Otofa
Producer: Laboratoires Bouchara-Recordati Ireland
Code of automatic telephone exchange: S02AA12
Release form: Liquid dosage forms. Drops are ear.
General characteristics. Structure:
Active agent: Rifamycinum of sodium of 2.6 g (2 000 000 ME)
Excipients: a macrogoal of 400 - 25 g, ascorbic acid - 500 mg, dinatrium эдетат - 12 mg, potassium disulphite - 150 mg, a lity hydroxide - 135 mg, the water purified - to 100 ml.
Pharmacological properties:
Pharmacodynamics. Rifamycinum shows antimicrobic activity concerning the majority of the gram-positive and gram-negative microorganisms causing development of infectious and inflammatory diseases of a middle ear. The mechanism of action of Rifamycinum is caused by formation of a stable complex with a DNA-dependent RNA polymerase which interferes with growth of bacteria.
Pharmacokinetics. The research on pharmacokinetics was not conducted in connection with low system absorption.
Indications to use:
Chronic average otitis in the period of an aggravation, including in the presence of steady perforation of a tympanic membrane; the isolated purulent damages of a tympanic membrane; states after operative measures on a middle ear.
Route of administration and doses:
The adult dig in in outside acoustical pass 5 drops 2 times a day or fill in drug solution for several minutes 2 times a day; drug can be used for washing of a drum cavity through an attikovy cannula.
To children dig in in outside acoustical pass 3 drops 2 times a day or fill in drug solution for several minutes 2 times a day.
Treatment duration — usually no more than 7 days.
Before use of ear drops of Otof it is recommended to warm a bottle, having taken it in a hand, in order to avoid the unpleasant feelings caused by hit of cold liquid in an ear.
Features of use:
During use it is necessary to avoid a touch to a tip of a dropper both fingers, and an ear to reduce risk of an infection. Simultaneous use with any other medicines for topical treatment is not recommended. Topical administration of antibacterial drugs can serve as the sensitization reason to active agents and lead to system reactions. It is necessary to stop immediately drug use if arose rash on skin or other system manifestations of allergic reactions. If symptoms of a disease remain after 10 days of treatment, it is necessary to reconsider treatment tactics.
It is necessary to prevent contact of drug with clothes because solution can leave spots on fabric.
Use during pregnancy and feeding by a breast. Adequate and well controlled clinical trials of safety of use of drug at pregnancy were not conducted, but considering that the insignificant amount of drug gets to blood, and also in view of results of tests of connections which concern to group of Rifamycinum, drug it is possible to use during pregnancy.
Considering that the insignificant amount of drug gets to breast milk, the women applying ear drops on the basis of Rifamycinum can use drug during feeding by a breast.
Children. It is applied on doctor's orders to treatment of children without age restrictions.
Ability to influence speed of response at control of vehicles or work with other mechanisms. Does not influence.
Side effects:
As drug contains sulfites, there is a risk of allergic reactions, including an anaphylaxis and a bronchospasm. Coloring of a tympanic membrane in pink color is possible (that can be seen at an otoskopiya).
Interaction with other medicines:
Clinically significant interactions are not revealed. If you accept any other medicines for topical administration, surely report about it to the doctor.
Contraindications:
Hypersensitivity to drug components.
Overdose:
Due to low extent of absorption in a system blood stream the overdose is improbable.
Storage conditions:
At a temperature not above 25 °C.
To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
100 ml of ear drops contain Rifamycinum of sodium 2,6 g that corresponds to 2000000 ME; in bottles with a pipette of 10 ml.