Animal NDC 69043-043-05 Xylazine
Animal Product Information
Xylazine Images
Xylazine Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Description:
Xylazine is an alpha2-adrenoreceptor agonist with sedative properties. The chemical name for Xylazine is 2-(2,6-dimethylphenylamino)-4H-5,6-dihydro-1,3-thiazine. The formula for the hydrochloride salt is C12H16N2S.HCl. Xylazine Injection is a clear, colorless solution. Each mL of sterile Xylazine Injection contains xylazine HCl equivalent to 100 mg xylazine base; 0.9 mg methylparaben and 0.1 mg propylparaben as preservatives; 6.12 mg sodium citrate dihydrate; water for injection, q.s. hydrochloric acid and/or sodium citrate dihydrate may also be used as necessary to adjust the pH.
Warnings:User Safety Warnings
Not for use in humans. Keep out of reach of children.
Avoid skin, eye or mucosal contact. Use caution while handling and using filled syringes.
Absorption of the active ingredients is possible following exposure via the skin, eye or mucosa. In case of accidental eye exposure, flush eyes with water for 15 minutes, remove contact lenses then continue to flush. In case of accidental skin exposure, wash with soap and water and remove contaminated clothing. If symptoms occur, seek the advice of a physician.
In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician. DO NOT DRIVE as sedation, loss of consciousness, and changes in blood pressure may occur.
Persons with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid any exposure to this product.
Pregnant women should exercise special caution to avoid exposure. Uterine contractions and decreased fetal blood pressure may occur after accidental systemic exposure.
Persons with known hypersensitivity to any of the ingredients should avoid contact with xylazine injection.
Caution should be exercised when handling sedated animals. Handling or any other sudden stimuli, including noise, may cause a defense reaction in an animal that appears to be heavily sedated.
Animal Safety Warnings
Intracarotid arterial injection should be avoided. As with many drugs, including tranquilizers, immediate and violent seizures followed by collapse may result from inadvertent administration into the carotid artery. Although the reaction with Xylazine Injection is usually transient and the recovery rapid and complete, special care should be taken to assure that the needle is in the jugular vein rather than the carotid artery.
Other Warnings
Do not use in horses intended for human consumption.
Precautions:
Debilitated horses with depressed respiration, cardiac disease, renal or liver impairment, shock or any other stress conditions should be carefully monitored whenever Xylazine Injection is administered.
Xylazine Injection produces an additive effect to central nervous system depressants and caution should be taken when administering barbiturate compounds in conjunction with Xylazine Injection. Barbiturates should be administered at a reduced dosage and to the desired effect, and when injected intravenously should be given slowly.
Arrhythmias resulting in partial atrioventricular (AV) blocks and bradycardia are transient changes which may occur, but that can be counteracted to a large degree by the administration of atropine prior to or following Xylazine Injection.
Analgesic effect is variable and depth should be carefully determined prior to surgical or clinical procedures. Variability of analgesia occurs most frequently at the distal extremities of horses. In spite of sedation, the practitioner should proceed with caution since defense reactions may not be diminished.
Horses under the influence of Xylazine Injection are particularly sensitive to noise and care should be taken accordingly to avoid risk of injury. Sedation for transport is most successful if actual transport is initiated after full effect of the drug has been obtained and the horse’s stability maintained in the standing position.
Package Label.Principal Display Panel
NDC 69043-043-05
Xylazine Injection
(100 mg/mL)
Sedative
For intravenous (IV) or intramuscular (IM) use in horses only
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Approved by FDA under NADA # 140-442
Net contents: 50 mL
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