Mitaban

Mitaban (amitraz) is indicated for treatment of generalized demodicosis (Demodex canis) in dogs. Current data do not yet support use for treatment of localized demodicosis or scabies. 10.6mL

WARNING:
Toxicology studies conducted in the dog and other species suggest amitraz may alter the animal's ability to maintain homeostasis. Animals treated with MITABAN (amitraz) should not be subjected to stress for a period of at least 24 hours post treatment. Adverse reactions including three fatalities were reported during the clinical studies. In excess of 1100 patients with generalized demodicosis were topically treated with MITABAN.

CONTRAINDICATIONS:
•Fertility impairment studies have not been conducted in the canine with MITABAN (amitraz). It is not known whether MITABAN may cause impairment of fertility in dogs.
•Reproduction studies during pregnancy have not been conducted with MITABAN. It is not known whether MITABAN may harm the embryo or fetus.
•The safety of MITABAN has not been established for dogs less than four months of age.

WARNINGS:
•Please refer to warning at the beginning of the package insert.
•Not for human use. Keep out of reach of children.
•MITABAN (amitraz) may be harmful if swallowed by humans. If swallowed do not induce vomiting (contains xylol) and immediately call a physician. Avoid inhalation of vapors (xylol) and contamination of feed and food stuffs.
•MITABAN is flammable; when diluted with water the mixture is not flammable.
•MITABAN (concentrate or diluted) may cause eye or skin irritation in sensitive persons. Do not get in eyes on skin or on clothing. If in eyes wash with water for 15 minutes and call a physician immediately.
•Protect exposed skin (e.g. with rubber gloves etc.) when mixing MITABAN with water and treating animals. Wash hands and arms with soap and water after treatment of the pet(s). Dispose of unused MITABAN-water solution by flushing down the drain. Rinse the MITABAN container with water and do not reuse.
•Avoid handling pets immediately after treatment. Contact may cause skin irritation in sensitive individuals during the first few days after treatment.
•Amitraz the active ingredient in MITABAN has been shown to cause liver tumors in female mice.
•Ingestion or inhalation may cause central nervous system depression.

PRECAUTIONS:
•Though eye or dermal irritation was not reported during controlled experiments such effects have been infrequently reported from clinical use.
•Consistent with good veterinary practice it is recommended that a protectant be used in the eyes of patients prior to facial treatment with any topical therapy.
•Well-controlled experiments with MITABAN® (amitraz) have not been conducted to determine the compatibility range with other products.

ADVERSE REACTIONS AND SIDE EFFECTS:
Ingestion of MITABAN may increase the risk of adverse effects. Therefore appropriate care should be exercised both during and immediately after MITABAN application to minimize the opportunity for exposure by the oral route.
The most frequently observed adverse reaction in the clinical studies was transient sedation which occurred in approximately 8% of the generalized demodicosis patients. This effect was observed within 2 to 6 hours post treatment and usually dissipated within 24 to 72 hours. In approximately 40% of the affected generalized demodicosis patients the effect dissipated in less than 24 hours. Sedation often was less apparent when additional MITABAN (amitraz) treatments were applied however in approximately 35% of the generalized demodicosis patients sleepiness was observed after each treatment. Transient pruritus which clinical investigators considered to be an indirect effect due to an inflammatory reaction associated with dead mites occurred in less than 3% of the generalized demodicosis patients. This effect usually occurred and dissipated within 24-48 hours post treatment. Other observations noted by the clinical investigators and/or clients were a low incidence (less than 1%) of convulsions ataxia hyper excitability personality change hypothermia appetite stimulation bloat polyuria vomition diarrhea anorexia edema erythema and other varying degrees of skin irritation. Three fatalities were recorded.

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