OTOFA

Active material: Rifamiцin
When ATH: S02AA12
CCF: Antibacterial drug for local use in ENT practice
ICD-10 codes (testimony): H60, H66, H72, Z29.2
When CSF: 06.08.04
Manufacturer: Laboratoires Bouchara-RECORDATI (France)

Pharmaceutical form, composition and packaging

Ear Drops 2.6%1 ml1 fl.
rifamycin sodium26 mg (20 thousand IU)260 mg (200 thousand IU)

Excipients: macrogol 400, vitamin C, sodium edetate, potassium metabisulfite, lithium hydroxide, Purified water.

10 ml – vials of dark glass (1) complete with dosing pipette – packs cardboard.

 

Pharmacological action

Rifamycin antibiotic for topical use in otorhinolaryngology. The mechanism of action of rifamycin linked to form a stable complex with DNA dependent RNA polymerase, which prevents the growth of bacteria. It is active against Most Gram-positive and Gram-negative bacteria, causing the development of infectious and inflammatory diseases of the outer and middle ear.

 

Pharmacokinetics

Research pharmacokinetics Otofa not conducted in connection with low systemic absorption.

 

Testimony

Acute and chronic otitis:

- Otitis externa;

- Acute otitis media (incl. perforation of the eardrum);

- Chronic otitis media;

- Conditions after surgeries on middle ear.

 

Dosage regimen

Adults buried in the ear of 5 drops 3 times / day or the drug is poured into the ear of a few minutes 2 times / day.

Babies buried in the ear of 3 drops 3 times / day or the drug is poured into the ear of a few minutes 2 times / day.

The average duration of therapy – 7 days.

Before using ear drops it is recommended to warm the bottle, holding it in your hand, in order to avoid unpleasant sensations, related to exposure to the cold fluid in the ear.

 

Side effect

Rarely: allergic skin reactions.

 

Contraindications

- Hypersensitivity to the rifamycin.

 

Pregnancy and lactation

Adequate and well-controlled clinical studies on the safety of the drug Otofa during pregnancy and lactation (breast-feeding) not performed.

 

Cautions

The drug gives the pink color eardrum (visible at otoscopy).

Avoid contact of the product with clothing, tk. the solution may stain fabric.

 

Overdose

Due to the low degree of systemic absorption of overdose is unlikely.

 

Drug Interactions

Clinically significant drug interactions Otofa drug with other drugs have been identified.

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

Conditions and terms

The drug should be stored at temperatures above 25 ° C. Shelf life – 3 year.

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