The instruction for medical use
of Niotit-DF medicine
A trade name
of Niotit-DF
the International unlicensed name
Is not present
the Dosage form
of the Drop ear, 10 ml
Structure
10 ml of solution contain
active agents: chloramphenicol of 0.1 g,
lidocaine hydrochloride of 0.1 g,
excipients: boric acid of 0.1 g, alcohol of 70%.
Description
Transparent colourless or slightly yellowish color liquid.
Pharmacotherapeutic group
Drugs for treatment of otological diseases others.
The code of automatic telephone exchange S02DA30
the Pharmacological
Pharmacokinetics At properties topical administration in the form of ear drops system absorption low.
A pharmacodynamics
of Niotit-DF - the combined drug for topical administration. Has antibacterial and mestnoanesteziruyushchy effect. Chloramphenicol bacteriostatic antibiotic of a broad spectrum of activity. Breaks process of synthesis of protein in a microbic cell (having good lipophilicity, gets through a cellular membrane of bacteria and back contacts a subunit of 5OS of bacterial ribosomes in which movement of amino acids to the growing peptide chains is delayed that leads to disturbance of synthesis of protein). It is active concerning the majority of strains of the gram-positive and gram-negative microorganisms (Staphylococcus spp., Streptococcus spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Serratia spp., Proteus spp., etc.) causing development of the infectious and inflammatory diseases of an external and middle ear resistant to penicillin, tetracyclines, streptocides.
Lidocaine the hydrochloride possessing mestnoanesteziruyushchy action takes off the sharp pain accompanying the majority of diseases of an ear. The combination in alcohol solution of antibacterial and mestnoanesteziruyushchy means enhances therapeutic effect of drug.
Indications
- external otitis without perforation of a tympanic membrane
- not purulent average otitis
the Route of administration and doses
Before use of Niotita-DF should be carried out a toilet of external acoustical pass. For this purpose, the small piece of sterile cotton wool is wound on the probe or for the end of a match, free from sulfur. At the same time on the end of the probe or a match of vatu it is necessary to fluff up. To the patient delay an auricle back and up to level external acoustical pass. The probe or a match with cotton wool are slowly and carefully entered deep into acoustical pass to a tympanic membrane (depth of 2.0 cm). (Clockwise) on walls of acoustical pass collect by accurately rotary motions of the probe or a match pathological contents and take back. Change vatu and repeat a toilet until cotton wool and external acoustical pass do not become dry and clean.
Then on a back upper wall of acoustical pass dig in drug, having inclined at the same time the patient's head in the opposite direction. After burying several times a cotton ball press a trestle, kind of massing it and an ear. Drug is kept in fish soup of 10-15 min., then, having inclined the head in the opposite direction, it is poured out. External acoustical pass is dried up and covered with a tampon from sterile cotton wool.
Drops have to be warm, have body temperature (not to cause irritation of a labyrinth). For this purpose before burying the bottle with drug is put for several minutes in warm water (35-36 wasps).
If use Niotit-DF in a bottle complete with a plastic dropper, then before use it is necessary to replace a bottle cover with a dropper.
In external acoustical pass dig in 3-4 times a day:
- to children 3 years on 3-5 drops are more senior
- to adults and children 14 years on 4-5 drops
the Course of treatment are more senior: for children - 2-5 days, for adults - 5-10 days.
It is also possible to put the cotton turunda moistened with drug. From a piece of sterile cotton wool twist a dense flagellum 2-2.5 cm long. Moisten it with several drops of warm drug and rotary motions enter into acoustical pass, previously having delayed an auricle back and up. It is necessary to leave a tip of a turunda outside that it easily could be taken. The humidity of a turunda is maintained, digging in every 3-5 hours warm medicine. Once a day the turunda is changed. Duration of use of drug by means of a turunda is defined by the doctor.
Side effects
Seldom
- irritation of skin and mucous membranes
- local allergic reactions in the form of rash, an itching, reddening and puffiness of fabrics
of the Contraindication
- perforation of a tympanic membrane of the infectious or traumatic nature
- the increased individual sensitivity
- pregnancy and the period of a lactation
- children's age up to 3 years
- viral and fungal infections of ears
- eczema of external acoustical pass
- oppression of a marrowy hemopoiesis
- a sharp intermittent porphyria
- deficit glyukozo-6-fosfatdegidrogenazy
Medicinal interactions
are not recommended to be applied to any of drug components along with other ear medicines.
At simultaneous use with erythromycin, clindamycin, lincomycin the mutual weakening of action is noted because chloramphenicol can force out these drugs from the connected state or interfere with their linking with a subunit 50S of bacterial ribosomes.
Reduces antibacterial effect of aminoglycosides, penicillin, polymyxin B, tetracyclines, cephalosporins, erythromycin. Also it is not compatible to ascorbic acid, a hydrocortisone, group B vitamins.
Special instructions
it is not necessary to appoint drug with the preventive purpose.
In the course of treatment the systematic control of a picture of peripheral blood is necessary.
With care appoint to the patients receiving earlier treatment by cytostatic drugs or radiation therapy.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Overdose
At topical administration of overdose it was not observed.
Symptoms at accidental intake: nausea, vomiting, diarrhea, headache, skin rashes, confusion of consciousness, fall of temperature of a body.
Treatment is symptomatic, it is necessary to provide sufficient intake of liquid in an organism.
A form of release and packing
On 10 ml of drug in glass bottles with the screw-on plastic cover combining a glass dropper and a nipple from rubber or in the glass bottles corked by the screwing-up plastic cover complete with a plastic dropper. On one bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard or on one bottle together with a plastic dropper and the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the place protected from light, at a temperature not over 20 of 0C.
To store out of children's reach!
The period of storage
After opening of a bottle drug is suitable 3 years within 28 days.
Not to apply after the expiration date specified on packing.
Prescription status
Without prescription
DOSFARM LLP Producer, 050034, Kazakhstan, Almaty, Chaplygin St., 3
the Owner of the registration certificate
of DOSFARM LLP, 050034, Kazakhstan, Almaty, Chaplygin St., 3
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of DOSFARM LLP, Republic of Kazakhstan, Almaty, Chaplygin St., 3, ph./fax: (727) 253-03-88, el. address: dospharm@dospharm.kz
of Niotit-DF medicine
A trade name
of Niotit-DF
the International unlicensed name
Is not present
the Dosage form
of the Drop ear, 10 ml
Structure
10 ml of solution contain
active agents: chloramphenicol of 0.1 g,
lidocaine hydrochloride of 0.1 g,
excipients: boric acid of 0.1 g, alcohol of 70%.
Description
Transparent colourless or slightly yellowish color liquid.
Pharmacotherapeutic group
Drugs for treatment of otological diseases others.
The code of automatic telephone exchange S02DA30
the Pharmacological
Pharmacokinetics At properties topical administration in the form of ear drops system absorption low.
A pharmacodynamics
of Niotit-DF - the combined drug for topical administration. Has antibacterial and mestnoanesteziruyushchy effect. Chloramphenicol bacteriostatic antibiotic of a broad spectrum of activity. Breaks process of synthesis of protein in a microbic cell (having good lipophilicity, gets through a cellular membrane of bacteria and back contacts a subunit of 5OS of bacterial ribosomes in which movement of amino acids to the growing peptide chains is delayed that leads to disturbance of synthesis of protein). It is active concerning the majority of strains of the gram-positive and gram-negative microorganisms (Staphylococcus spp., Streptococcus spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Serratia spp., Proteus spp., etc.) causing development of the infectious and inflammatory diseases of an external and middle ear resistant to penicillin, tetracyclines, streptocides.
Lidocaine the hydrochloride possessing mestnoanesteziruyushchy action takes off the sharp pain accompanying the majority of diseases of an ear. The combination in alcohol solution of antibacterial and mestnoanesteziruyushchy means enhances therapeutic effect of drug.
Indications
- external otitis without perforation of a tympanic membrane
- not purulent average otitis
the Route of administration and doses
Before use of Niotita-DF should be carried out a toilet of external acoustical pass. For this purpose, the small piece of sterile cotton wool is wound on the probe or for the end of a match, free from sulfur. At the same time on the end of the probe or a match of vatu it is necessary to fluff up. To the patient delay an auricle back and up to level external acoustical pass. The probe or a match with cotton wool are slowly and carefully entered deep into acoustical pass to a tympanic membrane (depth of 2.0 cm). (Clockwise) on walls of acoustical pass collect by accurately rotary motions of the probe or a match pathological contents and take back. Change vatu and repeat a toilet until cotton wool and external acoustical pass do not become dry and clean.
Then on a back upper wall of acoustical pass dig in drug, having inclined at the same time the patient's head in the opposite direction. After burying several times a cotton ball press a trestle, kind of massing it and an ear. Drug is kept in fish soup of 10-15 min., then, having inclined the head in the opposite direction, it is poured out. External acoustical pass is dried up and covered with a tampon from sterile cotton wool.
Drops have to be warm, have body temperature (not to cause irritation of a labyrinth). For this purpose before burying the bottle with drug is put for several minutes in warm water (35-36 wasps).
If use Niotit-DF in a bottle complete with a plastic dropper, then before use it is necessary to replace a bottle cover with a dropper.
In external acoustical pass dig in 3-4 times a day:
- to children 3 years on 3-5 drops are more senior
- to adults and children 14 years on 4-5 drops
the Course of treatment are more senior: for children - 2-5 days, for adults - 5-10 days.
It is also possible to put the cotton turunda moistened with drug. From a piece of sterile cotton wool twist a dense flagellum 2-2.5 cm long. Moisten it with several drops of warm drug and rotary motions enter into acoustical pass, previously having delayed an auricle back and up. It is necessary to leave a tip of a turunda outside that it easily could be taken. The humidity of a turunda is maintained, digging in every 3-5 hours warm medicine. Once a day the turunda is changed. Duration of use of drug by means of a turunda is defined by the doctor.
Side effects
Seldom
- irritation of skin and mucous membranes
- local allergic reactions in the form of rash, an itching, reddening and puffiness of fabrics
of the Contraindication
- perforation of a tympanic membrane of the infectious or traumatic nature
- the increased individual sensitivity
- pregnancy and the period of a lactation
- children's age up to 3 years
- viral and fungal infections of ears
- eczema of external acoustical pass
- oppression of a marrowy hemopoiesis
- a sharp intermittent porphyria
- deficit glyukozo-6-fosfatdegidrogenazy
Medicinal interactions
are not recommended to be applied to any of drug components along with other ear medicines.
At simultaneous use with erythromycin, clindamycin, lincomycin the mutual weakening of action is noted because chloramphenicol can force out these drugs from the connected state or interfere with their linking with a subunit 50S of bacterial ribosomes.
Reduces antibacterial effect of aminoglycosides, penicillin, polymyxin B, tetracyclines, cephalosporins, erythromycin. Also it is not compatible to ascorbic acid, a hydrocortisone, group B vitamins.
Special instructions
it is not necessary to appoint drug with the preventive purpose.
In the course of treatment the systematic control of a picture of peripheral blood is necessary.
With care appoint to the patients receiving earlier treatment by cytostatic drugs or radiation therapy.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Overdose
At topical administration of overdose it was not observed.
Symptoms at accidental intake: nausea, vomiting, diarrhea, headache, skin rashes, confusion of consciousness, fall of temperature of a body.
Treatment is symptomatic, it is necessary to provide sufficient intake of liquid in an organism.
A form of release and packing
On 10 ml of drug in glass bottles with the screw-on plastic cover combining a glass dropper and a nipple from rubber or in the glass bottles corked by the screwing-up plastic cover complete with a plastic dropper. On one bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard or on one bottle together with a plastic dropper and the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the place protected from light, at a temperature not over 20 of 0C.
To store out of children's reach!
The period of storage
After opening of a bottle drug is suitable 3 years within 28 days.
Not to apply after the expiration date specified on packing.
Prescription status
Without prescription
DOSFARM LLP Producer, 050034, Kazakhstan, Almaty, Chaplygin St., 3
the Owner of the registration certificate
of DOSFARM LLP, 050034, Kazakhstan, Almaty, Chaplygin St., 3
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of DOSFARM LLP, Republic of Kazakhstan, Almaty, Chaplygin St., 3, ph./fax: (727) 253-03-88, el. address: dospharm@dospharm.kz
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