Description

XylaMed Injection

Xylazine hydrochloride 100 mg/mL Injection

Sedative and analgesic for use in horses and cervidae only

Approved by FDA

Mfd/Mktd by: Bimeda-MTC Animal Health Inc., USA

Dosage form: Liquid for injection

Presentation: 

50 mL multiple dose vials
Case size – 12

Ingredients & Composition:

Each mL contains 100 mg XylaMed (xylazine base equivalent); 0.9 mg methylparaben; 0.1 mg propylparaben; water for injection; citric acid, and sodium citrate for pH adjustment to 5.5±0.3.

Active Ingredients:
Xylazine hydrochloride  11.7%
(Equivalent to 10% base)
Inert Ingredients:                          88.3%

Description / Action: 

XylaMed injection contains xylazine hydrochloride a non-narcotic compound. It has sedative and analgesic as well as muscle relaxant properties. Its analgesic and sedative activities are related to CNS (central nervous system) depression.

Pharmacology:

Xylazine has muscle-relaxation property which is based upon inhibition of the intraneural transmission of impulses in the CNS and in horses it develops within 3 to 5 minutes following intravenous administration and within 10 to 15 minutes after intramuscular injection.

Depth of sleep like state is dose-dependent. Usually sleep state is maintained for 1 to 2 hours, while analgesia induced lasts from 15 to 30 minutes. The centrally acting muscle relaxant effect complements sedation and analgesia due to relaxation of the skeletal musculature.

In equines and Cervidae respiratory rate is reduced as in natural sleep under the influence of xylazine. Following treatment, the heart rate is decreased. A transient change in the cardiac muscle conductivity may occur which is evidenced by a partial AV Block (atrioventricular block). This resembles the AV block often observed in normal horses. Although a partial A-V block may occasionally occur following intramuscular injection, the incidence is less than when it is administered intravenously. In equines transient rise in blood pressure followed by a slight decrease is seen after Intravenous administration.

Xylazine does not affect blood clotting time and other haematological parameters.

Class: Sedative / Anaesthetic (Alpha-2 adrenoreceptor antagonist)

Indication / Uses:

XylaMed is indicated to produce a state of sedation accompanied by a shorter period of analgesia in

• • Horses
  • Cervidae (Fallow Deer, Mule Deer, Sika Deer, White-Tailed Deer, and Elk)

Horses:

It has been used successfully as follows:

1. 1. Diagnostic procedures-oral and opthalmic examinations, vaginal examination, rectal palpation, abdominal palpation, radiographic examinations and catheterization of the bladder.
   2. Orthopedic procedures (application of casting materials and splints).
   3. Dental procedures.
   4. Minor surgical procedures of short duration (removal of cutaneous neoplasms, debridement of dead tissue and suturing of minor lacerations).
   5. To calm and facilitate handling of aggressive /fractious equines. It also reduces physical stress and risk to both animal and practitioner.
   6. For sedation and relief of pain following an injury or surgery (therapeutic).
   7. Major surgical procedures when used:
   8. As a preanesthetic to general anesthesia.
   9. In conjunction with local anaesthetics.

Cervidae:

It may be used for the following:

1. 1. To calm and facilitate handling of aggressive or fractious animals.
   2. Diagnostic procedures.
   3. Minor surgical procedures.
   4. For sedation and relief of pain following injury or surgery (therapeutic medication).
   5. As a preanesthetic to local anesthesia.

At the recommended dosages xylazine hydrochloride can be used in conjunction with local anaesthetics, such as lignocaine, procaine or lidocaine during major surgical procedures.

Dosage & administration:

Route: Intravenous or intramuscular

Horses:

1. 1. Dosage:

Intravenously-0.5 mL/100 lbs body weight (0.5 mg/lb)

Intramuscularly-1.0 mL/100 lbs body weight (1.0 mg/lb)

After administration until the full effect, the animal should be allowed to rest quietly. This sedation is usually maintained for 1 to 2 hours, and analgesia which lasts for 15 to 30 minutes.

1. 2. Preanesthetic to Local Anesthesia:

Xylazine can be used at the recommended dosages in conjunction with local anesthetics, such as lignocaine, procaine or lidocaine.

1. 3. Preanesthetic to General Anesthesia:

At the recommended dosage xylazine produces an additive effect to central nervous system depressants like pentobarbital sodium, thiopental sodium and thiamylal sodium and the dosage of such compounds should be reduced and administered to the desired effect. In combination or sedation with xylazine, only 1/3 to 1/2 of the calculated dosage of the barbiturates will be needed to produce a surgical plane of anesthesia. Post-anesthetic or emergence excitement has not been observed in animals preanesthetized with XylaMed.

It has been used successfully as a preanesthetic agent for variety of anaesthetic agents like thiopental sodium, pentobarbital sodium, thiamylal sodium, ether, nitrous oxide, glyceryl guaiacolate, halothane, and methoxyflurane.

Cervidae:

Administer intramuscularly

Can be administered by either hand syringe or syringe dart, in the heavy muscles of the croup or shoulder.

Dosage Range:

Fallow Deer (Dama dama)-2.0 to 4.0 mL/100 lbs b.wt. (2.0 to 4.0 mg/lb).

Mule Deer (Odocoileus hemionus)-1.0 to 2.0 mL/100 lbs b.wt. (1.0 to 2.0 mg/lb).

Sika Deer (Cervus nippon)-1.0 to 2.0 mL/100 lbs b.wt. (1.0 to 2.0 mg/lb).

White-Tailed Deer (Odocoileus virginianus)-1.0 to 2.0 mL/100 lbs b.wt. (1.0 to 2.0 mg/lb).

Elk (Cervus canadensis)-0.25 to 0.5 mL/100 lbs b.wt. (0.25 to 0.5 mg/lb).

Following injection until the full effect has been reached the animal should be allowed to rest quietly.

These dosages produce sedation which is usually maintained for 1 to 2 hours and analgesia which lasts for 15 to 30 minutes.

Side-Effects:

Slight muscle tremors, bradycardia with partial A-V heart block and a reduced respiratory rate are occasionally observed with recommended dosage with XylaMed, in both horses and Cervidae. Movement in response to loud /sharp voice stimuli may be observed. Sweating (rarely profuse) has been also been reported in horses following administration. In Cervidae, various vocalizations (groaning, bellowing, grunting, bleating, snoring) on expiration, salivation, protruding tongue, audible grinding of molar teeth, and hyperthermia have also been noted in some cases.

Precautions /Contraindications:

Care should be taken before administration to horses or Cervidae already having advanced liver or kidney disease, significant respiratory depression, severe endotoxic or traumatic shock, severe pathologic heart disease, or stress conditions such as extreme cold, heat, high altitude or fatigue.

Do not use XylaMed along with with tranquilizers.

Depth of analgesia should be carefully assayed prior to surgical/clinical procedures because analgesic effect is variable. In both horses and Cervidae variability of analgesia occurs most frequently at the distal extremities. The practitioners and handlers must proceed with utmost caution in sedated horses and cervidae since defence reactions may not be diminished.

Horses:

Since an additive effect results from the use of XylaMed and the barbiturate compounds, it should be used with caution with these central nervous system depressants. Products such as thiamylal sodium which are known to produce respiratory depression or apnea, should be given at a reduced dosage when injected intravenously and should be administered slowly. Avoid perivascular injection during intravenous administration in order to achieve the desired effect. Negligible evidence of tissue irritation following perivascular injection of xylazine has been reported during studies.

Intracarotid Arterial Injection Should Be Avoided. Inadvertent administration of tranquilizers into carotid artery may result into immediate violent seizures followed by collapse. Although the reaction with XylaMed is usually transient and recovery may be rapid and complete but special care should be taken to assure that the needle is in the jugular vein rather than the carotid artery.

Following xylazine administration arrhythmia and Bradycardia in the form of incomplete AV block have been reported. Atropine given at standard dose prior to or following xylazine will greatly decrease the incidence of arrythmia and bradycardia.

Sedation for transport is most successful if actual transportation is begun after the full effect of the drug has been reached and the animal’s stability is maintained while standing. In addition, it should be noted that animals under the influence of XylaMed can be aroused by noise or other stimuli and this may increase the risk of injury.

Cervidae:

Preferably administer XylaMed to fasted Cervidae like all other ruminants. Administer in fasted animals is as a safeguard against aspiration of food material into the lungs and/or bloat during deep sedation.

Care should be taken to administer XylaMed in the heavy muscles of the croup or shoulder. Inadvertent subcutaneous, intraperitoneal or fat deposits/ administration will give unpredictable results.

Intra-arterial injection should be avoided. Inadvertent arterial administration may result into immediate violent seizures followed by collapse.

Keep the animal quiet without disturbing during induction or until the full effect of xylazine has been reached. It is usually 10 to 15 minutes following injection. The usual time to initial effect is 2 to 5 minutes. The administrator of the drug should be fully cognizant of this interval prior to administration of drug to free-ranging deer or elk, especially at night or in heavily wooded areas.

In case of the underdosing (faulty injection or miscalculation of weight) it is advisable to wait one hour before administering the second dose.

Adequate ventilation, especially in cages or crates, is mandatory, keep head and neck in position to ensure patent air passage and to prevent aspiration of stomach contents.

A sternal recumbent position is desirable. Animals should be prevented from assuming lateral recumbency during sedation and Efforts should be made to prevent from rising until complete recovery. Animals should also be protected from exposure to an extremely hot or cold environment.

The transportation should be carefully monitored in sedated cervidae in order to prevent injury, excessive struggling, or death.

Hyperthermia may occur, especially if the animals is highly excited / aggressive when the drug is being administered. Hosing the head and entire body with cold water has usually proven to be an effective deterrent.

The safety of XylaMed has not been demonstrated in pregnant Cervidae. Avoid use during the breeding season.

Care should be taken at all times and Cervidae should be observed closely after administration until all of the sedative effects of XylaMed are gone. Because usually darting is the method of administration and the difficulty in estimating body weights and the accepted theory that wild animals are more unpredictable in their response to sedatives and analgesics than the domesticated species.

Safety and Warnings:

Do not use less than 15 days before, or during the hunting season in Cervidae.

XylaMed is tolerated at 10 times the recommended dose in horses, and at doses above the recommended range in Cervidae. However, sometimes elevated dosages produce muscle tremors and long periods of sedation.

Xylazine should not be administered to horses intended for food and domestic food-producing animals.

Avoid accidental administration to humans. Should such exposure occur, notify a physician immediately. Artificial respiration may be indicated.

In Cervidae, occasional capture-associated deaths occur. Clinical trials reveal a mortality rate of approximately 3.5%.

Pharmaceutical precautions / Instructions: 

Store at 20°C -25°C (68° to 77°F) Do not freeze. Not for use in humans. Keep out of reach of children. US Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Substitute: Inj. Rompun, Inj. AnaSed, Inj. Xylo-B, Inj. Xylazin, Inj. Virbaxyl (Concentration varies)