Xylased 100 (Canada)

Company: Modern Veterinary Therapeutics

Xylazine Injection, Mfr. Std.

100 mg/mL

Veterinary Use Only

Sedative and analgesic for use in Horses Only

DIN 02545063

Sterile

Description

Xylased 100™ (Xylazine Injection) is a clear, colourless solution for intravenous or intramuscular administration supplied in 10 mL and 50 mL multiple-dose vials as a sterile solution. Each mL contains 100 mg xylazine (as xylazine hydrochloride).

Active Ingredient

Xylazine (as xylazine hydrochloride) 100 mg/mL

PRESERVATIVE: Methyl parahydroxybenzoate 1 mg/mL

THERAPEUTIC CLASSIFICATION: Alpha-2 agonist

Xylased 100 Indications

Xylased 100 should be used in horses when it is desirable to produce a state of sedation accompanied by a shorter period of analgesia. Xylazine has been used successfully as follows:

1. Diagnostic procedures - oral and ophthalmic examinations, abdominal palpation, rectal palpation, vaginal examination, catheterization of the bladder and radiographic examinations.

2. Orthopedic procedures, such as application of casting materials and splints.

3. Dental procedures.

4. Minor surgical procedures of short duration such as debridement, removal of cutaneous neoplasms and suturing of lacerations.

5. To calm and facilitate handling of fractious animals.

6. Therapeutic medication for sedation and relief of pain following injury or surgery.

7. Major surgical procedures:

a. When used as a preanesthetic to general anesthesia.

b. When used in conjunction with local anesthetics.

DOSAGE AND ADMINISTRATION

1. Intravenously - 0.5 mL/45 kg body weight (Equivalent to 1.1 mg/kg or 0.5 mg/lb).

Intramuscularly - 1.0 mL/45 kg body weight (Equivalent to 2.2 mg/kg or 1.0 mg/lb).

Following injection of Xylased 100, the animal should be allowed to rest quietly until the full effect has been reached. These dosages produce sedation which is usually maintained for 1 to 2 hours and analgesia which lasts for 15 to 30 minutes.

2. Preanesthetic to Local Anesthesia: Xylased 100 at the recommended dosages can be used in conjunction with local anesthetics such as procaine or lidocaine.

3. Preanesthetic to General Anesthesia: Xylased 100, at the recommended dosage rates, produces an additive effect to central nervous system depressants such as pentobarbital sodium, thiopental sodium and thiamylal sodium. Therefore, the dosage of such compounds should be reduced and administered to the desired effect. In general, 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 xylazine. Xylazine has been used successfully as a preanesthetic agent for pentobarbital sodium, thiopental sodium, thiamylal sodium, nitrous oxide, ether, halothane, and methoxyflurane anesthesia.

Contraindications

Do not use Xylased 100 in conjunction with tranquilizers.

Xylased 100 Cautions

Careful consideration should be given before administering to horses with significantly depressed respiration, severe pathologic heart disease, advanced liver or kidney disease, severe endotoxic or traumatic shock.

Since an additive effect results from the use of xylazine and the barbiturate compounds, it should be used with caution with these central nervous system depressants. Products known to produce respiratory depression or apnea, such as thiamylal sodium, should be given at a reduced dosage and, when injected intravenously, should be administered SLOWLY.

When intravenous administration is desired, avoid perivascular injection in order to achieve the desired effect. Intracarotid arterial injection should be avoided. As with many compounds, including tranquilizers, immediate violent seizures followed by collapse may result from inadvertent administration into the carotid artery. Although the reaction with xylazine is usually transient and recovery may be rapid and complete, special care should be taken to assure that the needle is in the jugular vein rather than the carotid artery.

Bradycardia and an arrhythmia in the form of incomplete atrioventricular block have been reported following xylazine administration. Although clinically the importance of this effect is questioned, a standard dose of atropine given prior to or following Xylased 100 will greatly decrease the incidence.

Following the use of Xylased 100, veterinarians and attendants should continue to use care and appropriate animal handling techniques, since conscious animals, although sedated, are capable of inflicting personal injury.

Warnings

This drug is for use in horses only.

This drug is not to be administered to horses that are to be slaughtered for use in food.

Xylazine is an alpha2-adrenergic agonist with sedative, some analgesic and muscle relaxant properties. Symptoms after absorption may include dose-dependent respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycemia. Ventricular arrhythmias have also been reported.

Do not eat, drink or smoke while handling the product. Strictly avoid self-injection, oral intake and any contact with skin, eyes or mucosa. In the case of accidental contact, wash exposed skin or eyes abundantly with water. If symptoms occur, seek medical advice. In the case of accidental oral intake or self-injection, seek the advice of a physician and show the package insert but DO NOT DRIVE.

If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased fetal blood pressure may occur after accidental systemic exposure.

Dispose the unused drug or waste materials in accordance with the provincial/municipal guidelines.

Keep out of reach of children.

Adverse Reactions

Xylased 100 used at recommended dosage levels may occasionally cause slight muscle tremors, bradycardia with partial A-V heart block and a reduced respiratory rate. Movement in response to sharp auditory stimuli may be observed.

Following repeated intramuscular injection at the same site, a swelling may occur and such swelling may persist for several weeks.

To report adverse drug events or for technical assistance, contact Modern Veterinary Therapeutics LLC at 1-888-590-9839.

Scientific Information

The chemical name is N-(2,6-Dimethylphenyl)-5,6-dihydro-4H-1,3-thiazin-2-amine hydrochloride.

Chemical Formula: C₁₂H₁₇ClN₂S. Molecular weight: 256.8 g/moL.

Chemical Structure: