Otibact® Eye Gel

Eye gel.

Antibacterial, antifungal, antipruritic and anti-inflammatory.

Each 5 g syringe contains:
Ciprofloxacin Hydrochloride Monohydrate…………………………. 58.2 mg
(Equivalent to 50 mg Ciprofloxacin base)
Clotrimazole……………………………………………………………………………. 50.0 mg
Triamcinolone acetonide…………………………………………………….. 2.5 mg
Excipients c.s.p……………………………………………………………………. 5.0 g

Otibact® Otic gel is indicated for the treatment of acute and chronic otitis externa caused by mixed infection of Staphylococcus intermedius or Pseudomonas aeruginosa and Malassezia pachydermatis, sensitive to the active ingredients of the association. Its anti-inflammatory effect reduces the levels of erythema, pruritus and secretion in the external ear canals of dogs.

Dogs.

Topical administration into the ear canal.

Clean and dry the ear canal, removing earwax and exudate. Trim excess hair from the area to be treated. Apply a dose of 0.5 g (one brand of the graduated syringe), once daily, 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 markings from 1 to 10, each of which allows a dose of 0.5 g to be administered. Rotate the wheel at the base of the plunger, retracting it towards the free end of the plunger and fixing it on the mark corresponding to the day of treatment. Once the wheel is fixed at the mark for the day of administration, push the plunger until the wheel touches the base of the syringe to release the contents. After application, massage the ear canal for better distribution of the product.

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

• 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 assessed before using this preparation, as fluoroquinolones, including Ciprofloxacin, should not be used as a 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 ear canal should be examined to ensure the integrity of the tympanic membrane (to prevent damage to the cochlear and vestibular apparatus).
• Keep out of reach of children and pets.

• Occasionally, clotrimazole may cause erythema, hives, blisters, edema, itching, and general skin irritation.
• Cushing’s syndrome has been reported in dogs in association with prolonged and repeated corticosteroid therapy.
• Use of this medication for more than 10 days may delay wound healing.

Do not use concomitantly with other pharmaceutical products.

• Do not handle by people who are hypersensitive to any active ingredient in the composition.
• In case of contact with skin, eyes or mucous membranes, wash immediately with plenty of water.
• In case of accidental ingestion, go immediately to a medical center and show the product insert.

Dispose of waste of this product with caution along with household waste. Do not dispose of containers with product residues on the ground or in waterways. For expired or unused products, contact the manufacturing laboratory.

Store at temperatures between 2 and 25°C. Do not freeze. Once opened, use within 10 days. Discard the unused product after that period of time.
Peru: Store at a temperature between 2 and 30 °C, away from light. Once opened, the syringe should be used within 10 days and stored between 15 and 30 °C, away from light.

Chile: Sale under prescription Withheld Veterinary Doctor.
Peru: Over-the-counter.

Chile: Reg. SAG N° 2322
Peru: Reg. SENASA F.F9.66.I.0008

VETERINARY USE
EXTERNAL USE

1 syringe with 5 g of product

Laboratorio Drag Pharma Chile Invetec S.A.
Lautaro N° 300. Quilicura. Santiago. Chile.