Medetomidine Hydrochloride Injection 1mg/ml

Medetomidine Hydrochloride is indicated for use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures with the exception of those requiring muscle relaxation, and minor dental procedures where intubation is not required, in dogs over 12 weeks of age. The IV route of administration is more efficacious for dental care.

Indications

For use as a sedative and analgesic in the restraint of dogs and cats.

Dogs: A sedative and analgesic for use in the restraint of dogs for clinical examinations and procedures, minor surgery and pre-anaesthesia./p>

Cats: A sedative for restraint.

Medetomidine Hydrochloride should be administered at the rate of 750 µg IV or 1,000 µg IM per square meter of body surface. See chart to the right.

Each mg of medetomidine contains 0.5mg of dexmedetomidine (active ingredient) and 0.5mg of levomedetomidine (inactive compound)

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Warnings:

Keep out of reach of children. Not for use in humans.Medetomidine hydrochloride can be absorbed and may cause irritation following direct exposure to skin, eyes, or mouth. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If irritation or other adverse reaction occurs (e.g., sedation, hypotension, bradycardia), seek medical attention.In case of accidental oral exposure or injection, seek medical attention.Precaution should be used while handling and using filled syringes.Users with cardiovascular disease (e.g., hypertension or ischemic heart disease) should take special precautions to avoid any exposure to this product.The safety data sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Modern Veterinary Therapeutics, LLC at 407-852-8039.For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth

Note to Physicians

This product contains an α₂-adrenergic agonist.

Contraindications

Medetomidine Hydrochloride should not be used in dogs with the following conditions: cardiac disease, respiratory disorders, liver or kidney diseases, dogs in shock, dogs which are severely debilitated, or dogs which are stressed due to extreme heat, cold or fatigue.

Precautions

In extremely nervous or excited dogs, levels of endogenous catecholamines are high due to the animal's state of agitation. The pharmacological response elicited by α₂-agonists (e.g., medetomidine) in such animals is often reduced, with depth and duration of sedative/analgesic effects ranging from slightly diminished to nonexistent. Highly agitated dogs should therefore be put at ease and allowed to rest quietly prior to receiving Med etomidine Hydrochloride. Allowing dogs to rest quietly for 10 to 15 minutes after injection may improve the response to Medetomidine Hydrochloride. In dogs not responding satisfactorily to treatment with Medetomidine Hydrochloride, repeat dosing is not recommended. Caution should be exercised when handling sedated animals. Handling or any other sudden stimuli may cause a defense reaction in an animal that is sedated. Medetomidine Hydrochloride is a potent α₂-agonist which should be used with caution with other sedative or analgesic drugs. Additive or synergistic effects are likely, possibly resulting in overdose. Although bradycardia may be partially prevented by prior (at least 5 minutes before) intravenous administration of an anticholinergic agent, the administration of anticholinergic agents to treat bradycardia either simultaneously with medetomidine or following sedation with medetomidine could lead to adverse cardiovascular effects. Special care is recommended when treating very young an imals and older animals. Information on the possible reproductive effects of medetomidine is limited; therefore, the drug is not recommended for use in dogs used for breeding purposes or in pregnant dogs.

Storage:

Storeat 20-25°C (68-77°F). Excursions between 15-30°C (59-86°F) are allowed. Protect from freezing. Use with in 28 days of the first puncture.