Medetomidine

Indications

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

Dosage and Administration

Placadine should be administered at the rate of 750 mcg IV or 1000 mcg IM per square meter of body surface. Use the table below to determine the correct dosage on the basis of body weight. Following injection of Placadine, the dog should be allowed to rest quietly for 15 minutes. TABLE

Contraindications

Placadine 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.

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 or www.modernveterinarytherapeutics.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae NOTE TO PHYSICIANS This product contains an α 2 -adrenergic agonist.

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 α 2 -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 Placadine. Allowing dogs to rest quietly for 10 to 15 minutes after injection may improve the response to Placadine. I n dogs not responding satisfactorily to treatment with Placadine, 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. Placadine is a potent α 2 -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 animals 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.

Adverse Reactions

As with all α 2 -agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists. Incidents of prolonged sedation, bradycardia, cyanosis, vomiting, apnea, death from circulatory failure with severe congestion of lungs, liver, kidney and recurrence of sedation after initial recovery have been reported. SIDE EFFECTS Bradycardia with occasional atrioventricular blocks will occur together with decreased respiratory rates. Body temperature is slightly or moderately decreased. Urination typically occurs during recovery at about 90 to 120 minutes posttreatment. In approximately 10% of treated dogs, occasional episodes of vomiting occur between 5 to 15 minutes posttreatment. An increase in blood glucose concentration is seen due to α 2 -adrenoreceptor-mediated inhibition of insulin secretion.

Description

Placadine (medetomidine hydrochloride) is a synthetic α 2 -adrenoreceptor agonist with sedative and analgesic properties. The chemical name is (±)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. It is a white, or almost white, crystalline, water soluble substance having a molecular weight of 236.7. The molecular formula is C 13 H 16 N 2 •HCl and the structural formula is: Each mL of Placadine contains 1.0 mg medetomidine hydrochloride, 1.0 mg methyl parahydroxybenzoate, 0.2 mg propylparahydroxybenzoate, 9.0 mg sodium chloride, up to 5.0 mg sodium hydroxide, up to 5.0 mg hydrochloric acid 0.1N, water for injection, q.s. structure

Storage

Store between 20°- 25°C (68°- 77°F) with excursion permitted between 15°- 30°C (59°- 86°F). Protect from freezing. Use within 28 days of the first puncture.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming medetomidine as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.