active substance: rifamycin;
1 ml solution contains sodium refalo in terms of rifamycin 26 mg/ml (20000 IU/ml);
excipients: macrogol 400, ascorbic acid, disodium edetate, potassium metabisulphite (E 224), lithium hydroxide, purified water.
Dosage form. Ear drops, solution.
Basic physical and chemical properties: transparent liquid red-orange color.
Drugs used in otology. An antimicrobial agent.
ATC code A12 Ѕ02А.
The pharmacological properties.
Rifamycin exhibits antimicrobial activity against many gram-positive and gram-negative microorganisms that cause the development of infectious-inflammatory diseases of the middle ear. The mechanism of action is associated with the formation of a stable complex with DNA-dependent RNA polymerase, which inhibits the growth of bacteria.
Rifamycin is active against Bacillus anthracis, Listeria monocytogenes, R. equi, Staphylococcus, Streptococci A, B, C, G, Streptococcus, B. catarrhalis, Brucella, H. ducreyi, H. influenzae, N. gonorrhoeae, N. meningitidis, Pasteurella, Bacteroides, C. difficile, C. perfringens, Fusobacterium, Peptostreptococcus, Propionibacterium acnes, Chlamydia, Coxellia burnettii, Legionella, Mycobacterium, Enterococci.
To action refalo resistant intestinal bacteria, atypical Mycobacterium.
Rifamycin ineffective against P. aeruginosa and with frequent clinical and microbiological lesions. This bacterium is responsible not less than 30 % of infections, which illustrates this drug.
Studies of pharmacokinetics have not been conducted due to the low systemic absorption.
Local treatment of certain types of discharge of pus from the ear:
condition after surgical intervention on the middle ear;
isolated suppurative lesions of the tympanic membrane;
exacerbation of chronic otitis media, with perforation of the tympanic membrane.
Hypersensitivity (Allergy) to any component of the drug.
Interaction with other medicinal products and other forms of interaction.
It is not recommended to use the drug in conjunction with any other drugs for local use.
Features of the application.
Not conducted research on the otitis of the outer passage, therefore, must adhere to official recommendations on the appropriate use of antibiotics in the treatment of this drug.
Local application of antibacterial drugs may cause sensitisation to the active substances and lead to systemic reactions.
You should immediately stop using the product if there is skin rash or other systemic manifestations of allergic reactions.
Do not swallow solution, do not use the injection.
In use, should avoid touching the edge of the drip as fingers and ear to reduce the risk of infection.
If symptoms persist after a 10-day course of treatment, the patient should contact the physician for review of the disease and treatment strategies.
Avoid contact with clothing, because the solution can leave stains on the fabric.
Use during pregnancy or breast-feeding.
Adequate and well-controlled studies in pregnant women did not.
Given the low systemic absorption refalo with the introduction of drops in the ear topical application of the drug during pregnancy or breast-feeding is allowed only on the recommendation of a doctor.
The ability to influence the reaction rate when driving motor transport or operating other mechanisms.
There were no cases of influence on velocity reactions while driving or operating other mechanisms.
Method of application and doses.
The drug is used topically in the form of instillation into the ear.
Drops instilled into the external auditory meatus of the affected ear each morning, repeat the procedure in the evening.
Adult dosage: 5 drops in affected ear 2 times a day.
The drug can be used for irrigation of the tympanic cavity through the cannula attikovu.
Dosage for children: 3 drops in affected ear 2 times a day.
The duration of treatment depends on the nature and severity of the disease and is determined individually. The average duration of treatment is 7 days.
Before applying the drops should warm the bottle by holding it in the palm of your hand to avoid the unpleasant sensation associated with contact with cold liquid in the ear. Tilt your head, put the right amount of drops in the ear several times to pull a little on your ear. Keep the head tilted for about 5 minutes to improve contact with the ear canal. If you need to repeat the procedure for the second ear.
Do not inject the drug under pressure.
After completion of treatment the vial should be discarded and not stored for re-use in the future.
To apply for the appointment of a physician for the treatment of children of all ages.
No cases of overdose were noted. Due to the low absorption overdose is unlikely.
Disorders of the immune system.
For the content of sulfites in the product there is a risk of allergic reactions, including anaphylaxis, bronchospasm and cutaneous manifestations, including rash, eczema.
Possible staining of the tympanic membrane in the pink color (which can be seen at otoscopy).
The expiration date. 3 years.
The storage conditions. Keep at temperature not exceeding 25 °C. Keep out of reach of children.
Packing. 10,0 ml vial, 1 bottle with dropper in cardboard box.