OTIBACT® Otic Gel.


Antibacterial - Antifungal - Antipruritic - Anti-inflammatory

OTIBACT® Otic Gel is indicated for the treatment of acute and chronic external otitis caused by mixed infection of Staphylococcus intermedius or Pseudomonas aeruginosa and Malassezia pachydermatis, sensitive to the active principles of the association. Its anti-inflammatory effect reduces the levels of erythema, itching and secretion in the external auditory canals of dogs.

Technical Specification

Species


Dogs.

Dosage form


Otic Gel.

Therapeutic action


Antibacterial - Antifungal - Antipruritic - Anti-inflammatory

Composition


Each 5 g syringe contains:
Ciprofloxacin Hydrochloride Monohydrate
(Equivalent to 50 mg of Ciprofloxacin base) ................... 58.2 mg
Clotrimazole .............................................................. 50.0 mg
Triamcinolone Acetonide ............................................... 2.5 mg
Excipients csp ................................................................ 5.0 g

Indications


OTIBACT® Otic Gel is indicated for the treatment of acute and chronic external otitis caused by mixed infection of Staphylococcus intermedius or Pseudomonas aeruginosa and Malassezia pachydermatis, sensitive to the active principles of the association. Its anti-inflammatory effect reduces the levels of erythema, itching and secretion in the external auditory canals of dogs.

Mode of application


Clean and dry the external auditory canal, removing wax and exudate. Trim excess hair from the area to be treated. Apply a dose of 0.5 g (one mark of the graduated syringe), once a day, directly into the ear canal, for 7 to 10 consecutive days. One syringe contains 10 doses for the complete treatment of one ear. The plunger of the syringe is graduated with marks from 1 to 10, each of which allows a dose of 0.5 g to be administered. Turn the wheel that comes at the base of the plunger, retracting it towards the free end of the plunger and fix it at the mark corresponding to the day of treatment. Once the wheel is set on the mark corresponding to the day of administration, push the plunger until the wheel stops against the base of the syringe to release the contents. After application, massage the ear canal for a better distribution of the product.

Route od administration and dosage


Topical administration in the external auditory canal.

Drug interactions


Do not apply in conjunction with another substance or veterinary drug.

Contraindications


  • Contraindicated in patients with hypersensitivity to any of its components.
  • Do not treat animals with perforation of the tympanic membrane.
  • Do not administer in females during the gestation or lactation period.
  • Do not administer in breeding animals.
  • Do not use with other drugs that can induce ototoxicity.
  • Do not use in dogs under 6 months of age and / or with less than 1 kg of body weight.

Special precautions for use


  • Before starting treatment, the identification of the etiological agent (s) should be carried out, either by smear or culture. In addition, the antibiotic susceptibility of pathogenic bacteria should be evaluated before using this preparation, since fluoroquinolones, including Ciprofloxacin, should not be used as the first line of treatment, unless there is justification for their use.
  • There is evidence that corticosteroids can be absorbed after topical application, causing systemic effects. Consequently, any animal using this product should be closely watched for signs such as polydipsia, polyuria, or increased weight gain.
  • Before applying the product, the external auditory canal should be examined to ensure the integrity of the tympanic membrane (in order to prevent damage to the vestibular and cochlear apparatus).

Special precautions for the operator


  • Wash your hands after administering the product.
  • If the product comes into contact with the eyes, wash with plenty of water.
  • In the case of accidental ingestion, do not induce vomiting. Get medical help.
  • Do not handle the drug if you have a known hypersensitivity to any of its components.

Warnings


Keep out of the reach of children.

Adverse effects


  • Occasionally Clotrimazole may cause erythema, hives, blisters, edema, itching, and generally skin irritation.
  • In dogs, Cushing's syndrome has been reported in association with prolonged and repeated therapy with corticosteroids.
  • Using this medicine for more than 10 days may delay wound healing.

Observations


Special precautions for disposal of unused product or waste material:
Dispose of any unused product remains in its original, tightly closed container. Dispose of this product waste carefully with household waste. Contact the manufacturing company or companies specialized in waste disposal, to receive recommendations on the disposal of expired or unused products.

Conservation


Store at a temperature between 2 and 30 ° C, protected from light.
Once opened, the syringe should be used within 10 days and stored between 15 and 30ºC, protected from light.

Condition of sale


Chile: Sale under Veterinary Medical prescription restricted.
Peru: Free Sale.

Presentation


1 syringe with 5 g of product

Prepared by


Laboratorio Drag Pharma Chile Invetec S.A.

Records


Chile: Reg. SAG Nº 2322
Perú: Reg. SENASA F.F9.66.I.0008

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Drag Pharma Lab is not responsible for the consequences of misuse of the products, and the use of this information without consulting a veterinarian