeated or prolonged without the regular control directed to an exception of the increased intraocular pressure, forming of a cataract or unexpected infections.
Aminoglikozidny antibiotics can cause irreversible, partial or full deafness if are applied systemically or locally on open wounds or the injured skin. This effect depends on a dose and amplifies in a renal failure or a liver. In spite of the fact that this effect was not registered at ophthalmologic use, such opportunity should be considered when to children or babies the high local dose is appointed.
Pregnancy and a lactation
Safety at use during pregnancy and a lactation is not established. Data on safety during pregnancy are insufficient. Topical administration of corticosteroids in preclinical trials can cause fetation pathology, including a wolf mouth and a delay of pre-natal development. Therefore, very small risk of rendering such effects and on a fruit of the person is possible.
There is a risk of ototoxicity for a fruit if drugs of aminoglikozidny antibiotics are used during pregnancy.
Temporary perception of visible objects in the form of indistinct contours can cause features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms At instillation in eyes, drug. Warn patients that at not clear sight they did not drive the car and did not work with the moving mechanisms posing a threat for health.
The overdose
Prolonged, frequent topical administration can make system impact. It is improbable that hit of contents of one bottle (up to 10 ml) in digestive tract caused serious undesirable reactions.
A form of release and packing
On 5 ml in bottles from dark glass corked by polyethylene traffic jams and the rolled-up aluminum caps. On 1 bottle and the polyethylene stopper dropper (packed hermetically into polyethylene) together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not above 25ºС.
To store out of children's reach!
2 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
the Producer
of Sanofi India Limited, India
the location Address: Aventis House, 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai - 400,093 India
the Owner of the registration certificate
of Sanofi India Limited, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. 187btelefon: +7 (727) 244-50-96факс: +7 (727) 258-25-96e-mail: quality.info@sanofi.com
Related Products
